Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 30, 2024 | Jun. 30, 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 | FY | ||
Document Fiscal Year Focus | 2023 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 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 | ||
Trading Symbol | ZVRA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | true | ||
Document Financial Statement Restatement Recovery Analysis [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 172,100,000 | ||
Entity Common Stock, Shares Outstanding | 43,426,186 | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Orlando, Florida |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Cash and cash equivalents | $ 43,049 | $ 65,466 |
Securities at fair value | 24,688 | 16,900 |
Short-term investments - other | 0 | 481 |
Accounts and other receivables | 17,377 | 8,299 |
Prepaid expenses and other current assets | 1,824 | 1,688 |
Total current assets | 86,938 | 92,834 |
Inventories | 9,841 | 671 |
Property and equipment, net | 736 | 794 |
Operating lease right-of-use assets | 790 | 988 |
Goodwill acquired | 4,701 | 0 |
Long-term investments - other | 0 | 20,000 |
Intangible assets, net | 69,227 | 0 |
Other long-term assets | 94 | 53 |
Total assets | 172,327 | 115,340 |
Liabilities and stockholders' equity | ||
Accounts payable and accrued expenses | 28,403 | 6,169 |
Line of credit payable | 37,700 | 0 |
Current portion of operating lease liabilities | 543 | 480 |
Current portion of discount and rebate liabilities | 4,550 | 4,655 |
Other current liabilities | 2,524 | 719 |
Total current liabilities | 73,720 | 12,023 |
Line of credit payable | 0 | 12,800 |
Secured promissory note | 5,066 | 0 |
Derivative and warrant liability | 16,100 | 10,202 |
Operating lease liabilities, less current portion | 456 | 843 |
Discount and rebate liabilities, less current portion | 7,663 | 4,327 |
Other long-term liabilities | 7,458 | 25 |
Total liabilities | 110,463 | 40,220 |
Commitments and contingencies (Note I) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023; 35,450,257 shares issued and 34,540,304 shares outstanding as of December 31, 2022 | 4 | 3 |
Additional paid-in capital | 472,664 | 436,269 |
Treasury stock, at cost | (10,983) | (7,536) |
Accumulated deficit | (399,778) | (353,729) |
Accumulated other comprehensive income | (43) | 113 |
Total stockholders' equity | 61,864 | 75,120 |
Total liabilities and stockholders' equity | 172,327 | 115,340 |
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 December 31, 2023 or December 31, 2022 | $ 0 | $ 0 |
Balance Sheets (Parentheticals)
Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Nov. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 | ||
Common stock, shares issued (in shares) | 43,110,360 | 35,450,257 | ||
Common stock, shares outstanding (in shares) | 41,534,668 | 34,540,304 | 35,005,640 | |
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 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue, net | $ 27,461 | $ 10,161 | |||
Operating expenses: | |||||
Cost of revenue | 2,945 | 222 | |||
Research and development | 39,806 | 19,803 | |||
Selling, general and administrative | 34,314 | 15,038 | |||
Total operating expenses | 77,065 | 52,726 | |||
Loss from operations | (49,604) | (42,565) | |||
Other (expense) income: | |||||
Interest expense | (1,501) | (335) | |||
Fair value adjustment related to derivative and warrant liability and CVR liability | (98) | 15,159 | |||
Fair value adjustment related to investments | 613 | (577) | |||
Interest and other income, net | 4,541 | 1,513 | |||
Total other income | 3,555 | 15,760 | |||
Loss before income taxes | (46,049) | (26,805) | |||
Income tax (expense) benefit | 0 | 33 | |||
Net loss | $ (10,365) | $ (2,573) | $ (13,217) | $ (46,049) | $ (26,772) |
Basic and diluted net loss per share of common stock: | |||||
Net loss (in dollars per share) | $ (1.3) | $ (0.78) | |||
Weighted average number of shares of common stock outstanding: | |||||
Basic and diluted (in shares) | 35,452,460 | 34,488,800 | |||
In Process Research and Development [Member] | |||||
Operating expenses: | |||||
Acquired in-process research and development | $ 0 | $ 17,663 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net loss | $ (46,049) | $ (26,772) |
Other comprehensive income: | ||
Foreign currency translation adjustment | (156) | 113 |
Other comprehensive income (loss) | (156) | 113 |
Comprehensive loss | $ (46,205) | $ (26,659) |
Statements of Changes in Stockh
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] | Revision of Prior Period, Error Correction, Adjustment [Member] Common Stock [Member] | Revision of Prior Period, Error Correction, Adjustment [Member] Additional Paid-in Capital [Member] | Revision of Prior Period, Error Correction, Adjustment [Member] Treasury Stock, Common [Member] | Revision of Prior Period, Error Correction, Adjustment [Member] Retained Earnings [Member] | Revision of Prior Period, Error Correction, Adjustment [Member] AOCI Attributable to Parent [Member] | Revision of Prior Period, Error Correction, Adjustment [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, 2021 | $ 4 | $ 396,957 | $ (2,814) | $ (267,029) | $ 0 | $ 127,118 | $ 0 | $ 34,470 | $ 0 | $ (59,928) | $ 0 | $ (25,458) | $ 4 | $ 431,427 | $ (2,814) | $ (326,957) | $ 0 | $ 101,660 |
Net income (loss) | (1,864) | 12,350 | ||||||||||||||||
Stock-based compensation expense | 0 | 918 | 0 | 0 | 0 | 918 | ||||||||||||
Shares repurchased as part of the Share Repurchase Program | (1) | 0 | (4,722) | 0 | 0 | (4,723) | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 50 | 0 | 0 | 0 | 50 | ||||||||||||
Balance at Mar. 31, 2022 | 121,499 | |||||||||||||||||
Balance at Dec. 31, 2021 | 4 | 396,957 | (2,814) | (267,029) | 0 | 127,118 | 0 | 34,470 | 0 | (59,928) | 0 | (25,458) | 4 | 431,427 | (2,814) | (326,957) | 0 | 101,660 |
Net income (loss) | (25,906) | 14,422 | ||||||||||||||||
Balance at Jun. 30, 2022 | 99,233 | |||||||||||||||||
Balance at Dec. 31, 2021 | 4 | 396,957 | (2,814) | (267,029) | 0 | 127,118 | 0 | 34,470 | 0 | (59,928) | 0 | (25,458) | 4 | 431,427 | (2,814) | (326,957) | 0 | 101,660 |
Net income (loss) | (32,522) | 8,722 | ||||||||||||||||
Balance at Sep. 30, 2022 | 93,794 | |||||||||||||||||
Balance at Dec. 31, 2021 | 4 | 396,957 | (2,814) | (267,029) | 0 | 127,118 | 0 | 34,470 | 0 | (59,928) | 0 | (25,458) | 4 | 431,427 | (2,814) | (326,957) | 0 | 101,660 |
Net income (loss) | 0 | (41,543) | (41,543) | 0 | 0 | 0 | (26,772) | 0 | (26,772) | |||||||||
Stock-based compensation expense | 0 | 4,294 | 0 | 0 | 0 | 4,294 | ||||||||||||
Shares repurchased as part of the Share Repurchase Program | (1) | 0 | (4,722) | 0 | 0 | (4,723) | ||||||||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 324 | 0 | 0 | 0 | 324 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 224 | 0 | 0 | 0 | 224 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 113 | 113 | ||||||||||||
Balance at Dec. 31, 2022 | 3 | 401,799 | (7,536) | (308,572) | 113 | 85,807 | 0 | 34,470 | 0 | (45,157) | 0 | (10,687) | 3 | 436,269 | (7,536) | (353,729) | 113 | 75,120 |
Balance at Mar. 31, 2022 | 121,499 | |||||||||||||||||
Net income (loss) | (24,042) | 2,072 | ||||||||||||||||
Stock-based compensation expense | 0 | 1,510 | 0 | 0 | 0 | 1,510 | ||||||||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 216 | 0 | 0 | 0 | 216 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 50 | 0 | 0 | 0 | 50 | ||||||||||||
Balance at Jun. 30, 2022 | 99,233 | |||||||||||||||||
Net income (loss) | (6,616) | (5,700) | ||||||||||||||||
Stock-based compensation expense | 0 | 911 | 0 | 0 | 0 | 911 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 65 | 0 | 0 | 0 | 65 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 201 | 201 | ||||||||||||
Balance at Sep. 30, 2022 | 93,794 | |||||||||||||||||
Balance at Dec. 31, 2022 | 3 | 401,799 | (7,536) | (308,572) | 113 | 85,807 | 0 | 34,470 | 0 | (45,157) | 0 | (10,687) | 3 | 436,269 | (7,536) | (353,729) | 113 | 75,120 |
Net income (loss) | (11,767) | (1,450) | 0 | 0 | 0 | (13,217) | 0 | (13,217) | ||||||||||
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 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | (176) | (176) | ||||||||||||
Balance at Mar. 31, 2023 | 71,404 | |||||||||||||||||
Balance at Dec. 31, 2022 | 3 | 401,799 | (7,536) | (308,572) | 113 | 85,807 | 0 | 34,470 | 0 | (45,157) | 0 | (10,687) | 3 | 436,269 | (7,536) | (353,729) | 113 | 75,120 |
Net income (loss) | (16,851) | 1,061 | ||||||||||||||||
Balance at Jun. 30, 2023 | 68,497 | |||||||||||||||||
Balance at Dec. 31, 2022 | 3 | 401,799 | (7,536) | (308,572) | 113 | 85,807 | 0 | 34,470 | 0 | (45,157) | 0 | (10,687) | 3 | 436,269 | (7,536) | (353,729) | 113 | 75,120 |
Net income (loss) | (30,896) | 4,739 | ||||||||||||||||
Balance at Sep. 30, 2023 | 67,470 | 3 | 452,608 | (10,983) | (379,886) | (220) | 61,524 | |||||||||||
Balance at Dec. 31, 2022 | $ 3 | $ 401,799 | $ (7,536) | $ (308,572) | $ 113 | 85,807 | $ 0 | $ 34,470 | $ 0 | $ (45,157) | $ 0 | (10,687) | 3 | 436,269 | (7,536) | (353,729) | 113 | 75,120 |
Net income (loss) | 0 | 0 | 0 | (46,049) | 0 | (46,049) | ||||||||||||
Stock-based compensation expense | 0 | 5,954 | 0 | 0 | 0 | 5,954 | ||||||||||||
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | (3,447) | 0 | 0 | (3,447) | ||||||||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 218 | 0 | 0 | 0 | 218 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 227 | 0 | 0 | 0 | 227 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | (156) | (156) | ||||||||||||
Issuance of common stock in connection with the Merger | 1 | 28,390 | 0 | 0 | 0 | 28,391 | ||||||||||||
Issuance of common stock | 0 | 6,106 | 0 | 0 | 0 | 6,106 | ||||||||||||
Issuance of warrants | 0 | (4,500) | 0 | 0 | 0 | (4,500) | ||||||||||||
Balance at Dec. 31, 2023 | 4 | 472,664 | (10,983) | (399,778) | (43) | 61,864 | ||||||||||||
Balance at Mar. 31, 2023 | 71,404 | |||||||||||||||||
Net income (loss) | (5,084) | 2,511 | 0 | 0 | 0 | (2,573) | 0 | (2,573) | ||||||||||
Stock-based compensation expense | 0 | 1,103 | 0 | 0 | 0 | 1,103 | ||||||||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 165 | 0 | 0 | 0 | 165 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 25 | 0 | 0 | 0 | 25 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | (162) | (162) | ||||||||||||
Balance at Jun. 30, 2023 | 68,497 | |||||||||||||||||
Net income (loss) | (14,045) | $ 3,678 | 0 | 0 | 0 | (10,367) | 0 | (10,365) | ||||||||||
Stock-based compensation expense | 0 | 1,387 | 0 | 0 | 0 | 1,387 | ||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 71 | 0 | 0 | 0 | 71 | ||||||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 5 | 5 | ||||||||||||
Issuance of common stock in connection with the Merger | 0 | 11,500 | 0 | 0 | 0 | 11,500 | ||||||||||||
Balance at Sep. 30, 2023 | $ 67,470 | $ 3 | $ 452,608 | $ (10,983) | $ (379,886) | $ (220) | $ 61,524 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (46,049) | $ (26,772) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,954 | 4,294 |
Depreciation and amortization expense | 1,006 | 944 |
Fair value adjustment related to derivative and warrant liability and CVR liability | 98 | (15,159) |
Fair value adjustment related to investments | (613) | 577 |
Loss on sublease and disposal of property and equipment | 157 | 9 |
Consulting fees paid in common stock | 227 | 224 |
Gain on foreign currency exchange rates | (198) | (91) |
Change in assets and liabilities: | ||
Accounts and other receivables | (9,078) | (6,772) |
Prepaid expenses and other current assets | 152 | (894) |
Inventories | 206 | 147 |
Operating lease right-of-use assets | 326 | 277 |
Other long-term assets | (5) | 386 |
Accounts payable and accrued expenses | 11,130 | 3,131 |
Discount and rebate liabilities | 3,231 | 3,782 |
Operating lease liabilities | (439) | (389) |
Other liabilities | 360 | (74) |
Net cash used in operating activities | (33,535) | (18,717) |
Cash flows from investing activities: | ||
Acquisitions, net | (30,401) | (14,090) |
Purchases of property and equipment | (296) | (93) |
Purchases of investments | (45,814) | (23,861) |
Maturities of investments | 59,121 | 1,325 |
Net cash used in investing activities | (17,390) | (36,719) |
Cash flows from financing activities: | ||
Proceeds from issuance of debt | 42,431 | 12,800 |
Proceeds from insurance financing arrangements | 1,256 | 1,273 |
Proceeds from Employee Stock Purchase Plan | 218 | 324 |
Proceeds from stock issuance | 6,106 | 0 |
Payments of principal on insurance financing arrangements | (564) | (1,306) |
Repayment of debt | (17,531) | 0 |
Payment to repurchase shares as part of the Share Repurchase Program | (3,447) | (4,723) |
Repayment of principal on finance lease liabilities | (5) | (16) |
Net cash provided by financing activities | 28,464 | 8,352 |
Effect of exchange rate changes on cash and cash equivalents | 44 | 204 |
Net decrease in cash and cash equivalents | (22,417) | (46,880) |
Cash and cash equivalents, beginning of period | 65,466 | 112,346 |
Cash and cash equivalents, end of period | 43,049 | 65,466 |
Supplemental cash flow information: | ||
Cash paid for interest | 456 | 321 |
Right-of-use assets obtained in exchange for lease liabilities | 0 | 123 |
Supplemental disclosure of noncash investing activities: | ||
Issuance of common stock in connection with the Merger (Note R) | (28,390) | 0 |
Issuance of secured promissory note for the Merger (Note R) | (5,066) | 0 |
Issuance of contingent value rights for the Merger (Note R) | (8,562) | 0 |
In Process Research and Development [Member] | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | $ 0 | $ 17,663 |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arr Line Items | |
Material Terms of Trading Arrangement [Text Block] | 9B. OTHER INFORMATION Trading Arrangements During the three December 31, 2023, none 16a 1 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 |
Note A - Description of Busines
Note A - Description of Business, Basis of Presentation and Significant Transactions | 12 Months Ended |
Dec. 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 . (t 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 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 year ended December 31, 2023, December 31, 2023, may 1 2 3 4 one 5 The Company’s ability to continue operating as a going concern is contingent upon its ability to secure sufficient financing and/or reduce spending to maintain operations. Unless the Company is able to restructure the amounts outstanding on its margin loan facility, we may 2024. no one not Basis of Presentation The Company prepared the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the Company’s opinion, reflect all adjustments, including normal recurring items that are necessary. All significant intercompany accounts and transactions have been eliminated in consolidation. Merger On August 30, 2023, November 17, 2023 ( Note R for fu Arimoclomol Acquisition On May 15, 2022, Zevra Denmark A/S (“Zevra DK”), a newly formed Danish company and wholly-owned subsidiary of the Company entered into an asset purchase agreement (the “Arimoclomol Purchase Agreement”) with Orphazyme A/S in restructuring, a Danish public limited liability company (“Orphazyme”). The Arimoclomol Purchase Agreement closed on May 31, 2022. The Company accounted for the arimoclomol acquisition as an asset acquisition as the majority of the value of the assets acquired related to the arimoclomol acquired in-process research and development (“IPR&D”) asset. The intangible asset associated with IPR&D relates to arimoclomol. The estimated fair value of $17.7 million was determined using the excess earnings valuation method, a variation of the income valuation approach. The excess earnings valuation method estimates the value of an intangible asset equal to the present value of the incremental after-tax cash flows attributable to that intangible asset over its remaining economic life. Some of the more significant assumptions utilized in our asset valuations included projected revenues, probability of commercial success, and the discount rate. The fair value using the excess earnings valuation method was determined using an estimated weighted average cost of capital of 42%, which reflects the risks inherent in future cash flow projections and represents a rate of return that a market participant would expect for this asset. This fair value measurement was based on significant inputs not 3 In accordance with Accounting Standards Codification (ASC) Subtopic 730 10 25, Accounting for Research and Development Costs not no a $0.8 m 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 February 1, 2022. In connection with the Merger, Zevra and Nantahala (as defined in Note R) 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 Entry into 2021 ATM Agreement On July 2, 2021, “2021 may 2021 3. may 415 1933, may 2021 3 2021 July 12, 2021. December 31, 2023 2022, 2021 Share Repurchase Program On December 20, 2021, may December 31, 2023. December 31, 2023, Reclassifications Certain reclassifications were made to the 2022 2023. no |
Note B - Summary of Significant
Note B - Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | B. Summary of Significant Accounting Policies Use of Estimates The preparation of these consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of long-term investments, the fair value of the derivative and warrant liability and discount and rebate liabilities, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit and investments with multiple financial institutions, the balances of which frequently exceed insured limits, and accounts receivable, which are concentrated amongst a limited number of customers. Cash and Cash Equivalents The Company considers any highly liquid investments with an original maturity of three Investments The Company maintains investment securities that are classified as available-for-sale securities for which the Company has elected the fair value option under ASC 825, Financial Instruments. As such, these securities are carried at fair value with unrealized gains and losses included in fair value adjustment related to investments on the consolidated statements of operations. The securities primarily consist of U.S. Treasury securities and U.S. government-sponsored agency securities and are included in securities at fair value in the consolidated balance sheets. As of December 31, 2023, 2022, $24.7 m $0.6 s. In addition, the Company held certificates of deposit totaling $20.5 million as of December 31, 2022, December 31, 2022. May 2023. Variable Interest Entities The primary beneficiary of a variable interest entity ("VIE") is required to consolidate the assets and liabilities of the VIE. When the Company obtains a variable interest in another entity, it assesses at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE, and if so, whether the Company is the primary beneficiary of the VIE based on its power to direct the activities of the VIE that most significantly impact the VIE's economic performance and the Company's obligation to absorb losses or the rights to receive benefits from the VIE that could potentially be significant to the VIE. To assess whether the Company has the power to direct the activities of the VIE that most significantly impact the VIE's economic performance, the Company considers all the facts and circumstances, including the Company's role in establishing the VIE and the Company's ongoing rights and responsibilities. The assessment includes identifying the activities that most significantly impact the VIE's economic performance and identifying which party, if any, has the power to direct those activities. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) are deemed to have the power to direct the activities of a VIE. To assess whether the Company has the obligation to absorb losses of the VIE or the rights to receive benefits from the VIE that could potentially be significant to the VIE, the Company considers all of its economic interests that are deemed to be variable interests in the VIE. This assessment requires judgement in determining whether these interests, in the aggregate, are considered potentially significant to the VIE. As of December 31, 2023, not December 31, 2022. Goodwill and Intangible Assets Goodwill represents the excess of the consideration transferred over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill is not fourth not one 35, first not not The Company's goodwill balance was $4.7 million as of December 31, 2023. December 31, 2022. December 31, 2022, 350 not not no December 31, 2023. Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not fourth was $2.0 mil December 31, 2023. December 31, 2022, May 2022 December 31, 2023, 2022. As of December 31, 2023, $67.2 milli eleven $0.8 m December 31, 2023. For intangible assets subject to amortization, estimated amortization expense for the five December 31, 2023, 2024 $ 6,182 2025 $ 6,182 2026 $ 6,182 2027 $ 6,182 2028 $ 6,182 Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three ten Impairment of Long-Lived Assets Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not December 31, 2023, 2022. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers 606” five 1 2 3 4 5 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, following market approval. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability (rebate). An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drug products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate. For the years ended December 31, 2023, 2022, December 31, 2023, December 31, 2022, December 31, 2023, December 31, 2022, December 31, 2023, 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 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-methylphenidate (“d-MPH”), including AZSTARYS, or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder. Corium was tasked by Commave, to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Corium agreed to pay milestone payments 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 not not not December 31, 2023, .5 December 31, 2022, December 31, 2023, 2022. In accordance with the terms of the Company’s Termination Agreement with Aquestive Therapeutics dated March 20, 2012, KP879 KP1077 December 31, 2023, 2022, Relief 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 ( December 31, 2023, not There was no deferred revenue related to this agreement as of December 31, 2023. Product Revenue, net On December 27, 2022, 44 20 1.2m 2 November 17, 2023, third December 31, 2023, 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 received payments from Corium of $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 December 31, 2022, third For the years ended December 31, 2023, 2022 December 31, 2023, 2022, March 31, 2023. Cost of Revenue The components of cost of revenue are royalties and expenses directly attributable to revenue. To date, the Company has generated revenue from the AZSTARYS License Agreement, sales of arimoclomol under the Arimoclomol EAP, reimbursement of out-of-pocket third 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 may Inventory As discussed in Note A, a portion of the purchase price for Arimoclomol was allocated to inventory acquired representing the value of inventory associated with forecasted EAP revenues, which 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 December 31, 2023 2022, 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 December 31, 2023 December 31, 2022 Raw Materials $ 2,938 $ — Work in progress 1,884 — Finished goods 5,019 671 Total inventory $ 9,841 $ 671 Research and Development Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clin ical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services. The Company enters into contractual agreements with third pleted over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not Patent Costs Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations. Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not Uncertain tax positions are recognized only when the Company believes it is more likely than not t the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company did not December 31, 2023, 2022 The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no 2015, 2017 may On December 22, 2017, 1, 2018 ” ("Ta x January 1, 2018, not Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers an d directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees using a fair value approach under Accounting Standards Codification ("ASC") subtopic 505 50. Basic and Diluted Net Loss per Share of Common Stock The Company uses the two entitle the holders to participate in dividends and earnings of the Company. The two Segment and Geographic Information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is ava ilable and regularly reviewed by the chief operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. The Company holds assets in both the United States and Europe as of December 31, 2023 2022 Foreign currency Assets and liabilities are translated into the reporting currency using the exchange rates in effect on the consolidated balance sheet dates. Equity accounts are translated at historical rates, except for the change in retained earnings during the year, which is the result of the income statement translation process. Revenue and expense accounts are translated using the weighted average exchange rate during the period. The cumulative translation adjustments associated with the net assets of foreign subsidiaries are recorded in accumulated other comprehensive income/loss in the accompanying consolidated statements of stockholders’ equity. 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 consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not |
Note C - Restatement of Previou
