Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 03, 2024 | |
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 | 2024 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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, $0.0001 par value per share | |
Trading Symbol | ZVRA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 41,853,494 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Assets | ||
Cash and cash equivalents | $ 42,849 | $ 43,049 |
Securities at fair value | 9,868 | 24,688 |
Accounts and other receivables | 8,305 | 17,377 |
Prepaid expenses and other current assets | 1,868 | 1,824 |
Total current assets | 62,890 | 86,938 |
Inventories | 12,426 | 9,841 |
Property and equipment, net | 695 | 736 |
Operating lease right-of-use assets | 1,086 | 790 |
Goodwill acquired | 4,701 | 4,701 |
Intangible assets, net | 67,699 | 69,227 |
Other long-term assets | 1,786 | 94 |
Total assets | 151,283 | 172,327 |
Liabilities and stockholders' equity | ||
Accounts payable and accrued expenses | 22,785 | 28,403 |
Line of credit payable | 0 | 37,700 |
Current portion of operating lease liabilities | 583 | 543 |
Current portion of discount and rebate liabilities | 4,452 | 4,550 |
Other current liabilities | 2,089 | 2,524 |
Total current liabilities | 29,909 | 73,720 |
Secured promissory note | 5,059 | 5,066 |
Line of credit payable | 37,939 | 0 |
Warrant liability | 11,535 | 16,100 |
Operating lease liabilities, less current portion | 705 | 456 |
Discount and rebate liabilities, less current portion | 8,781 | 7,663 |
Other long-term liabilities | 8,537 | 7,458 |
Total liabilities | 102,465 | 110,463 |
Commitments and contingencies (Note D) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 43,426,186 shares issued and 41,850,494 shares outstanding as of March 31, 2024; 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023 | 4 | 4 |
Additional paid-in capital | 476,056 | 472,664 |
Treasury stock, at cost | (10,983) | (10,983) |
Accumulated deficit | (416,400) | (399,778) |
Accumulated other comprehensive income (loss) | 141 | (43) |
Total stockholders' equity | 48,818 | 61,864 |
Total liabilities and stockholders' equity | 151,283 | 172,327 |
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, 2024 or December 31, 2023 | $ 0 | $ 0 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 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) | 43,426,186 | 43,110,360 |
Common stock, shares outstanding (in shares) | 41,850,494 | 41,534,668 |
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, 2024 | Mar. 31, 2023 | |
Revenue, net | $ 3,425 | $ 3,176 |
Cost of product revenue (excluding $1,528 in intangible asset amortization for the three months ended March 31, 2024, shown separately below) | 175 | 125 |
Intangible asset amortization | 1,528 | 0 |
Operating expenses: | ||
Research and development | 12,277 | 8,655 |
Selling, general and administrative | 9,931 | 7,227 |
Total operating expenses | 22,208 | 15,882 |
Loss from operations | (20,486) | (12,831) |
Other income (expense): | ||
Interest expense | (735) | (182) |
Fair value adjustment related to warrant and CVR liability | 3,627 | (1,545) |
Fair value adjustment related to investments | (27) | 196 |
Interest and other income, net | 929 | 1,042 |
Total other income (expense) | 3,794 | (489) |
Loss before income taxes | (16,692) | (13,320) |
Income tax benefit | 70 | 103 |
Net loss | $ (16,622) | $ (13,217) |
Basic and diluted net loss per share of common stock: | ||
Net loss (in dollars per share) | $ (0.4) | $ (0.38) |
Weighted average number of shares of common stock outstanding: | ||
Basic and diluted (in shares) | 41,778,774 | 34,466,542 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net loss | $ (16,622) | $ (13,217) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | 184 | (176) |
Other comprehensive loss: | 184 | (176) |
Comprehensive loss | $ (16,438) | $ (13,393) |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Previously Reported [Member] Common Stock [Member] | Previously Reported [Member] Additional Paid-in Capital [Member] | Previously Reported [Member] Treasury Stock, Common [Member] | Previously Reported [Member] Retained Earnings [Member] | Previously Reported [Member] AOCI Attributable to Parent [Member] | Previously Reported [Member] | 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, 2022 | $ 3 | $ 436,269 | $ (7,536) | $ (353,729) | $ 113 | $ 75,120 | ||||||
Net Income (loss) | $ 0 | $ 0 | $ 0 | $ (13,217) | $ 0 | $ (13,217) | ||||||
Stock-based compensation expense | 0 | 945 | 0 | 0 | 0 | 945 | ||||||
Issuance of common stock in exchange for consulting services | 0 | 42 | 0 | 0 | 0 | 42 | ||||||
Other comprehensive loss | 0 | 0 | 0 | 0 | (176) | (176) | ||||||
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | (3,447) | 0 | 0 | (3,447) | ||||||
Balance at Mar. 31, 2023 | 3 | 437,256 | (10,983) | (366,946) | (63) | 59,267 | ||||||
Balance at Dec. 31, 2023 | $ 4 | $ 472,664 | $ (10,983) | $ (399,778) | $ (43) | $ 61,864 | 61,864 | |||||
Net Income (loss) | 0 | 0 | 0 | (16,622) | 0 | (16,622) | ||||||
Stock-based compensation expense | 0 | 2,119 | 0 | 0 | 0 | 2,119 | ||||||
Issuance of common stock in exchange for consulting services | 0 | 56 | 0 | 0 | 0 | 56 | ||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 71 | 0 | 0 | 0 | 71 | ||||||
Issuance of common stock for options exercised | 0 | 1,146 | 0 | 0 | 0 | 1,146 | ||||||
Other comprehensive loss | 0 | 0 | 0 | 0 | 184 | 184 | ||||||
Balance at Mar. 31, 2024 | $ 4 | $ 476,056 | $ (10,983) | $ (416,400) | $ 141 | $ 48,818 |
Unaudited Condensed Consolida_6
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (16,622) | $ (13,217) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 2,119 | 945 |
Non-cash interest expense | 239 | 0 |
Depreciation and amortization expense | 1,562 | 79 |
Fair value adjustment related to warrant and CVR liability | (3,627) | 1,545 |
Fair value adjustment related to investments | 27 | (196) |
Consulting fees paid in common stock | 56 | 42 |
Loss (gain) on foreign currency exchange | 229 | (240) |
Change in assets and liabilities: | ||
Accounts and other receivables | 9,072 | 477 |
Prepaid expenses and other assets | (44) | 703 |
Inventories | (2,585) | 51 |
Operating lease right-of-use assets | 123 | 80 |
Accounts payable and accrued expenses | (7,306) | 3,836 |
Discount and rebate liability | 1,020 | 1,528 |
Operating lease liabilities | (130) | (107) |
Other liabilities | (298) | 429 |
Net cash used in operating activities | (16,165) | (4,045) |
Cash flows from investing activities: | ||
Purchases of property and equipment | 0 | (29) |
Maturities (purchases) of investments | 14,793 | (17,526) |
Net cash provided by (used in) investing activities | 14,793 | (17,555) |
Cash flows from financing activities: | ||
Proceeds from issuance of debt | 0 | 12,914 |
Repayment of debt | 0 | (12,800) |
Payments to repurchase shares as part of the Share Repurchase Program | 0 | (3,447) |
Proceeds from issuance of stock | 1,217 | 0 |
Payment of principal on insurance financing arrangements | 0 | (415) |
Repayment of principal on finance lease liabilities | 0 | (2) |
Net cash provided by (used in) financing activities | 1,217 | (3,750) |
Effect of exchange rate changes on cash and cash equivalents | (45) | 65 |
Net decrease in cash and cash equivalents | (200) | (25,285) |
Cash and cash equivalents, beginning of period | 43,049 | 65,466 |
Cash and cash equivalents, end of period | 42,849 | 40,181 |
Supplemental cash flow information: | ||
Cash paid for interest | 140 | 68 |
Supplemental disclosure of noncash financing activities: | ||
Cost accrued in connection with the Credit Agreement (Note D) | $ 1,726 | $ 0 |
Note A - Description of Busines
Note A - Description of Business, Basis of Presentation and Significant Transactions | 3 Months Ended |
