0001437749-22-011122 | 10-Q | XBRL Viewer | Windtree Therapeutics INC DE

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Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Mar. 31, 2022	May 05, 2022
Document Information [Line Items]
Entity Central Index Key	0000946486
Entity Registrant Name	WINDTREE THERAPEUTICS INC /DE/
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2022
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
Document Transition Report	false
Entity File Number	000-26422
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	94-3171943
Entity Address, Address Line One	2600 Kelly Road, Suite 100
Entity Address, City or Town	Warrington
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	18976-3622
City Area Code	215
Local Phone Number	488-9300
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	WINT
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		29,406,172

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 15,541	$ 22,348
Prepaid expenses and other current assets	906	1,143
Total current assets	16,447	23,491
Property and equipment, net	548	1,011
Restricted cash	154	154
Operating lease right-of-use assets	2,207	2,381
Intangible assets	32,070	32,070
Goodwill	15,682	15,682
Total assets	67,108	74,789
Current Liabilities:
Accounts payable	724	693
Accrued expenses	3,554	3,408
Operating lease liabilities - current portion	472	528
Loans payable - current portion	0	294
Total current liabilities	4,750	4,923
Operating lease liabilities - non-current portion	1,944	2,071
Restructured debt liability - contingent milestone payments	15,000	15,000
Other liabilities	3,800	3,800
Deferred tax liabilities	6,885	7,114
Total liabilities	32,379	32,908
Stockholders’ Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2022 and December 31, 2021	0	0
Common stock, $0.001 par value; 120,000,000 shares authorized at March 31, 2022 and December 31, 2021; 28,469,298 and 28,268,950 shares issued at March 31, 2022 and December 31, 2021, respectively; 28,469,274 and 28,268,926 shares outstanding at March 31, 2022 and December 31, 2021, respectively	28	28
Additional paid-in capital	831,206	830,231
Accumulated deficit	(793,451)	(785,324)
Treasury stock (at cost); 24 shares	(3,054)	(3,054)
Total stockholders’ equity	34,729	41,881
Total liabilities & stockholders’ equity	$ 67,108	$ 74,789

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorize (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	28,469,298	28,268,950
Common stock, shares outstanding (in shares)	28,469,274	28,268,926
Treasury stock, shares (in shares)	24	24

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Expenses:
Research and development	$ 5,345	$ 4,410
General and administrative	2,988	4,669
Total operating expenses	8,333	9,079
Operating loss	(8,333)	(9,079)
Interest income	1	50
Interest expense	(13)	(41)
Other income, net	218	109
Total other income, net	206	118
Net loss	$ (8,127)	$ (8,961)
Net loss per common share
Basic and diluted (in dollars per share)	$ (0.29)	$ (0.51)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	28,295	17,695

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands	ATM Program [Member] Common Stock [Member]	ATM Program [Member] Additional Paid-in Capital [Member]	ATM Program [Member]	Share Purchase Agreement, December 2019 [Member] Additional Paid-in Capital [Member]	Share Purchase Agreement, December 2019 [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Treasury Stock [Member]	Total
Balance (in shares) at Dec. 31, 2020						16,922
Balance at Dec. 31, 2020						$ 17	$ 790,277	$ (717,688)	$ (3,054)	$ 69,552
Net loss								(8,961)		(8,961)
Issuance of common stock and common stock warrants, net of issuance costs (in shares)						9,230
Issuance of common stock and common stock warrants, net of issuance costs						$ 9	27,381			27,390
Stock-based compensation expense							2,443			2,443
Issuance of common stock, ATM Program, net of issuance costs (in shares)	105
Issuance of common stock, ATM Program, net of issuance costs	$ 0	$ 570	$ 570
Issuance of common stock warrants, equity consideration for service agreement				$ 494	$ 494
Balance (in shares) at Mar. 31, 2021						26,257
Balance at Mar. 31, 2021						$ 26	821,165	(726,649)	(3,054)	91,488
Balance (in shares) at Dec. 31, 2021						28,269
Balance at Dec. 31, 2021						$ 28	830,231	(785,324)	(3,054)	41,881
Net loss								(8,127)		(8,127)
Stock-based compensation expense							770			770
Issuance of common stock, ATM Program, net of issuance costs (in shares)	200
Issuance of common stock, ATM Program, net of issuance costs	$ 0	$ 205	$ 205
Balance (in shares) at Mar. 31, 2022						28,469
Balance at Mar. 31, 2022						$ 28	$ 831,206	$ (793,451)	$ (3,054)	$ 34,729