Note C - Restatement of Previously Issued Consolidated Financial Statements | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Error Correction [Text Block] | C. Restatement of Previously Issued Consolidated Financial Statements In connection with the preparation of the Company's consolidated financial statements as of and for the fiscal year ended December 31, 2023, not December 31, 2022. The misstatements were material to the previously issued financial statements of the Company and as a result, the Company has restated its consolidated balance sheet, consolidated statement of operations, consolidated statement of stockholder's equity, and consolidated statement of cash flows as of and for the fiscal year ended December 31, 2022, not December 31, 2022. December 31, 2022, not As of December 31, 2022 CORRECTED CONSOLIDATED BALANCE SHEET As previously reported Impact of Adjustments As Restated Prepaid expenses and other current assets $ 1,877 $ (189 ) $ 1,688 Total current assets 93,023 (189 ) 92,834 Total assets 115,529 (189 ) 115,340 Other current liabilities 422 297 719 Total current liabilities 11,726 297 12,023 Derivative and warrant liability 1 10,201 10,202 Total liabilities 29,722 10,498 40,220 Additional paid-in capital 401,799 34,470 436,269 Accumulated deficit (308,572 ) (45,157 ) (353,729 ) Total stockholder's equity 85,807 (10,687 ) 75,120 Total liabilities and stockholder's equity 115,529 (189) 115,340 For the Year Ended December 31, 2022 CORRECTED CONSOLIDATED STATEMENT OF OPERATIONS As previously reported Impact of Adjustments As Restated Revenue, net $ 10,458 $ (297 ) $ 10,161 Operating expenses: Cost of revenue 343 (121 ) 222 Research and development 19,614 189 19,803 Selling, general and administrative 15,343 (305 ) 15,038 Total operating expenses 52,963 (237 ) 52,726 Loss from operations (42,505 ) (60 ) (42,565 ) Fair value adjustment related to derivative and warrant liability 328 14,831 15,159 Interest and other income, net 760 753 1,513 Total other income 176 15,584 15,760 Loss before income taxes (42,329 ) 15,524 (26,805 ) Income tax (expense) benefit 786 (753 ) 33 Net loss $ (41,543 ) $ 14,771 $ (26,772 ) Basic and diluted net loss per share of common stock: Net loss $ (1.20 ) $ 0.42 $ (0.78 ) For the Year Ended December 31, 2022 CORRECTED CONSOLIDATED STATEMENT OF CASH FLOWS As previously reported Impact of Adjustments As Restated Cash flows from operating activities: Net (loss) income $ (41,543 ) $ 14,771 $ (26,772 ) Adjustments to reconcile net loss to net cash used in operating activities: Change in fair value of derivative and warrant liability (328 ) (14,831 ) (15,159 ) Change in assets and liabilities: Prepaid expenses and other current assets (657 ) (237 ) (894 ) Other liabilities (371 ) 297 (74 ) Additional Paid-In Capital Accumulated Deficit CORRECTED STATEMENT OF STOCKHOLDERS' EQUITY As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Balance at December 31, 2021 $ 396,957 $ 34,470 $ 431,427 $ (267,029 ) $ (59,928 ) $ (326,957 ) Net loss — — — (41,543 ) 14,771 (26,772 ) Balance at December 31, 2022 401,799 34,470 436,269 (308,572 ) (45,157 ) (353,729 ) All referenced amounts for prior periods in these financial statements and the notes herein reflect the balances and amounts on a restated basis. Restatement of Interim Financial Information (Unaudited) Due to the misstatements described above, the Company has restated its unaudited condensed consolidated balance sheets, condensed consolidated statements of stockholder's equity, condensed consolidated statements of operations, and condensed consolidated statement of cash flows for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023, September 30, 2023. not March 31, 2023 March 31, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 40,181 $ — $ 40,181 $ 100,242 $ — $ 100,242 Securities at fair value 34,403 — 34,403 — — — Short-term investments - other 20,700 — 20,700 1,338 — 1,338 Accounts and other receivables 7,822 — 7,822 3,320 — 3,320 Prepaid expenses and other current assets 1,174 — 1,174 880 (426 ) 454 Total current assets 104,280 — 104,280 105,780 (426 ) 105,354 Inventories 620 — 620 — — — Property and equipment, net 744 — 744 835 — 835 Operating lease right-of-use assets 898 — 898 1,090 — 1,090 Long-term investments - other — — — 17,564 — 17,564 Other long-term assets 53 — 53 437 — 437 Total assets $ 106,595 $ — $ 106,595 $ 125,706 $ (426 ) $ 125,280 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 10,098 $ 393 $ 10,491 $ 2,582 $ — $ 2,582 Current portion of operating lease liabilities 470 — 470 356 — 356 Current portion of discount and rebate liabilities 4,746 — 4,746 — — — Other current liabilities 302 — 302 7 — 7 Total current liabilities 15,616 393 16,009 2,945 — 2,945 Line of credit payable 12,914 — 12,914 — — — Derivative and warrant liability 3 11,744 11,747 89 12,682 12,771 Operating lease liabilities, less current portion 736 — 736 1,144 — 1,144 Discount and rebate liabilities, less current portion 5,764 — 5,764 — — — Other long-term liabilities 158 — 158 29 — 29 Total liabilities 35,191 12,137 47,328 4,207 12,682 16,889 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 35,457,496 33,881,804 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 402,786 34,470 437,256 397,925 34,470 432,395 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (320,339 ) (46,607 ) (366,946 ) (268,893 ) (47,578 ) (316,471 ) Accumulated other comprehensive (loss) income (63 ) — (63 ) — — — Total stockholders' equity 71,404 (12,137 ) 59,267 121,499 (13,108 ) 108,391 Total liabilities and stockholders' equity $ 106,595 $ — $ 106,595 $ 125,706 $ (426 ) $ 125,280 June 30, 2023 June 30, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 66,196 $ — $ 66,196 $ 76,779 $ — $ 76,779 Securities at fair value 20,696 — 20,696 — — — Short-term investments - other 479 — 479 4,199 — 4,199 Accounts and other receivables 14,033 — 14,033 2,820 — 2,820 Prepaid expenses and other current assets 2,023 — 2,023 3,637 (426 ) 3,211 Total current assets 103,427 — 103,427 87,435 (426 ) 87,009 Inventories 546 — 546 779 — 779 Property and equipment, net 689 — 689 904 — 904 Operating lease right-of-use assets 803 — 803 1,165 — 1,165 Long-term investments - other — — — 33,535 — 33,535 Other long-term assets 53 — 53 440 — 440 Total assets $ 105,518 $ — $ 105,518 $ 124,258 $ (426 ) $ 123,832 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 10,510 $ — $ 10,510 $ 3,600 $ — $ 3,600 Current portion of capital lease obligation — — — 469 — 469 Current portion of operating lease liabilities 456 — 456 — — — Current portion of discount and rebate liabilities 6,965 — 6,965 1,796 — 1,796 Other current liabilities 321 — 321 1,294 48 1,342 Total current liabilities 18,252 — 18,252 7,159 48 7,207 Line of credit payable 12,709 — 12,709 12,800 — 12,800 Derivative and warrant liability — 9,624 9,624 57 10,562 10,619 Operating lease liabilities, less current portion 627 — 627 1,082 — 1,082 Discount and rebate liabilities, less current portion 5,114 — 5,114 3,900 — 3,900 Other long-term liabilities 319 — 319 27 — 27 Total liabilities 37,021 9,624 46,645 25,025 10,610 35,635 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 35,503,697 33,928,005 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 405,127 34,470 439,597 399,701 34,470 434,171 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (325,425 ) (44,094 ) (369,519 ) (292,935 ) (45,506 ) (338,441 ) Accumulated other comprehensive (loss) income (225 ) — (225 ) — — — Total stockholders' equity 68,497 (9,624 ) 58,873 99,233 (11,036 ) 88,197 Total liabilities and stockholders' equity $ 105,518 $ — $ 105,518 $ 124,258 $ (426 ) $ 123,832 September 30, 2023 September 30, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 43,269 $ — $ 43,269 $ 70,059 $ — $ 70,059 Securities at fair value 39,672 — 39,672 — — — Secured corporate notes 41,999 — 41,999 — — — Short-term investments - other 485 — 485 5,832 — 5,832 Accounts and other receivables 9,927 — 9,927 6,583 — 6,583 Prepaid expenses and other current assets 1,661 — 1,661 2,659 (426 ) 2,233 Total current assets 137,013 — 137,013 85,133 (426 ) 84,707 Inventories 481 — 481 596 — 596 Property and equipment, net 642 — 642 852 — 852 Operating lease right-of-use assets 698 — 698 1,068 — 1,068 Long-term investments - other — — — 31,463 — 31,463 Other long-term assets 148 — 148 439 — 439 Total assets $ 138,982 $ — $ 138,982 $ 119,551 $ (426 ) $ 119,125 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 13,080 $ — $ 13,080 $ 4,279 $ — $ 4,279 Current portion of operating lease liabilities 433 — 433 474 — 474 Current portion of discount and rebate liabilities 7,890 — 7,890 2,825 171 2,996 Other current liabilities 311 — 311 853 — 853 Total current liabilities 21,714 — 21,714 8,431 171 8,602 Line of credit payable 38,801 — 38,801 12,800 — 12,800 Derivative and warrant liability — 5,948 5,948 35 16,139 16,174 Secured promissory note 5,073 — 5,073 — — — Operating lease liabilities, less current portion 517 — 517 956 — 956 Discount and rebate liabilities, less current portion 4,987 — 4,987 3,509 — 3,509 Other long-term liabilities 420 — 420 26 — 26 Total liabilities 71,512 5,948 77,460 25,757 16,310 42,067 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 37,787,402 36,211,710 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 418,138 34,470 452,608 400,677 34,470 435,147 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (339,468 ) (40,418 ) (379,886 ) (299,551 ) (51,206 ) (350,757 ) Accumulated other comprehensive (loss) income (220 ) — (220 ) 201 — 201 Total stockholders' equity 67,470 (5,948 ) 61,522 93,794 (16,736 ) 77,058 Total liabilities and stockholders' equity $ 138,982 $ — $ 138,982 $ 119,551 $ (426 ) $ 119,125 Three months ended March 31, 2023 2023 2023 2022 2022 2022 Condensed consolidated statements of operations (UNAUD As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 2,879 $ 297 $ 3,176 $ 3,965 $ — $ 3,965 Operating expenses: Cost of revenue 125 — 125 8 — 8 Research and development 8,844 (189 ) 8,655 3,082 — 3,082 Selling, general and administrative 6,834 393 7,227 2,734 — 2,734 Acquired In-process research and development — — — — — — Severance expense — — — — — — Total operating expenses 15,803 204 16,007 5,824 — 5,824 Loss from operations (12,924 ) 93 (12,831 ) (1,859 ) — (1,859 ) Other (expense) income: Interest expense (182 ) — (182 ) (5 ) — (5 ) Fair value adjustment related to derivative and warrant liability (2 ) (1,543 ) (1,545 ) 241 12,350 12,591 Fair value adjustment related to investments 196 — 196 (352 ) — (352 ) Interest and other income, net 1,042 — 1,042 107 — 107 Total other (expense) income 1,054 (1,543 ) (489 ) (9 ) 12,350 12,341 Loss before income taxes (11,870 ) (1,450 ) (13,320 ) (1,868 ) 12,350 10,482 Income tax (expense) benefit 103 — 103 4 — 4 Net (loss) income $ (11,767 ) $ (1,450 ) $ (13,217 ) $ (1,864 ) $ 12,350 $ 10,486 Basic and diluted net loss per share of common stock: Net (loss) income $ (0.34 ) $ (0.04) $ (0.38 ) $ (0.05 ) $ 0.35 $ 0.30 Weighted average number of shares of common stock outstanding: Basic and diluted 34,466,542 34,466,542 34,506,597 34,506,597 Three months ended June 30, Six months ended June 30, 2023 2023 2023 2022 2022 2022 2023 2023 2023 2022 2022 2022 As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 8,470 $ — $ 8,470 $ 1,300 $ (48 ) $ 1,252 $ 11,349 $ 297 $ 11,646 $ 5,265 $ (48 ) $ 5,217 Operating expenses: Cost of revenue 677 — 677 51 (20 ) 31 802 — 802 59 (20 ) 39 Research and development 7,433 — 7,433 4,795 — 4,795 16,277 (189 ) 16,088 7,877 — 7,877 Selling, general and administrative 7,005 (393 ) 6,612 3,558 20 3,578 13,839 — 13,839 6,292 20 6,312 Acquired In-process research and development — — — 17,663 — 17,663 — — — 17,663 — 17,663 Total operating expenses 15,115 (393) 14,722 26,067 — 26,067 30,918 (189 ) 30,729 31,891 — 31,891 Loss from operations (6,645 ) (393) (6,252 ) (24,767 ) (48 ) (24,815 ) (19,569 ) 486 (19,083 ) (26,626 ) (48 ) (26,674 ) Other (expense) income: Interest expense (197 ) — (197 ) (36 ) — (36 ) (379 ) — (379 ) (41 ) — (41 ) Fair value adjustment related to derivative and warrant liability — 2,118 2,118 32 2,120 2,152 — 575 575 273 14,470 14,743 Fair value adjustment related to investments 131 — 131 (352 ) — (352 ) 327 — 327 (495 ) — (495 ) Interest and other income, net 1,553 — 1,553 366 753 1,119 2,593 — 2,593 264 753 1,017 Total other (expense) income 1,487 2,118 3,605 10 2,873 2,883 2,541 575 3,116 1 15,223 15,224 Loss before income taxes (5,158 ) 2,511 (2,647 ) (24,757 ) 2,825 (21,932 ) (17,028 ) 1,061 (15,967 ) (26,625 ) 15,175 (11,450 ) Income tax (expense) benefit 74 74 715 (753 ) (38 ) 177 — 177 719 (753 ) (34 ) Net (loss) income $ (5,084 ) $ 2,511 $ (2,573 ) $ (24,042 ) $ 2,072 $ (21,970 ) $ (16,851 ) $ 1,061 $ (15,790 ) $ (25,906 ) $ 14,422 $ (11,484 ) Basic and diluted net loss per share of common stock: Net (loss) income $ (0.15 ) $ 0.07 $ (0.08 ) $ (0.70 ) 0.06 $ (0.64 ) $ (0.49 ) 0.03 $ (0.46 ) $ (0.75 ) 0.42 $ (0.33 ) Weighted average number of shares of common stock outstanding: Basic and diluted 33,898,233 — 33,898,233 34,447,206 — 34,447,206 34,180,818 — 34,180,818 34,476,737 — 34,476,737 Three months ended September 30, Nine months ended September 30, 2023 2023 2023 2022 2022 2022 2023 2023 2023 2022 2022 2022 As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 2,895 — $ 2,895 $ 2,874 $ (123 ) $ 2,751 $ 14,244 $ 297 $ 14,541 $ 8,139 $ (171 ) $ 7,968 Operating expenses: Cost of revenue 144 — 144 141 (50 ) 91 946 — 946 200 (70 ) 130 Research and development 12,297 — 12,297 5,385 — 5,385 28,574 (189 ) 28,385 13,262 — 13,262 Selling, general and administrative 5,818 — 5,818 3,974 50 4,024 19,657 — 19,657 10,266 70 10,336 Acquired in-process research and development — — — — — — — — — 17,663 — 17,663 Total operating expenses 18,259 — 18,259 9,500 — 9,500 49,177 (189) 48,988 41,391 — 41,391 Loss from operations (15,364 ) — (15,364 ) (6,626 ) (123 ) (6,749 ) (34,933 ) 486 (34,447 ) (33,252 ) (171 ) (33,423 ) Other income (expense): Interest expense (366 ) — (366 ) (124 ) — (124 ) (745 ) — (745 ) (165 ) — (165 ) Fair value adjustment related to derivative and warrant liability — 3,678 3,678 22 (5,577 ) (5,555 ) — 4,253 4,253 295 8,893 9,188 Fair value adjustment related to investments 124 — 124 (139 ) — (139 ) 451 — 451 (634 ) — (634 ) Interest and other income, net 1,738 — 1,738 218 — 218 4,331 — 4,331 482 753 1,235 Total other income (expense) 1,496 3,678 5,174 (23 ) (5,577 ) (5,600 ) 4,037 4,253 8,290 (22 ) 9,646 9,624 Loss before income taxes (13,868 ) 3,678 (10,190 ) (6,649 ) (5,700 ) (12,349 ) (30,896 ) 4,739 (26,157 ) (33,274 ) 9,475 (23,799 ) Income tax (expense) benefit (177 ) — (177 ) 33 — 33 — — 752 (753 ) (1 ) Net loss $ (14,045 ) $ 3,678 $ (10,367 ) $ (6,616 ) $ (5,700 ) $ (12,316 ) $ (30,896 ) $ 4,739 $ (26,157 ) $ (32,522 ) $ 8,722 $ (23,800 ) Basic and diluted net loss per share of common stock: Net (loss) income $ (0.40 ) $ 0.10 $ (0.30 ) $ (0.19 ) $ (0.17) $ (0.36 ) $ (0.90 ) $ 0.14 $ (0.76 ) $ (0.94 ) $ 0.25 $ (0.69 ) Weighted average number of shares of common stock outstanding: Basic and diluted 34,724,614 — 34,724,614 34,494,702 — 34,494,702 34,364,075 — 34,364,075 34,482,791 — 34,482,791 Condensed Consolidated Statements of Changes in Stockholders' Equity (UNAUDITED) Common Stock Additional Paid-in Capital (As Restated) Treasury Stock Accumulated Deficit (As Restated) Other Comprehensive Income (Loss) Total Stockholders' (Deficit) Equity (As Restated) Balance December 31, 2021 (As Reported) $ 4 $ 396,957 $ (2,814 ) $ (267,029 ) $ — $ 127,118 Effect of Restatement — 34,470 — (59,928) — (25,458 ) Balance December 31, 2021 (As Restated) $ 4 $ 431,427 $ (2,814 ) $ (326,957 ) $ — $ 101,660 Net loss (As Restated) — — — 10,486 — 10,486 Stock-based compensation expense — 918 — — — 918 Shares repurchased as part of the Share Repurchase Program (1 ) — (4,722 ) — — (4,723 ) Issuance of common stock in exchange for consulting services — 50 — — — 50 Balance as of March 31, 2022 (As Restated) $ 3 $ 432,395 $ (7,536 ) $ (316,471 ) $ — $ 108,391 Net loss (As Restated) — — — (21,970 ) — (21,970 ) Stock-based compensation expense — 1,510 — — — 1,510 Issuance of common stock in exchange for consulting services — 50 — — — 50 Issuance of common stock as part of the Employee Stock Purchase Plan — 216 — — — 216 Balance as of June 30, 2022 (As Restated) $ 3 $ 434,171 $ (7,536 ) $ (338,441 ) $ — $ 88,197 Net loss (As Restated) — — — (12,316 ) — (12,316 ) Stock-based compensation expense — 911 — — — 911 Issuance of common stock in exchange for consulting services — 65 — — — 65 Other comprehensive income — — — — 201 201 Balance as of September 30, 2022 (As Restated) $ 3 $ 435,147 $ (7,536 ) $ (350,757 ) $ 201 $ 77,058 Balance December 31, 2022 (As Reported) $ 3 $ 401,799 $ (7,536 ) $ (308,572 ) $ 113 $ 85,807 Effect of Restatement — 34,470 — (45,157 ) — (10,687 ) Balance December 31, 2022 (As Restated) $ 3 $ 436,269 $ (7,536 ) $ (353,729 ) $ 113 $ 75,120 Net loss (As Restated) — — — (13,217 ) — (13,217 ) Stock-based compensation expense — 591 — — — 591 Shares repurchased as part of the Share Repurchase Program — — (3,447 ) — — (3,447 ) Issuance of common stock in exchange for consulting services — 42 — — — 42 Severance expense — 354 — — — 354 Other comprehensive loss — — — — (176 ) (176 ) Balance as of March 31, 2023 (As Restated) $ 3 $ 437,256 $ (10,983 ) $ (366,946 ) $ (63 ) $ 59,267 Net loss (As Restated) — — — (2,573 ) — (2,573 ) Stock-based compensation expense — 1,103 — — — 1,103 Issuance of common stock in exchange for consulting services — 25 — — — 25 Severance expense — 1,048 — — — 1,048 Issuance of common stock as part of the Employee Stock Purchase Plan — 165 — — — 165 Other comprehensive loss — — — — (162 ) (162 ) Balance as of June 30, 2023 (As Restated) $ 3 $ 439,597 $ (10,983 ) $ (369,519 ) $ (225 ) $ 58,873 Net loss (As Restated) — — — (10,367 ) — (10,365 ) Stock-based compensation expense — 1,387 — — — 1,387 Issuance of common stock in connection with the Proposed Merger (Note K) — 11,500 — — — 11,500 Issuance of common stock in exchange for consulting services — 71 — — — 71 Severance expense — 53 — — — 53 Other comprehensive loss — — — — 5 5 Balance as of September 30, 2023 $ 3 $ 452,608 $ (10,983 ) $ (379,886 ) $ (220 ) $ 61,524 Three Months Ended March 31, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net income (loss) $ (11,767 ) $ (1,450 ) $ (13,217 ) $ (1,864 ) $ 12,350 $ 10,486 Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 591 — 591 918 — 918 Severance expense 354 — 354 — — — Depreciation and amortization expense 79 — 79 65 — 65 Fair value adjustment related to derivative and warrant liability 2 1,543 1,545 (241 ) (12,350 ) (12,591 ) Fair value adjustment related to investments (196 ) — (196 ) 352 — 352 Consulting fees paid in common stock 42 — 42 50 — 50 Gain on foreign currency exchange rates (240 ) — (240 ) — — — Change in assets and liabilities: Accounts and other receivables 477 — 477 (1,792 ) — (1,792 ) Prepaid expenses and other current assets 703 — 703 303 — 303 Inventories 51 — 51 — — — Operating lease right-of-use assets 80 — 80 51 — 51 Accounts payable and accrued expenses 3,929 (93) 3,836 (486 ) — (486 ) Discount and rebate liabilities 1,528 — 1,528 — — — Operating lease liabilities (107 ) — (107 ) (88 ) — (88 ) Other liabilities 429 — 429 (821 ) — (821 ) Net cash used in operating activities (4,045 ) — (4,045 ) (3,553 ) — (3,553 ) Cash flows from investing activities: Purchases of property and equipment (29 ) — (29 ) (16 ) — (16 ) Purchases of investments (17,526 ) — (17,526 ) (3,832 ) — (3,832 ) Net cash used in investing activities (17,555 ) — (17,555 ) (3,848 ) — (3,848 ) Cash flows from financing activities: Proceeds from issuance of debt 12,914 — 12,914 — — — Payments of principal on insurance financing arrangements (415 ) — (415 ) — — — Repayment of debt (12,800 ) — (12,800 ) — — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (2 ) — (2 ) (10 ) — (10 ) Net cash provided by financing activities (3,750 ) — (3,750 ) (4,733 ) — (4,733 ) Effect of exchange rate changes on cash and cash equivalents 65 — 65 — — — Net decrease in cash and cash equivalents (25,285 ) — (25,285 ) (12,134 ) — (12,134 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 40,181 — $ 40,181 $ 100,212 — $ 100,212 Supplemental cash flow information: Cash paid for interest $ 68 — $ 68 $ 5 — $ 5 Six Months Ended June 30, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net loss $ (16,851 ) $ 1,061 $ (15,790 ) $ (25,906 ) $ 14,422 $ (11,484 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 1,694 — 1,694 2,428 — 2,428 Severance expense 1,402 — 1,402 — — — Depreciation and amortization expense 157 — 157 246 — 246 Fair value adjustment related to derivative and warrant liability — (481 ) (481 ) (273 ) (14,470 ) (14,743 ) Fair value adjustment related to investments (327 ) — (327 ) 495 — 495 Loss on sublease and disposal of property and equipment — — — 9 — 9 Consulting fees paid in common stock 67 — 67 100 — 100 Acquired in-process research and development — — — 17,663 — 17,663 Gain on foreign currency exchange rates (138 ) — (138 ) — — — Change in assets and liabilities: Accounts and other receivables (5,734 ) — (5,734 ) (1,292 ) — (1,292 ) Prepaid expenses and other current assets (146 ) (189 ) (335 ) (1,892 ) — (1,892 ) Inventories 125 — 125 39 — 39 Operating lease right-of-use assets 161 — 161 (24 ) — (24 ) Accounts payable and accrued expenses 3,338 (391 ) 2,947 630 — 630 Discount and rebate liabilities 3,097 — 3,097 496 — 496 Operating lease liabilities (216 ) — (216 ) (37 ) — (37 ) Other liabilities 622 — 622 (339 ) 48 (291 ) Net cash used in operating activities (12,749 ) — (12,749 ) (7,657 ) — (7,657 ) Cash flows from investing activities: Acquisitions, net — — — (14,090 ) — (14,090 ) Purchases of property and equipment (52 ) — (52 ) (31 ) — (31 ) Purchases of investments (17,467 ) — (17,467 ) (23,832 ) — (23,832 ) Maturities of long-term investments, net 34,000 — 34,000 1,025 — 1,025 Net cash used in investing activities 16,481 — 16,481 (36,928 ) — (36,928 ) Cash flows from financing activities: Proceeds from issuance of debt 12,800 — 12,800 12,800 — 12,800 Proceeds from insurance financing arrangements 1,256 — 1,256 1,273 — 1,273 Proceeds from Employee Stock Purchase Plan 166 — 166 216 — 216 Payments of principal on insurance financing arrangements (564 ) — (564 ) (469 ) — (469 ) Repayment of debt (13,007 ) — (13,007 ) — — — Payment of offering costs — — — (68 ) — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (3 ) — (3 ) (11 ) — (11 ) Net cash provided by financing activities (2,799 ) — (2,799 ) 9,018 — 9,086 Effect of exchange rate changes on cash and cash equivalents (203 ) — (203 ) — — — Net decrease in cash and cash equivalents 730 — 730 (35,567 ) — (35,499 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 66,196 $ — $ 66,196 $ 76,779 $ — $ 76,847 Supplemental cash flow information: Cash paid for interest $ 261 — $261 $ 41 — $ 41 Nine Months Ended September 30, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net loss $ (30,896 ) $ 4,739 $ (26,157 ) $ (32,522 ) $ 8,722 $ (23,800 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 3,081 — 3,081 3,339 — 3,339 Severance expense 1,401 — 1,401 — — — Depreciation and amortization expense 219 — 219 644 — 644 Fair value adjustment related to derivative and warrant liability — (4,159 ) (4,159 ) (295 ) (8,893 ) (9,188 ) Fair value adjustment related to investments (451 ) — (451 ) 634 — 634 Loss on sublease and disposal of property and equipment 157 — 157 9 — 9 Consulting fees paid in common stock 138 — 138 165 — 165 Acquired in-process research and development — — — 17,663 — 17,663 Gain on foreign currency exchange rates (30 ) — (30 ) — — — Change in assets and liabilities: Accounts and other receivables (1,628 ) — (1,628 ) (4,646 ) — (4,646 ) Prepaid expenses and other current assets 216 (189 ) 27 (1,196 ) — (1,196 ) Inventories 190 — 190 280 — 280 Operating lease right-of-use assets 243 — 243 82 — 82 Other long-term assets (93 ) — (93 ) - — — Accounts payable and accrued expenses 5,791 (391 ) 5,400 1,262 — 1,262 Discount and rebate liabilities 3,895 — 3,895 858 — 858 Operating lease liabilities (326 ) — (326 ) (160 ) — (160 ) Other liabilities 716 — 716 (372 ) 171 (201 ) Net cash used in operating activities (17,377 ) — (17,377 ) (14,255 ) — (14,255 ) Cash flows from investing activities: Acquisitions, net — — — (14,090 ) — (14,090 ) Purchases of property and equipment (224 ) — (224 ) (59 ) — (59 ) Purchases of investments (45,821 ) — (45,821 ) (23,832 ) — (23,832 ) Purchases of Secured corporate notes (25,426 ) — (25,426 ) — — — Maturities of long-term investments, net 43,496 — 43,496 1,325 — 1,325 Net cash used in investing activities (27,975 ) — (27,975 ) (36,656 ) — (36,656 ) Cash flows from financing activities: Proceeds from issuance of debt 38,801 — 38,801 12,800 — 12,800 Proceeds from insurance financing arrangements 1,256 — 1,256 1,273 — 1,273 Proceeds from Employee Stock Purchase Plan 219 — 219 216 — 216 Payments of principal on insurance financing arrangements (564 ) — (564 ) (876 ) — (876 ) Repayment of debt (12,800 ) — (12,800 ) — — — Payment of offering costs — — — (68 ) — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (5 ) — (5 ) (13 ) — (13 ) Net cash provided by financing activities 23,460 — 23,460 8,609 — 8,677 Effect of exchange rate changes on cash and cash equivalents (305 ) — (305 ) 15 — 15 Net decrease in cash and cash equivalents (22,197 ) — (22,197 ) (42,287 ) —- (42,219 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 43,269 $ — $ 43,269 $ 70,059 $ — $ 70,127 Supplemental cash flow information: Cash paid for interest $ 456 $ — $ 456 $ 165 $ — $ 165 Right-of-use assets obtained in exchange for lease liabilities — — — — — — Supplemental disclosure of noncash investing activities: Issuance of common stock in connection with the Merger (Note K) (11,500 ) — (11,500 ) — — — Supplemental disclosure of noncash financing activities: Issuance of secured promissory note for the Merger (Note K) (5,073 ) — (5,073 ) — — — |
