Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 30, 2022 | Jun. 30, 2021 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0000946486 | ||
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 000-26422 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 94-3171943 | ||
Entity Address, Address Line One | 2600 Kelly Road, Suite 100 | ||
Entity Address, City or Town | Warrington | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 18976-3622 | ||
City Area Code | 215 | ||
Local Phone Number | 488-9300 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | WINT | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 44,100,000 | ||
Entity Common Stock, Shares Outstanding | 28,469,274 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 22,348 | $ 16,930 |
Prepaid expenses and other current assets | 1,143 | 1,188 |
Total current assets | 23,491 | 18,118 |
Property and equipment, net | 1,011 | 924 |
Restricted cash | 154 | 154 |
Operating lease right-of-use assets | 2,381 | 917 |
Intangible assets | 32,070 | 77,090 |
Goodwill | 15,682 | 15,682 |
Total assets | 74,789 | 112,885 |
Current Liabilities: | ||
Accounts payable | 693 | 1,161 |
Accrued expenses | 3,408 | 3,813 |
Operating lease liabilities - current portion | 528 | 805 |
Loans payable - current portion | 294 | 352 |
Total current liabilities | 4,923 | 6,131 |
Operating lease liabilities - non-current portion | 2,071 | 201 |
Loans payable - non-current portion | 0 | 2,423 |
Restructured debt liability - contingent milestone payments | 15,000 | 15,000 |
Other liabilities | 3,800 | 2,800 |
Deferred tax liabilities | 7,114 | 16,778 |
Total liabilities | 32,908 | 43,333 |
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2021 and 2020 | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2021 and 2020; 28,268,950 and 16,921,506 shares issued at December 31, 2021 and 2020, respectively; 28,268,926 and 16,921,482 shares outstanding at December 31, 2021 and 2020, respectively | 28 | 17 |
Additional paid-in capital | 830,231 | 790,277 |
Accumulated deficit | (785,324) | (717,688) |
Treasury stock (at cost); 24 shares | (3,054) | (3,054) |
Total stockholders’ equity | 41,881 | 69,552 |
Total liabilities & stockholders’ equity | $ 74,789 | $ 112,885 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorize (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 28,268,950 | 16,921,506 |
Common stock, shares outstanding (in shares) | 28,268,926 | 16,921,482 |
Treasury stock, shares (in shares) | 24 | 24 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Expenses: | ||
Research and development | $ 17,787 | $ 15,373 |
General and administrative | 14,473 | 14,944 |
Loss on impairment of intangible assets | 45,020 | 0 |
Total operating expenses | 77,280 | 30,317 |
Operating loss | (77,280) | (30,317) |
Interest income | 91 | 122 |
Interest expense | (114) | (125) |
Other expense, net | (320) | (2,246) |
Total other expense, net | (343) | (2,249) |
Loss before income taxes | (77,623) | (32,566) |
Deferred income tax benefit | 9,987 | 0 |
Net loss | $ (67,636) | $ (32,566) |
Net loss per common share | ||
Basic and diluted (in dollars per share) | $ (2.73) | $ (2.08) |
Weighted average number of common shares outstanding | ||
Basic and diluted (in shares) | 24,760 | 15,654 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | ATM Program [Member]Common Stock [Member] | ATM Program [Member]Additional Paid-in Capital [Member] | ATM Program [Member]Retained Earnings [Member] | ATM Program [Member]Treasury Stock [Member] | ATM Program [Member] | Share Purchase Agreement, December 2019 [Member]Common Stock [Member] | Share Purchase Agreement, December 2019 [Member]Additional Paid-in Capital [Member] | Share Purchase Agreement, December 2019 [Member]Retained Earnings [Member] | Share Purchase Agreement, December 2019 [Member]Treasury Stock [Member] | Share Purchase Agreement, December 2019 [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Treasury Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2019 | 13,697 | ||||||||||||||
Balance at Dec. 31, 2019 | $ 14 | $ 763,097 | $ (685,122) | $ (3,054) | $ 74,935 | ||||||||||
Net loss | (32,566) | (32,566) | |||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 3,172 | ||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | $ 3 | 20,243 | 20,246 | ||||||||||||
Modification of warrants | 1,112 | 1,112 | |||||||||||||
Vesting of restricted stock units (in shares) | 35 | ||||||||||||||
Vesting of restricted stock units | 0 | ||||||||||||||
Exercise of common stock warrants (in shares) | 18 | ||||||||||||||
Exercise of common stock warrants | 141 | 141 | |||||||||||||
Stock-based compensation expense | 5,684 | 5,684 | |||||||||||||
Balance (in shares) at Dec. 31, 2020 | 16,922 | ||||||||||||||
Balance at Dec. 31, 2020 | $ 17 | 790,277 | (717,688) | $ (3,054) | 69,552 | ||||||||||
Net loss | (67,636) | (67,636) | |||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 9,230 | ||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | $ 9 | 27,381 | 27,390 | ||||||||||||
Stock-based compensation expense | 7,238 | 7,238 | |||||||||||||
Issuance of common stock, ATM Program, net of issuance costs (in shares) | 2,117 | ||||||||||||||
Issuance of common stock, ATM Program, net of issuance costs | $ 2 | $ 4,841 | $ 4,843 | ||||||||||||
Issuance of common stock warrants, equity consideration for service agreement | $ 494 | $ 494 | |||||||||||||
Balance (in shares) at Dec. 31, 2021 | 28,269 | ||||||||||||||
Balance at Dec. 31, 2021 | $ 28 | $ 830,231 | $ (785,324) | $ (3,054) | $ 41,881 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (67,636) | $ (32,566) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 192 | 168 |
Stock-based compensation | 7,238 | 5,684 |
Non-cash expense related to warrant modifications | 0 | 1,112 |
Non-cash lease expense | 677 | 473 |
Non-cash expense related to equity consideration for a service agreement | 494 | 0 |
Loss on impairment of intangible assets | 45,020 | 0 |
Deferred income tax benefit | (9,987) | 0 |
Unrealized loss on foreign exchange rate changes | 396 | 1,142 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 1,365 | 1,147 |
Accounts payable | (468) | (547) |
Collaboration and device development payable | 0 | (1,975) |
Accrued expenses | (407) | 585 |
Operating lease liabilities | (548) | (538) |
Net cash used in operating activities | (23,664) | (25,315) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (279) | (291) |
Net cash used in investing activities | (279) | (291) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock and warrants, net of issuance costs | 27,390 | 20,246 |
Proceeds from ATM Program, net of expenses | 4,843 | 0 |
Proceeds from research and development funding arrangement | 1,000 | 2,800 |
Proceeds from exercise of common stock warrants | 0 | 141 |
Principal payments on loans payable | (3,872) | (3,229) |
Proceeds from Paycheck Protection Program loan | 0 | 547 |
Principal payments on Paycheck Protection Program loan | 0 | (547) |
Net cash provided by financing activities | 29,361 | 19,958 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 5,418 | (5,648) |
Cash, cash equivalents, and restricted cash - beginning of year | 17,084 | 22,732 |
Cash, cash equivalents, and restricted cash - end of year | 22,502 | 17,084 |
Supplementary disclosure of non-cash activity: | ||
Operating lease liabilities arising from obtaining right-of-use assets | 2,141 | 249 |
Prepayment of insurance through third-party financing | $ 1,321 | $ 1,056 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | Note 1 We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Our development programs are primarily focused in the treatment of acute cardiovascular and secondarily in acute pulmonary diseases. Our lead product candidate, istaroxime, is a first two 2 2 2 Ca2 2a, SERCA2a, SERCA2a. SERCA2a not Our pulmonary product candidate portfolio consists of a KL4 KL4 September 2020, 2 19 KL4 2, 2, 19, January 2022, 20 2 KL4 19 19 19 Previously, we were also developing AEROSURF (lucinactant for inhalation), a novel drug/medical device combination product for noninvasive delivery of aerosolized KL4 November 2020, KL4 2 KL4 19 January 2022, not June 12, 2017, KL4 KL4 KL4 one Our ability to advance our development programs is dependent upon our ability to secure additional capital in both the near and long-term, through public or private equity offerings; through potential strategic opportunities, including licensing agreements, drug product development and marketing collaboration arrangements, pharmaceutical research cooperation arrangements or other similar transactions in geographic markets, including the U.S., and/or through potential grants and other funding commitments from U.S. government agencies, in each case, if available. We have engaged with potential counterparties in various markets and will continue to pursue non-dilutive sources of capital as well as potential private and public offerings. There can be no none |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or US GAAP, and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. All adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. The accompanying consolidated financial statements reflect the 1-for- 3 April 29, 2020. |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 3 ’ We are subject to risks common to companies in the biotechnology industry, including but not may not We have incurred net losses since inception. Our net loss was $67.6 million and $32.6 million, respectively, for the years ended December 31, 2021 2020 . Included in our net loss for the year ended December 31, 2021 is a $45.0 million loss on impairment of intangible assets related to rostafuroxin and a related $10.0 million deferred income tax benefit ( see, Note 4 ). We expect to continue to incur operating losses for at least the next several years. As of December 31, 2021 , we had an accumulated deficit of $785.3 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans. In March 2021, $27.4 million related to a public offering of 9,230,500 units at a price per unit of $3.25 . Each unit consisted of one one March 2021 March 2021 $3.60 per share and expire five We are party to an At-The-Market Offering Agreement with Ladenburg Thalmann & Co. Inc., or Ladenburg, pursuant to which we may $10.0 million of shares of our common stock through Ladenburg as agent and/or principal through an at-the-market program, or the ATM Program. For the year ended December 31, 2021 , we sold 2,116,944 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $5.0 million and net proceeds of approximately $4.8 million (s ee, Note 10 ). As of December 31, 2021 , we had cash and cash equivalents of $22.3 million and current liabilities of $4.9 million. As of March 31, 2022 , we believe that we have sufficient resources available to support our development activities and business operations and satisfy our obligations into the first 2023. not 10 12 12 To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential licensing arrangements, alliances and drug product collaborations focused on specified geographic markets; however, none no none not 12 12 The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not |
