0001437749-21-011908 | 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, 2021	May 12, 2021
Document Information [Line Items]
Entity Registrant Name	WINDTREE THERAPEUTICS INC /DE/
Entity Central Index Key	0000946486
Trading Symbol	wint
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Current Reporting Status	Yes
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Interactive Data Current	Yes
Entity Common Stock, Shares Outstanding (in shares)		26,257,065
Entity Shell Company	false
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
Amendment Flag	false
Title of 12(b) Security	Common Stock, $0.001 par value

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and cash equivalents	$ 38,490	$ 16,930
Prepaid expenses and other current assets	851	1,188
Total current assets	39,341	18,118
Property and equipment, net	879	924
Restricted cash	154	154
Operating lease right-of-use assets	2,747	917
Intangible assets	77,090	77,090
Goodwill	15,682	15,682
Total assets	135,893	112,885
Current Liabilities:
Accounts payable	939	1,161
Accrued expenses	3,744	3,813
Operating lease liabilities - current portion	392	805
Loans payable - current portion	2,409	352
Total current liabilities	7,484	6,131
Operating lease liabilities - non-current portion	2,438	201
Loans payable - non-current portion		2,423
Restructured debt liability - contingent milestone payments	15,000	15,000
Other liabilities	2,800	2,800
Deferred tax liabilities	16,683	16,778
Total liabilities	44,405	43,333
Stockholders’ Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2021 and December 31, 2020
Common stock, $0.001 par value; 120,000,000 shares authorized at March 31, 2021 and December 31, 2020; 26,257,089 and 16,921,506 shares issued at March 31, 2021 and December 31, 2020, respectively; 26,257,065 and 16,921,482 shares outstanding at March 31, 2021 and December 31, 2020, respectively	26	17
Additional paid-in capital	821,165	790,277
Accumulated deficit	(726,649)	(717,688)
Treasury stock (at cost); 24 shares	(3,054)	(3,054)
Total stockholders’ equity	91,488	69,552
Total liabilities & stockholders’ equity	$ 135,893	$ 112,885

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2021	Dec. 31, 2020
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorize (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	26,257,089	16,921,506
Common stock, shares outstanding (in shares)	26,257,065	16,921,482
Treasury stock, shares (in shares)	24	24

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Expenses:
Research and development	$ 4,410	$ 3,461
General and administrative	4,669	3,242
Total operating expenses	9,079	6,703
Operating loss	(9,079)	(6,703)
Other (expense) income:
Interest income	50	89
Interest expense	(41)	(44)
Other income, net	109	124
Total other (expense) income, net	118	169
Net loss	$ (8,961)	$ (6,534)
Net loss per common share
Basic and diluted (in dollars per share)	$ (0.51)	$ (0.48)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	17,695	13,697

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	September 2020 At The Market Offering [Member] Common Stock [Member]	September 2020 At The Market Offering [Member] Additional Paid-in Capital [Member]	September 2020 At The Market Offering [Member]	Share Purchase Agreement, December 2019 [Member] Additional Paid-in Capital [Member]	Share Purchase Agreement, December 2019 [Member]	March 2021 Public Offering [Member] Common Stock [Member]	March 2021 Public Offering [Member] Additional Paid-in Capital [Member]	March 2021 Public Offering [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Treasury Stock [Member]	Total
Balance (in shares) at Dec. 31, 2019									13,697,000
Balance at Dec. 31, 2019									$ 14	$ 763,097	$ (685,122)	$ (3,054)	$ 74,935
Net loss											(6,534)		(6,534)
Stock-based compensation expense										1,689			1,689
Balance (in shares) at Mar. 31, 2020									13,697,000
Balance at Mar. 31, 2020									$ 14	764,786	(691,656)	$ (3,054)	70,090
Balance (in shares) at Dec. 31, 2020									16,922,000
Balance at Dec. 31, 2020									$ 17	790,277	(717,688)	$ (3,054)	69,552
Net loss											(8,961)		(8,961)
Stock-based compensation expense										2,443			2,443
Issuance of common stock, ATM Program (in shares)	105,000		105,083
Issuance of common stock, ATM Program		$ 570	$ 570
Issuance of common stock warrants, equity consideration for service agreement				$ 494	$ 494
Issuance of common stock and common stock warrants, net of issuance costs (in shares)						9,230,000
Issuance of common stock and common stock warrants, net of issuance costs						$ 9	$ 27,381	$ 27,390
Balance (in shares) at Mar. 31, 2021									26,257,000
Balance at Mar. 31, 2021									$ 26	$ 821,165	$ (726,649)	$ (3,054)	$ 91,488

- Definition

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

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+ Details

- 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.

