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Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Jun. 30, 2020	Aug. 13, 2020
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)		16,886,482
Entity Shell Company	false
Document Type	10-Q
Document Period End Date	Jun. 30, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q2
Amendment Flag	false
Title of 12(b) Security	Common Stock, $0.001 par value

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Jun. 30, 2020	Dec. 31, 2019
Current Assets:
Cash and cash equivalents	$ 31,515	$ 22,578
Prepaid expenses and other current assets	2,121	1,283
Total current assets	33,636	23,861
Property and equipment, net	727	798
Restricted cash	154	154
Operating lease right-of-use assets	1,034	1,390
Intangible assets	77,090	77,090
Goodwill	15,682	15,682
Total assets	128,323	118,975
Current Liabilities:
Accounts payable	1,223	1,708
Collaboration and device development payable, net	968	1,972
Accrued expenses	3,676	3,226
Operating lease liabilities - current portion	651	750
Loans payable - current portion	5,714	161
Total current liabilities	12,232	7,817
Operating lease liabilities - non-current portion	506	794
Loans payable - non-current portion		4,608
Restructured debt liability - contingent milestone payments	15,000	15,000
Other liabilities	1,000
Deferred tax liabilities	16,129	15,821
Total liabilities	44,867	44,040
Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2020 and December 31, 2019
Common stock, $0.001 par value; 120,000,000 shares authorized at June 30, 2020 and December 31, 2019; 16,868,756 and 13,697,419 shares issued at June 30, 2020 and December 31, 2019, respectively; 16,868,732 and 13,697,395 shares outstanding at June 30, 2020 and December 31, 2019, respectively	17	14
Additional paid-in capital	787,707	763,097
Accumulated deficit	(701,214)	(685,122)
Treasury stock (at cost); 24 shares	(3,054)	(3,054)
Total stockholders' equity	83,456	74,935
Total liabilities & stockholders' equity	$ 128,323	$ 118,975

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Jun. 30, 2020	Dec. 31, 2019
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)	16,868,756	13,697,419
Common stock, shares outstanding (in shares)	16,868,732	13,697,395
Treasury stock, shares (in shares)	24	24

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Revenues		$ 158		$ 198
Expenses:
Research and development	4,495	3,413	7,956	6,755
General and administrative	3,453	3,240	6,695	6,595
Total operating expenses	7,948	6,653	14,651	13,350
Operating loss	(7,948)	(6,495)	(14,651)	(13,152)
Other income (expense):
Interest income	5	39	94	99
Interest expense	(31)	(117)	(75)	(253)
Other (expense) income, net	(1,584)	136	(1,460)	332
Total other (expense) income, net	(1,610)	58	(1,441)	178
Net loss	$ (9,558)	$ (6,437)	$ (16,092)	$ (12,974)
Net loss per common share Basic and diluted (in dollars per share)	$ (0.63)	$ (0.60)	$ (1.12)	$ (1.21)
Weighted average number of common shares outstanding Basic and diluted (in shares)	15,091	10,730	14,394	10,722
License [Member]
Revenues		$ 158		$ 198

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Net loss	$ (9,558)	$ (6,437)	$ (16,092)	$ (12,974)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		(28)		12
Comprehensive loss	$ (9,558)	$ (6,465)	$ (16,092)	$ (12,962)

