0001437749-23-005703 | 10-K | XBRL Viewer

Subsequent Events [Text Block]

R.	Subsequent Events

The Company evaluated events and transactions occurring subsequent to December 31, 2022, through March 7, 2023, the date the accompanying financial statements were issued. During this period, there were no subsequent events, other than the debt activity discussed in Note G, the adoption of the 2023 Plan discussed in Note K, and the significant events disclosed in Note Q, that required recognition in the accompanying consolidated financial statements nor were there any additional nonrecognized subsequent events that required disclosure.

Note H - Commitments and Contingencies

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Text Block]

H.	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 is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not 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. As of December 31, 2022, and 2021, no accruals have been made related to commitments and contingencies.

Note D - Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2022

Other Current Assets [Text Block]

D.	Prepaid Expenses and Other Current Assets

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

	*December 31,*
	*2022*		*2021*
Prepaid insurance	$	577	$	637
Prepaid offering costs		-		293
Other prepaid expenses and current assets		1,300		252
Total prepaid expenses and other current assets	$	1,877	$	1,182

Note M - Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Net operating loss carryforwards	$ 66,373	$ 60,977
Deferred Tax Assets, Tax Credit Carryforwards, Research	6,900	6,411
Stock-based compensation	4,185	4,807
174 expenses	3,730	0
Right-of-use liability	359	424
Property and equipment	(22)	(14)
Other deferred tax assets	598	288
Total gross deferred tax assets	82,167	72,921
Right-of-use asset	(336)	(401)
Other deferred tax liabilities	0	(9)
Total gross deferred tax liabilities	(336)	(410)
Deferred tax assets less liabilities	81,831	72,511
Valuation allowance	(81,831)	(72,511)
Net deferred tax asset (liability)	$ 0	$ 0

Note F - Accounts Payable and Accrued Expenses

12 Months Ended

Dec. 31, 2022

Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block]

F.	Accounts Payable and Accrued Expenses

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

	*December 31,*
	*2022*		*2021*
Accrued banking fees		-		700
Accrued payroll		1,673		1,054
Accrued professional fees		256		259
Accounts payable		3,611		516
Other accrued expenses		629		509
Total accounts payable and accrued expenses	$	6,169	$	3,038

Note K - Stock-based Compensation - Information Regarding Currently Outstanding and Exercisable Options (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Options outstanding, number of shares (in shares)	2,456,407	1,273,879
Outstanding, weighted average remaining contractual term (Year)	8 years 6 months 3 days	8 years 8 months 23 days
Exercisable, number of options (in shares)	615,001
Exercisable, weighted average remaining contractual term (Year)	6 years 11 months 26 days
Exercise Price Range One [Member]
Lower range (in dollars per share)	$ 2.848
Upper range (in dollars per share)	$ 10.00
Options outstanding, number of shares (in shares)	2,175,436
Outstanding, weighted average remaining contractual term (Year)	8 years 10 months 24 days
Exercisable, number of options (in shares)	351,151
Exercisable, weighted average remaining contractual term (Year)	8 years 2 months 8 days
Exercise Price Range Two [Member]
Lower range (in dollars per share)	$ 10.01
Upper range (in dollars per share)	$ 30.00
Options outstanding, number of shares (in shares)	69,375
Outstanding, weighted average remaining contractual term (Year)	8 years 2 months 1 day
Exercisable, number of options (in shares)	69,375
Exercisable, weighted average remaining contractual term (Year)	8 years 2 months 1 day
Exercise Price Range Three [Member]
Lower range (in dollars per share)	$ 30.01
Upper range (in dollars per share)	$ 50.00
Options outstanding, number of shares (in shares)	68,514
Outstanding, weighted average remaining contractual term (Year)	6 years 1 month 9 days
Exercisable, number of options (in shares)	51,393
Exercisable, weighted average remaining contractual term (Year)	6 years 1 month 9 days
Exercise Price Range Four [Member]
Lower range (in dollars per share)	$ 50.01
Upper range (in dollars per share)	$ 70.00
Options outstanding, number of shares (in shares)	41,866
Outstanding, weighted average remaining contractual term (Year)	4 years 29 days
Exercisable, number of options (in shares)	41,866
Exercisable, weighted average remaining contractual term (Year)	4 years 29 days
Exercise Price Range Five [Member]
Lower range (in dollars per share)	$ 70.01
Upper range (in dollars per share)	$ 327.20
Options outstanding, number of shares (in shares)	101,216
Outstanding, weighted average remaining contractual term (Year)	3 years 8 months 12 days
Exercisable, number of options (in shares)	101,216
Exercisable, weighted average remaining contractual term (Year)	3 years 8 months 12 days

Significant Accounting Policies (Policies)	12 Months Ended
Significant Accounting Policies (Policies)	Dec. 31, 2022
Accounting Policies [Abstract]
Use of Estimates, Policy [Policy Text Block]	*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 long-term investments, 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 Risk, Credit Risk, Policy [Policy Text Block]	*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, Policy [Policy Text Block]	*Cash and Cash Equivalents* The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents.
Investment, Policy [Policy Text Block]	*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 ASC 825, 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, 2022, and 2021, the Company held securities with an aggregate fair value of $16.9 million and $14.9 million, respectively, that contained aggregate unrealized losses of approximately $577,000 and $13,000, respectively. 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. In addition, the Company holds certificates of deposit totaling $20.5 million and $0.5 million as of December 31, 2022, and 2021, respectively, and are included in long-term investments - other in the consolidated balance sheets. 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.
Property, Plant and Equipment, Policy [Policy Text Block]	*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 to ten 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.
Debt, Policy [Policy Text Block]	*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. In the first quarter of 2021, all outstanding debt was extinguished through a series of debt payments and a conversion of debt principal and interest to Series B-2 Preferred Stock (Note G). As a result of the debt extinguishment, the associated discount and debt issuance costs were written off and recorded as a loss on extinguishment.
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]	*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, 2022 , or 2021 .
Revenue from Contract with Customer [Policy Text Block]	Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”) and, as a result, follows the five-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; and 5) recognizing revenue when the performance obligations have been fulfilled. Arimoclomol Early Access Program Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under the remunerated early access compassionate use program in France (“French nATU”). An early access compassionate use program is a program giving specific patients access to a drug, which is not yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currently no appropriate treatment are considered for early access compassionate use programs. Further, to be considered for the early 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 ASC 606, the Company recognizes revenue when fulfilling its performance obligation under the Arimoclomol Early 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. Under the French nATU, the manufacturer can set its own price for the drug products until a price agreement with the authorities is in place. 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, which 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 marketing approval. 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 year ended December 31, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $4.8 million, which is net of a clawback liability of $3.8 million. As part of the Arimoclomol Purchase Agreement the Company assumed an estimated reserve liability of $5.2 million related to revenue generated from the Arimoclomol EAP in France. The total estimate reserve liability as of December 31, 2022, including the additional clawback liability for the year ended December 31, 2022, was $9.0 million. As of December 31, 2022, this estimated reserve liability is recorded as discount and rebate liabilities in the consolidated balance sheet and is separated into current and long-term based upon the timing of the expected payment to the French regulators. Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one 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 would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not 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. *AZSTARYS License Agreement* In September 2019, the Company entered into a Collaboration and License Agreement (the "AZSTARYS License Agreement") with Commave Therapeutics SA (“Commave”), an affiliate of GPC. Under the AZSTARYS License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-methylphenidate (“d-MPH”), including AZSTARYS, or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder. Corium was tasked by Commave, to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Corium agreed to pay milestone payments 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. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product. In April 2021, the Company entered into Amendment No. 1 to the AZSTARYS License Agreement (the "AZSTARYS Amendment"). Pursuant to the AZSTARYS Amendment, the Company and Commave agreed to modify the compensation terms of the AZSTARYS License Agreement. Pursuant to the AZSTARYS Amendment, Commave paid the Company $10.0 million in connection with the entry into the AZSTARYS Amendment as a result of the regulatory approval of AZSTARYS in the United States, which occurred on March 2, 2021. Commave also paid the Company $10.0 million following the receipt of the scheduling determination of the compound SDX by the U.S. Drug Enforcement Agency ("DEA"), which occurred on May 7, 2021. In addition, the AZSTARYS Amendment increased the total remaining future regulatory and sales milestone payments related to AZSTARYS up to an aggregate of $590.0 million in payments upon the occurrence of specified regulatory milestones related to AZSTARYS and upon the achievement of specified U.S. net sales milestones. Commave also agreed to be responsible for and reimburse the Company for all of the development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the AZSTARYS License Agreement. As part of this agreement, the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics, Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to AZSTARYS, KP879 or KP1077 under the AZSTARYS License Agreement. The AZSTARYS License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations at inception. The Company further determined that the transaction price, at inception, under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the AZSTARYS License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price. The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type of transaction. The Company determined that the intellectual property licensed under the AZSTARYS License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the AZSTARYS License Agreement. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and the achievement of certain U.S. sales milestones. Further, Commave will pay the Company quarterly, tiered royalty payments based on a range of percentages of Net Sales (as defined in the AZSTARYS License Agreement). 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 are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not 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 years ended December 31, 2022, and 2021, the Company recognized revenue under the AZSTARYS License Agreement of $0.9 million and $20.9 million, respectively. There was no deferred revenue related to this agreement as of December 31, 2022, and 2021. Consulting Arrangements The Company enters into consulting arrangements with third parties that fall under the scope of ASC 606. These arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization support services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket third-party research and development, regulatory and commercial costs. Corium Consulting Agreement In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of AZSTARYS (together, “Corium Consulting Services”). Corium is a portfolio company of GPC and was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement, as discussed above. Under the Corium Consulting Agreement, the Company is entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which was paid in quarterly installments through March 31, 2022. The remaining $2.0 million was conditioned upon the approval by the FDA of the NDA for Corium's product candidate, ADLARITY. This $2.0 million was earned in the first quarter of 2022. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services. The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. The Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass-through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of December 31, 2022, the Company has recognized approximately all of the consulting services and third-party pass-through costs under the Corium Consulting Agreement. For the years ended December 31, 2022, and 2021, the Company recognized revenue under the Corium Consulting Agreement of $4.7 million and $7.7 million, respectively. As of December 31, 2022, the Company had no deferred revenue related to this agreement. As of December 31, 2021, the Company had deferred revenue related to this agreement of $0.4 million. Other Consulting Arrangements For the years ended December 31, 2022, and 2021, the Company recognized revenue under other consulting arrangements of $0.1 million and $0.1 million, respectively. There was no deferred revenue from other consulting arrangements as of December 31, 2022, or 2021.
Receivable [Policy Text Block]	Accounts and Other Receivables Accounts and other receivables consist of receivables under the AZSTARYS License Agreement and Arimoclomol EAP, as well as receivables related to consulting arrangements, 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 reimbursable third-party costs and royalties on product sales. Receivables under the Arimoclomol EAP are recorded for product sales under the French nATU. These receivables, as well as the receivables related to consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date.
Inventory, Policy [Policy Text Block]	*Inventory* As discussed in Note A, a portion of the purchase price was allocated to inventory acquired representing the value of inventory associated with forecasted EAP revenues and as of December 31, 2022, the Company had inventory of $0.7 million remaining. Inventories are stated at net realizable value using the first-in, first-out method of valuation. The Company may scale-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 may not be approved for marketing on a timely basis, or ever. This risk notwithstanding, the Company may scale-up and build pre-launch inventory of product that have not received final regulatory approval when the Company believes such action is appropriate in relation to the commercial value of the product launch opportunity. Inventory manufactured prior to regulatory approval is recorded as research and development expense until regulatory approval for the product is obtained. As of December 31, 2022, and 2021, the Company did not have pre-launch inventory that qualified for capitalization.
Research and Development Expense, Policy [Policy Text Block]	*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, clinical 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 with third-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 has not 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.
Intangible Assets, Finite-Lived, Policy [Policy Text Block]	*Patent Costs* Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations.
Income Tax, Policy [Policy Text Block]	*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 than not to be realized. Uncertain tax positions are recognized only when the Company believes it is more likely than not 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 did not have any accrued interest or penalties associated with uncertain tax positions as of December 31, 2022 and 2021. The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2015, although carryforward attributes that were generated prior to 2017 may still 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 year 2018” ("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 has not 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.
Share-Based Payment Arrangement [Policy Text Block]	*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") subtopic 505-50. The Company values equity instruments and stock options granted using the Black-Scholes option pricing model.
Earnings Per Share, Policy [Policy Text Block]	*Basic and Diluted Net Loss per Share of Common Stock* The Company uses the two-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. The two-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 Reporting, Policy [Policy Text Block]	*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 assets in both the United States and Europe as of December 31, 2022 and 2021.
Foreign Currency Transactions and Translations Policy [Policy Text Block]	*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.
New Accounting Pronouncements, Policy [Policy Text Block]	**Application of New or Revised Accounting Standards—Adopted** From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In August 2020, the FASB issued Accounting Standards Update (“ASU”) No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40); Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which addresses issues identified as a result of the complexities associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This update addresses, among other things, the number of accounting models for convertible debt instruments and convertible preferred stock, targeted improvements to the disclosures for convertible instruments and earnings-per-share (“EPS”) guidance and amendments to the guidance for the derivatives scope exception for contracts in an entity’s own equity, as well as the related EPS guidance. This update applies to all entities that issue convertible instruments and/or contracts in an entity’s own equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2020-06 did not have a material impact on the Company’s consolidated financial statements and disclosures. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40); Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the FASB Emerging Issues Task Force (“ASU 2021-04”), which aims to clarify and reduce diversity in issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. This update applies to all entities that issue freestanding written call options that are classified in equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2021-04 did not have a material impact on the Company’s consolidated financial statements and disclosures.

