Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
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 | Q1 | |
Document Fiscal Year Focus | 2023 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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, $0.0001 par value per share | |
Trading Symbol | ZVRA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 33,881,804 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Cash and cash equivalents | $ 40,181 | $ 65,466 |
Securities at fair value | 34,403 | 16,900 |
Short-term investments - other | 20,700 | 481 |
Accounts and other receivables | 7,822 | 8,299 |
Prepaid expenses and other current assets | 1,174 | 1,877 |
Total current assets | 104,280 | 93,023 |
Inventories | 620 | 671 |
Property and equipment, net | 744 | 794 |
Operating lease right-of-use assets | 898 | 988 |
Long-term investments - other | 0 | 20,000 |
Other long-term assets | 53 | 53 |
Total assets | 106,595 | 115,529 |
Liabilities and stockholders' equity | ||
Accounts payable and accrued expenses | 10,098 | 6,169 |
Current portion of operating lease liabilities | 470 | 480 |
Current portion of discount and rebate liabilities | 4,746 | 4,655 |
Other current liabilities | 302 | 422 |
Total current liabilities | 15,616 | 11,726 |
Line of credit payable | 12,914 | 12,800 |
Derivative and warrant liability | 3 | 1 |
Operating lease liabilities, less current portion | 736 | 843 |
Discount and rebate liabilities, less current portion | 5,764 | 4,327 |
Other long-term liabilities | 158 | 25 |
Total liabilities | 35,191 | 29,722 |
Commitments and contingencies (Note D) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 35,457,496 shares issued and 33,881,804 shares outstanding as of March 31, 2023; 35,450,257 shares issued and 34,540,304 shares outstanding as of December 31, 2022 | 3 | 3 |
Additional paid-in capital | 402,786 | 401,799 |
Treasury stock, at cost | (10,983) | (7,536) |
Accumulated deficit | (320,339) | (308,572) |
Accumulated other comprehensive (loss) income | (63) | 113 |
Total stockholders' equity | 71,404 | 85,807 |
Total liabilities and stockholders' equity | 106,595 | 115,529 |
Undesignated Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2023 or December 31, 2022 | $ 0 | $ 0 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Preferred stock, shares authorized (in shares) | 10,000,000 | |
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) | 35,457,496 | 35,450,257 |
Common stock, shares outstanding (in shares) | 33,881,804 | 34,540,304 |
Undesignated Preferred Stock [Member] | ||
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 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue, net | $ 2,879 | $ 3,965 |
Operating expenses: | ||
Cost of revenue | 125 | 8 |
Research and development | 8,844 | 3,082 |
Selling, general and administrative | 6,834 | 2,734 |
Total operating expenses | 15,803 | 5,824 |
Loss from operations | (12,924) | (1,859) |
Other (expense) income: | ||
Interest expense | (182) | (5) |
Fair value adjustment related to derivative and warrant liability | (2) | 241 |
Fair value adjustment related to investments | 196 | (352) |
Interest and other income, net | 1,042 | 107 |
Total other (expense) income | 1,054 | (9) |
Loss before income taxes | (11,870) | (1,868) |
Income tax benefit | 103 | 4 |
Net income (loss) | (11,767) | (1,864) |
Net loss attributable to common stockholders | $ (11,767) | $ (1,864) |
Basic and diluted net loss per share of common stock: | ||
Net loss attributable to common stockholders (in dollars per share) | $ (0.34) | $ (0.05) |
Weighted average number of shares of common stock outstanding: | ||
Basic and diluted (in shares) | 34,466,542 | 34,506,597 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net loss attributable to common stockholders | $ (11,767) | $ (1,864) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustment | (176) | 0 |
Other comprehensive (loss) income | (176) | 0 |
Comprehensive loss | $ (11,943) | $ (1,864) |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2021 | $ 4 | $ 396,957 | $ (2,814) | $ (267,029) | $ 127,118 | |
Net Income (loss) | 0 | 0 | 0 | (1,864) | (1,864) | |
Stock-based compensation expense | 0 | 918 | 0 | 0 | 918 | |
Shares repurchased as part of the Share Repurchase Program | (1) | 0 | (4,722) | 0 | (4,723) | |
Issuance of common stock in exchange for consulting services | 0 | 50 | 0 | 0 | 50 | |
Other comprehensive loss | 0 | |||||
Balance at Mar. 31, 2022 | 3 | 397,925 | (7,536) | (268,893) | 121,499 | |
Balance at Dec. 31, 2022 | 3 | 401,799 | (7,536) | $ (308,572) | 113 | 85,807 |
Net Income (loss) | 0 | 0 | 0 | (11,767) | 0 | (11,767) |
Stock-based compensation expense | 0 | 591 | 0 | 0 | 0 | 591 |
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | (3,447) | 0 | 0 | (3,447) |
Issuance of common stock in exchange for consulting services | 0 | 42 | 0 | 0 | 0 | 42 |
Severance expense | 0 | 354 | 0 | 0 | 0 | 354 |
Other comprehensive loss | 0 | 0 | 0 | 0 | (176) | (176) |
Balance at Mar. 31, 2023 | $ 3 | $ 402,786 | $ (10,983) | $ (320,339) | $ (63) | $ 71,404 |
Unaudited Condensed Consolida_6
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (11,767) | $ (1,864) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 591 | 918 |
Non-cash severance expense | 354 | 0 |
Depreciation and amortization expense | 79 | 65 |
Fair value adjustment related to derivative and warrant liability | 2 | (241) |
Fair value adjustment related to investments | (196) | 352 |
Consulting fees paid in common stock | 42 | 50 |
Gain on foreign currency exchange | (240) | 0 |