Note 4 - Accounting Policies an
Note 4 - Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 4 – Accounting Policies and Recent Accounting Pronouncements Principles of Consolidation The consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and our wholly owned subsidiary, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited, or CVie Therapeutics,; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). Goodwill and Intangible Assets We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development, or IPR&D, assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not may When testing our goodwill and indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not not December 1, 2021 , we elected to perform a quantitative assessment. When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances. During the second 2021, not 2 June 30, 2021, not June 30, 2021 $17.0 million. We then compared this fair value to the carrying value of approximately $54.8 million and recorded a loss on impairment of intangible assets of $37.8 million during the second 2021. As part of our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets, we reassessed certain of the assumptions related to our rostafuroxin drug candidate due to the current macroeconomic conditions which have made it harder to secure the funding needed to conduct the additional phase 2 December 1, 2021 was approximately $9.7 million. We then compared this fair value to the carrying value of approximately $17.0 million, and recorded an additional loss on impairment of intangible assets of $7.2 million in the fourth 2021. second $45.0 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2021 . No 2021 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not may one no no may not December 1, 2021 , we estimated the fair value of our reporting unit based upon the quoted market price and related market capitalization of our common stock, adjusted for an estimated control premium. Based on the quantitative test performed, we determined that the fair value of our reporting unit exceeded its carrying value and no The following table represents identifiable intangible assets and goodwill as of December 31, 2021 2020 : December 31, (in thousands) 2021 2020 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 9,730 54,750 Intangible assets 32,070 77,090 Goodwill $ 15,682 $ 15,682 Foreign Currency Transactions The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are not other expense, net . Foreign currency transactions resulted in losses of approximately $0.3 million and $1.2 million, respectively, for the years ended December 31, 2021 2020 . Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents are held at domestic and foreign financial institutions and consist of liquid investments, money market funds, and U.S. Treasury notes with a maturity from date of purchase of 90 Fair Value of Financial Instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying value of cash equivalents is equal to their respective fair values at December 31, 2021 2020 , respectively. Accounts payable and accrued expenses are carried at cost, which approximates fair value because of their short maturity. The carrying value of loans payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten Restricted Cash Restricted cash consists principally of a $140,000 certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our lease agreement dated May 26, 2004 $14,000 in deposits held by our landlord for our offices in Taipei, Taiwan. Leases Leases are accounted for under Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 842, Leases 842. one not 12 not Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may not At the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether we have the right to direct the use of the asset. We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any one no not Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not 12 Long-lived Assets Our long-lived assets, primarily consisting of property and equipment, are reviewed for impairment when events or changes in circumstances indicate that the carrying value of an asset may not No December 31, 2021 2020 as management believes there are no not Collaborative Arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, Note 12 . Severance In July 2020, two August 2021 2020, 2020, 2020. $0.9 million, was accrued at the date of the separations, and was paid ratably through August 2021. December 31, 2021 2020 , $0.5 million and $0.4 million, respectively, was paid and no December 31, 2021 . Restructured Debt Liability – Contingent Milestone Payment In conjunction with the November 2017 see, 9 October 27, 2017, not Research and Development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical, medical and regulatory operations, and (c) direct clinical and preclinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development Stock-based Compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation 718. See, 11 Warrant Accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging Contracts in Entity ’ 815, Income Taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes 740, We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not For the year ended December 31, 2021 Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended December 31, 2021 2020 December 31, 2021 2020 We do not Concentration of Suppliers We currently obtain the APIs of our drug products from a single supplier. In addition, our drug products are produced at one Segment and Geographic Information We currently operate in one one not December 31, 2021 COVID- 19 The COVID- 19 may 19 10 19, 2 2020 2021 19 may 19 one may 19 19 one may 2022 We are not may Recent Accounting Pronouncements In December 2019, 2019 12, Income Taxes (Topic 740 2019 12. 2019 12 740 December 15, 2020, 2019 12 January 1, 2021, not |
Note 5 - Fair Value Measurement
Note 5 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 5 Fair value is defined as the exchange price that would be received for an asset or 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 is based on three first two ● Level 1 ● Level 2 1 not ● Level 3 no Fair Value on a Recurring Basis The tables below categorize assets measured at fair value on a recurring basis as of December 31, 2021 2020 Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 21,104 $ 21,104 $ - $ - Total Assets $ 21,104 $ 21,104 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2020 Level 1 Level 2 Level 3 Cash equivalents: U.S. Treasury notes $ 9,101 $ 9,101 $ - $ - Money market funds 6,518 6,518 - - Total Assets $ 15,619 $ 15,619 $ - $ - Fair Value on a Non-Recurring Basis The table below categorizes assets measured at fair value on a non-recurring basis for the period presented: Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 9,730 $ - $ - $ 9,730 The only asset or liability measured at fair value on a non-recurring basis during the year ended December 31, 2021 2020 was the IPR&D intangible asset related to our rostafuroxin drug candidate, which was recorded at its estimated fair value as a result of the impairment tests performed during 2021 see Note 4 – Goodwill and Intangible Assets). Significant factors considered in estimating the fair value of the IPR&D intangible asset include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for the IPR&D asset were estimated based on forecasted revenue and costs, taking into account the expected product life cycle, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D asset; (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. Quantitative information about the significant unobservable inputs used in the fair value measurement of the IPR&D asset included a discount rate of approximately 19.0% and a tax rate of 30.0%. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidate and market conditions which could result in future impairment charges related to the indefinite-lived intangible asset balance. |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 6 Property and equipment is comprised of the following: December 31, (in thousands) 2021 2020 Manufacturing, laboratory & office equipment $ 4,703 $ 4,591 Leasehold improvements 2,649 2,482 Furniture & fixtures 390 390 Subtotal 7,742 7,463 Accumulated depreciation and amortization (6,731 ) (6,539 ) Property and equipment, net $ 1,011 $ 924 Depreciation expense on property and equipment was $0.2 million for each of the years ended December 31, 2021 2020 |
