0001437749-22-007757 | 10-K | XBRL Viewer | Windtree Therapeutics INC DE

Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

Note 1 – The Company and Description of Business

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-in-class, dual-acting agent being developed to improve cardiac function in patients with acute heart failure, or AHF, with a potentially differentiated safety profile from existing treatments. Istaroxime demonstrated significant improvement in both diastolic and systolic aspects of cardiac function and was generally well tolerated in two phase 2 clinical trials. Istaroxime has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or FDA. Based on the profile observed in our phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure in acute decompensated heart failure patients, we initiated a phase 2 global clinical study to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions Stage B shock), a severe form of heart failure characterized by very low blood pressure and risk for hypoperfusion to critical organs. We believe that istaroxime has the potential to fulfill an unmet need in early cardiogenic shock. Our heart failure cardiovascular portfolio also includes sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, activators which activate SERCA2a. This research program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds. As potential oral agents, these candidates would be developed for chronic heart failure. In addition, our cardiovascular drug product candidates include rostafuroxin, a novel product candidate for the treatment of hypertension in patients with a specific genetic profile. We are pursuing potential licensing arrangements and/or other strategic partnerships and do not intend to advance this product candidate without securing such an arrangement or partnership.

Our pulmonary product candidate portfolio consists of a KL4 surfactant platform to address a range of serious respiratory conditions in children and adults. KL4 surfactant has been in development as a liquid instillate for noninvasive delivery as an aerosol. In September 2020, the FDA accepted our investigational new drug, or IND, application for an open-label phase 2 pilot study to assess safety and tolerability in the COVID-19 acute respiratory distress syndrome, or ARDS, population and the ability of our KL4 surfactant liquid instillate to impact key respiratory parameters in the treatment of lung injury and ARDS resulting from severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, the causative agent in novel coronavirus, or COVID-19, infections. In January 2022, we completed enrollment of 20 patients in our phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury. The study demonstrated that intratracheal administration of reconstituted lyophilized lucinactant was generally safe and well tolerated. Lucinactant was safely administered to critically ill, mechanically ventilated patients with severe COVID-19 associated ARDS. Oxygenation and other physiological parameters were stable to improved after dosing, supporting the feasibility of this treatment approach to develop a potential treatment for critically ill patients with ARDS due to COVID-19 or other causes.

Previously, we were also developing AEROSURF (lucinactant for inhalation), a novel drug/medical device combination product for noninvasive delivery of aerosolized KL4 surfactant using our ADS technology for the treatment of respiratory distress syndrome, or RDS, in premature infants. We suspended all internal AEROSURF clinical activities in November 2020, because istaroxime, our lead product candidate, has become our primary focus for investment and execution as we believe development of istaroxime represents a greater value opportunity for us and our stockholders than development of KL4 surfactant. Since completing our phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs that were not already transferred to our licensee in Asia, Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), under the terms of our License, Development and Commercialization Agreement between us and Lee’s (HK) dated as of June 12, 2017, as amended, or the Asia License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of active pharmaceutical ingredients, or APIs, and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions.

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 assurance, however, that we will be able to identify and enter into public or private securities offerings on acceptable terms and in amounts sufficient to meet our needs or qualify for non-dilutive funding opportunities under any grant programs sponsored by U.S. government agencies, private foundations and/or leading academic institutions, or identify and enter into any strategic transactions that will provide the additional capital that we will require. If none of these alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, we potentially could be forced to limit or cease our development activities, which would have a material adverse effect on our business, financial condition and results of operations.

Note 2 - Basis of Presentation

12 Months Ended

Dec. 31, 2021

Basis of Accounting [Text Block]

Note 2 – Basis of Presentation

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 reverse split of our common stock that was approved by our Board of Directors and controlling stockholders and made effective on April 29, 2020. All share and per share information herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Note 3 - Liquidity Risks and Management's Plans

12 Months Ended

Dec. 31, 2021

Liquidity Disclosures [Text Block]

Note 3 – Liquidity Risks and Management’s Plans

We are subject to risks common to companies in the biotechnology industry, including but not limited to, the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, and risks associated with our international locations and activities abroad, including but not limited to having foreign suppliers, manufacturers and clinical sites in support of our development activities.

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 and 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 – Accounting Policies and Recent Accounting Pronouncements). 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, we received net proceeds of approximately $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 share of our common stock and a warrant to purchase one share of common stock, or the March 2021 Warrants. The March 2021 Warrants were immediately exercisable for shares of common stock at a price of $3.60 per share and expire five years from the date of issuance.

We are party to an At-The-Market Offering Agreement with Ladenburg Thalmann & Co. Inc., or Ladenburg, pursuant to which we may offer and sell, from time to time at our sole discretion, up to a maximum of $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 (see, Note 10 – Stockholders’ Equity).

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 quarter of 2023. We do not have sufficient cash and cash equivalents as of the date of this Annual Report on Form 10-K to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements are issued.

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 of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If none of these alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, we will not have sufficient cash resources and liquidity to fund our business operations for at least the next 12 months following the date that the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through 12 months after the issuance of the accompanying financial statements.

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 include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

Note 4 - Accounting Policies and Recent Accounting Pronouncements

12 Months Ended

Dec. 31, 2021

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 amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate that the carrying value may be impaired.

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 that the fair values of our reporting unit and indefinite-lived intangible assets are less than their respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessment that it is more likely than not that the fair value of our reporting unit or indefinite-lived intangible assets are less than their respective carrying values, we perform a quantitative assessment. When conducting our annual impairment test of goodwill and indefinite-lived intangible assets as of 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 quarter of 2021, we concluded an initial process to test the industry’s interest in investing in our rostafuroxin drug candidate and were not able to secure a licensing transaction or other strategic opportunity at that time. Based on feedback received from potential licensing partners, we have determined that there is a need for an additional phase 2 clinical trial to demonstrate efficacy in non-Caucasian patients in treatment resistant hypertension. Due to these developments, and in connection with the preparation of the interim unaudited condensed consolidated financial statements as of and for the period ending June 30, 2021, we determined that the fair value of the IPR&D related to our rostafuroxin drug candidate was more likely than not less than its carrying value. As a result, we performed the required quantitative impairment assessment of the related intangible asset. We estimated the fair value of the asset using MPEEM and determined that the fair value as of June 30, 2021 was approximately $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 quarter of 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 clinical trial and have therefore delayed our intended development of rostafuroxin. As a result, we concluded that the fair value of the IPR&D related to our rostafuroxin drug candidate was again less than its carrying value. We estimated the fair value of the asset using MPEEM and determined that the fair value as of 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 quarter of 2021. When combined with the loss on impairment of intangible assets recorded during the second quarter, we recorded a loss on impairment of intangible assets totaling $45.0 million within operating expenses in our consolidated statements of operations during the year ended December 31, 2021 . No events or changes in the business environment occurred during 2021 that would indicate that the fair value of the IPR&D related to our istaroxime drug candidate was impaired.

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 amortized. It is reviewed for impairment at least annually or when events or changes in the business environment indicate that its carrying value may be impaired. Our company consists of one reporting unit. In order to perform the quantitative goodwill impairment test, we compare the estimated fair value of our reporting unit to its carrying value. If the fair value exceeds the carrying value, no further evaluation is required, and no impairment exists. If the carrying value exceeds the fair value, the difference between the carrying value and the fair value is recorded as an impairment loss, the amount of which may not exceed the total amount of goodwill. When performing our annual goodwill impairment assessment as of 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 impairment exists.