+ References + Details

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash flows from operating activities:
Net loss	$ (8,961)	$ (6,534)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	45	42
Amortization of debt discount		3
Stock-based compensation	2,443	1,689
Non-cash lease expense	170	177
Non-cash expense related to equity consideration for a service agreement	494
Unrealized gain on foreign exchange rate changes	(109)
Changes in:
Prepaid expenses and other current assets	337	(16)
Accounts payable	(222)	(307)
Collaboration and device development payable		(108)
Accrued expenses	(69)	(238)
Operating lease liabilities	(176)	(190)
Net cash used in operating activities	(6,048)	(5,482)
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs	27,390
Proceeds from the ATM Program, net of expenses	570
Principal payments on loans payable	(352)	(199)
Net cash provided by (used in) financing activities	27,608	(199)
Effect of exchange rate changes on cash and cash equivalents		(98)
Net increase (decrease) in cash, cash equivalents, and restricted cash	21,560	(5,779)
Cash, cash equivalents, and restricted cash - beginning of period	17,084	22,732
Cash, cash equivalents, and restricted cash - end of period	38,644	16,953
Operating lease liabilities arising from obtaining right-of-use assets	$ 2,000

Note 1 - The Company and Description of Business	3 Months Ended
Note 1 - The Company and Description of Business	Mar. 31, 2021
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 and medical device 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 acute pulmonary diseases. Our lead acute cardiovascular 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 the phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure in heart failure patients, we initiated a small clinical study to evaluate istaroxime for the treatment of early cardiogenic shock, a severe form of heart failure characterized by very low blood pressure and hypo-perfusion to critical organs. We believe that istaroxime may fulfill an unmet need in early cardiogenic shock. In addition, our drug product candidates include rostafuroxin, a novel medicine for the treatment of hypertension in patients with a specific genetic profile, for which we are pursuing potential out-licensing transactions or other strategic opportunities and not advancing on our own. Our cardiovascular portfolio also includes early exploratory research programs to evaluate potential preclinical product candidates for development, including oral and intravenous sarco (endo) plasmic reticulum Ca2 + -ATPase 2a, or SERCA2a, activator heart failure compounds. Our lead pulmonary product candidate is our proprietary lyophilized KL4 surfactant (lucinactant), which we believe may potentially support a product pipeline, alone or in combination with our proprietary Aerosol Delivery System, or ADS, technology, to address a broad range of serious respiratory conditions in children and adults. We are developing KL4 surfactant to be delivered either as a liquid instillate or noninvasively as an aerosol. In September 2020, the FDA accepted our investigational new drug, or IND, application for a small phase 2 pilot study to assess the ability of our KL4 surfactant liquid instillate to impact key respiratory parameters in the treatment of lung injury and acute respiratory distress syndrome, or ARDS, resulting from severe acute respiratory syndrome coronavirus 2, or SARS-CoV- 2, the causative agent in novel coronavirus, or COVID- 19, infections. We dosed the first patient in this clinical trial in January 2021 and plan to enroll up to 20 patients with COVID- 19 and ARDS who are on mechanical ventilation, with results expected in the third quarter of 2021. Our aerosolized product candidate, AEROSURF® (lucinactant for inhalation), is 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. Our licensee in Asia, Lee's Pharmaceutical (HK) Ltd., or Lee's (HK), has agreed to fund and conduct a phase 2b clinical bridging study for AEROSURF in Asia, referred to as the phase 2b bridging study, 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. Accordingly, we have suspended our AEROSURF clinical activities and ceased enrollment in the phase 2b bridging study being conducted in the European Union. To support the future development of AEROSURF and our lyophilized KL4 surfactant liquid instillate in markets outside of Asia, including the United States, or U.S., we are pursuing one or more licensing transactions, collaboration arrangements or other strategic opportunities. 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 outside of Asia, 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. 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, 2020 that we filed with the Securities and Exchange Commission, or the SEC, on March 29, 2021 , 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
Note 2 - Basis of Presentation	Mar. 31, 2021
Notes to Financial Statements
Basis of Accounting [Text Block]	Note 2 - Basis of Presentation These interim unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States, 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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 . There have been no changes to our significant accounting policies since December 31, 2020 . The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2020 contained in our Annual Report on Form 10 -K for the year ended December 31, 2020 .