Note 7 - Accrued Expenses
Note 7 - Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | Note 7 Accrued expenses are comprised of the following: December 31, (in thousands) 2021 2020 Research and development $ 1,500 $ 1,207 Salaries, bonus and benefits 1,218 1,214 Severance - 474 Professional fees 391 455 Manufacturing operations 46 41 Other 253 422 Total accrued expenses $ 3,408 $ 3,813 |
Note 8 - Loans Payable
Note 8 - Loans Payable | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Short-term Debt [Text Block] | Note 8 Current Portion Loan Payable to Bank Direct Capital Finance In June 2020, million of certain premiums at a annual interest rate. Payments of approximately were due monthly from July 2020 March 2021. December 31, 2020, million. The balance of the loan was repaid during the first 2021. In June 2021, million of certain premiums at a annual interest rate. Payments of approximately are due monthly from July 2021 March 2022. December 31, 2021 , the outstanding principal of the loan was million. Non-Current Portion O-Bank Co., Ltd. Credit Facility In September 2016, 12 September 2017. 90 September 11, 2019 six March 11, 2020. March 2020, March 2022, In the second 2020, August 2020. November 2020, June 2021, As of December 31, 2020, million and was classified as loans payable - non-current portion. There was no December 31, 2021, no |
Note 9 - Restructured Debt Liab
Note 9 - Restructured Debt Liability | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 9 On October 27, 2017, $15.0 million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement . The liability has been recorded at the full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or the milestones are not As of December 31, 2021 2020 , the restructured debt liability balance was million. |
Note 10 - Stockholders' Equity
Note 10 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 10 March 2021 On March 23, 2021, March 2021 units with each unit consisting of one March 2021 March 2021 per share and expire five March 2021 March 2021 The closing of the March 2021 March 25, 2021. per unit resulting in gross proceeds to us of million. After deducting underwriting discounts and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the March 2021 March 2021 million. We have determined that the appropriate accounting treatment under ASC 480, Distinguishing Liabilities from Equity 480, March 2021 March 2021 March 2021 not 815, Derivatives and Hedging 815, 815 10 15 74, March 2021 March 2021 May 2020 On May 20, 2020, May 2020 units with each unit consisting of one May 2020 May 2020 per share and expire five years from the date of issuance. The shares of common stock and the May 2020 May 2020 In addition, we granted the Underwriters a 45 additional shares of common stock and/or May 2020 additional shares of common stock, which such Overallotment Option was exercised in full. The closing of the May 2020 May 22, 2020, per unit. After deducting underwriting discounts and commissions and offering expenses of million payable by us, and excluding the proceeds, if any, from the exercise of the May 2020 May 2020 million. We have determined that the appropriate accounting treatment under ASC 480 May 2020 May 2020 May 2020 not 815 815 10 15 74, May 2020 May 2020 At-The-Market Program On September 17, 2020, may million of shares of our common stock through Ladenburg as agent and/or principal through an at-the-market program, or the ATM Program. When we issue sales notices to Ladenburg, we designate the maximum amount of shares to be sold by Ladenburg daily and the minimum price per share at which shares may may 415 4 We agreed to pay Ladenburg a commission of of the gross sales price of any shares sold pursuant to the ATM Program. The rate of compensation will not For the year ended December 31, 2021 , we sold shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately million and net proceeds of approximately million. As of March 31, 2022 , approximately million remains available under the ATM Program. Warrant Amendments On April 24, 2020, December 24, 2018, No. 1 June 24, 2020 December 24, 2020 90 December 24, 2020. May 2020 December 24, 2020. On May 6, 2020, December 6, 2019, No. 1 December 5, 2021. 90 December 24, 2020. May 2020 While there is no 718 20, Compensation – Stock Compensation 718 20. For the Series F Warrants, the amendment to the terms related to a six 18 We have determined, based on the guidance in ASC 718 20 million, which was recorded as an increase to equity, with a corresponding expense recognized in the consolidated statement of operations as other expense for the year ended December 31, 2020. Common Shares Reserved for Future Issuance Common shares reserved for potential future issuance upon exercise of warrants The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants: December 31, Expiration (in thousands, except price per share data) 2021 2020 Exercise Price Date Investors - March 2021 financing 9,231 - $ 3.60 03/25/26 Service Agreement - 2021 warrants 170 - $ 8.25 02/09/24 Investors - May 2020 financing 3,155 3,155 $ 7.98 05/22/25 Investors - December 2019 financing 1,458 1,458 $ 12.09 12/06/24 Investors - AEROSURF 988 988 $ - 02/14/24 Investors - December 2018 financing - long-term 1,296 1,296 $ 12.15 12/04/23 Investors - December 2018 financing - short-term - - $ 11.04 12/24/20 Battelle - 2018 payables restructuring agreement (1) 25 25 $ 19.50 12/07/23 Panacea Venture Management Company Ltd. 63 63 $ 12.00 07/02/23 LPH II Investments Limited 45 45 $ 16.56 04/04/25 Investors - February 2017 financing 117 117 $ 82.20 02/15/24 Investors - July 2015 financing 80 80 $ 588.00 07/22/22 Battelle - 2014 collaboration agreement 1 1 $ 4,200.00 10/10/24 Total 16,629 7,228 ( 1 See, 12 , for further details on the Battelle collaboration agreement. Common shares reserved for potential future issuance upon granting of additional equity incentive awards The 2020 2020 1,535,500 2020 2020 January 1 January 1, 2022) See, 11 . As of December 31, 2021 , we had million shares available for potential future issuance under the 2020 |
Note 11 - Stock Options and Sto
Note 11 - Stock Options and Stock-based Employee Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | Note 11 Long-term Incentive Plans On November 23, 2020, 2020 December 24, 2020 January 20, 2021, 2020 2011 2011 2020 2020 may As of December 31, 2021 , there were 1.9 million shares of our common stock authorized under the 2020 0.6 million shares remained available for issuance as of December 31, 2021 . The 2020 January 1 January 1, 2022) 4% January 1, 2022 1.1 An administrative committee, currently the Compensation Committee of the Board of Directors, or Committee delegates, may may Stock options and RSUs outstanding and available for future issuance are as follows December 31, (in thousands) 2021 2020 Stock Options and RSUs Outstanding 2020 Plan 1,256 - 2011 Plan 1,567 1,688 Non-Plan 564 215 Total Outstanding 3,387 1,903 Available for Future Grants under 2020 Plan 631 230 No 2020 may three first 10 5635 4 three first 10 A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2021 1,903 $ 15.57 Granted 1,621 4.88 Forfeited or expired (137 ) 33.23 Outstanding at December 31, 2021 3,387 $ 9.74 8.2 Vested and exercisable at December 31, 2021 1,685 $ 14.06 7.4 Vested and expected to vest at December 31, 2021 3,184 $ 9.78 8.2 During the year ended December 31, 2020, December 31, 2021 2020 Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended December 31, 2021 2020 no December 31, 2021 2020 December 31, 2021 Stock-Based Compensation We recognized stock-based compensation expense in accordance with ASC Topic 718 December 31, 2021 2020 Stock-based compensation expense was classified as follows: Year Ended December 31, (in thousands) 2021 2020 Research and development $ 2,940 $ 2,098 General and administrative 4,298 3,586 Total $ 7,238 $ 5,684 The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant. Year Ended December 31, 2021 2020 Weighted average expected volatility 104 % 103 % Weighted average expected term 6.7 7.0 Weighted average risk-free interest rate 0.49 % 0.54 % Expected dividends - - The total fair value of the underlying shares of the options vested during 2021 2020 December 31, 2021 2020 2011 |
Note 12 - Collaboration, Licens