The following table represents identifiable intangible assets and goodwill as of December 31, 2021 and 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 denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in 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 and 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 days or less that are readily convertible into cash.

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 and 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 to ten years). Leasehold improvements are amortized over the shorter of the estimated useful lives or the remaining term of the lease. Repairs and maintenance costs are charged to expense as incurred.

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 for our headquarters location in Warrington, Pennsylvania and $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, or ASC 842. At the inception of an arrangement, we determine whether an arrangement is, or contains, a lease based on the unique facts and circumstances present in the arrangement. An arrangement is, or contains, a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than one year are generally recognized on the balance sheet as operating lease right-of-use assets and current and non-current operating lease liabilities, as applicable. It is our policy not to recognize on the balance sheet leases with terms of 12 months or less. We typically only include the initial lease term in our assessment of a lease arrangement. Options to extend a lease are not included in our assessment unless there is reasonable certainty that we will renew.

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 be required for items such as incentives received. The interest rate implicit in our leases is typically not readily determinable. As a result, we utilize our incremental borrowing rate, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment.

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 of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset, the present value of the lease payments equals or exceeds substantially all of the fair value of the asset, or the leased asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does not meet any of these criteria. Currently, all of our leases are classified as operating leases.

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 included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less.

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 be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value. No impairment was recorded during the years ended December 31, 2021 and 2020 as management believes there are no circumstances that indicate that the carrying value of the assets will not be recoverable.

Collaborative Arrangements

We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements. See, Note 12 – Collaboration, Licensing and Research Funding Agreements.

Severance

In July 2020, we entered into separation agreements with two executives, which provide that the former employees are entitled to receive: (i) a severance amount equal to the sum of their respective base salaries then in effect and their respective annual target bonus amounts, payable in equal installments through August 2021 and (ii) subject to certain exceptions, a pro rata bonus commensurate with the bonus of other contract executives for the year 2020, prorated for the number of days of their respective employment during 2020, and payable at the time that other contract executives are paid bonuses with respect to 2020. The severance amount related to the departure of these executives is approximately $0.9 million, was accrued at the date of the separations, and was paid ratably through August 2021. During the years ended December 31, 2021 and 2020, $0.5 million and $0.4 million, respectively, was paid and no further amounts are due as of December 31, 2021.

Restructured Debt Liability – Contingent Milestone Payment

In conjunction with the November 2017 restructuring and retirement of long-term debt (see, Note 9 – Restructured Debt Liability), we have established a $15.0 million long-term liability for contingent milestone payments potentially due under the Exchange and Termination Agreement dated as of October 27, 2017, or Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are not achieved and the liability is written off as a gain on debt restructuring.

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, or ASC Topic 718. See, Note 11 – Stock Options and Stock-based Employee Compensation, for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter.

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’s Own Equity, or ASC Topic 815, as either derivative liabilities or equity instruments depending on the specific terms of the warrant agreement.

Income Taxes

We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, or ASC Topic 740, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.

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 assured.

For the year ended December 31, 2021, we recorded a deferred income tax benefit of $10.0 million. The deferred income tax benefit recorded for this period relates solely to the reduction of the deferred tax liabilities as a result of the loss on impairment of intangible assets related to rostafuroxin.

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 and 2020, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 20.0 million and 9.1 million shares, respectively. As of December 31, 2021 and 2020, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per common share.

We do not have any components of other comprehensive (loss) income.

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 contract manufacturer. These single source providers also perform various studies as well as quality control release and stability testing and other activities related to our development and manufacturing activities. At the present time these providers are located outside of the U.S. The loss of either the supplier of our APIs or our drug product contract manufacturer could have a material adverse effect on our operations.

Segment and Geographic Information

We currently operate in one operating segment, which is the research and development of products focused on acute cardiovascular and acute pulmonary diseases. We are managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do not operate separate lines of business with respect to our product candidates. We operate primarily in the U.S. and Asia. Long-lived assets, consisting of intangible assets of $32.1 million and goodwill of $15.7 million, were located outside the U.S. as of December 31, 2021.

COVID-19

The COVID-19 pandemic continues to evolve, and we continue to closely monitor its impact on our business and operations, including its continued impact on our clinical development plans and timelines, and financial condition. There has been intermittent impact of the pandemic in differing geographies, and there may be continued impact, particularly in light of the surge of new COVID-19 cases relating to new variants, such as the delta and omicron variants. As of the date of this Annual Report on Form 10-K, our operations, capital and financial resources and overall liquidity position and outlook have been impacted by COVID-19, primarily due to delays experienced in our operations, including in clinical study initiation and enrollment. The extended timelines have required us to expend more of our capital resources than planned to achieve our projected milestones. For example, our phase 2 study of istaroxime for early cardiogenic shock in heart failure patients experienced delays in trial initiation and enrollment in 2020 and 2021. The full extent, duration, or impact that the COVID-19 pandemic will have, directly or indirectly, on our financial condition and operations, including ongoing and planned clinical trials, will depend on future developments that are highly uncertain and cannot be accurately predicted. These potential future developments include new information that may emerge concerning the severity of the COVID-19 outbreak, the severity and transmissibility of new variants of the virus, information about any resurgences in one or more geographic locations where our current or intended clinical trial sites, our principal executive offices, research and development laboratories or manufacturing facilities are located, and the actions taken to contain it or treat its impact, which may include, among others, the timing and extent of government reopening activities and the economic impact on local, regional, national, and international markets. In addition, regional impact and responses to the COVID-19 pandemic have affected where a clinical trial could be executed and how various elements of the clinical trial are performed. Going forward, the pandemic could also impact how monitoring/auditing of clinical trial sites and data occur. The maintenance, or strategic re-implementation, of mitigating COVID-19 measures in one or more geographic locations where our clinical trial sites, principal executive offices, research and development laboratories or other facilities are located remains possible and if realized, we believe there could be further impact on the clinical development of our product candidates, which may include potential delays, halts or modifications to our ongoing and planned trials in 2022 and beyond.

We are not aware of any specific event or circumstance that would require us to further update our estimates, judgments or revise the carrying value of our assets or liabilities as of the date of issuance of these consolidated financial statements. These estimates may change, as new events occur and additional information is obtained.

Recent Accounting Pronouncements

In December 2019, the FASB issued Accounting Standards Update, or ASU, 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, or ASU 2019-12. ASU 2019-12 simplifies the accounting for income taxes by removing exceptions within the general principles of ASC Topic 740 regarding the calculation of deferred tax liabilities, the incremental approach for intra-period tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax), which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU was effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years, with early adoption permitted. We adopted ASU 2019-12 on January 1, 2021, which did not have a material impact on our consolidated financial statements and related disclosures

Note 5 - Fair Value Measurements

12 Months Ended

Dec. 31, 2021

Fair Value Disclosures [Text Block]

Note 5 – Fair Value Measurements

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 levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

●

Level 1 - Quoted prices in active markets for identical assets and liabilities.