Change in assets and liabilities: | ||
Accounts and other receivables | 477 | (1,792) |
Prepaid expenses and other assets | 703 | 303 |
Inventories | 51 | 0 |
Operating lease right-of-use assets | 80 | 51 |
Accounts payable and accrued expenses | 3,929 | (486) |
Discount and rebate liability | 1,528 | 0 |
Operating lease liabilities | (107) | (88) |
Other liabilities | 429 | (821) |
Net cash used in operating activities | (4,045) | (3,553) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (29) | (16) |
Purchases of investments | (17,526) | (3,832) |
Net cash used in investing activities | (17,555) | (3,848) |
Cash flows from financing activities: | ||
Proceeds from issuance of debt | 12,914 | 0 |
Repayment of debt | (12,800) | 0 |
Payments of principal on insurance financing arrangements | (415) | 0 |
Payment to repurchase shares as part of the share repurchase program | (3,447) | (4,723) |
Repayment of principal on finance lease liabilities | (2) | (10) |
Net cash used in financing activities | (3,750) | (4,733) |
Effect of exchange rate changes on cash and cash equivalents | 65 | 0 |
Net decrease in cash and cash equivalents | (25,285) | (12,134) |
Cash and cash equivalents, beginning of period | 65,466 | 112,346 |
Cash and cash equivalents, end of period | 40,181 | 100,212 |
Supplemental cash flow information: | ||
Cash paid for interest | $ 68 | $ 5 |
Note A - Description of Busines
Note A - Description of Business, Basis of Presentation and Significant Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
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 rare disease company melding science, data and patient need to create transformational therapies for diseases with limited or no first KP1077 eing developed as a treatment for idiopathic hypersomnia ("IH"), a rare neurological sleep disorder, and narcolepsy. KP1077 KP1077 February 21, 2023. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions 10 8 03 X. not three March 31, 2023, not may December 31, 2023. This interim information should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10 December 31, 2022, March 7, 2023. Basis of Presentation The Company prepared the consolidated financial statements in accordance with U.S. GAAP and the rules and regulations of the SEC and, in the Company's opinion, reflect all adjustments, including normal recurring items that are necessary. Arimoclomol Acquisition On May 15, 2022, February 21, 2023) ( May 31, 2022. 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 the Company's 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 3 In accordance with Accounting Standards Codification ("ASC"), Subtopic 730 10 25, Accounting for Research and Development Costs not no d a $0.8 million income tax benefit for the year ended December 31, 2022, 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 ( 2 Amendment to Registration Statement on Form S- 3 On January 25, 2022, 1 No. 333 250945 3 January 2021 February 1, 2022. On March 1, 2023, Entry into 2021 ATM Agreement On July 2, 2021, "2021 may 2021 3. may 415 1933, may 2021 3 2021 July 12, 2021. March 31, 2023, 2021 Share Repurchase Program On December 20, 2021, may December 31, 2023. may 10b 18 1934, not may March 31, 2023, Reclassifications Certain reclassifications were made to the 2022 2023. no |
Note B - Summary of Significant
Note B - Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | B. Summary of Significant Accounting Policies Use of Estimates The preparation of 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 investments and 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. 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 March 31, 2023, December 31, 2022, March 31, 2023, December 31, 2022, Revenue Recognition The Company recognizes revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers 606” five 1 2 3 4 5 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 no 606, three March 31, 2023, March 31, 2023, three March 31, 2023, December 31, 2022, March 31, 2023, December 31, 2022, 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 may 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 Up-front Fees: Milestone Payments: not not not may AZSTARYS License Agreement In September 2019, In April 2021, No. 1 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 KP879 KP1077 The AZSTARYS License Agreement is within the scope of ASC 606, not 606, third two $10.0 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 percentage 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 not not three March 31, 2023 2022, $0.6 mi March 31, 2023, December 31, 2022. Consulting Arrangements The Company enters into consulting arrangements with third 606. may third Corium Consulting Agreement In July 2020, Under the Corium Consulting Agreement, the Company was 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. first 2022. 606, not third third not not not The Company determined that the performance of consulting services, including reimbursement of third third 606 For the three March 31, 2023, 2022, March 31, 2023, December 31, 2022, March 31, 2023. Foreign currency Assets and liabilities are translated into the reporting currency using the exchange rates in effect on the unaudited consolidated condensed 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 unaudited condensed consolidated statements of stockholders’ equity. 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 March 31, 2023, 0.2 m $1.0 December 31, 2022, $0.2 m $0.9 million and other receivables of $0.4 m March 31, 2023, December 31, 2022, no |
Note C - Debt Obligations