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash flows from operating activities:
Net loss	$ (8,127)	$ (8,961)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	466	45
Stock-based compensation	770	2,443
Non-cash lease expense	174	170
Non-cash expense related to equity consideration for a service agreement	0	494
Unrealized gain on foreign exchange rate changes	(236)	(109)
Changes in assets and liabilities:
Prepaid expenses and other current assets	239	337
Accounts payable	31	(222)
Accrued expenses	151	(69)
Operating lease liabilities	(183)	(176)
Net cash used in operating activities	(6,715)	(6,048)
Cash flows from investing activities:
Purchase of property and equipment	(3)	0
Net cash used in investing activities	(3)	0
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs	0	27,390
Proceeds from ATM Program, net of issuance costs	205	570
Principal payments on loans payable	(294)	(352)
Net cash (used in) provided by financing activities	(89)	27,608
Net (decrease) increase in cash, cash equivalents, and restricted cash	(6,807)	21,560
Cash, cash equivalents, and restricted cash - beginning of period	22,502	17,084
Cash, cash equivalents, and restricted cash - end of period	15,695	38,644
Operating lease liabilities arising from obtaining right-of-use assets	$ 0	$ 2,000

Note 1 - The Company and Description of Business

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

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 on the treatment of acute cardiovascular diseases and secondarily on 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 three 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 recently completed this Phase 2 global clinical study of istaroxime and, in April 2022, we announced positive topline results with istaroxime in raising systolic blood pressure, the critical clinical objective in treating patients in cardiogenic shock. Further details of the study results are planned to be presented at the European Society of Cardiology Heart Failure meeting in late May 2022.

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 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 aerosol delivery system, or ADS, technology for the treatment of respiratory distress syndrome 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 began 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 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 securities 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 securities 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.

The reader is referred to, and encouraged to read in its entirety, “Item 1 – Business” in our Annual Report on Form 10-K for the year ended December 31, 2021 that we filed with the Securities and Exchange Commission, or the SEC, on March 31, 2022, which contains a discussion of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs.

Note 2 - Basis of Presentation

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Basis of Accounting [Text Block]

Note 2 – Basis of Presentation

The interim unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or US GAAP, for interim financial information in accordance with the instructions to Form 10-Q and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete consolidated financial statements. Intercompany balances and transactions have been eliminated in consolidation. All adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the three months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. There have been no changes to our significant accounting policies since December 31, 2021. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with our annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2021 contained in our Annual Report on Form 10-K for the year ended December 31, 2021.

Note 3 - Liquidity Risks and Management's Plans

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

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 $8.1 million and $9.0 million, respectively, for the three-month periods ended March 31, 2022 and 2021. We expect to continue to incur operating losses for at least the next several years. As of March 31, 2022, we had an accumulated deficit of $793.5 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.

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 three months ended March 31, 2022, we sold 200,348 shares of our common stock under the ATM Program resulting in aggregate gross and net proceeds to us of approximately $0.2 million (see, Note 8 – Stockholders’ Equity). During April 2022, we sold 936,898 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $1.1 million and net proceeds of approximately $1.0 million (see, Note 11 – Subsequent Events).