Note 12 - Collaboration, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Corporate Partnership, Licensing and Research Funding Agreements [Text Block] | Note 12 Collaboration Agreement Battelle Memorial Institute In October 2014, 3 2 2b three 3 3 3 3 Licensing and Research Funding Agreements Lee ’ In June 2017, ’ ’ August 2017. ’ KL4 2012 ’ 12 Under the Asia License Agreement, Lee ’ may ’ may ’ 3 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES We will be eligible to receive tiered royalties based on a percent of Net Sales (as defined in the Asia License Agreement), depending on the product, in the range of high single to low-to-mid double-digit percentages. Royalties are payable on a country-by-country basis until the latest of (i) the expiration of the last valid patent claim covering the product in the country of sale, (ii) the expiration or revocation of any applicable regulatory exclusivity in the country of sale, and (iii) ten 10 first three one Under the Asia License Agreement, Lee ’ KL4 ’ ’ ’ ten 10 first first first first not The Asia License Agreement is accounted for in accordance with ASC Topic 606 second 2019 no no ’ On March 18, 2020, April 1, 2020 September 30, 2020 September 1, 2020. August 2020, October 2020. September 1, 2020 six November 12, 2020, 2021 “ ” 2021, no December 31, 2021 Since the 2018 2 KL4 19 January 2022, not KL4 KL4 KL4 one To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid 125% of the amounts funded by Lee ’ ’ KL4/AEROSURF third not ’ As of December 31, 2021 2020 We have determined that the Term Sheet and the PF Agreement are within the scope of ASC 730 20, Research and Development Arrangements 730 20. not ’ ’ We have determined that the appropriate accounting treatment under ASC 730 20 ’ KL4/AEROSURF We have also determined that the Term Sheet and the PF Agreement are not 815, 815 10 15 59, WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Philip Morris USA Inc. and Philip Morris Products S.A. Under license agreements with Philip Morris USA Inc., or PMUSA, and Philip Morris Products S.A., or PMPSA, we hold exclusive worldwide licenses to the ADS technology for use with pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) for all respiratory diseases and conditions (the foregoing uses in each territory, the Exclusive Field), and an exclusive license in the U.S. for use with certain non-surfactant drugs to treat specified respiratory indications in humans in designated hospital se ttings. We generally are obligated to pay royalties at a rate equal to a low single-digit percent of sales of products sold in the Exclusive Field (as defined in the license agreements) in the territories, including sales of aerosol devices that are not no not Johnson & Johnson and Ortho Pharmaceutical Corporation We, Johnson & Johnson, or J&J, and its wholly owned subsidiary, Ortho Pharmaceutical Corporation, are parties to a license agreement granting to us an exclusive worldwide license to the J&J KL4 Laboratorios del Dr. Esteve, S.A. We have a strategic alliance with Laboratorios del Dr. Esteve, S.A., or Esteve, for the development, marketing and sales of a broad portfolio of potential KL4 May 2002 January 2013. KL4 3 2004 KL4 Universita degli Studi di Milano-Bicocca Effective April 13, 2015, SERCA2a SERCA2a three Under the collaboration agreement, intellectual property resulting from the collaboration, including patents and know-how, will be jointly owned by the parties. For the development of any new SERCA2a ’ 12 not SERCA2a ten first On March 19, 2021, SERCA2a SERCA2a SERCA2a SERCA2a SERCA2a 1 SERCA2a ten first |
Note 13 - Related Party Transac
Note 13 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | Note 13 Lee ’ As of December 31, 2021 2020 , Lee ’ 17% and 29% , respectively. We entered into the following transactions with Lee ’ 2021 and 2020 : ● In March 2020, ’ ’ August 2020, ’ $2.8 million in 2020 $1.0 million in 2021. December 31, 2021 2020 , the liability balance related to the payments under the PF Agreement was $3.8 million and $2.8 million, respectively, and is recorded in other liabilities. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF No December 31, 2021 ( see Note 12 – Lee ’ ● We incurred $0.2 million in research and development expenses for services provided by an affiliate of Lee’s Holdings to our wholly owned subsidiary, CVie Therapeutics, during 2020; ● On December 31, 2021, Panacea Venture As of December 31, 2021 2020 , Panacea ’ 8% and 14% , respectively. James Huang, who in connection with the CVie Acquisition in December 2018 During 2020 , we entered into the following transactions with Panacea: ● In May 2020, May 2020 ee, Note 10 – May 2020 |
Note 14 - Litigation
Note 14 - Litigation | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Legal Matters and Contingencies [Text Block] | Note 14 We are not We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not no not |
Note 15 - Income Taxes
Note 15 - Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 15 – Income Taxes The components of the benefit for income taxes for the years ended December 31, 2021 2020 December 31, (in thousands) 2021 2020 Current expense (benefit): Federal $ - $ - State - - Foreign - - Total current expense (benefit) - - Deferred expense (benefit): Federal - - State - - Foreign (9,987 ) - Total deferred expense (benefit) (9,987 ) - Total income tax expense (benefit) $ (9,987 ) $ - For the year ended December 31, 2021 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES The reconciliation of the income tax benefit computed at the federal statutory rates to our recorded tax benefit for the years ended December 31, 2021 2020 December 31, (in thousands) 2021 2020 Income tax benefit, statutory rates $ (16,301 ) $ (6,837 ) State taxes on income, net of federal benefit (1,390 ) (125 ) Net operating loss expirations 2,184 1,835 Research and development tax credit 94 (1,213 ) Foreign rate differential 462 22 Employee related and other (186 ) 193 Interest related - 34 Income tax expense / (benefit), statutory rates (15,137 ) (6,091 ) Valuation allowance 5,150 6,091 Income tax benefit, net $ (9,987 ) $ - The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities as of December 31, 2021 2020 December 31, (in thousands) 2021 2020 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 187,905 $ 183,793 Research and development tax credit 18,538 18,632 Compensation expense on stock 4,568 3,525 Other accrued 2,006 1,811 Depreciation 115 112 Total long-term deferred tax assets 213,132 207,873 Long-term deferred liabilities: IPR&D (7,114 ) (16,778 ) Total long-term deferred tax liabilities (7,114 ) (16,778 ) Valuation allowance (213,132 ) (207,873 ) Deferred tax liabilities, net $ (7,114 ) $ (16,778 ) We are in a net deferred tax liability position as of December 31, 2021 2020 not December 31, 2021 2020 2021 2020 At December 31, 2021 2020 2040 At December 31, 2021 2020 seven 7 Future realization of the tax benefits of existing temporary differences and net operating loss carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period. As of December 31, 2021 2020 not not not December 31, 2021 2020 Under Internal Revenue Code Section 382, “ ” ’ may not “ ” “ ” 382. may may “ ” “ ” “ ” may Utilization of net operating loss, or NOL, and research and development, or R&D, credit carryforwards may 382 1986 may may WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES A full valuation allowance has been provided against our deferred tax assets and, if a future assessment requires an adjustment, an adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no |
Note 16 - Leases
Note 16 - Leases | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 16 Our operating leases consist primarily of facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan. We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. We also maintain offices in Taipei, Taiwan where we perform certain manufacturing development and preclinical activities related to our cardiovascular drug product candidates. In January 2021, five March 1, 2022 February 28, 2027. Throughout the term of our leases, we are responsible for paying certain variable lease costs, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The following table contains a summary of the lease costs recognized under ASC 842 December 31, 2021 2020 Year Ended December 31, (in thousands) 2021 2020 Operating lease cost $ 857 $ 826 Variable lease cost 45 29 Total lease cost $ 902 $ 855 Other Information Operating cash flows used for operating leases $ 734 $ 895 Operating lease liabilities arising from obtaining right-of-use assets $ 2,141 $ 249 Weighted average remaining lease term (in years) 4.8 1.3 Weighted average incremental borrowing rate 7.12 % 9.00 % Future minimum lease payments under our non-cancelable operating leases as of December 31, 2021 (in thousands) December 31, 2021 2022 $ 689 2023 575 2024 560 2025 570 2026 581 Thereafter 97 Total lease payments 3,072 Less imputed interest (473 ) Total operating lease liabilities at December 31, 2021 $ 2,599 |
Note 17 - Subsequent Events
Note 17 - Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 17 In January 2022, KL4 not KL4 KL4 September 30, 2022. KL4 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and our wholly owned subsidiary, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited, or CVie Therapeutics,; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Goodwill and Intangible Assets We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development, or IPR&D, assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not may When testing our goodwill and indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than not not December 1, 2021 , we elected to perform a quantitative assessment. When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions which could result in future impairment charges related to our indefinite-lived intangible asset balances. During the second 2021, not 2 June 30, 2021, not June 30, 2021 $17.0 million. We then compared this fair value to the carrying value of approximately $54.8 million and recorded a loss on impairment of intangible assets of $37.8 million during the second 2021. As part of our annual quantitative impairment assessment of indefinite-lived IPR&D intangible assets, we reassessed certain of the assumptions related to our rostafuroxin drug candidate due to the current macroeconomic conditions which have made it harder to secure the funding needed to conduct the additional phase 2 December 1, 2021 was approximately $9.7 million. We then compared this fair value to the carrying value of approximately $17.0 million, and recorded an additional loss on impairment of intangible assets of $7.2 million in the fourth 2021. second $45.0 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2021 . No 2021 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not may one no no may not December 1, 2021 , we estimated the fair value of our reporting unit based upon the quoted market price and related market capitalization of our common stock, adjusted for an estimated control premium. Based on the quantitative test performed, we determined that the fair value of our reporting unit exceeded its carrying value and no The following table represents identifiable intangible assets and goodwill as of December 31, 2021 2020 : December 31, (in thousands) 2021 2020 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 9,730 54,750 Intangible assets 32,070 77,090 Goodwill $ 15,682 $ 15,682 |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Transactions The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are not other expense, net . Foreign currency transactions resulted in losses of approximately $0.3 million and $1.2 million, respectively, for the years ended December 31, 2021 2020 . |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents Cash and cash equivalents are held at domestic and foreign financial institutions and consist of liquid investments, money market funds, and U.S. Treasury notes with a maturity from date of purchase of 90 |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying value of cash equivalents is equal to their respective fair values at December 31, 2021 2020 , respectively. Accounts payable and accrued expenses are carried at cost, which approximates fair value because of their short maturity. The carrying value of loans payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Restricted cash consists principally of a $140,000 certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our lease agreement dated May 26, 2004 $14,000 in deposits held by our landlord for our offices in Taipei, Taiwan. |