Mar. 31, 2024 | |
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 combining science, data and patient needs to create transformational therapies for diseases with limited or no first December 21, 2023, September 21, 2024. KP1077 KP1077 KP1077 ® The Company changed its name from KemPharm, Inc. to Zevra Therapeutics, Inc. effective as of February 21, 2023. March 1, 2023, Going Concern The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. During the three March 31, 2024, 2023, March 31, 2024, The Company’s ability to continue operating as a going concern is contingent upon its ability to generate revenue from approved products or obtain product candidate regulatory approvals, which would generate revenue, milestones, and cash flow sufficient to support ongoing operations and the satisfaction of financial covenants. These factors raise substantial doubt as to the Company’s ability to continue as a going concern for at least one not The Company's liquidity needs will be largely determined by the success of operations through the progression of its products and product candidates in the future. The Company also may 1 2 3 4 one 5 not not may Basis of Presentation The Company prepared the unaudited condensed consolidated financial statements in accordance with U.S. 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. Merger On August 30, 2023, November 17, 2023 ( Am endment to Registration Statement on Form S- 3 In connection with the Merger, Zevra and Nantahala concurrently entered into a registration rights agreement, pursuant to which Zevra agreed to file a resale registration statement with respect to the resale of the Zevra common stock issuable to Nantahala. On February 5, 2024, 3 No. 333 276856 On April 5, 2024, 3 No. 333 250945 April 8, 2024. 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, 2024, 2021 Share Repurchase Program On December 20, 2021, December 31, 2023. December 31, 2023, hased 1,575,692 shares of its common stock for approximately $11.0 million. |
Note B - Summary of Significant
Note B - Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
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 unaudited condensed 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 825" . Treasury securities and March 31, 2024, December 31, 2023, 9.9 m 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 t Variable Interest Entities The primary beneficiary of a variable interest entity ("VIE") is required to consolidate the assets and liabilities of the VIE. When the Company obtains a variable interest in another entity, it assesses at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE, and if so, whether the Company is the primary beneficiary of the VIE based on its power to direct the activities of the VIE that most significantly impact the VIE's economic performance and the Company's obligation to absorb losses or the rights to receive benefits from the VIE that could potentially be significant to the VIE. To assess whether the Company has the power to direct the activities of the VIE that most significantly impact the VIE's economic performance, the Company considers all the facts and circumstances, including the Company's role in establishing the VIE and the Company's ongoing rights and responsibilities. The assessment includes identifying the activities that most significantly impact the VIE's economic performance and identifying which party, if any, has the power to direct those activities. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) are deemed to have the power to direct the activities of a VIE. To assess whether the Company has the obligation to absorb losses of the VIE or the rights to receive benefits from the VIE that could potentially be significant to the VIE, the Company considers all of its economic interests that are deemed to be variable interests in the VIE. This assessment requires judgement in determining whether these interests, in the aggregate, are considered potentially significant to the VIE. As of March 31, 2024, December 31, 2023, 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 Licensing Agreements 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 Product Revenues, Net Net revenues from product sales is recognized at the transaction price when the customer obtains control of the Company's products, which occurs at a point in time, typically upon receipt of the product by the customer. The Company's net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC 606 Inventories The value of inventory is recorded at its net realizable value. The Company determines the cost of its other inventories, which includes amounts related to materials and manufacturing overhead, on a first first The Company may may not may not March 31, 2024, December 31, 2023, not The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first may not 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. Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, 480 815, 815 480, 480, 815, For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the unaudited condensed consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not New Accounting Pronouncements Not Segment Reporting (Topic 280 In November 2023, 2023 07, 280 December 15, 2023, December 15, 2024. Income Taxes (Topic 740 In December 2023, 2023 09, 740 December 15, 2024. |
Note C - Inventories
Note C - Inventories | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | C. Inventories March 31, December 31, 2024 2023 Raw materials $ 4,044 $ 2,938 Work in progress 3,309 1,884 Finished goods 5,073 5,019 Total inventory $ 12,426 $ 9,841 |
Note D - Debt Obligations
Note D - Debt Obligations | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | D. Debt Obligations Secured Promissory Note In connection with the Merger (Note L), on August 30, 2023, March 1, 2024, six twenty first second August 30, 2026, third April 2024, March 1, 2024, April 5, 2024. March 31, 2024, As of March 31, 2024, December 31, 2023, March 31, December 31, 2024 2023 Secured promissory note $ 5,000 $ 5,000 Unamortized original issue premium 132 148 Less: debt issuance costs (73 ) (82 ) Secured promissory note, net $ 5,059 $ 5,066 Future minimum principal payments under the secured promissory note as of March 31, 2024, Year Ending December 31, 2024 $ — 2025 1,200 2026 3,800 Total minimum payments 5,000 Plus: unamortized debt premium and debt issuance costs 59 Secured promissory note, net $ 5,059 Line of Credit On January 26, 2023, ts are used as collateral for the loan and the amount the Company is able to borrow is limited to 80-90% of its outstanding investment balance held with Wells Fargo. The margin account bore interest at the Prime rate minus 225 basis-points. As of March 31, 2024, December 31, 2023, April 2024, March 31, 2024, March 31, 2024, Term Loans As a subsequent event, on April 5, 2024 ( Under the terms of the Credit Agreement, the Lenders provided a senior secured loan facility to the Company in the aggregate principal amount of $100.0 million, which is divided into three two not 18 December 31, 2024 ( The principal amount of the Term Loans outstanding (the “Outstanding Principal Amount”) will bear interest at a rate equal to 3 plus December 31, 2025, 3 plus December 31, 2025, not four March 31, 2026, 3 plus 3 March 31, 2026. fifth March 31, 2024. The Credit Agreement contains customary affirmative and negative covenants by the Company, which among other things, will require the Company to provide certain financial reports to the Lenders, meet certain minimum net product sales amounts, and limit the ability of the Company to incur or guarantee additional indebtedness, engage in certain transactions, and effect a consolidation or merger, without consent. The obligations of the Company under the Credit Agreement may first |