●

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

●

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

The tables below categorize assets measured at fair value on a recurring basis as of December 31, 2021 and 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 and 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 – Accounting Policies and Recent Accounting Pronouncements – 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.

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Note 6 - Property and Equipment

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment Disclosure [Text Block]

Note 6 – Property and Equipment

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 and 2020.

Note 7 - Accrued Expenses

12 Months Ended

Dec. 31, 2021

Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block]

Note 7 – Accrued Expenses

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

12 Months Ended

Dec. 31, 2021

Short-term Debt [Text Block]

Note 8 – Loans Payable

Current Portion

Loan Payable to Bank Direct Capital Finance

In June 2020, we entered into an insurance premium financing and security agreement with Bank Direct Capital Finance, or Bank Direct. Under the agreement, we financed $1.1 million of certain premiums at a 4.26% annual interest rate. Payments of approximately $117,000 were due monthly from July 2020 through March 2021. As of December 31, 2020, the outstanding principal of the loan was $0.4 million. The balance of the loan was repaid during the first quarter of 2021.

In June 2021, we entered into an insurance premium financing and security agreement with Bank Direct. Under the agreement, we financed $1.3 million of certain premiums at a 3.37% annual interest rate. Payments of approximately $147,000 are due monthly from July 2021 through March 2022. As of December 31, 2021, the outstanding principal of the loan was $0.3 million.

Non-Current Portion

O-Bank Co., Ltd. Credit Facility

In September 2016, CVie Therapeutics entered into a 12-month revolving credit facility of approximately $2.9 million with O-Bank Co., Ltd., or O-Bank, to finance operating activities, or the O-Bank Facility. The O-Bank Facility was later renewed and increased to approximately $5.8 million in September 2017. The O-Bank Facility was guaranteed by Lee’s Pharmaceutical Holdings Limited, or Lee’s Holdings, which pledged bank deposits in the amount of 110% of the actual borrowing amount. Interest, payable in cash on a monthly basis, was determined based on the 90-day Taipei Interbank Offer Rate, or TAIBOR, plus 0.91%. The O-Bank Facility expired on September 11, 2019 and the loans were set to mature six months after the expiration date, on March 11, 2020. In March 2020, the O-Bank Facility was amended, among other things, to extend the maturity date to March 2022, to decrease the total amount of the O-Bank Facility to approximately $5.0 million, to change the applicable interest rate to the TAIBOR plus 1.17% and to adjust the term to 24-month non-revolving.

In the second quarter of 2020, we were informed by Lee’s Holdings of their desire to reduce the amount of pledged bank deposits with O-Bank by 50%. To remain in compliance with the terms of the O-Bank Facility, we repaid approximately $2.3 million of the outstanding principal in August 2020. In November 2020, Lee’s Holdings committed to maintain the required level of pledged bank deposits with O-Bank through the date of full repayment of the O-Bank Facility. In June 2021, we repaid the remaining outstanding principal of the O-Bank Facility of approximately $2.5 million.

As of December 31, 2020, the outstanding principal of the O-Bank Facility was approximately $2.4 million and was classified as loans payable - non-current portion. There was no outstanding principal balance as of December 31, 2021, and the O-Bank Facility is no longer available to us.

Note 9 - Restructured Debt Liability

12 Months Ended

Dec. 31, 2021

Long-term Debt [Text Block]

Note 9 – Restructured Debt Liability

On October 27, 2017, we and Deerfield entered into the Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P., or the Deerfield Loan, in the aggregate principal amount of $25.0 million and (ii) warrants to purchase up to 8,333 shares of our common stock at an exercise price of $2,360.40 per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of $2.5 million, (ii) 23,703 shares of common stock, representing 2% of fully-diluted shares outstanding (as defined in the Exchange and Termination Agreement) on the closing date, and (iii) the right to receive certain milestone payments based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to $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 $15.0 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 achieved and the liability is written off as a gain on debt restructuring.

As of December 31, 2021 and 2020, the restructured debt liability balance was $15.0 million.

Note 10 - Stockholders' Equity

12 Months Ended

Dec. 31, 2021

Stockholders' Equity Note Disclosure [Text Block]

Note 10 – Stockholders’ Equity

March 2021 Public Offering

On March 23, 2021, we entered into an underwriting agreement with Oppenheimer & Co. Inc. as representative for the several underwriters named therein, relating to a public offering, or the March 2021 Offering, of an aggregate of 9,230,500 units with each unit consisting of one share of common stock and a warrant, or the March 2021 Warrants. The March 2021 Warrants were immediately exercisable for shares of common stock at a price of $3.60 per share and expire five years from the date of issuance. The shares of common stock and the March 2021 Warrants were immediately separable and were issued separately in the March 2021 Offering.

The closing of the March 2021 Offering occurred on March 25, 2021. The offering price to the public was $3.25 per unit resulting in gross proceeds to us of $30.0 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 Warrants issued pursuant to the March 2021 Offering, the net proceeds to us were approximately $27.4 million.

We have determined that the appropriate accounting treatment under ASC 480, Distinguishing Liabilities from Equity, or ASC 480, is to classify the common stock and the March 2021 Warrants issued in the March 2021 Offering as equity. We have also determined that the March 2021 Warrants are not in their entirety a derivative under the scope of ASC 815, Derivatives and Hedging, or ASC 815, due to the scope exception under ASC 815-10-15-74, nor are there any material embedded derivatives that require separate accounting. We allocated the net proceeds from the March 2021 Offering based on the relative fair value of the common stock and the March 2021 Warrants.

May 2020 Public Offering

On May 20, 2020, we entered into an underwriting agreement, or the Underwriting Agreement, with Ladenburg as representative for the several underwriters named therein, or collectively, the Underwriters, relating to a public offering, or the May 2020 Offering, of an aggregate of 2,758,620 units with each unit consisting of one share of our common stock and a warrant, or the May 2020 Warrants. The May 2020 Warrants are immediately exercisable for shares of common stock at a price of $7.975 per share and expire five years from the date of issuance. The shares of common stock and the May 2020 Warrants were immediately separable and were issued separately in the May 2020 Offering.

In addition, we granted the Underwriters a 45-day option, or the Overallotment Option, to purchase up to 413,793 additional shares of common stock and/or May 2020 Warrants to purchase up to 413,793 additional shares of common stock, which such Overallotment Option was exercised in full.

The closing of the May 2020 Offering occurred on May 22, 2020, inclusive of the Overallotment Option. The offering price to the public was $7.25 per unit. After deducting underwriting discounts and commissions and offering expenses of $2.8 million payable by us, and excluding the proceeds, if any, from the exercise of the May 2020 Warrants issued pursuant to the May 2020 Offering, the net proceeds to us were approximately $20.2 million.

We have determined that the appropriate accounting treatment under ASC 480 is to classify the common stock and the May 2020 Warrants issued in the May 2020 Offering as equity. We have also determined that the May 2020 Warrants are not in their entirety a derivative under the scope of ASC 815 due to the scope exception under ASC 815-10-15-74, nor are there any material embedded derivatives that require separate accounting. We allocated the net proceeds from the May 2020 Offering based on the relative fair value of the common stock and the May 2020 Warrants.

At-The-Market Program

On September 17, 2020, we entered into an At-The-Market Offering Agreement with Ladenburg pursuant to which we may offer and sell, from time to time at our sole discretion, up to a maximum of $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. 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 be sold. Ladenburg may sell shares by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) under the Securities Act, or in privately negotiated transactions.