- 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

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Treasury Stock [Member]	Total
Balance (in shares) at Dec. 31, 2018	10,711,000
Balance at Dec. 31, 2018	$ 11	$ 728,804	$ (657,647)		$ (3,054)	$ 68,114
Net loss			(6,537)			(6,537)
Vesting of restricted stock units (in shares)	18,000
Vesting of restricted stock units
Withholding tax payments related to net share settlements of restricted stock units		(151)				(151)
Stock-based compensation expense		1,530				1,530
Unrealized gain (loss) on marketable securities				40		40
Balance (in shares) at Mar. 31, 2019	10,729,000
Balance at Mar. 31, 2019	$ 11	730,183	(664,184)	40	$ (3,054)	62,996
Balance (in shares) at Dec. 31, 2018	10,711,000
Balance at Dec. 31, 2018	$ 11	728,804	(657,647)		$ (3,054)	68,114
Net loss						(12,974)
Unrealized gain (loss) on marketable securities						12
Balance (in shares) at Jun. 30, 2019	10,729,000
Balance at Jun. 30, 2019	$ 11	731,922	(670,621)	12	$ (3,054)	58,270
Balance (in shares) at Mar. 31, 2019	10,729,000
Balance at Mar. 31, 2019	$ 11	730,183	(664,184)	40	$ (3,054)	62,996
Net loss			(6,437)			(6,437)
Stock-based compensation expense		1,739				1,739
Unrealized gain (loss) on marketable securities				(28)		(28)
Balance (in shares) at Jun. 30, 2019	10,729,000
Balance at Jun. 30, 2019	$ 11	731,922	(670,621)	12	$ (3,054)	$ 58,270
Balance (in shares) at Dec. 31, 2019	13,697,000					13,697,395
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, 2019	13,697,000					13,697,395
Balance at Dec. 31, 2019	$ 14	763,097	(685,122)		$ (3,054)	$ 74,935
Net loss						(16,092)
Unrealized gain (loss) on marketable securities
Balance (in shares) at Jun. 30, 2020	16,869,000					16,868,732
Balance at Jun. 30, 2020	$ 17	787,707	(701,214)		$ (3,054)	$ 83,456
Balance (in shares) at Mar. 31, 2020	13,697,000
Balance at Mar. 31, 2020	$ 14	764,786	(691,656)		$ (3,054)	70,090
Net loss			(9,558)			(9,558)
Stock-based compensation expense		1,566				1,566
Unrealized gain (loss) on marketable securities
Issuance of common stock and common stock warrants, net of issuance costs (in shares)	3,172,000
Issuance of common stock and common stock warrants, net of issuance costs	$ 3	20,243				20,246
Modification of warrants		1,112				$ 1,112
Balance (in shares) at Jun. 30, 2020	16,869,000					16,868,732
Balance at Jun. 30, 2020	$ 17	$ 787,707	$ (701,214)		$ (3,054)	$ 83,456

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019
Cash flows from operating activities:
Net loss	$ (16,092)	$ (12,974)
Adjustments to reconcile net loss to net cash used in operating activities:
Recognition of deferred revenue		(198)
Depreciation	82	139
Amortization of debt discount	3	92
Stock-based compensation	3,255	3,269
Non-cash expense related to warrant modifications	1,112
Non-cash lease expense	356	436
Realized gain on investments		(61)
Changes in:
Prepaid expenses and other current assets	218	(68)
Accounts payable	(485)	(2,696)
Collaboration and device development payable	(1,007)	(1,187)
Accrued expenses	425	(1,726)
Operating lease liabilities	(387)	(465)
Other liabilities		59
Net cash used in operating activities	(12,520)	(15,380)
Cash flows from investing activities:
Proceeds from sale of marketable securities		11,488
Purchase of property and equipment	(12)	(226)
Net cash (used in) provided by investing activities	(12)	11,262
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs	20,246
Proceeds from research and development funding arrangement	1,000
Proceeds from Payroll Protection Program loan	547
Principle payments on Payroll Protection Program loan	(547)
Principle payments on loans payable	(199)	(474)
Payment for taxes related to net share settlements of restricted stock units		(151)
Net cash provided by (used in) financing activities	21,047	(625)
Effect of exchange rate changes on cash and cash equivalents	422	(338)
Net increase (decrease) in cash, cash equivalents and restricted cash	8,937	(5,081)
Cash, cash equivalents and restricted cash - beginning of period	22,732	11,358
Cash, cash equivalents and restricted cash - end of period	31,669	6,277
Prepayment of insurance through 3rd party financing	$ 1,056	$ 708

