Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 29, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-35068 | ||
Entity Registrant Name | TALPHERA, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 41-2193603 | ||
Entity Address, Address Line One | 1850 Gateway Drive, Suite 175 | ||
Entity Address, City or Town | San Mateo | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94404 | ||
City Area Code | 650 | ||
Local Phone Number | 216-3500 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | TLPH | ||
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] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 12,073,654 | ||
Entity Common Stock, Shares Outstanding (in shares) | 16,969,103 | ||
Auditor Firm ID | 207 | ||
Auditor Name | BPM LLP | ||
Auditor Location | Walnut Creek, California | ||
Entity Central Index Key | 0001427925 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 5,721 | $ 15,275 |
Restricted cash | 0 | 5,000 |
Short-term investments | 3,660 | 495 |
Prepaid expenses and other current assets | 2,175 | 1,865 |
Assets of discontinued operations | 0 | 1,931 |
Total current assets | 11,556 | 24,566 |
In-process research and development asset | 8,819 | 8,819 |
Other assets | 20 | 166 |
Assets of discontinued operations | 0 | 13,936 |
Total assets | 20,395 | 47,487 |
Current Liabilities: | ||
Accounts payable | 1,336 | 1,256 |
Accrued and other liabilities | 2,445 | 2,531 |
Long-term debt, current portion | 0 | 5,363 |
Liabilities of discontinued operations, current portion | 731 | 4,620 |
Total current liabilities | 4,512 | 13,770 |
Warrant liability | 1,778 | 7,098 |
Other long-term liabilities | 0 | 810 |
Liabilities of discontinued operations | 0 | 3,995 |
Total liabilities | 6,290 | 25,673 |
Commitments and Contingencies | ||
us-gaap_StockholdersEquityAbstract | ||
Common stock, $0.001 par value—200,000,000 shares authorized as of December 31, 2023 and 2022; 16,952,519 and 8,243,680 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 17 | 8 |
Additional paid-in capital | 458,314 | 447,635 |
Accumulated deficit | (444,226) | (425,829) |
Total stockholders’ equity | 14,105 | 21,814 |
Total Liabilities and Stockholders’ Equity | $ 20,395 | $ 47,487 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 200,000,000 | 200,000,000 |
Common Stock, Shares, Issued (in shares) | 16,952,519 | 8,243,680 |
Common Stock, Shares, Outstanding (in shares) | 16,952,519 | 8,243,680 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Total revenue | $ 651 | $ 0 |
us-gaap_OperatingCostsAndExpensesAbstract | ||
Research and development | 5,546 | 3,341 |
Selling, general and administrative | 11,994 | 17,011 |
Impairment of property and equipment | 0 | 4,948 |
Total operating costs and expenses | 17,540 | 25,300 |
Loss from operations | (16,889) | (25,300) |
Interest expense | (134) | (1,116) |
Interest income and other income, net | 6,736 | 366 |
Non-cash interest income on liability related to sale of future royalties | 0 | 1,136 |
Non-cash gain on extinguishment of liability related to the sale of future royalties | 0 | 84,052 |
Total other income, net | 6,602 | 84,438 |
Net income (loss) before provision for income taxes | (10,287) | 59,138 |
Provision for income taxes | 0 | (13) |
Net (loss) income from continuing operations | (10,287) | 59,125 |
Net loss from discontinued operations – See Note 3 | (8,110) | (11,370) |
Net income (loss) | (18,397) | 47,755 |
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | 0 | (186) |
Income allocated to participating securities | 0 | (5,240) |
Net income (loss) attributable to Common Shareholders, basic | (18,397) | 42,329 |
Net income (loss) attributable to Common Shareholders, diluted | $ (18,397) | $ 42,342 |
us-gaap_EarningsPerShareBasicAbstract | ||
(Loss) income from continuing operations (in dollars per share) | $ (0.72) | $ 7.27 |
Loss from discontinued operations (in dollars per share) | (0.57) | (1.54) |
Net income (loss) per share of common stock, basic (in dollars per share) | (1.29) | 5.73 |
us-gaap_EarningsPerShareDilutedAbstract | ||
(Loss) income from continuing operations (in dollars per share) | (0.72) | 7.25 |
Loss from discontinued operations (in dollars per share) | (0.57) | (1.53) |
Net (loss) income per share (in dollars per share) | $ (1.29) | $ 5.72 |
Shares used in computing net (loss) income per share of common stock, basic – See Note 12 (in shares) | 14,263,744 | 7,385,348 |
Shares used in computing net (loss) income per share of common stock, diluted – See Note 12 (in shares) | 14,263,744 | 7,406,986 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Preferred Stock [Member] Redeemable Convertible Preferred Stock [Member] | Preferred Stock [Member] | Common Stock [Member] Redeemable Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Redeemable Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] Redeemable Convertible Preferred Stock [Member] | Retained Earnings [Member] | Redeemable Convertible Preferred Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 0 | 6,840,967 | ||||||||
Balance at Dec. 31, 2021 | $ 0 | $ 7 | $ 437,684 | $ (473,584) | $ (35,893) | |||||
Issuance of Series A Redeemable Convertible Preferred Stock and Warrants (in shares) | 3,000 | 0 | 0 | 1 | ||||||
Issuance of Series A Redeemable Convertible Preferred Stock and Warrants | $ 129 | $ 0 | $ 873,074 | $ 110 | 789 | $ 0 | 0 | $ 110 | 790 | |
Deemed dividends related to Series A Redeemable Convertible Preferred Stock | $ 186 | |||||||||
Deemed dividends related to Series A Redeemable Convertible Preferred Stock | (186) | (186) | ||||||||
Redemption of Series A Redeemable Convertible Preferred Stock and Warrants (in shares) | (3,000) | 0 | ||||||||
Redemption of Series A Redeemable Convertible Preferred Stock and Warrants | $ (315) | $ 0 | 0 | 0 | 0 | |||||
Stock-based compensation | $ 0 | $ 0 | 2,889 | 0 | 2,889 | |||||
Issuance of common stock in connection with asset purchase (in shares) | 0 | 481,026 | ||||||||
Issuance of common stock in connection with asset purchase | $ 0 | $ 0 | 5,511 | 0 | 5,511 | |||||
Modification of equity-classified warrants | $ 0 | $ 0 | 822 | 0 | 822 | |||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes (in shares) | 0 | 37,672 | ||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes | $ 0 | $ 0 | (58) | 0 | (58) | |||||
Issuance of common stock upon ESPP purchase (in shares) | 0 | 10,941 | ||||||||
Issuance of common stock upon ESPP purchase | $ 0 | $ 0 | 74 | 0 | 74 | |||||
Net income (loss) | $ 0 | $ 0 | 0 | 47,755 | 47,755 | |||||
Balance (in shares) at Dec. 31, 2022 | 0 | 8,243,680 | ||||||||
Balance at Dec. 31, 2022 | $ 0 | $ 8 | 447,635 | (425,829) | 21,814 | |||||
Stock-based compensation | $ 0 | $ 0 | 1,729 | 0 | 1,729 | |||||
Issuance of common stock in connection with asset purchase (in shares) | 0 | 69,808 | ||||||||
Issuance of common stock in connection with asset purchase | $ 0 | $ 0 | 77 | 0 | 77 | |||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes (in shares) | 0 | 27,450 | ||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes | $ 0 | $ 0 | (22) | 0 | (22) | |||||
Issuance of common stock upon ESPP purchase (in shares) | 0 | 42,209 | ||||||||
Issuance of common stock upon ESPP purchase | $ 0 | $ 1 | 44 | 0 | 45 | |||||
Net income (loss) | $ 0 | $ 0 | 0 | (18,397) | (18,397) | |||||
Net proceeds from issuance of common stock and warrants in connection with equity financings (in shares) | 0 | 5,340,591 | ||||||||
Net proceeds from issuance of common stock and warrants in connection with equity financings | $ 0 | $ 5 | 8,851 | 0 | 8,856 | |||||
Exercise of pre-funded warrants (in shares) | 0 | 3,228,781 | ||||||||
Exercise of pre-funded warrants | $ 0 | $ 3 | 0 | 0 | 3 | |||||
Balance (in shares) at Dec. 31, 2023 | 0 | 16,952,519 | ||||||||
Balance at Dec. 31, 2023 | $ 0 | $ 17 | $ 458,314 | $ (444,226) | $ 14,105 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net (loss) income | $ (18,397) | $ 47,755 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Non-cash interest income on liability related to the sale of future royalties | 0 | (1,136) |
Depreciation and amortization | 311 | 1,647 |
Non-cash interest expense related to debt financing | 53 | 393 |
Non-cash issuance costs for warrant liability | 0 | 775 |
Revaluation of liability for Lowell holdback shares | (723) | 0 |
Stock-based compensation | 1,729 | 2,889 |
Non-cash gain on extinguishment of liability related to the sale of future royalties | 0 | (84,152) |
Impairment of property and equipment | 0 | 4,948 |
Revaluation of warrant liability | (5,320) | 0 |
Impairment of net assets held for sale | 6,853 | 0 |
Impairment of fixed assets | 1,065 | 0 |
Gain on termination of lease liabilities | 1,098 | 0 |
Gain on extinguishment of debt liability | 400 | 0 |
Other | (24) | (60) |
Impairment of fixed assets | 1,065 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (189) | (149) |
Inventories | 61 | (107) |
Prepaid expenses and other assets | 244 | 299 |
Other assets | 226 | 0 |
Accounts payable | (575) | 551 |
Accrued liabilities | (1,132) | (1,613) |
Operating lease liabilities | (147) | (285) |
Deferred revenue | (29) | (86) |
Net cash used in operating activities | (17,492) | (28,331) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (100) | (364) |
Purchase of investments | (3,651) | (7,861) |
Sale of the DSUVIA assets | 2,723 | 0 |
Cash paid for asset acquisition, net of cash acquired | 0 | (1,687) |
Proceeds from maturities of investments | 500 | 46,362 |
Net cash provided by (used in) investing activities | (528) | 36,450 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of long-term debt | (5,416) | (8,433) |
Net proceeds from issuance of Series A Redeemable Convertible Preferred Stock and Warrants | 0 | 239 |
Redemption of Series A Redeemable Convertible Preferred Stock | 0 | (315) |
Net proceeds from issuance of common stock in connection with exercise of pre-funded warrants | 3 | 0 |
Net proceeds from issuance of common stock through equity plans | 45 | 74 |
Payment of employee tax obligations related to vesting of restricted stock units | 22 | 58 |
Net cash (used in) provided by financing activities | 3,466 | (507) |
Net change in cash, cash equivalents and restricted cash | (14,554) | 7,612 |
Cash, cash equivalents and restricted cash—Beginning of period | 20,275 | 12,663 |
Cash, cash equivalents and restricted cash—End of period | 5,721 | 20,275 |
Supplemental Disclosures of Cash Flow Information: | ||
Cash paid for interest | 119 | 824 |
Income taxes paid | 0 | 13 |
Cash, cash equivalents and restricted cash—End of period | ||
Purchases of property and equipment in accounts payable and accrued expenses | 0 | 825 |
Equity issuance costs from modification of November 2021 Financing Warrants | 0 | 47 |
Equity issuance costs in accounts payable and accrued expenses | 0 | 51 |
(Settlement)/liability for held back shares issued in connection with asset acquisition | (77) | 800 |
Issuance of common stock in connection with asset acquisition | 0 | 5,511 |
Establishment of right-of-use asset and lease liability | 0 | 127 |
Fair value of warrants issued to placement agent | 263 | 0 |
July 2023 Private Placement Offering [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering | 8,856 | 0 |
December 2022 Financing [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering | 0 | 7,528 |
ATM Agreement [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering | $ 0 | $ 458 |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arr Line Items | |
Material Terms of Trading Arrangement [Text Block] | Item 9B. Other Information None. |
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 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 1. Organization and Summary of Significant Accounting Policies The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005 as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024 to Talphera, Inc. The Company’s operations are based in San Mateo, California. Talphera is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s product development portfolio features Niyad™ (a regional anticoagulant for the dialysis circuit), two ready-to-use pre-filled syringe, or PFS, product candidates (Fedsyra and phenylephrine), and LTX-608 (a nafamostat formulation for direct IV infusion) that the Company intends to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment. On March 12, 2023, the Company entered into an Asset Purchase Agreement, or the DSUVIA Agreement, with Vertical Pharmaceuticals, LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of the Company relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product. The closing of the DSUVIA Agreement occurred on April 3, 2023 (see Note 3, “Discontinued Operations”). On January 7, 2022, the Company acquired Lowell Therapeutics, Inc., or Lowell, a privately held company (see Note 4, “Asset Acquisition” below) and, as a result acquired the Niyad™ On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Laboratoire Aguettant, or Aguettant, pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States an ephedrine pre-filled syringe for injection, and (ii) a phenylephrine PFS for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the U.S. Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2023 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The termination of the Zalviso Royalty Monetization resulted in net income for the year ended December 31, 2022; however, prior to this, the Company had incurred recurring operating losses and negative cash flows from operating activities since inception and expects to continue to incur operating losses and negative cash flows in the future. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Although, the Company raised additional capital in January 2024 (see Note 16, “Subsequent Events”), considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, management expects to need additional capital to fund its planned operations prior to the 12-month anniversary of the date this Annual Report on Form 10-K is filed with the United States Securities and Exchange Commission, or the SEC. Management may seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity Offering SM Additional funds may not be available when the Company needs them on terms that are acceptable to the Company, or at all. If adequate funds are not available, the Company may be required to further reduce its workforce or delay the development of its regulatory filing plans for its product candidates in advance of the date on which the Company’s cash resources are exhausted to ensure that the Company has sufficient capital to meet its obligations and continue on a path designed to preserve stockholder value. In addition, if additional funds are raised through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish rights to its technologies, future revenue streams or product candidates, or to grant licenses on terms that may not be favorable to the Company. Basis of Presentation The preparation of financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. The Company’s audited financial statements as of December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2023, were recast to reflect discontinued operations and filed with the Company’s Current Report on Form 8-K on August 1, 2023. See Note 3, “Discontinued operations” below. Reclassifications Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year's presentation. In particular, property and equipment, net and restricted cash, net of current portion have been reclassified as other assets, and operating lease liabilities, current portion, has been reclassified as accrued and other liabilities in the consolidated balance sheets. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management believes its most significant accounting estimates relate to fair value of warrants, impairment of long-lived assets, management’s assessment of going concern, revenue recognition, liability for royalty monetization and accrued clinical trial liabilities. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks. On May 30, 2019, the Company entered into a Loan Agreement with Oxford Finance LLC, or Oxford, or the Lender. The Loan Agreement requires that the Company always maintain unrestricted cash of not less than $5.0 million in accounts subject to control agreements in favor of the Lender, tested monthly as of the last day of the month. The Company has classified these unrestricted funds as restricted cash on the consolidated balance sheets. On April 3, 2023, the Company repaid Oxford the full amount due under the loan, and the Loan Agreement was terminated with no further obligations by either party. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts in the consolidated statements of cash flows: Balance as of December 31, 2023 December 31, 2021 Cash and cash equivalents $ 5,721 $ 15,275 Restricted cash — 5,000 Total cash, cash equivalents, and restricted cash $ 5,721 $ 20,275 Short-Term Investments All marketable securities are classified as available for sale and consist of commercial paper and U.S. government sponsored enterprise debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. When the fair value of an available-for-sale security falls below the amortized cost basis it is evaluated to determine if any of the decline in value is attributable to credit loss. Decreases in fair value attributable to credit loss are recorded directly to the consolidated statement of operations with a corresponding allowance for credit losses, limited to the amount that the fair value is less than the amortized cost basis. If the credit quality subsequently improves the allowance is reversed up to a maximum of the previously recorded credit losses. When the Company intends to sell an impaired available-for-sale security, or if it is more likely than not that the Company will be required to sell the security prior to recovering the amortized cost basis, the entire fair value adjustment will immediately be recognized in the consolidated statement of operations with no corresponding allowance for credit losses. Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: Level I—Unadjusted quoted prices in active markets for identical assets or liabilities; Level II—Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level III—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Segment Information The Company operates in a single segment, the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s revenue relates to the Company’s services performed to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement (as defined in Note 3, “Discontinued Operations” below). Concentration of Risk The Company invests cash that is currently not being used for operational purposes in accordance with its investment policy in debt securities of U.S. government sponsored agencies, commercial paper and overnight deposits. The Company is exposed to credit risk in the event of default by the institutions holding the cash equivalents and available-for-sale securities to the extent recorded on the consolidated balance sheets. The Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows. The Company relies on a single contract manufacturer, or CMO, for the active pharmaceutical ingredient, or API, for Niyad™ and a second single contract manufacturer for the finished Niyad product. All revenue relates to the Company’s services for fees earned on the sales of DSUVIA to the DoD by Alora. Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. The Company realigned its cost structure from a focus on commercialization to a focus on advancing its late-stage development pipeline, namely the Niyad product candidates and the pre-filled syringes. As a result, the Company decided to not focus any development resources on Zalviso in the United States. In addition, due to the termination of the agreements with Grünenthal for Zalviso in Europe and the related withdrawal of the Marketing Authorization in Europe in July 2022 , . . Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use (a) the Company must reasonably expect that it will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) the Company’s use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis. Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the Company has classified the results of the DSUVIA business as discontinued operations in its consolidated statements of operations for all periods presented. All assets and liabilities associated with the DSUVIA business were classified as assets and liabilities of discontinued operations in the consolidated balance sheets for the periods presented. All amounts included in the notes to the consolidated financial statements relate to continuing operations unless otherwise noted. (See Note 3, “Discontinued Operations”). Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company’s revenue relates to the Company’s services performed to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement (as defined in Note 3, “Discontinued Operations” below). The Company’s performance obligation is to serve as the exclusive sales agent for selling DSUVIA to the DoD through the term of the Marketing Agreement. The non-creditable and non-refundable revenues are variable consideration based on 75% of net sales of DSUVIA to the DoD during the period subject to certain adjustments. The Company evaluates if it is a principal or an agent in a transaction to determine whether revenue should be recorded on a gross or net basis depending on if it obtains control over the goods and services before they are transferred to customers. The Company is acting as an agent in relation to DSUVIA sales to the DoD. The consideration in the Marketing Agreement reflects a variable amount, for which the Company estimates the amount of consideration to which it will be entitled by using the expected value method. The Company includes in the transaction price the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. Revenues are recognized when the DoD obtains control of the product, at which time the Company has an unconditional right to receive payment for such revenue earned. Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 Equity Incentive Plan, or 2020 EIP, the 2011 Equity Incentive Plan, or 2011 EIP, and employee share purchases related to the Amended and Restated 2011 Employee Stock Purchase Plan, or ESPP, is based on estimated fair values at grant date. The Company determines the grant date fair value of the awards using the Black-Scholes option-pricing model and generally recognizes the fair value as stock-based compensation expense on a straight-line basis over the vesting period of the respective awards. The Company applies the graded-vesting attribution method to awards with market conditions that include graded-vesting features. Additionally, the Company uses the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term. The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may reasonably affect the volatility of the Company’s stock in the future. The risk‑free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for the expected term of the award. The Company recognizes forfeitures when they occur and does not anticipate paying dividends in the near future. Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company s Own Stock Restructuring Costs The Company’s restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. In May 2022, the Company initiated a reorganization that eliminated approximately 40% of its employees, primarily within the commercial organization. For the year ended December 31, 2022, the Company incurred approximately $0.5 million in employee termination benefits related to this restructuring, all of which has been paid. This headcount reduction was completed in the second quarter of 2022. No additional expenses were incurred in connection with this cost reduction plan. Non-Cash Interest Income on Liability Related to Sale of Future Royalties In September 2015, the Company sold certain royalty and milestone payment rights from the sales of Zalviso in the European Union by Grünenthal to PDL for gross proceeds of $65.0 million, or the Zalviso Royalty Monetization. Grünenthal terminated the Grünenthal Agreements effective November 13, 2020. The terms of the Grünenthal Agreements were extended to May 2021 to enable Grünenthal to sell down its Zalviso inventory. The rights to market and sell Zalviso in the Territory reverted back to the Company in May 2021. Under the Zalviso Royalty Monetization, the Company had a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Zalviso Royalty Monetization was accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company was required to estimate the total amount of future royalty and milestone payments to be received by the Company and payments made to PDL, up to a capped amount of $195.0 million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the $61.2 million of net proceeds the Company received, was to be amortized as interest expense over the life of the liability. Consequently, the Company imputed interest on the unamortized portion of the liability and recorded interest expense, or interest income, as these estimates were updated and recorded non-cash royalty revenues and non-cash interest income (expense), net, within its consolidated statements of operations over the term of the Zalviso Royalty Monetization. When the expected payments under the Zalviso Royalty Monetization were lower than the gross proceeds of $65.0 million received, the Company deferred recognition of any probable contingent gain until the Zalviso Royalty Monetization liability expired. See Note 7, “Liability Related to Sale of Future Royalties”. Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. Net Income (Loss) per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 260, Earnings per Share The Company applies the two-class method to compute basic and, if more dilutive than other methods, diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders (including pre-funded warrants). Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date. In addition, the Company is required to calculate diluted net income or loss per share under the two-class method if the effect is more dilutive than the application of another dilutive method of calculating diluted EPS (i.e., the treasury stock, if-converted, or contingently issuable share method). In periods where there is a net loss, no allocation of undistributed net loss to participating securities is performed if the holders of these securities are not contractually obligated to participate in the Company’s losses. The Company’s participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A Redeemable Convertible Preferred Stock, and the Series A and Series B Common Stock Warrants, the placement agent Series A and Series B Common Stock Warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information). For additional information regarding the net income (loss) per share, see Note 12, “Net Income (Loss) per Share of Common Stock”. Recently Adopted Accounting Pronouncements In June 2016, the FASB, issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Recently Issued Accounting Pronouncements On December 14, 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements. |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Investments and Fair Value Measurement Disclosure [Text Block] | 2. Investments and Fair Value Measurement Investments The Company classifies its marketable securities as available for sale and records its investments at fair value. Available-for-sale securities are carried at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income (loss). As of December 31, 2023 and 2022, the contractual maturity of all investments held was less than one year. The tables below summarize the Company’s cash, cash equivalents and investments (in thousands): As of December 31, 2023 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 1,342 $ — $ — $ 1,342 Money market funds 90 — — 90 U.S. government agency securities 1,896 — — 1,896 Commercial paper 2,393 — — 2,393 Total cash and cash equivalents 5,721 — — 5,721 Short-term investments: U.S. government agency securities 3,362 — — 3,362 Commercial paper 298 — — 298 Total short-term investments 3,660 — — 3,660 Total cash, cash equivalents, and short-term investments $ 9,381 $ — $ — $ 9,381 As of December 31, 2022 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash, cash equivalents and restricted cash: Cash $ 13,275 $ — $ — $ 13,275 Money market funds 321 — — 321 U.S. government agency securities 2,444 — — 2,444 Commercial paper 4,235 — — 4,235 Total cash, cash equivalents and restricted cash 20,275 — — 20,275 Short-term investments: Commercial paper 495 — — 495 Total short-term investments 495 — — 495 Total cash, cash equivalents, restricted cash and short-term investments $ 20,770 $ — $ — $ 20,770 At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic conditions. There were no material realized or unrealized gains or losses on marketable securities for the years ended December 31, 2023 or 2022. As such, we did not record a credit allowance for the year ended December 31, 2023. Fair Value Measurement The Company’s financial instruments consist of Level I and II assets. Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. For Level II instruments, the Company estimates fair value by utilizing third-party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. Such Level II instruments typically include U.S. Treasury, U.S. government agency securities and commercial paper. As of December 31, 2023 and December 31, 2022, the Company held, in addition to Level II assets, a warrant liability related to the December 2022 Common Stock Warrants (see Note 10, “Warrants” below for further description). The fair value of the warrant liability was estimated using the Black Scholes Model which uses as inputs the following weighted average assumptions: dividend yield, expected term in years; equity volatility; and risk-free interest rate (see Note 10, “Warrants” below). The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period. The estimated fair value of the warrant liability represents a Level III measurement. Changes to the estimated fair value of these liabilities are recorded in interest income and other income, net in the consolidated statements of operations. The following tables set forth the fair value of the Company’s financial assets by level within the fair value hierarchy (in thousands): As of December 31, 2023 Fair Value Level I Level II Level III Assets Money market funds $ 90 $ 90 $ — $ — U.S. government agency securities 5,258 — 5,258 — Commercial paper 2,691 — 2,691 — Total assets measured at fair value $ 8,039 $ 90 $ 7,949 $ — Liabilities Warrant liability $ 1,778 $ — $ — $ 1,778 Total liabilities measured at fair value $ 1,778 $ — $ — $ 1,778 As of December 31, 2022 Fair Value Level I Level II Level III Assets Money market funds $ 321 312 — — U.S. government agency securities 2,444 — 2,444 — Commercial paper 4,730 — 4,730 — Total assets measured at fair value $ 7,495 $ 321 $ 7,174 $ — Liabilities Warrant liability $ 7,098 $ — $ — $ 7,098 Total liabilities measured at fair value $ 7,098 $ — $ — $ 7,098 The following table sets forth a summary of the changes in the fair value of the Company’s Level III warrant liability for the years ended December 31, 2023 and 2022 (in thousands): Year Ended December 31, 2023 Year Ended Fair value—beginning of period $ 7,098 $ — Issuance of December 2022 Common Stock Warrants — 7,098 Change in fair value of December 2022 Common Stock Warrants (5,320 ) — Fair value—end of period $ 1,778 $ 7,098 There were no transfers between Level I, Level II or Level III of the fair value hierarchy during the years ended December 31, 2023 or 2022. |
Note 3 - Discontinued Operation
Note 3 - Discontinued Operations | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Disposal Groups, Including Discontinued Operations, Disclosure [Text Block] | 3. Discontinued Operations Asset Purchase Agreement On April 3, 2023, the Company, closed the transactions contemplated by the DSUVIA Agreement entered into on March 12, 2023, with Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of the Company relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product. The Product expressly excludes the pharmaceutical product referred to as Zalviso (sufentanil sublingual tablets, each 15 mcg), any other multi-dose administration system containing sufentanil sublingual tablets (whether as the sole active ingredient or in combination with other active ingredients), and any single-dose formulation of sufentanil for use outside of a medically supervised setting. With the closing of the transaction, the Company is entitled to receive (a) up to $116.5 million in sales-based milestones, (b) quarterly payments in an amount equal to 15% of net sales based on sales of the Product to all customers, other than sales to the United States DoD under the Marketing Agreement (as defined below), pursuant to which Alora will pay the Company 75% of Product net sales to the DoD, and sales by or on behalf of Laboratoire Aguettant, or Aguettant, and (c) 20% of any consideration, excluding royalty payments based on sales of the Product and subject to customary exclusions, received by Alora or its affiliates in connection with a grant to any third party of a license related to the Product, or by Alora or its affiliates or equity holders in connection with a sale or transfer to any third party of an ownership interest in any assets acquired by Alora under the DSUVIA Agreement. The DSUVIA Agreement contains customary representations, warranties, and covenants by each party. Alora agreed not to practice, license or otherwise exploit any of the intellectual property rights acquired by it under the DSUVIA Agreement to manufacture, develop or commercialize any product (other than the Product) that is or has been commercialized by the Company or its affiliate as of the date of the DSUVIA Agreement, or any product that is competitive with any such product. In addition, Alora will use commercially reasonable efforts to maintain regulatory approvals for and commercialize the Product in the United States. The DSUVIA Agreement also contains indemnification rights for each of the Company and Alora for breaches of representations, warranties, and covenants, as well as certain other matters, subject to certain specified limitations. The Closing included the execution of the Amended DZUVEO Agreement (as defined below) and the Amended and Restated Supply Agreement (as defined below) between the Company and Aguettant, as well as certain ancillary agreements between the Company and Alora. Such ancillary agreements include (a) an intellectual property agreement, pursuant to which Alora granted fully-paid, royalty-free and perpetual licenses to the Company under certain specified intellectual property rights acquired by Alora under the DSUVIA Agreement for, among other things, the development, manufacture, commercialization and exploitation of certain products, including Zalviso, (b) a transition services agreement, pursuant to which, during the period specified therein, the Company will be paid to provide certain services (including, manufacturing technology transfer, supply chain, regulatory, and medical affairs services) to Alora, and distribute, on behalf of Alora, certain inventory of the Product transferred to Alora under the DSUVIA Agreement, and (c) an ongoing marketing agreement, or the Marketing Agreement, pursuant to which the Company will have the exclusive right to market and offer the Product for sale to the DoD and Alora will pay to the Company 75% of net sales of the Product sold to the DoD, subject to adjustment in certain circumstances. Amendments to Certain Agreements Between the Company and Aguettant The Company and Aguettant are parties to (a) the License and Commercialization Agreement, dated July 14, 2021, pursuant to which Aguettant obtained the exclusive right to develop and commercialize DZUVEO in certain European countries for the management of acute moderate to severe pain in adults in medically monitored settings, or the DZUVEO Agreement, and (b) the supply agreement, dated December 6, 2021, with respect to the manufacture and supply of DZUVEO in form of bulk product by the Company to Aguettant, or the Supply Agreement. Pursuant to the DSUVIA Agreement, the Company and Aguettant entered into an amendment to the DZUVEO Agreement, or the Amended DZUVEO Agreement, and an amendment and restatement to the Supply Agreement, or the Amended and Restated Supply Agreement. Pursuant to the Amended DZUVEO Agreement, (a) Aguettant’s obligations to make sales-based milestone payments and to achieve certain levels of minimum sales terminated, (b) the Company agreed to manufacture and supply DZUVEO in the form of bulk products (i.e., products that are pre-packaged in labeled pouches and packed in bright stock cartons for shipment) to Aguettant or its affiliates or sublicensees, and Aguettant will be responsible for manufacturing finished products from bulk products, before Aguettant establishes a semi-automated packaging line for the Product, and (c) after Aguettant has established such semi-automated packaging line, the Company will cause DZUVEO to be manufactured and supplied in the form of bulk tablets (i.e., products in tablet forms supplied in bulk (not packaged) quantities) to Aguettant or its affiliates or sublicensees, and Aguettant will be responsible for manufacturing finished products from bulk tablets. The Amended and Restated Supply Agreement will govern the manufacture and supply of DZUVEO in the form of bulk products or bulk tablets, and contain customary terms, including those with respect to manufacturing requirements, forecast, delivery, and post-delivery inspection. Pursuant to the DSUVIA Agreement, the Company assigned the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement to Alora. In addition, the Company and Aguettant amended the License and Commercialization Agreement, dated July 14, 2021, pursuant to which the Company obtained exclusive rights to develop and commercialize certain ephedrine pre-filled syringe and certain phenylephrine prefilled syringe in the United States, or the PFS Agreement (see Note 5, “In-License Agreement” below). The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the assets and liabilities associated with these operations have been classified as assets and liabilities of discontinued operations in the consolidated balance sheets at December 31, 2023 and 2022. The operations and cash flows of the DSUVIA business are presented as discontinued for all periods presented. The following table presents the results of the discontinued operations (in thousands): Year ended December 31, 2023 2022 Total revenues $ 501 $ 1,771 Cost of goods sold 711 1,508 Selling, general and administrative expense 731 9,744 Impairment of net assets held for sale 6,853 — Impairment of fixed assets 1,065 — Gain on termination of lease liabilities (1,098 ) — Research and development expenses 349 1,852 Loss from discontinued operations (8,110 ) (11,333 ) Interest expense — 37 Net loss from discontinued operations $ (8,110 ) $ (11,370 ) The following table summarizes the carrying amounts of major classes of assets and liabilities of discontinued operations for each of the periods presented (in thousands). December 31, 2023 December 31, 2022 Accounts receivable, net $ — $ 309 Inventories — 1,178 Prepaid expenses and other current assets — 444 Total current assets of discontinued operations — 1,931 Property, plant and equipment, net — 10,261 Operating lease right-of-use assets — 3,499 Other assets — 176 Total non-current assets of discontinued operations — 13,936 Total assets of discontinued operations $ — $ 15,867 Accounts payable $ 10 $ 784 Accrued liabilities 721 1,720 Operating lease liabilities, current portion — 1,601 Note payable, current portion — 400 Deferred revenue, current portion — 115 Total current liabilities of discontinued operations 731 4,620 Operating lease liabilities, net of current portion — 2,959 Deferred revenue, net of current portion — 1,036 Total non-current liabilities of discontinued operations — 3,995 Total liabilities of discontinued operations 731 8,615 Net assets (liabilities) of discontinued operations $ (731 ) $ 7,252 The following table presents the significant non-cash items and purchases of property and equipment for the discontinued operations that are included in the consolidated statements of cash flows (in thousands): Year Ended December 31, 2023 2022 Cash flows from operating activities: Depreciation and amortization $ 215 $ 1,465 Stock-based compensation 19 250 Impairment of net assets held for sale 6,853 — Impairment of fixed assets 1,065 — Gain on termination of lease liabilities (1,098 ) — Gain on extinguishment of debt (400 ) — Purchases of property and equipment (100 ) (364 ) The following table represents the loss on sale of discontinued operations for the year ended December 31, 2023: Year Ended December 31, 2023 Cash proceeds $ 2,723 Less: net assets transferred (8,723 ) Less: disposal costs (853 ) Loss on sale of discontinued operations, before income taxes (6,853 ) Income tax expense — Loss on sale of discontinued operations $ (6,853 ) |
Note 4 - Asset Acquisition
Note 4 - Asset Acquisition | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Business Combination Disclosure [Text Block] | 4. Asset Acquisition On January 7, 2022, the Company closed its acquisition of Lowell and acquired the product nafamostat, and the associated patents and historical know-how. The acquisition was valued at approximately $32.5 million plus cash acquired of $3.5 million and certain other adjustments. All options to purchase capital stock and all shares of Lowell capital stock issued and outstanding immediately before the effective time of the merger were cancelled in exchange for the right to receive (i) 450,477 shares of the Company’s common stock issued at a five day daily volume weighted average price of $11.46 per share as of January 7, 2022, or the Acquisition Date, valued at $5.2 million on closing, (ii) cash in the amount of $3.5 million, (iii) 69,808 shares of the Company’s common stock to be held back to satisfy any potential indemnification and other obligations of Lowell and its securityholders valued at $0.8 million, (iv) $0.5 million cash and stock paid for sellers’ transaction costs and (v) up to $26.0 million of contingent consideration payable in cash or stock at the Company's option, upon the achievement of regulatory and sales-based milestones. The shares issued in the merger were issued in a private placement pursuant to the exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Securities Act, including Rule 506 of Regulation D promulgated under the Securities Act, or Regulation D, without general solicitation as a transaction not involving any public offering. The merger has been accounted for as an asset acquisition of a single IPR&D asset that has an alternative future use. The initial measurement of the asset purchased of $8.8 million was based on the purchase cost of $12.4 million including (i) $6.0 million common stock fair value on the closing date (issued and held back on the acquisition date), (ii) $0.5 million seller’s costs paid by the Company, (iii) $3.5 million cash and (iv) approximately $2.5 million of transaction costs less purchase price allocated to cash acquired of $3.5 million. Due to the nature of regulatory and sales-based milestones, the contingent consideration of up to $26.0 million was not included in the initial cost of the assets purchased as they are contingent upon events that are outside the Company’s control, such as regulatory approvals and issuance of patents, and are not considered probable until notification is received. However, upon achievement or anticipated achievement of each milestone, the Company shall recognize the related, appropriate payment as an additional cost of the acquired IPR&D asset. As of December 31, 2023, none of the contingent events have occurred. The following table summarizes the total consideration for the acquisition and the value of the IPR&D asset acquired (in thousands): Consideration Cash $ 3,536 Issuance of common stock to Lowell security holders in connection with asset acquisition 5,161 Issuance of common stock to settle Lowell’s transaction costs in connection with asset acquisition 350 Liability for issuance of 69,808 hold back shares to Lowell securityholders (1) 800 Transaction costs 2,521 Total consideration $ 12,368 IPR&D Asset Acquired Purchase price $ 12,368 Cash acquired (3,549 ) Total IPR&D asset acquired (2) $ 8,819 (1) (2) The IPR&D asset has initially been accounted for as an indefinite-lived asset, and as a long-lived asset, it is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If the IPR&D asset achieves regulatory approval and the asset life is determined to be finite, the asset’s useful life will be estimated, and the asset will be amortized over its remaining useful life. No |
Note 5 - In-license Agreement
Note 5 - In-license Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