Lessee, Leases [Policy Text Block] | Leases Leases are accounted for under Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 842, Leases 842. one not 12 not Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may not At the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether we have the right to direct the use of the asset. We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any one no not Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not 12 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-lived Assets Our long-lived assets, primarily consisting of property and equipment, are reviewed for impairment when events or changes in circumstances indicate that the carrying value of an asset may not No December 31, 2021 2020 as management believes there are no not |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative Arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, Note 12 . |
Severance Cost [Policy Text Block] | Severance In July 2020, two August 2021 2020, 2020, 2020. $0.9 million, was accrued at the date of the separations, and was paid ratably through August 2021. December 31, 2021 2020 , $0.5 million and $0.4 million, respectively, was paid and no December 31, 2021 . |
Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block] | Restructured Debt Liability – Contingent Milestone Payment In conjunction with the November 2017 see, 9 October 27, 2017, not |
Research and Development Expense, Policy [Policy Text Block] | Research and Development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical, medical and regulatory operations, and (c) direct clinical and preclinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development |
Share-based Payment Arrangement [Policy Text Block] | Stock-based Compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation 718. See, 11 |
Derivatives, Policy [Policy Text Block] | Warrant Accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging Contracts in Entity ’ 815, |
Income Tax, Policy [Policy Text Block] | Income Taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes 740, We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not For the year ended December 31, 2021 |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended December 31, 2021 2020 December 31, 2021 2020 We do not |
Concentration of Suppliers [Policy Text Block] | Concentration of Suppliers We currently obtain the APIs of our drug products from a single supplier. In addition, our drug products are produced at one |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information We currently operate in one one not December 31, 2021 |
Effect of COVID-19 Pandemic [Policy Text Block] | COVID- 19 The COVID- 19 may 19 10 19, 2 2020 2021 19 may 19 one may 19 19 one may 2022 We are not may |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In December 2019, 2019 12, Income Taxes (Topic 740 2019 12. 2019 12 740 December 15, 2020, 2019 12 January 1, 2021, not |
Note 4 - Accounting Policies _2
Note 4 - Accounting Policies and Recent Accounting Pronouncements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Intangible Assets and Goodwill [Table Text Block] | December 31, (in thousands) 2021 2020 Istaroxime drug candidate $ 22,340 $ 22,340 Rostafuroxin drug candidate 9,730 54,750 Intangible assets 32,070 77,090 Goodwill $ 15,682 $ 15,682 |
Note 5 - Fair Value Measureme_2
Note 5 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 21,104 $ 21,104 $ - $ - Total Assets $ 21,104 $ 21,104 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2020 Level 1 Level 2 Level 3 Cash equivalents: U.S. Treasury notes $ 9,101 $ 9,101 $ - $ - Money market funds 6,518 6,518 - - Total Assets $ 15,619 $ 15,619 $ - $ - |
Fair Value Measurements, Nonrecurring [Table Text Block] | Fair Value Fair value measurement using December 31, (in thousands) 2021 Level 1 Level 2 Level 3 Intangible assets: Rostafuroxin drug candidate $ 9,730 $ - $ - $ 9,730 |
Note 6 - Property and Equipme_2
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, (in thousands) 2021 2020 Manufacturing, laboratory & office equipment $ 4,703 $ 4,591 Leasehold improvements 2,649 2,482 Furniture & fixtures 390 390 Subtotal 7,742 7,463 Accumulated depreciation and amortization (6,731 ) (6,539 ) Property and equipment, net $ 1,011 $ 924 |
Note 7 - Accrued Expenses (Tabl
Note 7 - Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, (in thousands) 2021 2020 Research and development $ 1,500 $ 1,207 Salaries, bonus and benefits 1,218 1,214 Severance - 474 Professional fees 391 455 Manufacturing operations 46 41 Other 253 422 Total accrued expenses $ 3,408 $ 3,813 |
Note 10 - Stockholders' Equity
Note 10 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Common Shares Reserved for Future Issuance, Warrants [Table Text Block] | December 31, Expiration (in thousands, except price per share data) 2021 2020 Exercise Price Date Investors - March 2021 financing 9,231 - $ 3.60 03/25/26 Service Agreement - 2021 warrants 170 - $ 8.25 02/09/24 Investors - May 2020 financing 3,155 3,155 $ 7.98 05/22/25 Investors - December 2019 financing 1,458 1,458 $ 12.09 12/06/24 Investors - AEROSURF 988 988 $ - 02/14/24 Investors - December 2018 financing - long-term 1,296 1,296 $ 12.15 12/04/23 Investors - December 2018 financing - short-term - - $ 11.04 12/24/20 Battelle - 2018 payables restructuring agreement (1) 25 25 $ 19.50 12/07/23 Panacea Venture Management Company Ltd. 63 63 $ 12.00 07/02/23 LPH II Investments Limited 45 45 $ 16.56 04/04/25 Investors - February 2017 financing 117 117 $ 82.20 02/15/24 Investors - July 2015 financing 80 80 $ 588.00 07/22/22 Battelle - 2014 collaboration agreement 1 1 $ 4,200.00 10/10/24 Total 16,629 7,228 |
Note 11 - Stock Options and S_2
Note 11 - Stock Options and Stock-based Employee Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block] | December 31, (in thousands) 2021 2020 Stock Options and RSUs Outstanding 2020 Plan 1,256 - 2011 Plan 1,567 1,688 Non-Plan 564 215 Total Outstanding 3,387 1,903 Available for Future Grants under 2020 Plan 631 230 |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | (in thousands, except for weighted-average data) Stock Options Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (In Yrs) Outstanding at January 1, 2021 1,903 $ 15.57 Granted 1,621 4.88 Forfeited or expired (137 ) 33.23 Outstanding at December 31, 2021 3,387 $ 9.74 8.2 Vested and exercisable at December 31, 2021 1,685 $ 14.06 7.4 Vested and expected to vest at December 31, 2021 3,184 $ 9.78 8.2 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year Ended December 31, (in thousands) 2021 2020 Research and development $ 2,940 $ 2,098 General and administrative 4,298 3,586 Total $ 7,238 $ 5,684 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2021 2020 Weighted average expected volatility 104 % 103 % Weighted average expected term 6.7 7.0 Weighted average risk-free interest rate 0.49 % 0.54 % Expected dividends - - |
Note 15 - Income Taxes (Tables)
Note 15 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, (in thousands) 2021 2020 Current expense (benefit): Federal $ - $ - State - - Foreign - - Total current expense (benefit) - - Deferred expense (benefit): Federal - - State - - Foreign (9,987 ) - Total deferred expense (benefit) (9,987 ) - Total income tax expense (benefit) $ (9,987 ) $ - |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, (in thousands) 2021 2020 Income tax benefit, statutory rates $ (16,301 ) $ (6,837 ) State taxes on income, net of federal benefit (1,390 ) (125 ) Net operating loss expirations 2,184 1,835 Research and development tax credit 94 (1,213 ) Foreign rate differential 462 22 Employee related and other (186 ) 193 Interest related - 34 Income tax expense / (benefit), statutory rates (15,137 ) (6,091 ) Valuation allowance 5,150 6,091 Income tax benefit, net $ (9,987 ) $ - |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, (in thousands) 2021 2020 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 187,905 $ 183,793 Research and development tax credit 18,538 18,632 Compensation expense on stock 4,568 3,525 Other accrued 2,006 1,811 Depreciation 115 112 Total long-term deferred tax assets 213,132 207,873 Long-term deferred liabilities: IPR&D (7,114 ) (16,778 ) Total long-term deferred tax liabilities (7,114 ) (16,778 ) Valuation allowance (213,132 ) (207,873 ) Deferred tax liabilities, net $ (7,114 ) $ (16,778 ) |