We agreed to pay Ladenburg a commission of 3% of the gross sales price of any shares sold pursuant to the ATM Program. The rate of compensation will not apply when Ladenburg acts as principal.

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.

As of March 31, 2022, approximately $5.0 million remains available under the ATM Program.

Warrant Amendments

On April 24, 2020, we and each of the holders of our Series F Warrants dated as of December 24, 2018, or the Series F Warrants, entered into Amendment No. 1 to the Series F Warrant to Purchase Common Stock whereby the expiration date of the Series F Warrants was extended from June 24, 2020 to December 24, 2020 in consideration for the holders agreeing to be bound by a lock-up provision with respect to any shares of our common stock or securities convertible, exchangeable or exercisable into shares of our common stock that are beneficially owned, held or acquired by the holders for a period of 90 days following the earlier of (i) the closing date of our next public offering of securities, or (ii) December 24, 2020. The lock-up provision commenced upon closing of the May 2020 Offering discussed above and has expired. The Series F Warrants expired on December 24, 2020.

On May 6, 2020, we and certain holders of our Series I Warrants dated as of December 6, 2019, or the Series I Warrants, entered into Amendment No. 1 to the Series I Warrant to Purchase Common Stock pursuant to which the exercise price of the Series I Warrants was amended from $12.09 to $9.67 if the Series I Warrants are exercised, in whole or in part, prior to December 5, 2021. In addition, the certain holders of the Series I Warrants agreed to be bound by a lockup provision with respect to any shares of our common stock or securities convertible, exchangeable or exercisable into shares of our common stock that are beneficially owned, held or acquired by such holders for a period of 90 days following the earlier of (i) the closing date of our next public offering of securities, or (ii) December 24, 2020. The lock-up provision commenced upon closing of the May 2020 Offering discussed above and has expired.

While there is no specific guidance that addresses the modification of an equity-classified contract, such as the amendments to the Series F Warrants and the Series I Warrants, it is the practice to determine the accounting for such modifications based on analogy to the share-based compensation guidance. The model for a modified share-based payment award that is classified as equity and remains classified in equity after the modification is addressed in ASC 718-20, Compensation – Stock Compensation, or ASC 718-20. Pursuant to that guidance, the incremental fair value from the modification (the change in the fair value of the instrument before and after the modification) is recognized as an expense in the income statement to the extent the modified instrument has a higher fair value.

For the Series F Warrants, the amendment to the terms related to a six-month extension of the expiration date and the incremental fair value from the modification was determined by comparing the Black-Scholes value before and after the modification. The amendment to the Series I Warrants related to a reduced exercise price for an 18-month period and the reversion after that period to the initial exercise price. As a result, the incremental fair value was determined by comparing the Black-Scholes value before the modification to a Monte Carlo valuation after the modification.

We have determined, based on the guidance in ASC 718-20 and our valuation of the Series F Warrants and the Series I Warrants, that the incremental fair value resulting from the modifications is $1.1 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, Note 12 – Collaboration, Licensing and Research Funding Agreements, for further details on the Battelle collaboration agreement.

Common shares reserved for potential future issuance upon granting of additional equity incentive awards

The 2020 Equity Incentive Plan, or the 2020 Plan, initially provided for up to a maximum of 1,535,500 shares of common stock to be available for issuance pursuant to stock-based awards granted under the 2020 Plan. The 2020 Plan is subject to automatic annual increases on January 1 of each year (beginning with January 1, 2022) of the lesser of (i) 4% of the number of shares of our common stock issued and outstanding on the last day of the immediately preceding fiscal year, and (ii) such smaller number of shares as determined by our board. See, Note 11 – Stock Options and Stock-based Employee Compensation.

As of December 31, 2021, we had 0.6 million shares available for potential future issuance under the 2020 Plan.

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

Note 11 - Stock Options and Stock-based Employee Compensation

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Text Block]

Note 11 – Stock Options and Stock-based Employee Compensation

Long-term Incentive Plans

On November 23, 2020, our Board of Directors adopted our 2020 Plan, which was subsequently approved by our majority stockholders by written consent on December 24, 2020 and became effective on January 20, 2021, or the Effective Date. On the Effective Date, the 2020 Plan replaced our 2011 long-term incentive plan, or the 2011 Plan, and the 2020 Plan became our primary plan for providing equity-based compensation to our eligible employees, consultants, and non-employee directors. Awards under the 2020 Plan may include stock options, stock appreciation rights, or SARs, restricted stock awards, or RSAs, restricted stock units, or RSUs, other performance and stock-based awards, and dividend equivalents.

As of December 31, 2021, there were 1.9 million shares of our common stock authorized under the 2020 Plan, of which 0.6 million shares remained available for issuance as of December 31, 2021.

The 2020 Plan is subject to automatic annual increases on January 1 of each year (beginning with January 1, 2022) of the lesser of (i) 4% of the number of shares of our common stock issued and outstanding on the last day of the immediately preceding fiscal year, and (ii) such smaller number of shares as determined by our board. The annual increase on January 1, 2022 was approximately 1.1 million shares.

An administrative committee, currently the Compensation Committee of the Board of Directors, or Committee delegates, may determine the types, the number of shares covered by, and the terms and conditions of, such awards. Eligible participants may include any of our employees, directors, advisors or consultants.

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 SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the 2020 Plan. Although individual grants may vary, option awards generally are exercisable upon vesting, vest in a series of three successive, equal installments beginning with the first anniversary of the grant date and have a 10-year term. Non-Plan stock options outstanding are in connection with the hiring of certain executive officers and other employees. Inducement grants were awarded in accordance with Nasdaq Listing Rule 5635(c)(4) and the inducement grants vest in a series of three successive, equal installments beginning with the first anniversary of the grant date and have a 10-year term.

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, 35,000 RSUs vested at a weighted-average grant date fair value of $11.85. As of December 31, 2021 and 2020, there were no unvested RSUs.

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 and 2020 was $4.03 and $5.98, respectively. There were no RSUs granted during the years ended December 31, 2021 and 2020. The total intrinsic value of options outstanding, vested, and exercisable as of December 31, 2021 are each $0.

Stock-Based Compensation

We recognized stock-based compensation expense in accordance with ASC Topic 718 of $7.2 million and $5.7 million, respectively, for each of the years ended December 31, 2021 and 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 and 2020 is $6.7 million and $7.1 million, respectively. As of December 31, 2021, there was $4.2 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2020 Plan and the 2011 Plan. That cost is expected to be recognized over a weighted-average vesting period of 1.8 years.