Note C - Debt Obligations | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | C. Debt Obligations Line of Credit On May 31, 2022, 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 was May 31, 2025. December 31, 2022, December 31, 2022. December 31, 2022. not January 31, 2023, May 2023. March 31, 2023. March 31, 2023. On January 26, 2023, 80 90% March 31, 20 23, |
Note D - Commitments and Contin
Note D - Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | D. Commitments and Contingencies 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 not During the first 2023, October 25, 2018. April 2023, three March 31, 2023. December 31, 2022 |
Note E - Stock and Warrants
Note E - Stock and Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | E. Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of March 31, 2023 December 31, 2022 s, 35,457,496 and 35 ,450,257 March 31, 2023, December 31, 2022, 33,881,804 an March 31, 2023 December 31, 2022 As of March 31, 2023 December 31, 2022 March 31, 2023 December 31, 2022 Outstanding awards under equity incentive plans 6,024,889 2,456,407 Outstanding common stock warrants 4,252,490 4,252,600 Possible future issuances under equity incentive plans 3,731,263 4,421,508 Possible future issuances under employee stock purchase plans 1,417,365 1,417,365 Total common shares reserved for future issuance 15,426,007 12,547,880 Common Stock Activity The following table summarizes common stock activity for the three March 31, 2023 : Shares of Common Stock Balance as of January 1, 2023 34,540,304 Common stock issued as compensation to third-parties 7,129 Common stock repurchased as a result of the Stock Repurchase Plan (665,739 ) Common stock issued as a result of stock warrants exercised 110 Balance as of March 31, 2023 33,881,804 Authorized, Issued, and Outstanding Preferred Stock As of March 31, 2023, December 31, 2022, none Warrants Warrants to Purchase Common Stock In June 2014, June 2, 2024, December 2022 260, Earnings per Share may 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 $36.80 per share (the “KVK Warrant”). The KVK Warrant is initially not four October 24, 2023.The 815 815 On January 12, 2021, fifth March 31, 20 23, r 3,030,991 sha On January 12, 2021, February 3, 2021, March 31, 2023, January 2021 Warrant Exercise Inducement Letters and Issuance of Warrants On January 26, 2021, “January 2021 “January 2021 "January 2021 January 2021 fifth March 31, 2023, January 2021 June 2021 Warrant Exercise Inducement Letters and Issuance of Warrants On June 18, 2021, “June 2021 January 2021 "January 2021 January 2021 “June 2021 January 2021 June 2021 December 31, 2026, March 31, 2023, no June 2021 |
Note F - Stock-based Compensati
Note F - Stock-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | F. 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, April 2015, 2014 “2014 April 2015. 2014 June 2021, 2014 2014 April 2021, January 1, 2031 2014 162 may 2014 March 31, 2023. 2014 January 1 January 1, 2016, January 1, 2031, December 31 2014 January 1, 2023, 2014 During the three March 31, 2023, 2022, In June 2021, April 2021. may first October 1, 2021, first May 31, 2022. March 31, 2023, 82,635 shar In January 2023, 2023 "2023" may 2023 Stock-based compensation expense recorded under the Incentive Stock Plan, 2014 2014 Three months ended March 31, 2023 2022 Research and development $ 572 $ 311 Selling, general and administrative 19 607 Total stock-based compensation expense $ 591 $ 918 There was no stock-based compensation expense related to performance-based awards recognized during the three March 31, 2023, 2022. As a result of the modification of certain stock options in connection with the Transition Agreement, as further discussed in Note J, the Company recaptured $0.9 million in stock-compensation expense and recognized $0.4 million in severance expense for the three March 31, 2023. |
Note G - Fair Value of Financia
Note G - Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | G. 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 three ● Level 1—Observable ● Level 2—Observable ● Level 3—Unobservable no The carrying amounts of certain financial instruments, including cash and cash equivalents, investments 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 March 31, 2023, December 31, 2022 ( Balance as of March 31, 2023 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) OTA Warrant liability $ 3 $ — $ — $ 3 Total liabilities $ 3 $ — $ — $ 3 Securities: U.S. government-sponsored agency securities $ 7,290 $ — $ 7,290 $ — U.S. Treasury securities 27,113 27,113 — — Total assets $ 34,403 $ 27,113 $ 7,290 $ — Balance as of December 31, 2022 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (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 $ — The Company’s OTA Warrant liability, embedded Warrant Put Option and securities are measured at fair value on a recurring basis. As of March 31, 2023, December 31, 2022, March 31, 2023, December 31, 2022, three March 31, 2023, 2022, The derivative liability for the OTA Warrant wa s $3,000 March 31, 2023, December 31, 2022, $0 a March 31, 2023, December 31, 2022. 10% $38 .5 $463 .8 fourth quarter of 2023. The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of March 31, 2023, December 31, 2022, no not not three March 31, 2023, 2022, 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 Three months ended March 31, 2023 2022 Balance as of beginning of period $ 1 $ 306 Adjustment to fair value 2 (305 ) Balance as of end of period $ 3 $ 1 |
Note H - Net Loss Per Share