Note D - Accounts and Other Rec
Note D - Accounts and Other Receivables | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | D. Accounts and Other Receivables Accounts and other receivables consist of the following (in thousands): December 31, 2023 2022 Accounts receivable $ 16,119 $ 7,185 Other receivables 1,258 1,114 Total accounts and other receivables $ 17,377 $ 8,299 |
Note E - Prepaid Expenses and O
Note E - Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Other Current Assets [Text Block] | E. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2023 2022 Prepaid insurance $ 1,172 $ 577 Other prepaid expenses and current assets 652 1,111 Total prepaid expenses and other current assets $ 1,824 $ 1,688 |
Note F - Property and Equipment
Note F - Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | F. Property and Equipment Property and equipment consists of the following (in thousands): December 31, 2023 2022 Laboratory equipment $ 711 $ 710 Furniture and office equipment 157 104 Computers and hardware 643 462 Leasehold improvements 710 710 Finance lease right-of-use assets 149 251 Total property and equipment 2,370 2,237 Less: accumulated depreciation and amortization (1,634 ) (1,443 ) Property and equipment, net $ 736 $ 794 The estimated useful lives of property and equipment are as follows: Useful Life Asset Category (in years) Laboratory equipment 10 Furniture and office equipment 5 - 10 Computers and hardware 3 - 7 Leasehold improvements 9 Depreciation and amortization expense, including amounts pertaining to assets held under finance leases, was approximately $245,000 and $257,000 for the years ended December 31, 2023 2022 |
Note G - Accounts Payable and A
Note G - Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | G. Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following (in thousands): December 31, 2023 2022 Accrued payroll 10,671 1,673 Accrued professional fees 675 256 Accounts payable 13,987 3,611 Other accrued expenses 3,070 629 Total accounts payable and accrued expenses $ 28,403 $ 6,169 |
Note H - Debt Obligations
Note H - Debt Obligations | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | H. Debt Obligations Secured Promissory Note In connection with the Merger (Note R), on August 30, 2023, six twenty first second August 30, 2026, third December 31, 2023. may Not e R. As of Decemb 31, 2023, December 31, 2023 Secured promissory note $ 5,000 Unamortized original issue premium 148 Less: debt issuance costs (82 ) Secured promissory note, net $ 5,066 Future minimum December 31, 2023, Year Ending December 31, 2023 2024 $ — 2025 1,200 2026 3,800 Total minimum payments 5,000 Plus: unamortized debt premium and debt issuance costs 66 Secured promissory note, net $ 5,066 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 is May 31, 2025, December 31, 2022. December 31, 2022, December 31, 2022. January 31, 2023, May 7, 2023. On January 26, 2023, investments 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 "Collateral Requirement"). The margin account bears interest at the Prime rate minus 225 basis-points. As of December 31, 2023, December 31, 2023, 2024 |
Note I - Commitments and Contin
Note I - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | I. Commitments and Contingencies Legal Matters From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not not APADAZ License Agreement On May 31, 2023, October 25, 2018. December 31, 2023, October 2023. Stockholder Litigation Related to the Merger On October 12, 2023, No. 1:23 08995 14 20 1934 not October 17, 2023, December 13, 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 December 31, 2023 2022, |
Note J - Stock and Warrants
Note J - Stock and Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | J. Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of December 31, 2023, 2022, s, 43,110,360 and 35,450,2 57 December 31, 2023, 2022, an December 31, 2023, 2022, As of December 31, 2023, 2022, December 31, 2023 2022 Outstanding awards under equity incentive plans 8,023,142 2,456,407 Outstanding common stock warrants 5,603,729 4,252,600 Possible future issuances under equity incentive plans 1,728,885 4,421,508 Possible future issuances under employee stock purchase plan 1,340,172 1,417,365 Total common shares reserved for future issuance 16,695,928 12,547,880 Common Stock Activity The following table summarizes common stock activity for the years ended December 31, 2023, 2022 Shares of Common Stock Balance as of January 1, 2022 35,005,640 Common stock issued as compensation to third-parties 41,821 Common stock repurchased as a result of the Stock Repurchase Program (589,792 ) Common stock issued as a result of the Employee Stock Purchase Plan 82,635 Balance as of December 31, 2022 34,540,304 Common stock issued as compensation to third-parties 44,791 Common stock issued as a result of stock warrants exercised 110 Common stock issued as a result of stock options exercised 7,500 Common stock repurchased as a result of the Stock Repurchase Program (665,739 ) Common stock issued in connection with the Merger (Note R) 7,530,509 Common stock issued as a result of the Employee Stock Purchase Plan 77,193 Balance as of December 31, 2023 41,534,668 Authorized, Issued, and Outstanding Preferred Stock As of December 31, 2023, 2022, December 31, 2023, 2022, no Warrants to Purchase Common Stock In prior periods, the Company issued warrants to purchase common stock to various third h 4,221,240 December 31, 2023, 260, Earnings per Share may In connection with the Merger (Note R), in November 2023, "2023 November 22, 2028. December 31, 2023, none 480, 815, November 2023, Based on the conclusion reached regarding the liability classification of the 2023 2021 “2021 December 31, 2022, 2023. 2021 2023 2021 December 31, 2022, As noted above, the Company determined that these warrants and the Put Option should be recorded as a liability and stated at fair value at each reporting period. Changes to the fair value of the warrant liability are recorded through the consolidated statements of operations as a fair value adjustment. As of December 31, 2023, 2022, December 31, 2023, December 31, 2022. |
Note K - Stock-based Compensati
Note K - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | K. Stock-Based Compensation The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO. In November 2014, April 2015, 2014 “2014 April 2015. 2014 June 2021, 2014 2014 April 2021, 4,900,000 January 1, 2031 2014 162 may 2014 December 31, 2023. 2014 January 1 January 1, 2016, January 1, 2031, December 31 2014 January 1, 2024, 2014 by 1,661,386 shar During the year ended December 31, 2023, December 31,2022, In June 2021, April 2021. may first October 1, 2021, first May 31, 2022. December 31, 2023, 159,82 8 In January 2023, 2023 “2023 may 2023 February 2024, 2023 2023 In May 2023, 2014 Stock-based compensation expense recorded under the Incentive Stock Plan, A&R 2014 2023 Year ended December 31, 2023 2022 Research and development $ 2,664 $ 1,443 General and administrative 3,290 2,851 Total stock-based compensation expense $ 5,954 $ 4,294 There was no stock-based compensation expense related to performance-based awards recognized during the year ended December 31, 2023. There was $0.4 million of stock-based compensation related to performance-based awards recognized during the year ended December 31, 2022. As a result of the Mickle Transition Agreement and the Pascoe Transition Agreement, as further discussed in Note P , December 31, 2023. Stock Option Awards The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the option, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the option. The expected term represents the period of time the stock options are expected to be outstanding. Due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected term of the stock options, the Company uses the simplified method to estimate the expected term for its “plain vanilla” stock options. Under the simplified method, the expected term of an option is presumed to be the mid-point between the vesting date and the end of the contractual term. Some options, for example those that have exercise prices in excess of the fair value of the underlying stock, are not no not not The Company recognizes compensation expense related to stock-based payment transactions upon satisfaction of the requisite service or vesting requirements. Forfeitures are estimated at the time of grant and revised based on actual forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Using the Black-Scholes option-pricing model, the weighted-average fair value of awards granted during the years ended December 31, 2023, 2022, s $3.65 an Year Ended December 31, 2023 2022 Risk-free interest rate 3.34% - 4.79% 1.70% - 3.80% Expected term (in years) 5.50 - 10.00 5.50 - 7.00 Expected volatility 89.48% - 93.67% 91.28% - 98.91% Expected dividend yield 0 0 2014 2023 for the year ended December 31, 2023 , Weighted Weighted Avg Aggregate Number of Average Remaining Intrinsic Options Exercise Price Contractual Term Value Outstanding balance at January 1, 2023 2,456,407 $ 16.84 8.51 $ 11,819 Granted 5,779,679 $ 4.68 — — Exercised or released 7,500 $ 4.67 — — Canceled or forfeited 205,444 $ 4.70 — $ 122 Expired — — — — Outstanding balance at December 31, 2023 8,023,142 $ 8.40 8.68 $ 11,089 Exercisable at December 31, 2023 2,408,165 $ 16.28 7.81 $ 1,778 Vested and expected to vest at December 31, 2023 6,972,858 $ 8.96 8.62 $ 9,112 Information regarding currently outstanding and exercisable options as of December 31, 2023 , Options Outstanding Options Exercisable Weighted Avg Weighted Avg Number of Remaining Number of Remaining Exercise Price Shares Contractual Term Shares Contractual Term $2.848 to $10.00 7,742,171 8.84 2,127,194 8.25 $10.01 to $30.00 69,375 7.17 69,375 7.17 $30.01 to $50.00 68,514 5.11 68,514 5.11 $50.01 to $70.00 41,866 3.08 41,866 3.08 $70.01 to $327.20 101,216 2.70 101,216 2.70 8,023,142 8.68 2,408,165 7.81 The total fair value of stock options vested during the years ended December 31, 2023 2022 $9.2 m 7 Unvested stock options as of December 31, 2023 2022 Number of Unvested Shares December 31, Exercise Price 2023 2022 $2.848 to $10.00 5,614,977 1,824,285 $30.01 to $50.00 — 17,121 Total number of unvested stock options 5,614,977 1,841,406 As of December 31, 2023 , there was $13.8 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the A&R 2014 Plan and 2023 December 31, 2023. December 31, 2022. |
Note L - Fair Value of Financia
Note L - Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | L. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three three ● Level 1—Observable ● Level 2—Observable ● Level 3—Unobservable no The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts and other receivables, accounts payable and accrued expenses, the Nantahala Note, and the margin account approximate their respective fair values due to the short-term nature of such instruments. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of December 31, 2023 2022 Quoted Prices Significant in Active Other Significant Balance at Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2023 (Level 1) (Level 2) (Level 3) CVR liability (Note R) $ 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 $ — $ — Quoted Prices Significant in Active Other Significant Balance at Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2022 (Level 1) (Level 2) (Level 3) Warrant liabilities (As Restated) $ 10,202 $ — $ — $ 10,202 Total liabilities $ 10,202 $ — $ — $ 10,202 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 common stock warrant liabilities were recorded at fair value using the Black-Scholes option pricing model. The following assumptions were used in determining the fair value of the warrant liabilities valued using the Black-Scholes option pricing model as of December 31, 2023, 2022: December 31, 2023 December 31, 2022 Risk-free interest rate 3.76% - 4.12% 4.01% - 4.12% Volatility 62.01% - 92.42% 98.33% - 103.01% Dividend yield —% —% Expected term (years) 2.0 - 4.9 3.0 - 4.0 Weighted average fair value 2.94 2.94 The following table is a reconciliation for the common stock warrant liabilities measured at fair value using Level 3 Balance at December 31, 2021 (As Restated) $ 25,032 Change in fair value measurement (As Restated) (14,830 ) Balance at December 31, 2022 (As Restated) $ 10,202 Fair value of warrants issued 4,500 Change in fair value measurement 1,398 Balance at December 31, 2023 $ 16,100 For the years ended December 31, 2023, 2022, |
Note M - Income Taxes
Note M - Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | M. Income Taxes The Company ’s financial statements include a total state tax expense of$ 31,000 December 31, 2022 not December 31, 2023. $0.8 mi December 31, 2022. Year ended December 31, 2023 2022 (As Restated) Federal statutory rate 21.00 % 21.00 % Effect of: Change in valuation allowance (23.29 ) (34.77 ) Return to provision and deferred true-up (2.41 ) (5.37 ) Federal research and development credit 4.09 1.82 State research and development credit — 0.12 Change in rate (0.01 ) 0.80 State tax benefit (net of federal) 5.19 4.78 Warrant liability — 12.39 Stock-based compensation (0.20 ) (1.09 ) Global intangible low-taxed income credit (3.41 ) (1.92 ) Foreign research and development excess benefit (0.86 ) 2.17 Other (0.10 ) 0.19 Federal income tax provision effective rate — % 0.12 % The components of deferred tax assets and liabilities are as follows (in thousands): December 31, 2023 2022 Deferred tax assets relating to: Net operating loss carryforwards $ 90,743 $ 66,373 Research and development tax carryforward 20,670 6,900 Stock-based compensation 5,154 4,185 174 expenses 30,241 3,730 Right-of-use liability 265 359 Property and equipment 23 22 Other deferred tax assets 1,951 598 Total gross deferred tax assets 149,047 82,167 Deferred tax liabilities relating to: Right-of-use asset 249 (336 ) Intangibles 14,473 — Total gross deferred tax liabilities 14,722 (336 ) Deferred tax assets less liabilities 134,324 81,831 Valuation allowance (134,488 ) (81,831 ) Net deferred tax asset (liability) $ (164 ) $ — In assessing the realizability of deferred tax assets, management considers whether it is more likely than not not not not The Company recorded refundable research and development tax credit as other income and not 740 December 31, 2022, 2023. no In accordance with the Tax Cuts and Jobs Act of 2017, not no The Company has federal operating loss carryforwards totaling $350 million, $145.3 million of which, if not no not 2027. may 382 may ASC 740 10, not” not not not not |
Note N - Net Loss Per Share
Note N - Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | N. 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: December 31, 2023 2022 Awards under equity incentive plans 1,728,885 2,456,407 Common stock warrants 5,603,729 4,252,600 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 7,332,614 6,709,007 A reconciliation from net loss to basic net loss attributable to common stockholders per share of common stock and diluted net loss attributable to common stockholders per share of common stock for the years ended December 31, 2023 2022, December 31, 2023 2022 (As Restated) Basic and diluted net loss per share of common stock: Net loss, basic and diluted $ (46,049 ) $ (26,772 ) Weighted average number of shares of common stock outstanding, basic and diluted 35,452 34,489 Basic and diluted net loss per share of common stock $ (1.30 ) $ (0.78 ) |
Note O - Leases
Note O - Leases | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Lease Disclosure [Text Block] | O. Leases The Company has operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. The Company determines if an arrangement is a lease at contract inception. Lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date. The Company does not 12 not Effective June 1, 2021, one two February 2026. The components of lease expense were as follows (in thousands): Year Ended December 31, Lease Cost 2023 2022 Finance lease cost: Amortization of right-of-use assets $ 102 $ 129 Interest on lease liabilities — 2 Total finance lease cost 102 131 Operating lease cost 437 418 Short-term lease cost 171 210 Variable lease cost 40 39 Less: sublease income (157 ) (157 ) Total lease costs $ 593 $ 641 Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ — $ 2 Financing cash flows from finance leases 5 16 Operating cash flows from operating leases 552 522 Operating cash flows from short-term leases 171 210 Operating cash flows from variable lease costs 40 39 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases — 123 Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate): December 31, 2023 2022 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (882 ) (780 ) Property and equipment, net $ 149 $ 251 Other current liabilities $ — $ 6 Other long-term liabilities — — Total finance lease liabilities $ — $ 6 Operating Leases Operating lease right-of-use assets $ 790 $ 988 Total operating lease right-of-use assets $ 790 $ 988 Current portion of operating lease liabilities $ 543 $ 480 Operating lease liabilities, less current portion 456 843 Total operating lease liabilities $ 999 $ 1,323 Weighted Average Remaining Lease Term Finance leases (in years) 0 1 Operating leases (in years) 2 3 Weighted Average Discount Rate Finance leases 14.3 % 14.3 % Operating leases 7.6 % 7.3 % Maturities on lease liabilities were as follows (in thousands): Finance Operating Year Ending December 31, Leases Leases 2024 $ — $ 644 2025 — 389 2026 — 30 Total lease payments — 1,063 Less: future interest expense — (64 ) Lease liabilities $ — $ 999 |
Note P - Employee Benefit Plan
Note P - Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Compensation and Employee Benefit Plans [Text Block] | P. Employee Benefit Plan The Company has a 401 “401 may 401 and $0.2 million for the years ended December 31, 2023 2022, The Company has a discretionary profit-sharing plan (the “Profit Sharing Plan”) that covers all employees. Employees become eligible participants in the Profit Sharing Plan once they have provided three no 2023 2022. |
Note Q - Significant Events
Note Q - Significant Events | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Significant Events [Text Block] | Q. Significant Events On January 6, 2023, 2023 April 25, 2023. January 6, 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 “Mickle Transition Agreement”) and (ii) a consulting agreement with Dr. Mickle (the “Consulting Agreement”). Pursuant to the terms of the Mickle 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 2014 December 31, 2023, y $0.6 millio At the Annual Meeting, each of John B. Bode, Douglas W. Calder, and Corey Watton was elected as a director of the Company and each of Richard W. Pascoe, Christopher A. Posner, and David S. Tierney ceased serving on the Company's Board of Directors. After the Annual Meeting, the Company's Board of Directors accepted the resignation of Richard W. Pascoe from his role as Chief Executive Officer on May 5, 2023, June 1, 2023, 12 12 nine December 31, 2023, $0.3 m On May 3, 2023, not 2024 In May 2023, June 1, 2023. On August 7, 2023, 2024 On August 7, 2023, On October 7, 2023, October 10, 2023. October 10, 2023 ( October 10, 2023, 2023 first October 10, 2024 ( twelve one six eighteen 12 On October 10, 2023, In January 2024, On Januar y 20, 2 024, 2024 |
Note R - Merger
Note R - Merger | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Mergers, Acquisitions and Dispositions Disclosures [Text Block] | R. 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; ( 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 4,538 85,022 Liabilities Accounts payable and accrued expenses $ 10,718 Deferred collaboration funding 1,500 Operating lease liabilities 175 12,393 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 December 31, 2023, 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. $42,0 00 November 18, 2023, December 31, 2023. The following pro forma combined results of operations present the acquisition as if it had occurred on January 1, 2022. pro forma combined results of operations do not one not Year Ended December 31, 2023 Year Ended December 31, 2022 Pro forma revenue $ 27,705 $ 10,458 Pro forma net loss (78,875 ) (80,652 ) The Company expensed approximately $ 2.2 December 31, 2023, 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 following table provides a reconciliation of the beginning and ending balances related to the contingent consideration liabilities for the CVRs (dollars in thousands): Balance at December 31, 2022 $ 0 Initial estimate of contingent consideration at the Effective Time 8,562 Change in fair value recognized in earnings (1,300 ) Balance at December 31, 2023 $ 7,262 For the year ended December 31, 2023, 1.3 |
Note S - Subsequent Events
Note S - Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | S. Subsequent Events The Company evaluated events and transactions occurring subsequent to December 31, 2023, rough April , 2024, no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of these consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of long-term investments, the fair value of the derivative and warrant liability and discount and rebate liabilities, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit and investments with multiple financial institutions, the balances of which frequently exceed insured limits, and accounts receivable, which are concentrated amongst a limited number of customers. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers any highly liquid investments with an original maturity of three |
Investment, Policy [Policy Text Block] | Investments The Company maintains investment securities that are classified as available-for-sale securities for which the Company has elected the fair value option under ASC 825, Financial Instruments. As such, these securities are carried at fair value with unrealized gains and losses included in fair value adjustment related to investments on the consolidated statements of operations. The securities primarily consist of U.S. Treasury securities and U.S. government-sponsored agency securities and are included in securities at fair value in the consolidated balance sheets. As of December 31, 2023, 2022, $24.7 m $0.6 s. In addition, the Company held certificates of deposit totaling $20.5 million as of December 31, 2022, December 31, 2022. May 2023. |
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 December 31, 2023, not December 31, 2022. |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Goodwill and Intangible Assets Goodwill represents the excess of the consideration transferred over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill is not fourth not one 35, first not not The Company's goodwill balance was $4.7 million as of December 31, 2023. December 31, 2022. December 31, 2022, 350 not not no December 31, 2023. Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not fourth was $2.0 mil December 31, 2023. December 31, 2022, May 2022 December 31, 2023, 2022. As of December 31, 2023, $67.2 milli eleven $0.8 m December 31, 2023. For intangible assets subject to amortization, estimated amortization expense for the five December 31, 2023, 2024 $ 6,182 2025 $ 6,182 2026 $ 6,182 2027 $ 6,182 2028 $ 6,182 |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three ten |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not December 31, 2023, 2022. |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers 606” five 1 2 3 4 5 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, following market approval. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability (rebate). An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drug products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate. For the years ended December 31, 2023, 2022, December 31, 2023, December 31, 2022, December 31, 2023, December 31, 2022, December 31, 2023, 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 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-methylphenidate (“d-MPH”), including AZSTARYS, or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder. Corium was tasked by Commave, to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Corium agreed to pay milestone payments 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 not not not December 31, 2023, .5 December 31, 2022, December 31, 2023, 2022. In accordance with the terms of the Company’s Termination Agreement with Aquestive Therapeutics dated March 20, 2012, KP879 KP1077 December 31, 2023, 2022, Relief 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 ( December 31, 2023, not There was no deferred revenue related to this agreement as of December 31, 2023. Product Revenue, net On December 27, 2022, 44 20 1.2m 2 November 17, 2023, third December 31, 2023, 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 received payments from Corium of $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 December 31, 2022, third For the years ended December 31, 2023, 2022 December 31, 2023, 2022, March 31, 2023. |
Cost of Goods and Service [Policy Text Block] | Cost of Revenue The components of cost of revenue are royalties and expenses directly attributable to revenue. To date, the Company has generated revenue from the AZSTARYS License Agreement, sales of arimoclomol under the Arimoclomol EAP, reimbursement of out-of-pocket third |
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 may |