Note G - Debt Obligations (Details Textual) - USD ($) $ in Millions											12 Months Ended
	Jan. 31, 2023	Jan. 26, 2023	May 31, 2022	Feb. 08, 2021	Jan. 12, 2021	Jan. 01, 2021	Apr. 23, 2020	Jan. 13, 2020	Dec. 18, 2019	Jun. 02, 2014	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Jun. 30, 2016	Feb. 09, 2016
Certificates of Deposit, at Carrying Value											$ 20.5	$ 0.5
Wells Fargo Bank, N.A. [Member] \| Subsequent Event [Member]
Debt Instrument, Face Amount		$ 12.8
Wells Fargo Bank, N.A. [Member] \| Prime Rate [Member] \| Subsequent Event [Member]
Debt Instrument, Basis Spread on Variable Rate		2.25%
December 2020 Exchange Agreement [Member]
Debt Conversion, Original Debt, Amount					$ 31.5
Debt Conversion, Converted Instrument, Shares Issued (in shares)					31,476.98412
Debt Conversion, Converted Instrument, Warrants or Options Issued (in shares)					3,632,019
2021 Notes [Member]
Debt Instrument, Face Amount															$ 86.3
Debt Instrument, Interest Rate, Stated Percentage															5.50%
Debt Instrument, Cancellation of Debt, Amount								$ 3.0	$ 71.4
The 2019 Notes [Member]
Debt Instrument, Face Amount									$ 71.4
Debt Instrument, Interest Rate, Stated Percentage									6.75%
January 2020 Note [Member]
Debt Instrument, Face Amount								$ 3.0
The December 2020 Exchange Agreement [Member]
Repayments of Debt						$ 30.3
The December 2019 and January 2020 Notes [Member]
Long-term Debt, Gross													$ 60.8
Deerfield Facility Agreement [Member]
Long-term Debt, Gross													$ 7.5
The Facility Notes [Member]
Debt Instrument, Interest Rate, Stated Percentage					6.75%
Long-term Debt, Total					$ 7.6
Repayments of Long-term Debt, Total					$ 30.3
Paycheck Protection Program CARES Act [Member]
Proceeds from Issuance of Long-term Debt, Total							$ 0.8
Deerfield Facility Agreement [Member]
Line of Credit Facility, Maximum Borrowing Capacity										$ 60.0
Line of Credit Facility, Interest Rate at Period End										9.75%				6.75%
Repayments of Long-term Debt, Total				$ 8.0
Deerfield Facility Agreement [Member] \| Series D Redeemable Convertible Preferred Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)										14,423,076
Deerfield Facility Agreement [Member] \| Term Notes [Member]
Proceeds from Secured Notes Payable										$ 15.0
Deerfield Facility Agreement [Member] \| Deerfield Convertible Notes [Member]
Proceeds from Secured Notes Payable										$ 10.0
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)													120,192
Revolving Credit Facility [Member] \| Ameris Bank [Member]
Line of Credit Facility, Maximum Borrowing Capacity			$ 20.0								20.0
Proceeds from Lines of Credit, Total											12.8
Certificates of Deposit, at Carrying Value											12.8
Line of Credit Facility, Remaining Borrowing Capacity											$ 7.2
Revolving Credit Facility [Member] \| Ameris Bank [Member] \| Subsequent Event [Member]
Repayments of Lines of Credit	$ 12.8
Revolving Credit Facility [Member] \| Ameris Bank [Member] \| Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member]
Debt Instrument, Basis Spread on Variable Rate			1.60%
Debt Instrument, SOFR Floor on Basis Spread of Variable Rate			0.00%

Note N - Net Loss Per Share

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Text Block]

N.	Net Loss Per Share

For all periods presented herein, the Company did not use the two-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 are not obligated to participate in a loss. The two-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 the two-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 have no obligation to fund losses. Diluted net income attributable to common stockholders per share of common stock is computed under the two-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 the two 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 did not utilize the two-class approach as the Company was in a net loss position and the holders of the participating securities have no 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 period 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,*
	*2022*		*2021*
Awards under equity incentive plans		2,456,407		1,273,879
Common stock warrants		4,252,600		4,221,350
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		6,709,007		5,495,229

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, 2022, and 2021, is as follows (in thousands):

	*December 31,*
	*2022*			*2021*
Basic and diluted net loss per share of common stock:

Net loss	$	(41,543	)	$	(8,555	)
Less: Dividends declared or accumulated		-			(54,342	)
Net loss attributable to common stockholders	$	(41,543	)	$	(62,897	)
Less: Net loss attributable to participating securities	$	-		$	-
Undistributed net loss attributable to shares of common stockholders, basic and diluted	$	(41,543	)	$	(62,897	)
Weighted average number of shares of common stock outstanding, basic and diluted		34,489			29,766
Basic and diluted net loss attributable to common stockholders per share of common stock	$	(1.20	)	$	(2.11	)

Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Underwritten Public Offering [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	Underwritten Public Offering [Member] Common Stock [Member]	Underwritten Public Offering [Member] Additional Paid-in Capital [Member]	Underwritten Public Offering [Member] Treasury Stock [Member]	Underwritten Public Offering [Member] Retained Earnings [Member]	Underwritten Public Offering [Member]	January 2021 Inducement Warrants [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	January 2021 Inducement Warrants [Member] Common Stock [Member]	January 2021 Inducement Warrants [Member] Additional Paid-in Capital [Member]	January 2021 Inducement Warrants [Member] Treasury Stock [Member]	January 2021 Inducement Warrants [Member] Retained Earnings [Member]	January 2021 Inducement Warrants [Member]	Warrants to Purchase Common Stock [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	Warrants to Purchase Common Stock [Member] Common Stock [Member]	Warrants to Purchase Common Stock [Member] Additional Paid-in Capital [Member]	Warrants to Purchase Common Stock [Member] Treasury Stock [Member]	Warrants to Purchase Common Stock [Member] Retained Earnings [Member]	Warrants to Purchase Common Stock [Member]	Exchange Warrants [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	Exchange Warrants [Member] Common Stock [Member]	Exchange Warrants [Member] Additional Paid-in Capital [Member]	Exchange Warrants [Member] Treasury Stock [Member]	Exchange Warrants [Member] Retained Earnings [Member]	Exchange Warrants [Member]	June 2021 Inducement Warrants [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	June 2021 Inducement Warrants [Member] Common Stock [Member]	June 2021 Inducement Warrants [Member] Additional Paid-in Capital [Member]	June 2021 Inducement Warrants [Member] Treasury Stock [Member]	June 2021 Inducement Warrants [Member] Retained Earnings [Member]	June 2021 Inducement Warrants [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member] Common Stock [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member] Additional Paid-in Capital [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member] Treasury Stock [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member] Retained Earnings [Member]	Conversion of Facility Notes into Series B-2 Preferred Stock [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member] Preferred Stock [Member] Undesignated Preferred Stock [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member] Common Stock [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member] Additional Paid-in Capital [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member] Treasury Stock [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member] Retained Earnings [Member]	Conversion of Series B-2 Preferred Stock into Common Stock [Member]	Preferred Stock [Member] Undesignated Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Treasury Stock [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Total
Balance at Dec. 31, 2020																																											$ 0	$ 0	$ 192,062	$ 0	$ (258,474)		$ (66,412)
Net income (loss)																																											0	0	0	0	(8,555)		(8,555)
Stock-based compensation expense																																											0	0	2,436	0	0		2,436
Issuance of common stock in connection with Public Offering, net of discounts and commissions	$ 0	$ 1	$ 49,284	$ 0	$ 0	$ 49,285
Issuance of common stock in connection with the exercise of warrants in the January 2021 Inducement Transaction, net of discounts and commissions							$ 0	$ 1	$ 40,390	$ 0	$ 0	$ 40,391
Issuance of common stock in connection with the exercise of common stock warrants													$ 0	$ 0	$ 30,819	$ 0	$ 0	$ 30,819							$ 0	$ 1	$ 36,559	$ 0	$ 0	$ 36,560
Fair value of warrants issued							0	0	38,437	0	0	38,437							$ 0	$ 0	$ 15,990	$ 0	$ 0	$ 15,990	0	0	17,089	0	0	17,089
Issuance of stock as a result of conversion																															$ 29,056	$ 0	$ 0	$ 0	$ 0	$ 29,056	$ (29,056)	$ 1	$ 29,055	$ 0	$ 0	$ 0
Deemed dividend related the Inducement Transaction							$ 0	$ 0	$ (37,444)	$ 0	$ 0	$ (37,444)													$ 0	$ 0	$ (16,898)	$ 0	$ 0	$ (16,898)
Shares repurchased as part of the Share Repurchase Program																																											0	0	0	(2,814)	0		(2,814)
Offering expenses charged to equity																																											0	0	(1,124)	0	0		(1,124)
Issuance of common stock in exchange for consulting services																																											0	0	302	0	0		302
Balance at Dec. 31, 2021																																											0	4	396,957	(2,814)	(267,029)	0	127,118
Other comprehensive income																																																	0
Net income (loss)																																											0	0	0	0	(41,543)	0	(41,543)
Stock-based compensation expense																																											0	0	4,294	0	0	0	4,294
Issuance of common stock in exchange for consulting services																																												0	224	0	0	0	224
Balance at Dec. 31, 2022																																											0	3	401,799	(7,536)	(308,572)	113	85,807
Shares repurchased as part of the Share Repurchase Program																																											0	(1)	0	(4,722)	0	0	(4,723)
Issuance of common stock as part of the Employee Stock Purchase Plan																																												0	324	0	0	0	324
Other comprehensive income																																											$ 0	$ 0	$ 0	$ 0	$ 0	$ 113	$ 113

Note P - Employee Benefit Plan

12 Months Ended

Dec. 31, 2022

Compensation and Employee Benefit Plans [Text Block]

P.	Employee Benefit Plan

The Company has a 401(k) retirement plan (the “401(k) Plan”) that covers substantially all employees. The Company may provide a discretionary match with a maximum amount of 4% of the participant’s compensation, which vests immediately. The Company made matching contributions under the 401(k) Plan of $197,000 and $164,000 for the years ended December 31, 2022, and 2021, 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 made no contributions to the Profit Sharing Plan in 2022, or 2021.

Note F - Accounts Payable and Accrued Expenses - Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Accrued banking fees	$ 0	$ 700
Accrued payroll	1,673	1,054
Accrued professional fees	256	259
Accounts payable	3,611	516
Other accrued expenses	629	509
Total accounts payable and accrued expenses	$ 6,169	$ 3,038

Note O - Leases - Lease Cost (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Amortization of right-of-use assets	$ 129	$ 129
Interest on lease liabilities	2	9
Total finance lease cost	131	138
Operating lease cost	418	365
Short-term lease cost	210	199
Variable lease cost	39	47
Less: sublease income	(157)	(91)
Total lease costs	$ 641	$ 658

Note K - Stock-based Compensation (Tables)

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	*Year ended December 31,*
	*2022*		*2021*
Research and development	$	1,443	$	914
General and administrative		2,851		1,522
Total stock-based compensation expense	$	4,294	$	2,436

Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

	*Year Ended December 31,*
	*2022*	*2021*
Risk-free interest rate	1.70% - 3.80%	0.92% - 1.55%
Expected term (in years)	5.50 - 7.00	5.50 - 10.00
Expected volatility	91.28% - 98.91%	96.91% - 102.57%
Expected dividend yield	0	0

Share-Based Payment Arrangement, Option, Activity [Table Text Block]

			*Weighted*		*Weighted Avg*		*Aggregate*
	*Number of*		*Average*		*Remaining*		*Intrinsic*
	*Options*		*Exercise Price*		*Contractual Term*		*Value*
Outstanding balance at January 1, 2022		1,273,879	$	27.58		8.73	$	254,207
Granted		1,434,245	$	6.32
Exercised or released		-	$	-
Canceled or forfeited		245,593	$	9.23			$	74,033
Expired		6,124	$	93.60
Outstanding balance at December 31, 2022		2,456,407	$	16.84		8.51	$	11,819
Exercisable at December 31, 2022		615,001	$	44.52		6.99	$	2,722
Vested and expected to vest at December 31, 2022		2,375,700	$	17.15		8.49	$	11,628

Share-Based Payment Arrangement, Option, Exercise Price Range [Table Text Block]

	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 $10.00		2,175,436		8.90		351,151		8.19
$10.01 to $30.00		69,375		8.17		69,375		8.17
$30.01 to $50.00		68,514		6.11		51,393		6.11
$50.01 to $70.00		41,866		4.08		41,866		4.08
$70.01 to $327.20		101,216		3.70		101,216		3.70
		2,456,407		8.51		615,001		6.99

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]

	Number of Unvested Options
	December 31,
Exercise Price	2022		2021
$2.848 to $10.00		1,824,285		861,139
$10.01 to $30.00		-		60,000
$30.01 to $50.00		17,121		36,190
$50.01 to $70.00		-		-
$70.01 to $327.20		-		9,335
Total number of unvested stock options		1,841,406		966,664

Note O - Leases (Tables)

12 Months Ended

Dec. 31, 2022

Lease, Cost [Table Text Block]

	*Year Ended December 31,*
Lease Cost	*2022*			*2021*
Finance lease cost:
Amortization of right-of-use assets	$	129		$	129
Interest on lease liabilities		2			9
Total finance lease cost		131			138
Operating lease cost		418			365
Short-term lease cost		210			199
Variable lease cost		39			47
Less: sublease income		(157	)		(91	)
Total lease costs	$	641		$	658

Schedule of Leases Cash Flow Information [Table Text Block]

	*Year Ended December 31,*
	*2022*		*2021*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	2	$	9
Financing cash flows from finance leases		16		173
Operating cash flows from operating leases		522		460
Operating cash flows from short-term leases		210		199
Operating cash flows from variable lease costs		39		47

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	-	$	-
Operating leases		123		-

Schedule of Leases Balance Sheet Information [Table Text Block]

	*December 31,*
	*2022*			*2021*
Finance Leases
Property and equipment, at cost	$	1,031		$	1,031
less: accumulated depreciation and amortization		(780	)		(651	)
Property and equipment, net	$	251		$	380

Other current liabilities	$	6		$	15
Other long-term liabilities		-			6
Total finance lease liabilities	$	6		$	21

Operating Leases
Operating lease right-of-use assets	$	988		$	1,141
Total operating lease right-of-use assets	$	988		$	1,141

Current portion of operating lease liabilities	$	480		$	356
Operating lease liabilities, less current portion		843			1,232
Total operating lease liabilities	$	1,323		$	1,588

Weighted Average Remaining Lease Term
Finance leases	1 year			1 year
Operating leases	3 years			4 years

Weighted Average Discount Rate
Finance leases		14.3	%		12.0	%
Operating leases		7.3	%		7.5	%

Operating and Finance Lease, Liability, Maturity [Table Text Block]

	*Finance*			*Operating*
Year Ending December 31,	*Leases*			*Leases*
2023	$	7		$	563
2024		-			488
2025		-			389
2026		-			30
2027		-			-
Thereafter		-			-
Total lease payments		7			1,470
Less: future interest expense		(1	)		(147	)
Lease liabilities	$	6		$	1,323

Note A - Description of Business, Basis of Presentation, and Significant Transactions - Consideration Paid and Purchase Price Allocation for the Acquisition of Arimoclomol (Details) - Arimoclomol Purchase Agreement [Member] - USD ($)
$ in Thousands

12 Months Ended

May 15, 2022

Dec. 31, 2022

Cash

$ 12,800

Assumed reserve liability

5,200

$ 9,000

Total consideration

18,000

Total consideration

18,000

Direct transaction costs associated with the acquisition (1)

^[1]

1,290

Total purchase price to be allocated

19,290

Property and equipment, inventory and assembled workforce acquired

1,627

Total allocated purchase price

19,290

In Process Research and Development [Member]

IPR&D (2)

^[2]

$ 17,663

[1]	As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees and legal expenses.
[2]	The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset.

Note K - Stock-based Compensation

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement [Text Block]

K.	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’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 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 Restated 2014 Equity Incentive Plan (the "A&R 2014 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, 2031 and eliminated individual grant limits that applied under the 2014 Plan to awards that were intended to comply with the exemption for "performance-based compensation" under Code Section 162(m). The maximum number of shares of common stock that may be issued under the A&R 2014 Plan is 6,889,885 as of December 31, 2022. The number of shares of common stock reserved for issuance under the A&R 2014 Plan will automatically increase on January 1 of 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 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the A&R 2014 Plan, on January 1, 2023, the common stock reserved for issuance under the A&R 2014 Plan automatically increased by 1,381,612 shares.