Note H - Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | H. Net Loss Per Share For all periods presented herein, the Company did not two not two Under the two No no two two two As noted above, for all periods presented herein, the Company did not two no 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: Three months ended March 31, 2023 2022 Awards under equity incentive plans 6,024,889 2,186,769 Common stock warrants 4,252,490 4,252,600 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 10,277,379 6,439,369 A reconciliation from net loss to basic and diluted net loss attributable to common stockholders per share of common stock for the three March 31, 2023, 2022, Three months ended March 31, 2023 2022 Net loss per share of common stock: Net loss $ (11,767 ) $ (1,864 ) Less: Dividends declared or accumulated — — Undistributed net loss attributable to shares of common stockholders, basic and diluted $ (11,767 ) $ (1,864 ) Weighted average number of shares of common stock outstanding, basic and diluted 34,467 34,507 Basic and diluted net loss attributable to common stockholders per share of common stock $ (0.34 ) $ (0.05 ) |
Note I - Leases
Note I - Leases | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Lease Disclosure [Text Block] | I. 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 12 not Effective June 1, 2021, one two February 2026. The components of lease expense were as follows (in thousands): Three months ended March 31, Lease Cost 2023 2022 Finance lease cost: Amortization of right-of-use assets $ 32 $ 32 Interest on lease liabilities — 1 Total finance lease cost 32 33 Operating lease cost 113 91 Short-term lease cost 55 50 Variable lease cost 13 13 Less: sublease income (39 ) (39 ) Total lease costs $ 174 $ 148 Supplemental cash flow information related to leases was as follows (in thousands): Three months ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ — $ 1 Financing cash flows from finance leases 2 10 Operating cash flows from operating leases 142 117 Operating cash flows from short-term leases 55 50 Operating cash flows from variable lease costs 13 13 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases — — Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate): March 31, December 31, 2023 2022 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (812 ) (780 ) Property and equipment, net $ 219 $ 251 Other current liabilities $ 5 $ 6 Other long-term liabilities — — Total finance lease liabilities $ 5 $ 6 Operating Leases Operating lease right-of-use assets $ 898 $ 988 Total operating lease right-of-use assets $ 898 $ 988 Current portion of operating lease liabilities $ 470 $ 480 Operating lease liabilities, less current portion 736 843 Total operating lease liabilities $ 1,206 $ 1,323 Weighted Average Remaining Lease Term Finance leases 1 year 1 year Operating leases 3 years 3 years Weighted Average Discount Rate Finance leases 14.3 % 14.3 % Operating leases 7.4 % 7.3 % Maturities of lease liabilities were as follows (in thousands): Finance Operating Year Ending December 31, Leases Leases 2023 (excluding the three months ended March 31, 2023) $ 5 $ 419 2024 — 488 2025 — 390 2026 — 30 2027 — — Total lease payments 5 1,327 Less: future interest expense 0 (121 ) Lease liabilities $ 5 $ 1,206 |
Note J - Significant Events
Note J - Significant Events | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Significant Events [Text Block] | J. Significant Events On January 6, 2023, April 25, 2023. January 6, 2023, 2023 April 25, 2023. January 6, 2023, 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, 2014 January 9, 2023. first January 6, 2024 ( 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 may 18 first 2023 April 25, 2023. 2014 three March 31, 2023. March 31, 2023, At the Company's 2023 April 25, 2023, May 5, 2023, June 1, 2023, May 3, 2023, not 2024 May 2023, June 1, 2023. |
Note K - Subsequent Events
Note K - Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | K. Subsequent Events The Company evaluated events and transactions occurring subsequent to March 31, 2023, May 15, 2023, no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of 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 investments and 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. |
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 March 31, 2023, December 31, 2022, March 31, 2023, December 31, 2022, |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition The Company recognizes revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers 606” five 1 2 3 4 5 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 no 606, three March 31, 2023, March 31, 2023, three March 31, 2023, December 31, 2022, March 31, 2023, December 31, 2022, 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 may 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 Up-front Fees: Milestone Payments: not not not may AZSTARYS License Agreement In September 2019, In April 2021, No. 1 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 KP879 KP1077 The AZSTARYS License Agreement is within the scope of ASC 606, not 606, third two $10.0 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 percentage 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 not not three March 31, 2023 2022, $0.6 mi March 31, 2023, December 31, 2022. Consulting Arrangements The Company enters into consulting arrangements with third 606. may third Corium Consulting Agreement In July 2020, Under the Corium Consulting Agreement, the Company was 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. first 2022. 606, not third third not not not The Company determined that the performance of consulting services, including reimbursement of third third 606 For the three March 31, 2023, 2022, March 31, 2023, December 31, 2022, March 31, 2023. |