Inventory, Policy [Policy Text Block] | Inventory As discussed in Note A, a portion of the purchase price for Arimoclomol was allocated to inventory acquired representing the value of inventory associated with forecasted EAP revenues, which 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 December 31, 2023 2022, 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 December 31, 2023 December 31, 2022 Raw Materials $ 2,938 $ — Work in progress 1,884 — Finished goods 5,019 671 Total inventory $ 9,841 $ 671 |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clin ical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services. The Company enters into contractual agreements with third pleted over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Patent Costs Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations. |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not Uncertain tax positions are recognized only when the Company believes it is more likely than not t the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company did not December 31, 2023, 2022 The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no 2015, 2017 may On December 22, 2017, 1, 2018 ” ("Ta x January 1, 2018, not |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers an d directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees using a fair value approach under Accounting Standards Codification ("ASC") subtopic 505 50. |
Earnings Per Share, Policy [Policy Text Block] | Basic and Diluted Net Loss per Share of Common Stock The Company uses the two entitle the holders to participate in dividends and earnings of the Company. The two |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is ava ilable and regularly reviewed by the chief operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. The Company holds assets in both the United States and Europe as of December 31, 2023 2022 |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign currency Assets and liabilities are translated into the reporting currency using the exchange rates in effect on the consolidated balance sheet dates. Equity accounts are translated at historical rates, except for the change in retained earnings during the year, which is the result of the income statement translation process. Revenue and expense accounts are translated using the weighted average exchange rate during the period. The cumulative translation adjustments associated with the net assets of foreign subsidiaries are recorded in accumulated other comprehensive income/loss in the accompanying consolidated statements of stockholders’ equity. |
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 consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not |
Note A - Description of Busin_2
Note A - Description of Business, Basis of Presentation and Significant Transactions (Tables) | 12 Months Ended |
Dec. 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 B - Summary of Significa_2
Note B - Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | 2024 $ 6,182 2025 $ 6,182 2026 $ 6,182 2027 $ 6,182 2028 $ 6,182 |
Schedule of Inventory, Current [Table Text Block] | December 31, 2023 December 31, 2022 Raw Materials $ 2,938 $ — Work in progress 1,884 — Finished goods 5,019 671 Total inventory $ 9,841 $ 671 |
Note C - Restatement of Previ_2
Note C - Restatement of Previously Issued Consolidated Financial Statements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Error Corrections and Prior Period Adjustments [Table Text Block] | As of December 31, 2022 CORRECTED CONSOLIDATED BALANCE SHEET As previously reported Impact of Adjustments As Restated Prepaid expenses and other current assets $ 1,877 $ (189 ) $ 1,688 Total current assets 93,023 (189 ) 92,834 Total assets 115,529 (189 ) 115,340 Other current liabilities 422 297 719 Total current liabilities 11,726 297 12,023 Derivative and warrant liability 1 10,201 10,202 Total liabilities 29,722 10,498 40,220 Additional paid-in capital 401,799 34,470 436,269 Accumulated deficit (308,572 ) (45,157 ) (353,729 ) Total stockholder's equity 85,807 (10,687 ) 75,120 Total liabilities and stockholder's equity 115,529 (189) 115,340 March 31, 2023 March 31, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 40,181 $ — $ 40,181 $ 100,242 $ — $ 100,242 Securities at fair value 34,403 — 34,403 — — — Short-term investments - other 20,700 — 20,700 1,338 — 1,338 Accounts and other receivables 7,822 — 7,822 3,320 — 3,320 Prepaid expenses and other current assets 1,174 — 1,174 880 (426 ) 454 Total current assets 104,280 — 104,280 105,780 (426 ) 105,354 Inventories 620 — 620 — — — Property and equipment, net 744 — 744 835 — 835 Operating lease right-of-use assets 898 — 898 1,090 — 1,090 Long-term investments - other — — — 17,564 — 17,564 Other long-term assets 53 — 53 437 — 437 Total assets $ 106,595 $ — $ 106,595 $ 125,706 $ (426 ) $ 125,280 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 10,098 $ 393 $ 10,491 $ 2,582 $ — $ 2,582 Current portion of operating lease liabilities 470 — 470 356 — 356 Current portion of discount and rebate liabilities 4,746 — 4,746 — — — Other current liabilities 302 — 302 7 — 7 Total current liabilities 15,616 393 16,009 2,945 — 2,945 Line of credit payable 12,914 — 12,914 — — — Derivative and warrant liability 3 11,744 11,747 89 12,682 12,771 Operating lease liabilities, less current portion 736 — 736 1,144 — 1,144 Discount and rebate liabilities, less current portion 5,764 — 5,764 — — — Other long-term liabilities 158 — 158 29 — 29 Total liabilities 35,191 12,137 47,328 4,207 12,682 16,889 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 35,457,496 33,881,804 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 402,786 34,470 437,256 397,925 34,470 432,395 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (320,339 ) (46,607 ) (366,946 ) (268,893 ) (47,578 ) (316,471 ) Accumulated other comprehensive (loss) income (63 ) — (63 ) — — — Total stockholders' equity 71,404 (12,137 ) 59,267 121,499 (13,108 ) 108,391 Total liabilities and stockholders' equity $ 106,595 $ — $ 106,595 $ 125,706 $ (426 ) $ 125,280 June 30, 2023 June 30, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 66,196 $ — $ 66,196 $ 76,779 $ — $ 76,779 Securities at fair value 20,696 — 20,696 — — — Short-term investments - other 479 — 479 4,199 — 4,199 Accounts and other receivables 14,033 — 14,033 2,820 — 2,820 Prepaid expenses and other current assets 2,023 — 2,023 3,637 (426 ) 3,211 Total current assets 103,427 — 103,427 87,435 (426 ) 87,009 Inventories 546 — 546 779 — 779 Property and equipment, net 689 — 689 904 — 904 Operating lease right-of-use assets 803 — 803 1,165 — 1,165 Long-term investments - other — — — 33,535 — 33,535 Other long-term assets 53 — 53 440 — 440 Total assets $ 105,518 $ — $ 105,518 $ 124,258 $ (426 ) $ 123,832 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 10,510 $ — $ 10,510 $ 3,600 $ — $ 3,600 Current portion of capital lease obligation — — — 469 — 469 Current portion of operating lease liabilities 456 — 456 — — — Current portion of discount and rebate liabilities 6,965 — 6,965 1,796 — 1,796 Other current liabilities 321 — 321 1,294 48 1,342 Total current liabilities 18,252 — 18,252 7,159 48 7,207 Line of credit payable 12,709 — 12,709 12,800 — 12,800 Derivative and warrant liability — 9,624 9,624 57 10,562 10,619 Operating lease liabilities, less current portion 627 — 627 1,082 — 1,082 Discount and rebate liabilities, less current portion 5,114 — 5,114 3,900 — 3,900 Other long-term liabilities 319 — 319 27 — 27 Total liabilities 37,021 9,624 46,645 25,025 10,610 35,635 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 35,503,697 33,928,005 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 405,127 34,470 439,597 399,701 34,470 434,171 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (325,425 ) (44,094 ) (369,519 ) (292,935 ) (45,506 ) (338,441 ) Accumulated other comprehensive (loss) income (225 ) — (225 ) — — — Total stockholders' equity 68,497 (9,624 ) 58,873 99,233 (11,036 ) 88,197 Total liabilities and stockholders' equity $ 105,518 $ — $ 105,518 $ 124,258 $ (426 ) $ 123,832 September 30, 2023 September 30, 2022 Corrected Condensed Consolidated Balance Sheets (UNAUDITED) As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Assets Current assets: Cash and cash equivalents $ 43,269 $ — $ 43,269 $ 70,059 $ — $ 70,059 Securities at fair value 39,672 — 39,672 — — — Secured corporate notes 41,999 — 41,999 — — — Short-term investments - other 485 — 485 5,832 — 5,832 Accounts and other receivables 9,927 — 9,927 6,583 — 6,583 Prepaid expenses and other current assets 1,661 — 1,661 2,659 (426 ) 2,233 Total current assets 137,013 — 137,013 85,133 (426 ) 84,707 Inventories 481 — 481 596 — 596 Property and equipment, net 642 — 642 852 — 852 Operating lease right-of-use assets 698 — 698 1,068 — 1,068 Long-term investments - other — — — 31,463 — 31,463 Other long-term assets 148 — 148 439 — 439 Total assets $ 138,982 $ — $ 138,982 $ 119,551 $ (426 ) $ 119,125 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 13,080 $ — $ 13,080 $ 4,279 $ — $ 4,279 Current portion of operating lease liabilities 433 — 433 474 — 474 Current portion of discount and rebate liabilities 7,890 — 7,890 2,825 171 2,996 Other current liabilities 311 — 311 853 — 853 Total current liabilities 21,714 — 21,714 8,431 171 8,602 Line of credit payable 38,801 — 38,801 12,800 — 12,800 Derivative and warrant liability — 5,948 5,948 35 16,139 16,174 Secured promissory note 5,073 — 5,073 — — — Operating lease liabilities, less current portion 517 — 517 956 — 956 Discount and rebate liabilities, less current portion 4,987 — 4,987 3,509 — 3,509 Other long-term liabilities 420 — 420 26 — 26 Total liabilities 71,512 5,948 77,460 25,757 16,310 42,067 Commitments and contingencies (Note D) Stockholders’ equity: Preferred stock: Undesignated preferred stock, $ 0.0001 10,000,000 no — — — — — — Common stock, $ 0.0001 250,000,000 37,787,402 36,211,710 35,450,257 34,540,304 3 — 3 3 — 3 Additional paid-in capital 418,138 34,470 452,608 400,677 34,470 435,147 Treasury stock, at cost (10,983 ) — (10,983 ) (7,536 ) — (7,536 ) Accumulated deficit (339,468 ) (40,418 ) (379,886 ) (299,551 ) (51,206 ) (350,757 ) Accumulated other comprehensive (loss) income (220 ) — (220 ) 201 — 201 Total stockholders' equity 67,470 (5,948 ) 61,522 93,794 (16,736 ) 77,058 Total liabilities and stockholders' equity $ 138,982 $ — $ 138,982 $ 119,551 $ (426 ) $ 119,125 |
Corrected Statement of Operations [Table Text Block] | For the Year Ended December 31, 2022 CORRECTED CONSOLIDATED STATEMENT OF OPERATIONS As previously reported Impact of Adjustments As Restated Revenue, net $ 10,458 $ (297 ) $ 10,161 Operating expenses: Cost of revenue 343 (121 ) 222 Research and development 19,614 189 19,803 Selling, general and administrative 15,343 (305 ) 15,038 Total operating expenses 52,963 (237 ) 52,726 Loss from operations (42,505 ) (60 ) (42,565 ) Fair value adjustment related to derivative and warrant liability 328 14,831 15,159 Interest and other income, net 760 753 1,513 Total other income 176 15,584 15,760 Loss before income taxes (42,329 ) 15,524 (26,805 ) Income tax (expense) benefit 786 (753 ) 33 Net loss $ (41,543 ) $ 14,771 $ (26,772 ) Basic and diluted net loss per share of common stock: Net loss $ (1.20 ) $ 0.42 $ (0.78 ) Three months ended March 31, 2023 2023 2023 2022 2022 2022 Condensed consolidated statements of operations (UNAUD As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 2,879 $ 297 $ 3,176 $ 3,965 $ — $ 3,965 Operating expenses: Cost of revenue 125 — 125 8 — 8 Research and development 8,844 (189 ) 8,655 3,082 — 3,082 Selling, general and administrative 6,834 393 7,227 2,734 — 2,734 Acquired In-process research and development — — — — — — Severance expense — — — — — — Total operating expenses 15,803 204 16,007 5,824 — 5,824 Loss from operations (12,924 ) 93 (12,831 ) (1,859 ) — (1,859 ) Other (expense) income: Interest expense (182 ) — (182 ) (5 ) — (5 ) Fair value adjustment related to derivative and warrant liability (2 ) (1,543 ) (1,545 ) 241 12,350 12,591 Fair value adjustment related to investments 196 — 196 (352 ) — (352 ) Interest and other income, net 1,042 — 1,042 107 — 107 Total other (expense) income 1,054 (1,543 ) (489 ) (9 ) 12,350 12,341 Loss before income taxes (11,870 ) (1,450 ) (13,320 ) (1,868 ) 12,350 10,482 Income tax (expense) benefit 103 — 103 4 — 4 Net (loss) income $ (11,767 ) $ (1,450 ) $ (13,217 ) $ (1,864 ) $ 12,350 $ 10,486 Basic and diluted net loss per share of common stock: Net (loss) income $ (0.34 ) $ (0.04) $ (0.38 ) $ (0.05 ) $ 0.35 $ 0.30 Weighted average number of shares of common stock outstanding: Basic and diluted 34,466,542 34,466,542 34,506,597 34,506,597 Three months ended June 30, Six months ended June 30, 2023 2023 2023 2022 2022 2022 2023 2023 2023 2022 2022 2022 As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 8,470 $ — $ 8,470 $ 1,300 $ (48 ) $ 1,252 $ 11,349 $ 297 $ 11,646 $ 5,265 $ (48 ) $ 5,217 Operating expenses: Cost of revenue 677 — 677 51 (20 ) 31 802 — 802 59 (20 ) 39 Research and development 7,433 — 7,433 4,795 — 4,795 16,277 (189 ) 16,088 7,877 — 7,877 Selling, general and administrative 7,005 (393 ) 6,612 3,558 20 3,578 13,839 — 13,839 6,292 20 6,312 Acquired In-process research and development — — — 17,663 — 17,663 — — — 17,663 — 17,663 Total operating expenses 15,115 (393) 14,722 26,067 — 26,067 30,918 (189 ) 30,729 31,891 — 31,891 Loss from operations (6,645 ) (393) (6,252 ) (24,767 ) (48 ) (24,815 ) (19,569 ) 486 (19,083 ) (26,626 ) (48 ) (26,674 ) Other (expense) income: Interest expense (197 ) — (197 ) (36 ) — (36 ) (379 ) — (379 ) (41 ) — (41 ) Fair value adjustment related to derivative and warrant liability — 2,118 2,118 32 2,120 2,152 — 575 575 273 14,470 14,743 Fair value adjustment related to investments 131 — 131 (352 ) — (352 ) 327 — 327 (495 ) — (495 ) Interest and other income, net 1,553 — 1,553 366 753 1,119 2,593 — 2,593 264 753 1,017 Total other (expense) income 1,487 2,118 3,605 10 2,873 2,883 2,541 575 3,116 1 15,223 15,224 Loss before income taxes (5,158 ) 2,511 (2,647 ) (24,757 ) 2,825 (21,932 ) (17,028 ) 1,061 (15,967 ) (26,625 ) 15,175 (11,450 ) Income tax (expense) benefit 74 74 715 (753 ) (38 ) 177 — 177 719 (753 ) (34 ) Net (loss) income $ (5,084 ) $ 2,511 $ (2,573 ) $ (24,042 ) $ 2,072 $ (21,970 ) $ (16,851 ) $ 1,061 $ (15,790 ) $ (25,906 ) $ 14,422 $ (11,484 ) Basic and diluted net loss per share of common stock: Net (loss) income $ (0.15 ) $ 0.07 $ (0.08 ) $ (0.70 ) 0.06 $ (0.64 ) $ (0.49 ) 0.03 $ (0.46 ) $ (0.75 ) 0.42 $ (0.33 ) Weighted average number of shares of common stock outstanding: Basic and diluted 33,898,233 — 33,898,233 34,447,206 — 34,447,206 34,180,818 — 34,180,818 34,476,737 — 34,476,737 Three months ended September 30, Nine months ended September 30, 2023 2023 2023 2022 2022 2022 2023 2023 2023 2022 2022 2022 As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Revenue, net $ 2,895 — $ 2,895 $ 2,874 $ (123 ) $ 2,751 $ 14,244 $ 297 $ 14,541 $ 8,139 $ (171 ) $ 7,968 Operating expenses: Cost of revenue 144 — 144 141 (50 ) 91 946 — 946 200 (70 ) 130 Research and development 12,297 — 12,297 5,385 — 5,385 28,574 (189 ) 28,385 13,262 — 13,262 Selling, general and administrative 5,818 — 5,818 3,974 50 4,024 19,657 — 19,657 10,266 70 10,336 Acquired in-process research and development — — — — — — — — — 17,663 — 17,663 Total operating expenses 18,259 — 18,259 9,500 — 9,500 49,177 (189) 48,988 41,391 — 41,391 Loss from operations (15,364 ) — (15,364 ) (6,626 ) (123 ) (6,749 ) (34,933 ) 486 (34,447 ) (33,252 ) (171 ) (33,423 ) Other income (expense): Interest expense (366 ) — (366 ) (124 ) — (124 ) (745 ) — (745 ) (165 ) — (165 ) Fair value adjustment related to derivative and warrant liability — 3,678 3,678 22 (5,577 ) (5,555 ) — 4,253 4,253 295 8,893 9,188 Fair value adjustment related to investments 124 — 124 (139 ) — (139 ) 451 — 451 (634 ) — (634 ) Interest and other income, net 1,738 — 1,738 218 — 218 4,331 — 4,331 482 753 1,235 Total other income (expense) 1,496 3,678 5,174 (23 ) (5,577 ) (5,600 ) 4,037 4,253 8,290 (22 ) 9,646 9,624 Loss before income taxes (13,868 ) 3,678 (10,190 ) (6,649 ) (5,700 ) (12,349 ) (30,896 ) 4,739 (26,157 ) (33,274 ) 9,475 (23,799 ) Income tax (expense) benefit (177 ) — (177 ) 33 — 33 — — 752 (753 ) (1 ) Net loss $ (14,045 ) $ 3,678 $ (10,367 ) $ (6,616 ) $ (5,700 ) $ (12,316 ) $ (30,896 ) $ 4,739 $ (26,157 ) $ (32,522 ) $ 8,722 $ (23,800 ) Basic and diluted net loss per share of common stock: Net (loss) income $ (0.40 ) $ 0.10 $ (0.30 ) $ (0.19 ) $ (0.17) $ (0.36 ) $ (0.90 ) $ 0.14 $ (0.76 ) $ (0.94 ) $ 0.25 $ (0.69 ) Weighted average number of shares of common stock outstanding: Basic and diluted 34,724,614 — 34,724,614 34,494,702 — 34,494,702 34,364,075 — 34,364,075 34,482,791 — 34,482,791 |
Corrected Statement of Cash Flows [Table Text Block] | For the Year Ended December 31, 2022 CORRECTED CONSOLIDATED STATEMENT OF CASH FLOWS As previously reported Impact of Adjustments As Restated Cash flows from operating activities: Net (loss) income $ (41,543 ) $ 14,771 $ (26,772 ) Adjustments to reconcile net loss to net cash used in operating activities: Change in fair value of derivative and warrant liability (328 ) (14,831 ) (15,159 ) Change in assets and liabilities: Prepaid expenses and other current assets (657 ) (237 ) (894 ) Other liabilities (371 ) 297 (74 ) Three Months Ended March 31, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net income (loss) $ (11,767 ) $ (1,450 ) $ (13,217 ) $ (1,864 ) $ 12,350 $ 10,486 Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 591 — 591 918 — 918 Severance expense 354 — 354 — — — Depreciation and amortization expense 79 — 79 65 — 65 Fair value adjustment related to derivative and warrant liability 2 1,543 1,545 (241 ) (12,350 ) (12,591 ) Fair value adjustment related to investments (196 ) — (196 ) 352 — 352 Consulting fees paid in common stock 42 — 42 50 — 50 Gain on foreign currency exchange rates (240 ) — (240 ) — — — Change in assets and liabilities: Accounts and other receivables 477 — 477 (1,792 ) — (1,792 ) Prepaid expenses and other current assets 703 — 703 303 — 303 Inventories 51 — 51 — — — Operating lease right-of-use assets 80 — 80 51 — 51 Accounts payable and accrued expenses 3,929 (93) 3,836 (486 ) — (486 ) Discount and rebate liabilities 1,528 — 1,528 — — — Operating lease liabilities (107 ) — (107 ) (88 ) — (88 ) Other liabilities 429 — 429 (821 ) — (821 ) Net cash used in operating activities (4,045 ) — (4,045 ) (3,553 ) — (3,553 ) Cash flows from investing activities: Purchases of property and equipment (29 ) — (29 ) (16 ) — (16 ) Purchases of investments (17,526 ) — (17,526 ) (3,832 ) — (3,832 ) Net cash used in investing activities (17,555 ) — (17,555 ) (3,848 ) — (3,848 ) Cash flows from financing activities: Proceeds from issuance of debt 12,914 — 12,914 — — — Payments of principal on insurance financing arrangements (415 ) — (415 ) — — — Repayment of debt (12,800 ) — (12,800 ) — — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (2 ) — (2 ) (10 ) — (10 ) Net cash provided by financing activities (3,750 ) — (3,750 ) (4,733 ) — (4,733 ) Effect of exchange rate changes on cash and cash equivalents 65 — 65 — — — Net decrease in cash and cash equivalents (25,285 ) — (25,285 ) (12,134 ) — (12,134 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 40,181 — $ 40,181 $ 100,212 — $ 100,212 Supplemental cash flow information: Cash paid for interest $ 68 — $ 68 $ 5 — $ 5 Six Months Ended June 30, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net loss $ (16,851 ) $ 1,061 $ (15,790 ) $ (25,906 ) $ 14,422 $ (11,484 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 1,694 — 1,694 2,428 — 2,428 Severance expense 1,402 — 1,402 — — — Depreciation and amortization expense 157 — 157 246 — 246 Fair value adjustment related to derivative and warrant liability — (481 ) (481 ) (273 ) (14,470 ) (14,743 ) Fair value adjustment related to investments (327 ) — (327 ) 495 — 495 Loss on sublease and disposal of property and equipment — — — 9 — 9 Consulting fees paid in common stock 67 — 67 100 — 100 Acquired in-process research and development — — — 17,663 — 17,663 Gain on foreign currency exchange rates (138 ) — (138 ) — — — Change in assets and liabilities: Accounts and other receivables (5,734 ) — (5,734 ) (1,292 ) — (1,292 ) Prepaid expenses and other current assets (146 ) (189 ) (335 ) (1,892 ) — (1,892 ) Inventories 125 — 125 39 — 39 Operating lease right-of-use assets 161 — 161 (24 ) — (24 ) Accounts payable and accrued expenses 3,338 (391 ) 2,947 630 — 630 Discount and rebate liabilities 3,097 — 3,097 496 — 496 Operating lease liabilities (216 ) — (216 ) (37 ) — (37 ) Other liabilities 622 — 622 (339 ) 48 (291 ) Net cash used in operating activities (12,749 ) — (12,749 ) (7,657 ) — (7,657 ) Cash flows from investing activities: Acquisitions, net — — — (14,090 ) — (14,090 ) Purchases of property and equipment (52 ) — (52 ) (31 ) — (31 ) Purchases of investments (17,467 ) — (17,467 ) (23,832 ) — (23,832 ) Maturities of long-term investments, net 34,000 — 34,000 1,025 — 1,025 Net cash used in investing activities 16,481 — 16,481 (36,928 ) — (36,928 ) Cash flows from financing activities: Proceeds from issuance of debt 12,800 — 12,800 12,800 — 12,800 Proceeds from insurance financing arrangements 1,256 — 1,256 1,273 — 1,273 Proceeds from Employee Stock Purchase Plan 166 — 166 216 — 216 Payments of principal on insurance financing arrangements (564 ) — (564 ) (469 ) — (469 ) Repayment of debt (13,007 ) — (13,007 ) — — — Payment of offering costs — — — (68 ) — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (3 ) — (3 ) (11 ) — (11 ) Net cash provided by financing activities (2,799 ) — (2,799 ) 9,018 — 9,086 Effect of exchange rate changes on cash and cash equivalents (203 ) — (203 ) — — — Net decrease in cash and cash equivalents 730 — 730 (35,567 ) — (35,499 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 66,196 $ — $ 66,196 $ 76,779 $ — $ 76,847 Supplemental cash flow information: Cash paid for interest $ 261 — $261 $ 41 — $ 41 Nine Months Ended September 30, 2023 2022 As Reported Impact of Adjustments As Restated As Reported Impact of Adjustments As Restated Condensed Consolidated Statements of Cash Flows (UNAUDITED) Cash flows from operating activities: Net loss $ (30,896 ) $ 4,739 $ (26,157 ) $ (32,522 ) $ 8,722 $ (23,800 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 3,081 — 3,081 3,339 — 3,339 Severance expense 1,401 — 1,401 — — — Depreciation and amortization expense 219 — 219 644 — 644 Fair value adjustment related to derivative and warrant liability — (4,159 ) (4,159 ) (295 ) (8,893 ) (9,188 ) Fair value adjustment related to investments (451 ) — (451 ) 634 — 634 Loss on sublease and disposal of property and equipment 157 — 157 9 — 9 Consulting fees paid in common stock 138 — 138 165 — 165 Acquired in-process research and development — — — 17,663 — 17,663 Gain on foreign currency exchange rates (30 ) — (30 ) — — — Change in assets and liabilities: Accounts and other receivables (1,628 ) — (1,628 ) (4,646 ) — (4,646 ) Prepaid expenses and other current assets 216 (189 ) 27 (1,196 ) — (1,196 ) Inventories 190 — 190 280 — 280 Operating lease right-of-use assets 243 — 243 82 — 82 Other long-term assets (93 ) — (93 ) - — — Accounts payable and accrued expenses 5,791 (391 ) 5,400 1,262 — 1,262 Discount and rebate liabilities 3,895 — 3,895 858 — 858 Operating lease liabilities (326 ) — (326 ) (160 ) — (160 ) Other liabilities 716 — 716 (372 ) 171 (201 ) Net cash used in operating activities (17,377 ) — (17,377 ) (14,255 ) — (14,255 ) Cash flows from investing activities: Acquisitions, net — — — (14,090 ) — (14,090 ) Purchases of property and equipment (224 ) — (224 ) (59 ) — (59 ) Purchases of investments (45,821 ) — (45,821 ) (23,832 ) — (23,832 ) Purchases of Secured corporate notes (25,426 ) — (25,426 ) — — — Maturities of long-term investments, net 43,496 — 43,496 1,325 — 1,325 Net cash used in investing activities (27,975 ) — (27,975 ) (36,656 ) — (36,656 ) Cash flows from financing activities: Proceeds from issuance of debt 38,801 — 38,801 12,800 — 12,800 Proceeds from insurance financing arrangements 1,256 — 1,256 1,273 — 1,273 Proceeds from Employee Stock Purchase Plan 219 — 219 216 — 216 Payments of principal on insurance financing arrangements (564 ) — (564 ) (876 ) — (876 ) Repayment of debt (12,800 ) — (12,800 ) — — — Payment of offering costs — — — (68 ) — — Payment to repurchase shares as part of the Share Repurchase Program (3,447 ) — (3,447 ) (4,723 ) — (4,723 ) Repayment of principal on finance lease liabilities (5 ) — (5 ) (13 ) — (13 ) Net cash provided by financing activities 23,460 — 23,460 8,609 — 8,677 Effect of exchange rate changes on cash and cash equivalents (305 ) — (305 ) 15 — 15 Net decrease in cash and cash equivalents (22,197 ) — (22,197 ) (42,287 ) —- (42,219 ) Cash and cash equivalents, beginning of period 65,466 — 65,466 112,346 — 112,346 Cash and cash equivalents, end of period $ 43,269 $ — $ 43,269 $ 70,059 $ — $ 70,127 Supplemental cash flow information: Cash paid for interest $ 456 $ — $ 456 $ 165 $ — $ 165 Right-of-use assets obtained in exchange for lease liabilities — — — — — — Supplemental disclosure of noncash investing activities: Issuance of common stock in connection with the Merger (Note K) (11,500 ) — (11,500 ) — — — Supplemental disclosure of noncash financing activities: Issuance of secured promissory note for the Merger (Note K) (5,073 ) — (5,073 ) — — — |