During the years ended December 31, 2022, and 2021, no stock options were exercised.

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 may be issued under the ESPP is 1,500,000. The first offering period under the ESPP began on October 1, 2021, and the first purchase date occurred on May 31, 2022. As of December 31, 2022, 82,635 shares have been issued under the ESPP.

In January 2023, our Board approved the 2023 Employment Inducement Award Plan (“2023 Plan”). The maximum number of shares of common stock that may be issued under the 2023 Plan is 1,500,000.

Stock-based compensation expense recorded under the Incentive Stock Plan, 2014 Plan, A&R 2014 Plan, and ESPP is included in the following line items in the accompanying consolidated statements of operations (in thousands):

	*Year ended December 31,*
	*2022*		*2021*
Research and development	$	1,443	$	914
General and administrative		2,851		1,522
Total stock-based compensation expense	$	4,294	$	2,436

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, are not 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 assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not 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, 22 and 2021, fair value was $5.01 and $7.53 per share, respectively. The assumptions used to estimate fair value are as follows:

	*Year Ended December 31,*
	*2022*	*2021*
Risk-free interest rate	1.70% - 3.80%	0.92% - 1.55%
Expected term (in years)	5.50 - 7.00	5.50 - 10.00
Expected volatility	91.28% - 98.91%	96.91% - 102.57%
Expected dividend yield	0	0

The activity under the Incentive Stock Plan, 2014 Plan and A&R 2014 Plan for the year ended December 31, 2022, is summarized as follows:

			*Weighted*		*Weighted Avg*		*Aggregate*
	*Number of*		*Average*		*Remaining*		*Intrinsic*
	*Options*		*Exercise Price*		*Contractual Term*		*Value*
Outstanding balance at January 1, 2022		1,273,879	$	27.58		8.73	$	254,207
Granted		1,434,245	$	6.32
Exercised or released		-	$	-
Canceled or forfeited		245,593	$	9.23			$	74,033
Expired		6,124	$	93.60
Outstanding balance at December 31, 2022		2,456,407	$	16.84		8.51	$	11,819
Exercisable at December 31, 2022		615,001	$	44.52		6.99	$	2,722
Vested and expected to vest at December 31, 2022		2,375,700	$	17.15		8.49	$	11,628

Information regarding currently outstanding and exercisable options as of December 31, 2022, 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 $10.00		2,175,436		8.90		351,151		8.19
$10.01 to $30.00		69,375		8.17		69,375		8.17
$30.01 to $50.00		68,514		6.11		51,393		6.11
$50.01 to $70.00		41,866		4.08		41,866		4.08
$70.01 to $327.20		101,216		3.70		101,216		3.70
		2,456,407		8.51		615,001		6.99

The total fair value of stock options vested during the years ended December 31, 2022 and 2021, was $3.7 million and $2.0 million, respectively.

Unvested stock options as of December 31, 2022 and 2021, were as follows:

	Number of Unvested Options
	December 31,
Exercise Price	2022		2021
$2.848 to $10.00		1,824,285		861,139
$10.01 to $30.00		-		60,000
$30.01 to $50.00		17,121		36,190
$50.01 to $70.00		-		-
$70.01 to $327.20		-		9,335
Total number of unvested stock options		1,841,406		966,664

As of December 31, 2022, there was $8.2 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the 2014 Plan and A&R 2014 Plan. That compensation cost is expected to be recognized over a weighted-average period of 2.82 years.

There was $0.4 million and $0.4 million

stock-based compensation expense related to performance-based awards recognized during the years ended

December 31, 2022, and 2021, respectively.

Note C - Accounts and Other Receivables

12 Months Ended

Dec. 31, 2022

Loans, Notes, Trade and Other Receivables Disclosure [Text Block]

C.	Accounts and Other Receivables

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

	*December 31,*
	*2022*		*2021*
Accounts receivable	$	7,185	$	1,421
Other receivables		1,114		107
Total accounts and other receivables	$	8,299	$	1,528

Note J - Common Stock and Warrants

12 Months Ended

Dec. 31, 2022

Stockholders' Equity Note Disclosure [Text Block]

J.	Common Stock and Warrants

Authorized, Issued, and Outstanding Common Shares

As of December 31, 2022, and 2021, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares, 35,450,257 and 35,325,801 shares of common stock were issued as of December 31, 2022, and 2021, respectively, and 34,540,304 and 35,005,640 shares of common stock were outstanding as of December 31, 2022, and 2021, respectively.

As of December 31, 2022, and 2021, the Company had reserved authorized shares of common stock for future issuance as follows:

	*December 31,*
	*2022*		*2021*
Outstanding awards under equity incentive plans		2,456,407		1,273,879
Outstanding common stock warrants		4,252,600		4,252,600
Possible future issuances under equity incentive plans		4,421,508		4,209,935
Possible future issuances under employee stock purchase plan		1,417,365		1,500,000
Total common shares reserved for future issuance		12,547,880		11,236,414

Common Stock Activity

The following table summarizes common stock activity for the years ended December 31, 2022 and 2021:

	*Shares of*
	*Common Stock*
Balance as of January 1, 2021		4,537,321
Common stock issued as a result of the Public Offering		7,139,498
Common stock issued as a result of Series B-2 Preferred Stock conversions		4,842,699
Common stock issued as a result of warrant exercises		18,772,510
Common stock issued as compensation to third-parties		35,129
Adjustment for cash paid in lieu of DTC fractional shares		(1,356	)
Common stock repurchased as a result of the Stock Repurchase Program		(320,161	)
Balance as of December 31, 2021		35,005,640
Common stock issued as compensation to third-parties		41,821
Common stock repurchased as a result of the Stock Repurchase Program		(589,792	)
Common stock issued as a result of the Employee Stock Purchase Plan		82,635
Balance as of December 31, 2022		34,540,304

Warrants

On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the OTA Warrant to purchase 14,423,076 shares of Series D Preferred (Note G). The Company recorded the fair value of the OTA Warrant as a debt discount and a warrant liability. The OTA Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the Company’s initial public offering (the “IPO”), the OTA Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock. at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the OTA Warrant became $93.60 and the shares of the Company’s common stock issuable upon exercise of the OTA Warrant became 120,192 shares of common stock. As a result of the January 2021 Inducement Transaction (discussed below) the anti-dilution provisions within the OTA Warrant were triggered and the exercise price was reduced from $93.60 per share to $46.25 per share. In addition, as a result of the June 2021 Inducement Transaction (discussed below) the anti-dilution provision within the OTA Warrant were triggered and the exercise price was reduced from $46.25 per share to $38.34 per share. The Company amortized the debt discount over the term of the Deerfield Convertible Note and the expense was recorded as interest expense related to amortization of debt issuance costs and discount in the consolidated statements of operations. The Deerfield Convertible Note was extinguished in February 2021 and the remaining debt discount was written off and recognized as a loss on extinguishment of debt.

The Company determined that the OTA Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the OTA Warrant automatically converted into warrants to purchase the Company’s common stock. The OTA Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the consolidated statements of operations as a fair value adjustment (Note L).

In connection with the APADAZ License Agreement, in October 2018, the Company issued to KVK a warrant to purchase up to 31,250 shares of common stock of the Company at an exercise price of $2.30 per share (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 7812.5 shares, up to an aggregate of 31,250 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the KVK Warrant became $36.80 and the shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares of common stock.

The Company determined that, since KVK qualifies as a customer under ASC 606, the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC 815 and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC 815 and are recorded as fair value adjustment related to derivative and warrant liability in the consolidated statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC 606 and are recorded as a change in contract asset on the consolidated balance sheets.

Pre-Funded Warrants

On January 12, 2021, pursuant to the terms of the Underwriting Agreement, the Company issued pre-funded warrants to purchase 926,844 shares of the Company’s common stock to specified investors in the Public Offering. Each pre-funded warrant had an initial exercise price per share equal to $0.0001. The pre-funded warrants were immediately exercisable. In January 2021, all pre-funded warrants were exercised for 926,841 shares of common stock and gross proceeds of approximately $72.

Warrants to Purchase Common Stock

On January 12, 2021, pursuant to the terms of the Underwriting Agreement and December 2020 Exchange Agreement, the Company issued warrants to purchase 12,078,361 shares of the Company’s common stock (collectively, the “Offering Warrants”) in the Public Offering and in connection with the transactions contemplated under the December 2020 Exchange Agreement. The Offering Warrants were immediately exercisable and expire on the fifth anniversary of their issuance date, at an exercise price per share of common stock equal to $6.50 per share. A holder (together with its affiliates) may not exercise any portion of the Offering Warrant to the extent that the holder and its affiliates would own more than 4.99% of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the Offering Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the Offering Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the Offering Warrants, including any voting rights, until they exercise their Offering Warrants. The Offering Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction (as described in the Offering Warrants), the holders of the Offering Warrants will be entitled to receive upon exercise of the Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Offering Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the Offering Warrants have the right to require the Company or a successor entity to redeem the Offering Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the Offering Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the Offering Warrants have the right to require the Company or a successor entity to redeem the Offering Warrants in the amount of the Black Scholes value of the unexercised portion of the Offering Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. The Offering Warrants meet the equity classification requirements and thus are recorded in additional paid-in capital on the accompanying consolidated balance sheets. As of December 31, 2022, 3,461,858 Offering Warrants have been exercised for 3,030,881 shares of common stock and gross proceeds of approximately $16.9 million. These amounts are exclusive of the Offering Warrants exercised as part of the January 2021 Inducement Transaction discussed below.

Underwriter Warrant

On January 12, 2021, pursuant to the terms of the Underwriting Agreement, the Company issued to the Underwriter a warrant to purchase 806,932 shares of the Company’s common stock (the “Underwriter Warrant”). The Underwriter Warrant is subject to substantially the same terms and conditions as the Warrants. If the Underwriter exercises any additional portion of its over-allotment option, then the Company shall issue the Underwriter an additional Underwriter Warrant exercisable for a number of shares of common stock equal to 5.0% of the number of shares of common stock issued in such over-allotment exercise (including the shares of common stock issuable upon the exercise of any Warrants issued in connection therewith). In connection with the closing of the Underwriter's partial exercise of its over-allotment option, on February 3, 2021, the Underwriter was issued an additional warrant to purchase 18,702 shares of common stock. As of December 31, 2022, 400,000 Underwriter Warrants have been exercised for 400,000 shares of common stock and gross proceeds of approximately $3.3 million.

January 2021 Warrant Exercise Inducement Letters and Issuance of Warrants

On January 26, 2021, the Company entered into warrant exercise inducement offer letters ( “January 2021 Inducement Transaction”) with certain holders of warrants issued in the Public Offering discussed above (the "Existing Warrants") (collectively, the “Exercising Holders”) pursuant to which such holders agreed to exercise for cash their Existing Warrants to purchase 6,620,358 shares of the Company’s common stock in exchange for the Company’s agreement to issue new warrants to purchase up to 7,944,430 shares of the Company’s common stock (the “January 2021 Inducement Warrants”) on substantially the same terms as the Existing Warrants. The Company received aggregate gross proceeds of approximately $44.0 million from the exercise of the Existing Warrants by the Exercising Holders and the sale of the January 2021 Inducement Warrants. The Company engaged Roth as its exclusive placement agent in connection with these transactions and paid Roth a fee equal to 6% of gross proceeds from the exercise of the Existing Warrants by the Exercising Holders and the sale of the January 2021 Inducement Warrants.

The January 2021 Inducement Warrants were immediately exercisable and expire on the fifth anniversary of their issuance date. The January 2021 Inducement Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice, provided that payment in full for the number of shares of the Company’s common stock purchased upon such exercise is delivered to the Company in accordance with the terms of the January 2021 Inducement Warrants. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrants. A holder (together with its affiliates) may not exercise any portion of the January 2021 Inducement Warrant to the extent that the holder and its affiliates would own more than 4.99% (or, upon election by a holder prior to the issuance of its January 2021 Inducement Warrants, 9.99%) of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the January 2021 Inducement Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the January 2021 Inducement Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the January 2021 Inducement Warrants, including any voting rights, until they exercise their January 2021 Inducement Warrants. The January 2021 Inducement Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction (as described in the January 2021 Inducement Warrants), the holders of the January 2021 Inducement Warrants will be entitled to receive upon exercise of the January 2021 Inducement Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the January 2021 Inducement Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the January 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the January 2021 Inducement Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the January 2021 Inducement Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the January 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the January 2021 Inducement Warrants in the amount of the Black Scholes value of the unexercised portion of the January 2021 Inducement Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. As of December 31, 2022, 1,676,921 January 2021 Inducement Warrants have been exercised for 1,676,921 shares of common stock and gross proceeds of approximately $10.7 million. These amounts are exclusive of the January 2021 Inducement Warrants exercised as part of the June 2021 Inducement Transaction discussed below.

In accordance with the January 2021 Inducement Transaction we recognized a deemed dividend of $37.4 million for the year ended December 31, 2021, which is the difference between the grant date fair value of the January 2021 Inducement Warrants and the purchase price of the January 2021 Inducement Warrants. This deemed dividend is added to net loss to arrive at net loss attributable to common stockholders on the consolidated statements of operations.

June 2021 Warrant Exercise Inducement Letters and Issuance of Warrants

On June 18, 2021, the Company entered into warrant exercise inducement offer letters ( “June 2021 Inducement Transaction”) with certain holders of warrants issued in the January 2021 Inducement Transaction discussed above (the "January 2021 Inducement Warrants") (collectively, the “June 2021 Exercising Holders”) pursuant to which such holders agreed to exercise for cash their January 2021 Inducement Warrants to purchase 6,117,509 shares of the Company’s common stock in exchange for the Company’s agreement to issue new warrants to purchase up to 1,529,379 shares of the Company’s common stock (the “June 2021 Inducement Warrants”) on substantially the same terms as the January 2021 Inducement Warrants,. The Company received aggregate gross proceeds of approximately $39.1 million from the exercise of the January 2021 Inducement Warrants by the June 2021 Exercising Holders and the sale of the June 2021 Inducement Warrants. The Company engaged Roth as its exclusive placement agent in connection with these transactions and paid Roth a fee equal to 6% of gross proceeds from the exercise of the January 2021 Inducement Warrants by the June 2021 Exercising Holders and the sale of the June 2021 Inducement Warrants.

The June 2021 Inducement Warrants were immediately exercisable and expire on December 31, 2026. The June 2021 Inducement Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice, provided that payment in full for the number of shares of the Company’s common stock purchased upon such exercise is delivered to the Company in accordance with the terms of the June 2021 Inducement Warrants. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrants. A holder (together with its affiliates) may not exercise any portion of the June 2021 Inducement Warrant to the extent that the holder and its affiliates would own more than 4.99% (or, upon election by a holder prior to the issuance of its June 2021 Inducement Warrants, 9.99%) of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the June 2021 Inducement Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the June 2021 Inducement Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the June 2021 Inducement Warrants, including any voting rights, until they exercise their June 2021 Inducement Warrants. The June 2021 Inducement Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction (as described in the June 2021 Inducement Warrants), the holders of the June 2021 Inducement Warrants will be entitled to receive upon exercise of the June 2021 Inducement Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the June 2021 Inducement Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the June 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the June 2021 Inducement Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the June 2021 Inducement Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the June 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the June 2021 Inducement Warrants in the amount of the Black Scholes value of the unexercised portion of the June 2021 Inducement Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. As of December 31, 2022, and 2021, no June 2021 Inducement Warrants have been exercised.