Note 3 - Liquidity Risks and Management's Plans	3 Months Ended
Note 3 - Liquidity Risks and Management's Plans	Mar. 31, 2021
Notes to Financial Statements
Liquidity Disclosures [Text Block]	Note 3 - Liquidity Risks and Management ' s Plans As of March 31, 2021 , we had cash and cash equivalents of $38.5 million and current liabilities of $7.5 million. On March 25, 2021, we completed a registered public offering, or the March 2021 Offering, of 9,230,500 shares of our common stock and warrants to purchase 9,230,500 shares of our common stock, at a combined price of $3.25 resulting in net proceeds of $27.4 million ( see , Note 8 - Stockholders' Equity ). We also have 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. As of 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 (s ee, Note 8 - Stockholders' Equity ). 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 $9.0 million and $6.5 million, respectively, for the three -month periods ended March 31, 2021 and 2020 . We expect to continue to incur operating losses for at least the next several years. As of March 31, 2021 , we had an accumulated deficit of $726.6 million. Our future success is dependent on our ability to identify 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 believe that our cash and cash equivalents as of the filing date of our Quarterly Report on Form 10 -Q for the quarterly period ended March 31, 2021 are sufficient to fund operations through at least the next 12 months. In the future, we will need to raise additional capital to continue funding our development activities and operations. We plan to obtain funding through a combination of public or private equity offerings, or strategic transactions including collaborations, licensing arrangements or other strategic partnerships. There is inherent uncertainty associated with these fundraising activities, and thus they are not considered probable. Our funding requirements are based on estimates that are subject to risks and uncertainties and may change as a result of many factors currently unknown. Although management continues to pursue the plans described above, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, including as a result of market volatility following the COVID- 19 pandemic. Until such time as we can generate substantial product revenues, if ever, we expect to finance our cash needs through a combination of equity offerings, strategic partnerships and licensing arrangements. The terms of any future financing may adversely affect the holdings or the rights of our existing stockholders.

Note 4 - Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Significant Accounting Policies [Text Block]

Note

- 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.

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 long-term growth rate, (iii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iv) 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.

Based on our annual quantitative impairment assessment of our indefinite-lived IPR&D intangible assets as of

December 1, 2020,

we concluded that the assets were

not

impaired, and

subsequent events or changes in circumstances have occurred indicating the intangible assets are more likely than

not

impaired. With respect to IPR&D related to our rostafuroxin drug candidate, we are evaluating possible out-licensing arrangements and anticipate securing an agreement in

2021.

However, if we are unable to secure an out-licensing agreement during

2021,

or if we secure an agreement for an amount less than anticipated, there is a risk for impairment of this intangible asset in the near term.

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. When conducting our annual impairment test of goodwill as of

December 1, 2020,

we elected to perform a quantitative assessment. 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,

further evaluation is required, and

impairment exists. If the carrying amount 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, 2020,

we determined 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, the fair value of our reporting unit exceeded its carrying value and

impairment loss was recognized as of

December 31, 2020

Goodwill is reviewed for impairment at least annually or when events or changes in the business environment indicate that its carrying value

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 our closing share price following the

March 2021

Offering, which was completed on

March 25, 2021,

due to both market conditions and the dilution of our common stock as a result of the

March 2021

Offering. While this trend began prior to the filing of our Annual Report on Form

-K for the year ended

December 31, 2020

that we filed with the SEC on

March 29, 2021

, we believe that the

March 2021

Offering priced at

$3.25

per unit corroborated the results of our quantitative analysis of goodwill as of

December 1, 2020.

However, if our share price does

not

improve during the remainder of the

second

quarter, our reporting unit is at risk for future impairment in the near term.

The following table represents identifiable intangible assets as of

March 31, 2021

and

December 31, 2020

		March 31,		December 31,
(in thousands)	2021		2020

Rostafuroxin drug candidate	$	54,750	$	54,750
Istaroxime drug candidate		22,340		22,340
Intangible assets		77,090		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) income, net

. Foreign currency transactions resulted in

gains

of approximately

$0.1

million and

$0.2

million, respectively, for the

three

-month periods ended

March 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, including intangible assets and goodwill, 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

days or less that are readily convertible into cash.