In-license Agreement [Text Block] | 5. In-License Agreement On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe for injection, and (ii) a phenylephrine pre-filled syringe for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the United States. The PFS Agreement has an initial term of ten (10) five The Company will purchase each product from Aguettant at an agreed price, or the PFS Purchase Price, subject to adjustment. The Company will also make revenue share payments that, combined with the PFS Purchase Price, will range from 40% to 45% of net sales in the United States. The Company and Aguettant will agree on minimum sales obligations twelve (12) The Company has the right to grant sublicenses to its affiliates or, with the prior approval of Aguettant, third parties, subject to certain limitations. In connection with the Company’s and Aguettant’s agreement to enter into the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement, the parties entered into an amendment to the PFS Agreement, or the Amended PFS Agreement, pursuant to which, effective April 3, 2023, (a) Aguettant paid the Company a complementary payment in the amount of EUR 1,500,000, and (b) the Company’s obligation to make a certain specified sales-milestone payment terminated such that the maximum amount in sales-based milestone payments that Aguettant is entitled to receive has been reduced from $24.0 million to $21.0 million. As of December 31, 2023, there have been no payments by the Company to Aguettant under the PFS Agreement. |
Note 6 - Long-term Debt
Note 6 - Long-term Debt | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Long-Term Debt [Text Block] | 6. Long-Term Debt Loan Agreement with Oxford On May 30, 2019, the Company entered into the Loan Agreement with Oxford Finance LLC, or Oxford, as the Lender. Under the Loan Agreement, the Lender made a term loan to the Company in an aggregate principal amount of $25.0 million, or the Loan, which was funded on May 30, 2019. As of December 31, 2022, the accrued balance due under the Loan Agreement with Oxford was $5.4 million. Interest expense related to the Loan Agreement was $0.1 million for the year ended December 31, 2023, $0.1 million of which represented amortization of the debt discount. Interest expense related to the Loan Agreement was $1.1 million, of which $0.4 million represented amortization of the debt discount, and $2.2 million for the year ended December 31, 2022 and the effective interest rate was approximately 13.6%. In connection with the closing of the divestment of DSUVIA to Alora, on April 3, 2023, the Company paid Oxford the remaining amount due of approximately $3.4 million including accrued interest and fees under the Loan, and the Loan Agreement was terminated with no further obligations by either party. In connection with the Loan Agreement, on May 30, 2019, the Company issued warrants to the Lender and its affiliates, which are exercisable for an aggregate of 8,833 shares of the Company’s common stock with a per share exercise price of $56.60, or the Warrants. The Warrants have been classified within stockholders’ equity and accounted for as a discount to the loan by allocating the gross proceeds on a relative fair value basis. For further discussion, see Note 10, “Warrants”. |
Note 7 - Liability Related to S
Note 7 - Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 7. Liability Related to Sale of Future Royalties On September 18, 2015, the Company entered into the Zalviso Royalty Monetization with PDL for which it received gross proceeds of $65.0 million. Under the Zalviso Royalty Monetization, PDL was to receive 75% of the European royalties under the Amended License Agreement with Grünenthal, as well as 80% of the first four commercial milestones worth $35.6 million (or 80% of $44.5 million), up to a capped amount of $195.0 million over the life of the arrangement. The Company periodically assessed the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments were greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company prospectively adjusted the amortization of the liability and the effective interest rate. Grünenthal notified the Company that it was terminating the Amended License Agreement effective November 13, 2020. On August 31, 2020, PDL sold its royalty interest for Zalviso to SWK Funding, LLC, or SWK, under the Zalviso Royalty Monetization. The terms of the Grünenthal Agreements were extended to May 12, 2021 to enable Grünenthal to sell down its Zalviso inventory. The rights to market and sell Zalviso in Europe reverted back to the Company on May 12, 2021. On May 31, 2022, the Company entered into a Termination Agreement with SWK to fully terminate the Zalviso Royalty Monetization for which the Company paid cash consideration of $0.1 million, and neither PDL nor SWK retains any further interest in the Zalviso Royalty Monetization. Accordingly, effective May 31, 2022, the Zalviso Royalty Monetization is no longer reflected on the Company’s consolidated financial statements or other records as a sale of assets to PDL or SWK and all security interests and other liens of every type held by the parties to the Zalviso Royalty Monetization have been terminated and automatically released without further action by any party. The $84.1 million gain on extinguishment of the liability related to the sale of future royalties is recognized in the consolidated statements of operations as other income. The effective interest income rate for the year ended December 31, 2022 was approximately 3.2%. The following table shows the activity within the liability account during the year ended December 31, 2022 (in thousands): Year ended Period from Liability related to sale of future royalties — beginning balance $ 85,288 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue — (1,083 ) Non-cash interest (income) expense recognized (1,136 ) 24,051 Consideration paid for termination of Royalty Monetization (100 ) (100 ) Gain on extinguishment of liability related to sale of future royalties (84,052 ) (84,052 ) Liability related to sale of future royalties as of December 31, 2022 $ — $ — |
Note 8 - Commitments and Contin
Note 8 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 8. Commitments and Contingencies Litigation On June 8, 2021, a securities class action complaint was filed in the U.S. District Court for the Northern District of California against the Company and two On July 6, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the securities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S. District Court for the Northern District of California. The complaints name nine of the Company’s officers and directors and also assert state and federal claims based on the same alleged misstatements as the securities class action complaint. All four complaints seek unspecified damages, attorneys’ fees, and other costs. On December 6, 2021, the Court entered an order consolidating all four actions and staying the consolidated action pending the outcome of any motion to dismiss the securities class action. On February 16, 2024, another purported shareholder derivative complaint was filed in the Court of Chancery of the State of Delaware. The complaint names nine of the Company’s officers and directors and asserts the same claims as those in the previously filed derivative actions. The Company has not yet been served. Please see “Part I., Item 1A. Risk Factors—Risks of a General Nature—Litigation may substantially increase our costs and harm our business.” The Company believes that these lawsuits are without merit and intends to vigorously defend against them. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot estimate the reasonably possible loss or range of loss that may result from these actions. It is reasonably possible that this estimate may change in the near term. An adverse outcome regarding these matters could materially adversely affect the Company’s financial condition, results of operations, and cash flows. Termination Agreement and Mutual Release Between the Company and Catalent On March 12, 2023, the Company and Catalent Pharma Solutions, LCC, or Catalent, entered into a termination agreement and mutual release, or the Termination Agreement, to terminate the Site Readiness Agreement with an effective date of August 15, 2019 and as amended on September 24, 2020, the SRA Agreement, and the commercial supply agreement with an effective date of March 31, 2021, the CSA Agreement. Pursuant to the Termination Agreement, as of the date on which the Company has removed and transported certain equipment from Catalent’s site, the SRA Agreement and the CSA Agreement will terminate except with respect to certain specified provisions of such agreements. |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | 9. Stockholders Equity The Company is authorized to issue two classes of stock to be designated, respectively, as “Common Stock” and “Preferred Stock.” The total number of shares which the Company is authorized to issue is 210,000,000 shares, and includes 200,000,000 shares of Common Stock, each having a par value of $0.001, and 10,000,000 shares of Preferred Stock, each having a par value of $0.001. Each outstanding share of Common Stock entitles the holder thereof to one vote on each matter properly submitted to the stockholders of the Company for their vote. The rights, preferences and privileges of the holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Preferred Stock that we may designate in the future. As of December 31, 2023, there are no Subject to the preferences that may be applicable to any outstanding shares of Preferred Stock, the holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared by the Company’s board of directors. No dividends have been declared to date. Preferred Stock On August 3, 2022, the Company entered into a securities purchase agreement with LPC, or the Purchaser, pursuant to which the Company issued, in a private placement transaction, 3,000 shares of Series A Redeemable Convertible Preferred Stock, par value $0.001 per share, with $100 per share stated value, together with a warrant to purchase up to an aggregate of 81,150 shares of common stock at an exercise price of $4.07 per share, for $0.3 million (see Note 10, “Warrants”). The transaction price of $0.3 million was allocated to the Series A Redeemable Convertible Preferred Stock and warrants based on their relative fair values. The Series A Redeemable Convertible Preferred Stock was initially recorded at $0.1 million separately from stockholders’ equity in the Company’s consolidated balance sheets due to the shares being redeemable based on contingent events outside of the Company’s control. The Series A Redeemable Convertible Preferred Stock was convertible, at the option of the holders, into shares of common stock at a conversion price of approximately $3.70 per share, subject to adjustment and beneficial ownership limitations set forth in the Certificate of Designation. The Company had the option to redeem the Series A Redeemable Convertible Preferred Stock for cash at 105% of the Stated Value on the date of and for 15 days following the Reverse Stock Split, subject to the Purchaser’s right to convert the shares prior to such redemption. The Purchaser had the right to require the Company to redeem the shares of Series A Redeemable Convertible Preferred Stock for cash at 110% of the Stated Value of such shares commencing after the Company’s right to redeem expired. The Series A Redeemable Convertible Preferred Stock was required to redeemed for cash at 110% of the Stated Value upon a delisting event. As a result, the Series A Redeemable Convertible Preferred Stock was recorded separately from stockholders’ equity because it was redeemable upon the occurrence of redemption events that were considered not solely withing the Company’s control. As such, during the year ended December 31, 2022, the Company recognized approximately $0.2 million in deemed dividends related to the Series A Redeemable Convertible Preferred Stock in the consolidated statements of operations and the consolidated statements of changes in redeemable convertible preferred stock and stockholders’ equity. The holders of the Series A Redeemable Convertible Preferred Stock were entitled to certain registration rights, rights for approval of increases in the authorized shares of such series, and to dividends paid on common stock on an as-if converted basis. The Series A Redeemable Convertible Preferred stock had no voting rights, other than the right to (i) vote exclusively on the Reverse Stock Split and any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split and (ii) to 1,000,000 votes per each share of Series A Redeemable Convertible Preferred Stock, to vote together with the common stock, as a single class; to the extent cast on the Reverse Stock Split in the same proportion as shares of common stock. In addition, in the event of any liquidation, dissolution, or winding-up of the Company, the holders of the Series A Redeemable Convertible Preferred Stock were entitled to receive 110% the preferred stock’s Stated Value plus any declared but unpaid dividends before any payment was made to holders of common stock. On October 11, 2022, the Company and LPC entered into the Securities Redemption Agreement whereby on October 12, 2022, the Company redeemed for cash at a price equal to 105% of the Stated Value per share all 3,000 outstanding shares of Series A Redeemable Convertible Preferred Stock for $0.3 million. As a result, all shares of such series were retired and are no longer outstanding. On October 25, 2022, the Company filed a certificate of elimination to its amended and restated certificate of incorporation which (i) eliminated the previous designation of 3,000 shares of Series A Redeemable Convertible Preferred Stock from the Company’s amended and restated certificate of incorporation and (ii) caused such shares of Series A Redeemable Convertible Preferred Stock to resume their status as authorized but unissued and non-designated shares of preferred stock. Common Stock July 2023 Private Placement On July 17, 2023, the Company entered into a securities purchase agreement, or the Purchase Agreement, with several institutional investors, or the Purchasers, relating to the issuance and sale to the Purchasers in a private placement of 5,340,591 shares of common stock, par value $0.001 per share, pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of common stock at an exercise price of $0.001 per share, or the July 2023 Pre-Funded Warrants; July 2023 Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share; and July 2023 Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share. See Note 10, “Warrants” for additional information regarding the July 2023 Pre-Funded Warrants, and July 2023 Series A and Series B common stock warrants. The private placement closed on July 20, 2023. The combined offering price was $1.36 per share of common stock and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant, or in the case of July 2023 Pre-Funded Warrants, $1.359 per pre-funded warrant and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant (which is the purchase price per share of common stock and accompanying warrants less $0.001). The aggregate gross proceeds to the Company from the private placement were approximately $10.0 million, before deducting placement agent fees and other expenses payable by the Company of approximately $1.1 million, and excluding the proceeds, if any, from the exercise of the July 2023 Pre-Funded Warrants and July 2023 Series A and July 2023 Series B common stock warrants issued in the private placement. The potential gross proceeds from the July 2023 Series A common stock warrants and July 2023 Series B common stock warrants, if fully exercised for cash, is approximately $16.3 million. In May 2023, the Company engaged H.C. Wainwright & Co., LLC to act as placement agent in the private placement. As compensation, the Company paid the placement agent a cash fee equal to 5.25% of the aggregate gross proceeds generated from the private placement and reimbursed certain expenses of the placement agent in connection with the private placement totaling $0.1 million. The placement agent will be entitled to an additional one-time payment of $200,000 upon the exercise of the July 2023 Series A and Series B common stock warrants resulting in cumulative aggregate gross proceeds to the Company of at least $9.5 million in cash. As of December 31, 2023, none of the July 2023 Series A or Series B common stock warrants were exercised. In addition, the Company issued to the placement agent fully vested July 2023 Series A common stock warrants, or placement agent July 2023 Series A common stock warrants, to purchase 183,824 shares of common stock and fully vested July 2023 Series B common stock warrants, or placement agent July 2023 Series B common stock warrants, to purchase 183,823 shares of common stock. See Note 10, “Warrants” for additional information regarding the placement agent July 2023 Series A and Series B common stock warrants. December 2022 Registered Direct Offering On December 29, 2022, the Company completed the December 2022 Financing in which it issued (i) 748,744 shares of its common stock, par value $0.001 per share, (ii) the December 2022 Pre-Funded Warrants to purchase 2,632,898 shares of common stock, and (iii) the December 2022 Common Stock Warrants, which accompany the common stock and December 2022 Pre-Funded Warrants, to purchase an aggregate of 4,227,052 shares of common stock (see Note 10, “Warrants”). The shares of common stock and accompanying December 2022 Warrants were sold at a combined offering price of $2.22625 per share and accompanying common warrant, and the December 2022 Pre-Funded Warrants and accompanying December 2022 Common Stock Warrants were sold at a combined offering price of $2.22615 per December 2022 Pre-Funded Warrant and accompanying December 2022 Common Stock Warrant. The December 2022 Financing resulted in aggregate gross proceeds of $7.5 million, before $1.7 million of transaction costs, $0.8 million of which were non-cash issuance costs, excluding the proceeds, if any, from the exercise of the December 2022 Pre-Funded Warrants and the December 2022 Common Stock Warrants. The common stock was allocated $0.1 million of the gross proceeds received based on its relative fair value to the other instruments issued (see Note 10, “Warrants”). January 2024 Private Placement On January 17, 2024, the Company entered into a private placement with certain institutional investors for aggregate gross proceeds of $6.0 million upfront, an additional $10.0 million committed upon the announcement of positive clinical trial results for the Company’s NEPHRO study of Niyad, and an additional $2.0 million if Talphera stock trades above a specified price following the NEPHRO registration trial announcement, before deducting offering expenses payable by us (see Note 16, “Subsequent Events” below for additional information). ATM Agreement On June 21, 2016, the Company entered into a Controlled Equity Offering SM The Company issued and sold 124,330 shares of common stock pursuant to the ATM Agreement and received net proceeds of $0.5 million, after deducting fees and expenses, during the year ended December 31, 2022. No As of December 31, 2023, the Company had the ability to offer and sell shares of the Company’s common stock having an aggregate offering price of up to $35.6 million under the ATM Agreement. The Company’s ability to sell shares under the ATM Agreement will be limited until the Company is no longer subject to the SEC’s “baby shelf” limitations. Stock Plans 2011 Equity Incentive Plan In January 2011, the Board of Directors adopted, and the Company’s stockholders approved, the 2011 Equity Incentive Plan, or 2011 EIP. The initial aggregate number of shares of the Company’s common stock that were issuable pursuant to stock awards under the 2011 EIP was approximately 93,750 shares. The number of shares of common stock reserved for issuance under the 2011 EIP automatically increased on January 1 of each year, starting on January 1, 2012 and continuing through January 1, 2020, by 4% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or such lesser number of shares of common stock as determined by the Board of Directors. As of June 16, 2020, no Amended 2020 Equity Incentive Plan On June 16, 2020, at the 2020 Annual Meeting of Stockholders of the Company, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Company’s 2020 Equity Incentive Plan, or the 2020 EIP. The initial aggregate number of shares of the Company’s common stock issuable pursuant to stock awards under the 2020 EIP was 275,000 shares. In addition, the share reserve will be increased by the number of returning shares, if any, as such shares become available from time to time under the 2011 EIP, for an additional number of shares not to exceed 744,608 shares. The term of any option granted under the 2020 EIP is determined on the date of grant but shall not be longer than 10 years. The Company issues new shares for settlement of vested restricted stock units and exercises of stock options. The Company does not have a policy of purchasing its shares relating to its stock-based programs. On October 10, 2023, at the 2023 Annual Meeting of Stockholders of the Company, upon the recommendation of the Company’s Board of Directors, the Company’s stockholders approved an amendment and restatement of the Company’s 2020 Equity Incentive Plan, or the Amended 2020 Plan, to increase the number of authorized shares reserved for issuance thereunder by 1,500,000 shares, subject to adjustment for certain changes in the Company’s capitalization. The aggregate number of shares of the Company’s common stock that may be issued under the Amended 2020 Plan will not exceed the sum of: (i) 1,990,000 shares, and (ii) up to 744,608 shares subject to outstanding awards granted under the 2011 Equity Incentive Plan that may become available for issuance under the Amended 2020 Plan, as such shares become available from time to time. Amended and Restated 2011 Employee Stock Purchase Plan Additionally, on June 16, 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2011 Employee Stock Purchase Plan, or the Amended ESPP, which increased the aggregate number of shares of the Company’s common stock reserved for issuance under the 2011 Employee Stock Purchase Plan, or ESPP, to 245,000 shares, subject to adjustment for certain changes in the Company’s capitalization, and removed the “evergreen” provision from the ESPP. In the year ended December 31, 2023, there were 42,209 shares issued under the Amended ESPP. The weighted average fair value of shares issued under the Amended ESPP in 2023 and 2022 was $1.08 and $6.82 per share, respectively. As of December 31, 2023, there were 169,667 shares available for future grant under the Amended ESPP. |
Note 10 - Warrants