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 unaudited consolidated condensed 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 unaudited condensed consolidated statements of stockholders’ equity. |
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 March 31, 2023, 0.2 m $1.0 December 31, 2022, $0.2 m $0.9 million and other receivables of $0.4 m March 31, 2023, December 31, 2022, no |
Note A - Description of Busin_2
Note A - Description of Business, Basis of Presentation and Significant Transactions (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
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 |
Note E - Stock and Warrants (Ta
Note E - Stock and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block] | March 31, 2023 December 31, 2022 Outstanding awards under equity incentive plans 6,024,889 2,456,407 Outstanding common stock warrants 4,252,490 4,252,600 Possible future issuances under equity incentive plans 3,731,263 4,421,508 Possible future issuances under employee stock purchase plans 1,417,365 1,417,365 Total common shares reserved for future issuance 15,426,007 12,547,880 |
Schedule of Common Stock Outstanding Roll Forward [Table Text Block] | Shares of Common Stock Balance as of January 1, 2023 34,540,304 Common stock issued as compensation to third-parties 7,129 Common stock repurchased as a result of the Stock Repurchase Plan (665,739 ) Common stock issued as a result of stock warrants exercised 110 Balance as of March 31, 2023 33,881,804 |
Note F - Stock-based Compensa_2
Note F - Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three months ended March 31, 2023 2022 Research and development $ 572 $ 311 Selling, general and administrative 19 607 Total stock-based compensation expense $ 591 $ 918 |
Note G - Fair Value of Financ_2
Note G - Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Balance as of March 31, 2023 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) OTA Warrant liability $ 3 $ — $ — $ 3 Total liabilities $ 3 $ — $ — $ 3 Securities: U.S. government-sponsored agency securities $ 7,290 $ — $ 7,290 $ — U.S. Treasury securities 27,113 27,113 — — Total assets $ 34,403 $ 27,113 $ 7,290 $ — Balance as of December 31, 2022 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (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 $ — |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three months ended March 31, 2023 2022 Balance as of beginning of period $ 1 $ 306 Adjustment to fair value 2 (305 ) Balance as of end of period $ 3 $ 1 |
Note H - Net Loss Per Share (Ta
Note H - Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three months ended March 31, 2023 2022 Awards under equity incentive plans 6,024,889 2,186,769 Common stock warrants 4,252,490 4,252,600 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 10,277,379 6,439,369 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three months ended March 31, 2023 2022 Net loss per share of common stock: Net loss $ (11,767 ) $ (1,864 ) Less: Dividends declared or accumulated — — Undistributed net loss attributable to shares of common stockholders, basic and diluted $ (11,767 ) $ (1,864 ) Weighted average number of shares of common stock outstanding, basic and diluted 34,467 34,507 Basic and diluted net loss attributable to common stockholders per share of common stock $ (0.34 ) $ (0.05 ) |
Note I - Leases (Tables)
Note I - Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three months ended March 31, Lease Cost 2023 2022 Finance lease cost: Amortization of right-of-use assets $ 32 $ 32 Interest on lease liabilities — 1 Total finance lease cost 32 33 Operating lease cost 113 91 Short-term lease cost 55 50 Variable lease cost 13 13 Less: sublease income (39 ) (39 ) Total lease costs $ 174 $ 148 |
Schedule of Leases Cash Flow Information [Table Text Block] | Three months ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ — $ 1 Financing cash flows from finance leases 2 10 Operating cash flows from operating leases 142 117 Operating cash flows from short-term leases 55 50 Operating cash flows from variable lease costs 13 13 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases — — |
Schedule of Leases Balance Sheet Information [Table Text Block] | March 31, December 31, 2023 2022 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (812 ) (780 ) Property and equipment, net $ 219 $ 251 Other current liabilities $ 5 $ 6 Other long-term liabilities — — Total finance lease liabilities $ 5 $ 6 Operating Leases Operating lease right-of-use assets $ 898 $ 988 Total operating lease right-of-use assets $ 898 $ 988 Current portion of operating lease liabilities $ 470 $ 480 Operating lease liabilities, less current portion 736 843 Total operating lease liabilities $ 1,206 $ 1,323 Weighted Average Remaining Lease Term Finance leases 1 year 1 year Operating leases 3 years 3 years Weighted Average Discount Rate Finance leases 14.3 % 14.3 % Operating leases 7.4 % 7.3 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, Leases Leases 2023 (excluding the three months ended March 31, 2023) $ 5 $ 419 2024 — 488 2025 — 390 2026 — 30 2027 — — Total lease payments 5 1,327 Less: future interest expense 0 (121 ) Lease liabilities $ 5 $ 1,206 |
Note A - Description of Busin_3
Note A - Description of Business, Basis of Presentation and Significant Transactions (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