Note 1 - The Company and Description of Business

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

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

Note

–

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 pulmonary diseases. Our lead cardiovascular product candidate, istaroxime, a

first

-in-class, dual-acting agent being developed to improve cardiac function in patients with acute heart failure, or AHF, and cardiogenic shock with a potentially differentiated safety profile from existing treatments. Istaroxime demonstrated significant improvement in diastolic and systolic function in phase

clinical trials and has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or the FDA. Our lead pulmonary product candidate is AEROSURF (lucinactant for inhalation), a novel drug/medical device combination for non-invasive delivery of our proprietary aerosolized

KL4

surfactant, using our proprietary Aerosol Delivery System, or ADS, technology for the treatment of respiratory distress syndrome, or RDS, in premature infants. AEROSURF has been granted Fast Track designation by the FDA for the treatment of RDS. We are also developing plans to conduct a small pilot study of our proprietary

KL4

surfactant for treatment of lung injury resulting from severe novel coronavirus, or SARS-CoV-

the causative agent in COVID-

19,

or COVID-

19,

infections, if we are able to secure the required regulatory approvals necessary to initiate the study. Our other drug product candidates include rostafuroxin, a novel medicine for the treatment of hypertension, in patients with a specific genetic profile. We also have a number of pipeline preclinical product candidates that we are evaluating for progression into clinical development. We are evaluating and pursuing a number of early exploratory research programs to identify potential product candidates, including oral and intravenous SERCA

heart failure compounds and other product candidates utilizing our

KL4

surfactant and ADS technologies.

December 2018,

we acquired CVie Investments Limited, or CVie Investments, an exempted company with limited liability incorporated under the laws of the Cayman Islands, which we refer to herein as the CVie Acquisition. Since the CVie Acquisition, we have operated CVie Investments, and its wholly-owned subsidiary, CVie Therapeutics, a Taiwan corporation organized under the laws of the People's Republic of China, as a subsidiary focused on the development of drug product candidates for cardiovascular diseases.

May 2020,

upon completing a public financing and meeting listing requirements for The Nasdaq Stock Market LLC, our common stock began trading on the Nasdaq Capital Market.

The reader is referred to, and encouraged to read in its entirety, “Item

– Business” in our Annual Report on Form

-K for the year ended

December 31, 2019

that we filed with the Securities and Exchange Commission, or the SEC, on

April 3, 2020,

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

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Basis of Accounting [Text Block]

Note

–

Basis of Presentation

These interim unaudited condensed consolidated financial statements have been 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

-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. When necessary, prior year's condensed consolidated financial statements have been reclassified to conform to the current year presentation. Operating results for the

three

and

six

months ended

June 30, 2020

are

not

necessarily indicative of the results that

may

be expected for the year ending

December 31, 2020.

There have been

changes to our significant accounting policies since

December 31, 2019.

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, 2019

contained in our Annual Report on Form

-K for the year ended

December 31, 2019.

The interim unaudited condensed consolidated financial statements reflect the

-for-

reverse split of our common stock that was approved by our Board of Directors and controlling stockholders and made effective on

April 29, 2020.

All share and per share information data herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Note 3 - Liquidity Risks and Management's Plans

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Liquidity Disclosures [Text Block]

Note

–

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 reliance on

third

party manufacturers.

We have incurred net losses since inception. Our net loss was

$9.6

million and

$6.4

million, respectively, for the

three

-month periods ended

June 30, 2020

and

2019.

Our net loss was

$16.1

million and

$13.0

million, respectively, for the

six

-month periods ended

June 30, 2020

and

2019.

We expect to continue to incur operating losses for at least the next several years. As of

June 30, 2020,

we had an accumulated deficit of

$701.2

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.

May 2020,

we received net proceeds of approximately

$20.2

million related to a public offering of

3,172,413

units, inclusive of

413,793

units related to a fully exercised over-allotment option, at a price per unit of

$7.25.