Corrected Equity Statement [Table Text Block] | Additional Paid-In Capital Accumulated Deficit CORRECTED STATEMENT OF STOCKHOLDERS' EQUITY As previously reported Impact of Adjustments As Restated As previously reported Impact of Adjustments As Restated Balance at December 31, 2021 $ 396,957 $ 34,470 $ 431,427 $ (267,029 ) $ (59,928 ) $ (326,957 ) Net loss — — — (41,543 ) 14,771 (26,772 ) Balance at December 31, 2022 401,799 34,470 436,269 (308,572 ) (45,157 ) (353,729 ) Condensed Consolidated Statements of Changes in Stockholders' Equity (UNAUDITED) Common Stock Additional Paid-in Capital (As Restated) Treasury Stock Accumulated Deficit (As Restated) Other Comprehensive Income (Loss) Total Stockholders' (Deficit) Equity (As Restated) Balance December 31, 2021 (As Reported) $ 4 $ 396,957 $ (2,814 ) $ (267,029 ) $ — $ 127,118 Effect of Restatement — 34,470 — (59,928) — (25,458 ) Balance December 31, 2021 (As Restated) $ 4 $ 431,427 $ (2,814 ) $ (326,957 ) $ — $ 101,660 Net loss (As Restated) — — — 10,486 — 10,486 Stock-based compensation expense — 918 — — — 918 Shares repurchased as part of the Share Repurchase Program (1 ) — (4,722 ) — — (4,723 ) Issuance of common stock in exchange for consulting services — 50 — — — 50 Balance as of March 31, 2022 (As Restated) $ 3 $ 432,395 $ (7,536 ) $ (316,471 ) $ — $ 108,391 Net loss (As Restated) — — — (21,970 ) — (21,970 ) Stock-based compensation expense — 1,510 — — — 1,510 Issuance of common stock in exchange for consulting services — 50 — — — 50 Issuance of common stock as part of the Employee Stock Purchase Plan — 216 — — — 216 Balance as of June 30, 2022 (As Restated) $ 3 $ 434,171 $ (7,536 ) $ (338,441 ) $ — $ 88,197 Net loss (As Restated) — — — (12,316 ) — (12,316 ) Stock-based compensation expense — 911 — — — 911 Issuance of common stock in exchange for consulting services — 65 — — — 65 Other comprehensive income — — — — 201 201 Balance as of September 30, 2022 (As Restated) $ 3 $ 435,147 $ (7,536 ) $ (350,757 ) $ 201 $ 77,058 Balance December 31, 2022 (As Reported) $ 3 $ 401,799 $ (7,536 ) $ (308,572 ) $ 113 $ 85,807 Effect of Restatement — 34,470 — (45,157 ) — (10,687 ) Balance December 31, 2022 (As Restated) $ 3 $ 436,269 $ (7,536 ) $ (353,729 ) $ 113 $ 75,120 Net loss (As Restated) — — — (13,217 ) — (13,217 ) Stock-based compensation expense — 591 — — — 591 Shares repurchased as part of the Share Repurchase Program — — (3,447 ) — — (3,447 ) Issuance of common stock in exchange for consulting services — 42 — — — 42 Severance expense — 354 — — — 354 Other comprehensive loss — — — — (176 ) (176 ) Balance as of March 31, 2023 (As Restated) $ 3 $ 437,256 $ (10,983 ) $ (366,946 ) $ (63 ) $ 59,267 Net loss (As Restated) — — — (2,573 ) — (2,573 ) Stock-based compensation expense — 1,103 — — — 1,103 Issuance of common stock in exchange for consulting services — 25 — — — 25 Severance expense — 1,048 — — — 1,048 Issuance of common stock as part of the Employee Stock Purchase Plan — 165 — — — 165 Other comprehensive loss — — — — (162 ) (162 ) Balance as of June 30, 2023 (As Restated) $ 3 $ 439,597 $ (10,983 ) $ (369,519 ) $ (225 ) $ 58,873 Net loss (As Restated) — — — (10,367 ) — (10,365 ) Stock-based compensation expense — 1,387 — — — 1,387 Issuance of common stock in connection with the Proposed Merger (Note K) — 11,500 — — — 11,500 Issuance of common stock in exchange for consulting services — 71 — — — 71 Severance expense — 53 — — — 53 Other comprehensive loss — — — — 5 5 Balance as of September 30, 2023 $ 3 $ 452,608 $ (10,983 ) $ (379,886 ) $ (220 ) $ 61,524 |
Note D - Accounts and Other R_2
Note D - Accounts and Other Receivables (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block] | December 31, 2023 2022 Accounts receivable $ 16,119 $ 7,185 Other receivables 1,258 1,114 Total accounts and other receivables $ 17,377 $ 8,299 |
Note E - Prepaid Expenses and_2
Note E - Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | December 31, 2023 2022 Prepaid insurance $ 1,172 $ 577 Other prepaid expenses and current assets 652 1,111 Total prepaid expenses and other current assets $ 1,824 $ 1,688 |
Note F - Property and Equipme_2
Note F - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2023 2022 Laboratory equipment $ 711 $ 710 Furniture and office equipment 157 104 Computers and hardware 643 462 Leasehold improvements 710 710 Finance lease right-of-use assets 149 251 Total property and equipment 2,370 2,237 Less: accumulated depreciation and amortization (1,634 ) (1,443 ) Property and equipment, net $ 736 $ 794 |
Property, Plant and Equipment, Useful Life [Table Text Block] | Useful Life Asset Category (in years) Laboratory equipment 10 Furniture and office equipment 5 - 10 Computers and hardware 3 - 7 Leasehold improvements 9 |
Note G - Accounts Payable and_2
Note G - Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | December 31, 2023 2022 Accrued payroll 10,671 1,673 Accrued professional fees 675 256 Accounts payable 13,987 3,611 Other accrued expenses 3,070 629 Total accounts payable and accrued expenses $ 28,403 $ 6,169 |
Note H - Debt Obligations (Tabl
Note H - Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Long-Term Debt Instruments [Table Text Block] | December 31, 2023 Secured promissory note $ 5,000 Unamortized original issue premium 148 Less: debt issuance costs (82 ) Secured promissory note, net $ 5,066 |
Schedule of Maturities of Long-Term Debt [Table Text Block] | Year Ending December 31, 2023 2024 $ — 2025 1,200 2026 3,800 Total minimum payments 5,000 Plus: unamortized debt premium and debt issuance costs 66 Secured promissory note, net $ 5,066 |
Note J - Stock and Warrants (Ta
Note J - Stock and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block] | December 31, 2023 2022 Outstanding awards under equity incentive plans 8,023,142 2,456,407 Outstanding common stock warrants 5,603,729 4,252,600 Possible future issuances under equity incentive plans 1,728,885 4,421,508 Possible future issuances under employee stock purchase plan 1,340,172 1,417,365 Total common shares reserved for future issuance 16,695,928 12,547,880 |
Schedule of Common Stock Outstanding Roll Forward [Table Text Block] | Shares of Common Stock Balance as of January 1, 2022 35,005,640 Common stock issued as compensation to third-parties 41,821 Common stock repurchased as a result of the Stock Repurchase Program (589,792 ) Common stock issued as a result of the Employee Stock Purchase Plan 82,635 Balance as of December 31, 2022 34,540,304 Common stock issued as compensation to third-parties 44,791 Common stock issued as a result of stock warrants exercised 110 Common stock issued as a result of stock options exercised 7,500 Common stock repurchased as a result of the Stock Repurchase Program (665,739 ) Common stock issued in connection with the Merger (Note R) 7,530,509 Common stock issued as a result of the Employee Stock Purchase Plan 77,193 Balance as of December 31, 2023 41,534,668 |
Note K - Stock-based Compensa_2
Note K - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year ended December 31, 2023 2022 Research and development $ 2,664 $ 1,443 General and administrative 3,290 2,851 Total stock-based compensation expense $ 5,954 $ 4,294 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2023 2022 Risk-free interest rate 3.34% - 4.79% 1.70% - 3.80% Expected term (in years) 5.50 - 10.00 5.50 - 7.00 Expected volatility 89.48% - 93.67% 91.28% - 98.91% Expected dividend yield 0 0 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Weighted Weighted Avg Aggregate Number of Average Remaining Intrinsic Options Exercise Price Contractual Term Value Outstanding balance at January 1, 2023 2,456,407 $ 16.84 8.51 $ 11,819 Granted 5,779,679 $ 4.68 — — Exercised or released 7,500 $ 4.67 — — Canceled or forfeited 205,444 $ 4.70 — $ 122 Expired — — — — Outstanding balance at December 31, 2023 8,023,142 $ 8.40 8.68 $ 11,089 Exercisable at December 31, 2023 2,408,165 $ 16.28 7.81 $ 1,778 Vested and expected to vest at December 31, 2023 6,972,858 $ 8.96 8.62 $ 9,112 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Table Text Block] | Options Outstanding Options Exercisable Weighted Avg Weighted Avg Number of Remaining Number of Remaining Exercise Price Shares Contractual Term Shares Contractual Term $2.848 to $10.00 7,742,171 8.84 2,127,194 8.25 $10.01 to $30.00 69,375 7.17 69,375 7.17 $30.01 to $50.00 68,514 5.11 68,514 5.11 $50.01 to $70.00 41,866 3.08 41,866 3.08 $70.01 to $327.20 101,216 2.70 101,216 2.70 8,023,142 8.68 2,408,165 7.81 |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Number of Unvested Shares December 31, Exercise Price 2023 2022 $2.848 to $10.00 5,614,977 1,824,285 $30.01 to $50.00 — 17,121 Total number of unvested stock options 5,614,977 1,841,406 |
Note L - Fair Value of Financ_2
Note L - Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Quoted Prices Significant in Active Other Significant Balance at Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2023 (Level 1) (Level 2) (Level 3) CVR liability (Note R) $ 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 $ — $ — Quoted Prices Significant in Active Other Significant Balance at Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2022 (Level 1) (Level 2) (Level 3) Warrant liabilities (As Restated) $ 10,202 $ — $ — $ 10,202 Total liabilities $ 10,202 $ — $ — $ 10,202 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 Measurement Inputs and Valuation Techniques [Table Text Block] | December 31, 2023 December 31, 2022 Risk-free interest rate 3.76% - 4.12% 4.01% - 4.12% Volatility 62.01% - 92.42% 98.33% - 103.01% Dividend yield —% —% Expected term (years) 2.0 - 4.9 3.0 - 4.0 Weighted average fair value 2.94 2.94 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Balance at December 31, 2021 (As Restated) $ 25,032 Change in fair value measurement (As Restated) (14,830 ) Balance at December 31, 2022 (As Restated) $ 10,202 Fair value of warrants issued 4,500 Change in fair value measurement 1,398 Balance at December 31, 2023 $ 16,100 |
Note M - Income Taxes (Tables)
Note M - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year ended December 31, 2023 2022 (As Restated) Federal statutory rate 21.00 % 21.00 % Effect of: Change in valuation allowance (23.29 ) (34.77 ) Return to provision and deferred true-up (2.41 ) (5.37 ) Federal research and development credit 4.09 1.82 State research and development credit — 0.12 Change in rate (0.01 ) 0.80 State tax benefit (net of federal) 5.19 4.78 Warrant liability — 12.39 Stock-based compensation (0.20 ) (1.09 ) Global intangible low-taxed income credit (3.41 ) (1.92 ) Foreign research and development excess benefit (0.86 ) 2.17 Other (0.10 ) 0.19 Federal income tax provision effective rate — % 0.12 % |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2023 2022 Deferred tax assets relating to: Net operating loss carryforwards $ 90,743 $ 66,373 Research and development tax carryforward 20,670 6,900 Stock-based compensation 5,154 4,185 174 expenses 30,241 3,730 Right-of-use liability 265 359 Property and equipment 23 22 Other deferred tax assets 1,951 598 Total gross deferred tax assets 149,047 82,167 Deferred tax liabilities relating to: Right-of-use asset 249 (336 ) Intangibles 14,473 — Total gross deferred tax liabilities 14,722 (336 ) Deferred tax assets less liabilities 134,324 81,831 Valuation allowance (134,488 ) (81,831 ) Net deferred tax asset (liability) $ (164 ) $ — |
Note N - Net Loss Per Share (Ta
Note N - Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, 2023 2022 Awards under equity incentive plans 1,728,885 2,456,407 Common stock warrants 5,603,729 4,252,600 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 7,332,614 6,709,007 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | December 31, 2023 2022 (As Restated) Basic and diluted net loss per share of common stock: Net loss, basic and diluted $ (46,049 ) $ (26,772 ) Weighted average number of shares of common stock outstanding, basic and diluted 35,452 34,489 Basic and diluted net loss per share of common stock $ (1.30 ) $ (0.78 ) |
Note O - Leases (Tables)
Note O - Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year Ended December 31, Lease Cost 2023 2022 Finance lease cost: Amortization of right-of-use assets $ 102 $ 129 Interest on lease liabilities — 2 Total finance lease cost 102 131 Operating lease cost 437 418 Short-term lease cost 171 210 Variable lease cost 40 39 Less: sublease income (157 ) (157 ) Total lease costs $ 593 $ 641 |
Schedule of Leases Cash Flow Information [Table Text Block] | Year Ended December 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ — $ 2 Financing cash flows from finance leases 5 16 Operating cash flows from operating leases 552 522 Operating cash flows from short-term leases 171 210 Operating cash flows from variable lease costs 40 39 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases — 123 |
Schedule of Leases Balance Sheet Information [Table Text Block] | December 31, 2023 2022 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (882 ) (780 ) Property and equipment, net $ 149 $ 251 Other current liabilities $ — $ 6 Other long-term liabilities — — Total finance lease liabilities $ — $ 6 Operating Leases Operating lease right-of-use assets $ 790 $ 988 Total operating lease right-of-use assets $ 790 $ 988 Current portion of operating lease liabilities $ 543 $ 480 Operating lease liabilities, less current portion 456 843 Total operating lease liabilities $ 999 $ 1,323 Weighted Average Remaining Lease Term Finance leases (in years) 0 1 Operating leases (in years) 2 3 Weighted Average Discount Rate Finance leases 14.3 % 14.3 % Operating leases 7.6 % 7.3 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, Leases Leases 2024 $ — $ 644 2025 — 389 2026 — 30 Total lease payments — 1,063 Less: future interest expense — (64 ) Lease liabilities $ — $ 999 |
Note R - Merger (Tables)
Note R - Merger (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 4,538 85,022 Liabilities Accounts payable and accrued expenses $ 10,718 Deferred collaboration funding 1,500 Operating lease liabilities 175 12,393 Fair Value of Net Assets Acquired $ 72,629 |
Business Acquisition, Pro Forma Information [Table Text Block] | Year Ended December 31, 2023 Year Ended December 31, 2022 Pro forma revenue $ 27,705 $ 10,458 Pro forma net loss (78,875 ) (80,652 ) |
Schedule of Business Acquisitions by Acquisition, Contingent Consideration [Table Text Block] | Balance at December 31, 2022 $ 0 Initial estimate of contingent consideration at the Effective Time 8,562 Change in fair value recognized in earnings (1,300 ) Balance at December 31, 2023 $ 7,262 |
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 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Feb. 05, 2024 | Oct. 31, 2023 | Aug. 30, 2023 | Dec. 20, 2021 | Jul. 02, 2021 | ||
Net Income (Loss) Attributable to Parent | $ (10,365) | $ (2,573) | $ (13,217) | $ (46,049) | $ (26,772) | ||||||||
Retained Earnings (Accumulated Deficit) | (399,778) | $ (353,729) | |||||||||||
Cash, Cash Equivalents, and Short-Term Investments | 67,700 | ||||||||||||
Sale of Stock, Authorized Amount | $ 350,000 | ||||||||||||
Stock Issued During Period, Value, New Issues | $ 6,106 | ||||||||||||
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 | |||||||||||
Subsequent Event [Member] | |||||||||||||
Common Stock Registered, Shares (in shares) | 2,269,721 | ||||||||||||
Arimoclomol Purchase Agreement [Member] | |||||||||||||
Payments to Acquire Productive Assets, Total | $ 12,800 | ||||||||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | $ 12,200 | $ 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 | |||||||||||
Bridge Loan [Member] | |||||||||||||
Financing Receivable, Maximum Limit | $ 18,000 | $ 18,000 | |||||||||||
[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 | 12 Months Ended | |||
May 15, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Cash | $ 12,800 | |||
Assumed reserve liability | 5,200 | $ 12,200 | $ 9,000 | |
Total consideration | 18,000 | |||
Total consideration | 18,000 | |||
Direct transaction costs associated with the acquisition (1) | [1] | 1,290 | ||
Total purchase price to be allocated | 19,290 | |||
Property and equipment, inventory and assembled workforce acquired | 1,627 | |||
Total allocated purchase price | 19,290 | |||
In Process Research and Development [Member] | ||||
IPR&D (2) | [2] | $ 17,663 | ||
[1]As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees and legal expenses.[2]The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset. |
Note B - Summary of Significa_3
Note B - Summary of Significant Accounting Policies (Details Textual) $ in Thousands | 9 Months Ended | 12 Months Ended | ||||||
May 15, 2022 USD ($) | Mar. 20, 2012 | Sep. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | May 07, 2021 USD ($) | Jul. 31, 2020 USD ($) | |
Investments, Fair Value Disclosure | $ 24,700 | $ 16,900 | ||||||
Unrealized Gain (Loss) on Investments | 600 | (600) | ||||||
Certificates of Deposit, at Carrying Value | 20,500 | |||||||
Noncontrolling Interest in Variable Interest Entity | 0 | |||||||
Goodwill | 4,701 | 0 | ||||||
Goodwill, Impairment Loss | 0 | |||||||
Finite-Lived Intangible Assets, Net | 67,200 | |||||||
Amortization of Intangible Assets | 800 | |||||||
Impairment, Long-Lived Asset, Held-for-Use | 0 | 0 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 27,461 | 10,161 | ||||||
Inventory, Net, Total | 9,841 | $ 671 | ||||||
Income Tax Examination, Penalties and Interest Accrued | $ 0 | |||||||
Income tax returns under examination | 0 | |||||||
Pre-launch Inventory that Qualified for Capitalization [Member] | ||||||||
Inventory, Net, Total | $ 0 | |||||||
Consulting Services [Member] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 200 | |||||||
GPC Member | License [Member] | ||||||||
Impairment, Long-Lived Asset, Held-for-Use | $ 0 | 0 | ||||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | $ 590,000 | |||||||
Aquestive Therapeutics [Member] | ||||||||
Royalty Obligation, Percentage of Regulatory Milestone and Royalty Payments | 10% | |||||||
Aquestive Therapeutics [Member] | License [Member] | ||||||||
Contract with Customer, Liability, Revenue Recognized | $ 15,000 | |||||||
Revenue from Contract with Customer, Including Assessed Tax | 18,000 | 900 | ||||||
Royalty Revenue, Percent | 10% | |||||||
Royalty Expense | 1,800 | 100 | ||||||
Relief Therapeutics [Member] | License [Member] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 0 | |||||||
Maximum Royalty Percentage | 10% | |||||||
Deferred Revenue | $ 0 | |||||||
Corium, Inc [Member] | Consulting Services [Member] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | 4,700 | |||||||
Deferred Revenue | 0 | |||||||
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 Purchase Agreement [Member] | ||||||||
Contract with Customer, Liability, Revenue Recognized | 8,700 | 4,800 | ||||||
Contract with Customer, Clawback Liability | 5,100 | 3,800 | ||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | $ 12,200 | 9,000 | |||||
Minimum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||||||
Maximum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 10 years | |||||||
In Process Research and Development [Member] | ||||||||
Indefinite-Lived Intangible Assets (Excluding Goodwill) | $ 2,000 | 0 | ||||||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 0 | $ 0 |
Note B - Summary of Significa_4
Note B - Summary of Significant Accounting Policies - Amortization of Intangible Assets (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
2024 | $ 6,182 |
2025 | 6,182 |
2026 | 6,182 |
2027 | 6,182 |
2028 | $ 6,182 |
Note B - Summary of Significa_5
Note B - Summary of Significant Accounting Policies - Components of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Raw Materials | $ 2,938 | $ 0 |
Work in progress | 1,884 | 0 |
Finished goods | 5,019 | 671 |
Total inventory | $ 9,841 | $ 671 |
Note C - Restatement of Previ_3
Note C - Restatement of Previously Issued Consolidated Financial Statements (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Retained Earnings (Accumulated Deficit) | $ (399,778) | $ (353,729) | ||||||||||
Derivative and Warrant Liability, Noncurrent | 16,100 | 10,202 | ||||||||||
Fair Value Adjustment of Warrants | 98 | (15,159) | ||||||||||
Nonoperating Income (Expense) | 3,555 | 15,760 | ||||||||||
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ (46,205) | (26,659) | ||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||||||||||
Retained Earnings (Accumulated Deficit) | (59,500) | |||||||||||
Additional Paid in Capital | 34,500 | |||||||||||
Derivative and Warrant Liability, Noncurrent | 10,200 | |||||||||||
Fair Value Adjustment of Warrants | $ (3,678) | $ (2,118) | $ 1,543 | $ 5,577 | $ (2,120) | $ (12,350) | $ (575) | $ (14,470) | $ (4,253) | $ (8,893) | 14,800 | |
Nonoperating Income (Expense) | 3,678 | 2,118 | (1,543) | (5,577) | 2,873 | 12,350 | 575 | 15,223 | 4,253 | 9,646 | 14,800 | |
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | 14,800 | |||||||||||
As Restated [Member] | ||||||||||||
Retained Earnings (Accumulated Deficit) | (379,886) | (369,519) | (366,946) | (350,757) | (338,441) | (316,471) | (369,519) | (338,441) | (379,886) | (350,757) | (353,729) | |
Derivative and Warrant Liability, Noncurrent | 5,948 | 9,624 | 11,747 | 16,174 | 10,619 | 12,771 | 9,624 | 10,619 | 5,948 | 16,174 | 10,202 | |
Fair Value Adjustment of Warrants | (3,678) | (2,118) | 1,545 | 5,555 | (2,152) | (12,591) | (575) | (14,743) | (4,253) | (9,188) | (15,159) | |
Nonoperating Income (Expense) | 5,174 | 3,605 | (489) | (5,600) | 2,883 | 12,341 | 3,116 | 15,224 | 8,290 | 9,624 | 15,760 | |
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | 26,600 | |||||||||||
Previously Reported [Member] | ||||||||||||
Retained Earnings (Accumulated Deficit) | (339,468) | (325,425) | (320,339) | (299,551) | (292,935) | (268,893) | (325,425) | (292,935) | (339,468) | (299,551) | (308,572) | |
Derivative and Warrant Liability, Noncurrent | 0 | 0 | 3 | 35 | 57 | 89 | 0 | 57 | 0 | 35 | 1 | |
Fair Value Adjustment of Warrants | 0 | 0 | 2 | (22) | (32) | (241) | 0 | (273) | 0 | (295) | (328) | |
Nonoperating Income (Expense) | $ 1,496 | $ 1,487 | $ 1,054 | $ (23) | $ 10 | $ (9) | $ 2,541 | $ 1 | $ 4,037 | $ (22) | 176 | |
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ 41,400 |
Note C - Restatement of Previ_4
Note C - Restatement of Previously Issued Consolidated Financial Statements - Revision of Prior Period Balance Sheets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Prepaid expenses and other current assets | $ 1,824 | $ 1,688 | |||||||
Total current assets | 86,938 | 92,834 | |||||||
Total assets | 172,327 | 115,340 | |||||||
Other current liabilities | 2,524 | 719 | |||||||
Total current liabilities | 73,720 | 12,023 | |||||||
Derivative and Warrant Liability, Noncurrent | 16,100 | 10,202 | |||||||
Total liabilities | 110,463 | 40,220 | |||||||
Additional paid-in capital | 472,664 | 436,269 | |||||||
Retained Earnings (Accumulated Deficit) | (399,778) | (353,729) | |||||||
Total stockholder's equity | 61,864 | $ 61,524 | 75,120 | $ 101,660 | |||||
Total liabilities and stockholder's equity | 172,327 | 115,340 | |||||||
Assets | |||||||||
Cash and cash equivalents | 43,049 | 65,466 | |||||||
Securities at fair value | 24,688 | 16,900 | |||||||
Short-term investments - other | 0 | 481 | |||||||
Accounts and other receivables | 17,377 | 8,299 | |||||||
Prepaid expenses and other current assets | 1,824 | 1,688 | |||||||
Total current assets | 86,938 | 92,834 | |||||||
Inventories | 9,841 | 671 | |||||||
Property and equipment, net | 736 | 794 | |||||||
Operating lease right-of-use assets | 790 | 988 | |||||||
Long-term investments - other | 0 | 20,000 | |||||||
Other long-term assets | 94 | 53 | |||||||
Total assets | 172,327 | 115,340 | |||||||
Liabilities and stockholders' equity | |||||||||
Accounts payable and accrued expenses | 28,403 | 6,169 | |||||||
Current portion of operating lease liabilities | 543 | 480 | |||||||
Current portion of discount and rebate liabilities | 4,550 | 4,655 | |||||||
Other current liabilities | 2,524 | 719 | |||||||
Total current liabilities | 73,720 | 12,023 | |||||||
Line of credit payable | 0 | 12,800 | |||||||
Derivative and Warrant Liability, Noncurrent | 16,100 | 10,202 | |||||||
Operating lease liabilities, less current portion | 456 | 843 | |||||||
Discount and rebate liabilities, less current portion | 7,663 | 4,327 | |||||||
Other long-term liabilities | 7,458 | 25 | |||||||
Total liabilities | 110,463 | 40,220 | |||||||
Secured promissory note | 5,066 | 0 | |||||||
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 | 4 | 3 | |||||||
Additional paid-in capital | 472,664 | 436,269 | |||||||
Treasury stock, at cost | (10,983) | (7,536) | |||||||
Retained Earnings (Accumulated Deficit) | (399,778) | (353,729) | |||||||
Accumulated other comprehensive (loss) income | (43) | 113 | |||||||
Total stockholder's equity | 61,864 | 61,524 | 75,120 | 101,660 | |||||
Total liabilities and stockholder's equity | $ 172,327 | 115,340 | |||||||
Previously Reported [Member] | |||||||||
Prepaid expenses and other current assets | 1,661 | $ 2,023 | $ 1,174 | 1,877 | $ 2,659 | $ 3,637 | $ 880 | ||
Total current assets | 137,013 | 103,427 | 104,280 | 93,023 | 85,133 | 87,435 | 105,780 | ||
Total assets | 138,982 | 105,518 | 106,595 | 115,529 | 119,551 | 124,258 | 125,706 | ||
Other current liabilities | 311 | 321 | 302 | 422 | 853 | 1,294 | 7 | ||
Total current liabilities | 21,714 | 18,252 | 15,616 | 11,726 | 8,431 | 7,159 | 2,945 | ||
Derivative and Warrant Liability, Noncurrent | 0 | 0 | 3 | 1 | 35 | 57 | 89 | ||
Total liabilities | 71,512 | 37,021 | 35,191 | 29,722 | 25,757 | 25,025 | 4,207 | ||
Additional paid-in capital | 418,138 | 405,127 | 402,786 | 401,799 | 400,677 | 399,701 | 397,925 | ||
Retained Earnings (Accumulated Deficit) | (339,468) | (325,425) | (320,339) | (308,572) | (299,551) | (292,935) | (268,893) | ||
Total stockholder's equity | 67,470 | 68,497 | 71,404 | 85,807 | 93,794 | 99,233 | 121,499 | 127,118 | |
Total liabilities and stockholder's equity | 138,982 | 105,518 | 106,595 | 115,529 | 119,551 | 124,258 | 125,706 | ||
Assets | |||||||||
Cash and cash equivalents | 43,269 | 66,196 | 40,181 | 70,059 | 76,779 | 100,242 | |||
Securities at fair value | 39,672 | 20,696 | 34,403 | 0 | 0 | 0 | |||
Short-term investments - other | 485 | 479 | 20,700 | 5,832 | 4,199 | 1,338 | |||
Accounts and other receivables | 9,927 | 14,033 | 7,822 | 6,583 | 2,820 | 3,320 | |||
Prepaid expenses and other current assets | 1,661 | 2,023 | 1,174 | 1,877 | 2,659 | 3,637 | 880 | ||