Note E - Revenue, Net
Note E - Revenue, Net | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | E. Revenue, net Licensing Agreements AZSTARYS License Agreement 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, as amended, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, including AZSTARYS, or any other product candidates containing SDX and developed to treat ADHD or any other 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, Commave agreed to pay milestone payments up to an aggregate of $590.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS, additional fixed payments upon the achievement of specified U.S. sales milestones, and quarterly, tiered royalty payments based on a range of percentages of net sales (as defined in the AZSTARYS License Agreement). Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product. The AZSTARYS License Agreement is within the scope of ASC 606, not 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 ents. 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 three March 31, 2024, 2023, million and $0.6 million no March 31, 2024, December 31, 2023. In accordance with the terms of the Company’s Termination Agreement with Aquestive Therapeutics dated March 20, 2012, KP1077 Relief Exclusive License Agreement As a condition to entering into the Merger Agreement, Acer and Relief Therapeutics, Inc. ("Relief") entered into an exclusive license agreement on August 30, 2023 ( three March 31, 2024, not no March 31, 2024, December 31, 2023. Product Revenues, Net Arimoclomol Expanded Access Program Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under the remunerated expanded access compassionate use program in France (“French nATU”). An expanded access compassionate use program is a program giving specific patients access to a drug, which is not no In accordance with ASC 606, The French Health Authorities and the manufacturer have agreed to a price for sales during the French nATU, but the final transaction price depends on the terms and conditions in the contracts with the French Health Authorities and is subject to price negotiations with the French Health Authorities, following market approval. Any excess in the price charged the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability (rebate). An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drugs products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate. For the three March 31, 2024, of $2.2 million, which is net of a clawback liability of $1.3 millio three March 31, 2023, $2.0 million, which is net of a clawback liability of $1.3 m March 31, 2024, December 31, 2023, s $13.2 mil $12.2 mi March 31, 2024, December 31, 2023, OLPRUVA Product Sales On December 27, 2022, 44 20 1.2m2 November 17, 2023, third single specialty pharmacy provider. For the three March 31, 2024, 2023, Q1 2024. Accounts and Other Receivables Accounts and other receivables consist of receivables from product sales, receivables under the AZSTARYS License Agreement and Arimoclomol EAP, as well as 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, 2024, $4.8 m $1.2 mi $2.2 m December 31, 2023, mi $11.4 m and other receivables of $1.3 m March 31, 2024, December 31, 2023, |
Note F - Commitments and Contin
Note F - Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | F. 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 Stockholder Litigation Related to the Merger On October 12, 2023, No. 1:23 08995 14 20 1934 October 30, 2023, DEF14A December 8, 2023, On October 20, 2023, No. 1:23 01185 14 20 1934 14a 9 not On October 20, 2023, No. 1:23 01186 14 20 1934 14a 9 not As of March 31, 2024, December 31, 2023 |
Note G - Stock and Warrants
Note G - Stock and Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Equity [Text Block] | G. Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of March 31, 2024 December 31, 2023 s, 43,426,186 and 43,110,360 share March 31, 2024, December 31, 2023, d 41,850,494 and 41,534,668 sh March 31, 2024 December 31, 2023 As of March 31, 2024 December 31, 2023 March 31, 2024 December 31, 2023 Outstanding awards under equity incentive plans 9,324,407 8,023,142 Outstanding common stock warrants 5,603,729 5,603,729 Possible future issuances under equity incentive plans 4,366,537 1,728,885 Possible future issuances under employee stock purchase plans 1,340,172 1,340,172 Total common shares reserved for future issuance 20,634,845 16,695,928 Common Stock Activity The following table summarizes common stock activity for the three March 31, 2024 : Shares of Common Stock Balance as of January 1, 2024 41,534,668 Common stock issued as compensation to third parties 9,000 Common stock issued as a result of stock options exercised 306,826 Balance as of March 31, 2024 41,850,494 Authorized, Issued, and Outstanding Preferred Stock As of March 31, 2024, December 31, 2023, none Warrants to Purchase Common Stock The Company has issued warrants to purchase common stock to various third March 31, 2024, 260, Earnings per Share may In connection with the Merger (Note L), in November 2023, "2023 November 22, 2028. March 31, 2024, December 31, 2023, none 480, 815, The Company determined that its outstanding warrants and the Put Option should be recorded as a liability and stated at fair value at each reporting period. Changes to the fair value of the warrant liability are recorded through the unaudited condensed consolidated statements of operations as a fair value adjustment related to warrant and CVR liability. As of March 31, 2024, December 31, 2023, $11.5 m $4.6 m three March 31, 2024, 2023, |
Note H - Stock-based Compensati
Note H - Stock-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | H. 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, 4,900,000 til January 1, 2031 2014 162 may 2014 March 31, 2024 2014 January 1 January 1, 2031, December 31 2014 January 1, 2024, 2014 1,661,386 During the three March 31, 2024, three March 31, 2023, In June 2021, April 2021. may first October 1, 2021, first May 31, 2022. March 31, 2024, 159,828 shar In January 2023, 2023 "2023 2023 February 2024, 2023 2023 In May 2023, 2014 Stock-based compensation expense recorded under the Incentive Stock Plan, A&R 2014 2023 Three months ended March 31, 2024 2023 Research and development $ 853 $ 572 Selling, general and administrative 1,266 19 Total stock-based compensation expense $ 2,119 $ 591 There was no stock-based compensation expense related to performance-based awards recognized during the three March 31, 2024, 2023. |
Note I - Fair Value of Financia
Note I - Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | I. 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, 2024, December 31, 2023 ( Balance as of March 31, 2024 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) CVR liability (Note L) 8,200 $ — $ — $ 8,200 Warrant liabilities 11,535 — — 11,535 Total liabilities $ 19,735 $ — $ — $ 19,735 — Securities: U.S. Treasury securities 9,868 9,868 — — Total assets $ 9,868 $ 9,868 $ — $ — Balance as of December 31, 2023 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) CVR liability (Note L) $ 7,262 $ — $ — $ 7,262 Warrant liabilities 16,100 — — 16,100 Total liabilities $ 23,362 $ — $ — $ 23,362 — Securities: U.S. Treasury securities $ 24,688 $ 24,688 $ — $ — Total assets $ 24,688 $ 24,688 $ — $ — The com mon stock warrant li March 31, 2024, December 31, 2023: March 31, 2024 December 31, 2023 Risk-free interest rate 4.14% - 4.57 % 3.76% - 4.12 % Volatility 59.43% - 92.76 % 62.01% - 92.42 % Dividend yield 0 % 0 % Expected term (years) 1.8 - 4.6 2.0 - 4.9 Weighted average fair value 2.17 2.94 The following table is a reconciliation for the common stock warrant liabilities measured at fair val ue using Level 3 Balance as of December 31, 2023 $ 16,100 Change in fair value measurement (4,565 ) Balance as of March 31, 2024 $ 11,535 For the three March 31, 2024, 2023, |