As of March 31, 2022, we had cash and cash equivalents of $15.5 million and current liabilities of $4.8 million. As of May 5, 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 Quarterly Report on Form 10-Q 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 securities 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. Further, if the market price of our common stock should remain below $1.00 for 30 consecutive business days, we would be out of compliance with the requirements for continued listing on Nasdaq and would be subject to potential delisting. If we were then unable to re-achieve compliance with the Nasdaq listing requirements within 180 days after receipt of a delisting notice, we would be subject to delisting, which likely would further impair the liquidity and value of our common stock. 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 condensed consolidated 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 - Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Significant Accounting Policies [Text Block]

Note 4 – Summary of Significant Accounting Policies

Principles of Consolidation

The interim unaudited condensed consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited; 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 the carrying value may be impaired. During the three months ended March 31, 2022 and 2021, no events or changes in circumstances occurred indicating that our IPR&D intangible assets were more likely than not 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 loss was recognized as of December 31, 2021.

Throughout the year, we consider whether any events or changes in the business environment have occurred which indicate that goodwill may be impaired. For example, a significant decline in our share price and market capitalization may suggest that the fair value of our reporting unit has fallen below its carrying amount, indicating that an interim goodwill impairment test is required. Accordingly, we monitor changes in our share price during interim periods between annual impairment tests and consider overall stock market conditions, the underlying reasons for the decline in our share price, the significance of the decline, and the duration of time that our securities have been trading at a lower value. We have experienced a declining trend in the closing share price of our common stock following the announcement of positive topline results in our Phase 2 global clinical study of istaroxime for the treatment of early cardiogenic shock. While this trend began prior to the filing of this Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, we believe that the sale during April 2022 of 936,898 shares of our common stock under the ATM Program at a weighted average price per share of $1.13 corroborated our conclusions that there were no impairment indicators for goodwill as of March 31, 2022. However, if our share price does not improve during the remainder of the second quarter of 2022, our reporting unit may be at risk for future impairment in the near term.

The following table represents identifiable intangible assets as of March 31, 2022 and December 31, 2021:

		*March 31,*		*December 31,*
(in thousands)	*2022*		*2021*

Istaroxime drug candidate	$	22,340	$	22,340
Rostafuroxin drug candidate		9,730		9,730
Intangible assets		32,070		32,070

Goodwill	$	15,682	$	15,682

Foreign Currency Transactions

The functional currency for our foreign subsidiaries is U.S. 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 income, net. Foreign currency transactions resulted in gains of approximately $0.2 million and $0.1 million for the three-month periods ended March 31, 2022 and 2021, respectively.

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, including intangible assets and goodwill, at the date of the financial statements and the reported amounts of 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.

Severance

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 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 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. In February 2022, management communicated its commitment to provide severance payments to impacted employees, provided that they remain employed with us through their expected termination dates. The total severance cost for impacted employees is approximately $0.4 million, which is being ratably accrued over the expected service periods of the employees, and is expected to be paid ratably through September 30, 2022. We incurred $0.3 million of expense related to these severance arrangements during the three months ended March 31, 2022, which is included in research and development expense. The related liability as of March 31, 2022 is also $0.3 million and is included as part of accrued expenses.

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.

During the first quarter of 2021, we determined that certain manufacturing and laboratory equipment assets related to the KL4 surfactant platform would be abandoned by March 31, 2022. We accelerated depreciation of these assets during the first quarter, resulting in $0.4 million of additional depreciation expense for the three months ended March 31, 2022. The assets are recorded at their estimated salvage value as of March 31, 2022.

Restructured Debt Liability – Contingent Milestone Payment

In conjunction with the November 2017 restructuring and retirement of long-term debt (see, Note 7 – 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 the 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 track direct research and development expenses by preclinical and clinical programs, which include third-party costs such as contract research organization, consulting, and clinical trial costs. We do not allocate indirect research and development expenses, which include product development and manufacturing expenses and clinical, medical, and regulatory operations expenses, to specific programs. Indirect research and development expenses include personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, regulatory, and medical affairs. Research and development costs are charged to operations as incurred in accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 730, Research and Development.

Income Taxes

We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, 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.

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. As of March 31, 2022 and 2021, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was 21.4 million and 19.9 million shares, respectively. For the three months ended March 31, 2022 and 2021, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.

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

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. As of the date of the issuance of this Quarterly Report on Form 10-Q, 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 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 interim unaudited condensed consolidated financial statements. These estimates may change as new events occur and additional information is obtained.