Note 10 - Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Warrants Disclosure [Text Block] | 10. Warrants The activity related to warrants during the years ended December 31, 2023 and 2022, is summarized as follows: Common Stock from Warrants Weighted-average Outstanding at December 31, 2021 883,833 $ 5.15 Granted 6,941,100 $ 1.27 Outstanding at December 31, 2022 7,824,933 $ 1.71 Granted 17,085,897 $ 0.99 Exercised (3,228,781 ) $ (0.0003 ) Outstanding at December 31, 2023 21,682,049 $ 1.40 Exercisable at December 31, 2023 21,682,049 $ 1.40 At December 31, 2023, the range of exercise prices for shares under warrants and the weighted-average remaining contractual life is as follows: Warrants Outstanding Warrants Exercisable Warrant Exercise Price Number of Warrants Weighted- Average Remaining Contractual Life (Years) Number of Warrants Weighted- Average Exercise Price $ 0.001 1,416,473 Unlimited 1,416,473 $ 0.001 $ 1.11 14,787,044 4.62 14,787,044 $ 1.11 $ 1.70 367,647 4.62 367,647 $ 1.70 $ 2.07 4,977,052 5.07 4,977,052 $ 2.07 $ 20.00 125,000 2.92 125,000 $ 20.00 $ 56.60 8,833 5.49 8,833 $ 56.60 Total 21,682,049 5.06 21,682,049 $ 1.40 July 2023 Private Placement Warrants On July 20, 2023, the Company issued pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of common stock at an exercise price of $0.001 per share, or the July 2023 Pre-Funded Warrants, the July 2023 Series A Common Stock Warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share, and the July 2023 Series B Common Stock Warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share. The July 2023 Pre-Funded Warrants were exercisable immediately following the closing date of the July 2023 Private Placement, or July 20, 2023, and have an unlimited term and an exercise price of $0.001 per share. The July 2023 Series A and Series B common stock warrants were exercisable immediately following the closing date of July 20, 2023 and have a five The Company evaluated the July 2023 Pre-Funded Warrants, and the July 2023 Series A and Series B Common Stock Warrants under ASC 815-40 and determined that they did not require liability classification and met the requirements for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity. Accordingly, the proceeds were allocated between common stock and the 2023 Pre-Funded Warrants, Series A and Series B common stock warrants at their respective relative fair value basis to stockholders’ equity and as a component of additional paid-in capital on the consolidated balance sheets. The fair value of the July 2023 Series A and Series B Common Stock Warrants was determined using a Black-Scholes option pricing model and the common stock based on the closing date share price and were recorded in additional paid-in capital within stockholders' equity on the consolidated balance sheets. The placement agent July 2023 Series A and Series B Common Stock Warrants have the same terms as the July 2023 Series A and Series B Common Stock Warrants to be issued to the purchasers, except such warrants do not have a Black Scholes provision in the event of a fundamental transaction and the exercise price of such warrants is $1.70 per share, which is 125% of the combined offering price per share. The Company concluded that the placement agent July 2023 Series A and Series B Common Stock Warrants are freestanding equity-linked derivative instruments that met the criteria for equity classification. The placement agent July 2023 Series A and Series B Common Stock Warrants were valued at approximately $0.3 million, using the Black-Scholes option pricing model as follows: exercise price of $1.70 per share, stock price of $1.07 per share, expected life of 5 years, volatility of 94.3%, a risk-free rate of 4.08% and 0% expected dividend yield. As of December 31, 2023, all of the July 2023 Series A and Series B Common Stock Warrants and the placement agent July 2023 Series A and Series B Common Stock Warrants had not been exercised and were still outstanding, while 595,883 of the July 2023 Pre-Funded Warrants were exercised in the year ended December 31, 2023 and 1,416,473 remained outstanding as of December 31, 2023. On January 17, 2024, certain of these July 2023 Series A and Series B Common Stock Warrants were amended to reduce the exercise price to $0.77 per share in connection with the January 2024 Private Placement (see Note 16, “Subsequent Events” below for additional information). December 2022 Registered Direct Offering Warrants On December 29, 2022, the Company issued pre-funded warrants to purchase 2,632,898 shares of common stock, or the December 2022 Pre-Funded Warrants, and common warrants to purchase an aggregate of 4,227,052 shares of common stock, or the December 2022 Common Stock Warrants. The December 2022 Pre-Funded Warrants were exercisable immediately following the closing date of the December 2022 Registered Direct Offering, or December 29, 2022, had an unlimited term and an exercise price of $0.0001 per share. The December 2022 Common Stock Warrants were exercisable following the six-month anniversary of the closing date of December 29, 2022, have a six In the event of certain fundamental transactions involving the Company, the holder of the December 2022 Common Stock Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs. The December 2022 Pre-Funded Warrants did not provide similar rights to the Purchaser. Therefore, the Company accounted for the December 2022 Common Stock Warrants as a liability, while the December 2022 Pre-Funded Warrants met the permanent equity criteria classification. The December 2022 Pre-Funded Warrants were classified as a component of permanent equity, or APIC, because they were freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the December 2022 Pre-Funded Warrants did not provide any guarantee of value or return. The December 2022 Common Stock Warrants were valued upon issuance at approximately $7.1 million, using the Black-Scholes option pricing model as follows: exercise price of $2.07 per share, stock price of $2.13 per share, expected life of 6 years, volatility of 95.44%, a risk-free rate of 3.93% and 0% expected dividend yield. Accordingly, the Company allocated the fair value of $7.1 million of the gross proceeds received to Warrant liability on it consolidated balance sheets. The aggregate remaining gross proceeds of $0.4 million were allocated to the two remaining securities using the relative fair value method, resulting in the common stock and the December 2022 Pre-Funded Warrants being allocated values of $0.1 million and $0.3 million, respectively, and such amount being recorded to stockholders’ equity. At December 31, 2023, the December 2022 Common Stock Warrants were valued at approximately $1.8 million, using the Black-Scholes option pricing model as follows: exercise price of $2.07 per share, stock price of $0.74 per share, expected life of 5 years, volatility of 94.05%, a risk-free rate of 3.84% and 0% expected dividend yield. See Note 2, “Investments and Fair Value Measurement” above. As of December 31, 2023, none of the 4,227,052 December 2022 Common Stock Warrants had been exercised and were still outstanding, while the 2,632,898 December 2022 Pre-Funded Warrants were exercised in full in the year ended December 31, 2023. August 2022 LPC Warrant The August 2022 LPC Warrant had an original exercise price of $4.07 per share (subject to adjustment for stock splits, reverse stock splits and similar recapitalization events), became immediately exercisable and has a term ending on February 3, 2028. In addition, through August 3, 2023, if the Company issued or sold (or is deemed to have issued or sold) any common stock, convertible securities or options (as defined in the August 2022 LPC Warrant), for a consideration per share, or the New Issuance Price, less than a price equal to the exercise price in effect immediately prior to such issue or sale or deemed issuance or sale, each of the foregoing, a dilutive issuance, then immediately after such dilutive issuance, the exercise price then in effect for the August 2022 LPC Warrant shall be reduced to an amount equal to the New Issuance Price, or the Down Round Feature. In December 2022, the Down Round Feature was triggered due to the price per share received from the issuance of common stock and warrants in connection with the December 2022 Financing. In July 2023, the Down Round Feature was again triggered due to the price per share received from the issuance of common stock and warrants in connection with the in connection with the July 2023 Private Placement. In each instance, the Company calculated the value of the effect of the Down Round Feature measured as the difference between the warrants’ fair value, using the Black-Scholes option-pricing model, before and after the Down Round Feature was triggered using the then current exercise price and the new exercise price. The difference in fair value of the effect of the Down Round Feature was immaterial in both instances and had no impact on net loss per share in the periods presented. This down round feature expired on August 3, 2023. The August 2022 LPC Warrant was originally valued at approximately $0.3 million using the Black-Scholes option pricing model as follows: exercise price of $4.07 per share, stock price of $4.44 per share, expected life of 5.5 years, volatility of 89.94%, a risk-free rate of 2.86% and 0% expected dividend yield. The Series A Redeemable Convertible Preferred Stock and the August 2022 LPC Warrant were issued in a unit structure with the August 2022 LPC Warrant eligible to be classified in stockholders’ equity, therefore the aggregate net proceeds of $0.2 million were allocated to the two securities using the relative fair value method, resulting in the Series A Redeemable Convertible Preferred Stock and the August 2022 LPC Warrant being allocated values of $0.1 million and $0.1 million, respectively, and recorded to stockholders’ equity. As of December 31, 2023, the August 2022 LPC Warrant had not been exercised and was still outstanding. November 2021 Financing Warrants On November 15, 2021, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company, in a registered direct offering, sold (i) an aggregate of 875,000 shares of the Company’s common stock, and (ii) warrants to purchase up to an aggregate of 875,000 shares of common stock, for an aggregate purchase price of $14.0 million. The November 2021 Financing Warrants had an original exercise price of $20.00 per share and became exercisable, if the holder’s post-exercise beneficial ownership is less than or equal to 9.99%, 6 months after their issuance date and had a five-year term through November 15, 2026. The November 2021 Financing warrants were valued at approximately $8.6 million using the Black-Scholes option pricing model as follows: exercise price of $20.00 per share, stock price of $14.92 per share, expected life of five Upon the closing of the December 2022 Financing, 750,000 of the 875,000 November 2021 Financing Warrants were modified, to reduce the exercise price of the warrants from $20.00 per share to $2.07 per share and to extend the expiration date to December 29, 2028. The modification of these November 2021 Financing Warrants lowered the exercise price to the price per share in the December 2022 Financing. These November 2021 Financing Warrants remained a freestanding equity-classified instrument following the modification. The Company concluded that the modification of these November 2021 Financing Warrants provided more favorable terms to the Purchaser with the purpose of inducing the Purchaser to complete the December 2022 Financing. Pursuant to ASU 2021-04, the Company remeasured the fair value of the November 2021 Financing Warrants as of the modification date based on the modified terms and recorded the increase in fair value of $0.8 million as equity issuance costs, $0.7 million of which was allocated to selling, general and administrative expenses and $0.1 million of which was allocated to additional paid in capital, based on the relative fair values of the 2022 Warrants, classified as liabilities, and the Common Stock and Pre-funded Warrants, classified in equity, respectively. The fair value assumptions related to the modification of these 750,000 November 2021 Financing Warrants as of December 29, 2022 were as follows: exercise price of $2.07 per share, stock price of $2.13 per share, expected life of six The remaining warrants issued in the November 17, 2021 registered direct offering for 125,000 shares of the Company’s common stock are currently exercisable at a price of $20.00 per share and expire on November 15, 2026. As of December 31, 2023, all of the November 2021 Financing Warrants had not been exercised and were still outstanding. Loan Agreement Warrants In connection with the Loan Agreement, on May 30, 2019, the Company issued warrants to the Lender and its affiliates, which are exercisable for an aggregate of 8,833 shares of the Company’s common stock with a per share exercise price of $56.60, or the Loan Agreement Warrants. The Loan Agreement Warrants may be exercised on a cashless basis. The Loan Agreement Warrants are exercisable for a term beginning on the date of issuance and ending on the earlier to occur of ten As of December 31, 2023, Loan Agreement Warrants to purchase 8,833 shares of common stock issued to the Lender and its affiliates had not been exercised and were still outstanding. These warrants expire in May 2029. January 2024 Private Placement On January 17, 2024, the Company entered into a private placement with certain institutional investors for aggregate gross proceeds of $6.0 million upfront an additional $10.0 million committed upon the announcement of positive clinical trial results for the Company’s NEPHRO study of Niyad, and an additional $2.0 million if Talphera stock trades above a specified price following the NEPHRO registration trial announcement, before deducting offering expenses payable by us (see Note 16, “Subsequent Events” below for additional information). |
Note 11 - Stock-based Compensat
Note 11 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 11. Stock-Based Compensation The Company recorded total stock-based compensation expense for stock options, stock awards and the Amended ESPP as follows (in thousands): December 31, December 31, Research and development $ 498 $ 570 Selling, general and administrative 1,212 2,069 Discontinued operations 19 250 Total $ 1,729 $ 2,889 The following table summarizes restricted stock unit activity under the Company’s Equity Incentive Plans: Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2022 88,711 $ 34.16 Granted 58,502 7.75 Vested (44,744 ) 35.46 Forfeited (19,691 ) 25.00 Restricted stock units outstanding, December 31, 2022 82,778 $ 16.97 Granted 48,158 1.67 Vested (40,356 ) 19.28 Forfeited (4,348 ) 12.56 Restricted stock units outstanding, December 31, 2023 86,232 $ 7.57 The following table summarizes stock option activity under the Company’s Equity Incentive Plans: Number Weighted- Weighted- Aggregate (in thousands) December 31, 2022 725,623 $ 52.98 Granted 288,929 1.67 Forfeited (14,673 ) 9.72 Expired (106,558 ) 83.88 Exercised — — December 31, 2023 893,321 $ 33.41 6.3 $ 1 Vested and exercisable options—December 31, 2023 488,725 $ 53.69 4.3 $ — Vested and expected to vest—December 31, 2023 893,321 $ 33.41 6.3 $ 1 As of December 31, 2023, there were 1,631,319 shares available for future grant under the 2020 EIP. Additional information regarding the Company’s stock options outstanding and vested and exercisable as of December 31, 2023 is summarized below: Options Outstanding Options Vested and Exercisable Exercise Prices Number of Weighted-Average Weighted-Average Shares Subject Weighted-Average $0.684 - $1.76 281,505 9.2 $ 1.67 — $ — $4.62 - $6.93 15,350 8.5 $ 5.21 12,818 $ 4.93 $8.03 - $12.045 86,817 8.1 $ 8.08 40,123 $ 8.09 $14.40 - $21.60 14,633 5.9 $ 16.55 13,418 $ 16.61 $22.40 - $33.60 11,700 7.1 $ 28.62 11,386 $ 28.68 $34,40 - $51.60 280,662 5.4 $ 41.01 208,326 $ 42.23 $57.40 - $86.10 169,213 2.7 $ 64.86 169,213 $ 64.86 $94.60 - $141.90 17,371 1.0 $ 127.59 17,371 $ 127.59 $204.40 - $306.60 16,070 0.2 $ 206.24 16,070 $ 206.24 893,321 6.3 $ 33.41 488,725 $ 53.69 The weighted average grant-date fair value of options granted during the years ended December 31, 2023 and 2022 was $1.32 and $5.80 per share, respectively. As of December 31, 2023, total stock-based compensation expense related to unvested options to be recognized in future periods was $0.9 million which is expected to be recognized over a weighted-average period of 2.1 years. The grant date fair value of options vested during the years ended December 31, 2023 and 2022 was $0.9 million and $1.7 million, respectively. The total intrinsic value of options exercised during the years ended December 31, 2023 and 2022 was $0 and $0, respectively. The Company has granted performance-based stock options to certain of its executive officers, which are included in the stock option tables and associated disclosures above. The Company uses the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term. The performance-based stock options are eligible to vest subject to the satisfaction of the service-based vesting requirements and attainment of share price target goals, a market-based condition. No The Company used the following assumptions to calculate the fair value of each time-based stock option: Year Ended December 31, 2023 2022 Expected term (in years) 6.3 6.3 Risk-free interest rate 3.9% - 4.6% 1.6% - 3.0% Expected volatility 94% 88% Expected dividend rate 0% 0% |
Note 12 - Net Income (Loss) per
Note 12 - Net Income (Loss) per Share of Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 12. Net Income (Loss) per Share of Common Stock The Company applies the two-class method to compute basic net income (loss) per share by dividing the net income (loss) attributable to common shareholders by the weighted average number of shares of common stock outstanding for the period. The diluted net income (loss) per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the more dilutive of the 1) treasury stock method, if-converted method, or contingently issuable share method, as applicable, or 2) the two-class method. For purposes of this calculation, options to purchase common stock, RSUs, and warrants to purchase common stock were considered to be common stock equivalents. The July 2023 Series A and Series B Common Stock Warrants, the placement agent July 2023 Series A and Series B Common Stock Warrants, the December 2022 Common Stock Warrants, the Series A Redeemable Convertible Preferred Stock and the November 2021 Financing Warrants are all participating securities which, by definition, entitle the holders thereof to participate in dividends and other distributions of assets by the Company to its holders of common shares as though the holder then held common shares; however, there is no contractual obligation on the part of the warrantholders to participate in the Company’s losses. Given that the Company’s participating securities do not have a contractual obligation to share in the Company’s losses, net loss for the year ended December 31, 2023 was attributed entirely to common stockholders. For the year ended December 31, 2022, the Company presented diluted EPS using the two-class method as it was more dilutive. In periods with a reported net loss, common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. Potential common shares that are issuable for little or no cash consideration, such as the Company’s July 2023 and December 2022 Pre-Funded Warrants issued with a de minimis exercise price of $0.001 and $0.0001 per share, respectively, are considered outstanding common shares which are included in the calculation of basic and diluted net income (loss) per share in all circumstances. The following table sets forth the computation of the Company’s basic and diluted net income (loss) per share of common stock during the years ended December 31, 2023 and 2022 (in thousands, except for share and per share amounts): Year Ended December 31, 2023 2022 (in thousands, except share and per share amounts) Basic net income (loss) per common share: Net income (loss) from continuing operations $ (10,287 ) $ 59,125 Less: deemed dividends related to Series A Redeemable Convertible Preferred Stock — (186 ) Less: income allocated to participating securities — (5,240 ) Net income (loss) from continuing operations attributable to common shareholders, basic (10,287 ) 53,699 Net loss from discontinued operations attributable to common shareholders, basic (8,110 ) (11,370 ) Net income (loss) attributable to common shareholders, basic $ (18,397 ) $ 42,329 Weighted average shares outstanding — basic 14,263,744 7,385,348 Income (loss) from continuing operations, basic $ (0.72 ) $ 7.27 Loss from discontinued operations, basic $ (0.57 ) $ (1.54 ) Net income (loss) per share, basic $ (1.29 ) $ 5.73 Diluted net income (loss) per common share: Net income (loss) from continuing operations $ (10,287 ) $ 59,125 Less: deemed dividends related to Series A Redeemable Convertible Preferred Stock — (186 ) Less: income allocated to participating securities — (5,227 ) Net income (loss) from continuing operations attributable to common shareholders, diluted (10,287 ) $ 53,712 Net loss from discontinued operations attributable to common shareholders, diluted (8,110 ) $ (11,370 ) Net income (loss) attributable to common shareholders, diluted $ (18,397 ) $ 42,342 Weighted average shares outstanding — basic 14,263,744 7,385,348 Dilutive effect of warrants — 20,285 Dilutive effect of RSUs — 1,353 Weighted average shares outstanding — diluted 14,263,744 7,406,986 Income (loss) from continuing operations, diluted $ (0.72 ) $ 7.25 Loss from discontinued operations, diluted $ (0.57 ) $ (1.53 ) Net income (loss) per share, diluted $ (1.29 ) $ 5.72 The following outstanding shares of common stock equivalents were excluded from the computation of diluted net income (loss) per share of common stock for the periods presented because including them would have been antidilutive: Year Ended December 31, 2023 2022 ESPP, RSUs and stock options to purchase common stock 979,553 815,710 Common stock warrants 20,265,576 133,833 |
Note 13 - Accrued Liabilities
Note 13 - Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 13. Accrued Liabilities Accrued liabilities consist of the following (in thousands): December 31, 2023 2022 Accrued compensation and employee benefits $ 2,005 $ 1,732 Accrued professional services 121 456 Other accrued liabilities 319 343 Total accrued liabilities $ 2,445 $ 2,531 |
Note 14 - 401(k) Plan
Note 14 - 401(k) Plan | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | 14. 401(k) Plan The Company sponsors a 401(k) plan that stipulates that eligible employees can elect to contribute to the 401(k) plan, subject to certain limitations. Pursuant to the 401(k) plan, the Company makes a matching contribution of up to 4% of the related compensation. Under the vesting schedule, employees have ownership in the matching employer contributions based on the number of years of vesting service completed. Company contributions were $0.2 million and $0.3 million for the years ended December 31, 2023 and 2022, respectively. |
Note 15 - Income Taxes