Total current assets | 137,013 | 103,427 | 104,280 | 93,023 | 85,133 | 87,435 | 105,780 | ||
Inventories | 481 | 546 | 620 | 596 | 779 | 0 | |||
Property and equipment, net | 642 | 689 | 744 | 852 | 904 | 835 | |||
Operating lease right-of-use assets | 698 | 803 | 898 | 1,068 | 1,165 | 1,090 | |||
Long-term investments - other | 0 | 0 | 0 | 31,463 | 33,535 | 17,564 | |||
Other long-term assets | 148 | 53 | 53 | 439 | 440 | 437 | |||
Total assets | 138,982 | 105,518 | 106,595 | 115,529 | 119,551 | 124,258 | 125,706 | ||
Secured corporate notes | 41,999 | 0 | |||||||
Liabilities and stockholders' equity | |||||||||
Accounts payable and accrued expenses | 13,080 | 10,510 | 10,098 | 4,279 | 3,600 | 2,582 | |||
Current portion of operating lease liabilities | 433 | 456 | 470 | 474 | 0 | 356 | |||
Current portion of discount and rebate liabilities | 7,890 | 6,965 | 4,746 | 2,825 | 1,796 | 0 | |||
Other current liabilities | 311 | 321 | 302 | 422 | 853 | 1,294 | 7 | ||
Total current liabilities | 21,714 | 18,252 | 15,616 | 11,726 | 8,431 | 7,159 | 2,945 | ||
Line of credit payable | 38,801 | 12,709 | 12,914 | 12,800 | 12,800 | 0 | |||
Derivative and Warrant Liability, Noncurrent | 0 | 0 | 3 | 1 | 35 | 57 | 89 | ||
Operating lease liabilities, less current portion | 517 | 627 | 736 | 956 | 1,082 | 1,144 | |||
Discount and rebate liabilities, less current portion | 4,987 | 5,114 | 5,764 | 3,509 | 3,900 | 0 | |||
Other long-term liabilities | 420 | 319 | 158 | 26 | 27 | 29 | |||
Total liabilities | 71,512 | 37,021 | 35,191 | 29,722 | 25,757 | 25,025 | 4,207 | ||
Current portion of capital lease obligation | 0 | 469 | |||||||
Secured promissory note | 5,073 | 0 | |||||||
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 | 0 | 0 | 0 | 0 | |||
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 | 3 | 3 | 3 | 3 | |||
Additional paid-in capital | 418,138 | 405,127 | 402,786 | 401,799 | 400,677 | 399,701 | 397,925 | ||
Treasury stock, at cost | (10,983) | (10,983) | (10,983) | (7,536) | (7,536) | (7,536) | |||
Retained Earnings (Accumulated Deficit) | (339,468) | (325,425) | (320,339) | (308,572) | (299,551) | (292,935) | (268,893) | ||
Accumulated other comprehensive (loss) income | (220) | (225) | (63) | 201 | 0 | 0 | |||
Total stockholder's equity | 67,470 | 68,497 | 71,404 | 85,807 | 93,794 | 99,233 | 121,499 | 127,118 | |
Total liabilities and stockholder's equity | 138,982 | 105,518 | 106,595 | 115,529 | 119,551 | 124,258 | 125,706 | ||
Revision of Prior Period, Adjustment [Member] | |||||||||
Prepaid expenses and other current assets | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
Total current assets | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
Total assets | (189) | (426) | (426) | (426) | |||||
Other current liabilities | 0 | 0 | 0 | 297 | 0 | 48 | 0 | ||
Total current liabilities | 0 | 0 | 393 | 297 | 171 | 48 | 0 | ||
Derivative and Warrant Liability, Noncurrent | 5,948 | 9,624 | 11,744 | 10,201 | 16,139 | 10,562 | 12,682 | ||
Total liabilities | 5,948 | 9,624 | 12,137 | 10,498 | 16,310 | 10,610 | 12,682 | ||
Additional paid-in capital | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | ||
Retained Earnings (Accumulated Deficit) | (40,418) | (44,094) | (46,607) | (45,157) | (51,206) | (45,506) | (47,578) | ||
Total stockholder's equity | (5,948) | (9,624) | (12,137) | (10,687) | (16,736) | (11,036) | (13,108) | ||
Total liabilities and stockholder's equity | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
Assets | |||||||||
Cash and cash equivalents | 0 | 0 | 0 | 0 | 0 | 0 | |||
Securities at fair value | 0 | 0 | 0 | 0 | 0 | 0 | |||
Short-term investments - other | 0 | 0 | 0 | 0 | 0 | 0 | |||
Accounts and other receivables | 0 | 0 | 0 | 0 | 0 | 0 | |||
Prepaid expenses and other current assets | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
Total current assets | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
Inventories | 0 | 0 | 0 | 0 | 0 | 0 | |||
Property and equipment, net | 0 | 0 | 0 | 0 | 0 | 0 | |||
Operating lease right-of-use assets | 0 | 0 | 0 | 0 | 0 | 0 | |||
Long-term investments - other | 0 | 0 | 0 | 0 | 0 | 0 | |||
Other long-term assets | 0 | 0 | 0 | 0 | 0 | 0 | |||
Total assets | (189) | (426) | (426) | (426) | |||||
Secured corporate notes | 0 | 0 | |||||||
Liabilities and stockholders' equity | |||||||||
Accounts payable and accrued expenses | 0 | 0 | 393 | 0 | 0 | 0 | |||
Current portion of operating lease liabilities | 0 | 0 | 0 | 0 | 0 | 0 | |||
Current portion of discount and rebate liabilities | 0 | 0 | 0 | 171 | 0 | 0 | |||
Other current liabilities | 0 | 0 | 0 | 297 | 0 | 48 | 0 | ||
Total current liabilities | 0 | 0 | 393 | 297 | 171 | 48 | 0 | ||
Line of credit payable | 0 | 0 | 0 | 0 | 0 | 0 | |||
Derivative and Warrant Liability, Noncurrent | 5,948 | 9,624 | 11,744 | 10,201 | 16,139 | 10,562 | 12,682 | ||
Operating lease liabilities, less current portion | 0 | 0 | 0 | 0 | 0 | 0 | |||
Discount and rebate liabilities, less current portion | 0 | 0 | 0 | 0 | 0 | 0 | |||
Other long-term liabilities | 0 | 0 | 0 | 0 | 0 | 0 | |||
Total liabilities | 5,948 | 9,624 | 12,137 | 10,498 | 16,310 | 10,610 | 12,682 | ||
Current portion of capital lease obligation | 0 | 0 | |||||||
Secured promissory note | 0 | 0 | |||||||
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 | 0 | 0 | 0 | 0 | |||
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 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Additional paid-in capital | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | ||
Treasury stock, at cost | 0 | 0 | 0 | 0 | 0 | 0 | |||
Retained Earnings (Accumulated Deficit) | (40,418) | (44,094) | (46,607) | (45,157) | (51,206) | (45,506) | (47,578) | ||
Accumulated other comprehensive (loss) income | 0 | 0 | 0 | 0 | 0 | 0 | |||
Total stockholder's equity | (5,948) | (9,624) | (12,137) | (10,687) | (16,736) | (11,036) | (13,108) | ||
Total liabilities and stockholder's equity | 0 | 0 | 0 | (189) | (426) | (426) | (426) | ||
As Restated [Member] | |||||||||
Prepaid expenses and other current assets | 1,661 | 2,023 | 1,174 | 1,688 | 2,233 | 3,211 | 454 | ||
Total current assets | 137,013 | 103,427 | 104,280 | 92,834 | 84,707 | 87,009 | 105,354 | ||
Total assets | 138,982 | 105,518 | 106,595 | 115,340 | 119,125 | 123,832 | 125,280 | ||
Other current liabilities | 311 | 321 | 302 | 719 | 853 | 1,342 | 7 | ||
Total current liabilities | 21,714 | 18,252 | 16,009 | 12,023 | 8,602 | 7,207 | 2,945 | ||
Derivative and Warrant Liability, Noncurrent | 5,948 | 9,624 | 11,747 | 10,202 | 16,174 | 10,619 | 12,771 | ||
Total liabilities | 77,460 | 46,645 | 47,328 | 40,220 | 42,067 | 35,635 | 16,889 | ||
Additional paid-in capital | 452,608 | 439,597 | 437,256 | 436,269 | 435,147 | 434,171 | 432,395 | ||
Retained Earnings (Accumulated Deficit) | (379,886) | (369,519) | (366,946) | (353,729) | (350,757) | (338,441) | (316,471) | ||
Total stockholder's equity | 61,522 | 58,873 | 59,267 | 75,120 | 77,058 | 88,197 | 108,391 | 101,660 | |
Total liabilities and stockholder's equity | 138,982 | 105,518 | 106,595 | 115,340 | 119,125 | 123,832 | 125,280 | ||
Assets | |||||||||
Cash and cash equivalents | 43,269 | 66,196 | 40,181 | 70,059 | 76,779 | 100,242 | |||
Securities at fair value | 39,672 | 20,696 | 34,403 | 0 | 0 | 0 | |||
Short-term investments - other | 485 | 479 | 20,700 | 5,832 | 4,199 | 1,338 | |||
Accounts and other receivables | 9,927 | 14,033 | 7,822 | 6,583 | 2,820 | 3,320 | |||
Prepaid expenses and other current assets | 1,661 | 2,023 | 1,174 | 1,688 | 2,233 | 3,211 | 454 | ||
Total current assets | 137,013 | 103,427 | 104,280 | 92,834 | 84,707 | 87,009 | 105,354 | ||
Inventories | 481 | 546 | 620 | 596 | 779 | 0 | |||
Property and equipment, net | 642 | 689 | 744 | 852 | 904 | 835 | |||
Operating lease right-of-use assets | 698 | 803 | 898 | 1,068 | 1,165 | 1,090 | |||
Long-term investments - other | 0 | 0 | 0 | 31,463 | 33,535 | 17,564 | |||
Other long-term assets | 148 | 53 | 53 | 439 | 440 | 437 | |||
Total assets | 138,982 | 105,518 | 106,595 | 115,340 | 119,125 | 123,832 | 125,280 | ||
Secured corporate notes | 41,999 | 0 | |||||||
Liabilities and stockholders' equity | |||||||||
Accounts payable and accrued expenses | 13,080 | 10,510 | 10,491 | 4,279 | 3,600 | 2,582 | |||
Current portion of operating lease liabilities | 433 | 456 | 470 | 474 | 0 | 356 | |||
Current portion of discount and rebate liabilities | 7,890 | 6,965 | 4,746 | 2,996 | 1,796 | 0 | |||
Other current liabilities | 311 | 321 | 302 | 719 | 853 | 1,342 | 7 | ||
Total current liabilities | 21,714 | 18,252 | 16,009 | 12,023 | 8,602 | 7,207 | 2,945 | ||
Line of credit payable | 38,801 | 12,709 | 12,914 | 12,800 | 12,800 | 0 | |||
Derivative and Warrant Liability, Noncurrent | 5,948 | 9,624 | 11,747 | 10,202 | 16,174 | 10,619 | 12,771 | ||
Operating lease liabilities, less current portion | 517 | 627 | 736 | 956 | 1,082 | 1,144 | |||
Discount and rebate liabilities, less current portion | 4,987 | 5,114 | 5,764 | 3,509 | 3,900 | 0 | |||
Other long-term liabilities | 420 | 319 | 158 | 26 | 27 | 29 | |||
Total liabilities | 77,460 | 46,645 | 47,328 | 40,220 | 42,067 | 35,635 | 16,889 | ||
Current portion of capital lease obligation | 0 | 469 | |||||||
Secured promissory note | 5,073 | 0 | |||||||
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 | 0 | 0 | 0 | 0 | |||
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 | 3 | 3 | 3 | 3 | |||
Additional paid-in capital | 452,608 | 439,597 | 437,256 | 436,269 | 435,147 | 434,171 | 432,395 | ||
Treasury stock, at cost | (10,983) | (10,983) | (10,983) | (7,536) | (7,536) | (7,536) | |||
Retained Earnings (Accumulated Deficit) | (379,886) | (369,519) | (366,946) | (353,729) | (350,757) | (338,441) | (316,471) | ||
Accumulated other comprehensive (loss) income | (220) | (225) | (63) | 201 | 0 | 0 | |||
Total stockholder's equity | 61,522 | 58,873 | 59,267 | 75,120 | 77,058 | 88,197 | 108,391 | $ 101,660 | |
Total liabilities and stockholder's equity | $ 138,982 | $ 105,518 | $ 106,595 | $ 115,340 | $ 119,125 | $ 123,832 | $ 125,280 |
Note C - Restatement of Previ_5
Note C - Restatement of Previously Issued Consolidated Financial Statements - Revision of Prior Period Balance Sheets (Details) (Parentheticals) - $ / shares | Dec. 31, 2023 | Nov. 30, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 | |||||
Common stock, shares issued (in shares) | 43,110,360 | 35,450,257 | |||||
Common stock, shares outstanding (in shares) | 41,534,668 | 34,540,304 | 35,005,640 | ||||
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 | |||||
As Restated [Member] | |||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | |||
Common stock, shares issued (in shares) | 37,787,402 | 35,503,697 | 35,457,496 | 35,450,257 | |||
Common stock, shares outstanding (in shares) | 36,211,710 | 33,928,005 | 33,881,804 | 34,540,304 | |||
As Restated [Member] | Undesignated Preferred Stock [Member] | |||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | 0 | |||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 |
Note C - Restatement of Previ_6
Note C - Restatement of Previously Issued Consolidated Financial Statements - Revision of Prior Period Statement of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 27,461 | $ 10,161 | ||||||||||
Cost of revenue | 2,945 | 222 | ||||||||||
Research and development | 39,806 | 19,803 | ||||||||||
Selling, general and administrative | 34,314 | 15,038 | ||||||||||
Total operating expenses | 77,065 | 52,726 | ||||||||||
Loss from operations | (49,604) | (42,565) | ||||||||||
Fair value adjustment related to derivative and warrant liability | (98) | 15,159 | ||||||||||
Interest and other income, net | 4,541 | 1,513 | ||||||||||
Nonoperating Income (Expense) | 3,555 | 15,760 | ||||||||||
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | (46,049) | (26,805) | ||||||||||
Income tax (expense) benefit | 0 | 33 | ||||||||||
Net Income (Loss) Attributable to Parent | $ (10,365) | $ (2,573) | $ (13,217) | $ (46,049) | $ (26,772) | |||||||
Net loss (in dollars per share) | $ (1.3) | $ (0.78) | ||||||||||
Interest expense | $ (1,501) | $ (335) | ||||||||||
Fair value adjustment related to investments | $ 613 | $ (577) | ||||||||||
Basic and diluted (in shares) | 35,452,460 | 34,488,800 | ||||||||||
Previously Reported [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 2,895 | 8,470 | 2,879 | $ 2,874 | $ 1,300 | $ 3,965 | $ 11,349 | $ 5,265 | $ 14,244 | $ 8,139 | $ 10,458 | |
Cost of revenue | 144 | 677 | 125 | 141 | 51 | 8 | 802 | 59 | 946 | 200 | 343 | |
Research and development | 12,297 | 7,433 | 8,844 | 5,385 | 4,795 | 3,082 | 16,277 | 7,877 | 28,574 | 13,262 | 19,614 | |
Selling, general and administrative | 5,818 | 7,005 | 6,834 | 3,974 | 3,558 | 2,734 | 13,839 | 6,292 | 19,657 | 10,266 | 15,343 | |
Total operating expenses | 18,259 | 15,115 | 15,803 | 9,500 | 26,067 | 5,824 | 30,918 | 31,891 | 49,177 | 41,391 | 52,963 | |
Loss from operations | (15,364) | (6,645) | (12,924) | (6,626) | (24,767) | (1,859) | (19,569) | (26,626) | (34,933) | (33,252) | (42,505) | |
Fair value adjustment related to derivative and warrant liability | 0 | 0 | (2) | 22 | 32 | 241 | 0 | 273 | 0 | 295 | 328 | |
Interest and other income, net | 1,738 | 1,553 | 1,042 | 218 | 366 | 107 | 2,593 | 264 | 4,331 | 482 | 760 | |
Nonoperating Income (Expense) | 1,496 | 1,487 | 1,054 | (23) | 10 | (9) | 2,541 | 1 | 4,037 | (22) | 176 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | (13,868) | (5,158) | (11,870) | (6,649) | (24,757) | (1,868) | (17,028) | (26,625) | (30,896) | (33,274) | (42,329) | |
Income tax (expense) benefit | (177) | 74 | 103 | 33 | 715 | 4 | 177 | 719 | 0 | 752 | 786 | |
Net Income (Loss) Attributable to Parent | $ (14,045) | $ (5,084) | $ (11,767) | $ (6,616) | $ (24,042) | $ (1,864) | $ (16,851) | $ (25,906) | $ (30,896) | $ (32,522) | $ (41,543) | |
Net loss (in dollars per share) | $ (0.4) | $ (0.15) | $ (0.34) | $ (0.19) | $ (0.7) | $ (0.05) | $ (0.49) | $ (0.75) | $ (0.9) | $ (0.94) | $ (1.2) | |
Acquired In-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 17,663 | ||
Severance expense | 0 | 0 | ||||||||||
Interest expense | (366) | (197) | (182) | (124) | (36) | (5) | (379) | (41) | (745) | (165) | ||
Fair value adjustment related to investments | $ 124 | $ 131 | $ 196 | $ (139) | $ (352) | $ (352) | $ 327 | $ (495) | $ 451 | $ (634) | ||
Basic and diluted (in shares) | 34,724,614 | 33,898,233 | 34,466,542 | 34,494,702 | 34,447,206 | 34,506,597 | 34,180,818 | 34,476,737 | 34,364,075 | 34,482,791 | ||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 17,663 | ||
Revision of Prior Period, Adjustment [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ (297) | |||||||||||
Cost of revenue | (121) | |||||||||||
Research and development | 189 | |||||||||||
Selling, general and administrative | (305) | |||||||||||
Total operating expenses | (237) | |||||||||||
Loss from operations | (60) | |||||||||||
Fair value adjustment related to derivative and warrant liability | 14,831 | |||||||||||
Interest and other income, net | 753 | |||||||||||
Nonoperating Income (Expense) | 15,584 | |||||||||||
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | 15,524 | |||||||||||
Income tax (expense) benefit | (753) | |||||||||||
Net Income (Loss) Attributable to Parent | $ 14,771 | |||||||||||
Net loss (in dollars per share) | $ 0.42 | |||||||||||
As Restated [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 2,895 | 8,470 | 3,176 | 2,751 | 1,252 | 3,965 | 11,646 | 5,217 | 14,541 | 7,968 | $ 10,161 | |
Cost of revenue | 144 | 677 | 125 | 91 | 31 | 8 | 802 | 39 | 946 | 130 | 222 | |
Research and development | 12,297 | 7,433 | 8,655 | 5,385 | 4,795 | 3,082 | 16,088 | 7,877 | 28,385 | 13,262 | 19,803 | |
Selling, general and administrative | 5,818 | 6,612 | 7,227 | 4,024 | 3,578 | 2,734 | 13,839 | 6,312 | 19,657 | 10,336 | 15,038 | |
Total operating expenses | 18,259 | 14,722 | 16,007 | 9,500 | 26,067 | 5,824 | 30,729 | 31,891 | 48,988 | 41,391 | 52,726 | |
Loss from operations | (15,364) | (6,252) | (12,831) | (6,749) | (24,815) | (1,859) | (19,083) | (26,674) | (34,447) | (33,423) | (42,565) | |
Fair value adjustment related to derivative and warrant liability | 3,678 | 2,118 | (1,545) | (5,555) | 2,152 | 12,591 | 575 | 14,743 | 4,253 | 9,188 | 15,159 | |
Interest and other income, net | 1,738 | 1,553 | 1,042 | 218 | 1,119 | 107 | 2,593 | 1,017 | 4,331 | 1,235 | 1,513 | |
Nonoperating Income (Expense) | 5,174 | 3,605 | (489) | (5,600) | 2,883 | 12,341 | 3,116 | 15,224 | 8,290 | 9,624 | 15,760 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | (10,190) | (2,647) | (13,320) | (12,349) | (21,932) | 10,482 | (15,967) | (11,450) | (26,157) | (23,799) | (26,805) | |
Income tax (expense) benefit | (177) | 74 | 103 | 33 | (38) | 4 | 177 | (34) | 0 | (1) | 33 | |
Net Income (Loss) Attributable to Parent | $ (10,367) | $ (2,573) | $ (13,217) | $ (12,316) | $ (21,970) | $ 10,486 | $ (15,790) | $ (11,484) | $ (26,157) | $ (23,800) | $ (26,772) | |
Net loss (in dollars per share) | $ (0.3) | $ (0.08) | $ (0.38) | $ (0.36) | $ (0.64) | $ 0.3 | $ (0.46) | $ (0.33) | $ (0.76) | $ (0.69) | $ (0.78) | |
Acquired In-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 17,663 | ||
Severance expense | 0 | 0 | ||||||||||
Interest expense | (366) | (197) | (182) | (124) | (36) | (5) | (379) | (41) | (745) | (165) | ||
Fair value adjustment related to investments | $ 124 | $ 131 | $ 196 | $ (139) | $ (352) | $ (352) | $ 327 | $ (495) | $ 451 | $ (634) | ||
Basic and diluted (in shares) | 34,724,614 | 33,898,233 | 34,466,542 | 34,494,702 | 34,447,206 | 34,506,597 | 34,180,818 | 34,476,737 | 34,364,075 | 34,482,791 | ||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 0 | $ 17,663 | $ 0 | $ 17,663 | ||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 297 | (123) | (48) | 0 | 297 | (48) | 297 | (171) | ||
Cost of revenue | 0 | 0 | 0 | (50) | (20) | 0 | 0 | (20) | 0 | (70) | ||
Research and development | 0 | 0 | (189) | 0 | 0 | 0 | (189) | 0 | (189) | 0 | ||
Selling, general and administrative | 0 | (393) | 393 | 50 | 20 | 0 | 0 | 20 | 0 | 70 | ||
Total operating expenses | 0 | (393) | 204 | 0 | 0 | 0 | (189) | 0 | (189) | 0 | ||
Loss from operations | 0 | (393) | 93 | (123) | (48) | 0 | 486 | (48) | 486 | (171) | ||
Fair value adjustment related to derivative and warrant liability | 3,678 | 2,118 | (1,543) | (5,577) | 2,120 | 12,350 | 575 | 14,470 | 4,253 | 8,893 | $ (14,800) | |
Interest and other income, net | 0 | 0 | 0 | 0 | 753 | 0 | 0 | 753 | 0 | 753 | ||
Nonoperating Income (Expense) | 3,678 | 2,118 | (1,543) | (5,577) | 2,873 | 12,350 | 575 | 15,223 | 4,253 | 9,646 | $ 14,800 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | 3,678 | 2,511 | (1,450) | (5,700) | 2,825 | 12,350 | 1,061 | 15,175 | 4,739 | 9,475 | ||
Income tax (expense) benefit | 0 | 0 | 0 | (753) | 0 | 0 | (753) | (753) | ||||
Net Income (Loss) Attributable to Parent | $ 3,678 | $ 2,511 | $ (1,450) | $ (5,700) | $ 2,072 | $ 12,350 | $ 1,061 | $ 14,422 | $ 4,739 | $ 8,722 | ||
Net loss (in dollars per share) | $ 0.1 | $ 0.07 | $ (0.04) | $ (0.17) | $ 0.06 | $ 0.35 | $ 0.03 | $ 0.42 | $ 0.14 | $ 0.25 | ||
Acquired In-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||
Severance expense | 0 | 0 | ||||||||||
Interest expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Fair value adjustment related to investments | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||
Basic and diluted (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Note C - Restatement of Previ_7
Note C - Restatement of Previously Issued Consolidated Financial Statements - Revision of Prior Period Statement of Cash Flows (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Net Income (Loss) Attributable to Parent | $ (10,365,000) | $ (2,573,000) | $ (13,217,000) | $ (46,049,000) | $ (26,772,000) | |||||||
Fair Value Adjustment of Warrants | 98,000 | (15,159,000) | ||||||||||
Change in assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | 152,000 | (894,000) | ||||||||||
Net income (loss) | (5,000) | 386,000 | ||||||||||
Stock-based compensation expense | 5,954,000 | 4,294,000 | ||||||||||
Depreciation and amortization expense | 1,006,000 | 944,000 | ||||||||||
Fair value adjustment related to derivative and warrant liability and CVR liability | 98,000 | (15,159,000) | ||||||||||
Fair value adjustment related to investments | (613,000) | 577,000 | ||||||||||
Consulting fees paid in common stock | 227,000 | 224,000 | ||||||||||
Gain on foreign currency exchange rates | (198,000) | (91,000) | ||||||||||
Accounts and other receivables | (9,078,000) | (6,772,000) | ||||||||||
Inventories | 206,000 | 147,000 | ||||||||||
Operating lease right-of-use assets | 326,000 | 277,000 | ||||||||||
Accounts payable and accrued expenses | 11,130,000 | 3,131,000 | ||||||||||
Discount and rebate liabilities | 3,231,000 | 3,782,000 | ||||||||||
Operating lease liabilities | (439,000) | (389,000) | ||||||||||
Other liabilities | 360,000 | (74,000) | ||||||||||
Net cash used in operating activities | (33,535,000) | (18,717,000) | ||||||||||
Purchases of property and equipment | (296,000) | (93,000) | ||||||||||
Purchases of investments | (45,814,000) | (23,861,000) | ||||||||||
Net cash used in investing activities | (17,390,000) | (36,719,000) | ||||||||||
Proceeds from issuance of debt | 42,431,000 | 12,800,000 | ||||||||||
Payments of principal on insurance financing arrangements | (564,000) | (1,306,000) | ||||||||||
Repayment of debt | (17,531,000) | 0 | ||||||||||
Payment to repurchase shares as part of the Share Repurchase Program | (3,447,000) | (4,723,000) | ||||||||||
Repayment of principal on finance lease liabilities | (5,000) | (16,000) | ||||||||||
Net cash provided by financing activities | 28,464,000 | 8,352,000 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | 44,000 | 204,000 | ||||||||||
Net decrease in cash and cash equivalents | (22,417,000) | (46,880,000) | ||||||||||
Cash and cash equivalents, beginning of period | 65,466,000 | $ 112,346,000 | $ 65,466,000 | $ 112,346,000 | $ 65,466,000 | $ 112,346,000 | 65,466,000 | 112,346,000 | ||||
Cash and cash equivalents, end of period | 43,049,000 | 65,466,000 | ||||||||||
Cash paid for interest | 456,000 | 321,000 | ||||||||||
Net Income (Loss) Attributable to Parent | (10,365,000) | (2,573,000) | (13,217,000) | (46,049,000) | (26,772,000) | |||||||
Loss on sublease and disposal of property and equipment | 157,000 | 9,000 | ||||||||||
Acquisitions, net | (30,401,000) | (14,090,000) | ||||||||||
Maturities of long-term investments, net | 59,121,000 | 1,325,000 | ||||||||||
Proceeds from insurance financing arrangements | 1,256,000 | 1,273,000 | ||||||||||
Proceeds from Employee Stock Purchase Plan | 218,000 | 324,000 | ||||||||||
Issuance of common stock in connection with the Merger (Note K) | (28,390,000) | 0 | ||||||||||
Issuance of secured promissory note for the Merger (Note K) | (5,066,000) | 0 | ||||||||||
Previously Reported [Member] | ||||||||||||
Net Income (Loss) Attributable to Parent | (14,045,000) | (5,084,000) | (11,767,000) | $ (6,616,000) | $ (24,042,000) | (1,864,000) | (16,851,000) | (25,906,000) | (30,896,000) | (32,522,000) | (41,543,000) | |
Fair Value Adjustment of Warrants | 0 | 0 | 2,000 | (22,000) | (32,000) | (241,000) | 0 | (273,000) | 0 | (295,000) | (328,000) | |
Change in assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | 703,000 | 303,000 | (146,000) | (1,892,000) | 216,000 | (1,196,000) | (657,000) | |||||
Other liabilities | (371,000) | |||||||||||
Net income (loss) | (11,767,000) | (1,864,000) | (93,000) | 0 | ||||||||
Stock-based compensation expense | 591,000 | 918,000 | 1,694,000 | 2,428,000 | 3,081,000 | 3,339,000 | ||||||
Severance expense | 354,000 | 0 | 1,402,000 | 0 | 1,401,000 | 0 | ||||||
Depreciation and amortization expense | 79,000 | 65,000 | 157,000 | 246,000 | 219,000 | 644,000 | ||||||
Fair value adjustment related to derivative and warrant liability and CVR liability | 2,000 | (241,000) | 0 | (273,000) | 0 | (295,000) | ||||||
Fair value adjustment related to investments | (124,000) | (131,000) | (196,000) | 139,000 | 352,000 | 352,000 | (327,000) | 495,000 | (451,000) | 634,000 | ||
Consulting fees paid in common stock | 42,000 | 50,000 | 67,000 | 100,000 | 138,000 | 165,000 | ||||||
Gain on foreign currency exchange rates | (240,000) | 0 | (138,000) | 0 | (30,000) | 0 | ||||||
Accounts and other receivables | 477,000 | (1,792,000) | (5,734,000) | (1,292,000) | (1,628,000) | (4,646,000) | ||||||
Inventories | 51,000 | 0 | 125,000 | 39,000 | 190,000 | 280,000 | ||||||
Operating lease right-of-use assets | 80,000 | 51,000 | 161,000 | (24,000) | 243,000 | 82,000 | ||||||
Accounts payable and accrued expenses | 3,929,000 | (486,000) | 3,338,000 | 630,000 | 5,791,000 | 1,262,000 | ||||||
Discount and rebate liabilities | 1,528,000 | 0 | 3,097,000 | 496,000 | 3,895,000 | 858,000 | ||||||
Operating lease liabilities | (107,000) | (88,000) | (216,000) | (37,000) | (326,000) | (160,000) | ||||||
Other liabilities | 429,000 | (821,000) | 622,000 | (339,000) | 716,000 | (372,000) | ||||||
Net cash used in operating activities | (4,045,000) | (3,553,000) | (12,749,000) | (7,657,000) | (17,377,000) | (14,255,000) | ||||||
Purchases of property and equipment | (29,000) | (16,000) | (52,000) | (31,000) | (224,000) | (59,000) | ||||||
Purchases of investments | (17,526,000) | (3,832,000) | (17,467,000) | (23,832,000) | (45,821,000) | (23,832,000) | ||||||
Net cash used in investing activities | (17,555,000) | (3,848,000) | 16,481,000 | (36,928,000) | (27,975,000) | (36,656,000) | ||||||
Proceeds from issuance of debt | 12,914,000 | 0 | 12,800,000 | 12,800,000 | 38,801,000 | 12,800,000 | ||||||
Payments of principal on insurance financing arrangements | (415,000) | 0 | (564,000) | (469,000) | (564,000) | (876,000) | ||||||
Repayment of debt | (12,800,000) | 0 | (13,007,000) | 0 | (12,800,000) | 0 | ||||||