Note 5 - Fair Value Measurements

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

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 for the periods presented:

	*Fair Value*		*Fair value measurement using*
	*March 31,*
(in thousands)	*2022*		*Level 1*		*Level 2*		*Level 3*

Cash equivalents:
Money market funds	$	14,104	$	14,104	$	-	$	-
Total Assets	$	14,104	$	14,104	$	-	$	-

	*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	$	-	$	-

- Definition

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 - Loans Payable

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Short-Term Debt [Text Block]

Note 6 – Loans Payable

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. The balance of the loan was repaid during the first quarter of 2022.

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. The balance of the loan was repaid during the first quarter of 2021.

Note 7 - Restructured Debt Liability

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Long-Term Debt [Text Block]

Note 7 – 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 (see, Note 4 – Summary of Significant Accounting Policies). 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.

As of March 31, 2022 and December 31, 2021, the restructured debt liability balance was $15.0 million.

Note 8 - Stockholders' Equity

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note 8 – 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 are 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.

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 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 of 1933, as amended, 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 three months ended March 31, 2022, we sold 200,348 shares of our common stock under the ATM Program resulting in aggregate gross and net proceeds to us of approximately $0.2 million. For the three months ended March 31, 2021, we sold 105,083 shares of our common stock under the ATM Program resulting in aggregate gross and net proceeds to us of approximately $0.6 million. During April 2022, we sold 936,898 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $1.1 million and net proceeds of approximately $1.0 million (see, Note 11 – Subsequent Events).

As of May 5, 2022, approximately $3.7 million remained available under the ATM Program.

- Definition

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.

+ References

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-Name Accounting Standards Codification
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+ Details

Note 9 - Stock-based Employee Compensation

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Share-Based Payment Arrangement [Text Block]

Note 9 – Stock-Based Employee Compensation

We recognize expense in our condensed consolidated financial statements related to all stock-based awards granted to employees and non-employee directors based on their fair value on the date of grant. Compensation expense related to stock options is calculated using the Black-Scholes option-pricing model and is recognized ratably over the vesting period, which is typically three years. Compensation expense related to restricted stock unit, or RSU, awards is also recognized ratably over the vesting period, which typically has been between approximately one to three years.

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, 2022		3,387		$	9.74
Granted		835			1.02
Forfeited or expired		(49	)		6.06
Outstanding at March 31, 2022		4,173		$	8.04		8.2

Vested and exercisable at March 31, 2022		2,142		$	12.38		7.1

Vested and expected to vest at March 31, 2022		3,925		$	8.06		8.2

(in thousands, except for weighted-average data)
Restricted Stock Units	*Shares*		*Weighted- Average Grant Date Fair Value*

Outstanding at January 1, 2022		-	$	-
Awarded		554		1.02
Outstanding at March 31, 2022		554	$	1.02

Vested and exercisable at March 31, 2022		-	$	-

Vested and expected to vest at March 31, 2022		554	$	1.02

The table below summarizes the total stock-based compensation expense included in the interim unaudited condensed consolidated statements of operations for the periods presented:

	*Three Months Ended March 31,*
(in thousands)	*2022*		*2021*

Research and development	$	235	$	939
General and administrative		535		1,504
Total	$	770	$	2,443

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.

	*Three Months Ended March 31,*
	*2022*		*2021*

Weighted average expected volatility		106%		105%
Weighted average expected term (in years)		6.9		6.6
Weighted average risk-free interest rate		1.70%		0.48%
Expected dividends		-		-

Note 10 - Licensing and Research Funding Agreements

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

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

Note 10 – Licensing and Research Funding Agreements

In March 2020, we entered into a Term Sheet with Lee’s (HK), pursuant to which Lee’s (HK) provided financing for the development of AEROSURF. In August 2020, we entered into a Project Financing Agreement with Lee’s (HK), or the PF Agreement, formalizing the terms of the Term Sheet, and under which we received payments totaling $2.8 million through October 2020. In November 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 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.