Note 15 - Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 15. Income Taxes The Company recorded a provision for income taxes of $0 thousand and $13 thousand for the years ended December 31, 2023 and 2022, respectively. Net deferred tax assets as of December 31, 2023 and 2022 consist of the following (in thousands): December 31, December 31, Deferred tax assets: Accruals and other $ 1,717 $ 3,790 Research credits 7,839 7,392 Net operating loss carryforward 88,839 84,325 Section 59(e) R&D expenditures 1,937 3,496 Section 174 R&D expenditures 1,651 981 Total deferred tax assets 101,983 99,984 Deferred tax liabilities: IP from Acquisition (1,874 ) (2,052 ) Total deferred tax liabilities (1,874 ) (2,052 ) Valuation allowance (100,109 ) (97,932 ) Net deferred tax assets $ — $ — Reconciliations of the statutory federal income tax to the Company’s effective tax during the years ended December 31, 2023 and 2022 are as follows (in thousands): Year Ended December 31, 2023 2022 Tax at statutory federal rate $ (3,862 ) $ 10,031 State tax—net of federal benefit 2,495 823 Acquired assets — 1,728 Stock options 738 611 Other (431 ) 355 Change in valuation allowance 2,177 (13,520 ) Revaluation of Put Option Liability (1,117 ) (15 ) Provision for income taxes $ — $ 13 ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of deferred tax assets is dependent on future taxable income, if any, the timing and the amount of which are uncertain. Accordingly, the deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $2.2 million and decreased by $13.5 million during the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had federal net operating loss carryforwards of $377.7 million, of which $114.9 million federal net operating losses generated before January 1, 2018 will begin to expire in 2029. Federal net operating losses of $262.8 million generated from 2018 to 2023 will carryforward indefinitely but are subject to the 80% taxable income limitation. As of December 31, 2023, the Company had state net operating loss carryforwards of $137.4 million, which begin to expire in 2028. As of December 31, 2023, the Company had federal research credit carryovers of $7.0 million, which begin to expire in 2026. As of December 31, 2023, the Company had state research credit carryovers of $4.4 million, which will carryforward indefinitely. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research credits, to offset its post-change income may be limited. Based on an analysis performed by the Company as of December 31, 2013, it was determined that two ownership changes have occurred since inception of the Company. The first ownership change occurred in 2006 at the time of the Series A financing and, as a result of the change, $1.4 million in federal and state net operating loss carryforwards will expire unutilized. In addition, $26 thousand in federal and state research and development credits will expire unutilized. The second ownership change occurred in July 2013 at the time of the underwritten public offering; however, the Company believes the resulting annual imposed limitation on use of pre-change tax attributes is sufficiently high that the limit itself will not result in unutilized pre-change tax attributes. Uncertain Tax Positions A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2023 and 2022 is as follows (in thousands): Year Ended December 31, 2023 2022 Unrecognized benefit—beginning of period $ 2,678 $ 2,635 Gross increases—prior period tax positions — — Gross increases—current period tax positions 157 43 Unrecognized benefit—end of period $ 2,835 $ 2,678 The entire amount of the unrecognized tax benefits would not impact the Company’s effective tax rate if recognized. There were no 2005 In March 2020, the Coronavirus Aid, Relief and Economic Security, or CARES, Act was signed into law. The CARES Act included several tax changes as part of its economic package. These changes principally related to expanded net operating loss carryback periods, increases to interest deductibility limitations, and accelerated alternative minimum tax refunds. The Company has evaluated these items and determined that the items do not have a material effect on the Company's financial statements as of December 31, 2022 or 2023. Additionally, the CARES Act enacted the Employee Retention Credit, or ERC, to incentivize companies to retain employees, which was subsequently modified by extension of the CARES Act. Under the provisions of the CARES Act and its subsequent extension, the Company was eligible for ERCs, subject to certain criteria. Accordingly, the Company recorded a reduction in payroll taxes related to ERCs claimed for $1.4 million in the year ended December 31, 2021. These credits were recorded in the consolidated statements of operations as an offset to the related payroll expenses in the respective operating costs and expenses line item and are disclosed within prepaid expenses and other current assets on the Company’s consolidated balance sheets at December 31, 2023. |
Note 16 - Subsequent Events
Note 16 - Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 16. Subsequent Events Purchase Agreement with XOMA On January 12, 2024, the Company and XOMA (US) LLC, or XOMA, entered into a Payment Interest Purchase Agreement, or the Purchase Agreement, for the sale by the Company to XOMA, in exchange for $8.0 million, of the Company’s right, title and interest in and to certain amounts payable to the Company, or collectively, the Purchased Receivables, pursuant to the DSUVIA Agreement in respect of net sales of the Product, excluding sales of the Product by Aguettant. The Purchased Receivables include: (i) 100% of certain royalty payments based on net sales of the Product and potential sales-based milestone payments of up to $116.5 million in respect of net sales of the Product, in each case made on and after January 1, 2024 and excluding sales of the Product by Aguettant, and of certain associated license and acquisition payments relating to the Product, until XOMA has received a certain minimum amount of payments in respect of the foregoing, or the XOMA Threshold, or the Stepdown Date; and (ii) following the Stepdown Date, (A) 100% of royalty payments based on net sales of the Product other than net sales to the United States Department of Defense, or DoD and (B) 50% of each of the following: (a) payments based on net sales of the Product to the DoD, (b) potential sales-based milestone payments in respect of net sales of the Product and (c) certain associated license and acquisition payments relating to the Product. The Company has retained its right, title and interest in and to, following the Stepdown Date, 50% of each of the following: (a) payments based on net sales of the Product to the DoD, (b) potential sales-based milestone payments in respect of net sales of the Product and (c) of certain associated license and acquisition payments relating to the Product. The Purchase Agreement contains customary representations, warranties and agreements by the Company and XOMA, indemnification obligations of the parties and other obligations of the parties. Securities Purchase Agreements On January 17, 2024, the Company entered into Securities Purchase Agreements, or the Securities Purchase Agreements, with certain institutional investors, or the Purchasers, relating to the issuance and sale of pre-funded warrants to the Purchasers in a two-tranche private placement, or the Private Placement, to purchase shares of the Company’s common stock, par value $0.001 per share, or the Common Stock, at a purchase price of $0.769 per share and an exercise price of $0.001 per share, or the Pre-Funded Warrants. The Pre-Funded Warrants are exercisable immediately following each closing date of the Private Placement and have an unlimited term. The terms of the Private Placement include: (i) the first tranche of the Private Placement, which closed on January 22, 2024, resulted in the aggregate gross proceeds to the Company of approximately $6.0 million excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants issued in such tranche. (ii) the second tranche of the Private Placement, which is a conditional purchase by the Purchasers subject to either (a) the satisfaction or waiver of achieving a pivotal trial milestone event, or the Pivotal Trial Milestone, or (b) the satisfaction or waiver of the volume-weighted average price of the Common Stock for each of the immediately subsequent five (5) trading days following the Company’s announcement of its pivotal trial data being at least $0.92 per share, or the Price Milestone, which will result in additional aggregate gross proceeds to the Company of approximately $10.0 million with respect to the Pivotal Trial Milestone and $2.0 million with respect to the Price Milestone, excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants issued in such closing. In the first tranche of the Private Placement, the Company issued Pre-Funded Warrants to purchase up to 7,792,208 shares of Common Stock. In the second tranche of the Private Placement, the Company is expected to issue (i) in connection with achieving the Pivotal Trial Milestone, Pre-Funded Warrants to purchase up to 12,987,013 shares of Common Stock, and (ii) in connection with achieving the Price Milestone, Pre-Funded Warrants to purchase up to 2,597,402 shares of Common Stock. Any of the conditions in the second tranche can be waived by each Purchaser. The Securities Purchase Agreements contain customary representations, warranties and agreements by the Company and the Purchasers, indemnification rights and other obligations of the parties. Registration Rights Agreement In connection with the Private Placement, the Company entered into a registration rights agreement, dated January 17, 2024, with the Purchasers, or the Registration Rights Agreement, pursuant to which the Company has agreed to file one or more registration statements under the Securities Act of 1933, as amended, or the Securities Act with the Securities and Exchange Commission, or the SEC, covering the resale of the shares of Common Stock underlying the Pre-Funded Warrants no later than 15 days following the date of each applicable closing of the Private Placement, and to use reasonable best efforts to have the registration statements declared effective as promptly as practical thereafter, and in any event no later than 90 days following the applicable closing date in the event of a “full review” by the SEC. Amendment of Prior Warrants On July 20, 2023, in connection with a prior private placement, the Company issued to certain of the Purchasers (i) Series A common stock purchase warrants to purchase up to 3,676,473 shares of Common Stock and (ii) Series B common stock purchase warrants to purchase up to 3,676,473 shares of Common Stock, or the Prior Warrants. In connection with the current Private Placement, the Company and the Purchasers agreed to amend and restate, a portion of the outstanding Prior Warrants, representing (i) Series A common stock purchase warrants to purchase up to 2,941,178 shares of Common Stock and (ii) Series B common stock purchase warrants to purchase up to 2,941,178 shares of Common Stock, to reduce the exercise price thereunder to $0.77 per share. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Business Description of Entity [Policy Text Block] | The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005 as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024 to Talphera, Inc. The Company’s operations are based in San Mateo, California. Talphera is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s product development portfolio features Niyad™ (a regional anticoagulant for the dialysis circuit), two ready-to-use pre-filled syringe, or PFS, product candidates (Fedsyra and phenylephrine), and LTX-608 (a nafamostat formulation for direct IV infusion) that the Company intends to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment. On March 12, 2023, the Company entered into an Asset Purchase Agreement, or the DSUVIA Agreement, with Vertical Pharmaceuticals, LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of the Company relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product. The closing of the DSUVIA Agreement occurred on April 3, 2023 (see Note 3, “Discontinued Operations”). On January 7, 2022, the Company acquired Lowell Therapeutics, Inc., or Lowell, a privately held company (see Note 4, “Asset Acquisition” below) and, as a result acquired the Niyad™ On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Laboratoire Aguettant, or Aguettant, pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States an ephedrine pre-filled syringe for injection, and (ii) a phenylephrine PFS for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the U.S. Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2023 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The termination of the Zalviso Royalty Monetization resulted in net income for the year ended December 31, 2022; however, prior to this, the Company had incurred recurring operating losses and negative cash flows from operating activities since inception and expects to continue to incur operating losses and negative cash flows in the future. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Although, the Company raised additional capital in January 2024 (see Note 16, “Subsequent Events”), considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, management expects to need additional capital to fund its planned operations prior to the 12-month anniversary of the date this Annual Report on Form 10-K is filed with the United States Securities and Exchange Commission, or the SEC. Management may seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity Offering SM Additional funds may not be available when the Company needs them on terms that are acceptable to the Company, or at all. If adequate funds are not available, the Company may be required to further reduce its workforce or delay the development of its regulatory filing plans for its product candidates in advance of the date on which the Company’s cash resources are exhausted to ensure that the Company has sufficient capital to meet its obligations and continue on a path designed to preserve stockholder value. In addition, if additional funds are raised through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish rights to its technologies, future revenue streams or product candidates, or to grant licenses on terms that may not be favorable to the Company. |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The preparation of financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. The Company’s audited financial statements as of December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2023, were recast to reflect discontinued operations and filed with the Company’s Current Report on Form 8-K on August 1, 2023. See Note 3, “Discontinued operations” below. |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassifications Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year's presentation. In particular, property and equipment, net and restricted cash, net of current portion have been reclassified as other assets, and operating lease liabilities, current portion, has been reclassified as accrued and other liabilities in the consolidated balance sheets. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management believes its most significant accounting estimates relate to fair value of warrants, impairment of long-lived assets, management’s assessment of going concern, revenue recognition, liability for royalty monetization and accrued clinical trial liabilities. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks. On May 30, 2019, the Company entered into a Loan Agreement with Oxford Finance LLC, or Oxford, or the Lender. The Loan Agreement requires that the Company always maintain unrestricted cash of not less than $5.0 million in accounts subject to control agreements in favor of the Lender, tested monthly as of the last day of the month. The Company has classified these unrestricted funds as restricted cash on the consolidated balance sheets. On April 3, 2023, the Company repaid Oxford the full amount due under the loan, and the Loan Agreement was terminated with no further obligations by either party. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts in the consolidated statements of cash flows: Balance as of December 31, 2023 December 31, 2021 Cash and cash equivalents $ 5,721 $ 15,275 Restricted cash — 5,000 Total cash, cash equivalents, and restricted cash $ 5,721 $ 20,275 |
Marketable Securities, Policy [Policy Text Block] | Short-Term Investments All marketable securities are classified as available for sale and consist of commercial paper and U.S. government sponsored enterprise debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. When the fair value of an available-for-sale security falls below the amortized cost basis it is evaluated to determine if any of the decline in value is attributable to credit loss. Decreases in fair value attributable to credit loss are recorded directly to the consolidated statement of operations with a corresponding allowance for credit losses, limited to the amount that the fair value is less than the amortized cost basis. If the credit quality subsequently improves the allowance is reversed up to a maximum of the previously recorded credit losses. When the Company intends to sell an impaired available-for-sale security, or if it is more likely than not that the Company will be required to sell the security prior to recovering the amortized cost basis, the entire fair value adjustment will immediately be recognized in the consolidated statement of operations with no corresponding allowance for credit losses. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: Level I—Unadjusted quoted prices in active markets for identical assets or liabilities; Level II—Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level III—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. |
Segment Reporting, Policy [Policy Text Block] | Segment Information The Company operates in a single segment, the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s revenue relates to the Company’s services performed to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement (as defined in Note 3, “Discontinued Operations” below). |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Risk The Company invests cash that is currently not being used for operational purposes in accordance with its investment policy in debt securities of U.S. government sponsored agencies, commercial paper and overnight deposits. The Company is exposed to credit risk in the event of default by the institutions holding the cash equivalents and available-for-sale securities to the extent recorded on the consolidated balance sheets. The Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows. The Company relies on a single contract manufacturer, or CMO, for the active pharmaceutical ingredient, or API, for Niyad™ and a second single contract manufacturer for the finished Niyad product. All revenue relates to the Company’s services for fees earned on the sales of DSUVIA to the DoD by Alora. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. The Company realigned its cost structure from a focus on commercialization to a focus on advancing its late-stage development pipeline, namely the Niyad product candidates and the pre-filled syringes. As a result, the Company decided to not focus any development resources on Zalviso in the United States. In addition, due to the termination of the agreements with Grünenthal for Zalviso in Europe and the related withdrawal of the Marketing Authorization in Europe in July 2022 , . . |
Business Combinations Policy [Policy Text Block] | Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use (a) the Company must reasonably expect that it will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) the Company’s use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis. |
Discontinued Operations, Policy [Policy Text Block] | Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the Company has classified the results of the DSUVIA business as discontinued operations in its consolidated statements of operations for all periods presented. All assets and liabilities associated with the DSUVIA business were classified as assets and liabilities of discontinued operations in the consolidated balance sheets for the periods presented. All amounts included in the notes to the consolidated financial statements relate to continuing operations unless otherwise noted. (See Note 3, “Discontinued Operations”). |
Revenue [Policy Text Block] | Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company’s revenue relates to the Company’s services performed to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement (as defined in Note 3, “Discontinued Operations” below). The Company’s performance obligation is to serve as the exclusive sales agent for selling DSUVIA to the DoD through the term of the Marketing Agreement. The non-creditable and non-refundable revenues are variable consideration based on 75% of net sales of DSUVIA to the DoD during the period subject to certain adjustments. The Company evaluates if it is a principal or an agent in a transaction to determine whether revenue should be recorded on a gross or net basis depending on if it obtains control over the goods and services before they are transferred to customers. The Company is acting as an agent in relation to DSUVIA sales to the DoD. The consideration in the Marketing Agreement reflects a variable amount, for which the Company estimates the amount of consideration to which it will be entitled by using the expected value method. The Company includes in the transaction price the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. Revenues are recognized when the DoD obtains control of the product, at which time the Company has an unconditional right to receive payment for such revenue earned. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 Equity Incentive Plan, or 2020 EIP, the 2011 Equity Incentive Plan, or 2011 EIP, and employee share purchases related to the Amended and Restated 2011 Employee Stock Purchase Plan, or ESPP, is based on estimated fair values at grant date. The Company determines the grant date fair value of the awards using the Black-Scholes option-pricing model and generally recognizes the fair value as stock-based compensation expense on a straight-line basis over the vesting period of the respective awards. The Company applies the graded-vesting attribution method to awards with market conditions that include graded-vesting features. Additionally, the Company uses the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term. The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may reasonably affect the volatility of the Company’s stock in the future. The risk‑free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for the expected term of the award. The Company recognizes forfeitures when they occur and does not anticipate paying dividends in the near future. |