Severance

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 will be paid ratably through

August 2021.

During the

three

months ended

March 31, 2021

$0.2

million was paid and

$0.3

million remains accrued.

Restructured Debt Liability – Contingent Milestone Payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

see

Note

- 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, 2021

and

2020

, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was

19.9

million and

6.5

million shares, respectively. For the

three

months ended

March 31, 2021

and

2020

, 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-

The COVID-

pandemic continues to evolve, and we continue to closely monitor its impact on our business, operations, including its potential impact on our clinical development plans and timelines, and financial condition. As of the date of the issuance of this Quarterly Report on Form

-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 potentially extended timelines

may

force us to expend more of our capital resources than planned to achieve our projected milestones. For example, certain of our ongoing clinical trials, including our phase

study of istaroxime for early cardiogenic shock in heart failure patients, have experienced delays. The full extent, duration, or impact that the COVID-

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-

outbreak, the severity and transmissibility of new variants of the virus, information about any regional resurgences in

one

or more markets where our current or intended clinical trial sites, our principal executive offices, research and development laboratories or other facilities are located, and the actions taken to contain it or treat its impact, which

may

include, among others, the timing and extent of governments reopening activities and the economic impact on local, regional, national, and international markets. The maintenance, or strategic re-implementation, of mitigating COVID-

measures in

one

or more markets where our clinical trial sites, principal executive offices, research and development laboratories or other facilities are located remains possible and 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

2021.

We are

not

aware of any specific event or circumstance that would require us to 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 of Financial Instruments

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Fair Value Disclosures [Text Block]

Note

- Fair Value of Financial Instruments

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 and liabilities measured at fair value on a recurring basis for the periods presented:

	Fair Value		Fair value measurement using
	March 31,
(in thousands)	2021		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	32,077	$	32,077	$	-	$	-
U.S. Treasury notes		3,029		3,029		-		-
Total Assets	$	35,106	$	35,106	$	-	$	-


	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2020		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	6,518		6,518	$	-	$	-
U.S. Treasury notes		9,101		9,101		-		-
Total Assets	$	15,619	$	15,619	$	-	$	-

- 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 - Current and Non-current Portions	3 Months Ended
	Mar. 31, 2021
Notes to Financial Statements
Short-term Debt [Text Block]	Note 6 - Loans Payable - Current and Non-Current Portions O-Bank Co., Ltd. Credit Facility In September 2016, CVie Therapeutics Limited 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 is guaranteed by Lee's Pharmaceutical Holdings Limited, or Lee's, 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 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 committed to maintain the required level of pledged bank deposits with O-Bank through the date of full repayment of the O-Bank Facility. As of March 31, 2021 and December 31, 2020 , the outstanding principal of the O-Bank Facility was approximately $2.4 million. As of March 31, 2021 , the outstanding principal is classified as loans payable - current portion as it is due within one year of the balance sheet date. As of December 31, 2020, the outstanding principal was classified as loans payable - non-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 and there was no outstanding balance on the loan as of March 31, 2021 .

Note 7 - Restructured Debt Liability	3 Months Ended
Note 7 - Restructured Debt Liability	Mar. 31, 2021
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, 2021 and December 31, 2020 , the restructured debt liability balance was $15.0 million.

Note 8 - Stockholders' Equity	3 Months Ended
Note 8 - Stockholders' Equity	Mar. 31, 2021
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 the March 2021 Offering, for 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 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 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 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. As of 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.

Note 9 - Stock Options and Stock-based Employee Compensation

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Share-based Payment Arrangement [Text Block]

Note

- Stock Options and Stock-Based Employee Compensation

We recognize in our condensed consolidated financial statements all stock-based awards to employees and non-employee directors based on their fair value on the date of grant, calculated using the Black-Scholes option-pricing model. Compensation expense related to stock-based awards is recognized ratably over the vesting period, which for employees is typically

three

years. We recognize restricted stock unit awards to employees and non-employee directors based on their fair value on the date of grant. Compensation expense related to restricted stock unit awards is recognized ratably over the vesting period, which typically has been between approximately

six

months.