May 15, 2022 | Jul. 12, 2021 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 20, 2021 | Jul. 02, 2021 | ||
Sale of Stock, Authorized Amount | $ 350,000 | ||||||
Stock Repurchase Program, Authorized Amount | $ 50,000 | ||||||
Share Repurchase Program [Member] | |||||||
Treasury Stock, Common, Shares (in shares) | 1,575,692 | ||||||
Treasury Stock, Common, Value | $ 11,000 | ||||||
JMP and RBCCM [Member] | ATM Agreement Sales [Member] | |||||||
Equity Distribution Agreement, Maximum Aggregate Offering Price | $ 75,000 | ||||||
Equity Distribution Agreement, Commission Fee, Percentage of Gross Sales | 3% | ||||||
Stock Issued During Period, Value, New Issues | $ 75,000 | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | ||||||
Arimoclomol Purchase Agreement [Member] | |||||||
Payments to Acquire Productive Assets, Total | $ 12,800 | ||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | $ 10,500 | $ 9,000 | ||||
Estimated Weighted Average Cost of Capital | 42% | ||||||
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. |
Note A - Description of Busin_4
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 | 3 Months Ended | 12 Months Ended | ||
May 15, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | ||
Cash | $ 12,800 | |||
Assumed reserve liability | 5,200 | $ 10,500 | $ 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, legal expenses and auditor 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 B - Summary of Significa_2
Note B - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
May 15, 2022 | Mar. 20, 2012 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | May 07, 2021 | Jul. 31, 2020 | |
Investments, Fair Value Disclosure | $ 34,400 | $ 16,900 | |||||
Unrealized Gain (Loss) on Investments | (400) | (600) | |||||
Certificates of Deposit, at Carrying Value | 20,700 | 20,700 | |||||
Revenue from Contract with Customer, Including Assessed Tax | 2,879 | $ 3,965 | |||||
Income Taxes Receivable | 900 | ||||||
Accounts Receivable, Allowance for Credit Loss, Ending Balance | 0 | 0 | |||||
License [Member] | |||||||
Accounts Receivable, after Allowance for Credit Loss, Current | 600 | ||||||
Other Receivables | 700 | ||||||
Consulting Services [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | 200 | 3,500 | |||||
Deferred Revenue, Total | 0 | 0 | |||||
Accounts Receivable, after Allowance for Credit Loss, Current | 400 | ||||||
Income Taxes Receivable | 1,000 | ||||||
GPC Member | License [Member] | |||||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | $ 590,000 | ||||||
Deferred Revenue, Total | 0 | 0 | |||||
Accounts Receivable, after Allowance for Credit Loss, Current | 500 | ||||||
Aquestive Therapeutics [Member] | License [Member] | |||||||
Royalty Revenue, Percent | 10% | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 600 | 100 | |||||
Corium, Inc [Member] | |||||||
Accounts Receivable, after Allowance for Credit Loss, Current | 200 | ||||||
Corium, Inc [Member] | Consulting Services [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 2,000 | ||||||
Consulting Agreement, Maximum Amount to be Received | $ 15,600 | ||||||
Contract with Customer, Asset, after Allowance for Credit Loss, Total | 13,600 | ||||||
Consulting Agreement, Conditional Milestone Achievement to be Received | $ 2,000 | ||||||
Arimoclomol EAP [Member] | |||||||
Accounts Receivable, after Allowance for Credit Loss, Current | 6,300 | ||||||
Arimoclomol Purchase Agreement [Member] | |||||||
Contract with Customer, Liability, Revenue Recognized | 2,000 | ||||||
Contract with Customer, Clawback Liability | 1,300 | ||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | 10,500 | $ 9,000 | ||||
Accounts Receivable, after Allowance for Credit Loss, Current | 5,300 | ||||||
Consulting Services [Member] | |||||||
Accounts Receivable, after Allowance for Credit Loss, Current | $ 200 |
Note C - Debt Obligations (Deta
Note C - Debt Obligations (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | |||||
Jan. 31, 2023 | Jan. 26, 2023 | May 31, 2022 | Sep. 30, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | |
Line of Credit Facility, Maximum Borrowing Capacity | $ 20,000 | $ 20,000 | ||||
Line of Credit Facility, Maximum Amount Outstanding During Period | $ 12,800 | |||||
Certificates of Deposit, at Carrying Value | $ 20,700 | 20,700 | ||||
Line of Credit Facility, Remaining Borrowing Capacity | 7,200 | |||||
Wells Fargo Bank, N.A. [Member] | ||||||
Long-Term Line of Credit | 12,900 | |||||
Debt Instrument, Face Amount | $ 12,800 | |||||
Revolving Credit Facility [Member] | Ameris Bank [Member] | ||||||
Repayments of Lines of Credit | $ 12,800 | |||||
Long-Term Line of Credit | $ 0 | |||||
Asset Pledged as Collateral [Member] | ||||||
Certificates of Deposit, at Carrying Value | $ 12,800 | |||||
Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | ||||||
Debt Instrument, Basis Spread on Variable Rate | 1.60% | |||||
Prime Rate [Member] | Wells Fargo Bank, N.A. [Member] | ||||||
Debt Instrument, Basis Spread on Variable Rate | 225% |
Note D - Commitments and Cont_2
Note D - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Loss Contingency Accrual | $ 900 | $ 0 |
Note E - Stock and Warrants (De
Note E - Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||||||
Mar. 31, 2023 | Dec. 31, 2022 | Jun. 18, 2021 | Feb. 03, 2021 | Jan. 26, 2021 | Jan. 12, 2021 | Dec. 31, 2020 | Oct. 25, 2018 | |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 | ||||||
Common Stock, Shares, Issued (in shares) | 35,457,496 | 35,450,257 | ||||||
Common Stock, Shares, Outstanding (in shares) | 33,881,804 | 34,540,304 | ||||||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | |||||||