Note J - Net Loss Per Share
Note J - Net Loss Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | J. 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, 2024 2023 Awards under equity incentive plans 4,366,537 6,024,889 Common stock warrants 5,603,729 4,252,490 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 9,970,266 10,277,379 A reconciliation from net loss to basic and diluted net loss per share of common stock for the three March 31, 2024, 2023, Three months ended March 31, 2024 2023 Basic and diluted net loss per share of common stock: Net loss, basic and diluted $ (16,622 ) $ (13,217 ) Weighted average number of shares of common stock outstanding, basic and diluted 41,779 34,467 Basic and diluted net loss per share of common stock $ (0.40 ) $ (0.38 ) |
Note K - Leases
Note K - Leases | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Lease Disclosure [Text Block] | K. 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 2024 2023 Finance lease cost: Amortization of right-of-use assets $ 12 $ 32 Interest on lease liabilities — — Total finance lease cost 12 32 Operating lease cost 93 113 Short-term lease cost 59 55 Variable lease cost 13 13 Less: sublease income (39 ) (39 ) Total lease costs $ 138 $ 174 Supplemental cash flow information related to leases was as follows (in thousands): Three months ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Financing cash flows from finance leases $ — $ 2 Operating cash flows from operating leases 123 142 Operating cash flows from short-term leases 59 55 Operating cash flows from variable lease costs 13 13 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases 419 — 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, 2024 2023 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (894 ) (882 ) Property and equipment, net $ 137 $ 149 Other current liabilities $ — $ — Other long-term liabilities — — Total finance lease liabilities $ — $ — Operating Leases Operating lease right-of-use assets $ 1,086 $ 790 Total operating lease right-of-use assets $ 1,086 $ 790 Current portion of operating lease liabilities $ 583 $ 543 Operating lease liabilities, less current portion 705 456 Total operating lease liabilities $ 1,288 $ 999 Weighted Average Remaining Lease Term Operating leases (in years) 3 2 Weighted Average Discount Rate Finance leases 0.0 % 14.3 % Operating leases 9.3 % 7.6 % Maturities of lease liabilities were as follows (in thousands): Finance Operating Year Ending December 31, Leases Leases 2024 (excluding the three months ended March 31, 2024) $ — $ 531 2025 — 511 2026 — 142 2027 — 132 2028 — 155 Thereafter — 40 Total lease payments — 1,511 Less: future interest expense — (223 ) Lease liabilities $ — $ 1,288 |
Note L - Merger
Note L - Merger | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Mergers, Acquisitions and Dispositions Disclosures [Text Block] | L. Merger On August 30, 2023, ● Bridge Loan October 31, 2023, ● Purchase of Acer s Term Loans March 14, 2022, January 31, 2023 1 2 3 ● Purchase of Acer s Convertible June 16, 2023. ● Amendment to IP License Agreement and IP Termination Agreement: March 19, 2021, first third In connection with the closing of the Merger on November 17, 2023, one one 2820 The assets acquired and liabilities assumed were recorded based on their acquisition date fair values. Consideration for the Merger was $72.6 million and consists of (i) approximately 2.96 million shares of Zevra common stock valued at $12.8 million, (ii) the Bridge Loan advances of $17.8 million, (iii) $12.0 million in cash paid to Nantahala; (iv) 2.27 million shares of Zevra Common Stock issued to Nantahala valued at $11.5 million based on the VWAP of shares of Zevra Common Stock during the 20 consecutive trading days ending on the trading date prior to August 30, 2023; ( uired and liabilities assumed: Assets Cash $ 575 Prepaid expenses 278 Other current assets 11 Inventory 9,376 Property, plant, and equipment 35 Other noncurrent assets 209 Approved product - OLPRUVA 68,000 IPR&D - celiprolol 2,000 Goodwill acquired 4,701 85,185 Liabilities Accounts payable and accrued expenses $ 10,881 Deferred collaboration funding 1,500 Operating lease liabilities 175 12,556 Fair Value of Net Assets Acquired $ 72,629 The preliminary fair values assigned to the tangible and intangible assets acquired and liabilities assumed were determined using an income approach based on management’s estimates and assumptions, as well as other information compiled by management, including third one may March 31, 2024, not not The results of operations and changes in stockholders' equity for Acer were included in the Company's consolidated financial statements beginning November 18, 2023. The following pro forma combined r January 1, 2023. not one not Three Months Ended March 31, 2023 Pro forma revenue $ 3,176 Pro forma net loss (20,652 ) Cancellation of Acer Warrant On November 22, 2023, Contingent Consideration Contingent consideration liabilities relate to our liabilities arising in connection with the CVRs issued as a result of the Merger. The contingent consideration is classified as Level 3 The f ollowing table provides Balance at December 31, 2023 $ 7,262 Change in fair value recognized in earnings 938 Balance at March 31, 2024 $ 8,200 For the three March 31, 2024, a $0.9 million loss on the changes in market data and revenue projections. |
Note M - Goodwill & Intangible
Note M - Goodwill & Intangible Assets | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Goodwill and Intangible Assets Disclosure [Text Block] | M. Goodwill & Intangible Assets The Company's goodwill balance was $4.7 million as of March 31, 2024, December 31, 2023. As of March 31, 2024, December 31, 2023, $2.0 million As of March 31, 2024, December 31, 2023, eleven three March 31, 2024. three March 31, 2023. For intangible assets subject to amortization, estima five March 31, 2024, |
Note N - Subsequent Events
Note N - Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | N. Subsequent Events The Company evaluated events and transactions occurring subsequent to March 31, 2024, May 9, 2024, no |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Insider Trading Arr Line Items | |
Material Terms of Trading Arrangement [Text Block] | 5. Other Information (a) Disclosure in lieu of reporting on a Current Report on Form 8 None. (b) Material changes to the procedures by which security holders may None. (c) Insider Trading Arrangements and Policies. During the three March 31, 2024, no 10b5 1 10b5 1 408 |
Rule 10b5-1 Arrangement Adopted [Flag] | false |
Non-Rule 10b5-1 Arrangement Adopted [Flag] | false |
Rule 10b5-1 Arrangement Terminated [Flag] | false |
Non-Rule 10b5-1 Arrangement Terminated [Flag] | false |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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 unaudited condensed 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 825" . Treasury securities and March 31, 2024, December 31, 2023, 9.9 m 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 t |