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		1,339			5.46
Forfeited or expired		(2	)		11.85
Outstanding at March 31, 2021		3,240		$	11.39		8.6

Vested and exercisable at March 31, 2021		1,353		$	17.19		7.5

Vested and expected to vest at March 31, 2021		3,020		$	11.50		8.5

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)	2021		2020

Research and development	$	939	$	714
General and administrative		1,504		975
Total	$	2,443	$	1,689

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, 2021

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

Note 10 - Collaboration, Licensing and Research Funding Agreements	3 Months Ended
	Mar. 31, 2021
Notes to Financial Statements
Corporate Partnership, Licensing and Research Funding Agreements [Text Block]	Note 10 - Collaboration, Licensing and Research Funding Agreements In March 2020, we entered into the 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), the PF Agreement, formalizing the terms of the Term Sheet, and under which we have 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. Thereafter, 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) has 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. 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, 2021 , the liability balance related to the payments under the PF Agreement was $2.8 million and is recorded in other liabilities.

Significant Accounting Policies (Policies)

3 Months Ended

Mar. 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

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. With respect to IPR&D related to our rostafuroxin drug candidate, if we are unable to secure an out-licensing agreement during

2021,

or if we secure an agreement for an amount less than anticipated, we believe that it is reasonably possible that the intangible asset is at risk for impairment in the near term.

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. 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. As our average closing share price has declined subsequent to

March 31, 2021

, our reporting unit is at risk for future impairment if our share price does

not

improve.

The following table represents identifiable intangible assets as of

March 31, 2021

and

December 31, 2020

		March 31,		December 31,
(in thousands)	2021		2020

Rostafuroxin drug candidate	$	54,750	$	54,750
Istaroxime drug candidate		22,340		22,340
Intangible assets		77,090		77,090

Goodwill	$	15,682	$	15,682

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Foreign Currency Transactions

The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are

not

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) income, net

. Foreign currency transactions resulted in

gains

of approximately

$0.1

million and

$0.2

million, respectively, for the

three

-month periods ended

March 31, 2021

and

2020

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

days or less that are readily convertible into cash.

Severance Cost [Policy Text Block]

Severance

July 2020,

we entered into separation agreements with

two

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 will be paid ratably through

August 2021.

During the

three

months ended

March 31, 2021

$0.2

million was paid and

$0.3

million remains accrued.

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

Restructured Debt Liability – Contingent Milestone Payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

see

Note

- 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,

not

achieved and the liability is written off as a gain on debt restructuring.

Research and Development Expense, Policy [Policy Text Block]

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

730,

Research and Development

Income Tax, Policy [Policy Text Block]

Income Taxes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes

not

assured.

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

March 31, 2021

and

2020

, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants was

19.9

million and

6.5

million shares, respectively. For the

three

months ended

March 31, 2021

and

2020

, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.

Effect of COVID-19 Pandemic [Policy Text Block]

COVID-

The COVID-

-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 potentially extended timelines

may

force us to expend more of our capital resources than planned to achieve our projected milestones. For example, certain of our ongoing clinical trials, including our phase

study of istaroxime for early cardiogenic shock in heart failure patients, have experienced delays. The full extent, duration, or impact that the COVID-

may

emerge concerning the severity of the COVID-

outbreak, the severity and transmissibility of new variants of the virus, information about any regional resurgences in

one

may

include, among others, the timing and extent of governments reopening activities and the economic impact on local, regional, national, and international markets. The maintenance of or strategic re-implementation of mitigating COVID-

measures in

one

may

include potential delays, halts or modifications to our ongoing and planned trials in

2021.

We are

not

may

change, as new events occur and additional information is obtained.