In accordance with the June 2021 Inducement Transaction, we recognized a deemed dividend of $16.9 million for the year ended December 31, 2021, which is the difference between the grant date fair value of the June 2021 Inducement Warrants and the purchase price of the June 2021 Inducement Warrants. This deemed dividend is added to net loss to arrive at net loss attributable to common stockholders on the consolidated statements of operations.

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

Note L - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Financial liabilities measured at fair value on recurring basis	$ 1	$ 330
Total assets	16,900
US Government Agencies Debt Securities [Member]
Total assets	7,189
US Treasury Securities [Member]
Total assets	9,711
Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis	0	0
Total assets	9,711
Fair Value, Inputs, Level 1 [Member] \| US Government Agencies Debt Securities [Member]
Total assets	0
Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Total assets	9,711
Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis	0	24
Total assets	7,189
Fair Value, Inputs, Level 2 [Member] \| US Government Agencies Debt Securities [Member]
Total assets	7,189
Fair Value, Inputs, Level 2 [Member] \| US Treasury Securities [Member]
Total assets	0
Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis	1	306
Total assets	0
Fair Value, Inputs, Level 3 [Member] \| US Government Agencies Debt Securities [Member]
Total assets	0
Fair Value, Inputs, Level 3 [Member] \| US Treasury Securities [Member]
Total assets	0
OTA Warrant [Member]
Financial liabilities measured at fair value on recurring basis	1	288
OTA Warrant [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis	0	0
OTA Warrant [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis	0	0
OTA Warrant [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis	$ 1	288
Embedded Put Option [Member]
Financial liabilities measured at fair value on recurring basis		18
Embedded Put Option [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis		0
Embedded Put Option [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis		0
Embedded Put Option [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis		18
KVK Warrant Liability [Member]
Financial liabilities measured at fair value on recurring basis		24
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis		0
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis		24
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis		$ 0

Note L - Fair Value of Financial Instruments (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

			*Quoted Prices*		*Significant*
			*in Active*		*Other*		*Significant*
	*Balance at*		*Markets for*		*Observable*		*Unobservable*
	*December 31,*		*Identical Assets*		*Inputs*		*Inputs*
	*2022*		*(Level 1)*		*(Level 2)*		*(Level 3)*
OTA Warrant liability	$	1	$	-	$	-	$	1
Total liabilities	$	1	$	-	$	-	$	1
Securities:
U.S. government-sponsored agency securities	$	7,189	$	-	$	7,189	$	-
U.S. Treasury securities		9,711		9,711		-		-
Total assets	$	16,900	$	9,711	$	7,189	$	-

			*Quoted Prices*		*Significant*
			*in Active*		*Other*		*Significant*
	*Balance at*		*Markets for*		*Observable*		*Unobservable*
	*December 31,*		*Identical Assets*		*Inputs*		*Inputs*
	*2021*		*(Level 1)*		*(Level 2)*		*(Level 3)*
OTA Warrant liability	$	288	$	-	$	-	$	288
Embedded Warrant Put Option		18		-		-		18
KVK Warrant liability		24		-		24		-
Total liabilities	$	330	$	-	$	24	$	306

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

	*2022*			*2021*
Balance as of beginning of period	$	306		$	255
Adjustment to fair value		(305	)		51
Balance as of end of period	$	1		$	306

Note N - Net Loss Per Share (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

	*December 31,*
	*2022*		*2021*
Awards under equity incentive plans		2,456,407		1,273,879
Common stock warrants		4,252,600		4,221,350
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		6,709,007		5,495,229

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]

	*December 31,*
	*2022*			*2021*
Basic and diluted net loss per share of common stock:

Net loss	$	(41,543	)	$	(8,555	)
Less: Dividends declared or accumulated		-			(54,342	)
Net loss attributable to common stockholders	$	(41,543	)	$	(62,897	)
Less: Net loss attributable to participating securities	$	-		$	-
Undistributed net loss attributable to shares of common stockholders, basic and diluted	$	(41,543	)	$	(62,897	)
Weighted average number of shares of common stock outstanding, basic and diluted		34,489			29,766
Basic and diluted net loss attributable to common stockholders per share of common stock	$	(1.20	)	$	(2.11	)

Note P - Employee Benefit Plan (Details Textual) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Retirement Plan [Member]
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay	4.00%
Defined Contribution Plan, Employer Discretionary Contribution Amount	$ 197,000	$ 164,000
Profit Sharing Plan [Member]
Defined Contribution Plan, Employer Discretionary Contribution Amount	$ 0	$ 0
Defined Contribution Plan, Requisite Service Period (Year)	3 years

Note Q - Significant Events (Details Textual)			12 Months Ended
Note Q - Significant Events (Details Textual)	Jan. 09, 2023 shares	Jan. 06, 2023 USD ($) shares	Dec. 31, 2022 shares
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)			1,434,245
Chief Executive Officer [Member] \| 2014 Equity Incentive Plan [Member] \| Subsequent Event [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)	700,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Number of Installments	4
Company's President and Former Chief Executive Officer [Member] \| Subsequent Event [Member]
Transition Agreement, Continued Payment of Base Salary, Period (Month)		18 months
Transition Agreement, Continued Medical, Dental and Vision Coverage, Period (Month)		18 months
Transition Agreement, Monthly Consulting Fees \| $		$ 40,000
Company's President and Former Chief Executive Officer [Member] \| Subsequent Event [Member] \| Restricted Stock Units (RSUs) [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)		547,945

Note E - Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Table Text Block]

	*December 31,*
	*2022*			*2021*
Laboratory equipment	$	710		$	645
Furniture and office equipment		104			71
Computers and hardware		462			338
Leasehold improvements		710			724
Finance lease right-of-use assets		251			1,031
Total property and equipment		2,237			2,809
Less: accumulated depreciation and amortization		(1,443	)		(1,925	)
Property and equipment, net	$	794		$	884

Property, Plant and Equipment, Useful Life [Table Text Block]

		*Useful Life*
Asset Category		*(in years)*
Laboratory equipment		10
Furniture and office equipment		5 - 10
Computers and hardware		3 - 7
Leasehold improvements		9

Note K - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Stock based compensation expense	$ 4,294	$ 2,436
Research and Development Expense [Member]
Stock based compensation expense	1,443	914
General and Administrative Expense [Member]
Stock based compensation expense	$ 2,851	$ 1,522

Note E - Property and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment Disclosure [Text Block]

E.	Property and Equipment

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

	*December 31,*
	*2022*			*2021*
Laboratory equipment	$	710		$	645
Furniture and office equipment		104			71
Computers and hardware		462			338
Leasehold improvements		710			724
Finance lease right-of-use assets		251			1,031
Total property and equipment		2,237			2,809
Less: accumulated depreciation and amortization		(1,443	)		(1,925	)
Property and equipment, net	$	794		$	884

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

		*Useful Life*
Asset Category		*(in years)*
Laboratory equipment		10
Furniture and office equipment		5 - 10
Computers and hardware		3 - 7
Leasehold improvements		9

Depreciation and amortization expense, including amounts pertaining to assets held under finance leases, was approximately $298,000 and $257,000 for the years ended December 31, 2022 and 2021, respectively.

Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (41,543)	$ (8,555)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on extinguishment of debt	0	16,096
Stock-based compensation expense	4,294	2,436
Non-cash interest expense	0	8
Amortization of debt issuance costs and debt discount	(0)	150
Depreciation and amortization expense	944	257
Fair value adjustment related to derivative and warrant liability	(328)	26
Fair value adjustment related to investments	577	0
Loss on sublease and disposal of property and equipment	9	76
Consulting fees paid in common stock	224	302
Acquired in-process research and development	17,663	0
Gain on foreign currency exchange rates	(91)	0
Change in assets and liabilities:
Accounts and other receivables	(6,772)	1,051
Prepaid expenses and other assets	(657)	(825)
Inventories	147	0
Operating lease right-of-use assets	277	133
Other long-term assets	386	0
Accounts payable and accrued expenses	3,131	(1,113)
Discount and rebate liabilities	3,782	0
Operating lease liabilities	(389)	(326)
Other liabilities	(371)	723
Net cash (used in) provided by operating activities	(18,717)	10,439
Cash flows from investing activities:
Acquisitions, net	(14,090)	0
Purchases of property and equipment	(93)	(102)
Purchases of long-term investments, net	(22,536)	(15,422)
Net cash used in investing activities	(36,719)	(15,524)
Cash flows from financing activities:
Proceeds from Public Offering, net of discounts and commissions	0	49,285
Proceeds from Inducement Transaction, net of discounts and commissions	0	36,751
Proceeds from issuance of debt	12,800	0
Proceeds from insurance financing arrangements	1,273	0
Proceeds from Employee Stock Purchase Plan	324	0
Payments of principal on insurance financing arrangements	(1,306)	0
Payment to repurchase shares as part of the Share Repurchase Program	(4,723)
Payment of offering costs	0	(1,338)
Repayment of principal on finance lease liabilities	(16)	(173)
Payment of debt issuance costs	0	(2,881)
Repayment of principal on convertible notes	0	(37,924)
Net proceeds from exercise of common stock warrants	0	30,819
Net cash provided by financing activities	8,352	113,109
Effect of exchange rate changes on cash and cash equivalents	204	0
Net (decrease) increase in cash and cash equivalents	(46,880)	108,024
Cash and cash equivalents, beginning of period	112,346	4,322
Cash and cash equivalents, end of period	65,466	112,346
Supplemental cash flow information:
Cash paid for interest	321	218
Right-of-use assets obtained in exchange for lease liabilities	123	0
Amounts due for deferred offering costs included in accounts payable and accrued expenses	0	48
Fair value of warrants issued to underwriters in connection with Public Offering	0	3,485
Conversion of Facility Notes into Series B-2 Preferred Stock [Member]
Supplemental cash flow information:
Facility Notes principal converted to Series B-2 Preferred Stock	0	31,477
Warrants Issued in Connection with January 2021 Inducement Transaction [Member]
Cash flows from financing activities:
Proceeds from Inducement Transaction, net of discounts and commissions	$ 0	$ 41,384

Note A - Description of Business, Basis of Presentation, and Significant Transactions (Details Textual) - USD ($)
$ / shares in Units, $ in Thousands

12 Months Ended

May 15, 2022

Jul. 12, 2021

Feb. 01, 2021

Jan. 12, 2021

Jan. 08, 2021

Dec. 31, 2022

Dec. 31, 2021

Dec. 20, 2021

Jul. 02, 2021

Feb. 03, 2021

Sale of Stock, Authorized Amount

$ 350,000

Stock Repurchase Program, Authorized Amount

$ 50,000

Treasury Stock, Value, Total

$ 7,536

$ 2,814

Share Repurchase Program [Member]

Treasury Stock, Shares, Total (in shares)

909,953

Treasury Stock, Value, Total

$ 7,500

Roth Capital Partners, LLC [Member] | Pre-funded Warrants [Member]

Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)

926,844

Roth Capital Partners, LLC [Member] | Public Offering Warrants [Member]

Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)

12,078,361

7,692,307

Class of Warrant or Right, Offering Price, Per Related Warrant (in dollars per share)

$ 0.0001

Roth Capital Partners, LLC [Member] | Underwriter Warrants [Member]

Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)

806,932

754,035

18,702

Over Allotment Options, Number of Shares for Warrants (in shares)

1,153,846

Underwriting Agreement [Member] | Roth Capital Partners, LLC [Member]

Stock Issued During Period, Shares, New Issues (in shares)

6,765,463

Shares and Warrants Issued, Price Per Share (in dollars per share)

$ 6.50

Shares Issued, Price Per Share (in dollars per share)

$ 6.4999

Proceeds from Issuance or Sale of Equity, Total

$ 52,400

Over-Allotment Option [Member] | Roth Capital Partners, LLC [Member]

Stock Issued During Period, Shares, New Issues (in shares)

374,035

Purchase Agreement Optional Period to Shares (Day)

45 days

Purchase Agreement, Maximum, Additional Shares Available for Purchase During the Optional Period (in shares)

1,153,846

ATM Agreement Sales [Member] | JMP and RBCCM [Member]

Stock Issued During Period, Shares, New Issues (in shares)

Equity Distribution Agreement, Maximum Aggregate Offering Price

$ 75,000

Equity Distribution Agreement, Commission Fee, Percentage of Gross Sales

3.00%

Stock Issued During Period, Value, New Issues

$ 75,000

Arimoclomol Purchase Agreement [Member]

Payments to Acquire Productive Assets, Total

$ 12,800

Asset Acquisition, Consideration Transferred, Estimated Reserve Liability

$ 5,200

$ 9,000

Estimated Weighted Average Cost of Capital

42.00%

Effective Income Tax Rate Reconciliation, Tax Credit, Research, Amount

$ 800

Arimoclomol Purchase Agreement [Member] | In Process Research and Development [Member]

Asset Acquisition, Recognized Identifiable Assets, Finite-Lived Intangibles

^[1]

$ 17,663

[1]	The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset.

Balance Sheets (Parentheticals) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	250,000,000	250,000,000
Common stock, shares issued (in shares)	35,450,257	35,325,801
Common stock, shares outstanding (in shares)	34,540,304	35,005,640

Note O - Leases

12 Months Ended

Dec. 31, 2022

Lease Disclosure [Text Block]

O.	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 does not separate lease and non-lease components. Leases with a term of 12 months or less at commencement are not 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 of one of the two 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 Cost	*2022*			*2021*
Finance lease cost:
Amortization of right-of-use assets	$	129		$	129
Interest on lease liabilities		2			9
Total finance lease cost		131			138
Operating lease cost		418			365
Short-term lease cost		210			199
Variable lease cost		39			47
Less: sublease income		(157	)		(91	)
Total lease costs	$	641		$	658

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

	*Year Ended December 31,*
	*2022*		*2021*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	2	$	9
Financing cash flows from finance leases		16		173
Operating cash flows from operating leases		522		460
Operating cash flows from short-term leases		210		199
Operating cash flows from variable lease costs		39		47

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	-	$	-
Operating leases		123		-

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,*
	*2022*			*2021*
Finance Leases
Property and equipment, at cost	$	1,031		$	1,031
less: accumulated depreciation and amortization		(780	)		(651	)
Property and equipment, net	$	251		$	380

Other current liabilities	$	6		$	15
Other long-term liabilities		-			6
Total finance lease liabilities	$	6		$	21

Operating Leases
Operating lease right-of-use assets	$	988		$	1,141
Total operating lease right-of-use assets	$	988		$	1,141

Current portion of operating lease liabilities	$	480		$	356
Operating lease liabilities, less current portion		843			1,232
Total operating lease liabilities	$	1,323		$	1,588

Weighted Average Remaining Lease Term
Finance leases	1 year			1 year
Operating leases	3 years			4 years

Weighted Average Discount Rate
Finance leases		14.3	%		12.0	%
Operating leases		7.3	%		7.5	%

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

	*Finance*			*Operating*
Year Ending December 31,	*Leases*			*Leases*
2023	$	7		$	563
2024		-			488
2025		-			389
2026		-			30
2027		-			-
Thereafter		-			-
Total lease payments		7			1,470
Less: future interest expense		(1	)		(147	)
Lease liabilities	$	6		$	1,323

Note D - Prepaid Expenses and Other Current Assets - Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Prepaid insurance	$ 577	$ 637
Prepaid offering costs	0	293
Other prepaid expenses and current assets	1,300	252
Total prepaid expenses and other current assets	$ 1,877	$ 1,182

Note B - Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Significant Accounting Policies [Text Block]

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 long-term investments, 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 of three 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 ASC 825, 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, 2022, and 2021, the Company held securities with an aggregate fair value of $16.9 million and $14.9 million, respectively, that contained aggregate unrealized losses of approximately $577,000 and $13,000, respectively. 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. In addition, the Company holds certificates of deposit totaling $20.5 million and $0.5 million as of December 31, 2022, and 2021, respectively, and are included in long-term investments - other in the consolidated balance sheets. 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.