Warrants, Policy [Policy Text Block] | Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company s Own Stock |
Costs Associated with Exit or Disposal Activities or Restructurings, Policy [Policy Text Block] | Restructuring Costs The Company’s restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. In May 2022, the Company initiated a reorganization that eliminated approximately 40% of its employees, primarily within the commercial organization. For the year ended December 31, 2022, the Company incurred approximately $0.5 million in employee termination benefits related to this restructuring, all of which has been paid. This headcount reduction was completed in the second quarter of 2022. No additional expenses were incurred in connection with this cost reduction plan. |
Interest Expense, Policy [Policy Text Block] | Non-Cash Interest Income on Liability Related to Sale of Future Royalties In September 2015, the Company sold certain royalty and milestone payment rights from the sales of Zalviso in the European Union by Grünenthal to PDL for gross proceeds of $65.0 million, or the Zalviso Royalty Monetization. Grünenthal terminated the Grünenthal Agreements effective November 13, 2020. The terms of the Grünenthal Agreements were extended to May 2021 to enable Grünenthal to sell down its Zalviso inventory. The rights to market and sell Zalviso in the Territory reverted back to the Company in May 2021. Under the Zalviso Royalty Monetization, the Company had a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Zalviso Royalty Monetization was accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company was required to estimate the total amount of future royalty and milestone payments to be received by the Company and payments made to PDL, up to a capped amount of $195.0 million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the $61.2 million of net proceeds the Company received, was to be amortized as interest expense over the life of the liability. Consequently, the Company imputed interest on the unamortized portion of the liability and recorded interest expense, or interest income, as these estimates were updated and recorded non-cash royalty revenues and non-cash interest income (expense), net, within its consolidated statements of operations over the term of the Zalviso Royalty Monetization. When the expected payments under the Zalviso Royalty Monetization were lower than the gross proceeds of $65.0 million received, the Company deferred recognition of any probable contingent gain until the Zalviso Royalty Monetization liability expired. See Note 7, “Liability Related to Sale of Future Royalties”. |
Income Tax, Policy [Policy Text Block] | Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 260, Earnings per Share The Company applies the two-class method to compute basic and, if more dilutive than other methods, diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders (including pre-funded warrants). Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date. In addition, the Company is required to calculate diluted net income or loss per share under the two-class method if the effect is more dilutive than the application of another dilutive method of calculating diluted EPS (i.e., the treasury stock, if-converted, or contingently issuable share method). In periods where there is a net loss, no allocation of undistributed net loss to participating securities is performed if the holders of these securities are not contractually obligated to participate in the Company’s losses. The Company’s participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A Redeemable Convertible Preferred Stock, and the Series A and Series B Common Stock Warrants, the placement agent Series A and Series B Common Stock Warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information). For additional information regarding the net income (loss) per share, see Note 12, “Net Income (Loss) per Share of Common Stock”. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements In June 2016, the FASB, issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Recently Issued Accounting Pronouncements On December 14, 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements. |
Note 1 - Organization and Sum_2
Note 1 - Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Cash and Cash Equivalents [Table Text Block] | Balance as of December 31, 2023 December 31, 2021 Cash and cash equivalents $ 5,721 $ 15,275 Restricted cash — 5,000 Total cash, cash equivalents, and restricted cash $ 5,721 $ 20,275 |
Note 2 - Investments and Fair_2
Note 2 - Investments and Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of December 31, 2023 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 1,342 $ — $ — $ 1,342 Money market funds 90 — — 90 U.S. government agency securities 1,896 — — 1,896 Commercial paper 2,393 — — 2,393 Total cash and cash equivalents 5,721 — — 5,721 Short-term investments: U.S. government agency securities 3,362 — — 3,362 Commercial paper 298 — — 298 Total short-term investments 3,660 — — 3,660 Total cash, cash equivalents, and short-term investments $ 9,381 $ — $ — $ 9,381 As of December 31, 2022 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash, cash equivalents and restricted cash: Cash $ 13,275 $ — $ — $ 13,275 Money market funds 321 — — 321 U.S. government agency securities 2,444 — — 2,444 Commercial paper 4,235 — — 4,235 Total cash, cash equivalents and restricted cash 20,275 — — 20,275 Short-term investments: Commercial paper 495 — — 495 Total short-term investments 495 — — 495 Total cash, cash equivalents, restricted cash and short-term investments $ 20,770 $ — $ — $ 20,770 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of December 31, 2023 Fair Value Level I Level II Level III Assets Money market funds $ 90 $ 90 $ — $ — U.S. government agency securities 5,258 — 5,258 — Commercial paper 2,691 — 2,691 — Total assets measured at fair value $ 8,039 $ 90 $ 7,949 $ — Liabilities Warrant liability $ 1,778 $ — $ — $ 1,778 Total liabilities measured at fair value $ 1,778 $ — $ — $ 1,778 As of December 31, 2022 Fair Value Level I Level II Level III Assets Money market funds $ 321 312 — — U.S. government agency securities 2,444 — 2,444 — Commercial paper 4,730 — 4,730 — Total assets measured at fair value $ 7,495 $ 321 $ 7,174 $ — Liabilities Warrant liability $ 7,098 $ — $ — $ 7,098 Total liabilities measured at fair value $ 7,098 $ — $ — $ 7,098 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Year Ended December 31, 2023 Year Ended Fair value—beginning of period $ 7,098 $ — Issuance of December 2022 Common Stock Warrants — 7,098 Change in fair value of December 2022 Common Stock Warrants (5,320 ) — Fair value—end of period $ 1,778 $ 7,098 |
Note 3 - Discontinued Operati_2
Note 3 - Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Disposal Groups, Including Discontinued Operations [Table Text Block] | Year ended December 31, 2023 2022 Total revenues $ 501 $ 1,771 Cost of goods sold 711 1,508 Selling, general and administrative expense 731 9,744 Impairment of net assets held for sale 6,853 — Impairment of fixed assets 1,065 — Gain on termination of lease liabilities (1,098 ) — Research and development expenses 349 1,852 Loss from discontinued operations (8,110 ) (11,333 ) Interest expense — 37 Net loss from discontinued operations $ (8,110 ) $ (11,370 ) December 31, 2023 December 31, 2022 Accounts receivable, net $ — $ 309 Inventories — 1,178 Prepaid expenses and other current assets — 444 Total current assets of discontinued operations — 1,931 Property, plant and equipment, net — 10,261 Operating lease right-of-use assets — 3,499 Other assets — 176 Total non-current assets of discontinued operations — 13,936 Total assets of discontinued operations $ — $ 15,867 Accounts payable $ 10 $ 784 Accrued liabilities 721 1,720 Operating lease liabilities, current portion — 1,601 Note payable, current portion — 400 Deferred revenue, current portion — 115 Total current liabilities of discontinued operations 731 4,620 Operating lease liabilities, net of current portion — 2,959 Deferred revenue, net of current portion — 1,036 Total non-current liabilities of discontinued operations — 3,995 Total liabilities of discontinued operations 731 8,615 Net assets (liabilities) of discontinued operations $ (731 ) $ 7,252 Year Ended December 31, 2023 2022 Cash flows from operating activities: Depreciation and amortization $ 215 $ 1,465 Stock-based compensation 19 250 Impairment of net assets held for sale 6,853 — Impairment of fixed assets 1,065 — Gain on termination of lease liabilities (1,098 ) — Gain on extinguishment of debt (400 ) — Purchases of property and equipment (100 ) (364 ) Year Ended December 31, 2023 Cash proceeds $ 2,723 Less: net assets transferred (8,723 ) Less: disposal costs (853 ) Loss on sale of discontinued operations, before income taxes (6,853 ) Income tax expense — Loss on sale of discontinued operations $ (6,853 ) |
Note 4 - Asset Acquisition (Tab
Note 4 - Asset Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Business Acquisitions, by Acquisition [Table Text Block] | Consideration Cash $ 3,536 Issuance of common stock to Lowell security holders in connection with asset acquisition 5,161 Issuance of common stock to settle Lowell’s transaction costs in connection with asset acquisition 350 Liability for issuance of 69,808 hold back shares to Lowell securityholders (1) 800 Transaction costs 2,521 Total consideration $ 12,368 IPR&D Asset Acquired Purchase price $ 12,368 Cash acquired (3,549 ) Total IPR&D asset acquired (2) $ 8,819 |
Note 7 - Liability Related to_2
Note 7 - Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Year ended Period from Liability related to sale of future royalties — beginning balance $ 85,288 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue — (1,083 ) Non-cash interest (income) expense recognized (1,136 ) 24,051 Consideration paid for termination of Royalty Monetization (100 ) (100 ) Gain on extinguishment of liability related to sale of future royalties (84,052 ) (84,052 ) Liability related to sale of future royalties as of December 31, 2022 $ — $ — |
Note 10 - Warrants (Tables)
Note 10 - Warrants (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Common Stock from Warrants Weighted-average Outstanding at December 31, 2021 883,833 $ 5.15 Granted 6,941,100 $ 1.27 Outstanding at December 31, 2022 7,824,933 $ 1.71 Granted 17,085,897 $ 0.99 Exercised (3,228,781 ) $ (0.0003 ) Outstanding at December 31, 2023 21,682,049 $ 1.40 Exercisable at December 31, 2023 21,682,049 $ 1.40 |
Schedule of Warrants by Exercise Price [Table Text Block] | Warrants Outstanding Warrants Exercisable Warrant Exercise Price Number of Warrants Weighted- Average Remaining Contractual Life (Years) Number of Warrants Weighted- Average Exercise Price $ 0.001 1,416,473 Unlimited 1,416,473 $ 0.001 $ 1.11 14,787,044 4.62 14,787,044 $ 1.11 $ 1.70 367,647 4.62 367,647 $ 1.70 $ 2.07 4,977,052 5.07 4,977,052 $ 2.07 $ 20.00 125,000 2.92 125,000 $ 20.00 $ 56.60 8,833 5.49 8,833 $ 56.60 Total 21,682,049 5.06 21,682,049 $ 1.40 |
Note 11 - Stock-based Compens_2
Note 11 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | December 31, December 31, Research and development $ 498 $ 570 Selling, general and administrative 1,212 2,069 Discontinued operations 19 250 Total $ 1,729 $ 2,889 |
Share-Based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity [Table Text Block] | Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2022 88,711 $ 34.16 Granted 58,502 7.75 Vested (44,744 ) 35.46 Forfeited (19,691 ) 25.00 Restricted stock units outstanding, December 31, 2022 82,778 $ 16.97 Granted 48,158 1.67 Vested (40,356 ) 19.28 Forfeited (4,348 ) 12.56 Restricted stock units outstanding, December 31, 2023 86,232 $ 7.57 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number Weighted- Weighted- Aggregate (in thousands) December 31, 2022 725,623 $ 52.98 Granted 288,929 1.67 Forfeited (14,673 ) 9.72 Expired (106,558 ) 83.88 Exercised — — December 31, 2023 893,321 $ 33.41 6.3 $ 1 Vested and exercisable options—December 31, 2023 488,725 $ 53.69 4.3 $ — Vested and expected to vest—December 31, 2023 893,321 $ 33.41 6.3 $ 1 |
Schedule of Share-based Compensation, Stock Options Outstanding and Exercisable Activity [Table Text Block] | Options Outstanding Options Vested and Exercisable Exercise Prices Number of Weighted-Average Weighted-Average Shares Subject Weighted-Average $0.684 - $1.76 281,505 9.2 $ 1.67 — $ — $4.62 - $6.93 15,350 8.5 $ 5.21 12,818 $ 4.93 $8.03 - $12.045 86,817 8.1 $ 8.08 40,123 $ 8.09 $14.40 - $21.60 14,633 5.9 $ 16.55 13,418 $ 16.61 $22.40 - $33.60 11,700 7.1 $ 28.62 11,386 $ 28.68 $34,40 - $51.60 280,662 5.4 $ 41.01 208,326 $ 42.23 $57.40 - $86.10 169,213 2.7 $ 64.86 169,213 $ 64.86 $94.60 - $141.90 17,371 1.0 $ 127.59 17,371 $ 127.59 $204.40 - $306.60 16,070 0.2 $ 206.24 16,070 $ 206.24 893,321 6.3 $ 33.41 488,725 $ 53.69 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2023 2022 Expected term (in years) 6.3 6.3 Risk-free interest rate 3.9% - 4.6% 1.6% - 3.0% Expected volatility 94% 88% Expected dividend rate 0% 0% |
Note 12 - Net Income (Loss) p_2
Note 12 - Net Income (Loss) per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Year Ended December 31, 2023 2022 (in thousands, except share and per share amounts) Basic net income (loss) per common share: Net income (loss) from continuing operations $ (10,287 ) $ 59,125 Less: deemed dividends related to Series A Redeemable Convertible Preferred Stock — (186 ) Less: income allocated to participating securities — (5,240 ) Net income (loss) from continuing operations attributable to common shareholders, basic (10,287 ) 53,699 Net loss from discontinued operations attributable to common shareholders, basic (8,110 ) (11,370 ) Net income (loss) attributable to common shareholders, basic $ (18,397 ) $ 42,329 Weighted average shares outstanding — basic 14,263,744 7,385,348 Income (loss) from continuing operations, basic $ (0.72 ) $ 7.27 Loss from discontinued operations, basic $ (0.57 ) $ (1.54 ) Net income (loss) per share, basic $ (1.29 ) $ 5.73 Diluted net income (loss) per common share: Net income (loss) from continuing operations $ (10,287 ) $ 59,125 Less: deemed dividends related to Series A Redeemable Convertible Preferred Stock — (186 ) Less: income allocated to participating securities — (5,227 ) Net income (loss) from continuing operations attributable to common shareholders, diluted (10,287 ) $ 53,712 Net loss from discontinued operations attributable to common shareholders, diluted (8,110 ) $ (11,370 ) Net income (loss) attributable to common shareholders, diluted $ (18,397 ) $ 42,342 Weighted average shares outstanding — basic 14,263,744 7,385,348 Dilutive effect of warrants — 20,285 Dilutive effect of RSUs — 1,353 Weighted average shares outstanding — diluted 14,263,744 7,406,986 Income (loss) from continuing operations, diluted $ (0.72 ) $ 7.25 Loss from discontinued operations, diluted $ (0.57 ) $ (1.53 ) Net income (loss) per share, diluted $ (1.29 ) $ 5.72 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2023 2022 ESPP, RSUs and stock options to purchase common stock 979,553 815,710 Common stock warrants 20,265,576 133,833 |
Note 13 - Accrued Liabilities (
Note 13 - Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2023 2022 Accrued compensation and employee benefits $ 2,005 $ 1,732 Accrued professional services 121 456 Other accrued liabilities 319 343 Total accrued liabilities $ 2,445 $ 2,531 |
Note 15 - Income Taxes (Tables)
Note 15 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, December 31, Deferred tax assets: Accruals and other $ 1,717 $ 3,790 Research credits 7,839 7,392 Net operating loss carryforward 88,839 84,325 Section 59(e) R&D expenditures 1,937 3,496 Section 174 R&D expenditures 1,651 981 Total deferred tax assets 101,983 99,984 Deferred tax liabilities: IP from Acquisition (1,874 ) (2,052 ) Total deferred tax liabilities (1,874 ) (2,052 ) Valuation allowance (100,109 ) (97,932 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 2023 2022 Tax at statutory federal rate $ (3,862 ) $ 10,031 State tax—net of federal benefit 2,495 823 Acquired assets — 1,728 Stock options 738 611 Other (431 ) 355 Change in valuation allowance 2,177 (13,520 ) Revaluation of Put Option Liability (1,117 ) (15 ) Provision for income taxes $ — $ 13 |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Year Ended December 31, 2023 2022 Unrecognized benefit—beginning of period $ 2,678 $ 2,635 Gross increases—prior period tax positions — — Gross increases—current period tax positions 157 43 Unrecognized benefit—end of period $ 2,835 $ 2,678 |
Note 1 - Organization and Sum_3
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | ||||
Sep. 18, 2015 | May 31, 2022 | Sep. 30, 2015 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2022 | May 30, 2019 | |
Tangible Asset Impairment Charges | $ 0 | $ 4,948 | |||||
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent | 40% | ||||||
Restructuring Charges | 500 | ||||||
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | |||||
Royalty Arrangment Maximum Payments | 195,000 | ||||||
Net Proceeds from Sale of Future Royalties | $ 61,200 | 0 | $ 61,184 | ||||
Zalviso-related Assets [Member] | |||||||
Tangible Asset Impairment Charges | $ 4,900 | ||||||
Loan Agreement with Oxford Finance LLC [Member] | |||||||
Debt Instrument, Covenant, Minimum Required Unrestircted Cash | $ 5,000 |
Note 1 - Organization and Sum_4
Note 1 - Organization and Summary of Significant Accounting Policies - Schedule of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Cash and cash equivalents | $ 5,721 | $ 15,275 |
Restricted cash | 0 | 5,000 |
Total cash, cash equivalents, and restricted cash | $ 5,721 | $ 20,275 |
Note 2 - Investments and Fair_3
Note 2 - Investments and Fair Value Measurement - Summary of Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and cash equivalent, fair value | $ 20,275 | ||
Gross Unrealized Gains | 0 | ||
Total cash, cash equivalents and restricted cash | $ 5,721 | 20,275 | $ 12,663 |
Total cash, cash equivalents, restricted cash and short-term investments | 9,381 | 20,770 | |
Total cash, cash equivalents, restricted cash and short-term investments, fair value | 9,381 | 20,770 | |
Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 3,660 | 495 | |
Gross Unrealized Gains | 0 | 0 | |
Short-term investment, fair value | 3,660 | 495 | |
US Government Agencies Debt Securities [Member] | Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 3,362 | ||
Gross Unrealized Gains | 0 | ||
Short-term investment, fair value | 3,362 | ||
Commercial Paper [Member] | Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 298 | 495 | |
Gross Unrealized Gains | 0 | ||
Short-term investment, fair value | 298 | 495 | |
Cash and Cash Equivalents [Member] | Cash [Member] | |||
Cash, amortized cost | 1,342 | 13,275 | |
Cash and cash equivalent, fair value | 1,342 | 13,275 | |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | |||
Cash and cash equivalent, fair value | 90 | 321 | |
Money market funds, amortized cost | 90 | 321 | |
Cash and Cash Equivalents [Member] | US Government Agencies Debt Securities [Member] | |||
Cash and cash equivalent, fair value | 1,896 | 2,444 | |
U.S. government agency securities | 1,896 | 2,444 | |
Cash and Cash Equivalents [Member] | Commercial Paper [Member] | |||
Cash and cash equivalent, fair value | 4,235 | ||
Short-term investment, amortized Cost | 2,393 | ||
Commercial paper | $ 4,235 | ||
Short-term investment, fair value | $ 2,393 |
Note 2 - Investments and Fair_4
Note 2 - Investments and Fair Value Measurement - Fair Value of Financial Assets and Liabilities by Level Within Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Money market funds | $ 8,039 | $ 7,495 |
Liabilities, fair value | 1,778 | 7,098 |
Warrant Liability [Member] | ||
Liabilities, fair value | 1,778 | 7,098 |
Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 90 | 321 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 7,949 | 7,174 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
Liabilities, fair value | 1,778 | 7,098 |
Fair Value, Inputs, Level 3 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 1,778 | 7,098 |
Money Market Funds [Member] | ||
Money market funds | 90 | 321 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 90 | 312 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
US Government Agencies Debt Securities [Member] | ||
Money market funds | 5,258 | 2,444 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 0 | 0 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 5,258 | 2,444 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
Commercial Paper [Member] | ||
Money market funds | 2,691 | 4,730 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 0 | 0 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 2,691 | 4,730 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | $ 0 | $ 0 |
Note 2 - investments and Fair_5
Note 2 - investments and Fair Value Measurement - Changes in Level III Financial Liabilities (Details) - Warrant Liability [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair value—beginning of period | $ 7,098 | $ 0 |
Issuance of December 2022 Common Stock Warrants | 0 | 7,098 |
Change in fair value of December 2022 Common Stock Warrants | (5,320) | 0 |
Fair value—end of period | $ 1,778 | $ 7,098 |
Note 3 - Discontinued Operati_3
Note 3 - Discontinued Operations (Details Textual) - Discontinued Operations [Member] - DSUVIA [Member] $ in Millions | Apr. 03, 2023 USD ($) |
Disposal Group, Including Discontinued Operation, Maximum Amount in Sales-based Milestone | $ 116.5 |
Disposal Group, Including Discontinued Operation, Percentage of Royalty on Commercial Sales | 15% |
Disposal Group, Including Discontinued operations, Percentage of Sales, Excluding Royalty Payments | 20% |
Department of Defense [Member] | |
Disposal Group, Including Discontinued Operation, Percentage of Royalty on Commercial Sales | 75% |
Note 3 - Discontinued Operati_4
Note 3 - Discontinued Operations - Summary of Discontinued Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Impairment of net assets held for sale | $ 6,853 | $ 0 |
Total current assets of discontinued operations | 0 | 1,931 |
Impairment of fixed assets | 1,065 | 0 |
Gain on termination of lease liabilities | (1,098) | 0 |
Gain on termination of lease liabilities | (1,098) | 0 |
Gain on extinguishment of debt | (400) | 0 |
Purchase of property and equipment | (100) | (364) |
Total non-current assets of discontinued operations | 0 | 13,936 |