Note 12 - Collaboration, Licensing and Research Funding Agreements

12 Months Ended

Dec. 31, 2021

Corporate Partnership, Licensing and Research Funding Agreements [Text Block]

Note 12 – Collaboration, Licensing and Research Funding Agreements

Collaboration Agreement

Battelle Memorial Institute

In October 2014, we entered into a Collaboration Agreement with Battelle, or, as amended, the Battelle Collaboration Agreement, for the development of our new ADS for use in our phase 3 program. We had previously worked with Battelle, which has expertise in developing and integrating aerosol devices using innovative and advanced technologies, in connection with development of our phase 2 ADS used in the AEROSURF phase 2b clinical trial. Under the Battelle Collaboration Agreement, we and Battelle shared the costs of development for a three-stage development plan that included planning, executing the project plan and testing and completing verification and documentation of a new phase 3 ADS, putting us in a position to manufacture a new phase 3 ADS for use in the remaining AEROSURF development activities, including a potential phase 3 clinical program, and, if approved, initial commercial activities. We retained final decision-making authority over all matters related to the design, registration, manufacture, packaging, marketing, distribution and sale of the phase 3 ADS. We and Battelle shared the costs of the project plan equally. Battelle agreed to bear the cost of any cost overruns associated with the project plan and we agreed to bear the cost of any increase in cost resulting from changes in the scope of the product requirements. We also agreed that, if Battelle successfully completed the project plan in a timely manner, we would pay Battelle royalties equal to a low single-digit percentage of the worldwide net sales and license royalties on sales of AEROSURF for the treatment of RDS in premature infants, up to an initial aggregate limit of $25.0 million, which under a payment restructuring agreement (discussed below), was increased to $35.0 million. The Battelle Collaboration Agreement will end at the time we fulfill our payment obligations to Battelle, unless sooner terminated by a party as provided therein.

Licensing and Research Funding Agreements

Lee’s Pharmaceutical (HK) Ltd.

In June 2017, we entered into the Asia License Agreement with Lee’s (HK), an affiliate of Lee’s Holdings, and thereafter amended it effective August 2017. Under the Asia License Agreement, as amended, we granted to Lee’s (HK) an exclusive license with a right to sublicense (i) to develop, manufacture, and commercialize our KL4 surfactant products, including SURFAXIN, which was approved by the FDA in 2012 for RDS in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN, and AEROSURF, including the ADS, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the licensed territory, which includes the People’s Republic of China, or China, Hong Kong, Thailand, Taiwan and 12 other countries.

Under the Asia License Agreement, Lee’s (HK) made an upfront payment to us of $1.0 million. We also may receive up to $35.8 million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee’s (HK) may receive at a rate equal to low double digits. In addition, Lee’s (HK) is responsible for all costs and expenses in and for the licensed territory related to development activities, including a planned AEROSURF phase 3 clinical program, regulatory activities, and commercialization activities.

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) years after the first commercial sale in the country of sale. Thereafter, in consideration of licensed rights other than patent rights, royalties shall continue for the commercial life of each product and, for the initial three years, shall be in the range of low-to-mid single digits. In addition, in the event that one or more generic products are introduced, the royalty rates will be reduced, subject to certain minimums if we are subject to continuing obligations at the time to pay royalties under our in-license agreements.

Under the Asia License Agreement, Lee’s (HK) is responsible for all activities related to development, regulatory approval and commercialization of KL4 surfactant and drug/medical device combination products in the licensed territory. Lee’s (HK) will hold the product licenses for all non-aerosolized products in the licensed territory and will seek regulatory approval initially for SURFAXIN and SURFAXIN LS for RDS. We will hold the product license in the licensed territory (except where prohibited by law) for all aerosolized products and will designate Lee’s (HK) our exclusive agent and representative to develop and register AEROSURF and other aerosolized products in our name and on our behalf. Lee’s (HK) also has agreed that, except as provided in the Asia License Agreement, for a period of ten (10) years beginning with the later of the first commercial sale of the first aerosolized product and the first commercial sale of the first non-aerosolized product in China, it will not develop, register, manufacture, or commercialize any product for the prevention and/or treatment of RDS in premature infants or other diseases and conditions in humans, in either case, that administers, utilizes or contains pulmonary surfactant without our prior written consent.

The Asia License Agreement is accounted for in accordance with ASC Topic 606 and constitutes a contract with a customer. All revenue related to the $1.0 million upfront payment was recognized as of the second quarter of 2019 and no future material performance obligations are due. Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have no remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

On March 18, 2020, we entered into the Term Sheet with Lee’s (HK) pursuant to which Lee’s (HK) agreed to provide financing to fund the development of AEROSURF for the period April 1, 2020 through September 30, 2020 and make payments of up to $3.9 million (which was reduced to $2.8 million under specified circumstances) prior to September 1, 2020. In August 2020, we entered into a Project Financing Agreement with Lee’s (HK), or the PF Agreement with Lee’s (HK), formalizing the terms of the Term Sheet, and under which we received payments totaling $2.8 million through October 2020. Pursuant to the PF Agreement, Lee’s (HK) agreed to pay additional amounts to be set forth in an updated development budget to be agreed between the parties by September 1, 2020 and updated every six months thereafter, to fund the continued development of AEROSURF and to be paid with the payment schedule to be set forth in each updated development budget. In partial satisfaction of our obligations under the PF Agreement, we agreed to pay Lee’s (HK) 50% of any Commercialization Net Revenues (as defined in the PF Agreement) up to an amount that is equal to 125% of the Project Expenses (as defined in the PF Agreement) funded by Lee’s (HK). On November 12, 2020, Lee’s (HK) provided notice of termination of additional funding under the PF Agreement, and we and Lee’s (HK) revised our plans for the continued development of AEROSURF. Lee’s (HK) agreed to continue the development of AEROSURF in Asia at its own cost. Lee’s (HK) agreed to fund an additional $1.0 million to us in 2021 for certain transition and analytical services to be provided by us with respect to the development of AEROSURF, which will be considered “Project Expenses” under the terms of the PF Agreement. In 2021, we received payments totaling $1.0 million from Lee’s (HK) and no further amounts are due under the PF Agreement as of December 31, 2021.

Since the 2018 acquisition of CVie Investments Limited and CVie Therapeutics, istaroxime has become our primary focus for investment and execution due to what we believe represents a greater potential value opportunity for us and our stockholders. Since completing our phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs not already transferred to our licensee in Asia, Lee’s (HK), under the terms of our Asia License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions.

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’s (HK) for the development of AEROSURF, we will pay to Lee’s (HK) 50% of all revenue amounts and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio, excluding (i) payments for bona fide research and development services; (ii) reimbursement of patent expenses and (iii) all amounts paid to us under the Asia License Agreement, minus certain deductions and certain reductions for any payments made by us with respect to third party intellectual property not previously funded by Lee’s (HK).

As of December 31, 2021 and 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.

We have determined that the Term Sheet and the PF Agreement are within the scope of ASC 730-20, Research and Development Arrangements, or ASC 730-20. We concluded that there has not been a substantive and genuine transfer of risk related to the Term Sheet or the PF Agreement as there is a presumption that we are obligated to repay Lee’s (HK) based on the significant related party relationship that existed at the time the parties entered into the Term Sheet and the PF Agreement, including Lee’s (HK)’s ownership of outstanding shares of our common stock.

We have determined that the appropriate accounting treatment under ASC 730-20 is to record the proceeds received from Lee’s (HK) as cash and cash equivalents, as we have the ability to direct the usage of funds, and a long-term liability on our consolidated balance sheet when received. 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 patent portfolio.

We have also determined that the Term Sheet and the PF Agreement are not in their entirety a derivative under the scope of ASC 815, due to the scope exception under ASC 815-10-15-59, nor are there any embedded derivatives that require separate accounting.