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 to ten 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.

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. In the first quarter of 2021, all outstanding debt was extinguished through a series of debt payments and a conversion of debt principal and interest to Series B-2 Preferred Stock (Note G). As a result of the debt extinguishment, the associated discount and debt issuance costs were written off and recorded as a loss on extinguishment.

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, 2022 , or 2021 .

Revenue Recognition

The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”) and, as a result, follows the five-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; and 5) recognizing revenue when the performance obligations have been fulfilled.

Arimoclomol Early Access Program

Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under the remunerated early access compassionate use program in France (“French nATU”). An early access compassionate use program is a program giving specific patients access to a drug, which is not yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currently no appropriate treatment are considered for early access compassionate use programs. Further, to be considered for the early 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 ASC 606, the Company recognizes revenue when fulfilling its performance obligation under the Arimoclomol Early 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. Under the French nATU, the manufacturer can set its own price for the drug products until a price agreement with the authorities is in place. 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, which 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 marketing approval. 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 year ended December 31, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $4.8 million, which is net of a clawback liability of $3.8 million. As part of the Arimoclomol Purchase Agreement the Company assumed an estimated reserve liability of $5.2 million related to revenue generated from the Arimoclomol EAP in France. The total estimate reserve liability as of December 31, 2022, including the additional clawback liability for the year ended December 31, 2022, was $9.0 million. As of December 31, 2022, this estimated reserve liability is recorded as discount and rebate liabilities in the consolidated balance sheet and is separated into current and long-term based upon the timing of the expected payment to the French regulators.

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC 606.

The terms of the Company’s licensing agreements typically include one 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 would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not 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.

AZSTARYS License Agreement

In September 2019, the Company entered into a Collaboration and License Agreement (the "AZSTARYS License Agreement") with Commave Therapeutics SA (“Commave”), an affiliate of GPC. Under the AZSTARYS License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-methylphenidate (“d-MPH”), including AZSTARYS, or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder. Corium was tasked by Commave, to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Corium agreed to pay milestone payments 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. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product.

In April 2021, the Company entered into Amendment No. 1 to the AZSTARYS License Agreement (the "AZSTARYS Amendment"). Pursuant to the AZSTARYS Amendment, the Company and Commave agreed to modify the compensation terms of the AZSTARYS License Agreement. Pursuant to the AZSTARYS Amendment, Commave paid the Company $10.0 million in connection with the entry into the AZSTARYS Amendment as a result of the regulatory approval of AZSTARYS in the United States, which occurred on March 2, 2021. Commave also paid the Company $10.0 million following the receipt of the scheduling determination of the compound SDX by the U.S. Drug Enforcement Agency ("DEA"), which occurred on May 7, 2021. In addition, the AZSTARYS Amendment increased the total remaining future regulatory and sales milestone payments related to AZSTARYS up to an aggregate of $590.0 million in payments upon the occurrence of specified regulatory milestones related to AZSTARYS and upon the achievement of specified U.S. net sales milestones.

Commave also agreed to be responsible for and reimburse the Company for all of the development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the AZSTARYS License Agreement. As part of this agreement, the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products.

In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics, Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to AZSTARYS, KP879 or KP1077 under the AZSTARYS License Agreement.

The AZSTARYS License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations at inception. The Company further determined that the transaction price, at inception, under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the AZSTARYS License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type of transaction. The Company determined that the intellectual property licensed under the AZSTARYS License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the AZSTARYS License Agreement.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and the achievement of certain U.S. sales milestones. Further, Commave will pay the Company quarterly, tiered royalty payments based on a range of percentages of Net Sales (as defined in the AZSTARYS License Agreement). 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 are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not 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 years ended December 31, 2022, and 2021, the Company recognized revenue under the AZSTARYS License Agreement of $0.9 million and $20.9 million, respectively. There was no deferred revenue related to this agreement as of December 31, 2022, and 2021.

Consulting Arrangements

The Company enters into consulting arrangements with third parties that fall under the scope of ASC 606. These arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization support services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket third-party research and development, regulatory and commercial costs.

Corium Consulting Agreement

In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of AZSTARYS (together, “Corium Consulting Services”). Corium is a portfolio company of GPC and was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement, as discussed above.

Under the Corium Consulting Agreement, the Company is entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which was paid in quarterly installments through March 31, 2022. The remaining $2.0 million was conditioned upon the approval by the FDA of the NDA for Corium's product candidate, ADLARITY. This $2.0 million was earned in the first quarter of 2022. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services. The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. The Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass-through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments.

The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of December 31, 2022, the Company has recognized approximately all of the consulting services and third-party pass-through costs under the Corium Consulting Agreement.

For the years ended December 31, 2022, and 2021, the Company recognized revenue under the Corium Consulting Agreement of $4.7 million and $7.7 million, respectively. As of December 31, 2022, the Company had no deferred revenue related to this agreement. As of December 31, 2021, the Company had deferred revenue related to this agreement of $0.4 million.

Other Consulting Arrangements

For the years ended December 31, 2022, and 2021, the Company recognized revenue under other consulting arrangements of $0.1 million and $0.1 million, respectively. There was no deferred revenue from other consulting arrangements as of December 31, 2022, or 2021.

Accounts and Other Receivables

Accounts and other receivables consist of receivables under the AZSTARYS License Agreement and Arimoclomol EAP, as well as receivables related to consulting arrangements, 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 reimbursable third-party costs and royalties on product sales. Receivables under the Arimoclomol EAP are recorded for product sales under the French nATU. These receivables, as well as the receivables related to consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date.

Inventory

As discussed in Note A, a portion of the purchase price was allocated to inventory acquired representing the value of inventory associated with forecasted EAP revenues and as of December 31, 2022, the Company had inventory of $0.7 million remaining. Inventories are stated at net realizable value using the first-in, first-out method of valuation.

The Company may scale-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 may not be approved for marketing on a timely basis, or ever. This risk notwithstanding, the Company may scale-up and build pre-launch inventory of product that have not received final regulatory approval when the Company believes such action is appropriate in relation to the commercial value of the product launch opportunity. Inventory manufactured prior to regulatory approval is recorded as research and development expense until regulatory approval for the product is obtained. As of December 31, 2022, and 2021, the Company did not have pre-launch inventory that qualified for capitalization.

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, clinical 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 with third-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 has not 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.

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 than not to be realized.

Uncertain tax positions are recognized only when the Company believes it is more likely than not 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 did not have any accrued interest or penalties associated with uncertain tax positions as of December 31, 2022 and 2021.

The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2015, although carryforward attributes that were generated prior to 2017 may still 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 year 2018” ("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 has not 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") subtopic 505-50. 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 the two-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. The two-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 assets in both the United States and Europe as of December 31, 2022 and 2021.

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.

Application of New or Revised Accounting Standards—Adopted

From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date.

In August 2020, the FASB issued Accounting Standards Update (“ASU”) No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40); Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which addresses issues identified as a result of the complexities associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This update addresses, among other things, the number of accounting models for convertible debt instruments and convertible preferred stock, targeted improvements to the disclosures for convertible instruments and earnings-per-share (“EPS”) guidance and amendments to the guidance for the derivatives scope exception for contracts in an entity’s own equity, as well as the related EPS guidance. This update applies to all entities that issue convertible instruments and/or contracts in an entity’s own equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2020-06 did not have a material impact on the Company’s consolidated financial statements and disclosures.

In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40); Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the FASB Emerging Issues Task Force (“ASU 2021-04”), which aims to clarify and reduce diversity in issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. This update applies to all entities that issue freestanding written call options that are classified in equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2021-04 did not have a material impact on the Company’s consolidated financial statements and disclosures.

Note J - Common Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares	Dec. 31, 2022	Dec. 31, 2021
Common shares reserved for future issuance (in shares)	12,547,880	11,236,414
Warrant [Member]
Common shares reserved for future issuance (in shares)	4,252,600	4,252,600
Share-Based Payment Arrangement [Member]
Common shares reserved for future issuance (in shares)	2,456,407	1,273,879
Possible Future Issuances Under Equity Incentive Plans [Member]
Common shares reserved for future issuance (in shares)	4,421,508	4,209,935
Possible Future Issuances Under Employee Stock Purchase Plans [Member]
Common shares reserved for future issuance (in shares)	1,417,365	1,500,000

Document And Entity Information - USD ($)	12 Months Ended
Document And Entity Information - USD ($)	Dec. 31, 2022	Dec. 31, 2021	Mar. 03, 2023	Jun. 30, 2022
Document Information [Line Items]
Entity Central Index Key	0001434647
Entity Registrant Name	ZEVRA THERAPEUTICS, INC.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2022
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2022
Document Transition Report	false
Entity File Number	001-36913
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-5894398
Entity Address, Address Line One	1180 Celebration Boulevard, Suite 103
Entity Address, City or Town	Celebration
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34747
City Area Code	321
Local Phone Number	939-3416
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	ZVRA
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Public Float				$ 152,900,000
Entity Common Stock, Shares Outstanding			34,540,414
Auditor Firm ID	42	49
Auditor Name	Ernst & Young LLP	RSM US LLP
Auditor Location	Orlando, Florida	Orlando, Florida

Note K - Stock-based Compensation - Schedule of Stock Option Activity (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Outstanding, number of options (in shares)	1,273,879
Outstanding, weighted average exercise price (in dollars per share)	$ 27.58
Outstanding, weighted average remaining contractual term (Year)	8 years 6 months 3 days	8 years 8 months 23 days
Outstanding, aggregate intrinsic value	$ 11,819	$ 254,207
Granted, number of options (in shares)	1,434,245
Granted, weighted average exercise price (in dollars per share)	$ 6.32
Exercised or released, number of options (in shares)	0
Exercised or released, weighted average exercise price (in dollars per share)	$ 0
Canceled or forfeited, number of options (in shares)	245,593
Canceled or forfeited, weighted average exercise price (in dollars per share)	$ 9.23
Canceled or forfeited, aggregate intrinsic value	$ 74,033
Expired, number of options (in shares)	6,124
Expired, weighted average exercise price (in dollars per share)	$ 93.60
Outstanding, number of options (in shares)	2,456,407	1,273,879
Outstanding, weighted average exercise price (in dollars per share)	$ 16.84	$ 27.58
Exercisable, number of options (in shares)	615,001
Exercisable, weighted average exercise price (in dollars per share)	$ 44.52
Exercisable, weighted average remaining contractual term (Year)	6 years 11 months 26 days
Exercisable, aggregate intrinsic value	$ 2,722
Vested and expected to vest, number of options (in shares)	2,375,700
Vested and expected to vest, weighted average exercise price (in dollars per share)	$ 17.15
Vested and expected to vest, weighted average remaining contractual term (Year)	8 years 5 months 26 days
Vested and expected to vest, aggregate intrinsic value	$ 11,628

Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Net loss attributable to common stockholders	$ (41,543)	$ (62,897)
Other comprehensive income:
Foreign currency translation adjustment	113	0
Other comprehensive income	113	0
Comprehensive loss	$ (41,430)	$ (62,897)

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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Note E - Property and Equipment - Estimated Useful Lives of Property and Equipment (Details)	12 Months Ended
	Dec. 31, 2022
Minimum [Member]
Property and equipment, useful lives (Year)	3 years
Maximum [Member]
Property and equipment, useful lives (Year)	10 years
Laboratory Equipment [Member]
Property and equipment, useful lives (Year)	10 years
Furniture and Fixtures [Member] \| Minimum [Member]
Property and equipment, useful lives (Year)	5 years
Furniture and Fixtures [Member] \| Maximum [Member]
Property and equipment, useful lives (Year)	10 years
Computer and Hardware [Member] \| Minimum [Member]
Property and equipment, useful lives (Year)	3 years
Computer and Hardware [Member] \| Maximum [Member]
Property and equipment, useful lives (Year)	7 years
Leasehold Improvements [Member]
Property and equipment, useful lives (Year)	9 years

Note Q - Significant Events

12 Months Ended

Dec. 31, 2022

Significant Events [Text Block]

Q.	Significant Events

On January 6, 2023, the Board appointed Richard W. Pascoe to serve as the Company’s Chief Executive Officer, effective immediately. Concurrently with his appointment as Chief Executive Officer, Mr. Pascoe stepped down as the Company’s Executive Chairman. Mr. Pascoe will continue to serve as a member of the Board. Mr. Pascoe has been designated as the Company’s principal executive officer, succeeding Travis C. Mickle, Ph.D., the Company’s President and former Chief Executive Officer, in such role. On January 6, 2023, Dr. Mickle resigned his role (i) as Chief Executive Officer, effective immediately, and (ii) as President and as a member of the Board, in each case, effective as of the date of the Company’s 2023 Annual Meeting of Stockholders. Additionally, the Board has appointed Matthew R. Plooster, a member of the Board, as the Chairman of the Board.

In connection with Mr. Pascoe’s appointment as the Company’s Chief Executive Officer, the Company and Mr. Pascoe entered into an amendment to the employment agreement, dated November 5, 2021, by and between the Company and Mr. Pascoe (the “Amendment”). Pursuant to the Amendment, Mr. Pascoe became entitled to receive an option under the A&R 2014 Plan to purchase 700,000 shares of the Company’s common stock at an exercise price equal to the closing price of the Company’s common stock on January 9, 2023. The option will vest in four equal annual installments, with the first such installment occurring on January 6, 2024 (subject to Mr. Pascoe’s continued service to the Company through the applicable vesting date).