Net loss from discontinued operations | (8,110) | (11,370) |
Total current liabilities of discontinued operations | 731 | 4,620 |
Total non-current liabilities of discontinued operations | 0 | 3,995 |
Discontinued Operations [Member] | DSUVIA [Member] | ||
Total revenues | 501 | 1,771 |
Accounts receivable, net | 0 | 309 |
Depreciation and amortization | 215 | 1,465 |
Cash proceeds | 2,723 | |
Less: net assets transferred | 8,723 | |
Cost of goods sold | 711 | 1,508 |
Inventories | 0 | 1,178 |
Stock-based compensation | 19 | 250 |
Less: disposal costs | 853 | |
Loss on sale of discontinued operations, before income taxes | (6,853) | |
Selling, general and administrative expense | 731 | 9,744 |
Prepaid expenses and other current assets | 0 | 444 |
Impairment of net assets held for sale | 6,853 | 0 |
Income tax expense | 0 | |
Loss on sale of discontinued operations | (6,853) | |
Impairment of net assets held for sale | 6,853 | 0 |
Total current assets of discontinued operations | 0 | 1,931 |
Impairment of fixed assets | 1,065 | 0 |
Property, plant and equipment, net | 0 | 10,261 |
Gain on termination of lease liabilities | (1,098) | 0 |
Gain on termination of lease liabilities | (1,098) | 0 |
Operating lease right-of-use assets | 0 | 3,499 |
Gain on extinguishment of debt | (400) | 0 |
Research and development expenses | 349 | 1,852 |
Other assets | 0 | 176 |
Purchase of property and equipment | (100) | (364) |
Loss from discontinued operations | (8,110) | (11,333) |
Total non-current assets of discontinued operations | 0 | 13,936 |
Interest expense | 0 | 37 |
Total assets of discontinued operations | 0 | 15,867 |
Net loss from discontinued operations | (8,110) | (11,370) |
Accounts payable | 10 | 784 |
Accrued liabilities | 721 | 1,720 |
Operating lease liabilities, current portion | 0 | 1,601 |
Note payable, current portion | 0 | 400 |
Deferred revenue, current portion | 0 | 115 |
Total current liabilities of discontinued operations | 731 | 4,620 |
Operating lease liabilities, net of current portion | 0 | 2,959 |
Deferred revenue, net of current portion | 0 | 1,036 |
Total non-current liabilities of discontinued operations | 0 | 3,995 |
Total liabilities of discontinued operations | 731 | 8,615 |
Net assets (liabilities) of discontinued operations | $ (731) | $ 7,252 |
Note 4 - Asset Acquisition (Det
Note 4 - Asset Acquisition (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Jan. 07, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | ||
In Process Research and Development [Member] | ||||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 0 | $ 0 | ||
Lowell Therapeutics [Member] | ||||
Business Combination, Consideration Transferred, Net of Cash Acquired | $ 32,500 | |||
Cash Acquired from Acquisition | 3,549 | |||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Cash | 3,500 | |||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | [1] | 800 | ||
Business Combination, Cash and Stock Paid for Transaction Costs | 500 | |||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | [2] | 8,819 | ||
Business Combination, Consideration Transferred | 12,368 | |||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 6,000 | |||
Business Combination, Acquisition Related Costs | 500 | |||
Payments to Acquire Businesses, Gross | 3,536 | |||
Business Acquisition, Transaction Costs | 2,521 | |||
Lowell Therapeutics [Member] | Contingent Consideration Payable Upon Achievement of Milestones [Member] | ||||
Business Combination, Contingent Consideration, Liability | $ 26,000 | |||
Lowell Therapeutics [Member] | AcelRx Common Stock [Member] | ||||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Common Stock, Number (in shares) | 450,477 | |||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Fixed Value per Share (in dollars per share) | $ 11.46 | |||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Common Stock, Value | $ 5,200 | |||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations (in shares) | 69,808 | |||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | $ 800 | |||
[1]Recorded as Other long-term liabilities in the consolidated balance sheets at December 31, 2022. Shares were issued in the year ended December 31, 2023 and, accordingly, the related liability was extinguished.[2]Recorded as In-process research and development asset in the consolidated balance sheets. |
Note 4 - Asset Acquisition - Co
Note 4 - Asset Acquisition - Consideration for Acquisition (Details) - Lowell Therapeutics [Member] $ in Thousands | Jan. 07, 2022 USD ($) | |
Payments to Acquire Businesses, Gross | $ 3,536 | |
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 6,000 | |
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | 800 | [1] |
Business Acquisition, Transaction Costs | 2,521 | |
Business Combination, Consideration Transferred | 12,368 | |
Cash acquired | (3,549) | |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | 8,819 | [2] |
Common Stock [Member] | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 5,161 | |
Common Stock to Settle Transaction Costs [Member] | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 350 | |
[1]Recorded as Other long-term liabilities in the consolidated balance sheets at December 31, 2022. Shares were issued in the year ended December 31, 2023 and, accordingly, the related liability was extinguished.[2]Recorded as In-process research and development asset in the consolidated balance sheets. |
Note 4 - Asset Acquisition - _2
Note 4 - Asset Acquisition - Consideration for Acquisition (Details) (Parentheticals) | Jan. 07, 2022 shares |
Lowell Therapeutics [Member] | AcelRx Common Stock [Member] | |
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares (in shares) | 69,808 |
Note 5 - In-license Agreement (
Note 5 - In-license Agreement (Details Textual) - Aguettant [Member] - PFS Products [Member] $ in Millions | Jul. 14, 2021 | Apr. 03, 2023 USD ($) | Apr. 03, 2023 EUR (€) | Apr. 02, 2023 USD ($) |
License Agreement, Term (Year) | 10 years | |||
License Agreement, Renewal Term (Year) | 5 years | |||
License Agreement, Minimum Sales Obligation Term (Month) | 12 months | |||
Licensing Agreement, Complementary Payment | € | € 1,500,000 | |||
Licensing Agreement, Milestone Payments | $ | $ 21 | $ 24 | ||
Minimum [Member] | ||||
License Agreement, Percent of Revenue Share Payment to be Paid | 40% | |||
Maximum [Member] | ||||
License Agreement, Percent of Revenue Share Payment to be Paid | 45% |
Note 6 - Long-term Debt (Detail
Note 6 - Long-term Debt (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Apr. 03, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 30, 2019 | |
Amortization of Debt Discount (Premium) | $ 53 | $ 393 | |||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 8,833 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 56.6 | ||||
Loan Agreement with Oxford Finance LLC [Member] | |||||
Debt Instrument, Face Amount | $ 25,000 | ||||
Long-Term Debt | 5,400 | ||||
Interest Expense, Debt | 100 | 1,100 | $ 2,200 | ||
Amortization of Debt Discount (Premium) | $ 100 | $ 400 | |||
Debt Instrument, Interest Rate, Effective Percentage | 13.60% | ||||
Repayments of Debt | $ 3,400 |
Note 7 - Liability Related to_3
Note 7 - Liability Related to Sale of Future Royalties (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | |||
May 31, 2022 | Sep. 18, 2015 | Sep. 30, 2015 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2022 | |
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | ||||
Consideration Paid for Termination of Royalty Monetization | $ 100 | $ 100 | $ 100 | |||
Non-cash Gain on Termination of Liability Related to Sale of Future Royalties | $ 84,100 | $ 0 | $ 84,152 | |||
Effective Annual Interest Rate | 3.20% | |||||
SWK [Member] | ||||||
Percentage of Royalties and Rights Under Agreement | 75% | |||||
SWK [Member] | First Four Commercial Milestones [Member] | ||||||
Percentage of Royalties and Rights Under Agreement | 80% | |||||
Commercial Milestones Value Maximum Amount Available | $ 35,600 | |||||
AcelRX [Member] | First Four Commercial Milestones [Member] | ||||||
Commercial Milestones Value Maximum Amount Available | $ 44,500 |
Note 7 - Liability Related to_4
Note 7 - Liability Related to Sale of Future Royalties - Activity of Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | ||
May 31, 2022 | Sep. 30, 2015 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2022 | |
Liability related to sale of future royalties — beginning balance | $ 85,288 | $ 0 | |||
Proceeds from sale of future royalties | $ 61,200 | 0 | 61,184 | ||
Non-cash royalty revenue | 0 | (1,083) | |||
Non-cash interest (income) expense recognized | $ 0 | (1,136) | 24,051 | ||
Consideration paid for termination of Royalty Monetization | $ (100) | (100) | (100) | ||
Gain on extinguishment of liability related to sale of future royalties | $ 0 | (84,052) | (84,052) | ||
Liability related to sale of future royalties as of December 31, 2022 | $ 0 | $ 0 |
Note 8 - Commitments and Cont_2
Note 8 - Commitments and Contingencies (Details Textual) | Jun. 08, 2021 |
Purported Shareholder v. Company - Violation of Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 [Member] | |
Loss Contingency, Number of Defendants | 2 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Details Textual) | 1 Months Ended | 12 Months Ended | 18 Months Ended | |||||||||||||||
Jan. 17, 2024 USD ($) | Jul. 17, 2023 USD ($) $ / shares shares | May 31, 2023 USD ($) shares | Dec. 29, 2022 USD ($) $ / shares shares | Dec. 27, 2022 $ / shares shares | Oct. 12, 2022 USD ($) shares | Aug. 03, 2022 USD ($) $ / shares shares | May 09, 2019 USD ($) | Jun. 21, 2016 USD ($) | Jan. 31, 2011 shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Oct. 10, 2023 shares | Jul. 20, 2023 $ / shares shares | Jun. 17, 2021 shares | Jun. 16, 2020 shares | Dec. 31, 2011 | |
Stock, Shares Authorized (in shares) | 210,000,000 | 210,000,000 | ||||||||||||||||
Common Stock, Shares Authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | ||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||||||||||
Preferred Stock, Shares Issued (in shares) | 0 | 0 | ||||||||||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 | ||||||||||||||||
Proceeds from Issuance of Private Placement | $ | $ 10,000,000 | |||||||||||||||||
Warrants and Rights Outstanding | $ | $ 1,778,000 | $ 7,098,000 | $ 1,778,000 | |||||||||||||||
Non-cash Issuance Costs for Warrants | $ | $ 0 | 775,000 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ | $ 790,000 | |||||||||||||||||
Employee Stock Purchase Plan, Shares Issued, Weighted Average Fair Value (in dollars per share) | $ / shares | $ 1.08 | $ 6.82 | ||||||||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation (in shares) | 0 | |||||||||||||||||
2011 Equity Incentive Plan [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other Than Options, Outstanding (in shares) | 93,750,000,000 | |||||||||||||||||
Stock Option Plan Option Reserve Annual Increase as Percentage of Outstanding Shares Allowed | 4% | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 744,608 | 275,000 | ||||||||||||||||
2011 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares to be Added (in shares) | 744,608 | |||||||||||||||||
The 2020 Equity Incentive Plan [Member] | ||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 1,990,000 | 1,500,000 | ||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,631,319 | 1,631,319 | ||||||||||||||||
Employee Stock Purchase Plan (ESPP) [Member] | ||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 42,209 | 42,209 | 245,000,000,000 | |||||||||||||||
Amended ESPP [Member] | ||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 169,667 | 169,667 | ||||||||||||||||
Subsequent Event [Member] | Pivotal Trial Milestone [Member] | ||||||||||||||||||
Proceeds from Issuance of Private Placement | $ | $ 10,000,000 | |||||||||||||||||
Subsequent Event [Member] | Pivotal Share Price Milestone [Member] | ||||||||||||||||||
Proceeds from Issuance of Private Placement | $ | 2,000,000 | |||||||||||||||||
Securities Purchase Agreement [Member] | ||||||||||||||||||
Proceeds from Issuance or Sale of Equity | $ | $ 300,000 | |||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ | $ 200,000 | |||||||||||||||||
Private Placement [Member] | ||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | |||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 5,340,591 | |||||||||||||||||
Combined Offering Price (in dollars per share) | $ / shares | $ 1.36 | |||||||||||||||||
Sale of Equity, Price Per Share and Warrant (in dollars per share) | $ / shares | $ 1.359 | |||||||||||||||||
Payments of Stock Issuance Costs | $ | $ 1,100,000 | |||||||||||||||||
Private Placement [Member] | Subsequent Event [Member] | ||||||||||||||||||
Proceeds from Issuance of Private Placement | $ | $ 6,000,000 | |||||||||||||||||
Private Placement [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||||||||
Placement Agent Fee, Percentage of Gross Proceeds of Private Placement | 5.25% | |||||||||||||||||
Maximum Reimburse Amount of Private Placement | $ | $ 100,000 | |||||||||||||||||
One Time Payment Upon Exercise of Warrant | $ | 200,000 | |||||||||||||||||
Placement Agent Fee, Minimum Proceeds Required for Full One-time Payment | $ | $ 9,500,000 | |||||||||||||||||
December 2022 Financing [Member] | ||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | |||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 748,744 | |||||||||||||||||
Payments of Stock Issuance Costs | $ | $ 1,700,000 | |||||||||||||||||
Equity Offering, Price Per Unit (in dollars per share) | $ / shares | $ 2.22625 | |||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ | $ 7,500,000 | |||||||||||||||||
Non-cash Issuance Costs for Warrants | $ | $ 800,000 | |||||||||||||||||
ATM Agreement [Member] | ||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | 124,330 | ||||||||||||||||
Aggregate Offering Price, Maximum | $ | $ 80,000,000 | $ 40,000,000 | $ 35,600,000 | |||||||||||||||
Aggregate Offering Price, Increase During Period | $ | $ 40,000,000 | |||||||||||||||||
Stock Issued During Period, Value, New Issues | $ | $ 500,000 | |||||||||||||||||
August 2022 LPC Warrant [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 81,150 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 4.07 | |||||||||||||||||
Warrants and Rights Outstanding | $ | $ 300,000 | |||||||||||||||||
Prefund Warrants [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,012,356 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||||||||||
Prefund Warrants [Member] | Private Placement [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,012,356 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.001 | |||||||||||||||||
Series A Common Stock Warrants [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 3,676,473 | 7,352,947 | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | |||||||||||||||||
Series A Common Stock Warrants [Member] | Private Placement [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,352,947 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | |||||||||||||||||
Series A Common Stock Warrants [Member] | Private Placement [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 183,824 | |||||||||||||||||
Series B Common Stock Warrants [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 3,676,473 | 7,352,947 | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | |||||||||||||||||
Series B Common Stock Warrants [Member] | Private Placement [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,352,947 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | |||||||||||||||||
Series B Common Stock Warrants [Member] | Private Placement [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 183,823 | |||||||||||||||||
Common Stock and Series A and Series B Common Stock Warrants [Member] | ||||||||||||||||||
Warrants and Rights Outstanding | $ | $ 16,300,000 | |||||||||||||||||
The 2022 Prefunded Warrants [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,632,898 | 2,632,898 | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||
Warrants and Rights Outstanding, Measurement Input | 2.22615 | |||||||||||||||||
Common Warrants [Member] | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 4,227,052 | 4,227,052 | 4,227,052 | 4,227,052 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | $ 2.07 | $ 2.07 | |||||||||||||||
Warrants and Rights Outstanding | $ | $ 7,100,000 | $ 1,800,000 | $ 1,800,000 | |||||||||||||||
Common Warrants [Member] | December 2022 Financing [Member] | ||||||||||||||||||
Warrants and Rights Outstanding | $ | $ 100,000 | |||||||||||||||||
Redeemable Convertible Preferred Stock [Member] | ||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | |||||||||||||||||
Preferred Stock, Shares Outstanding (in shares) | 3,000 | |||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,000 | |||||||||||||||||
Preferred Stock Stated Value Per Share (in dollars per share) | $ / shares | $ 100 | |||||||||||||||||
Preferred Stock, Redemption Price Per Share (in dollars per share) | $ / shares | $ 3.7 | |||||||||||||||||
Preferred Stock, Company Option to Convert, Percentage of Stated Value | 105% | 105% | ||||||||||||||||
Preferred Stock, Purchaser Option to Convert, Percentage of Stated Value | 110% | |||||||||||||||||
Dividends, Preferred Stock | $ | $ 200,000 | |||||||||||||||||
Reverse Stock Split, Preferred Stock Votes per Share | 1,000,000 | |||||||||||||||||
Preferred Stock, Redemption Amount | $ | $ 300,000 | |||||||||||||||||
Preferred Stock, Elimination of Designation, Shares (in shares) | 3,000 | |||||||||||||||||
Stock Issued During Period, Value, New Issues | $ | $ 110,000 |
Note 10 - Warrants (Details Tex
Note 10 - Warrants (Details Textual) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||||||
Jan. 17, 2024 USD ($) $ / shares | Jul. 17, 2023 USD ($) $ / shares shares | Dec. 29, 2022 USD ($) $ / shares shares | Dec. 27, 2022 shares | Aug. 03, 2022 USD ($) $ / shares shares | Nov. 15, 2021 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Jul. 20, 2023 USD ($) $ / shares shares | Dec. 31, 2021 shares | May 30, 2019 $ / shares shares | |
Warrants and Rights Outstanding | $ 1,778 | $ 7,098 | |||||||||
Class of Warrant or Right, Exercised (in shares) | shares | 3,228,781 | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 21,682,049 | 7,824,933 | 883,833 | ||||||||
Equity Issuance Costs, Modification of Warrants | $ 0 | $ 47 | |||||||||
Proceeds from Issuance of Private Placement | $ 10,000 | ||||||||||
December 2022 Financing [Member] | |||||||||||
Proceeds from Issuance or Sale of Equity, After Warrant Adjustment | $ 400 | ||||||||||
Proceeds from Issuance of Common Stock | 100 | $ 0 | $ 7,528 | ||||||||
Proceeds from Issuance of Warrants | 300 | ||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 7,500 | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 748,744 | ||||||||||
Securities Purchase Agreement [Member] | |||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 200 | ||||||||||
Proceeds from Issuance or Sale of Equity | $ 300 | ||||||||||
2021 Registered Direct Offering [Member] | |||||||||||
Proceeds from Issuance or Sale of Equity | $ 14,000 | ||||||||||
Private Placement [Member] | |||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 5,340,591 | ||||||||||
Subsequent Event [Member] | Pivotal Trial Milestone [Member] | |||||||||||
Proceeds from Issuance of Private Placement | $ 10,000 | ||||||||||
Subsequent Event [Member] | Pivotal Share Price Milestone [Member] | |||||||||||
Proceeds from Issuance of Private Placement | 2,000 | ||||||||||
Subsequent Event [Member] | Private Placement [Member] | |||||||||||
Proceeds from Issuance of Common Stock | 6,000 | ||||||||||
Proceeds from Issuance of Private Placement | $ 6,000 | ||||||||||
Measurement Input, Risk Free Interest Rate [Member] | 2021 Registered Direct Offering [Member] | |||||||||||
Proceeds from Issuance of Common Stock | 8,400 | ||||||||||
Proceeds from Issuance or Sale of Equity | $ 14,000 | ||||||||||
Prefund Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,012,356 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||||
Prefund Warrants [Member] | Private Placement [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,012,356 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.001 | ||||||||||
Series A Common Stock Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 3,676,473 | 7,352,947 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | ||||||||||
Series A Common Stock Warrants [Member] | Private Placement [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 7,352,947 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | ||||||||||
Series B Common Stock Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 3,676,473 | 7,352,947 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | ||||||||||
Series B Common Stock Warrants [Member] | Private Placement [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 7,352,947 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.11 | ||||||||||
Series A and B Common Stock Warrants [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1.7 | ||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||||
Warrants and Rights Outstanding | $ 300 | ||||||||||
Series A and B Common Stock Warrants [Member] | Subsequent Event [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.77 | ||||||||||
Series A and B Common Stock Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0107 | ||||||||||
Series A and B Common Stock Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 5 | ||||||||||
Series A and B Common Stock Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.943 | ||||||||||
Series A and B Common Stock Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0408 | ||||||||||
Series A and B Common Stock Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0 | ||||||||||
The 2023 Prefunded Warrants [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.001 | ||||||||||
Class of Warrant or Right, Exercised (in shares) | shares | 595,883 | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 1,416,473 | ||||||||||
The 2022 Prefunded Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,632,898 | 2,632,898 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||
Warrants and Rights Outstanding, Measurement Input | 2.22615 | ||||||||||
Class of Warrant or Right, Exercised (in shares) | shares | 2,632,898 | ||||||||||
Common Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 4,227,052 | 4,227,052 | 4,227,052 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | $ 2.07 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 6 years | ||||||||||
Warrants and Rights Outstanding | $ 7,100 | $ 1,800 | |||||||||
Common Warrants [Member] | December 2022 Financing [Member] | |||||||||||
Warrants and Rights Outstanding | $ 100 | ||||||||||
Common Warrants [Member] | Minimum [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1 | ||||||||||