Note 16 - Leases (Tables)
Note 16 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year Ended December 31, (in thousands) 2021 2020 Operating lease cost $ 857 $ 826 Variable lease cost 45 29 Total lease cost $ 902 $ 855 Other Information Operating cash flows used for operating leases $ 734 $ 895 Operating lease liabilities arising from obtaining right-of-use assets $ 2,141 $ 249 Weighted average remaining lease term (in years) 4.8 1.3 Weighted average incremental borrowing rate 7.12 % 9.00 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | (in thousands) December 31, 2021 2022 $ 689 2023 575 2024 560 2025 570 2026 581 Thereafter 97 Total lease payments 3,072 Less imputed interest (473 ) Total operating lease liabilities at December 31, 2021 $ 2,599 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) | Apr. 29, 2020 |
Reverse Stock Split [Member] | |
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1 |
Note 3 - Liquidity Risks and _2
Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Mar. 25, 2021 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 17, 2020 |
Net Income (Loss) Attributable to Parent, Total | $ (67,636) | $ (32,566) | ||||
Impairment of Intangible Assets (Excluding Goodwill), Total | $ 7,200 | $ 37,800 | 45,020 | 0 | ||
Deferred Income Tax Expense (Benefit), Total | (9,987) | 0 | ||||
Retained Earnings (Accumulated Deficit), Ending Balance | $ (785,324) | $ (785,324) | (717,688) | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | ||||||
Proceeds from Issuance of Common Stock | $ 4,843 | 0 | ||||
Cash and Cash Equivalents, at Carrying Value, Ending Balance | $ 22,348 | 22,348 | 16,930 | |||
Liabilities, Current, Total | $ 4,923 | $ 4,923 | $ 6,131 | |||
March 2021 Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 3.60 | |||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||
March 2021 Public Offering [Member] | ||||||
Proceeds from Issuance or Sale of Equity, Total | $ 27,400 | |||||
Equity Issued During Period, Units, New Issues (in shares) | 9,230,500 | |||||
Stock and Warrants Issued, Price Per Share (in dollars per share) | $ 3.25 | |||||
Units, Number of Securities Called by Each Unit (in shares) | 1 | |||||
Units, Number of Warrants Called by Each Unit (in shares) | 1 | |||||
ATM Program [Member] | ||||||
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value | $ 10,000 | |||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,116,944 | |||||
Stock Issued During Period, Value, New Issues | $ 5,000 | |||||
Proceeds from Issuance of Common Stock | 4,800 | |||||
Rostafuroxin Drug Candidate [Member] | ||||||
Impairment of Intangible Assets (Excluding Goodwill), Total | 45,000 | |||||
Deferred Income Tax Expense (Benefit), Total | $ (10,000) |
Note 4 - Accounting Policies _3
Note 4 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) shares in Millions | Jul. 20, 2020USD ($) | Dec. 31, 2021USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Dec. 31, 2021USD ($)shares | Nov. 01, 2017USD ($) |
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 9,700,000 | $ 17,000,000 | $ 9,700,000 | $ 9,700,000 | |||
Intangible Assets, Net (Excluding Goodwill), Total | 17,000,000 | 54,800,000 | 17,000,000 | 17,000,000 | |||
Impairment of Intangible Assets (Excluding Goodwill), Total | 7,200,000 | $ 37,800,000 | $ 45,020,000 | $ 0 | |||
Number of Reporting Units | 1 | ||||||
Foreign Currency Transaction Loss, before Tax | $ 300,000 | 1,200,000 | |||||
Asset Impairment Charges, Total | 0 | 0 | |||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000,000 | 15,000,000 | 15,000,000 | $ 15,000,000 | |||
Deferred Income Tax Expense (Benefit), Total | $ (9,987,000) | 0 | |||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares) | shares | 20 | 9.1 | |||||
Number of Operating Segments | 1 | ||||||
Goodwill, Ending Balance | 15,682,000 | $ 15,682,000 | 15,682,000 | $ 15,682,000 | |||
Non-US [Member] | |||||||
Intangible Assets, Net (Excluding Goodwill), Total | 32,100,000 | 32,100,000 | 32,100,000 | ||||
Goodwill, Ending Balance | 15,700,000 | ||||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000,000 | ||||||
John A. Tattory and Kathryn Cole [Member] | |||||||
Severance Costs | $ 900,000 | ||||||
Payments for Severance Costs | 500,000 | $ 400,000 | |||||
Severance Accrual | 0 | 0 | 0 | ||||
Restricted Cash for Headquarters in Warrington, Pennsylvania [Member] | |||||||
Security Deposit | 140,000 | 140,000 | 140,000 | ||||
Restricted Cash for Offices in Taipei, Taiwan [Member] | |||||||
Security Deposit | $ 14,000 | $ 14,000 | $ 14,000 | ||||
Minimum [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | ||||||
Maximum [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 10 years |
Note 4 - Accounting Policies _4
Note 4 - Accounting Policies and Recent Accounting Pronouncements - Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Intangible assets | $ 32,070 | $ 77,090 |
Goodwill, Ending Balance | 15,682 | 15,682 |
Istaroxime Drug Candidate [Member] | ||
Intangible assets | 22,340 | 22,340 |
Rostafuroxin Drug Candidate [Member] | ||
Intangible assets | $ 9,730 | $ 54,750 |
Note 5 - Fair Value Measureme_3
Note 5 - Fair Value Measurements (Details Textual) | Dec. 01, 2021 |
Measurement Input, Discount Rate [Member] | |
Indefinite Lived Intangible Assets, Measurement Input | 0.190 |
Measurement Input, Tax Rate [Member] | |
Indefinite Lived Intangible Assets, Measurement Input | 0.300 |
Note 5 - Fair Value Measureme_4
Note 5 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Total Assets | $ 21,104 | $ 15,619 |
Fair Value, Inputs, Level 1 [Member] | ||
Total Assets | 21,104 | 15,619 |
Money Market Funds [Member] | ||
Cash equivalents | 21,104 | 6,518 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | $ 21,104 | 6,518 |
US Treasury Securities [Member] | ||
Cash equivalents | 9,101 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | $ 9,101 |
Note 5 - Fair Value Measureme_5
Note 5 - Fair Value Measurements - Assets Measured at Fair Value on a Non-recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Jun. 30, 2021 |
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 9,700 | $ 17,000 |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | ||
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 9,730 | |
Fair Value, Nonrecurring [Member] | Rostafuroxin Drug Candidate [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | $ 9,730 |
Note 6 - Property and Equipme_3
Note 6 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Depreciation, Total | $ 192 | $ 168 |
Note 6 - Property and Equipme_4
Note 6 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property and equipment, gross | $ 7,742 | $ 7,463 |
Accumulated depreciation and amortization | (6,731) | (6,539) |
Property and equipment, net | 1,011 | 924 |
Manufacturing, Laboratory, and Office Equipment [Member] | ||
Property and equipment, gross | 4,703 | 4,591 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 2,649 | 2,482 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | $ 390 | $ 390 |
Note 7 - Accrued Expenses - Acc
Note 7 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Research and development | $ 1,500 | $ 1,207 |
Salaries, bonus and benefits | 1,218 | 1,214 |
Severance | 0 | 474 |
Professional fees | 391 | 455 |
Manufacturing operations | 46 | 41 |
Other | 253 | 422 |
Total accrued expenses | $ 3,408 | $ 3,813 |
Note 8 - Loans Payable (Details
Note 8 - Loans Payable (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | ||||||
Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2017 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2016 | |
Loans Payable, Noncurrent, Total | $ 0 | $ 2,423,000 | ||||||
Revolving Credit Facility [Member] | O-Bank Co., Ltd. [Member] | ||||||||
Line of Credit Facility, Percent of Pledged Deposits Required | 110.00% | |||||||
Line of Credit Facility, Percent of Pledged Deposits Increase (Decrease) | 50.00% | |||||||
Repayments of Lines of Credit | $ 2,500,000 | $ 2,300,000 | ||||||
Loans Payable, Noncurrent, Total | $ 0 | 2,400,000 | ||||||
Revolving Credit Facility [Member] | O-Bank Co., Ltd. [Member] | Taipei Interbank Offer Rate (TAIBOR) [Member] | ||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.91% | |||||||
Nonrevolving Credit Facility [Member] | O-Bank Co., Ltd. [Member] | ||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5,000,000 | |||||||
Debt Instrument, Term (Month) | 24 months | |||||||
Nonrevolving Credit Facility [Member] | O-Bank Co., Ltd. [Member] | Taipei Interbank Offer Rate (TAIBOR) [Member] | ||||||||
Debt Instrument, Basis Spread on Variable Rate | 1.17% | |||||||
CVie Investments [Member] | Revolving Credit Facility [Member] | O-Bank Co., Ltd. [Member] | ||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5,800,000 | $ 2,900,000 | ||||||
Loan payable to Bank Direct Capital Finance [Member] | Loans Payable [Member] | ||||||||
Debt Instrument, Face Amount | $ 1,300,000 | $ 1,100,000 | $ 1,100,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 3.37% | 4.26% | 4.26% | |||||
Debt Instrument, Periodic Payment, Total | $ 147,000 | $ 117,000 | ||||||
Loans Payable to Bank, Total | $ 300,000 | $ 400,000 |
Note 9 - Restructured Debt Li_2
Note 9 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Oct. 27, 2017 | Dec. 31, 2021 | Dec. 31, 2020 |
Repayments of Long-term Debt, Total | $ 0 | $ 547 | |
Liability for Contingent Milestone Payment, Noncurrent | 15,000 | 15,000 | |
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||
Extinguishment of Debt, Amount | $ 25,000 | ||
Class of Warrant or Right, Number of Warrants Cancelled (in shares) | 8,333 | ||
Class of Warrant or Right, Exercise Price of Cancelled Warrants (in dollars per share) | $ 2,360.40 | ||