In connection with the management transition, the Company entered into (i) a transition agreement with Dr. Mickle (the “Transition Agreement”) and (ii) a consulting agreement with Dr. Mickle (the “Consulting Agreement”). Pursuant to the terms of the Transition Agreement, subject to his timely delivering a release of claims in the Company’s favor, Dr. Mickle will receive severance payments and benefits consisting of (i) continued payment of his base salary for 18 months following the date on which Dr. Mickle’s employment with the Company ends (the “Separation Date”), (ii) up to 18 months of continued medical, dental and vision coverage pursuant to COBRA and (iii) a one-time, lump sum bonus payment equal to a pro rata amount of his annual performance-based target bonus for the year in which the Separation Date occurs. In addition, immediately prior to the Separation Date, all outstanding options to purchase the Company’s common stock held by Dr. Mickle will be vested in full, and such accelerated vested options may be exercised through the later of (i) the 18-month anniversary of the date of the Transition Agreement and (ii) the date of the termination of the Consulting Agreement. Pursuant to the terms of the Consulting Agreement, Dr. Mickle has agreed to provide consulting services until the first anniversary of the Company’s 2023 Annual Meeting of Stockholders. In exchange for such services, Dr. Mickle will receive consulting fees of $40,000 per month. In addition, Dr. Mickle was granted, under the A&R 2014 Plan, 547,945 performance-based restricted stock units, which will vest in full upon the timely achievement of a clinical and development milestone, subject to forfeiture upon certain disqualifying events.

Note K - Stock-based Compensation - Black-Scholes Option-pricing Model (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Expected dividend yield	0.00%	0.00%
Minimum [Member]
Risk-free interest rate	1.70%	0.92%
Expected term (in years) (Year)	5 years 6 months	5 years 6 months
Expected volatility	91.28%	96.91%
Maximum [Member]
Risk-free interest rate	3.80%	1.55%
Expected term (in years) (Year)	7 years	10 years
Expected volatility	98.91%	102.57%

Note O - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating cash flows from finance leases	$ 2	$ 9
Financing cash flows from finance leases	16	173
Operating cash flows from operating leases	522	460
Operating cash flows from short-term leases	210	199
Operating cash flows from variable lease costs	39	47
Finance leases	0	0
Operating leases	$ 123	$ 0

Note L - Fair Value of Financial Instruments (Details Textual)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)
OTA Warrant [Member]
Liabilities, Fair Value Disclosure, Total	$ 1,000	$ 288,000
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Liquidity Event	30,000,000.0
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Fundamental Change	$ 379,000,000
OTA Warrant [Member] \| Weighted Average Probability of Liquidity Event [Member]
Derivative Liability, Measurement Input	0.25
OTA Warrant [Member] \| Weighted Average Probability of Fundamental Change [Member]
Derivative Liability, Measurement Input	0.28
Embedded Put Option [Member]
Liabilities, Fair Value Disclosure, Total	$ 0	$ 18,000

Note M - Income Taxes (Details Textual) - USD ($)	12 Months Ended
Note M - Income Taxes (Details Textual) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
State and Local Income Tax Expense (Benefit), Continuing Operations, Total	$ 31,000	$ 34,000
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total	(42,329,000)	(8,521,000)
Deferred Tax Assets, Tax Credit Carryforwards, Research	6,900,000	6,411,000
Foreign Tax Authority [Member] \| Danish [Member]
Deferred Tax Assets, Tax Credit Carryforwards, Research	800,000
State and Local Jurisdiction [Member]
Operating Loss Carryforwards	236,000,000.0
Operating Loss Carryforwards, Subject to Expiration	$ 138,100,000	$ 225,200,000
Operating Loss Carryforwards, Expiration, Beginning Year	2027	2027
Operating Loss Carryforwards, Not Subject to Expiration	$ 97,900,000

Note K - Stock-based Compensation - Nonvested Stock Option Awards (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2020
Number of unvested shares (in shares)	1,841,406	966,664
Exercise Price Range One [Member]
Lower range (in dollars per share)	$ 2.848
Number of unvested shares (in shares)	1,824,285	861,139
Exercise Price Range Two [Member]
Lower range (in dollars per share)	$ 10.01
Number of unvested shares (in shares)	0	60,000
Exercise Price Range Three [Member]
Lower range (in dollars per share)	$ 30.01
Number of unvested shares (in shares)	17,121	36,190
Exercise Price Range Four [Member]
Lower range (in dollars per share)	$ 50.01
Number of unvested shares (in shares)	0	0
Exercise Price Range Five [Member]
Lower range (in dollars per share)	$ 70.01
Number of unvested shares (in shares)	0	9,335

Note E - Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Property and equipment, gross	$ 2,237	$ 2,809
Less: accumulated depreciation and amortization	(1,443)	(1,925)
Property and equipment, net	794	884
Laboratory Equipment [Member]
Property and equipment, gross	710	645
Furniture and Fixtures [Member]
Property and equipment, gross	104	71
Computer and Hardware [Member]
Property and equipment, gross	462	338
Leasehold Improvements [Member]
Property and equipment, gross	710	724
Finance Lease, Right-of-Use Assets [Member]
Property and equipment, gross	$ 251	$ 1,031

Note M - Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Effective Income Tax Rate Reconciliation [Table Text Block]

	*Year ended December 31,*
	*2022*			*2021*
Federal statutory rate		21.00	%		21.00	%
Effect of:
Change in valuation allowance		(22.06	)		(28.39	)
Return to provision and deferred true-up		(3.41	)		(0.26	)
Federal research and development credit		1.16			-
State research and development credit		0.07			-
Change in rate		0.51			3.00
State tax benefit (net of federal)		3.03			5.14
Warrant liability		0.16			(0.06	)
Stock-based compensation		(0.69	)		(2.68	)
PPP Loan forgiveness		-			1.94
Global intangible low-taxed income credit		(1.22	)		-
Foreign research and development excess benefit		3.16			-
Other		0.15			(0.08	)
Federal income tax provision effective rate		1.86	%		(0.39	)%

Schedule of Deferred Tax Assets and Liabilities [Table Text Block]

	*December 31,*
	*2022*			*2021*
Deferred tax assets relating to:
Net operating loss carryforwards	$	66,373		$	60,977
Research and development tax carryforward		6,900			6,411
Stock-based compensation		4,185			4,807
174 expenses		3,730			-
Right-of-use liability		359			424
Property and equipment		22			14
Other deferred tax assets		598			288
Total gross deferred tax assets		82,167			72,921
Deferred tax liabilities relating to:
Right-of-use asset		(336	)		(401	)
Other deferred tax liabilities		-			(9	)
Total gross deferred tax liabilities		(336	)		(410	)
Deferred tax assets less liabilities		81,831			72,511
Valuation allowance		(81,831	)		(72,511	)
Net deferred tax asset (liability)	$	-		$	-

Note G - Debt Obligations

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Text Block]

G.	Debt Obligations

Deerfield Facility Agreement

In June 2014, the Company entered into a $60 million multi-tranche credit facility (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). At the time the Company entered into the Deerfield Facility Agreement, the Company borrowed the first tranche, which consisted of a term loan of $15 million (the “Term Note”) and a senior secured loan of $10 million (the “Deerfield Convertible Note”). The Deerfield Convertible Note originally bore interest at 9.75% per annum but was subsequently reduced to 6.75%.

Pursuant to the Deerfield Facility Agreement, the Company issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred, which is exercisable until June 2, 2024, and Deerfield assigned this warrant to OTA LLC in December of 2022 (the “OTA Warrant”). Upon completion of the Company’s initial public offering, the OTA Warrant automatically converted into a warrant to purchase 120,192 shares of the Company’s common stock. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note O). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement), OTA may require the Company to redeem the OTA Warrant for a cash amount equal to the Black-Scholes value of the portion of the OTA Warrant to be redeemed (the “Warrant Put Option”).

The Company recorded the fair value of the shares of Series D Preferred to debt issuance costs on the date of issuance. The Company also recorded the fair value of the OTA Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount were amortized over the term of the related debt and the expense was recorded as interest expense related to amortization of debt issuance costs and discount in the consolidated statements of operations. As discussed below, in the first quarter of 2021, the debt was extinguished, through a series of debt payments and a conversion of debt principal and interest to Series B-2 Preferred Stock. As a result of the debt extinguishment, the associated discount and debt issuance costs were written off and recorded as a loss on extinguishment in the consolidated statements of operations.

5.50% Senior Convertible Notes

In February 2016, the Company issued $86.3 million aggregate principal amount of its 5.50% Senior Convertible Notes due 2021 (the “2021 Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of several initial purchasers, who subsequently resold the 2021 Notes to qualified institutional buyers, including Kingdon Offshore Master Fund, LP (“Kingdon”) in reliance on the exemption from registration provided by Rule 144A under the Securities Act of 1933, as amended.

As described in more detail below, in multiple exchanges, all outstanding 2021 Notes were exchanged by the holders thereof for either shares of our common stock or senior secured convertible promissory notes issued under the terms of the Deerfield Facility Agreement.

2021 Note Exchange Effected in December 2019

In December 2019, the Company entered into the December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the “December 2019 Exchange Agreement”) with Deerfield and Deerfield Special Situations Fund LP (collectively, “the Deerfield Lenders”) and Delaware Street Capital Master Fund, L.P. (“DSC” and, collectively with the Deerfield Lenders, the “December 2019 Holders”). Under the December 2019 Exchange Agreement, the Company issued senior secured convertible promissory notes under the Deerfield Facility Agreement in the aggregate principal amount of approximately $71.4 million (the “December 2019 Notes”), in exchange for the cancellation of an aggregate of approximately $71.4 million principal amount and accrued interest of the Company’s 2021 Notes. The December 2019 Notes bore interest at 6.75% per annum.

2021 Note Exchange Effected in January 2020

In January 2020, the Company entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with Kingdon. Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of approximately $3.0 million (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3.0 million principal amount and accrued interest of the 2021 Note then owned by Kingdon.

December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement

In December 2020, the Company entered into a December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement (the “December 2020 Exchange Agreement”). with the Deerfield Lenders, DSC and Kingdon (collectively, the “Facility Agreement Note Holders”). Under the December 2020 Exchange Agreement, the Company and the Facility Agreement Note Holders agreed that the Company would make a cash pre-payment of a portion of principal amount of the Deerfield Convertible Note, the December 2019 Notes and the January 2020 Note to the Facility Agreement Note Holders (the “Debt Payment”) equal to approximately $30.3 million, plus accrued interest and that the Company would issue shares of its Series B-2 Preferred Stock and warrants exercisable for shares of its common stock (the “Exchange Warrants”), in exchange for the cancellation of a portion of the principal amount of the Deerfield Facility Agreement (such transaction, the “December 2020 Exchange”).

In anticipation of the Public Offering, and to meet the Nasdaq Listing Requirements, the Company agreed in December 2020 to restructure the December 2019 Notes and the January 2020 Note in the aggregate principal amount of $60.8 million and the Deerfield Note in the principal amount of $7.5 million (collectively the "the Facility Notes").

Under the terms of the December 2020 Exchange Agreement, the Company, on January 12, 2021, in connection with the closing of the Public Offering:

	●	Exchanged $31.5 million of the outstanding principal and accrued interest on the Facility Notes for (i) 31,476.98412 shares of Series B-2 Preferred Stock, and (ii) Exchange Warrants exercisable for 3,632,019 shares of the Company's common stock, and

	●	Made the Debt Payment, in partial repayment of the remaining outstanding principal and accrued interest of the Facility Notes.

Following the completion of these transactions, the aggregate balance of principal and accrued interest remaining outstanding under the Facility Notes was approximately $7.6 million. With respect to this remaining outstanding balance under the Facility Notes, the December 2020 Exchange Agreement amended the terms of that debt to provide that:

	●	The maturity date was amended to March 31, 2023, and the debt was prepayable upon specified conditions, and

	●	Interest would accrue at the rate of 6.75% per annum, payable quarterly, would be added to principal until June 30, 2021, and then be payable in cash thereafter.

The changes to the Facility Notes, under the December 2020 Exchange Agreement, were accounted for as a debt extinguishment as the cash flows immediately after the December 2020 Exchange Agreement were substantially different from the cash flows immediately prior to the December 2020 Exchange Agreement and while the Company was experiencing financial difficulties it was determined that the lender did not grant a concession. As such, a loss on extinguishment of debt is recorded in the consolidated statement of operations for the year ended December 31, 2021, and additional debt issuance costs related the new notes were capitalized and amortized using the effective interest method through the Payoff of Facility Agreement Notes (discussed below).

Payoff of Facility Agreement Notes and Termination of Facility Agreement

On February 8, 2021, the Company entered into a payoff letter with the Facility Agreement Note Holders, pursuant to which the Company agreed to pay off and thereby terminate the Facility Agreement.

Pursuant to the payoff letter, the Company paid a total of $8.0 million to the Facility Agreement Note Holders, representing the principal balance, accrued interest outstanding and a prepayment fee in repayment of the Company’s outstanding obligations under the Facility Agreement.

Pursuant to the payoff letter, all outstanding indebtedness and obligations of the Company owing to the Facility Agreement Note Holders under the Facility Agreement have been paid in full. The Facility Agreement and the notes thereunder, as well as the security interests in the assets of the Company securing the Facility Agreement and note obligations, have been terminated. The Facility Agreement Note Holders will retain the warrants previously issued to them by the Company.

The Company determined the payoff letter met the liability derecognition threshold under ASC 405-20, Liabilities - Extinguishment of Liabilities, as the Company repaid the debt (and has been relieved of the related obligation) without entering into new debt with the Facility Agreement Note Holders and there is no other continuing debt with the Facility Agreement Note Holders. The payoff letter resulted in a loss on extinguishment of debt which is shown within other (expense) income in the statements of operations for the year ended December 31, 2021.

PPP Loan

On April 23, 2020, the Company received proceeds of $0.8 million from a loan under the Paycheck Protection Program (“PPP Loan”) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. In May 2021, the Company received notice from the U.S. Small Business Administration that the principal and interest due under its PPP Loan had been forgiven in full. This gain on extinguishment is shown, net of the loss on extinguishment of debt discussed above, within other (expense) income in the statements of operations for the year ended December 31, 2021.

Line of Credit

On May 31, 2022, the Company and Ameris Bank, as lender, entered into a $20.0 million revolving loan agreement (the “Line of Credit”). Proceeds of the revolving facility provided by the Line of Credit are to be used for general corporate purposes. Loans under the Line of Credit bear interest at the Secured Overnight Financing Rate ("SOFR") plus 1.60%, with a SOFR floor of 0.00%.

The revolving facility under the Line of Credit is secured by a perfected security interest in deposit accounts. The revolving facility under the Line of Credit is subject to customary affirmative and negative covenants.

The latest maturity date of the loans under the Line of Credit is May 31, 2025. The Line of Credit contains customary events of default that could lead to an acceleration of the loans, including cross-default, bankruptcy and payment defaults. As of December 31, 2022, the Company has drawn $12.8 million from the Line of Credit to finance the transactions under the Arimoclomol Purchase Agreement, and this amount is supported by a $12.8 million certificate of deposit which is shown as long-term investments - other in the consolidated balance sheets. The remaining $7.2 million under the Line of Credit is in a separate interest-bearing certificate of deposit and is also recorded as long-term investments - other in the consolidated balance sheet as of December 31, 2022. These certificates of deposit are pledged as collateral against the Line of Credit and cannot be redeemed so long as the $20.0 million remains available under the Line of Credit. The total value of the certificates of deposit held with Ameris Banks must meet or exceed the amount available to borrow under the Line of Credit so long as the Line of Credit remains active.