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 March 31, 2022, the liability balance related to the payments under the PF Agreement was $3.8 million and is recorded in other liabilities.

Note 11 - Subsequent Events

3 Months Ended

Mar. 31, 2022

Notes to Financial Statements

Subsequent Events [Text Block]

Note 11 – Subsequent Events

During April 2022, we sold 936,898 shares of our common stock under the ATM Program resulting in aggregate gross proceeds to us of approximately $1.1 million and net proceeds of approximately $1.0 million

Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2022

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 as of March 31, 2022 and December 31, 2021:

		*March 31,*		*December 31,*
(in thousands)	*2022*		*2021*

Istaroxime drug candidate	$	22,340	$	22,340
Rostafuroxin drug candidate		9,730		9,730
Intangible assets		32,070		32,070

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

Severance Cost [Policy Text Block]

Severance

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

Property and Equipment

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

Income Tax, Policy [Policy Text Block]

Income Taxes

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

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

Effect of COVID-19 Pandemic [Policy Text Block]

COVID-19

Note 4 - Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2022

Notes Tables

Schedule of Intangible Assets and Goodwill [Table Text Block]

		*March 31,*		*December 31,*
(in thousands)	*2022*		*2021*

Istaroxime drug candidate	$	22,340	$	22,340
Rostafuroxin drug candidate		9,730		9,730
Intangible assets		32,070		32,070

Goodwill	$	15,682	$	15,682

Note 5 - Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2022

Notes Tables

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

	*Fair Value*		*Fair value measurement using*
	*March 31,*
(in thousands)	*2022*		*Level 1*		*Level 2*		*Level 3*

Cash equivalents:
Money market funds	$	14,104	$	14,104	$	-	$	-
Total Assets	$	14,104	$	14,104	$	-	$	-

	*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	$	-	$	-

Note 9 - Stock-based Employee Compensation (Tables)

3 Months Ended

Mar. 31, 2022

Notes Tables

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, 2022		3,387		$	9.74
Granted		835			1.02
Forfeited or expired		(49	)		6.06
Outstanding at March 31, 2022		4,173		$	8.04		8.2

Vested and exercisable at March 31, 2022		2,142		$	12.38		7.1

Vested and expected to vest at March 31, 2022		3,925		$	8.06		8.2

Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block]

(in thousands, except for weighted-average data)
Restricted Stock Units	*Shares*		*Weighted- Average Grant Date Fair Value*

Outstanding at January 1, 2022		-	$	-
Awarded		554		1.02
Outstanding at March 31, 2022		554	$	1.02

Vested and exercisable at March 31, 2022		-	$	-

Vested and expected to vest at March 31, 2022		554	$	1.02

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	*Three Months Ended March 31,*
(in thousands)	*2022*		*2021*

Research and development	$	235	$	939
General and administrative		535		1,504
Total	$	770	$	2,443

Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

	*Three Months Ended March 31,*
	*2022*		*2021*

Weighted average expected volatility		106%		105%
Weighted average expected term (in years)		6.9		6.6
Weighted average risk-free interest rate		1.70%		0.48%
Expected dividends		-		-

Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands		1 Months Ended	3 Months Ended		4 Months Ended
	Mar. 31, 2022	Apr. 30, 2022	Mar. 31, 2022	Mar. 31, 2021	Apr. 30, 2022	Dec. 31, 2021
Net Income (Loss) Attributable to Parent, Total			$ (8,127)	$ (8,961)
Retained Earnings (Accumulated Deficit), Total	$ (793,451)		(793,451)			$ (785,324)
Proceeds from Issuance of Common Stock			205	$ 570
Cash and Cash Equivalents, at Carrying Value, Total	15,541		$ 15,541			$ 22,348
ATM Program [Member]
Stock Issued During Period, Shares, New Issues (in shares)			200,348	105,083
Stock Issued During Period, Value, New Issues			$ 200	$ 600
Proceeds from Issuance of Common Stock	$ 4,800
ATM Program [Member] \| Subsequent Event [Member]
Stock Issued During Period, Shares, New Issues (in shares)		936,898			936,898
Stock Issued During Period, Value, New Issues		$ 1,100
Proceeds from Issuance of Common Stock		$ 1,000
Rostafuroxin Drug Candidate [Member]
Deferred Income Tax Expense (Benefit), Total			$ (10,000)