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 settings. 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 based on the ADS technology (unless we exercise our right to terminate the license with respect to a specific indication). While there is no legal obligation under the agreements to make minimum royalty payments, in the event we do not make quarterly minimum royalty payments, PMUSA and PMPSA can terminate the agreements. In making such payments, we are entitled to a reduction of future royalties in an amount equal to the excess of any minimum royalty paid over royalties actually earned in prior periods.

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 surfactant technology. Under the license agreement, we are obligated to pay fees of up to $2.5 million in the aggregate upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for certain designated products. We have paid $1.0 million to date for milestones that have been achieved. In addition, the license agreement requires that we make royalty payments at different rates, depending upon type of revenue and country, in amounts in the range of a high single-digit percent of net sales (as defined in the license agreement) of licensed products sold by us or sublicensees, or, if greater, a percentage of royalty income from sublicensees in the low double digits.

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 surfactant products in Andorra, Greece, Italy, Portugal, and Spain. Antonio Esteve, Ph.D., a principal of Esteve, served as a member of our Board of Directors from May 2002 until January 2013. Esteve will pay us a transfer price on sales of our KL4 surfactant products. We will be responsible for the manufacture and supply of all of the covered products and Esteve will be responsible for all sales and marketing in the territory. Esteve is obligated to make stipulated cash payments to us upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for the covered products. In addition, Esteve has agreed to contribute to phase 3 clinical trials for the covered products by conducting and funding development performed in the territory. As part of a 2004 restructuring in which Esteve returned certain rights to us in certain territories, or the Former Esteve Territories, we agreed to pay Esteve 10% of any cash up front and milestone fees (up to a maximum aggregate of $20.0 million) that we receive in connection with any strategic collaborations for the development and/or commercialization of certain of our KL4 surfactant products in the Former Esteve Territories.

Universita degli Studi di Milano-Bicocca

Effective April 13, 2015, CVie Therapeutics, entered into an Agreement for Scientific Collaboration with the Universita degli Studi di Milano-Bicocca, or Bicocca, in Milan, Italy, focused on defining the role of SERCA2a and phospholamban, or PLN, in modulating cardiac contraction, and discovering new small molecules to modulate SERCA2a activity or new drugs for treating chronic and acute human heart failure. The term of the collaboration agreement would have expired after three years but was extended for approximately an additional year, with option for further renewal.

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 compounds and diagnostic products suitable for further clinical development, we have the option to purchase Bicocca’s interest for up to 12 months after the filing of a patent application. If the option is not exercised, then the parties shall remain joint owners and each can use the intellectual property with consent of the other on terms to be defined. If we exercise an option, we have agreed to pay Bicocca (corresponding to stage of development): (i) € 0.1 million upon completion and the proof of concept of biological efficacy for new compounds modulating the SERCA2a activity caused by PLN mutations; and (ii) € 1.5 million upon obtaining marketing authorization in the U.S., EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties for any purchased intellectual property arising out of the collaboration in the range of a low- to mid-single digit percent of net sales for any products sold in any country for a period of ten years from the date of the first commercial sale.

On March 19, 2021, we entered into an Agreement for Scientific Collaboration, or the New SERCA2a Agreement, with Bicocca, which extends our collaboration. The New SERCA2a Agreement amends and restates the recently expired terms of the prior collaboration agreement. Under the New SERCA2a Agreement, we will provide Bicocca with approximately € 0.2 million for research activities and to cover laboratory space and operation costs. Results obtained from the collaboration will be jointly owned by the parties. However, Bicocca will assign to us its interest in patent applications and patents covering any new SERCA2a compounds and diagnostic products suitable for further clinical development. We have agreed to pay Bicocca (corresponding to stage of development): (i) € 25,000 for execution of an assignment to us of Bicocca’s interest in the patent at issue, (ii) € 75,000 for new SERCA2a compounds developed up to phase 1 studies in humans upon the completion and availability of the proof of concept of biological efficacy of new compounds on modulating the SERCA2a activity in cell-free systems, or its functional counterpart in isolated cells and (iii) € 1.5 million upon obtaining marketing authorization in the U.S., EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties on products generated from the collaboration in the range of a fraction of a single digit to a low single digit percent of net sales for any products sold in any country for a period of ten years from the date of the first commercial sale or until the expiry of patent(s) covering the products. In connection with our research activities, Bicocca agreed to provide us exclusive use of a research laboratory for the collaboration, and nonexclusive access to a physiology laboratory within the university. Bicocca serves as our primary location in Milan.

Note 13 - Related Party Transactions

12 Months Ended

Dec. 31, 2021

Note 13 – Related Party Transactions

Lee’s Pharmaceutical Holdings Limited

As of December 31, 2021 and 2020, Lee’s Holdings beneficial ownership of our issued and outstanding shares of common stock was 17% and 29%, respectively.

We entered into the following transactions with Lee’s Holdings during 2021 and 2020:

	●	In March 2020, we entered into the Term Sheet, with Lee’s (HK), pursuant to which Lee’s (HK) had agreed to provide financing for the development of AEROSURF. In August 2020, we entered into the PF Agreement with Lee’s (HK), formalizing the terms of the Term Sheet, under which we received payments of $2.8 million in 2020 and payments of $1.0 million in 2021. As of December 31, 2021 and 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 patent portfolio. No further amounts are due under the PF Agreement as of December 31, 2021 (see, Note 12 – Collaboration, Licensing and Research Funding Agreements – Lee’s Pharmaceutical (HK) Ltd.);

	●	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; and

	●	On December 31, 2021, we entered into a Master Manufacturing and Supply Agreement with an affiliate of Lee’s Holdings for the manufacture of our istaroxime drug product candidate.

Panacea Venture

As of December 31, 2021 and 2020, Panacea’s beneficial ownership of our issued and outstanding shares of common stock was 8% and 14%, respectively.

James Huang, who in connection with the CVie Acquisition in December 2018 was appointed as a director and Chairman of our Board, is a founding and Managing Partner to Panacea Venture, or Panacea.

During 2020, we entered into the following transactions with Panacea:

●

In May 2020, Panacea was an investor of $2.0 million in the May 2020 Offering (see, Note 10 – Stockholders’ Equity – May 2020 Public Offering);

Note 14 - Litigation

12 Months Ended

Dec. 31, 2021

Legal Matters and Contingencies [Text Block]

Note 14 – Litigation

We are not aware of any pending or threatened legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.

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 resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition.

Note 15 - Income Taxes

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Text Block]

Note 15 – Income Taxes

The components of the benefit for income taxes for the years ended December 31, 2021 and 2020 is as follows:

	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, we recorded a deferred income tax benefit of $10.0 million. The deferred income tax benefit recorded for this period relates solely to the reduction of the deferred tax liabilities as a result of the loss on impairment of intangible assets related to rostafuroxin.

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 and 2020 is as follows:

	*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 and 2020, are as follows:

	*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 and 2020. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured. It is our policy to classify interest and penalties recognized on uncertain tax positions as a component of income tax expense. There was neither interest nor penalties accrued as of December 31, 2021 and 2020, nor were any incurred in 2021 or 2020.