Repayments of Long-term Debt, Total | $ 2,500 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations (in shares) | 23,703 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding | 2.00% | ||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | $ 15,000 |
Note 10 - Stockholders' Equit_2
Note 10 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2022 | Mar. 25, 2021 | Sep. 17, 2020 | May 22, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 24, 2022 | Jan. 31, 2021 | May 06, 2020 | Dec. 06, 2019 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | ||||||||||
Proceeds from Issuance of Common Stock | $ 4,843 | $ 0 | ||||||||
Fair Value Adjustment of Warrants | $ 0 | $ 1,112 | ||||||||
The 2011 Long-term Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 1,535,500 | |||||||||
The 2020 Equity Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 631,000 | 230,000 | ||||||||
Subsequent Event [Member] | The 2020 Equity Incentive Plan [Member] | ||||||||||
Share-based Compensation Plan, Annual Increases to Shares of Common Stock Issued and Outstanding | 4.00% | |||||||||
March 2021 Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 3.60 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||
Over Allotment Warrants [Member] | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 413,793 | |||||||||
Series I Warrants Issued with Offering [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 9.67 | $ 12.09 | ||||||||
Series I and F Warrants Issued with Offering [Member] | ||||||||||
Fair Value Adjustment of Warrants | $ 1,100 | |||||||||
March 2021 Public Offering [Member] | ||||||||||
Equity Issued During Period, Units, New Issues (in shares) | 9,230,500 | |||||||||
Units, Number of Securities Called by Each Unit (in shares) | 1 | |||||||||
Stock and Warrants Issued, Price Per Share (in dollars per share) | $ 3.25 | |||||||||
Proceeds from Issuance or Sale of Equity, Gross Amount | $ 30,000 | |||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 27,400 | |||||||||
Public Offering [Member] | ||||||||||
Equity Issued During Period, Units, New Issues (in shares) | 2,758,620 | |||||||||
Units, Number of Securities Called by Each Unit (in shares) | 1 | |||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 20,200 | |||||||||
Units Issued, Price Per Unit (in dollars per share) | $ 7.25 | |||||||||
Payments of Stock Issuance Costs | $ 2,800 | |||||||||
Public Offering [Member] | Warrants Issued in Units [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 7.975 | |||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||
Over-Allotment Option [Member] | ||||||||||
Equity Issued During Period, Units, New Issues (in shares) | 413,793 | |||||||||
ATM Program [Member] | ||||||||||
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value | $ 10,000 | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,116,944 | |||||||||
Stock Issued During Period, Value, New Issues | $ 5,000 | |||||||||
Proceeds from Issuance of Common Stock | $ 4,800 | |||||||||
ATM Program [Member] | Subsequent Event [Member] | ||||||||||
Stock Offering Agreement, Remaining Amount Available | $ 5,000 | |||||||||
ATM Program [Member] | Ladenburg [Member] | ||||||||||
Commission Fee, Percent Fee | 3.00% |
Note 10 - Stockholders' Equit_3
Note 10 - Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Common stock, capital shares reserved for future issuance (in shares) | 16,629 | 7,228 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | |||
Expiration date | |||
Common stock, capital shares reserved for future issuance (in shares) | 16,629 | 7,228 | |
Service Agreement - 2021 warrants (in dollars per share) | |||
Expiration date | |||
Investors - March 2021 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 9,231 | 0 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 3.60 | ||
Expiration date | 03/25/26 | ||
Common stock, capital shares reserved for future issuance (in shares) | 9,231 | 0 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 3.60 | ||
Expiration date | 03/25/26 | ||
March 2021 Warrants [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 170 | 0 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 8.25 | ||
Expiration date | 02/09/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 170 | 0 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 8.25 | ||
Expiration date | 02/09/24 | ||
Investors - May 2020 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 3,155 | 3,155 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 7.98 | ||
Expiration date | 05/22/25 | ||
Common stock, capital shares reserved for future issuance (in shares) | 3,155 | 3,155 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 7.98 | ||
Expiration date | 05/22/25 | ||
Investors - December 2019 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1,458 | 1,458 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 12.09 | ||
Expiration date | 12/06/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1,458 | 1,458 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 12.09 | ||
Expiration date | 12/06/24 | ||
Investors - Aerosurf [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 988 | 988 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0 | ||
Expiration date | 02/14/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 988 | 988 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 0 | ||
Expiration date | 02/14/24 | ||
Investors - December 2018 Financing - Long-term [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1,296 | 1,296 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 12.15 | ||
Expiration date | 12/04/23 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1,296 | 1,296 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 12.15 | ||
Expiration date | 12/04/23 | ||
Investors - December 2018 Financing - Short-term [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 0 | 0 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 11.04 | ||
Expiration date | 12/24/20 | ||
Common stock, capital shares reserved for future issuance (in shares) | 0 | 0 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 11.04 | ||
Expiration date | 12/24/20 | ||
Battelle - 2018 Payables Restructuring Agreement [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | [1] | 25 | 25 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | [1] | $ 19.50 | |
Expiration date | [1] | 12/07/23 | |
Common stock, capital shares reserved for future issuance (in shares) | [1] | 25 | 25 |
Service Agreement - 2021 warrants (in dollars per share) | [1] | $ 19.50 | |
Expiration date | [1] | 12/07/23 | |
Panacea Venture Management Company Ltd. [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 63 | 63 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 12 | ||
Expiration date | 07/02/23 | ||
Common stock, capital shares reserved for future issuance (in shares) | 63 | 63 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 12 | ||
Expiration date | 07/02/23 | ||
LPH II Investments Limited [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 45 | 45 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16.56 | ||
Expiration date | 04/04/25 | ||
Common stock, capital shares reserved for future issuance (in shares) | 45 | 45 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 16.56 | ||
Expiration date | 04/04/25 | ||
Investors - February 2017 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 117 | 117 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 82.20 | ||
Expiration date | 02/15/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 117 | 117 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 82.20 | ||
Expiration date | 02/15/24 | ||
Investors - July 2015 Financing [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 80 | 80 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 588 | ||
Expiration date | 07/22/22 | ||
Common stock, capital shares reserved for future issuance (in shares) | 80 | 80 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 588 | ||
Expiration date | 07/22/22 | ||
Battelle 2014 Collaboration Agreement [Member] | |||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 4,200 | ||
Expiration date | 10/10/24 | ||
Common stock, capital shares reserved for future issuance (in shares) | 1 | 1 | |
Service Agreement - 2021 warrants (in dollars per share) | $ 4,200 | ||
Expiration date | 10/10/24 | ||
[1] | See, Note 14 - Collaboration, Licensing and Research Funding Agreements, for further details on the Battelle collaboration agreement. |
Note 11 - Stock Options and S_3
Note 11 - Stock Options and Stock-based Employee Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 600,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 4.03 | $ 5.98 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 0 | |
Share-based Payment Arrangement, Expense | 7,238 | $ 5,684 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 6,700 | $ 7,100 |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 4,200 | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 9 months 18 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Intrinsic Value | $ 0 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 0 | |
Restricted Stock Units (RSUs) [Member] | ||
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares) | 35,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value, Ending Balance (in dollars per share) | $ 11.85 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Ending Balance (in shares) | 0 | 0 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 0 | 0 |
The 2020 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 1,900,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 3 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | |
Non-plan Stock Options [Member] | Executive Officers and Employees [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year) | 3 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years |