Consolidation, Variable Interest Entity, Policy [Policy Text Block] | Variable Interest Entities The primary beneficiary of a variable interest entity ("VIE") is required to consolidate the assets and liabilities of the VIE. When the Company obtains a variable interest in another entity, it assesses at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE, and if so, whether the Company is the primary beneficiary of the VIE based on its power to direct the activities of the VIE that most significantly impact the VIE's economic performance and the Company's obligation to absorb losses or the rights to receive benefits from the VIE that could potentially be significant to the VIE. To assess whether the Company has the power to direct the activities of the VIE that most significantly impact the VIE's economic performance, the Company considers all the facts and circumstances, including the Company's role in establishing the VIE and the Company's ongoing rights and responsibilities. The assessment includes identifying the activities that most significantly impact the VIE's economic performance and identifying which party, if any, has the power to direct those activities. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) are deemed to have the power to direct the activities of a VIE. To assess whether the Company has the obligation to absorb losses of the VIE or the rights to receive benefits from the VIE that could potentially be significant to the VIE, the Company considers all of its economic interests that are deemed to be variable interests in the VIE. This assessment requires judgement in determining whether these interests, in the aggregate, are considered potentially significant to the VIE. As of March 31, 2024, December 31, 2023, |
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 Licensing Agreements 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 Product Revenues, Net Net revenues from product sales is recognized at the transaction price when the customer obtains control of the Company's products, which occurs at a point in time, typically upon receipt of the product by the customer. The Company's net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC 606 |
Inventory, Policy [Policy Text Block] | Inventories The value of inventory is recorded at its net realizable value. The Company determines the cost of its other inventories, which includes amounts related to materials and manufacturing overhead, on a first first The Company may may not may not March 31, 2024, December 31, 2023, not The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first may not |
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. |
Warrants [Policy Text Block] | Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, 480 815, 815 480, 480, 815, For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the unaudited condensed consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not |
New Accounting Pronouncements, Policy [Policy Text Block] | New Accounting Pronouncements Not Segment Reporting (Topic 280 In November 2023, 2023 07, 280 December 15, 2023, December 15, 2024. Income Taxes (Topic 740 In December 2023, 2023 09, 740 December 15, 2024. |
Note C - Inventories (Tables)
Note C - Inventories (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Inventory, Noncurrent [Table Text Block] | March 31, December 31, 2024 2023 Raw materials $ 4,044 $ 2,938 Work in progress 3,309 1,884 Finished goods 5,073 5,019 Total inventory $ 12,426 $ 9,841 |
Note D - Debt Obligations (Tabl
Note D - Debt Obligations (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Long-Term Debt Instruments [Table Text Block] | March 31, December 31, 2024 2023 Secured promissory note $ 5,000 $ 5,000 Unamortized original issue premium 132 148 Less: debt issuance costs (73 ) (82 ) Secured promissory note, net $ 5,059 $ 5,066 |
Schedule of Maturities of Long-Term Debt [Table Text Block] | Year Ending December 31, 2024 $ — 2025 1,200 2026 3,800 Total minimum payments 5,000 Plus: unamortized debt premium and debt issuance costs 59 Secured promissory note, net $ 5,059 |
Note G - Stock and Warrants (Ta
Note G - Stock and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block] | March 31, 2024 December 31, 2023 Outstanding awards under equity incentive plans 9,324,407 8,023,142 Outstanding common stock warrants 5,603,729 5,603,729 Possible future issuances under equity incentive plans 4,366,537 1,728,885 Possible future issuances under employee stock purchase plans 1,340,172 1,340,172 Total common shares reserved for future issuance 20,634,845 16,695,928 |
Schedule of Common Stock Outstanding Roll Forward [Table Text Block] | Shares of Common Stock Balance as of January 1, 2024 41,534,668 Common stock issued as compensation to third parties 9,000 Common stock issued as a result of stock options exercised 306,826 Balance as of March 31, 2024 41,850,494 |
Note H - Stock-based Compensa_2
Note H - Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three months ended March 31, 2024 2023 Research and development $ 853 $ 572 Selling, general and administrative 1,266 19 Total stock-based compensation expense $ 2,119 $ 591 |
Note I - Fair Value of Financ_2
Note I - Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Balance as of March 31, 2024 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) CVR liability (Note L) 8,200 $ — $ — $ 8,200 Warrant liabilities 11,535 — — 11,535 Total liabilities $ 19,735 $ — $ — $ 19,735 — Securities: U.S. Treasury securities 9,868 9,868 — — Total assets $ 9,868 $ 9,868 $ — $ — Balance as of December 31, 2023 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) CVR liability (Note L) $ 7,262 $ — $ — $ 7,262 Warrant liabilities 16,100 — — 16,100 Total liabilities $ 23,362 $ — $ — $ 23,362 — Securities: U.S. Treasury securities $ 24,688 $ 24,688 $ — $ — Total assets $ 24,688 $ 24,688 $ — $ — |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | March 31, 2024 December 31, 2023 Risk-free interest rate 4.14% - 4.57 % 3.76% - 4.12 % Volatility 59.43% - 92.76 % 62.01% - 92.42 % Dividend yield 0 % 0 % Expected term (years) 1.8 - 4.6 2.0 - 4.9 Weighted average fair value 2.17 2.94 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Balance as of December 31, 2023 $ 16,100 Change in fair value measurement (4,565 ) Balance as of March 31, 2024 $ 11,535 |
Note J - Net Loss Per Share (Ta
Note J - Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three months ended March 31, 2024 2023 Awards under equity incentive plans 4,366,537 6,024,889 Common stock warrants 5,603,729 4,252,490 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 9,970,266 10,277,379 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three months ended March 31, 2024 2023 Basic and diluted net loss per share of common stock: Net loss, basic and diluted $ (16,622 ) $ (13,217 ) Weighted average number of shares of common stock outstanding, basic and diluted 41,779 34,467 Basic and diluted net loss per share of common stock $ (0.40 ) $ (0.38 ) |
Note K - Leases (Tables)
Note K - Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three months ended March 31, Lease Cost 2024 2023 Finance lease cost: Amortization of right-of-use assets $ 12 $ 32 Interest on lease liabilities — — Total finance lease cost 12 32 Operating lease cost 93 113 Short-term lease cost 59 55 Variable lease cost 13 13 Less: sublease income (39 ) (39 ) Total lease costs $ 138 $ 174 |
Schedule of Leases Cash Flow Information [Table Text Block] | Three months ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Financing cash flows from finance leases $ — $ 2 Operating cash flows from operating leases 123 142 Operating cash flows from short-term leases 59 55 Operating cash flows from variable lease costs 13 13 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases 419 — |
Schedule of Leases Balance Sheet Information [Table Text Block] | March 31, December 31, 2024 2023 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (894 ) (882 ) Property and equipment, net $ 137 $ 149 Other current liabilities $ — $ — Other long-term liabilities — — Total finance lease liabilities $ — $ — Operating Leases Operating lease right-of-use assets $ 1,086 $ 790 Total operating lease right-of-use assets $ 1,086 $ 790 Current portion of operating lease liabilities $ 583 $ 543 Operating lease liabilities, less current portion 705 456 Total operating lease liabilities $ 1,288 $ 999 Weighted Average Remaining Lease Term Operating leases (in years) 3 2 Weighted Average Discount Rate Finance leases 0.0 % 14.3 % Operating leases 9.3 % 7.6 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, Leases Leases 2024 (excluding the three months ended March 31, 2024) $ — $ 531 2025 — 511 2026 — 142 2027 — 132 2028 — 155 Thereafter — 40 Total lease payments — 1,511 Less: future interest expense — (223 ) Lease liabilities $ — $ 1,288 |