Payment to repurchase shares as part of the Share Repurchase Program | (3,447,000) | (4,723,000) | (3,447,000) | (4,723,000) | (3,447,000) | (4,723,000) | ||||||
Repayment of principal on finance lease liabilities | (2,000) | (10,000) | (3,000) | (11,000) | (5,000) | (13,000) | ||||||
Net cash provided by financing activities | (3,750,000) | (4,733,000) | (2,799,000) | 9,018,000 | 23,460,000 | 8,609,000 | ||||||
Effect of exchange rate changes on cash and cash equivalents | 65,000 | 0 | (203,000) | 0 | (305,000) | 15,000 | ||||||
Net decrease in cash and cash equivalents | (25,285,000) | (12,134,000) | 730,000 | (35,567,000) | (22,197,000) | (42,287,000) | ||||||
Cash and cash equivalents, beginning of period | 66,196,000 | 40,181,000 | 65,466,000 | 76,779,000 | 100,212,000 | 112,346,000 | 65,466,000 | 112,346,000 | 65,466,000 | 112,346,000 | 65,466,000 | 112,346,000 |
Cash and cash equivalents, end of period | 43,269,000 | 66,196,000 | 40,181,000 | 70,059,000 | 76,779,000 | 100,212,000 | 66,196,000 | 76,779,000 | 43,269,000 | 70,059,000 | 65,466,000 | |
Cash paid for interest | 68,000 | 5,000 | 261,000 | 41,000 | 456,000 | 165,000 | ||||||
Net Income (Loss) Attributable to Parent | (14,045,000) | (5,084,000) | (11,767,000) | (6,616,000) | (24,042,000) | (1,864,000) | (16,851,000) | (25,906,000) | (30,896,000) | (32,522,000) | (41,543,000) | |
Severance expense | 354,000 | 0 | 1,402,000 | 0 | 1,401,000 | 0 | ||||||
Loss on sublease and disposal of property and equipment | 0 | 9,000 | 157,000 | 9,000 | ||||||||
Acquired in-process research and development | 0 | 0 | 0 | 0 | 17,663,000 | 0 | 0 | 17,663,000 | 0 | 17,663,000 | ||
Acquisitions, net | 0 | (14,090) | 0 | (14,090,000) | ||||||||
Maturities of long-term investments, net | 34,000,000 | 1,025,000 | 43,496,000 | 1,325,000 | ||||||||
Proceeds from insurance financing arrangements | 1,256,000 | 1,273,000 | 1,256,000 | 1,273,000 | ||||||||
Proceeds from Employee Stock Purchase Plan | 166,000 | 216,000 | 219,000 | 216,000 | ||||||||
Purchases of Secured corporate notes | (25,426,000) | 0 | ||||||||||
Issuance of common stock in connection with the Merger (Note K) | (11,500,000) | 0 | ||||||||||
Issuance of secured promissory note for the Merger (Note K) | (5,073,000) | 0 | ||||||||||
Revision of Prior Period, Adjustment [Member] | ||||||||||||
Net Income (Loss) Attributable to Parent | 14,771,000 | |||||||||||
Fair Value Adjustment of Warrants | (14,831,000) | |||||||||||
Change in assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | (237,000) | |||||||||||
Other liabilities | 297,000 | |||||||||||
Net Income (Loss) Attributable to Parent | 14,771,000 | |||||||||||
As Restated [Member] | ||||||||||||
Net Income (Loss) Attributable to Parent | (10,367,000) | (2,573,000) | (13,217,000) | (12,316,000) | (21,970,000) | 10,486,000 | (15,790,000) | (11,484,000) | (26,157,000) | (23,800,000) | (26,772,000) | |
Fair Value Adjustment of Warrants | (3,678,000) | (2,118,000) | 1,545,000 | 5,555,000 | (2,152,000) | (12,591,000) | (575,000) | (14,743,000) | (4,253,000) | (9,188,000) | (15,159,000) | |
Change in assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | 703,000 | 303,000 | (335,000) | (1,892,000) | 27,000 | (1,196,000) | (894,000) | |||||
Other liabilities | (74,000) | |||||||||||
Net income (loss) | (13,217,000) | 10,486,000 | (93,000) | 0 | ||||||||
Stock-based compensation expense | 591,000 | 918,000 | 1,694,000 | 2,428,000 | 3,081,000 | 3,339,000 | ||||||
Severance expense | 354,000 | 0 | 1,402,000 | 0 | 1,401,000 | 0 | ||||||
Depreciation and amortization expense | 79,000 | 65,000 | 157,000 | 246,000 | 219,000 | 644,000 | ||||||
Fair value adjustment related to derivative and warrant liability and CVR liability | 1,545,000 | (12,591,000) | (481,000) | (14,743,000) | (4,159,000) | (9,188,000) | ||||||
Fair value adjustment related to investments | (124,000) | (131,000) | (196,000) | 139,000 | 352,000 | 352,000 | (327,000) | 495,000 | (451,000) | 634,000 | ||
Consulting fees paid in common stock | 42,000 | 50,000 | 67,000 | 100,000 | 138,000 | 165,000 | ||||||
Gain on foreign currency exchange rates | (240,000) | 0 | (138,000) | 0 | (30,000) | 0 | ||||||
Accounts and other receivables | 477,000 | (1,792,000) | (5,734,000) | (1,292,000) | (1,628,000) | (4,646,000) | ||||||
Inventories | 51,000 | 0 | 125,000 | 39,000 | 190,000 | 280,000 | ||||||
Operating lease right-of-use assets | 80,000 | 51,000 | 161,000 | (24,000) | 243,000 | 82,000 | ||||||
Accounts payable and accrued expenses | 3,836,000 | (486,000) | 2,947,000 | 630,000 | 5,400,000 | 1,262,000 | ||||||
Discount and rebate liabilities | 1,528,000 | 0 | 3,097,000 | 496,000 | 3,895,000 | 858,000 | ||||||
Operating lease liabilities | (107,000) | (88,000) | (216,000) | (37,000) | (326,000) | (160,000) | ||||||
Other liabilities | 429,000 | (821,000) | 622,000 | (291,000) | 716,000 | (201,000) | ||||||
Net cash used in operating activities | (4,045,000) | (3,553,000) | (12,749,000) | (7,657,000) | (17,377,000) | (14,255,000) | ||||||
Purchases of property and equipment | (29,000) | (16,000) | (52,000) | (31,000) | (224,000) | (59,000) | ||||||
Purchases of investments | (17,526,000) | (3,832,000) | (17,467,000) | (23,832,000) | (45,821,000) | (23,832,000) | ||||||
Net cash used in investing activities | (17,555,000) | (3,848,000) | 16,481,000 | (36,928,000) | (27,975,000) | (36,656,000) | ||||||
Proceeds from issuance of debt | 12,914,000 | 0 | 12,800,000 | 12,800,000 | 38,801,000 | 12,800,000 | ||||||
Payments of principal on insurance financing arrangements | (415,000) | 0 | (564,000) | (469,000) | (564,000) | (876,000) | ||||||
Repayment of debt | (12,800,000) | 0 | (13,007,000) | 0 | (12,800,000) | 0 | ||||||
Payment to repurchase shares as part of the Share Repurchase Program | (3,447,000) | (4,723,000) | (3,447,000) | (4,723,000) | (3,447,000) | (4,723,000) | ||||||
Repayment of principal on finance lease liabilities | (2,000) | (10,000) | (3,000) | (11,000) | (5,000) | (13,000) | ||||||
Net cash provided by financing activities | (3,750,000) | (4,733,000) | (2,799,000) | 9,086,000 | 23,460,000 | 8,677,000 | ||||||
Effect of exchange rate changes on cash and cash equivalents | 65,000 | 0 | (203,000) | 0 | (305,000) | 15,000 | ||||||
Net decrease in cash and cash equivalents | (25,285,000) | (12,134,000) | 730,000 | (35,499,000) | (22,197,000) | (42,219,000) | ||||||
Cash and cash equivalents, beginning of period | 66,196,000 | 40,181,000 | 65,466,000 | 76,847,000 | 100,212,000 | 112,346,000 | 65,466,000 | 112,346,000 | 65,466,000 | 112,346,000 | 65,466,000 | 112,346,000 |
Cash and cash equivalents, end of period | 43,269,000 | 66,196,000 | 40,181,000 | 70,127,000 | 76,847,000 | 100,212,000 | 66,196,000 | 76,847,000 | 43,269,000 | 70,127,000 | 65,466,000 | |
Cash paid for interest | 68,000 | 5,000 | 261,000 | 41,000 | 456,000 | 165,000 | ||||||
Net Income (Loss) Attributable to Parent | (10,367,000) | (2,573,000) | (13,217,000) | (12,316,000) | (21,970,000) | 10,486,000 | (15,790,000) | (11,484,000) | (26,157,000) | (23,800,000) | (26,772,000) | |
Severance expense | 354,000 | 0 | 1,402,000 | 0 | 1,401,000 | 0 | ||||||
Loss on sublease and disposal of property and equipment | 0 | 9,000 | 157,000 | 9,000 | ||||||||
Acquired in-process research and development | 0 | 0 | 0 | 0 | 17,663,000 | 0 | 0 | 17,663,000 | 0 | 17,663,000 | ||
Acquisitions, net | 0 | (14,090) | 0 | (14,090,000) | ||||||||
Maturities of long-term investments, net | 34,000,000 | 1,025,000 | 43,496,000 | 1,325,000 | ||||||||
Proceeds from insurance financing arrangements | 1,256,000 | 1,273,000 | 1,256,000 | 1,273,000 | ||||||||
Proceeds from Employee Stock Purchase Plan | 166,000 | 216,000 | 219,000 | 216,000 | ||||||||
Purchases of Secured corporate notes | (25,426,000) | 0 | ||||||||||
Issuance of common stock in connection with the Merger (Note K) | (11,500,000) | 0 | ||||||||||
Issuance of secured promissory note for the Merger (Note K) | (5,073,000) | 0 | ||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||||||||||
Net Income (Loss) Attributable to Parent | 3,678,000 | 2,511,000 | (1,450,000) | (5,700,000) | 2,072,000 | 12,350,000 | 1,061,000 | 14,422,000 | 4,739,000 | 8,722,000 | ||
Fair Value Adjustment of Warrants | (3,678,000) | (2,118,000) | 1,543,000 | 5,577,000 | (2,120,000) | (12,350,000) | (575,000) | (14,470,000) | (4,253,000) | (8,893,000) | 14,800,000 | |
Change in assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | (189,000) | 0 | (189,000) | 0 | ||||||||
Fair value adjustment related to derivative and warrant liability and CVR liability | 1,543,000 | (12,350,000) | (481,000) | (14,470,000) | (4,159,000) | (8,893,000) | ||||||
Fair value adjustment related to investments | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Accounts payable and accrued expenses | (93,000) | 0 | ||||||||||
Purchases of investments | 0 | |||||||||||
Net cash used in investing activities | 0 | 0 | ||||||||||
Proceeds from issuance of debt | 0 | 0 | ||||||||||
Payments of principal on insurance financing arrangements | 0 | 0 | ||||||||||
Repayment of debt | 0 | 0 | ||||||||||
Payment to repurchase shares as part of the Share Repurchase Program | 0 | 0 | ||||||||||
Repayment of principal on finance lease liabilities | 0 | 0 | ||||||||||
Net cash provided by financing activities | 0 | 0 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | 0 | 0 | ||||||||||
Net decrease in cash and cash equivalents | 0 | 0 | ||||||||||
Cash and cash equivalents, beginning of period | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | $ 0 | 0 | ||
Cash and cash equivalents, end of period | 0 | 0 | $ 0 | |||||||||
Cash paid for interest | 0 | 0 | ||||||||||
Net Income (Loss) Attributable to Parent | 3,678,000 | 2,511,000 | (1,450,000) | (5,700,000) | 2,072,000 | 12,350,000 | 1,061,000 | 14,422,000 | 4,739,000 | 8,722,000 | ||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Note C - Restatement of Previ_8
Note C - Restatement of Previously Issued Consolidated Financial Statements - Revision of Prior Period Statement of Stockholder's Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Balance | $ 75,120 | $ 101,660 | $ 75,120 | $ 101,660 | $ 75,120 | $ 101,660 | $ 75,120 | $ 101,660 | ||||
Net income (loss) | $ (10,365) | $ (2,573) | (13,217) | (46,049) | (26,772) | |||||||
Balance | 61,524 | 61,524 | 61,864 | 75,120 | ||||||||
Net Income (Loss) Attributable to Parent | (10,365) | (2,573) | (13,217) | (46,049) | (26,772) | |||||||
Stock-based compensation expense | 1,387 | 1,103 | 591 | $ 911 | $ 1,510 | 918 | 5,954 | 4,294 | ||||
Shares repurchased as part of the Share Repurchase Program | (3,447) | (4,723) | (3,447) | (4,723) | ||||||||
Issuance of common stock in exchange for consulting services | 71 | 25 | 42 | 65 | 50 | 50 | 227 | 224 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 165 | 216 | 218 | 324 | ||||||||
Other comprehensive income | 5 | (162) | (176) | 201 | (156) | 113 | ||||||
Severance expense | 53 | 1,048 | 354 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 11,500 | 28,391 | ||||||||||
Additional Paid-in Capital [Member] | ||||||||||||
Balance | 436,269 | 431,427 | 436,269 | 431,427 | 436,269 | 431,427 | 436,269 | 431,427 | ||||
Net income (loss) | 0 | 0 | 0 | 0 | 0 | |||||||
Balance | 452,608 | 452,608 | 472,664 | 436,269 | ||||||||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | 0 | 0 | |||||||
Stock-based compensation expense | 1,387 | 1,103 | 591 | 911 | 1,510 | 918 | 5,954 | 4,294 | ||||
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | 0 | 0 | ||||||||
Issuance of common stock in exchange for consulting services | 71 | 25 | 42 | 65 | 50 | 50 | 227 | 224 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 165 | 216 | 218 | 324 | ||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Severance expense | 53 | 1,048 | 354 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 11,500 | 28,390 | ||||||||||
Common Stock [Member] | ||||||||||||
Balance | 3 | 4 | 3 | 4 | 3 | 4 | 3 | 4 | ||||
Net income (loss) | 0 | 0 | 0 | 0 | 0 | |||||||
Balance | 3 | 3 | 4 | 3 | ||||||||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | 0 | 0 | |||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Shares repurchased as part of the Share Repurchase Program | 0 | (1) | 0 | (1) | ||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 0 | 0 | 0 | ||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Severance expense | 0 | 0 | 0 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 0 | 1 | ||||||||||
Treasury Stock, Common [Member] | ||||||||||||
Balance | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) | ||||
Net income (loss) | 0 | 0 | 0 | 0 | 0 | |||||||
Balance | (10,983) | (10,983) | (10,983) | (7,536) | ||||||||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | 0 | 0 | |||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Shares repurchased as part of the Share Repurchase Program | (3,447) | (4,722) | (3,447) | (4,722) | ||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 0 | 0 | 0 | ||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Severance expense | 0 | 0 | 0 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 0 | 0 | ||||||||||
Retained Earnings [Member] | ||||||||||||
Balance | (353,729) | (326,957) | (353,729) | (326,957) | (353,729) | (326,957) | (353,729) | (326,957) | ||||
Net income (loss) | (10,367) | (2,573) | (13,217) | (46,049) | (26,772) | |||||||
Balance | (379,886) | (379,886) | (399,778) | (353,729) | ||||||||
Net Income (Loss) Attributable to Parent | (10,367) | (2,573) | (13,217) | (46,049) | (26,772) | |||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | 0 | 0 | ||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 0 | 0 | 0 | ||||||||
Other comprehensive income | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Severance expense | 0 | 0 | 0 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 0 | 0 | ||||||||||
AOCI Attributable to Parent [Member] | ||||||||||||
Balance | 113 | 0 | 113 | 0 | 113 | 0 | 113 | 0 | ||||
Net income (loss) | 0 | 0 | 0 | 0 | 0 | |||||||
Balance | (220) | (220) | (43) | 113 | ||||||||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | 0 | 0 | |||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Shares repurchased as part of the Share Repurchase Program | 0 | 0 | 0 | 0 | ||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 0 | 0 | 0 | ||||||||
Other comprehensive income | 5 | (162) | (176) | 201 | (156) | 113 | ||||||
Severance expense | 0 | 0 | 0 | |||||||||
Issuance of common stock in connection with the Proposed Merger (Note K) | 0 | 0 | ||||||||||
Previously Reported [Member] | ||||||||||||
Balance | 68,497 | 71,404 | 85,807 | 99,233 | 121,499 | 127,118 | 85,807 | 127,118 | 85,807 | 127,118 | 85,807 | 127,118 |
Net income (loss) | (14,045) | (5,084) | (11,767) | (6,616) | (24,042) | (1,864) | (16,851) | (25,906) | (30,896) | (32,522) | (41,543) | |
Balance | 67,470 | 68,497 | 71,404 | 93,794 | 99,233 | 121,499 | 68,497 | 99,233 | 67,470 | 93,794 | 85,807 | |
Net Income (Loss) Attributable to Parent | (14,045) | (5,084) | (11,767) | (6,616) | (24,042) | (1,864) | (16,851) | (25,906) | (30,896) | (32,522) | (41,543) | |
Previously Reported [Member] | Additional Paid-in Capital [Member] | ||||||||||||
Balance | 401,799 | 396,957 | 401,799 | 396,957 | 401,799 | 396,957 | 401,799 | 396,957 | ||||
Net income (loss) | 0 | |||||||||||
Balance | 401,799 | |||||||||||
Net Income (Loss) Attributable to Parent | 0 | |||||||||||
Previously Reported [Member] | Common Stock [Member] | ||||||||||||
Balance | 3 | 4 | 3 | 4 | 3 | 4 | 3 | 4 | ||||
Balance | 3 | |||||||||||
Previously Reported [Member] | Treasury Stock, Common [Member] | ||||||||||||
Balance | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) | ||||
Balance | (7,536) | |||||||||||
Previously Reported [Member] | Retained Earnings [Member] | ||||||||||||
Balance | (308,572) | (267,029) | (308,572) | (267,029) | (308,572) | (267,029) | (308,572) | (267,029) | ||||
Net income (loss) | (41,543) | |||||||||||
Balance | (308,572) | |||||||||||
Net Income (Loss) Attributable to Parent | (41,543) | |||||||||||
Previously Reported [Member] | AOCI Attributable to Parent [Member] | ||||||||||||
Balance | 113 | 0 | 113 | 0 | 113 | 0 | 113 | 0 | ||||
Balance | 113 | |||||||||||
Revision of Prior Period, Adjustment [Member] | ||||||||||||
Balance | (9,624) | (12,137) | (10,687) | (11,036) | (13,108) | (10,687) | (10,687) | (10,687) | ||||
Net income (loss) | 14,771 | |||||||||||
Balance | (5,948) | (9,624) | (12,137) | (16,736) | (11,036) | (13,108) | (9,624) | (11,036) | (5,948) | (16,736) | (10,687) | |
Net Income (Loss) Attributable to Parent | 14,771 | |||||||||||
Revision of Prior Period, Adjustment [Member] | Additional Paid-in Capital [Member] | ||||||||||||
Balance | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | ||||
Net income (loss) | 0 | |||||||||||
Balance | 34,470 | |||||||||||
Net Income (Loss) Attributable to Parent | 0 | |||||||||||
Revision of Prior Period, Adjustment [Member] | Retained Earnings [Member] | ||||||||||||
Balance | (45,157) | (59,928) | (45,157) | (59,928) | (45,157) | (59,928) | (45,157) | (59,928) | ||||
Net income (loss) | 14,771 | |||||||||||
Balance | (45,157) | |||||||||||
Net Income (Loss) Attributable to Parent | 14,771 | |||||||||||
As Restated [Member] | ||||||||||||
Balance | 58,873 | 59,267 | 75,120 | 88,197 | 108,391 | 101,660 | 75,120 | 101,660 | 75,120 | 101,660 | 75,120 | 101,660 |
Net income (loss) | (10,367) | (2,573) | (13,217) | (12,316) | (21,970) | 10,486 | (15,790) | (11,484) | (26,157) | (23,800) | (26,772) | |
Balance | 61,522 | 58,873 | 59,267 | 77,058 | 88,197 | 108,391 | 58,873 | 88,197 | 61,522 | 77,058 | 75,120 | |
Net Income (Loss) Attributable to Parent | (10,367) | (2,573) | (13,217) | (12,316) | (21,970) | 10,486 | (15,790) | (11,484) | (26,157) | (23,800) | (26,772) | |
As Restated [Member] | Additional Paid-in Capital [Member] | ||||||||||||
Balance | 439,597 | 437,256 | 436,269 | 434,171 | 432,395 | 431,427 | 436,269 | 431,427 | 436,269 | 431,427 | 436,269 | 431,427 |
Net income (loss) | 0 | 0 | 0 | 0 | ||||||||
Balance | 439,597 | 437,256 | 435,147 | 434,171 | 432,395 | 439,597 | 434,171 | 435,147 | 436,269 | |||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | 0 | ||||||||
As Restated [Member] | Common Stock [Member] | ||||||||||||
Balance | 3 | 3 | 3 | 3 | 3 | 4 | 3 | 4 | 3 | 4 | 3 | 4 |
Net income (loss) | 0 | 0 | 0 | |||||||||
Balance | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | |||||||||
As Restated [Member] | Treasury Stock, Common [Member] | ||||||||||||
Balance | (10,983) | (10,983) | (7,536) | (7,536) | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) | (7,536) | (2,814) |
Net income (loss) | 0 | 0 | 0 | |||||||||
Balance | (10,983) | (10,983) | (7,536) | (7,536) | (7,536) | (10,983) | (7,536) | (7,536) | (7,536) | |||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | |||||||||
As Restated [Member] | Retained Earnings [Member] | ||||||||||||
Balance | (369,519) | (366,946) | (353,729) | (338,441) | (316,471) | (326,957) | (353,729) | (326,957) | (353,729) | (326,957) | (353,729) | (326,957) |
Net income (loss) | (12,316) | (21,970) | 10,486 | (26,772) | ||||||||
Balance | (369,519) | (366,946) | (350,757) | (338,441) | (316,471) | (369,519) | (338,441) | (350,757) | (353,729) | |||
Net Income (Loss) Attributable to Parent | (12,316) | (21,970) | 10,486 | (26,772) | ||||||||
As Restated [Member] | AOCI Attributable to Parent [Member] | ||||||||||||
Balance | (225) | (63) | 113 | 0 | 0 | 0 | 113 | 0 | 113 | 0 | 113 | 0 |
Net income (loss) | 0 | 0 | 0 | |||||||||
Balance | (225) | (63) | 201 | 0 | 0 | (225) | 0 | 201 | 113 | |||
Net Income (Loss) Attributable to Parent | 0 | 0 | 0 | |||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||||||||||
Balance | (10,687) | (25,458) | (10,687) | (25,458) | (10,687) | (25,458) | (10,687) | (25,458) | ||||
Net income (loss) | 3,678 | 2,511 | (1,450) | (5,700) | 2,072 | 12,350 | 1,061 | 14,422 | 4,739 | 8,722 | ||
Balance | (10,687) | |||||||||||
Net Income (Loss) Attributable to Parent | $ 3,678 | $ 2,511 | (1,450) | $ (5,700) | $ 2,072 | 12,350 | 1,061 | 14,422 | 4,739 | 8,722 | ||
Revision of Prior Period, Error Correction, Adjustment [Member] | Additional Paid-in Capital [Member] | ||||||||||||
Balance | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | 34,470 | ||||
Balance | 34,470 | |||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | Common Stock [Member] | ||||||||||||
Balance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Balance | 0 | |||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | Treasury Stock, Common [Member] | ||||||||||||
Balance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Balance | 0 | |||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | Retained Earnings [Member] | ||||||||||||
Balance | (45,157) | (59,928) | (45,157) | (59,928) | (45,157) | (59,928) | (45,157) | (59,928) | ||||
Balance | (45,157) | |||||||||||
Revision of Prior Period, Error Correction, Adjustment [Member] | AOCI Attributable to Parent [Member] | ||||||||||||
Balance | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | 0 | ||||
Balance | $ 0 |
Note D - Accounts and Other R_3
Note D - Accounts and Other Receivables - Accounts and Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts receivable | $ 16,119 | $ 7,185 |
Other receivables | 1,258 | 1,114 |
Total accounts and other receivables | $ 17,377 | $ 8,299 |
Note E - Prepaid Expenses and_3
Note E - Prepaid Expenses and Other Current Assets - Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid insurance | $ 1,172 | $ 577 |
Other prepaid expenses and current assets | 652 | 1,111 |
Total prepaid expenses and other current assets | $ 1,824 | $ 1,688 |
Note F - Property and Equipme_3
Note F - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Depreciation, Depletion and Amortization | $ 1,006,000 | $ 944,000 |
Property and Equipment, Including Finance Leases [Member] | ||
Depreciation, Depletion and Amortization | $ 245,000 | $ 257,000 |
Note F - Property and Equipme_4
Note F - Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and equipment, gross | $ 2,370 | $ 2,237 |
Less: accumulated depreciation and amortization | (1,634) | (1,443) |
Property and equipment, net | 736 | 794 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 711 | 710 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 157 | 104 |
Computer and Hardware [Member] | ||
Property and equipment, gross | 643 | 462 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 710 | 710 |
Finance Lease, Right-of-Use Assets [Member] | ||
Property and equipment, gross | $ 149 | $ 251 |
Note F - Property and Equipme_5
Note F - Property and Equipment - Estimated Useful Lives of Property and Equipment (Details) | Dec. 31, 2023 |
Minimum [Member] | |
Property and equipment, useful lives (Year) | 3 years |
Maximum [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Laboratory Equipment [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Furniture and Fixtures [Member] | Minimum [Member] | |
Property and equipment, useful lives (Year) | 5 years |
Furniture and Fixtures [Member] | Maximum [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Computer and Hardware [Member] | Minimum [Member] | |
Property and equipment, useful lives (Year) | 3 years |
Computer and Hardware [Member] | Maximum [Member] | |
Property and equipment, useful lives (Year) | 7 years |
Leasehold Improvements [Member] | |
Property and equipment, useful lives (Year) | 9 years |
Note G - Accounts Payable and_3
Note G - Accounts Payable and Accrued Expenses - Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued payroll | $ 10,671 | $ 1,673 |
Accrued professional fees | 675 | 256 |
Accounts payable | 13,987 | 3,611 |
Other accrued expenses | 3,070 | 629 |
Total accounts payable and accrued expenses | $ 28,403 | $ 6,169 |
Note H - Debt Obligations (Deta
Note H - Debt Obligations (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Aug. 30, 2023 | Jan. 31, 2023 | Jan. 26, 2023 | May 31, 2022 | Nov. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Nov. 17, 2023 | |
Stock Issued During Period, Shares, Acquisitions (in shares) | 1,382,489 | 7,530,509 | ||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 20 | $ 20 | ||||||
Line of Credit Facility, Maximum Amount Outstanding During Period | 12.8 | |||||||
Certificates of Deposit, at Carrying Value | 20.5 | |||||||
Line of Credit Facility, Remaining Borrowing Capacity | 7.2 | |||||||
Wells Fargo Bank, N.A. [Member] | ||||||||
Line of Credit Facility, Remaining Borrowing Capacity | $ 6.4 | |||||||
Long-Term Line of Credit | $ 37.7 | |||||||
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% | |||||||
Revolving Credit Facility [Member] | Ameris Bank [Member] | ||||||||
Repayments of Lines of Credit | $ 12.8 | |||||||
Asset Pledged as Collateral [Member] | ||||||||
Certificates of Deposit, at Carrying Value | $ 12.8 | |||||||
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 | 2.25% | |||||||
SWK Loans [Member] | ||||||||
Payments to Acquire Notes Receivable | $ 12 | $ 12 | ||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | 98,683 | 98,683 | ||||||
Nantahala Note [Member] | ||||||||
Debt Instrument, Face Amount | $ 5 | $ 5 | $ 5 | |||||
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% | |||||||
Debt Instrument, Interest, Shares, Consecutive Trading Days For Calculation of VWAP (Day) | 20 days | |||||||
Debt Instrument, Periodic Payment, Interest | $ 0.6 |
Note H - Debt Obligations - Agg
Note H - Debt Obligations - Aggregate Principal Amount (Details) - Nantahala Note [Member] $ in Thousands | Dec. 31, 2023 USD ($) |
Secured promissory note | $ 5,000 |
Unamortized original issue premium | 148 |
Less: debt issuance costs | (82) |
Secured promissory note, net | $ 5,066 |
Note H - Debt Obligations - Fut
Note H - Debt Obligations - Future Minimum Principal Payments (Details) - Nantahala Note [Member] $ in Thousands | Dec. 31, 2023 USD ($) |