Common Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 2.13 | 0.74 | |||||||||
Common Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 6 | 5 | |||||||||
Common Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.9544 | 0.9405 | |||||||||
Common Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0393 | 0.0384 | |||||||||
Common Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0 | 0 | |||||||||
August 2022 LPC Warrant [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 81,150 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 4.07 | ||||||||||
Warrants and Rights Outstanding | $ 300 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 4.44 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 5.5 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.8994 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0286 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0 | ||||||||||
November 2021 Financing Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 875,000 | 125,000 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 20 | $ 20 | |||||||||
Warrants and Rights Outstanding | $ 8,600 | ||||||||||
Proceeds from Issuance of Warrants | $ 5,600 | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 875,000 | ||||||||||
November 2021 Financing Warrants [Member] | Maximum [Member] | |||||||||||
Class of Warrant or Right, Required Percentage of Ownership to Become Exercisable | 9.99% | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 14.92 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 5 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.9177 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0126 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0 | ||||||||||
Modified November 2021 Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 750,000 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | ||||||||||
Equity Issuance Costs, Modification of Warrants | $ 800 | ||||||||||
Modified November 2021 Warrants [Member] | Additional Paid-in Capital [Member] | |||||||||||
Equity Issuance Costs, Modification of Warrants | 100 | ||||||||||
Modified November 2021 Warrants [Member] | Selling, General and Administrative Expenses [Member] | |||||||||||
Equity Issuance Costs, Modification of Warrants | $ 700 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 2.13 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 6 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.9544 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0.0393 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input | 0 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 8,833 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 56.6 | ||||||||||
Warrants and Rights Outstanding, Term (Year) | 10 years | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 8,833 |
Note 10 - Warrants - Schedule o
Note 10 - Warrants - Schedule of Warrant Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Outstanding at December 31, 2021 (in shares) | 7,824,933 | 883,833 |
Granted, warrants (in shares) | 17,085,897 | 6,941,100 |
Exercised, warrants (in shares) | (3,228,781) | |
Outstanding at December 31, 2022 (in shares) | 21,682,049 | 7,824,933 |
Exercisable at December 31, 2023 (in shares) | 21,682,049 | |
Weighted Average [Member] | ||
Outstanding at December 31, 2021 (in dollars per share) | $ 1.71 | $ 5.15 |
Granted, warrants, exercise price (in dollars per share) | 0.99 | 1.27 |
Exercised, warrants, exercise price (in dollars per share) | (0.0003) | |
Outstanding at December 31, 2022 (in dollars per share) | 1.4 | $ 1.71 |
Exercisable at December 31, 2023 (in dollars per share) | $ 1.4 |
Note 10 - Warrants (Details)
Note 10 - Warrants (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Warrants (in shares) | 21,682,049 | 7,824,933 | 883,833 |
Number of Warrants (in shares) | 21,682,049 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 5 years 21 days | ||
Weighted Average [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 1.4 | $ 1.71 | $ 5.15 |
Weighted- Average Exercise Price (in dollars per share) | 1.4 | ||
Warrants Exercise Price One [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 0.001 | ||
Number of Warrants (in shares) | 1,416,473 | ||
Number of Warrants (in shares) | 1,416,473 | ||
Warrants Exercise Price One [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 0.001 | ||
Warrants Exercise Price Two [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 1.11 | ||
Number of Warrants (in shares) | 14,787,044 | ||
Number of Warrants (in shares) | 14,787,044 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 4 years 7 months 13 days | ||
Warrants Exercise Price Two [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 1.11 | ||
Warrants Exercise Price Three [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 1.7 | ||
Number of Warrants (in shares) | 367,647 | ||
Number of Warrants (in shares) | 367,647 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 4 years 7 months 13 days | ||
Warrants Exercise Price Three [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 1.7 | ||
Warrants Exercise Price Four [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 2.07 | ||
Number of Warrants (in shares) | 4,977,052 | ||
Number of Warrants (in shares) | 4,977,052 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 5 years 25 days | ||
Warrants Exercise Price Four [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 2.07 | ||
Warrants Exercise Price Five [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 20 | ||
Number of Warrants (in shares) | 125,000 | ||
Number of Warrants (in shares) | 125,000 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 2 years 11 months 1 day | ||
Warrants Exercise Price Five [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 20 | ||
Warrants Exercise Price Six [Member] | |||
Warrant Exercise Price (in dollars per share) | $ 56.6 | ||
Number of Warrants (in shares) | 8,833 | ||
Number of Warrants (in shares) | 8,833 | ||
Weighted- Average Remaining Contractual Life (Years) (Year) | 5 years 5 months 26 days | ||
Warrants Exercise Price Six [Member] | Weighted Average [Member] | |||
Weighted- Average Exercise Price (in dollars per share) | $ 56.6 |
Note 11 - Stock-based Compens_3
Note 11 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 1.32 | $ 5.8 |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 900 | |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 1 month 6 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 900 | $ 1,700 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 0 | $ 0 |
The 2020 Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,631,319 | |
The 2020 Equity Incentive Plan [Member] | Performance Shares [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Number of Shares (in shares) | 0 |
Note 11 - Stock-based Compens_4
Note 11 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-based compensation expense | $ 1,729 | $ 2,889 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 498 | 570 |
Selling, General and Administrative Expenses [Member] | ||
Stock-based compensation expense | 1,212 | 2,069 |
Discontinued Operation [Member] | ||
Stock-based compensation expense | $ 19 | $ 250 |
Note 11 - Stock-based Compens_5
Note 11 - Stock-based Compensation - Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restricted stock units outstanding, January 1, 2021 (in shares) | 82,778 | 88,711 |
Restricted stock units outstanding, January 1, 2021 (in dollars per share) | $ 16.97 | $ 34.16 |
Granted (in shares) | 48,158 | 58,502 |
Granted (in dollars per share) | $ 1.67 | $ 7.75 |
Vested (in shares) | (40,356) | (44,744) |
Vested (in dollars per share) | $ 19.28 | $ 35.46 |
Forfeited (in shares) | (4,348) | (19,691) |
Forfeited (in dollars per share) | $ 12.56 | $ 25 |
Restricted stock units outstanding, December 31, 2021 (in shares) | 86,232 | 82,778 |
Restricted stock units outstanding, December 31, 2021 (in dollars per share) | $ 7.57 | $ 16.97 |
Note 11 - Stock-based Compens_6
Note 11 - Stock-based Compensation - Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
December 31, 2021 (in shares) | shares | 725,623 |
December 31, 2021 (in dollars per share) | $ / shares | $ 52.98 |
Granted (in shares) | shares | 288,929 |
Granted (in dollars per share) | $ / shares | $ 1.67 |
Forfeited (in shares) | shares | (14,673) |
Forfeited (in dollars per share) | $ / shares | $ 9.72 |
Expired (in shares) | shares | (106,558) |
Expired (in dollars per share) | $ / shares | $ 83.88 |
Exercised (in shares) | shares | 0 |
Exercised (in dollars per share) | $ / shares | $ 0 |
December 31, 2022 (in shares) | shares | 893,321 |
December 31, 2022 (in dollars per share) | $ / shares | $ 33.41 |
December 31, 2022 (Year) | 6 years 3 months 18 days |
December 31, 2022 | $ | $ 1 |
Vested and exercisable options—December 31, 2022 (in shares) | shares | 488,725 |
Vested and exercisable options—December 31, 2022 (in dollars per share) | $ / shares | $ 53.69 |
Vested and exercisable options—December 31, 2022 (Year) | 4 years 3 months 18 days |
Vested and exercisable options—December 31, 2022 | $ | $ 0 |
Vested and expected to vest—December 31, 2022 (in shares) | shares | 893,321 |
Vested and expected to vest—December 31, 2022 (in dollars per share) | $ / shares | $ 33.41 |
Vested and expected to vest—December 31, 2022 (Year) | 6 years 3 months 18 days |
Vested and expected to vest—December 31, 2022 | $ | $ 1 |
Note 11 - Stock-based Compens_7
Note 11 - Stock-based Compensation - Stock Options Outstanding, Vested and Exercisable (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 893,321 | 725,623 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 3 months 18 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 33.41 | $ 52.98 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 488,725 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 53.69 | |
Exercise Price Range 1 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 0.684 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 1.76 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 281,505 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 9 years 2 months 12 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 1.67 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 0 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 0 | |
Exercise Price Range 2 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 4.62 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 6.93 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 15,350 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 6 months | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 5.21 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 12,818 | |
Exercise Price Range 3 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | $ 8.03 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 12.045 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 86,817 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 1 month 6 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 8.08 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 40,123 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 8.09 | |
Exercise Price Range 4 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 14.4 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 21.6 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 14,633 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 5 years 10 months 24 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 16.55 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 13,418 | |
Exercise Price Range 5 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 22.4 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 33.6 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 11,700 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 1 month 6 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 28.62 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 11,386 | |
Exercise Price Range 6 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | $ 3,440 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 51.6 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 280,662 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 5 years 4 months 24 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 41.01 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 208,326 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 42.23 | |
Exercise Price Range 7 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 57.4 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 86.1 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 169,213 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 2 years 8 months 12 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 64.86 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 169,213 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 64.86 | |
Exercise Price Range 8 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 94.6 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 141.9 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 17,371 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 1 year | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 127.59 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 17,371 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Exercisable and Vested, Weighted Average Exercise Price | $ 127.59 | |
Exercise Price Range 9 [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | $ 204.4 | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 306.6 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 16,070 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 2 months 12 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 206.24 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 16,070 |
Note 11 - Stock-based Compens_8
Note 11 - Stock-based Compensation - Assumptions to Calculate Fair Value of Each Performance-based Stock Option (Details) - Time-based Stock Option [Member] | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Expected term (in years) (Year) | 6 years 3 months 18 days | |
Risk-free interest rate, minimum | 3.90% | |
Risk-free interest rate, maximum | 4.60% | |
Expected volatility | 94% | 88% |
Expected dividend rate | 0% | 0% |
Minimum [Member] | ||
Expected term (in years) (Year) | 6 years 3 months 18 days | |
Risk-free interest rate, minimum | 1.60% | |
Maximum [Member] | ||
Risk-free interest rate, maximum | 3% |
Note 12 - Net Income (Loss) p_3
Note 12 - Net Income (Loss) per Share of Common Stock (Details Textual) - $ / shares | Jul. 17, 2023 | Dec. 29, 2022 |
The 2023 Prefunded Warrants [Member] | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.001 | |
The 2022 Prefunded Warrants [Member] | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 |
Note 12 - Net Income (Loss) p_4
Note 12 - Net Income (Loss) per Share of Common Stock - Computation of Basic and Diluted Net Income (Loss) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net income (loss) from continuing operations | $ (10,287) | $ 59,125 |
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | 0 | (186) |
Income allocated to participating securities | 0 | (5,240) |
Net income (loss) from continuing operations attributable to common shareholders, basic | (10,287) | 53,699 |
Net loss from discontinued operations attributable to common shareholders, basic | (8,110) | (11,370) |
Net income (loss) attributable to Common Shareholders, basic | $ (18,397) | $ 42,329 |
Weighted average shares outstanding — basic (in shares) | 14,263,744 | 7,385,348 |
Income (loss) from continuing operations, basic (in dollars per share) | $ (0.72) | $ 7.27 |
Loss from discontinued operations, basic (in dollars per share) | (0.57) | (1.54) |
Net income (loss) per share of common stock, basic (in dollars per share) | $ (1.29) | $ 5.73 |
Less: income allocated to participating securities | $ 0 | $ (5,227) |
Net income (loss) from continuing operations attributable to common shareholders, diluted | (10,287) | 53,712 |
Net loss from discontinued operations attributable to common shareholders, diluted | (8,110) | (11,370) |
Net income (loss) attributable to common shareholders, diluted | $ (18,397) | $ 42,342 |
Weighted average shares outstanding — basic (in shares) | 14,263,744 | 7,385,348 |
Dilutive effect of warrants (in shares) | 0 | 20,285 |
Dilutive effect of RSUs (in shares) | 0 | 1,353 |
Weighted average shares outstanding — diluted (in shares) | 14,263,744 | 7,406,986 |
Income (loss) from continuing operations, diluted (in dollars per share) | $ (0.72) | $ 7.25 |
Loss from discontinued operations, diluted (in dollars per share) | (0.57) | (1.53) |
Net (loss) income per share (in dollars per share) | $ (1.29) | $ 5.72 |
Note 12 - Net Income (Loss) P_5
Note 12 - Net Income (Loss) Per Share of Common Stock - Common Stock Excluded From Computation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
RSU's, ESPP, and Employee Stock Options [Member] | ||
ESPP, RSUs and stock options to purchase common stock (in shares) | 979,553 | 815,710 |
Warrant [Member] | ||
ESPP, RSUs and stock options to purchase common stock (in shares) | 20,265,576 | 133,833 |
Note 13 - Accrued Liabilities -
Note 13 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued compensation and employee benefits | $ 2,005 | $ 1,732 |
Accrued professional services | 121 | 456 |
Other accrued liabilities | 319 | 343 |
Total accrued liabilities | $ 2,445 | $ 2,531 |
Note 14 - 401(k) Plan (Details
Note 14 - 401(k) Plan (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan, Employer Discretionary Contribution Percentage | 4% | |
Contributions by Employer to Postemployment Benefit Obligations | $ 0.2 | $ 0.3 |
Note 15 - Income Taxes (Details
Note 15 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Expense (Benefit) | $ 0 | $ 13 | |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 2,200 | 13,500 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | $ 0 | $ 0 | |
Open Tax Year | 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2016 2017 2018 2019 2020 2021 2022 2023 | ||
Increase (Decrease) in Employee Related Liabilities | $ 1,400 | ||
Subject to Expiration [Member] | |||
Operating Loss Carryforwards | $ 1,400 | ||
Research Tax Credit Carryforward [Member] | Subject to Expiration [Member] | |||
Tax Credit Carryforward, Amount | 26 | ||
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards | 377,700 | ||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | 7,000 | ||
Domestic Tax Authority [Member] | Before Tax Year 2018 [Member] | |||
Operating Loss Carryforwards | 114,900 | ||
Domestic Tax Authority [Member] | Tax Years 2018 to 2022 [Member] | |||
Operating Loss Carryforwards | 262,800 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards | 137,400 | ||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | $ 4,400 |
Note 15 - Income Taxes - Net De
Note 15 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accruals and other | $ 1,717 | $ 3,790 |
Research credits | 7,839 | 7,392 |
Net operating loss carryforward | 88,839 | 84,325 |
Section 59(e) R&D expenditures | 1,937 | 3,496 |
Section 174 R&D expenditures | 1,651 | 981 |
Total deferred tax assets | 101,983 | 99,984 |
IP from Acquisition | 1,874 | 2,052 |
Total deferred tax liabilities | 1,874 | 2,052 |
Valuation allowance | (100,109) | (97,932) |
Net deferred tax assets | $ 0 | $ 0 |
Note 15 - Income Taxes - Reconc
Note 15 - Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Tax at statutory federal rate | $ (3,862) | $ 10,031 |
State tax—net of federal benefit | 2,495 | 823 |
Acquired assets | 0 | 1,728 |
Stock options | 738 | 611 |
Other | (431) | 355 |
Change in valuation allowance | 2,177 | (13,520) |
Revaluation of Put Option Liability | (1,117) | (15) |
Provision for income taxes | $ 0 | $ 13 |
Note 15 - Income Taxes - Reco_2
Note 15 - Income Taxes - Reconciliation of Beginning and Ending Balance of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Unrecognized benefit—beginning of period | $ 2,678 | $ 2,635 |
Gross increases—prior period tax positions | 0 | 0 |
Gross increases—current period tax positions | 157 | 43 |
Unrecognized benefit—end of period | $ 2,835 | $ 2,678 |
Note 16 - Subsequent Events (De
Note 16 - Subsequent Events (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Jan. 17, 2024 | Jan. 12, 2024 | Dec. 31, 2023 | Jul. 20, 2023 | Jul. 17, 2023 | Dec. 31, 2022 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Series A Common Stock Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.11 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,352,947 | 3,676,473 | ||||
Series B Common Stock Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.11 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,352,947 | 3,676,473 | ||||
Subsequent Event [Member] | Amended Series A Common Stock Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,941,178 | |||||
Subsequent Event [Member] | Amended Series B Common Stock Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,941,178 | |||||
Subsequent Event [Member] | Amended Series A and B Common Stock Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.77 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | ||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | 0.001 | |||||
Shares Issued, Price Per Share (in dollars per share) | $ 0.769 | |||||
Proceeds from Issuance of Common Stock | $ 6 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | Pivotal Share Price Milestone [Member] | ||||||
Proceeds from Issuance of Common Stock | $ 2 | |||||
Sale of Equity, Share Price Milestone (in dollars per share) | $ 0.92 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | Pivotal Trial Milestone [Member] | ||||||
Proceeds from Issuance of Common Stock | $ 10 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | Prefunded 2024 Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.001 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,792,208 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | Prefunded 2024 Warrants [Member] | Pivotal Share Price Milestone [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,597,402 | |||||
Subsequent Event [Member] | The January 2024 Private Placement [Member] | Prefunded 2024 Warrants [Member] | Pivotal Trial Milestone [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 12,987,013 | |||||
XOMA [Member] | Subsequent Event [Member] | ||||||
Proceeds From Sale of Receivables | $ 8 | |||||
License Agreement, Percentage of Royalty Payments Based on Net Sales and Milestone Payments | 100% | |||||
License Agreement, Milestone Payments to be Paid, Maximum | $ 116.5 | |||||
XOMA [Member] | Subsequent Event [Member] | Agreement After Stepdown Date [Member] | ||||||
License Agreement, Percentage of Royalty Payments Based on Net Sales and Milestone Payments | 50% | |||||
License Agreement, Percentage of Royalty Payments Excluding Department of Defense Sales and Milestone Payments | 100% |