Note 11 - Stock Options and S_4
Note 11 - Stock Options and Stock-based Employee Compensation - Stock Options and Restricted Stock Units (RSUs) Outstanding and Available for Future Issuance (Details) - shares | Dec. 31, 2021 | Jan. 31, 2021 | Dec. 31, 2020 |
Stock Options and RSUs Outstanding (in shares) | 3,387,000 | 1,903,000 | |
Stock Options and RSUs Outstanding (in shares) | 3,387,000 | 1,903,000 | |
The 2020 Equity Incentive Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 1,256,000 | 0 | |
Stock Options and RSUs Outstanding (in shares) | 1,256,000 | 0 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 631,000 | 230,000 | |
The 2011 Long-term Incentive Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 1,567,000 | 1,688,000 | |
Stock Options and RSUs Outstanding (in shares) | 1,567,000 | 1,688,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 1,535,500 | ||
Non-Plan [Member] | |||
Stock Options and RSUs Outstanding (in shares) | 564,000 | 215,000 | |
Stock Options and RSUs Outstanding (in shares) | 564,000 | 215,000 |
Note 11 - Stock Options and S_5
Note 11 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 1,903 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 15.57 |
Shares Granted (in shares) | shares | 1,621 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ / shares | $ 4.88 |
Shares Forfeited or Expired (in shares) | shares | (137) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 33.23 |
Shares Outstanding, Ending Balance (in shares) | shares | 3,387 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 9.74 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 8 years 2 months 12 days |
Shares Vested and Exercisable (in shares) | shares | 1,685 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 14.06 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 7 years 4 months 24 days |
Vested and expected to vest (in shares) | shares | 3,184 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ / shares | $ 9.78 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 8 years 2 months 12 days |
Note 11 - Stock Options and S_6
Note 11 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expense | $ 7,238 | $ 5,684 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expense | 2,940 | 2,098 |
Selling, General and Administrative Expenses [Member] | ||
Share-based Payment Arrangement, Expense | $ 4,298 | $ 3,586 |
Note 11 - Stock Options and S_7
Note 11 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted average expected volatility | 104.00% | 103.00% |
Weighted average expected term (Year) | 6 years 8 months 12 days | 7 years |
Weighted average risk-free interest rate | 0.49% | 0.54% |
Note 12 - Collaboration, Lice_2
Note 12 - Collaboration, Licensing and Research Funding Agreements (Details Textual) $ in Millions | Mar. 19, 2021EUR (€) | Aug. 31, 2017USD ($) | Oct. 31, 2014USD ($) | Jun. 30, 2019USD ($) | Jan. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Mar. 18, 2020 |
Proceeds from License Fees Received | $ 1 | ||||||||||
License Agreement With Lee’s [Member] | |||||||||||
License Agreement, Contingent Receivable, Maximum | $ 35.8 | ||||||||||
Term Sheet With Lee [Member] | |||||||||||
Financing of Product, Percent of Revenue Shared With Financer | 50.00% | ||||||||||
Financing of Product, Percent of Financing That Must be Repaid to Discontinue Revenue Sharing | 125.00% | ||||||||||
Proceeds for Payments to Develop Product | $ 1 | ||||||||||
Term Sheet With Lee [Member] | Other Liabilities [Member] | |||||||||||
Contractual Obligation, Total | 3.8 | $ 2.8 | |||||||||
Johnson and Johnson - License Agreement [Member] | |||||||||||
Potential License Fee Payable | $ 2.5 | ||||||||||
Payment of License Cost Subject to Regulatory Approval | $ 1 | ||||||||||
Percent of Cash Upfront and Milestone Fees Payable to Esteve | 10.00% | ||||||||||
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve | $ 20 | ||||||||||
Universita Degli Studi Do Miano-Biocca [Member] | |||||||||||
Payment of License Cost for New Compounds Modulating | € | € 100,000 | ||||||||||
Payment of License Cost Upon Obtaining Marketing Authorization | $ 21 | € 1,500,000 | |||||||||
Agreement for Scientific Collaboration, or the New SERCA2a Agreement, with Bicocca [Member] | |||||||||||
Payment of License Cost for Research Activities and to Cover Laboratory Space and Operation Costs | € | € 200,000 | ||||||||||
Payment of License Cost for Execution of an Assignment | € | 25,000 | ||||||||||
Payment of License Cost for New Compounds Developed | € | 75,000 | ||||||||||
Payment of License Cost upon Obtaining Marketing Authorization in the U.S., EU, or China of New Compounds | € | € 1,500,000 | ||||||||||
Maximum [Member] | Lee's [Member] | Lee's Loan to Support Operations [Member] | |||||||||||
Proceeds from Short-term Debt, Total | $ 1 | ||||||||||
Battelle Applies [Member] | |||||||||||
Maximum Royalty Paid on Completion of Activities Under the Agreement | $ 25 | $ 35 | |||||||||
Lee’s Pharmaceutical Holdings Limited [Member] | AEROSURF Funding Term Sheet [Member] | |||||||||||
Nonrefundable Payments, Maximum Financing to Be Received | $ 3.9 | ||||||||||
Nonrefundable Payments, Maximum Financing to Be Received Under Special Circumstances | $ 2.8 | ||||||||||
Nonrefundable Payments | $ 2.8 |
Note 13 - Related Party Trans_2
Note 13 - Related Party Transactions (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2020 | May 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
AEROSURF Funding Term Sheet [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||
Nonrefundable Payments | $ 2,800 | $ 1,000 | ||
Due to Related Parties, Total | 3,800 | $ 2,800 | ||
Contractual Obligation, Total | $ 0 | |||
Research and Development Expenses for Services Provided [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||
Related Party Transaction, Expenses from Transactions with Related Party | $ 200 | |||
May 2020 Public Offering [Member] | Panacea [Member] | ||||
Related Party Transaction, Amounts of Transaction | $ 2,000 | |||
Lee’s Pharmaceutical Holdings Limited [Member] | Windtree Therapeutics [Member] | ||||
Ownership Percentage | 17.00% | 29.00% | ||
Panacea [Member] | Windtree Therapeutics [Member] | ||||
Ownership Percentage | 8.00% | 14.00% |
Note 15 - Income Taxes (Details
Note 15 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Deferred Income Tax Expense (Benefit), Total | $ (9,987) | $ 0 |
Operating Loss Carryforwards, Total | 644,600 | 631,900 |
Operating Loss Carryforwards Not Subject to Expiration | 80,800 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards, Total | 598,900 | 585,300 |
State and Local Jurisdiction [Member] | Pennsylvania [Member] | ||
Operating Loss Carryforwards, Total | 595,400 | |
Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | 17,400 | 17,200 |
Orphan Drug Tax Credit [Member] | ||
Tax Credit Carryforward, Amount | $ 1,100 | $ 1,400 |
Note 15 - Income Taxes - Benefi
Note 15 - Income Taxes - Benefit for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Foreign | 0 | 0 |
Total current expense (benefit) | 0 | 0 |
Federal | 0 | 0 |
State | 0 | 0 |
Foreign | (9,987) | 0 |
Total deferred expense (benefit) | (9,987) | 0 |
Total income tax expense (benefit) | $ (9,987) | $ 0 |
Note 15 - Income Taxes - Income
Note 15 - Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income tax benefit, statutory rates | $ (16,301) | $ (6,837) |
State taxes on income, net of federal benefit | (1,390) | (125) |
Net operating loss expirations | 2,184 | 1,835 |
Research and development tax credit | 94 | (1,213) |
Foreign rate differential | 462 | 22 |
Employee related and other | (186) | 193 |
Interest related | 0 | 34 |
Income tax expense / (benefit), statutory rates | (15,137) | (6,091) |
Valuation allowance | 5,150 | 6,091 |
Total income tax expense (benefit) | $ (9,987) | $ 0 |
Note 15 - Income Taxes - Deferr
Note 15 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Net operating loss carryforwards (federal and state) | $ 187,905 | $ 183,793 |
Research and development tax credit | 18,538 | 18,632 |
Compensation expense on stock | 4,568 | 3,525 |
Other accrued | 2,006 | 1,811 |
Depreciation | 115 | 112 |
Total long-term deferred tax assets | 213,132 | 207,873 |
IPR&D | (7,114) | (16,778) |
Total long-term deferred tax liabilities | (7,114) | (16,778) |
Valuation allowance | (213,132) | (207,873) |
Deferred tax liabilities, net | $ (7,114) | $ (16,778) |
Note 16 - Leases (Details Textu
Note 16 - Leases (Details Textual) | 1 Months Ended |
Jan. 31, 2021 | |
Amendment to Extend Warrington, Pennsylvania Lease [Member] | |
Lessee, Operating Lease, Extended Term (Year) | 5 years |
Note 16 - Leases - Lease Costs
Note 16 - Leases - Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating lease cost | $ 857 | $ 826 |
Variable lease cost | 45 | 29 |
Total lease cost | 902 | 855 |
Operating cash flows used for operating leases | 734 | 895 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 2,141 | $ 249 |
Weighted average remaining lease term (in years) (Year) | 4 years 9 months 18 days | 1 year 3 months 18 days |
Weighted average incremental borrowing rate | 7.12% | 9.00% |
Note 16 - Leases - Future Minim
Note 16 - Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
2022 | $ 689 |
2023 | 575 |
2024 | 560 |
2025 | 570 |
2026 | 581 |
Thereafter | 97 |
Total lease payments | 3,072 |
Less imputed interest | (473) |
Total operating lease liabilities at December 31, 2021 | $ 2,599 |
Note 17 - Subsequent Events (De
Note 17 - Subsequent Events (Details Textual) - Forecast [Member] - USD ($) $ in Millions | 6 Months Ended | 9 Months Ended |
Jun. 30, 2022 | Sep. 30, 2022 | |
Severance Costs | $ 0.4 | |
Manufacturing and Laboratory Equipment [Member] | ||
Impairment of Long-Lived Assets to be Disposed of | $ 0.7 |