Note 4 - Summary of Significant Accounting Policies (Details Textual) $ / shares in Units, $ in Thousands	1 Months Ended	3 Months Ended		4 Months Ended
	Apr. 30, 2022 $ / shares shares	Mar. 31, 2022 USD ($) shares	Mar. 31, 2021 USD ($) shares	Apr. 30, 2022 $ / shares shares	Dec. 31, 2021 USD ($)	Nov. 01, 2017 USD ($)
Number of Reporting Units		1
Foreign Currency Transaction Gain, before Tax		$ 200	$ 100
Severance Costs		400
Severance Accrual		300
Depreciation, Total		466	$ 45
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000			$ 15,000
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares) \| shares		21,400,000	19,900,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent						$ 15,000
Manufacturing and Laboratory Equipment [Member]
Depreciation, Total		$ 400
ATM Program [Member]
Stock Issued During Period, Shares, New Issues (in shares) \| shares		200,348	105,083
Subsequent Event [Member] \| ATM Program [Member]
Stock Issued During Period, Shares, New Issues (in shares) \| shares	936,898			936,898
Subsequent Event [Member] \| ATM Program [Member] \| Weighted Average [Member]
Shares Issued, Price Per Share (in dollars per share) \| $ / shares	$ 1.13			$ 1.13

Note 4 - Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Intangible assets	$ 32,070	$ 32,070
Goodwill	15,682	15,682
Istaroxime Drug Candidate [Member]
Intangible assets	22,340	22,340
Rostafuroxin Drug Candidate [Member]
Intangible assets	$ 9,730	$ 9,730

- Definition

Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized.

+ References + Details

Note 5 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Total Assets	$ 14,104	$ 21,104
Fair Value, Inputs, Level 1 [Member]
Total Assets	14,104	21,104
Money Market Funds [Member]
Cash equivalents	14,104	21,104
Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	$ 14,104	$ 21,104

Note 6 - Loans Payable (Details Textual) - Loan payable to Bank Direct Capital Finance [Member] - Loans Payable [Member] - USD ($)	1 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Debt Instrument, Face Amount	$ 1,300,000	$ 1,100,000
Debt Instrument, Interest Rate, Stated Percentage	3.37%	4.26%
Debt Instrument, Periodic Payment, Total	$ 147,000	$ 117,000
Loans Payable to Bank, Total	$ 300,000

Note 7 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Millions	Oct. 27, 2017	Mar. 31, 2022	Dec. 31, 2021
Liability for Contingent Milestone Payment, Noncurrent		$ 15.0	$ 15.0
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Extinguishment of Debt, Amount	$ 25.0
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	$ 2.5
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	$ 15.0	$ 15.0	$ 15.0

Note 8 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended	3 Months Ended		4 Months Ended
	Mar. 31, 2022	Mar. 25, 2021	Mar. 23, 2021	Sep. 17, 2020	Apr. 30, 2022	Mar. 31, 2022	Mar. 31, 2021	Apr. 30, 2022	May 05, 2022
Proceeds from Issuance of Common Stock						$ 205	$ 570
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]
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
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)						200,348	105,083
Stock Issued During Period, Value, New Issues						$ 200	$ 600
Proceeds from Issuance of Common Stock	$ 4,800
ATM Program [Member] \| Subsequent Event [Member]
Stock Issued During Period, Shares, New Issues (in shares)					936,898			936,898
Stock Issued During Period, Value, New Issues					$ 1,100
Proceeds from Issuance of Common Stock					$ 1,000
Stock Offering Agreement, Remaining Amount Available									$ 3,700
ATM Program [Member] \| Ladenburg [Member]
Commission Fee, Percent Fee				3.00%