At December 31, 2021 and 2020, we had available carryforward net operating losses for federal tax purposes of $644.6 million and $631.9 million, respectively, research and development tax credit carryforward of $17.4 million and $17.2 million, respectively and orphan drug tax credit carryforwards of $1.1 million and $1.4 million, respectively. Of the of $644.6 million of federal net operating loss carryforwards, $80.8 million can be carried forward indefinitely. The remaining Federal net operating loss, research and development tax credit carryforwards and orphan drug credit carryforward will continue to expire through 2040.

At December 31, 2021 and 2020, we had available carryforward losses of approximately $598.9 million and $585.3 million, respectively, for state tax purposes. Of the $598.9 million state tax carryforward losses, $595.4 million is associated with the state of Pennsylvania, with the remainder associated with the other seven (7) states within which we have established tax nexus.

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 and 2020, we performed an evaluation to determine whether a valuation allowance was needed. We considered all available evidence, both positive and negative, which included the results of operations for the current and preceding years. We determined that it was not possible to reasonably quantify future taxable income and determined that it is more likely than not that all of the deferred tax assets will not be realized. Accordingly, we maintained a full valuation allowance as of December 31, 2021 and 2020.

Under Internal Revenue Code Section 382, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We have not completed a study to assess whether an “ownership change” has occurred or whether there have been multiple ownership changes since we became a “loss corporation” as defined in Section 382. Future changes in our stock ownership, which may be outside of our control, may trigger an “ownership change.” In addition, future equity offerings or acquisitions that have equity as a component of the purchase price could result in an “ownership change.” If an “ownership change” has occurred or does occur in the future, utilization of the NOL carryforwards or other tax attributes may be limited, which could potentially result in increased future tax liability to us.

Utilization of net operating loss, or NOL, and research and development, or R&D, credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. There also could be additional ownership changes in the future, which may result in additional limitations in the utilization of the carryforward NOLs and credits.

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 impact to the consolidated balance sheets or statements of operations if an adjustment were required.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Note 16 - Leases

12 Months Ended

Dec. 31, 2021

Lessee, Operating Leases [Text Block]

Note 16 – Leases

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, we entered into a lease amendment to extend the term of our Warrington, Pennsylvania lease for a period of five years commencing on March 1, 2022 and expiring on 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 and other information pertaining to our operating leases for the years ended December 31, 2021 and 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, are as follows:

(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

12 Months Ended

Dec. 31, 2021

Subsequent Events [Text Block]

Note 17 – Subsequent Events

In January 2022, in order to focus our resources on the development of our istaroxime pipeline, we began to reduce costs related to KL4 surfactant that were not already transferred to our licensee in Asia, Lee’s (HK), under the terms of our Asia License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. The total severance cost for impacted employees is approximately $0.4 million and is expected to be paid through September 30, 2022. In addition, we have approximately $0.7 million of net book value related to manufacturing and laboratory equipment related to KL4 surfactant, and we are currently evaluating the disposition or alternative future use of these assets.

Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

Goodwill and Intangible Assets, Policy [Policy Text Block]

Goodwill and Intangible Assets

The following table represents identifiable intangible assets and goodwill as of December 31, 2021 and 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

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

Fair Value of Financial Instruments, Policy [Policy Text Block]

Fair Value of Financial Instruments

Property, Plant and Equipment, Policy [Policy Text Block]

Property and Equipment

Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block]

Restricted Cash

Lessee, Leases [Policy Text Block]

Leases

Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]

Long-lived Assets

Collaborative Arrangement, Accounting Policy [Policy Text Block]

Collaborative Arrangements

Severance Cost [Policy Text Block]

Severance

Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block]

Restructured Debt Liability – Contingent Milestone Payment

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, or ASC Topic 718. See, Note 11 – Stock Options and Stock-based Employee Compensation, for a detailed description of our recognition of stock-based compensation expense. The fair value of stock option grants is recognized evenly over the vesting period of the options or over the period between the grant date and the time the option becomes non-forfeitable by the employee, whichever is shorter.

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’s Own Equity, or ASC Topic 815, as either derivative liabilities or equity instruments depending on the specific terms of the warrant agreement.

Income Tax, Policy [Policy Text Block]

Income Taxes

We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, or ASC Topic 740, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.

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 assured.

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 and 2020, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 20.0 million and 9.1 million shares, respectively. As of December 31, 2021 and 2020, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per common share.

We do not have any components of other comprehensive (loss) income.

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 contract manufacturer. These single source providers also perform various studies as well as quality control release and stability testing and other activities related to our development and manufacturing activities. At the present time these providers are located outside of the U.S. The loss of either the supplier of our APIs or our drug product contract manufacturer could have a material adverse effect on our operations.

Segment Reporting, Policy [Policy Text Block]

Segment and Geographic Information

We currently operate in one operating segment, which is the research and development of products focused on acute cardiovascular and acute pulmonary diseases. We are managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do not operate separate lines of business with respect to our product candidates. We operate primarily in the U.S. and Asia. Long-lived assets, consisting of intangible assets of $32.1 million and goodwill of $15.7 million, were located outside the U.S. as of December 31, 2021.

Effect of COVID-19 Pandemic [Policy Text Block]

COVID-19

The COVID-19 pandemic continues to evolve, and we continue to closely monitor its impact on our business and operations, including its continued impact on our clinical development plans and timelines, and financial condition. There has been intermittent impact of the pandemic in differing geographies, and there may be continued impact, particularly in light of the surge of new COVID-19 cases relating to new variants, such as the delta and omicron variants. As of the date of this Annual Report on Form 10-K, our operations, capital and financial resources and overall liquidity position and outlook have been impacted by COVID-19, primarily due to delays experienced in our operations, including in clinical study initiation and enrollment. The extended timelines have required us to expend more of our capital resources than planned to achieve our projected milestones. For example, our phase 2 study of istaroxime for early cardiogenic shock in heart failure patients experienced delays in trial initiation and enrollment in 2020 and 2021. The full extent, duration, or impact that the COVID-19 pandemic will have, directly or indirectly, on our financial condition and operations, including ongoing and planned clinical trials, will depend on future developments that are highly uncertain and cannot be accurately predicted. These potential future developments include new information that may emerge concerning the severity of the COVID-19 outbreak, the severity and transmissibility of new variants of the virus, information about any resurgences in one or more geographic locations where our current or intended clinical trial sites, our principal executive offices, research and development laboratories or manufacturing facilities are located, and the actions taken to contain it or treat its impact, which may include, among others, the timing and extent of government reopening activities and the economic impact on local, regional, national, and international markets. In addition, regional impact and responses to the COVID-19 pandemic have affected where a clinical trial could be executed and how various elements of the clinical trial are performed. Going forward, the pandemic could also impact how monitoring/auditing of clinical trial sites and data occur. The maintenance, or strategic re-implementation, of mitigating COVID-19 measures in one or more geographic locations where our clinical trial sites, principal executive offices, research and development laboratories or other facilities are located remains possible and if realized, we believe there could be further impact on the clinical development of our product candidates, which may include potential delays, halts or modifications to our ongoing and planned trials in 2022 and beyond.

We are not aware of any specific event or circumstance that would require us to further update our estimates, judgments or revise the carrying value of our assets or liabilities as of the date of issuance of these consolidated financial statements. These estimates may change, as new events occur and additional information is obtained.