On January 26, 2023, the Company and Wells Fargo, as lender, entered into a margin account agreement under which the Company initially borrowed $12.8 million. The margin account bears interest at the Prime rate minus 225 basis-points.

On January 31, 2023, the Company repaid the $12.8 million outstanding under the Line of Credit in full, but the line of credit remains available for future use. As such, the certificates of deposit continue to be classified as long-term investments - other.

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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-Name Accounting Standards Codification
-Topic 470
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Section 50
-Paragraph 1C
-Subparagraph (c)
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1I
-Subparagraph (d)
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 20
-Section 50
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-Subparagraph (g)
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Note L - Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Balance as of beginning of period	$ 306	$ 255
Adjustment to fair value	(305)	51
Balance as of end of period	$ 1	$ 306

Note O - Leases - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
2023, finance leases	$ 7
2023, operating leases	563
2024, finance leases	0
2024, operating leases	488
2025, finance leases	0
2025, operating leases	389
2026, finance leases	0
2026, operating leases	30
2027, finance leases	0
2027, operating leases	0
Thereafter, finance leases	0
Thereafter, operating leases	0
Total lease payments, finance leases	7
Total lease payments, operating leases	1,470
Less: future interest expense, finance leases	(1)
Less: future interest expense, operating leases	(147)
Lease liabilities, finance leases	6	$ 21
Lease liabilities, operating leases	$ 1,323	$ 1,588

Note D - Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2022

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block]

	*December 31,*
	*2022*		*2021*
Prepaid insurance	$	577	$	637
Prepaid offering costs		-		293
Other prepaid expenses and current assets		1,300		252
Total prepaid expenses and other current assets	$	1,877	$	1,182

Note B - Summary of Significant Accounting Policies (Details Textual)					3 Months Ended	12 Months Ended
	May 15, 2022 USD ($)	May 07, 2021 USD ($)	Mar. 02, 2021 USD ($)	Mar. 20, 2012	Mar. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Jul. 31, 2020 USD ($)
Investments, Fair Value Disclosure, Total						$ 16,900,000	$ 14,900,000
Unrealized Gain (Loss) on Investments						(577,000)	(13,000)
Certificates of Deposit, at Carrying Value						20,500,000	500,000
Impairment, Long-Lived Asset, Held-for-Use, Total						0	0
Revenue from Contract with Customer, Including Assessed Tax						10,458,000	28,650,000
Inventory, Noncurrent, Total						671,000	0
Income Tax Examination, Penalties and Interest Accrued						$ 0	0
Income tax returns under examination						0
Pre-launch Inventory that Qualified for Capitalization [Member]
Inventory, Net, Total						$ 0	0
Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax						100,000	100,000
Deferred Revenue, Total						0	0
GPC Member \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax		$ 10,000,000.0	$ 10,000,000.0
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized		$ 590,000,000.0
Deferred Revenue, Total						0	0
Aquestive Therapeutics [Member] \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax						900,000	20,900,000
Royalty Revenue, Percent				10.00%
Corium, Inc [Member] \| Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax					$ 2,000,000.0	4,700,000	7,700,000
Deferred Revenue, Total						0	$ 400,000
Consulting Agreement, Maximum Amount to be Received								$ 15,600,000
Contract with Customer, Asset, after Allowance for Credit Loss, Total								13,600,000
Consulting Agreement, Conditional Milestone Achievement to be Received								$ 2,000,000.0
Arimoclomol Purchase Agreement [Member]
Contract with Customer, Liability, Revenue Recognized						4,800,000
Contract with Customer, Clawback Liability						3,800,000
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability	$ 5,200,000					$ 9,000,000.0
Minimum [Member]
Property, Plant and Equipment, Useful Life (Year)						3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life (Year)						10 years

Note K - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	12 Months Ended
	Jan. 01, 2023	Jun. 30, 2021	Dec. 31, 2022	Dec. 31, 2021	Jan. 31, 2023
Employee Stock Purchase Plan, Maximum Number of Issuable Shares (in shares)		1,500,000
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares)			82,635
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate			0.00%	0.00%
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share)			$ 5.01	$ 7.53
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value			$ 3,700	$ 2,000
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total			$ 8,200
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)			2 years 9 months 25 days
Share-based Payment Arrangement, Expense			$ 4,294	2,436
Performance Shares [Member]
Share-based Payment Arrangement, Expense			$ 400	$ 400
2014 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)		4,900,000,000,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)			6,889,885
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding		4.00%
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares)			0	0
2014 Equity Incentive Plan [Member] \| Subsequent Event [Member]
Increase in Common Stock Reserved for Issuance (in shares)	1,381,612
The 2023 Plan [Member] \| Subsequent Event [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)					1,500,000

Note A - Description of Business, Basis of Presentation, and Significant Transactions

12 Months Ended

Dec. 31, 2022

Business Description and Basis of Presentation [Text Block]

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

Organization

Zevra Therapeutics, Inc. (the "Company") is a biotechnology company focused on the discovery, development, and commercialization of novel treatments for rare central nervous system (“CNS”) and neurodegenerative diseases, lysosomal storage disorders, and related treatment areas. The Company has a diverse product portfolio, combining a clinical-stage pipeline with new drug application (“NDA”) stage and commercial assets. The Company’s pipeline includes arimoclomol, an orally-delivered, first-in-class investigational product candidate for Niemann-Pick disease type C (“NPC”), and KP1077, which the Company is developing as a treatment for idiopathic hypersomnia (“IH”), a rare neurological sleep disorder, and narcolepsy. In addition, the U.S. Food and Drug Administration (“FDA”) has approved AZSTARYS®, formerly referred to as KP415, a once-daily treatment for attention deficit hyperactivity disorder (“ADHD”) in patients six years and older containing the Company’s prodrug, serdexmethylphenidate (“SDX”), which is being commercialized by Corium, Inc. (“Corium”), an affiliate of Gurnet Point Capital, L.P. (“GPC”), in the U.S. The FDA has also approved APADAZ®, an immediate-release combination product containing benzhydrocodone, the Company’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. (“KVK”) in the U.S. The Company changed its name from KemPharm, Inc. to Zevra Therapeutics, Inc. effective as of February 21, 2023.

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.

Arimoclomol Acquisition

On May 15, 2022, the Company and Zevra Denmark A/S (formerly known as KemPharm Denmark A/S prior to February 21, 2023) (“Zevra DK”), a newly formed Danish company and wholly-owned subsidiary of the Company entered into an asset purchase agreement (the “Arimoclomol Purchase Agreement”) with Orphazyme A/S in restructuring, a Danish public limited liability company (“Orphazyme”). The Arimoclomol Purchase Agreement closed on May 31, 2022. Under the terms of the Arimoclomol Purchase Agreement, Zevra DK purchased all of the assets and operations of Orphazyme related to arimoclomol and settled all of Orphazyme’s actual outstanding liabilities to its creditors with a cash payment of $12.8 million. In addition, Zevra DK agreed to assume an estimated reserve liability of $5.2 million related to revenue generated from Orphazyme’s Early Access Program in France.

The Company accounted for the arimoclomol acquisition as an asset acquisition as the majority of the value of the assets acquired related to the arimoclomol acquired in-process research and development (“IPR&D”) asset. The intangible asset associated with IPR&D relates to arimoclomol. The estimated fair value of $17.7 million was determined using the excess earnings valuation method, a variation of the income valuation approach. The excess earnings valuation method estimates the value of an intangible asset equal to the present value of the incremental after-tax cash flows attributable to that intangible asset over its remaining economic life. Some of the more significant assumptions utilized in our asset valuations included projected revenues, probability of commercial success, and the discount rate. The fair value using the excess earnings valuation method was determined using an estimated weighted average cost of capital of 42%, which reflects the risks inherent in future cash flow projections and represents a rate of return that a market participant would expect for this asset. This fair value measurement was based on significant inputs not observable in the market and thus represent Level 3 fair value measurement.

In accordance with Accounting Standards Codification (ASC) Subtopic 730-10-25, Accounting for Research and Development Costs, the up-front payments to acquire a new drug compound, as well as future milestone payments when paid or payable, are immediately expensed as acquired IPR&D in transactions other than a business combination provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Therefore, the portion of the purchase price that was allocated to the IPR&D assets acquired was immediately expensed. Other assets acquired and liabilities assumed, were recorded at fair value. The company also recorded a $0.8 million income tax benefit for the year-ended December 31, 2022, related to research and development credits that are expected to be realized from the local jurisdiction in Denmark.

The following represents the consideration paid and purchase price allocation for the acquisition of arimoclomol (in thousands):

Cash	$	12,800
Assumed reserve liability		5,200
Total consideration	$	18,000

Total consideration		18,000
Direct transaction costs associated with the acquisition (1)		1,290
Total purchase price to be allocated	$	19,290

Property and equipment, inventory and assembled workforce acquired		1,627
IPR&D (2)		17,663
Total allocated purchase price	$	19,290

(1) As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees and legal expenses.

(2) The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset.

Underwriting Agreement

On January 8, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC (the “Underwriter” or “Roth”), to issue and sell 6,765,463 shares of common stock of the Company, pre-funded warrants to purchase 926,844 shares of common stock and warrants to purchase 7,692,307 shares of common stock in an underwritten public offering (the “Public Offering”) pursuant to a registration statement on Form S-1 (File No. 333-250945) and a related prospectus, in each case filed with the SEC. The offering price to the public was $6.50 per share of common stock and accompanying warrant, representing a public offering price of $6.4999 per share of common stock and $0.0001 per related warrant. In addition, the Company granted the Underwriter an option to purchase, for a period of 45 days, up to an additional 1,153,846 shares of the Company’s common stock and/or warrants to purchase up to an additional 1,153,846 shares of the Company’s common stock and/or warrants to purchase up to an additional 1,153,846 of the Company’s common stock.

On January 8, 2021, the Underwriter exercised its over-allotment option, in part, for warrants to purchase 754,035 shares of the Company’s common stock. Further on February 1, 2021, the Underwriter again exercised its over-allotment option to purchase 374,035 shares of common stock.

On January 12, 2021, the Company closed the Public Offering. The aggregate gross proceeds to the Company from the Public Offering, including over-allotment, totaled approximately $52.4 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company.

On January 25, 2022, the Company filed an amendment to the registration statement on Form S-1 (File No. 333-250945) on Form S-3 covering the issuance of the shares of our common stock issuable upon the exercise of the warrants issued in the Public Offering and remaining unexercised as of the date of the amendment, which was declared effective on February 1, 2022.

Listing on the Nasdaq Stock Market

On January 7, 2021, the Company’s common stock was approved for listing on the Nasdaq Capital Market. The Company’s common stock began trading on the Nasdaq Capital Market on January 8, 2021, under the ticker symbol “KMPH”.

On October 19, 2021, the Company announced that its shares of common stock were approved for listing to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market commenced effective with the open of business on October 19, 2021, under the Company’s ticker symbol, “KMPH”. The Company was previously listed on the Nasdaq Capital Market, following its uplisting to the exchange in January 2021.

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".

Entry into 2021 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 may offer 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 the 2021 ATM Agreement will be made pursuant to a registration statement on Form S-3. JMP and RBCCM may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended. JMP and RBCCM 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 may impose). The Company will pay JMP and RBCCM a commission equal to 3.0% in the aggregate of the gross sales proceeds of any common stock sold through JMP and RBCCM under the 2021 ATM Agreement. The Company filed a registration statement on Form S-3 covering the sale of the shares of its common stock up to $350.0 million, $75.0 million of which was allocated to the sales of the shares of common stock issuable under the 2021 ATM Agreement, which was declared effective on July 12, 2021. As of December 31, 2022 and 2021, no shares have been issued or sold under the 2021 ATM Agreement.

Share Repurchase Program

On December 20, 2021, the Company initiated a share repurchase program (the “Share Repurchase Program”) pursuant to which the Company may repurchase up to $50 million of shares of its common stock through December 31, 2023. Capital allocation to the Share Repurchase Program will be based on a variety of factors, including our business results, the receipt of royalties and sales milestones under the AZSTARYS License Agreement (refer to Note B), and potentially other sources of non-dilutive capital that may become available to the Company. Repurchases will be made in compliance with Rule 10b-18 of the Securities Exchange Act of 1934, as amended, subject to a variety of factors, including the market price of the Company’s common stock, general market and economic conditions and applicable legal requirements. The exact number of shares to be repurchased by the Company is not guaranteed and the program may be suspended, modified, or discontinued at any time without prior notice. As of December 31, 2022, the Company has repurchased 909,953 shares of its common stock for approximately $7.5 million under the Share Repurchase Program.

Reclassifications

Certain reclassifications were made to the 2021 consolidated financial statements to conform to the classifications used in 2022. These reclassifications had no impact on the consolidated net loss, changes in stockholder's equity, or cash flows previously reported.