Note L - Merger (Tables)
Note L - Merger (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed [Table Text Block] | Assets Cash $ 575 Prepaid expenses 278 Other current assets 11 Inventory 9,376 Property, plant, and equipment 35 Other noncurrent assets 209 Approved product - OLPRUVA 68,000 IPR&D - celiprolol 2,000 Goodwill acquired 4,701 85,185 Liabilities Accounts payable and accrued expenses $ 10,881 Deferred collaboration funding 1,500 Operating lease liabilities 175 12,556 Fair Value of Net Assets Acquired $ 72,629 |
Business Acquisition, Pro Forma Information [Table Text Block] | Three Months Ended March 31, 2023 Pro forma revenue $ 3,176 Pro forma net loss (20,652 ) |
Schedule of Business Acquisitions by Acquisition, Contingent Consideration [Table Text Block] | Balance at December 31, 2023 $ 7,262 Change in fair value recognized in earnings 938 Balance at March 31, 2024 $ 8,200 |
Note A - Description of Busin_2
Note A - Description of Business, Basis of Presentation and Significant Transactions (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||
Jul. 12, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Feb. 05, 2024 | Oct. 31, 2023 | Aug. 30, 2023 | Dec. 20, 2021 | Jul. 02, 2021 | |
Net Income (Loss) Attributable to Parent | $ (16,622) | $ (13,217) | |||||||
Retained Earnings (Accumulated Deficit) | $ (416,400) | $ (399,778) | |||||||
Common Stock Registered, Shares (in shares) | 2,269,721 | ||||||||
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 | 0 | |||||||
Bridge Loan [Member] | |||||||||
Financing Receivable, Maximum Limit | $ 18,000 | $ 18,000 |
Note B - Summary of Significa_2
Note B - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Investments, Fair Value Disclosure | $ 9,900 | $ 24,700 |
Unrealized Gain (Loss) on Investments | (100) | 200 |
Pre-launch Inventory that Qualified for Capitalization [Member] | ||
Inventory, Net | $ 0 | $ 0 |
Note C - Inventories - Summary
Note C - Inventories - Summary of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Raw materials | $ 4,044 | $ 2,938 |
Work in progress | 3,309 | 1,884 |
Finished goods | 5,073 | 5,019 |
Total inventory | $ 12,426 | $ 9,841 |
Note D - Debt Obligations (Deta
Note D - Debt Obligations (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||
Apr. 05, 2024 | Aug. 30, 2023 | Jan. 31, 2023 | Jan. 26, 2023 | Nov. 30, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 01, 2024 | Dec. 31, 2023 | Nov. 17, 2023 | |
Stock Issued During Period, Shares, Acquisitions (in shares) | 1,382,489 | |||||||||
Proceeds from Issuance of Debt | $ 0 | $ 12,914 | ||||||||
Wells Fargo Bank, N.A. [Member] | ||||||||||
Long-Term Line of Credit | 37,900 | $ 37,700 | ||||||||
Line of Credit Facility, Remaining Borrowing Capacity | 3,800 | |||||||||
Wells Fargo Bank, N.A. [Member] | Prime Rate [Member] | ||||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.25% | |||||||||
Wells Fargo Bank, N.A. [Member] | Minimum [Member] | ||||||||||
Line of Credit Facility, Maximum Borrowing Capacity, Percentage of Investments | 80% | |||||||||
Wells Fargo Bank, N.A. [Member] | Maximum [Member] | ||||||||||
Line of Credit Facility, Maximum Borrowing Capacity, Percentage of Investments | 90% | |||||||||
SWK Loans [Member] | ||||||||||
Payments to Acquire Notes Receivable | $ 12,000 | $ 12,000 | ||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | 98,683 | 98,683 | ||||||||
Nantahala Note [Member] | ||||||||||
Debt Instrument, Face Amount | $ 5,000 | $ 5,000 | $ 5,000 | |||||||
Debt Instrument, Interest Rate, Stated Percentage | 9% | |||||||||
Debt Instrument, Interest Rate, Stated Percentage, If Unpaid Within Six Months | 12% | |||||||||
Debt Instrument, Interest Rate, Increase in Stated Percentage, If Unpaid Within Six Months | 3% | 3% | ||||||||
Debt Instrument, Interest, Shares, Consecutive Trading Days For Calculation of VWAP (Day) | 20 days | |||||||||
Debt Instrument, Periodic Payment, Interest | $ 600 | |||||||||
Debt Issuance Costs, Net | 73 | $ 82 | ||||||||
Term Loans Under Credit Agreement [Member | ||||||||||
Debt Issuance Costs, Net | $ 1,700 | |||||||||
Term Loans Under Credit Agreement [Member | Subsequent Event [Member] | ||||||||||
Debt Instrument, Face Amount | $ 100,000 | |||||||||
Proceeds from Issuance of Debt | 60,000 | |||||||||
Debt Instrument, Available Amount Until 18 Months Following Closing Date | 20,000 | |||||||||
Debt Instrument, Available Amount Until 18 Months Following Closing Date, Maximum Each Drawing | 10,000 | |||||||||
Debt Instrument, Available Amount Until December 31, 2024 | 20,000 | |||||||||
Debt Instrument, Net Product Sales Performance Benchmark | 100,000 | |||||||||
Debt Instrument, Net Product Sales Performance Benchmark in Next Year | $ 125,000 | |||||||||
Debt Instrument, Maximum Interest Payment, Percentage | 25% | |||||||||
Term Loans Under Credit Agreement [Member | Secured Overnight Financing Rate (SOFR) [Member] | Subsequent Event [Member] | ||||||||||
Debt Instrument, Basis Spread on Variable Rate | 7% | |||||||||
Debt Instrument, Basis Spread on Variable Rate When Performance Benchmark Meet | 6% | |||||||||
Debt Instrument, Basis Spread on Variable Rate When Performance Benchmark Meet in Next Year | 6.50% | |||||||||
Debt Instrument, Floor Rate | 4% |
Note D - Debt Obligations - Agg
Note D - Debt Obligations - Aggregate Principal Amount (Details) - Nantahala Note [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Secured promissory note | $ 5,000 | $ 5,000 |
Unamortized original issue premium | 132 | 148 |
Less: debt issuance costs | (73) | (82) |
Secured promissory note, net | $ 5,059 | $ 5,066 |
Note D - Debt Obligations - Fut
Note D - Debt Obligations - Future Minimum Principal Payments (Details) - Nantahala Note [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
2024 | $ 0 | |
2025 | 1,200 | |
2026 | 3,800 | |
Total minimum payments | 5,000 | $ 5,000 |
Plus: unamortized debt premium and debt issuance costs | 59 | |
Secured promissory note, net | $ 5,059 | $ 5,066 |
Note E - Revenue, Net (Details
Note E - Revenue, Net (Details Textual) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Mar. 20, 2012 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | May 07, 2021 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 3,425 | $ 3,176 | |||
Income Taxes Receivable | 100 | ||||
Arimoclomol Purchase Agreement [Member] | |||||
Contract with Customer, Liability, Revenue Recognized | 2,200 | 2,000 | |||
Contract with Customer, Clawback Liability | 1,300 | 1,300 | |||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | 13,200 | $ 12,200 | |||
Consulting Services [Member] | |||||
Accounts Receivable, after Allowance for Credit Loss, Current | 2,200 | 1,300 | |||
GPC Member | License [Member] | |||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | $ 590,000 | ||||
Accounts Receivable, after Allowance for Credit Loss, Current | 1,200 | 11,400 | |||
Aquestive Therapeutics [Member] | License [Member] | |||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,200 | $ 600 | |||
Royalty Revenue, Percent | 10% | ||||
Relief Therapeutics [Member] | License [Member] | |||||
Maximum Royalty Percentage | 10% | ||||
Arimoclomol EAP [Member] | |||||
Accounts Receivable, after Allowance for Credit Loss, Current | $ 4,800 | $ 4,700 | |||
JMP and RBCCM [Member] | ATM Agreement Sales [Member] | |||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | 0 |