Note 9 - Stock-based Employee Compensation (Details Textual)	3 Months Ended
	Mar. 31, 2022
Restricted Stock Units (RSUs) [Member] \| Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year)	1 year
The 2020 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year)	3 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

Note 9 - Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Shares Outstanding, Beginning Balance (in shares) \| shares	3,387
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) \| $ / shares	$ 9.74
Shares Granted (in shares) \| shares	835
Weighted Average Exercise Price, Granted (in dollars per share) \| $ / shares	$ 1.02
Shares Forfeited or Expired (in shares) \| shares	(49)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) \| $ / shares	$ 6.06
Shares Outstanding, Ending Balance (in shares) \| shares	4,173
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) \| $ / shares	$ 8.04
Weighted Average Remaining Contractual Life, Outstanding (Year)	8 years 2 months 12 days
Shares Vested and Exercisable (in shares) \| shares	2,142
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) \| $ / shares	$ 12.38
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	7 years 1 month 6 days
Vested and expected to vest (in shares) \| shares	3,925
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) \| $ / shares	$ 8.06
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	8 years 2 months 12 days

Note 9 - Stock-based Employee Compensation - Restricted Stock Unites (Details) - Restricted Stock Units (RSUs) [Member] shares in Thousands	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Shares Outstanding, Beginning Balance (in shares) \| shares	0
Weighted- Average Grant Date Fair Value, Outstanding, Beginning Balance (in dollars per share) \| $ / shares	$ 0
Awarded (in shares) \| shares	554
Awarded, Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) \| $ / shares	$ 1.02
Outstanding at March 31, 2022 (in shares) \| shares	554
Weighted- Average Grant Date Fair Value, Outstanding (in dollars per share) \| $ / shares	$ 1.02
Vested and exercisable at March 31, 2022 (in shares) \| shares	0
Vested and exercisable Weighted- Average Grant Date Fair Value (in dollars per share) \| $ / shares	$ 0
Vested and expected to vest at March 31, 2022 (in shares) \| shares	554
Vested and expected to vest Weighted- Average Grant Date Fair Value (in dollars per share) \| $ / shares	$ 1.02

Note 9 - Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Stock-based compensation expense	$ 770	$ 2,443
Research and Development Expense [Member]
Stock-based compensation expense	235	939
Selling, General and Administrative Expenses [Member]
Stock-based compensation expense	$ 535	$ 1,504

Note 9 - Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Weighted average expected volatility	106.00%	105.00%
Weighted average expected term (Year)	6 years 10 months 24 days	6 years 7 months 6 days
Weighted average risk-free interest rate	1.70%	0.48%

Note 10 - Licensing and Research Funding Agreements (Details Textual) - USD ($) $ in Millions	3 Months Ended	12 Months Ended
	Oct. 31, 2020	Dec. 31, 2021	Mar. 31, 2022	Mar. 18, 2020
AEROSURF Funding Term Sheet [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Nonrefundable Payments	$ 2.8
Term Sheet With Lee [Member]
Proceeds for Payments to Develop Product		$ 1.0
Financing of Product, Percent of Financing That Must be Repaid to Discontinue Revenue Sharing				125.00%
Financing of Product, Percent of Revenue Shared With Financer				50.00%
Contractual Obligation, Total			$ 3.8

Note 11 - Subsequent Events (Details Textual) - USD ($) $ in Thousands		1 Months Ended	3 Months Ended		4 Months Ended
	Mar. 31, 2022	Apr. 30, 2022	Mar. 31, 2022	Mar. 31, 2021	Apr. 30, 2022
Proceeds from Issuance of Common Stock			$ 205	$ 570
ATM Program [Member]
Stock Issued During Period, Shares, New Issues (in shares)			200,348	105,083
Stock Issued During Period, Value, New Issues			$ 200	$ 600
Proceeds from Issuance of Common Stock	$ 4,800
ATM Program [Member] \| Subsequent Event [Member]
Stock Issued During Period, Shares, New Issues (in shares)		936,898			936,898
Stock Issued During Period, Value, New Issues		$ 1,100
Proceeds from Issuance of Common Stock		$ 1,000