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

In December 2019, the FASB issued Accounting Standards Update, or ASU, 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, or ASU 2019-12. ASU 2019-12 simplifies the accounting for income taxes by removing exceptions within the general principles of ASC Topic 740 regarding the calculation of deferred tax liabilities, the incremental approach for intra-period tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax), which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU was effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years, with early adoption permitted. We adopted ASU 2019-12 on January 1, 2021, which did not have a material impact on our consolidated financial statements and related disclosures

Note 4 - Accounting Policies and Recent Accounting Pronouncements (Tables)

12 Months Ended

Dec. 31, 2021

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 Measurements (Tables)

12 Months Ended

Dec. 31, 2021

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 Equipment (Tables)

12 Months Ended

Dec. 31, 2021

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 (Tables)

12 Months Ended

Dec. 31, 2021

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 (Tables)

12 Months Ended

Dec. 31, 2021

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 Stock-based Employee Compensation (Tables)

12 Months Ended

Dec. 31, 2021

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)

12 Months Ended

Dec. 31, 2021

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)

12 Months Ended

Dec. 31, 2021

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 (Details Textual)	Apr. 29, 2020
Reverse Stock Split [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	1

Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended		12 Months Ended
	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 and Recent Accounting Pronouncements (Details Textual) shares in Millions		3 Months Ended		12 Months Ended		24 Months Ended
	Jul. 20, 2020 USD ($)	Dec. 31, 2021 USD ($)	Jun. 30, 2021 USD ($)	Dec. 31, 2021 USD ($) shares	Dec. 31, 2020 USD ($)	Dec. 31, 2021 USD ($) shares	Nov. 01, 2017 USD ($)
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure		$ 9,700,000	$ 17,000,000.0	$ 9,700,000		$ 9,700,000
Intangible Assets, Net (Excluding Goodwill), Total		17,000,000.0	54,800,000	17,000,000.0		17,000,000.0
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				20.0		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							$ 15,000,000.0
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 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 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 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 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 Equipment (Details Textual) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Depreciation, Total	$ 192	$ 168

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 - 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 Textual) - USD ($)	1 Months Ended				3 Months Ended
Note 8 - Loans Payable (Details Textual) - USD ($)	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, Maximum Borrowing Capacity				$ 5,800,000				$ 2,900,000
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			$ 5,000,000.0
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%
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 Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	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' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands					12 Months Ended
	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' 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)

Common stock, capital shares reserved for future issuance (in shares)

16,629

7,228

Service Agreement - 2021 warrants (in dollars per share)

Investors - March 2021 Financing [Member]

Common stock, capital shares reserved for future issuance (in shares)

9,231

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 3.60

Common stock, capital shares reserved for future issuance (in shares)

03/25/26

9,231

Service Agreement - 2021 warrants (in dollars per share)

$ 3.60

March 2021 Warrants [Member]

03/25/26

Common stock, capital shares reserved for future issuance (in shares)

170

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 8.25

Common stock, capital shares reserved for future issuance (in shares)

02/09/24

170

Service Agreement - 2021 warrants (in dollars per share)

$ 8.25

Investors - May 2020 Financing [Member]

02/09/24

Common stock, capital shares reserved for future issuance (in shares)

3,155

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 7.98

Common stock, capital shares reserved for future issuance (in shares)

05/22/25

3,155

Service Agreement - 2021 warrants (in dollars per share)

$ 7.98

Investors - December 2019 Financing [Member]

05/22/25

Common stock, capital shares reserved for future issuance (in shares)

1,458

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12.09

Common stock, capital shares reserved for future issuance (in shares)

12/06/24

1,458

Service Agreement - 2021 warrants (in dollars per share)

$ 12.09

Investors - Aerosurf [Member]

12/06/24

Common stock, capital shares reserved for future issuance (in shares)

988

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 0

Common stock, capital shares reserved for future issuance (in shares)

02/14/24

988

Service Agreement - 2021 warrants (in dollars per share)

$ 0

Investors - December 2018 Financing - Long-term [Member]

02/14/24

Common stock, capital shares reserved for future issuance (in shares)

1,296

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12.15

Common stock, capital shares reserved for future issuance (in shares)

12/04/23

1,296

Service Agreement - 2021 warrants (in dollars per share)

$ 12.15

Investors - December 2018 Financing - Short-term [Member]

12/04/23

Common stock, capital shares reserved for future issuance (in shares)

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 11.04

Common stock, capital shares reserved for future issuance (in shares)

12/24/20

Service Agreement - 2021 warrants (in dollars per share)

$ 11.04

Battelle - 2018 Payables Restructuring Agreement [Member]

12/24/20

Common stock, capital shares reserved for future issuance (in shares)

^[1]

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

^[1]

$ 19.50

Common stock, capital shares reserved for future issuance (in shares)

^[1]

12/07/23

^[1]

Service Agreement - 2021 warrants (in dollars per share)

^[1]

$ 19.50

Panacea Venture Management Company Ltd. [Member]

^[1]

12/07/23

Common stock, capital shares reserved for future issuance (in shares)

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12.00

Common stock, capital shares reserved for future issuance (in shares)

07/02/23

Service Agreement - 2021 warrants (in dollars per share)

$ 12.00

LPH II Investments Limited [Member]

07/02/23

Common stock, capital shares reserved for future issuance (in shares)

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 16.56

Common stock, capital shares reserved for future issuance (in shares)

04/04/25

Service Agreement - 2021 warrants (in dollars per share)

$ 16.56

Investors - February 2017 Financing [Member]

04/04/25

Common stock, capital shares reserved for future issuance (in shares)

117

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 82.20

Common stock, capital shares reserved for future issuance (in shares)

02/15/24

117

Service Agreement - 2021 warrants (in dollars per share)

$ 82.20

Investors - July 2015 Financing [Member]

02/15/24

Common stock, capital shares reserved for future issuance (in shares)

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 588.00

Common stock, capital shares reserved for future issuance (in shares)

07/22/22

Service Agreement - 2021 warrants (in dollars per share)

$ 588.00

Battelle 2014 Collaboration Agreement [Member]

07/22/22

Common stock, capital shares reserved for future issuance (in shares)

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 4,200.00

Common stock, capital shares reserved for future issuance (in shares)

10/10/24

Service Agreement - 2021 warrants (in dollars per share)

$ 4,200.00

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 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 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 Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	12 Months Ended
	Dec. 31, 2021 $ / shares shares
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 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 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, Licensing and Research Funding Agreements (Details Textual) $ in Millions		1 Months Ended		3 Months Ended	6 Months Ended	12 Months Ended
	Mar. 19, 2021 EUR (€)	Aug. 31, 2017 USD ($)	Oct. 31, 2014 USD ($)	Jun. 30, 2019 USD ($)	Jan. 31, 2021 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2019 USD ($)	Dec. 31, 2019 EUR (€)	Dec. 31, 2020 USD ($)	Sep. 30, 2020 USD ($)	Mar. 18, 2020
Proceeds from License Fees Received				$ 1.0
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						$ 1.0
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							$ 1.0
Percent of Cash Upfront and Milestone Fees Payable to Esteve							10.00%
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve							$ 20.0
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							$ 21.0	€ 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		$ 1.0
Battelle Applies [Member]
Maximum Royalty Paid on Completion of Activities Under the Agreement			$ 25.0			$ 35.0
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 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
Windtree Therapeutics [Member]
Ownership Percentage			8.00%	14.00%

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 - 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)