Note F - Commitments and Cont_2
Note F - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Loss Contingency Accrual | $ 0 | $ 0 |
Note G - Stock and Warrants (De
Note G - Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 3 Months Ended | ||
Nov. 22, 2023 | Nov. 30, 2023 | Dec. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 | |||
Common Stock, Shares, Issued (in shares) | 43,110,360 | 43,426,186 | |||
Common Stock, Shares, Outstanding (in shares) | 41,534,668 | 41,850,494 | |||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | |||
Class of Warrant or Right, Outstanding (in shares) | 5,603,729 | ||||
Stock Issued During Period, Shares, Acquisitions (in shares) | 1,382,489 | ||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Derivative and Warrant Liability, Noncurrent | $ 16,100 | $ 11,535 | |||
Fair Value Adjustment of Put Option, Net of Tax | $ 4,600 | $ 1,500 | |||
Acer Warrants [Member] | |||||
Proceeds from Warrant Exercises | $ 6,000 | ||||
Class of Warrants or Right, Exercised During Period (in shares) | 0 | 0 | |||
Acer Warrants [Member] | Common Stock [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,382,489 | ||||
Shares and Warrants Issued, Price Per Share (in dollars per share) | $ 4.34 | ||||
The Investor Warrant [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,920,306 | 2,920,306 | |||
Stock Issued During Period, Shares, New Issues (in shares) | 917,934 | 917,934 |
Note G - Stock and Warrants - R
Note G - Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Common shares reserved for future issuance (in shares) | 20,634,845 | 16,695,928 |
Warrant [Member] | ||
Common shares reserved for future issuance (in shares) | 5,603,729 | 5,603,729 |
Share-Based Payment Arrangement [Member] | ||
Common shares reserved for future issuance (in shares) | 9,324,407 | 8,023,142 |
Possible Future Issuances Under Equity Incentive Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 4,366,537 | 1,728,885 |
Possible Future Issuances Under Employee Stock Purchase Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 1,340,172 | 1,340,172 |
Note G - Stock and Warrants - C
Note G - Stock and Warrants - Common Stock Activity (Details) | 3 Months Ended |
Mar. 31, 2024 shares | |
Balance (in shares) | 41,534,668 |
Common stock issued as compensation to third parties (in shares) | 9,000 |
Common stock issued as a result of stock options exercised (in shares) | 306,826 |
Balance (in shares) | 41,850,494 |
Note H - Stock-based Compensa_3
Note H - Stock-based Compensation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 36 Months Ended | ||||
Jan. 01, 2024 | Jun. 30, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Feb. 29, 2024 | 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) | 159,828 | ||||||
Share-Based Payment Arrangement, Expense | $ 2,119 | $ 591 | |||||
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) | 9,932,883 | 9,932,883 | |||||
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) | 1,661,386 | ||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares) | 716,875 | 0 | |||||
The 2023 Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 4,500,000 | 1,500,000 |
Note H - Stock-based Compensa_4
Note H - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock based compensation expense | $ 2,119 | $ 591 |
Research and Development Expense [Member] | ||
Stock based compensation expense | 853 | 572 |
General and Administrative Expense [Member] | ||
Stock based compensation expense | $ 1,266 | $ 19 |
Note I - Fair Value of Financ_3
Note I - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Total liabilities | $ 19,735 | $ 23,362 |
Total assets | 9,868 | 24,688 |
US Treasury Securities [Member] | ||
Total assets | 9,868 | 24,688 |
Fair Value, Inputs, Level 1 [Member] | ||
Total liabilities | 0 | 0 |
Total assets | 9,868 | 24,688 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Total assets | 9,868 | 24,688 |
Fair Value, Inputs, Level 2 [Member] | ||
Total liabilities | 0 | 0 |
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Total liabilities | 19,735 | 23,362 |
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
CVR Liability [Member] | ||
Total liabilities | 8,200 | 7,262 |
CVR Liability [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total liabilities | 0 | 0 |
CVR Liability [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total liabilities | 0 | 0 |
CVR Liability [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total liabilities | 8,200 | 7,262 |
Warrants [Member] | ||
Total liabilities | 11,535 | 16,100 |
Warrants [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total liabilities | 0 | 0 |
Warrants [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total liabilities | 0 | 0 |
Warrants [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total liabilities | $ 11,535 | $ 16,100 |
Note I - Fair Value of Financ_4
Note I - Fair Value of Financial Instruments - Fair Value Assumptions for Warrant Liabilities (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 $ / shares | Dec. 31, 2023 $ / shares | |
Weighted average fair value (in dollars per share) | $ 2.17 | $ 2.94 |
Measurement Input, Expected Dividend Rate [Member] | ||
Risk-free interest rate | 0 | 0 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Risk-free interest rate | 0.0414 | 0.0376 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||
Risk-free interest rate | 0.5943 | 0.6201 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Risk-free interest rate | 1.8 | 2 |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Risk-free interest rate | 0.0457 | 0.0412 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||
Risk-free interest rate | 0.9276 | 0.9242 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Risk-free interest rate | 4.6 | 4.9 |
Note I - Fair Value of Financ_5
Note I - Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Balance | $ 16,100 |
Change in fair value measurement | (4,565) |
Balance | $ 11,535 |
Note J - Net Loss Per Share - A
Note J - Net Loss Per Share - Anti-dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive securities (in shares) | 9,970,266 | 10,277,379 |
Share-Based Payment Arrangement [Member] | ||
Antidilutive securities (in shares) | 4,366,537 | 6,024,889 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive securities (in shares) | 5,603,729 | 4,252,490 |
Note J - Net Loss Per Share - E
Note J - Net Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Income (Loss) Attributable to Parent | $ (16,622) | $ (13,217) |
Weighted average number of shares of common stock outstanding, basic and diluted (in shares) | 41,778,774 | 34,466,542 |
Basic and diluted net loss per share of common stock (in dollars per share) | $ (0.4) | $ (0.38) |
Note K - Leases (Details Textua
Note K - Leases (Details Textual) | 3 Months Ended |
Mar. 31, 2024 | |
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 K - Leases - Lease Cost (D
Note K - Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Amortization of right-of-use assets | $ 12 | $ 32 |
Interest on lease liabilities | 0 | 0 |
Total finance lease cost | 12 | 32 |
Operating lease cost | 93 | 113 |
Short-term lease cost | 59 | 55 |
Variable lease cost | 13 | 13 |
Less: sublease income | (39) | (39) |
Total lease costs | $ 138 | $ 174 |
Note K - Leases - Supplement Ca
Note K - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Financing cash flows from finance leases | $ 0 | $ 2 |
Operating cash flows from operating leases | 123 | 142 |
Operating cash flows from short-term leases | 59 | 55 |
Operating cash flows from variable lease costs | 13 | 13 |
Finance leases | 0 | 0 |
Operating leases | $ 419 | $ 0 |
Note K - Leases - Supplement Ba
Note K - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Assets | ||
Property and equipment, net | $ 695 | $ 736 |