Note 4 - Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

Schedule of Intangible Assets and Goodwill [Table Text Block]

		March 31,		December 31,
(in thousands)	2021		2020

Rostafuroxin drug candidate	$	54,750	$	54,750
Istaroxime drug candidate		22,340		22,340
Intangible assets		77,090		77,090

Goodwill	$	15,682	$	15,682

Note 5 - Fair Value of Financial Instruments (Tables)

3 Months Ended

Mar. 31, 2021

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)	2021		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	32,077	$	32,077	$	-	$	-
U.S. Treasury notes		3,029		3,029		-		-
Total Assets	$	35,106	$	35,106	$	-	$	-


	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2020		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	6,518		6,518	$	-	$	-
U.S. Treasury notes		9,101		9,101		-		-
Total Assets	$	15,619	$	15,619	$	-	$	-

Note 9 - Stock Options and Stock-based Employee Compensation (Tables)

3 Months Ended

Mar. 31, 2021

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, 2021		1,903		$	15.57
Granted		1,339			5.46
Forfeited or expired		(2	)		11.85
Outstanding at March 31, 2021		3,240		$	11.39		8.6

Vested and exercisable at March 31, 2021		1,353		$	17.19		7.5

Vested and expected to vest at March 31, 2021		3,020		$	11.50		8.5

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

	Three Months Ended March 31,
(in thousands)	2021		2020

Research and development	$	939	$	714
General and administrative		1,504		975
Total	$	2,443	$	1,689

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

	Three Months Ended
	March 31, 2021

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

Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended
	Mar. 25, 2021	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020	Sep. 17, 2020
Cash and Cash Equivalents, at Carrying Value, Ending Balance		$ 38,490		$ 16,930
Liabilities, Current, Total		7,484		6,131
Stock Issued During Period, Shares, New Issues (in shares)	9,230,500
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	9,230,500
Stock and Warrants Issued, Price Per Share (in dollars per share)	$ 3.25
Proceeds from Issuance or Sale of Equity, Total	$ 27,400
Net Income (Loss) Attributable to Parent, Total		(8,961)	$ (6,534)
Retained Earnings (Accumulated Deficit), Ending Balance		$ (726,649)		$ (717,688)
September 2020 At The Market Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)		105,083
Proceeds from Issuance or Sale of Equity, Total		$ 600
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value					$ 10,000

Note 4 - Summary of Significant Accounting Policies (Details Textual) $ / shares in Units, $ in Thousands, shares in Millions			3 Months Ended		12 Months Ended
	Dec. 01, 2020 USD ($)	Jul. 20, 2020 USD ($)	Mar. 31, 2021 USD ($) shares	Mar. 31, 2020 USD ($) shares	Dec. 31, 2020 USD ($)	Mar. 25, 2021 $ / shares	Nov. 01, 2017 USD ($)
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill)	$ 0
Number of Reporting Units			1
Goodwill, Impairment Loss					$ 0
Stock and Warrants Issued, Price Per Share (in dollars per share) \| $ / shares						$ 3.25
Foreign Currency Transaction Gain, before Tax			$ 100	$ 200
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			19.9	6.5
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent							$ 15,000
John A. Tattory and Kathryn Cole [Member]
Severance Costs		$ 900
Payments for Severance Costs			$ 200
John A. Tattory and Kathryn Cole [Member] \| Employee Severance [Member]
Severance Accrual			$ 300
March 2021 Public Offering [Member]
Stock and Warrants Issued, Price Per Share (in dollars per share) \| $ / shares						$ 3.25

Note 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Intangible assets	$ 77,090	$ 77,090
Goodwill	15,682	15,682
Rostafuroxin Drug Candidate [Member]
Intangible assets	54,750	54,750
Istaroxime Drug Candidate [Member]
Intangible assets	$ 22,340	$ 22,340

Note 5 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Total Assets	$ 35,106	$ 15,619
Fair Value, Inputs, Level 1 [Member]
Total Assets	35,106	15,619
Fair Value, Inputs, Level 2 [Member]
Total Assets
Fair Value, Inputs, Level 3 [Member]
Total Assets
Money Market Funds [Member]
Cash equivalents	32,077	6,518
Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	32,077	6,518
Money Market Funds [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
Money Market Funds [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents
US Treasury Securities [Member]
Cash equivalents	3,029	9,101
US Treasury Securities [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	3,029	9,101
US Treasury Securities [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
US Treasury Securities [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents

Note 6 - Loans Payable - Current and Non-current Portions (Details Textual) - USD ($)	1 Months Ended				3 Months Ended
	Aug. 31, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2017	Mar. 31, 2021	Jun. 30, 2020	Dec. 31, 2020	Sep. 30, 2016
Loans Payable, Noncurrent, Total							$ 2,423,000
Loan payable to Bank Direct Capital Finance [Member] \| Loans Payable [Member]
Debt Instrument, Face Amount		$ 1,100,000				$ 1,100,000
Debt Instrument, Interest Rate, Stated Percentage		4.26%				4.26%
Debt Instrument, Periodic Payment, Total		$ 117,000
Loans Payable to Bank, Total							400,000
Repayments of Bank Debt					400,000
Insurance Premium Financing and Security Agreement with Bank Direct [Member] \| Loans Payable [Member]
Loans Payable to Bank, Total					0
Revolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member]
Line of Credit Facility, Percent of Pledged Deposits Required				110.00%
Line of Credit Facility, Percent of Pledged Deposits Increase (Decrease)						(50.00%)
Repayments of Lines of Credit	$ 2,300,000
Loans Payable, Noncurrent, Total					$ 2,400,000		$ 2,400,000
Revolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate				0.91%
Nonrevolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member]
Line of Credit Facility, Maximum Borrowing Capacity			$ 5,000,000
Debt Instrument, Term (Month)			2 years
Nonrevolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate			1.17%
CVie Investments [Member] \| Revolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member]
Line of Credit Facility, Maximum Borrowing Capacity				$ 5,800,000				$ 2,900,000

Note 7 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands	Oct. 27, 2017	Mar. 31, 2021	Dec. 31, 2020
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 8 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands			3 Months Ended
	Mar. 25, 2021	Sep. 17, 2020	Mar. 31, 2021	Mar. 31, 2020
Stock and Warrants Issued, Price Per Share (in dollars per share)	$ 3.25
Proceeds from Issuance or Sale of Equity, Total	$ 27,400
Stock Issued During Period, Shares, New Issues (in shares)	9,230,500
Proceeds from Issuance of Common Stock			$ 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
Units, Number of Warrants Called by Each Unit (in shares)	1
September 2020 At The Market Offering [Member]
Proceeds from Issuance or Sale of Equity, Total			$ 600
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value		$ 10,000
Stock Issued During Period, Shares, New Issues (in shares)			105,083
Proceeds from Issuance of Common Stock			$ 600
September 2020 At The Market Offering [Member] \| Ladenburg [Member]
Commission Fee, Percent Fee		3.00%

Note 9 - Stock Options and Stock-based Employee Compensation (Details Textual)	3 Months Ended
	Mar. 31, 2021
Restricted Stock Units (RSUs) [Member] \| Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year)	180 days
Restricted Stock Units (RSUs) [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year)	1 year 180 days
The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period (Year)	3 years

Note 9 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	3 Months Ended
	Mar. 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	1,339
Weighted Average Exercise Price, Granted (in dollars per share) \| $ / shares	$ 5.46
Shares Forfeited or Expired (in shares) \| shares	(2)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) \| $ / shares	$ 11.85
Shares Outstanding, Ending Balance (in shares) \| shares	3,240
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) \| $ / shares	$ 11.39
Weighted Average Remaining Contractual Life, Outstanding (Year)	8 years 219 days
Shares Vested and Exercisable (in shares) \| shares	1,353
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) \| $ / shares	$ 17.19
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	7 years 182 days
Vested and expected to vest (in shares) \| shares	3,020
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) \| $ / shares	$ 11.50
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	8 years 182 days

Note 9 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Stock-based compensation expense	$ 2,443	$ 1,689
Research and Development Expense [Member]
Stock-based compensation expense	939	714
Selling, General and Administrative Expenses [Member]
Stock-based compensation expense	$ 1,504	$ 975

Note 9 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	3 Months Ended
	Mar. 31, 2021
Weighted average expected volatility	105.00%
Weighted average expected term (Year)	6 years 219 days
Weighted average risk-free interest rate	0.48%
Expected dividends

Note 10 - Collaboration, Licensing and Research Funding Agreements (Details Textual) - USD ($) $ in Millions	3 Months Ended	9 Months Ended
	Oct. 31, 2020	Sep. 30, 2021	Mar. 31, 2021	Mar. 18, 2020
AEROSURF Funding Term Sheet [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Nonrefundable Payments	$ 2.8
Term Sheet With Lee [Member]
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%
Term Sheet With Lee [Member] \| Other Liabilities [Member]
Contractual Obligation, Total			$ 2.8
Term Sheet With Lee [Member] \| Forecast [Member]
Proceeds for Payments to Develop Product		$ 1.0