Note O - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
less: accumulated depreciation and amortization	$ (1,443)	$ (1,925)
Lease liabilities, finance leases	6	21
Operating lease right-of-use assets	988	1,141
Total operating lease right-of-use assets	988	1,141
Current portion of operating lease liabilities	480	356
Operating lease liabilities, less current portion	843	1,232
Total operating lease liabilities	$ 1,323	$ 1,588
Finance leases (Year)	1 year	1 year
Operating leases (Year)	3 years	4 years
Finance leases	14.30%	12.00%
Operating leases	7.30%	7.50%
Property and Equipment, At Cost [Member]
Property and equipment, at cost	$ 1,031	$ 1,031
Accumulated Depreciation and Amortization [Member]
less: accumulated depreciation and amortization	(780)	(651)
Property and Equipment, Net [Member]
Property and equipment, net	251	380
Other Current Liabilities [Member]
Other current liabilities	6	15
Other Noncurrent Liabilities [Member]
Other long-term liabilities	0	6
Operating Lease Right-of-Use Assets [Member]
Operating lease right-of-use assets	988	1,141
Total operating lease right-of-use assets	988	1,141
Current Portion of Operating Lease Liabilities [Member]
Current portion of operating lease liabilities	480	356
Operating Lease Liabilities, Less Current Portion [Member]
Operating lease liabilities, less current portion	$ 843	$ 1,232

Note C - Accounts and Other Receivables (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block]

	*December 31,*
	*2022*		*2021*
Accounts receivable	$	7,185	$	1,421
Other receivables		1,114		107
Total accounts and other receivables	$	8,299	$	1,528

Note I - Preferred Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Millions		1 Months Ended	12 Months Ended
	Jan. 12, 2021	Mar. 31, 2021	Dec. 31, 2021	Dec. 31, 2022
Preferred Stock, Shares Authorized (in shares)			10,000,000	10,000,000
Preferred Stock, Shares Outstanding, Ending Balance (in shares)			0	0
Preferred Stock, Shares Issued (in shares)			0	0
Conversion of Series B-2 Preferred Stock into Common Stock [Member]
Conversion of Stock, Shares Issued (in shares)		4,842,699	4,842,699
The Facility Notes [Member]
Repayments of Long-term Debt, Total	$ 30.3
Series B-2 Convertible Preferred Stock [Member]
Preferred Stock, Convertible, Shares Issuable (in shares)	4,842,690
Preferred Stock, Convertible, Conversion Price (in dollars per share)	$ 6.4999
December 2020 Exchange Agreement [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares)	31,476.98412
Debt Conversion, Converted Instrument, Warrants or Options Issued (in shares)	3,632,019
Debt Conversion, Original Debt, Amount	$ 31.5

Note J - Common Stock and Warrants (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block]

	*December 31,*
	*2022*		*2021*
Outstanding awards under equity incentive plans		2,456,407		1,273,879
Outstanding common stock warrants		4,252,600		4,252,600
Possible future issuances under equity incentive plans		4,421,508		4,209,935
Possible future issuances under employee stock purchase plan		1,417,365		1,500,000
Total common shares reserved for future issuance		12,547,880		11,236,414

Schedule of Common Stock Outstanding Roll Forward [Table Text Block]

	*Shares of*
	*Common Stock*
Balance as of January 1, 2021		4,537,321
Common stock issued as a result of the Public Offering		7,139,498
Common stock issued as a result of Series B-2 Preferred Stock conversions		4,842,699
Common stock issued as a result of warrant exercises		18,772,510
Common stock issued as compensation to third-parties		35,129
Adjustment for cash paid in lieu of DTC fractional shares		(1,356	)
Common stock repurchased as a result of the Stock Repurchase Program		(320,161	)
Balance as of December 31, 2021		35,005,640
Common stock issued as compensation to third-parties		41,821
Common stock repurchased as a result of the Stock Repurchase Program		(589,792	)
Common stock issued as a result of the Employee Stock Purchase Plan		82,635
Balance as of December 31, 2022		34,540,304

Note O - Leases (Details Textual)	12 Months Ended
Note O - Leases (Details Textual)	Dec. 31, 2022
Lessee, Lease, Option to Extend, Maximum Term (Year)	5 years
Lessee, Lease, Option to Terminate, Term (Year)	1 year
Minimum [Member]
Lessee, Lease, Remaining Term of Contract (Year)	1 year
Maximum [Member]
Lessee, Lease, Remaining Term of Contract (Year)	4 years

Note L - Fair Value of Financial Instruments

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Text Block]

L.	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 a three-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. The three 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 and accounts payable and accrued expenses, 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, 2022 and 2021 (in thousands):

			*Quoted Prices*		*Significant*
			*in Active*		*Other*		*Significant*
	*Balance at*		*Markets for*		*Observable*		*Unobservable*
	*December 31,*		*Identical Assets*		*Inputs*		*Inputs*
	*2022*		*(Level 1)*		*(Level 2)*		*(Level 3)*
OTA Warrant liability	$	1	$	-	$	-	$	1
Total liabilities	$	1	$	-	$	-	$	1
Securities:
U.S. government-sponsored agency securities	$	7,189	$	-	$	7,189	$	-
U.S. Treasury securities		9,711		9,711		-		-
Total assets	$	16,900	$	9,711	$	7,189	$	-

			*Quoted Prices*		*Significant*
			*in Active*		*Other*		*Significant*
	*Balance at*		*Markets for*		*Observable*		*Unobservable*
	*December 31,*		*Identical Assets*		*Inputs*		*Inputs*
	*2021*		*(Level 1)*		*(Level 2)*		*(Level 3)*
OTA Warrant liability	$	288	$	-	$	-	$	288
Embedded Warrant Put Option		18		-		-		18
KVK Warrant liability		24		-		24		-
Total liabilities	$	330	$	-	$	24	$	306

The Company’s OTA Warrant liability, embedded Warrant Put Option and securities are measured at fair value on a recurring basis. As of December 31, 2022, and 2021, the OTA Warrant liability and embedded Warrant Put Option are reported on the accompanying consolidated balance sheets in derivative and warrant liability. As of December 31, 2022, and 2021, the securities are reported on the accompanying consolidated balance sheets in short-term and long-term investments. The Company used a Monte Carlo simulation to value the OTA Warrant liability and embedded Warrant Put Option for all periods presented herein. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the OTA Warrant liability and embedded Warrant Put Option are reflected in the accompanying consolidated statements of operations for the years ended December 31, 2022, and 2021, as a fair value adjustment related to derivative and warrant liability.

The derivative liability for the OTA Warrant was $1,000 and $288,000 at December 31, 2022, and 2021, respectively. The derivative liability for the embedded Warrant Put Option was $0 and $18,000 at December 31, 2022, and 2021, respectively. A 10% increase in the enterprise value would result in a negligible increase in the estimated fair value of the OTA Warrant liability and the estimated fair value of the embedded Warrant Put Option liability. In addition, the Company assumed a weighted-average probability of a liquidity event occurring of approximately 25% with an estimated probability-weighted value of approximately $30.0 million and a weighted-average probability of a fundamental change event occurring of approximately 28% with an estimated probability-weighted value of approximately $379 million, respectively, with estimated timing in each scenario of the fourth quarter of 2023.

The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of December 31, 2022, and 2021, the KVK Warrant liability is reported on the accompanying consolidated balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company's historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the consolidated statements of operations for the years ended December 31, 2022, and 2021, as a fair value adjustment related to derivative and warrant liability.

A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):

	*2022*			*2021*
Balance as of beginning of period	$	306		$	255
Adjustment to fair value		(305	)		51
Balance as of end of period	$	1		$	306

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Assets
Cash and cash equivalents	$ 65,466	$ 112,346
Securities at fair value	16,900	0
Short-term investments - other	481	0
Accounts and other receivables	8,299	1,528
Prepaid expenses and other current assets	1,877	1,182
Total current assets	93,023	115,056
Inventories	671	0
Property and equipment, net	794	884
Operating lease right-of-use assets	988	1,141
Securities at fair value	0	14,932
Long-term investments - other	20,000	490
Other long-term assets	53	438
Total assets	115,529	132,941
Liabilities and stockholders’ equity (deficit)
Accounts payable and accrued expenses	6,169	3,038
Current portion of operating lease liabilities	480	356
Current portion of discount and rebate liabilities	4,655	0
Other current liabilities	422	836
Total current liabilities	11,726	4,230
Line of credit payable	12,800	0
Derivative and warrant liability	1	330
Operating lease liabilities, less current portion	843	1,232
Discount and rebate liabilities, less current portion	4,327	0
Other long-term liabilities	25	31
Total liabilities	29,722	5,823
Commitments and contingencies (Note H)
Stockholders' equity:
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2022 or December 31, 2021	0	0
Common stock, $0.0001 par value, 250,000,000 shares authorized, 35,450,257 shares issued and 34,540,304 shares outstanding as of December 31, 2022; 35,325,801 shares issued and 35,005,640 shares outstanding as of December 31, 2021	3	4
Additional paid-in capital	401,799	396,957
Treasury stock, at cost	(7,536)	(2,814)
Accumulated deficit	(308,572)	(267,029)
Accumulated other comprehensive income	113	0
Total stockholders' equity	85,807	127,118
Total liabilities and stockholders' equity	$ 115,529	$ 132,941

Note N - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Antidilutive securities (in shares)	6,709,007	5,495,229
Share-Based Payment Arrangement [Member]
Antidilutive securities (in shares)	2,456,407	1,273,879
Warrants to Purchase Common Stock [Member]
Antidilutive securities (in shares)	4,252,600	4,221,350

Note F - Accounts Payable and Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]

	*December 31,*
	*2022*		*2021*
Accrued banking fees		-		700
Accrued payroll		1,673		1,054
Accrued professional fees		256		259
Accounts payable		3,611		516
Other accrued expenses		629		509
Total accounts payable and accrued expenses	$	6,169	$	3,038

Note M - Income Taxes - Schedule of Reconciliation of Difference Between Benefit for Income Taxes and Income Taxes at Statutory U.S. Federal Income Tax Rate (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Federal statutory rate	21.00%	21.00%
Change in valuation allowance	(22.06%)	(28.39%)
Return to provision and deferred true-up	(3.41%)	(0.26%)
Change in rate	0.51%	3.00%
Warrant liability	0.16%	(0.06%)
Stock-based compensation	(0.69%)	(2.68%)
PPP Loan forgiveness	0.00%	1.94%
Global intangible low-taxed income credit	(1.22%)	0.00%
Other	0.15%	(0.08%)
Federal income tax provision effective rate	1.86%	(0.39%)
Domestic Tax Authority [Member]
Research and development credit	1.16%	0.00%
State and Local Jurisdiction [Member]
Research and development credit	0.07%	0.00%
Foreign Tax Authority [Member]
Research and development credit	3.16%	0.00%

Note H - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Loss Contingency Accrual, Ending Balance	$ 0	$ 0

Note M - Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Text Block]

M.	Income Taxes

The Company’s financial statements include a total state tax expense of $31,000 and state tax benefit of $34,000 related to research and development credits on a loss before income taxes of approximately $42.3 million and $8.5 million for the years ended December 31, 2022 and 2021, respectively. The Company met the requirements to receive a tax credit of $0.8 million for losses in Denmark resulting from research and development costs, which is included in income tax benefit for the year ended December 31, 2022. A reconciliation of the difference between the (expense)/benefit for income taxes and 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,*
	*2022*			*2021*
Federal statutory rate		21.00	%		21.00	%
Effect of:
Change in valuation allowance		(22.06	)		(28.39	)
Return to provision and deferred true-up		(3.41	)		(0.26	)
Federal research and development credit		1.16			-
State research and development credit		0.07			-
Change in rate		0.51			3.00
State tax benefit (net of federal)		3.03			5.14
Warrant liability		0.16			(0.06	)
Stock-based compensation		(0.69	)		(2.68	)
PPP Loan forgiveness		-			1.94
Global intangible low-taxed income credit		(1.22	)		-
Foreign research and development excess benefit		3.16			-
Other		0.15			(0.08	)
Federal income tax provision effective rate		1.86	%		(0.39	)%

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

	*December 31,*
	*2022*			*2021*
Deferred tax assets relating to:
Net operating loss carryforwards	$	66,373		$	60,977
Research and development tax carryforward		6,900			6,411
Stock-based compensation		4,185			4,807
174 expenses		3,730			-
Right-of-use liability		359			424
Property and equipment		22			14
Other deferred tax assets		598			288
Total gross deferred tax assets		82,167			72,921
Deferred tax liabilities relating to:
Right-of-use asset		(336	)		(401	)
Other deferred tax liabilities		-			(9	)
Total gross deferred tax liabilities		(336	)		(410	)
Deferred tax assets less liabilities		81,831			72,511
Valuation allowance		(81,831	)		(72,511	)
Net deferred tax asset (liability)	$	-		$	-

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not 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 than not that the Company will not realize the benefits of these deductible differences in the future.

The Company recorded certain retainable research and development tax credits as income tax benefit in the consolidated statement of operations for the year ended December 31, 2022. 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 has no current period income tax expense.

In accordance with the Tax Cuts and Jobs Act of 2017, 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 has not 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 can no longer demonstrate that these earnings are indefinitely reinvested, a deferred tax liability will be recognized.

The Company has federal operating loss carryforwards totaling $236.0 million, $138.1 million of which, if not utilized, will begin to expire in 2027 and $97.9 million of which have no expiration date.

The Company also has certain state net operating loss carryforwards totaling $225.2 million, which, if not utilized, will begin to expire in 2027. Due to potential ownership changes that may have occurred or would occur in the future, Internal Revenue Code Section 382 may place additional limitations on the Company’s ability to utilize the net operating loss carryforward.

ASC 740-10, Accounting for Uncertainty in Income Taxes, uses the term “more likely than not” to evaluate whether or not a tax position will be sustained upon examination. The Company has not identified any tax positions that do not meet the more likely than not threshold.

On March 27, 2020, the CARES Act was enacted into law in response to the COVID-19 pandemic. The Company has evaluated the various income and payroll tax provisions and expects little or no impact to income tax expense.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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Note E - Property and Equipment (Details Textual) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Depreciation, Depletion and Amortization, Total	$ 944,000	$ 257,000
Property and Equipment, Including Finance Leases [Member]
Depreciation, Depletion and Amortization, Total	$ 298,000	$ 257,000

Note A - Description of Business, Basis of Presentation, and Significant Transactions (Tables)

12 Months Ended

Dec. 31, 2022

Asset Acquisition [Table Text Block]

Cash	$	12,800
Assumed reserve liability		5,200
Total consideration	$	18,000

Total consideration		18,000
Direct transaction costs associated with the acquisition (1)		1,290
Total purchase price to be allocated	$	19,290

Property and equipment, inventory and assembled workforce acquired		1,627
IPR&D (2)		17,663
Total allocated purchase price	$	19,290

Statements of Operations - USD ($)	12 Months Ended
Statements of Operations - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Revenue, net	$ 10,458,000	$ 28,650,000
Operating expenses:
Cost of revenue	343,000	2,059,000
Research and development	19,614,000	10,161,000
General and administrative	15,343,000	8,701,000
Acquired in-process research and development	17,663,000	0
Total operating expenses	52,963,000	20,921,000
(Loss) income from operations	(42,505,000)	7,729,000
Other (expense) income:
Loss on extinguishment of debt	0	(16,096,000)
Interest expense related to amortization of debt issuance costs and discount	0	(150,000)
Interest expense	(335,000)	(226,000)
Fair value adjustment related to derivative and warrant liability	328,000	(26,000)
Fair value adjustment related to investments	(577,000)	(13,000)
Interest and other income, net	760,000	261,000
Total other income (expense)	176,000	(16,250,000)
Loss before income taxes	(42,329,000)	(8,521,000)
Income tax benefit (expense)	786,000	(34,000)
Net income (loss)	(41,543,000)	(8,555,000)
Deemed dividend	0	(54,342,000)
Net loss attributable to common stockholders	$ (41,543,000)	$ (62,897,000)
Basic and diluted net loss per share of common stock:
Net loss attributable to common stockholders (in dollars per share)	$ (1.20)	$ (2.11)
Weighted average number of shares of common stock outstanding:
Basic and diluted (in shares)	34,488,800	29,766,347

Note N - Net Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Net loss	$ (41,543)	$ (8,555)
Less: Dividends declared or accumulated	0	(54,342)
Net loss attributable to common stockholders	(41,543)	(62,897)
Less: Net loss attributable to participating securities	0	0
Undistributed net loss attributable to shares of common stockholders, basic and diluted	$ (41,543)	$ (62,897)
Weighted average number of shares of common stock outstanding, basic and diluted (in shares)	34,488,800	29,766,347
Basic and diluted net loss attributable to common stockholders per share of common stock (in dollars per share)	$ (1.20)	$ (2.11)

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.