Deerfield Warrant [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 120,192 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 38.34 | |||||||
Warrant Issued to KVK [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 31,250 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 36.80 | |||||||
Public Offering Warrants [Member] | Roth Capital Partners, LLC [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 12,078,361 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.50 | |||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||
Class of Warrants or Right, Exercised During Period (in shares) | 3,461,968 | |||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 3,030,991 | |||||||
Proceeds from Warrant Exercises | $ 16.9 | |||||||
Underwriter Warrants [Member] | Roth Capital Partners, LLC [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 18,702 | 806,932 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 8.125 | |||||||
Class of Warrants or Right, Exercised During Period (in shares) | 400,000 | |||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 400,000 | |||||||
Proceeds from Warrant Exercises | $ 3.3 | |||||||
January 2021 Inducement Warrants [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 6,117,509 | 7,944,430 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.36 | |||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||
Class of Warrants or Right, Exercised During Period (in shares) | 1,676,921 | |||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 1,676,921 | |||||||
Proceeds from Warrant Exercises | $ 10.7 | |||||||
June 2021 Inducement Warrants [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,529,379 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16.50 |
Note E - Stock and Warrants - R
Note E - Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares | Mar. 31, 2023 | Dec. 31, 2022 |
Common shares reserved for future issuance (in shares) | 15,426,007 | 12,547,880 |
Warrant [Member] | ||
Common shares reserved for future issuance (in shares) | 4,252,490 | 4,252,600 |
Share-Based Payment Arrangement [Member] | ||
Common shares reserved for future issuance (in shares) | 6,024,889 | 2,456,407 |
Possible Future Issuances Under Equity Incentive Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 3,731,263 | 4,421,508 |
Possible Future Issuances Under Employee Stock Purchase Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 1,417,365 | 1,417,365 |
Note E - Stock and Warrants - C
Note E - Stock and Warrants - Common Stock Activity (Details) | 3 Months Ended |
Mar. 31, 2023 shares | |
Balance (in shares) | 34,540,304 |
Common stock issued as compensation to third-parties (in shares) | 7,129 |
Common stock repurchased as a result of the Stock Repurchase Plan (in shares) | (665,739) |
Common stock issued as a result of stock warrants exercised (in shares) | 110 |
Balance (in shares) | 33,881,804 |
Note F - Stock-based Compensa_3
Note F - Stock-based Compensation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | 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 Payment Arrangement, Expense | $ 591 | $ 918 | ||
Stock Compensation Expense Recaptured | 900 | |||
Severance Costs Recognized | 400 | |||
Performance Shares [Member] | ||||
Share-Based Payment Arrangement, Expense | $ 0 | $ 0 | ||
2014 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 4,900,000 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 8,271,497 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding | 4% | |||
Increase in Common Stock Reserved for Issuance (in shares) | 1,381,612 | |||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) | 0 | 0 | ||
The 2023 Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 1,500,000 |
Note F - Stock-based Compensa_4
Note F - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock based compensation expense | $ 591 | $ 918 |
Research and Development Expense [Member] | ||
Stock based compensation expense | 572 | 311 |
Selling, General and Administrative Expenses [Member] | ||
Stock based compensation expense | $ 19 | $ 607 |
Note G - Fair Value of Financ_3
Note G - Fair Value of Financial Instruments (Details Textual) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Liquidity Event | $ 38,500,000 | |
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Fundamental Change | 463,800,000 | |
OTA Warrant [Member] | ||
Liabilities, Fair Value Disclosure | 3,000 | $ 1,000 |
Embedded Put Option [Member] | ||
Liabilities, Fair Value Disclosure | $ 0 | $ 0 |
Deerfield Warrant Liability [Member] | Weighted Average Probability of Liquidity Event [Member] | ||
Derivative Liability, Measurement Input | 0.48 | |
Deerfield Warrant Liability [Member] | Weighted Average Probability of Fundamental Change [Member] | ||
Derivative Liability, Measurement Input | 0.30 |
Note G - Fair Value of Financ_4
Note G - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
OTA Warrant [Member] | ||
Liabilities, fair value | $ 3,000 | $ 1,000 |
Fair Value, Recurring [Member] | ||
Liabilities, fair value | 3,000 | 1,000 |
Total assets | 34,403,000 | 16,900,000 |
Fair Value, Recurring [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 7,290,000 | 7,189,000 |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Total assets | 27,113,000 | 9,711,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Liabilities, fair value | 0 | 0 |
Total assets | 27,113,000 | 9,711,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Total assets | 27,113,000 | 9,711,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Liabilities, fair value | 0 | 0 |