2024 | $ 0 |
2025 | 1,200 |
2026 | 3,800 |
Total minimum payments | 5,000 |
Plus: unamortized debt premium and debt issuance costs | 66 |
Secured promissory note, net | $ 5,066 |
Note I - Commitments and Cont_2
Note I - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2023 | May 31, 2023 | Dec. 31, 2022 |
Loss Contingency Accrual | $ 0 | $ 900 | $ 0 |
Note J - Stock and Warrants (De
Note J - Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||
Nov. 22, 2023 | Nov. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | |||
Common Stock, Shares, Issued (in shares) | 43,110,360 | 43,110,360 | 35,450,257 | |||
Common Stock, Shares, Outstanding (in shares) | 41,534,668 | 41,534,668 | 34,540,304 | 35,005,640 | ||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |||
Stock Issued During Period, Shares, Acquisitions (in shares) | 1,382,489 | 7,530,509 | ||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Derivative and Warrant Liability, Noncurrent | $ 16,100 | $ 16,100 | $ 10,202 | |||
Fair Value Adjustment of Put Option, Net of Tax | $ 1,400 | $ 14,800 | ||||
Warrants to Purchase Common Stock [Member] | ||||||
Class of Warrant or Right, Exercisable During Period (in shares) | 4,221,240 | 4,221,240 | ||||
Deerfield Warrant [Member] | Common Stock [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 120,192 | 120,192 | ||||
Acer Warrants [Member] | ||||||
Proceeds from Warrant Exercises | $ 6,000 | |||||
Class of Warrants or Right, Exercised During Period (in shares) | 0 | |||||
Warrants and Rights Outstanding | $ 4,500 | $ 4,500 | ||||
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 | ||||
The 2021 Warrants [Member] | ||||||
Class of Warrant or Right, Outstanding (in shares) | 4,100,000 | 4,100,000 |
Note J - Stock and Warrants - R
Note J - Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Common shares reserved for future issuance (in shares) | 16,695,928 | 12,547,880 |
Warrant [Member] | ||
Common shares reserved for future issuance (in shares) | 5,603,729 | 4,252,600 |
Share-Based Payment Arrangement [Member] | ||
Common shares reserved for future issuance (in shares) | 8,023,142 | 2,456,407 |
Possible Future Issuances Under Equity Incentive Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 1,728,885 | 4,421,508 |
Possible Future Issuances Under Employee Stock Purchase Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 1,340,172 | 1,417,365 |
Note J - Stock and Warrants - C
Note J - Stock and Warrants - Common Stock Activity (Details) - shares | 1 Months Ended | 12 Months Ended | 33 Months Ended | |
Nov. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Balance (in shares) | 34,540,304 | 35,005,640 | ||
Common stock issued as compensation to third-parties (in shares) | 44,791 | 41,821 | ||
Common stock repurchased as a result of the Stock Repurchase Program (in shares) | (665,739) | (589,792) | ||
Common stock issued as a result of the Employee Stock Purchase Plan (in shares) | 77,193 | 82,635 | 159,828 | |
Common stock issued as a result of stock warrants exercised (in shares) | 110 | |||
Common stock issued as a result of stock options exercised (in shares) | 7,500 | |||
Common stock issued in connection with the Merger (Note R) (in shares) | 1,382,489 | 7,530,509 | ||
Balance (in shares) | 41,534,668 | 34,540,304 | 41,534,668 |
Note K - Stock-based Compensa_3
Note K - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | 33 Months Ended | ||||
Jan. 01, 2024 | Jun. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | 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) | 77,193 | 82,635 | 159,828 | ||||
Share-Based Payment Arrangement, Expense | $ 5,954 | $ 4,294 | |||||
Severance Costs Recognized | $ 1,200 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share) | $ 3.65 | $ 5.01 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 9,200 | $ 3,000 | |||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 13,800 | $ 13,800 | |||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 10 months 13 days | ||||||
Performance Shares [Member] | |||||||
Share-Based Payment Arrangement, Expense | $ 0 | $ 400 | |||||
2014 Equity Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 4,900,000 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 8,271,497 | 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% | ||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares) | 7,500 | 0 | |||||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | |||||||
Increase in Common Stock Reserved for Issuance (in shares) | 1,661,386 | ||||||
The 2023 Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 1,500,000 | ||||||
The 2023 Plan [Member] | Subsequent Event [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 4,500,000 |
Note K - Stock-based Compensa_4
Note K - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock based compensation expense | $ 5,954 | $ 4,294 |
Research and Development Expense [Member] | ||
Stock based compensation expense | 2,664 | 1,443 |
General and Administrative Expense [Member] | ||
Stock based compensation expense | $ 3,290 | $ 2,851 |
Note K - Stock-based Compensa_5
Note K - Stock-based Compensation - Black-Scholes Option-pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Risk-free interest rate | 3.34% | 1.70% |
Expected term (in years) (Year) | 5 years 6 months | 5 years 6 months |
Expected volatility | 89.48% | 91.28% |
Maximum [Member] | ||
Risk-free interest rate | 4.79% | 3.80% |
Expected term (in years) (Year) | 10 years | 7 years |
Expected volatility | 93.67% | 98.91% |
Note K - Stock-based Compensa_6
Note K - Stock-based Compensation - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Outstanding, number of options (in shares) | 2,456,407 | |
Outstanding, weighted average exercise price (in dollars per share) | $ 16.84 | |
Outstanding, weighted average remaining contractual term (Year) | 8 years 8 months 4 days | 8 years 6 months 3 days |
Outstanding, aggregate intrinsic value | $ 11,089 | $ 11,819 |
Granted, number of options (in shares) | 5,779,679 | |
Granted, weighted average exercise price (in dollars per share) | $ 4.68 | |
Common stock issued as a result of stock options exercised (in shares) | 7,500 | |
Exercised or released, weighted average exercise price (in dollars per share) | $ 4.67 | |
Canceled or forfeited, number of options (in shares) | 205,444 | |
Canceled or forfeited, weighted average exercise price (in dollars per share) | $ 4.7 | |
Canceled or forfeited, aggregate intrinsic value | $ 122 | |
Expired, number of options (in shares) | 0 | |
Expired, weighted average exercise price (in dollars per share) | $ 0 | |
Outstanding, number of options (in shares) | 8,023,142 | 2,456,407 |
Outstanding, weighted average exercise price (in dollars per share) | $ 8.4 | $ 16.84 |
Exercisable, number of options (in shares) | 2,408,165 | |
Exercisable, weighted average exercise price (in dollars per share) | $ 16.28 | |
Exercisable, weighted average remaining contractual term (Year) | 7 years 9 months 21 days | |
Exercisable, aggregate intrinsic value | $ 1,778 | |
Vested and expected to vest, number of options (in shares) | 6,972,858 | |
Vested and expected to vest, weighted average exercise price (in dollars per share) | $ 8.96 | |
Vested and expected to vest, weighted average remaining contractual term (Year) | 8 years 7 months 13 days | |
Vested and expected to vest, aggregate intrinsic value | $ 9,112 |
Note K - Stock-based Compensa_7
Note K - Stock-based Compensation - Information Regarding Currently Outstanding and Exercisable Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Options outstanding, number of shares (in shares) | 8,023,142 | 2,456,407 |
Outstanding, weighted average remaining contractual term (Year) | 8 years 8 months 4 days | 8 years 6 months 3 days |
Exercisable, number of options (in shares) | 2,408,165 | |
Exercisable, weighted average remaining contractual term (Year) | 7 years 9 months 21 days | |
Exercise Price Range One [Member] | ||
Lower range (in dollars per share) | $ 2.848 | |
Upper range (in dollars per share) | $ 10 | |
Options outstanding, number of shares (in shares) | 7,742,171 | |
Outstanding, weighted average remaining contractual term (Year) | 8 years 10 months 2 days | |
Exercisable, number of options (in shares) | 2,127,194 | |
Exercisable, weighted average remaining contractual term (Year) | 8 years 3 months | |
Exercise Price Range Two [Member] | ||
Lower range (in dollars per share) | $ 10.01 | |
Upper range (in dollars per share) | $ 30 | |
Options outstanding, number of shares (in shares) | 69,375 | |
Outstanding, weighted average remaining contractual term (Year) | 7 years 2 months 1 day | |
Exercisable, number of options (in shares) | 69,375 | |
Exercisable, weighted average remaining contractual term (Year) | 7 years 2 months 1 day | |
Exercise Price Range Three [Member] | ||
Lower range (in dollars per share) | $ 30.01 | |
Upper range (in dollars per share) | $ 50 | |
Options outstanding, number of shares (in shares) | 68,514 | |
Outstanding, weighted average remaining contractual term (Year) | 5 years 1 month 9 days | |
Exercisable, number of options (in shares) | 68,514 | |
Exercisable, weighted average remaining contractual term (Year) | 5 years 1 month 9 days | |
Exercise Price Range Four [Member] | ||
Lower range (in dollars per share) | $ 50.01 | |
Upper range (in dollars per share) | $ 70 | |
Options outstanding, number of shares (in shares) | 41,866 | |
Outstanding, weighted average remaining contractual term (Year) | 3 years 29 days | |
Exercisable, number of options (in shares) | 41,866 | |
Exercisable, weighted average remaining contractual term (Year) | 3 years 29 days | |
Exercise Price Range Five [Member] | ||
Lower range (in dollars per share) | $ 70.01 | |
Upper range (in dollars per share) | $ 327.2 | |
Options outstanding, number of shares (in shares) | 101,216 | |
Outstanding, weighted average remaining contractual term (Year) | 2 years 8 months 12 days | |
Exercisable, number of options (in shares) | 101,216 | |
Exercisable, weighted average remaining contractual term (Year) | 2 years 8 months 12 days |
Note K - Stock-based Compensa_8
Note K - Stock-based Compensation - Nonvested Stock Option Awards (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of unvested shares (in shares) | 5,614,977 | 1,841,406 |
Exercise Price Range One [Member] | ||
Lower range (in dollars per share) | $ 2.848 | |
Upper range (in dollars per share) | $ 10 | |
Number of unvested shares (in shares) | 5,614,977 | 1,824,285 |
Exercise Price Range Three [Member] | ||
Lower range (in dollars per share) | $ 30.01 | |
Upper range (in dollars per share) | $ 50 | |
Number of unvested shares (in shares) | 0 | 17,121 |
Note L - Fair Value of Financ_3
Note L - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Total liabilities | $ 23,362 | $ 10,202 |
Total assets | 24,688 | 16,900 |
US Government Agencies Debt Securities [Member] | ||
Total assets | 7,189 | |
US Treasury Securities [Member] | ||
Total assets | 24,688 | 9,711 |
Fair Value, Inputs, Level 1 [Member] | ||
Total liabilities | 0 | 0 |
Total assets | 24,688 | 9,711 |
Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Total assets | 24,688 | 9,711 |
Fair Value, Inputs, Level 2 [Member] | ||
Total liabilities | 0 | 0 |
Total assets | 0 | 7,189 |
Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 7,189 | |
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Total liabilities | 23,362 | 10,202 |
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | |
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
CVR Liability [Member] | ||
Total liabilities | 7,262 | |
CVR Liability [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total liabilities | 0 | |
CVR Liability [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total liabilities | 0 | |
CVR Liability [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total liabilities | 7,262 | |
Warrants [Member] | ||
Total liabilities | 16,100 | 10,202 |
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 | $ 16,100 | $ 10,202 |
Note L - Fair Value of Financ_4
Note L - Fair Value of Financial Instruments - Fair Value Assumptions for Warrant Liabilities (Details) | 12 Months Ended | |
Dec. 31, 2023 $ / shares | Dec. 31, 2022 $ / shares | |
Weighted average fair value (in dollars per share) | $ 2.94 | $ 2.94 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Risk-free interest rate | 0.0376 | 0.0401 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||
Risk-free interest rate | 0.6201 | 0.9833 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Risk-free interest rate | 2 | 3 |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Risk-free interest rate | 0.0412 | 0.0412 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||
Risk-free interest rate | 0.9242 | 1.0301 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Risk-free interest rate | 4.9 | 4 |
Note L - Fair Value of Financ_5
Note L - Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Balance | $ 16,100 | $ 10,202 | $ 25,032 |
Change in fair value measurement (As Restated) | 1,398 | $ (14,830) | |
Fair value of warrants issued | $ 4,500 |
Note M - Income Taxes (Details
Note M - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
State and Local Income Tax Expense (Benefit), Continuing Operations | $ 31,000 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | (46,049,000) | $ (26,805,000) |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 20,670,000 | $ 6,900,000 |
State and Local Jurisdiction [Member] | ||
State and Local Income Tax Expense (Benefit), Continuing Operations | 0 | |
Operating Loss Carryforwards | $ 340,300,000 | |
Operating Loss Carryforwards, Expiration, Beginning Year | 2027 | |
Foreign Tax Authority [Member] | Danish [Member] | ||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 800,000 | |
Operating Loss Carryforwards | 4,700,000 | |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards | 350,000,000 | |
Operating Loss Carryforwards, Subject to Expiration | $ 145,300,000 | |
Operating Loss Carryforwards, Expiration, Beginning Year | 2027 | |
Operating Loss Carryforwards, Not Subject to Expiration | $ 204,700,000 | |
Research and Development [Member] | ||
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | $ 26,800,000 |
Note M - Income Taxes - Schedul
Note M - Income Taxes - Schedule of Reconciliation of Difference Between Benefit for Income Taxes and Income Taxes at Statutory U.S. Federal Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Federal statutory rate | 21% | 21% |
Change in valuation allowance | (23.29%) | (34.77%) |
Return to provision and deferred true-up | (2.41%) | (5.37%) |
Change in rate | (0.01%) | 0.80% |
State tax benefit (net of federal) | 5.19% | 4.78% |
Warrant liability | 0% | 12.39% |
Stock-based compensation | (0.20%) | (1.09%) |
Global intangible low-taxed income credit | (3.41%) | (1.92%) |
Other | (0.10%) | 0.19% |
Federal income tax provision effective rate | 0% | 0.12% |
Domestic Tax Authority [Member] | ||
Research and development credit | 4.09% | 1.82% |
State and Local Jurisdiction [Member] | ||
Research and development credit | 0% | 0.12% |
Foreign Tax Authority [Member] | ||
Research and development credit | (0.86%) | 2.17% |
Note M - Income Taxes - Compone
Note M - Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Net operating loss carryforwards | $ 90,743 | $ 66,373 |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 20,670 | 6,900 |
Stock-based compensation | 5,154 | 4,185 |
174 expenses | 30,241 | 3,730 |
Right-of-use liability | 265 | 359 |
Property and equipment | (23) | (22) |
Other deferred tax assets | 1,951 | 598 |
Total gross deferred tax assets | 149,047 | 82,167 |
Right-of-use asset | (249) | (336) |
Intangibles | 14,473 | |
Total gross deferred tax liabilities | (14,722) | (336) |
Deferred tax assets less liabilities | 134,324 | 81,831 |
Valuation allowance | (134,488) | $ (81,831) |
Net deferred tax asset (liability) | $ 164 |
Note N - Net Loss Per Share - A
Note N - Net Loss Per Share - Anti-dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive securities (in shares) | 7,332,614 | 6,709,007 |
Share-Based Payment Arrangement [Member] | ||
Antidilutive securities (in shares) | 1,728,885 | 2,456,407 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive securities (in shares) | 5,603,729 | 4,252,600 |
Note N - Net Loss Per Share - E
Note N - Net Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Net Income (Loss) Attributable to Parent | $ (10,365) | $ (2,573) | $ (13,217) | $ (46,049) | $ (26,772) |
Basic and diluted (in shares) | 35,452,460 | 34,488,800 | |||
Basic and diluted net loss per share of common stock (in dollars per share) | $ (1.3) | $ (0.78) |
Note O - Leases (Details Textua
Note O - Leases (Details Textual) | 12 Months Ended |
Dec. 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) | 4 years |
Note O - Leases - Lease Cost (D
Note O - Leases - Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Amortization of right-of-use assets | $ 102 | $ 129 |
Interest on lease liabilities | 0 | 2 |
Total finance lease cost | 102 | 131 |
Operating lease cost | 437 | 418 |
Short-term lease cost | 171 | 210 |
Variable lease cost | 40 | 39 |
Less: sublease income | (157) | (157) |
Total lease costs | $ 593 | $ 641 |
Note O - Leases - Supplement Ca
Note O - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating cash flows from finance leases | $ 0 | $ 2 |
Financing cash flows from finance leases | 5 | 16 |
Operating cash flows from operating leases | 552 | 522 |
Operating cash flows from short-term leases | 171 | 210 |
Operating cash flows from variable lease costs | 40 | 39 |
Finance leases | 0 | 0 |
Operating leases | $ 0 | $ 123 |
Note O - Leases - Supplement Ba
Note O - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
less: accumulated depreciation and amortization | $ (1,634) | $ (1,443) |
Lease liabilities, finance leases | 0 | 6 |
Operating lease right-of-use assets | 790 | 988 |
Operating lease right-of-use assets | 790 | 988 |
Current portion of operating lease liabilities | 543 | 480 |
Operating lease liabilities, less current portion | 456 | 843 |
Total operating lease liabilities | $ 999 | $ 1,323 |
Finance leases (in years) (Year) | 0 years | 1 year |
Operating leases (in years) (Year) | 2 years | 3 years |
Finance leases | 14.30% | 14.30% |
Operating leases | 7.60% | 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 | (882) | (780) |
Property and Equipment, Net [Member] | ||
Property and equipment, net | 149 | 251 |
Other Current Liabilities [Member] | ||
Other current liabilities | 0 | 6 |
Other Noncurrent Liabilities [Member] | ||
Other long-term liabilities | 0 | 0 |
Operating Lease Right-of-Use Assets [Member] | ||
Operating lease right-of-use assets | 790 | 988 |
Operating lease right-of-use assets | 790 | 988 |
Current Portion of Operating Lease Liabilities [Member] | ||
Current portion of operating lease liabilities | 543 | 480 |
Operating Lease Liabilities, Less Current Portion [Member] | ||
Operating lease liabilities, less current portion | $ 456 | $ 843 |
Note O - Leases - Maturities of
Note O - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
2024, finance leases | $ 0 | |
2024, operating leases | 644 | |
2025, finance leases | 0 | |
2025, operating leases | 389 | |
2026, finance leases | 0 | |
2026, operating leases | 30 | |
Total lease payments, finance leases | 0 | |
Total lease payments, operating leases | 1,063 | |
Less: future interest expense, finance leases | 0 | |
Less: future interest expense, operating leases | (64) | |
Lease liabilities, finance leases | 0 | $ 6 |
Lease liabilities, operating leases | $ 999 | $ 1,323 |
Note P - Employee Benefit Plan
Note P - Employee Benefit Plan (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Plan [Member] | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4% | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 300 | $ 200 |
Profit Sharing Plan [Member] | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0 | $ 0 |
Defined Contribution Plan, Requisite Service Period (Year) | 3 years |
Note Q - Significant Events (De
Note Q - Significant Events (Details Textual) | 12 Months Ended | |||
Oct. 07, 2023 USD ($) shares | Jan. 09, 2023 shares | Jan. 06, 2023 USD ($) shares | Dec. 31, 2023 USD ($) shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 5,779,679 | |||
Employee Severance [Member] | Dr. Mickle [Member] | ||||
Restructuring Charges | $ | $ 600,000 | |||
Employee Severance [Member] | Mr Pascoe [Member] | ||||
Restructuring Charges | $ | $ 300,000 | |||
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) | 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) | 547,945 | |||
President and Chief Executive Officer [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 600,000 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Number of Installments | 4 | |||
Base Salary | $ | $ 700,000 | |||
Annual Performance-based Target Bonus, Percentage of Base Salary | 60% | |||
Employment Agreement, Termination Without Cause, Rate of Base Salary | 1 | |||
Employment Agreement, Termination Without Cause, Continued COBRA Coverage Period (Month) | 12 months | |||
Employment Agreement, Termination on Change of Control, Rate of Base Salary | 1.5 | |||
Employment Agreement, Termination on Change of Control, Continued COBRA Coverage Period (Month) | 18 months | |||
Employment Agreement, Period of Post-termination Non-compete and Non-solicitations (Month) | 12 months | |||
President and 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) | 200,000 |
Note R - Merger (Details Textua
Note R - Merger (Details Textual) | 1 Months Ended | 3 Months Ended | 12 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 ($) shares | Mar. 14, 2022 USD ($) | Dec. 31, 2023 USD ($) | Nov. 30, 2023 shares | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Oct. 31, 2023 USD ($) | |
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 1,382,489 | 7,530,509 | ||||||||||||
Stock Issued During Period, Value, New Issues | $ 6,106,000 | |||||||||||||
Net Income (Loss) Attributable to Parent | $ (10,365,000) | $ (2,573,000) | $ (13,217,000) | (46,049,000) | $ (26,772,000) | |||||||||
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 | $ 12,000,000 | $ 12,000,000 | ||||||||||||
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 | $ 11,000,000 | |||||||||||||
SWK Loans and Marathon Notes [Member] | ||||||||||||||
Payments to Acquire Notes Receivable | $ 12,000,000 | |||||||||||||
Stock Issued During Period, Shares, Acquisitions (in shares) | shares | 2,270,000 | |||||||||||||
Asset Acquisition, Consideration Transferred, Equity Interest Issued and Issuable | $ 11,500,000 | |||||||||||||
VWAP, Consecutive Trading Days (Year) | 20 years | |||||||||||||
Nantahala Note [Member] | ||||||||||||||
Debt Instrument, Face Amount | $ 5,000,000 | $ 5,000,000 | $ 5,000,000 | |||||||||||
Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | ||||||||||||||
Maximum Royalty Percentage | 20% | |||||||||||||
Upfront Payment | $ 10,000,000 | |||||||||||||
Addiitonal Payment on First Anniversary | 1,500,000 | |||||||||||||
Maximum Royalty Obligation | $ 45,000,000 | |||||||||||||
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 | $ 7,000,000 | $ 6,500,000 | ||||||||||||
Maximum [Member] | Acer Therapeutics Inc [Member] | License Agreement and Termination Agreement [Member] | Relief [Member] | ||||||||||||||
Contractual Obligation | $ 56,500,000 | |||||||||||||
Bridge Loan [Member] | ||||||||||||||
Financing Receivable, Maximum Limit | 18,000,000 | $ 18,000,000 | ||||||||||||
Bridge Loan [Member] | Minimum [Member] | ||||||||||||||
Financing Receivable, Maximum Limit | 16,500,000 | |||||||||||||
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 | $ 76,000,000 | |||||||||||||
Business Combination, Consideration Transferred | $ 72,600,000 | |||||||||||||
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 | $ 12,800,000 | |||||||||||||
Business Combination, Contingent Consideration, Liability | 8,500,000 | $ 7,262,000 | 7,262,000 | $ 0 | ||||||||||
Repayments of Notes Payable | $ 1,000,000 | |||||||||||||
Revenues | 42,000 | |||||||||||||
Net Income (Loss) Attributable to Parent | $ (6,800,000) | |||||||||||||
Business Combination, Acquisition Related Costs | 2,200,000 | |||||||||||||
Gain (Loss) on Contingent Consideration, Change in Fair Value | $ 1,300,000 | |||||||||||||
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 | $ 4,000,000 | |||||||||||||
Acer Therapeutics Inc [Member] | Bridge Loan [Member] | ||||||||||||||
Business Combination, Consideration Transferred, Other | $ 17,800,000 | $ 16,500,000 |
Note R - Merger - Estimates and
Note R - Merger - Estimates and Assumptions Related to Fair Value of Assets and Liabilities Acquired (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Nov. 17, 2023 | Dec. 31, 2022 |
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 | $ 0 | |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | 85,022 | ||
Accounts payable and accrued expenses | 10,718 | ||
Deferred collaboration funding | 1,500 | ||
Operating lease liabilities | 175 | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Liabilities | 12,393 | ||
Fair Value of Net Assets Acquired | 72,629 | ||
Acer Therapeutics Inc [Member] | |||
Goodwill acquired | $ 4,538 |
Note R - Merger - Pro Forma Com
Note R - Merger - Pro Forma Combined Results of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pro forma revenue | $ 27,705 | $ 10,458 |
Pro forma net loss | $ (78,875) | $ (80,652) |
Note R - Merger - Reconciliatio
Note R - Merger - Reconciliation of Contingent Consideration Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Acer Therapeutics Inc [Member] | |
Initial estimate of contingent consideration at the Effective Time | $ 8,562 |
Acer Therapeutics Inc [Member] | |
Balance | 0 |
Change in fair value recognized in earnings | (1,300) |
Balance | $ 7,262 |