Liabilities, Current [Abstract] | ||
Other current liabilities | 2,089 | 2,524 |
Liabilities, Noncurrent [Abstract] | ||
Other long-term liabilities | $ 8,537 | 7,458 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | ||
Property and equipment, net | $ 137 | 149 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | ||
Other current liabilities | $ 0 | 0 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | ||
Other long-term liabilities | $ 0 | 0 |
Lease liabilities, finance leases | 0 | 0 |
Operating lease right-of-use assets | 1,086 | 790 |
Total operating lease right-of-use assets | 1,086 | 790 |
Current portion of operating lease liabilities | 583 | 543 |
Operating lease liabilities, less current portion | 705 | 456 |
Total operating lease liabilities | $ 1,288 | $ 999 |
Operating leases (in years) (Year) | 3 years | 2 years |
Finance leases (Year) | 0 years | 14 years 3 months 18 days |
Operating leases | 9.30% | 7.60% |
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 | $ (894) | $ (882) |
Note K - Leases - Maturities of
Note K - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
2024 (excluding the three months ended March 31, 2024), finance leases | $ 0 | |
2024 (excluding the three months ended March 31, 2024), operating leases | 531 | |
2025, finance leases | 0 | |
2025, operating leases | 511 | |
2026, finance leases | 0 | |
2026, operating leases | 142 | |
2027, finance leases | 0 | |
2027, operating leases | 132 | |
2028, finance leases | 0 | |
2028, operating leases | 155 | |
Thereafter, finance leases | 0 | |
Thereafter, operating leases | 40 | |
Total lease payments, finance leases | 0 | |
Total lease payments, operating leases | 1,511 | |
Less: future interest expense, finance leases | 0 | |
Less: future interest expense, operating leases | (223) | |
Lease liabilities, finance leases | 0 | $ 0 |
Lease liabilities, operating leases | $ 1,288 | $ 999 |
Note L - Merger (Details Textua
Note L - Merger (Details Textual) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||
Nov. 22, 2023 shares | Nov. 17, 2023 USD ($) $ / shares shares | Aug. 30, 2023 USD ($) shares | Jun. 16, 2023 USD ($) $ / shares shares | Jan. 31, 2023 USD ($) shares | Mar. 14, 2022 USD ($) | Nov. 30, 2023 shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Oct. 31, 2023 USD ($) | |
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 1,382,489 | |||||||||
The Investor Warrant [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 917,934 | 917,934 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,920,306 | 2,920,306 | ||||||||
SWK Loans [Member] | ||||||||||
Payments to Acquire Notes Receivable | $ 12,000 | $ 12,000 | ||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 98,683 | 98,683 | ||||||||
Marathon Convertible Notes [Member] | ||||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 2,171,038 | |||||||||
Asset Acquisition, Share Price (in dollars per share) | $ / shares | $ 5.0667 | |||||||||
Asset Acquisition, Consideration Transferred | $ 11,000 | |||||||||
SWK Loans and Marathon Notes [Member] | ||||||||||
Payments to Acquire Notes Receivable | $ 12,000 | |||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 2,270,000 | |||||||||
Asset Acquisition, Consideration Transferred, Equity Interest Issued and Issuable | $ 11,500 | |||||||||
VWAP, Consecutive Trading Days (Year) | 20 years | |||||||||
Nantahala Note [Member] | ||||||||||
Debt Instrument, Face Amount | $ 5,000 | $ 5,000 | $ 5,000 | |||||||
Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | ||||||||||
Maximum Royalty Percentage | 20% | |||||||||
Upfront Payment | $ 10,000 | |||||||||
Addiitonal Payment on First Anniversary | 1,500 | |||||||||
Maximum Royalty Obligation | $ 45,000 | |||||||||
Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | Europe [Member] | ||||||||||
Maximum Royalty Percentage | 10% | |||||||||
Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | Worldwide, Excluding Europe [Member] | ||||||||||
Maximum Royalty Percentage | 10% | |||||||||
Acer Therapeutics Inc [Member] | SWK Loans [Member] | ||||||||||
Proceeds from Issuance of Long-Term Debt | $ 7,000 | $ 6,500 | ||||||||
Maximum [Member] | Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | ||||||||||
Contractual Obligation | $ 56,500 | |||||||||
Bridge Loan [Member] | ||||||||||
Financing Receivable, Maximum Limit | 18,000 | $ 18,000 | ||||||||
Bridge Loan [Member] | Minimum [Member] | ||||||||||
Financing Receivable, Maximum Limit | 16,500 | |||||||||
Acer Therapeutics Inc [Member] | ||||||||||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable, Conversion Ratio | 0.121 | |||||||||
Business Acquisition, Share Price (in dollars per share) | $ / shares | $ 0.0001 | |||||||||
Business Combination, Contingent Consideration Arrangements, Range of Outcomes, Value, High | $ 76,000 | |||||||||
Business Combination, Consideration Transferred | $ 72,600 | |||||||||
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares (in shares) | shares | 2,960,000 | |||||||||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 12,800 | |||||||||
Business Combination, Contingent Consideration, Liability | 8,500 | $ 8,200 | $ 7,262 | |||||||
Repayments of Notes Payable | $ 1,000 | |||||||||
Gain (Loss) on Contingent Consideration, Change in Fair Value | $ 900 | |||||||||
Acer Therapeutics Inc [Member] | Acer Warrants [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 900,000 | |||||||||
Stock Issued During Period, Value, New Issues | $ 4,000 | |||||||||
Acer Therapeutics Inc [Member] | Bridge Loan [Member] | ||||||||||
Business Combination, Consideration Transferred, Other | $ 17,800 | $ 16,500 |
Note L - Merger - Estimates and
Note L - Merger - Estimates and Assumptions Related to Fair Value of Assets and Liabilities Acquired (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Nov. 17, 2023 |
Cash | $ 575 | ||
Prepaid expenses | 278 | ||
Other current assets | 11 | ||
Inventory | 9,376 | ||
Property, plant, and equipment | 35 | ||
Other noncurrent assets | 209 | ||
Approved product - OLPRUVA | 68,000 | ||
?IPR&D - celiprolol | 2,000 | ||
Goodwill acquired | $ 4,701 | $ 4,701 | |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | 85,185 | ||
Accounts payable and accrued expenses | 10,881 | ||
Deferred collaboration funding | 1,500 | ||
Operating lease liabilities | 175 | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Liabilities | 12,556 | ||
Fair Value of Net Assets Acquired | 72,629 | ||
Acer Therapeutics Inc [Member] | |||
Goodwill acquired | $ 4,701 |
Note L - Merger - Pro Forma Com
Note L - Merger - Pro Forma Combined Results of Operations (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Pro forma revenue | $ 3,176 |
Pro forma net loss | $ (20,652) |
Note L - Merger - Reconciliatio
Note L - Merger - Reconciliation of Contingent Consideration Liabilities (Details) - Acer Therapeutics Inc [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Balance | $ 7,262 |
Change in fair value recognized in earnings | 938 |
Balance | $ 8,200 |
Note M - Goodwill & Intangibl_2
Note M - Goodwill & Intangible Assets (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Goodwill | $ 4,701 | $ 4,701 | |
Indefinite-Lived Intangible Assets (Excluding Goodwill) | $ 2,000 | 2,000 | |
Finite-Lived Intangible Asset, Useful Life (Year) | 11 years | ||
Amortization of Intangible Assets | $ 1,500 | $ 0 | |
Finite-Lived Intangible Asset, Expected Amortization, Remainder of Fiscal Year | 6,200 | ||
Finite-Lived Intangible Asset, Expected Amortization, Year One | 6,200 | ||
Finite-Lived Intangible Asset, Expected Amortization, Year Two | 6,200 | ||
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 6,200 | ||
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 6,200 | ||
OLPRUVA [Member] | |||
Finite-Lived Intangible Assets, Net | $ 65,700 | $ 67,200 |