Total assets | 7,290,000 | 7,189,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 7,290,000 | 7,189,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Liabilities, fair value | 3,000 | 1,000 |
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | OTA Warrant [Member] | ||
Liabilities, fair value | 3,000 | 1,000 |
Fair Value, Recurring [Member] | OTA Warrant [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Recurring [Member] | OTA Warrant [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Recurring [Member] | OTA Warrant [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Liabilities, fair value | $ 3,000 | $ 1,000 |
Note G - Fair Value of Financ_5
Note G - 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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Balance as of beginning of period | $ 1 | $ 306 |
Adjustment to fair value | 2 | (305) |
Balance as of end of period | $ 3 | $ 1 |
Note H - Net Loss Per Share - A
Note H - Net Loss Per Share - Anti-dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive securities (in shares) | 10,277,379 | 6,439,369 |
Share-Based Payment Arrangement [Member] | ||
Antidilutive securities (in shares) | 6,024,889 | 2,186,769 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive securities (in shares) | 4,252,490 | 4,252,600 |
Note H - Net Loss Per Share - E
Note H - Net Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Income (loss) | $ (11,767) | $ (1,864) |
Less: Dividends declared or accumulated | 0 | 0 |
Undistributed net loss attributable to shares of common stockholders, basic and diluted | $ (11,767) | $ (1,864) |
Basic and diluted (in shares) | 34,466,542 | 34,506,597 |
Basic and diluted net loss attributable to common stockholders per share of common stock (in dollars per share) | $ (0.34) | $ (0.05) |
Note I - Leases (Details Textua
Note I - Leases (Details Textual) | 3 Months Ended |
Mar. 31, 2023 | |
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) | 3 years |
Note I - Leases - Lease Cost (D
Note I - Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Amortization of right-of-use assets | $ 32 | $ 32 |
Interest on lease liabilities | 0 | 1 |
Total finance lease cost | 32 | 33 |
Operating lease cost | 113 | 91 |
Short-term lease cost | 55 | 50 |
Variable lease cost | 13 | 13 |
Less: sublease income | (39) | (39) |
Total lease costs | $ 174 | $ 148 |
Note I - Leases - Supplement Ca
Note I - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating cash flows from finance leases | $ 0 | $ 1 |
Financing cash flows from finance leases | 2 | 10 |
Operating cash flows from operating leases | 142 | 117 |
Operating cash flows from short-term leases | 55 | 50 |
Operating cash flows from variable lease costs | 13 | 13 |
Finance leases | 0 | 0 |
Operating leases | $ 0 | $ 0 |
Note I - Leases - Supplement Ba
Note I - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Lease liabilities, finance leases | $ 5 | $ 6 |
Operating lease right-of-use assets | 898 | 988 |
Total operating lease right-of-use assets | 898 | 988 |
Current portion of operating lease liabilities | 470 | 480 |
Operating lease liabilities, less current portion | 736 | 843 |
Total operating lease liabilities | $ 1,206 | $ 1,323 |
Finance leases (Year) | 1 year | 1 year |
Operating leases (Year) | 3 years | 3 years |
Finance leases | 14.30% | 14.30% |
Operating leases | 7.40% | 7.30% |
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 | (812) | (780) |
Property and Equipment, Net [Member] | ||
Property and equipment, net | 219 | 251 |
Other Current Liabilities [Member] | ||
Other current liabilities | 5 | 6 |
Other Noncurrent Liabilities [Member] | ||
Other long-term liabilities | 0 | 0 |
Operating Lease Right-of-Use Assets [Member] | ||
Operating lease right-of-use assets | 898 | 988 |
Total operating lease right-of-use assets | 898 | 988 |
Current Portion of Operating Lease Liabilities [Member] | ||
Current portion of operating lease liabilities | 470 | 480 |
Operating Lease Liabilities, Less Current Portion [Member] | ||
Operating lease liabilities, less current portion | $ 736 | $ 843 |
Note I - Leases - Maturities of
Note I - Leases - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
2023, finance leases | $ 5 | |
2023, operating leases | 419 | |
2024, finance leases | 0 | |
2024, operating leases | 488 | |
2025, finance leases | 0 | |
2025, operating leases | 390 | |
2026, finance leases | 0 | |
2026, operating leases | 30 | |
2027, finance leases | 0 | |
2027, operating leases | 0 | |
Total lease payments, finance leases | 5 | |
Total lease payments, operating leases | 1,327 | |
Less: future interest expense, finance leases | 0 | |
Less: future interest expense, operating leases | (121) | |
Lease liabilities, finance leases | 5 | $ 6 |
Lease liabilities, operating leases | $ 1,206 | $ 1,323 |
Note J - Significant Events (De
Note J - Significant Events (Details Textual) | 3 Months Ended | |||
Jan. 09, 2023 shares | Jan. 06, 2023 USD ($) shares | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | |
Severance Costs | $ 1,000,000 | |||
Restructuring Charges | 354,000 | $ 0 | ||
Employee Severance [Member] | ||||
Restructuring Charges | 400,000 | |||
Restructuring Reserve | $ 1,000,000 | |||
Chief Executive Officer [Member] | 2014 Equity Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 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] | ||||
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] | Restricted Stock Units (RSUs) [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | shares | 547,945 |