Each unit consisted of

one

share of our common stock and a warrant to purchase

one

share of common stock, or the Warrant. The Warrants are immediately exercisable for shares of common stock at a price of

$7.975

per share and expire

five

years from the date of issuance.

March 2020,

we entered into a binding term sheet, or the Term Sheet, with Lee's Pharmaceutical (HK) Ltd., or Lee's (HK), pursuant to which Lee's (HK) will provide financing for the development of AEROSURF and in

August 2020,

we entered into a Project Financing Agreement with Lee's (HK), or the PF Agreement. In

April 2020,

we received the

first

non-refundable payment of

$1.0

million. In

August 2020,

we received the

second

non-refundable payment of

$1.4

million. The

third

non-refundable payment of

$0.4

million is due by

September 15, 2020.

In addition, Lee's (HK) will pay additional amounts to be set forth in an updated development budget to be agreed between the parties by

September 1, 2020

and updated every

six

months thereafter, to fund the continued development of AEROSURF and to be paid with the payment schedule to be set forth in each updated development budget. The timing of the receipt of these financing payments by Lee's (HK)

may

have an impact on the timing, progression and development of our AEROSURF programs. If Lee's (HK) subsequently terminates the PF Agreement, our Board of Directors has approved a plan to suspend or terminate AEROSURF development until such time as we are able to secure the capital required to fund the program.

We believe that our cash and cash equivalents as of the filing of our Quarterly Report on Form

-Q for the quarterly period ended

June 30, 2020

are sufficient to fund operations through at least the next

twelve

months. In the future, we will need to raise additional capital to continue funding our 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, however, 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

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-

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

6 Months Ended

Jun. 30, 2020

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, 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. The following table represents identifiable intangible assets as of

June 30, 2020

and

December 31, 2019:

(in thousands)	Carrying Value

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

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 its carrying value

may

be impaired.

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 income (expense), net. Foreign currency transactions resulted in losses of approximately

$0.5

million and gains of approximately

$0.1

million for the

three

-month periods ended

June 30, 2020

and

2019.

Foreign currency transactions resulted in losses of approximately

$0.3

million and gains of approximately

$0.3

million for the

six

-month periods ended

June 30, 2020

and

2019.

Use of Estimates

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Cash and Cash Equivalents

Cash and cash equivalents are held at domestic and foreign financial institutions and consist of liquid investments, money market funds, and U.S. Treasury notes with a maturity from date of purchase of

days or less that are readily convertible into cash.

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 Exchange and Termination Agreement, between ourselves and affiliates of Deerfield Management Company L.P., or Deerfield. The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are

not

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

Research and Development

We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic

730,

Research and Development

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

June 30, 2020

and

2019,

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

9.7

million and

5.2

million shares, respectively. For the

three

and

six

months ended

June 30, 2020

and

2019,

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

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.

COVID-

We are subject to risks and uncertainties as a result of the COVID-

pandemic. As of the date of issuance of these interim unaudited condensed consolidated financial statements, our operations, capital and financial resources and overall liquidity position and outlook have

not

been materially impacted by COVID-

while our operations have experienced some delays in clinical study initiation and early productivity. The full extent, duration, or full 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, including new information that

may

emerge concerning the severity of the COVID-

outbreak, including any regional outbreaks in

one

or more markets where 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 strategic re-implementation of mitigating COVID-

measures in

one

or more markets where our 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 the

third

quarter of

2020

and beyond.

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. Actual results

may

differ from these estimates under different assumptions or conditions and such differences

may

be material.

Recently Issued Accounting Standards

Recent Accounting Pronouncements

December 2019,

the FASB issued ASU

2019

12,

Income Taxes

(Topic

740

): Simplifying the Accounting for Income Taxes

, or ASU

2019

12.

ASU

2019

simplifies the accounting for income taxes by removing exceptions within the general principles of Topic

740

regarding the calculation of deferred tax liabilities, the incremental approach for intra-period tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax). which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU is effective for fiscal years beginning after

December 15, 2020

and will be applied either retrospectively or prospectively based upon the applicable amendments. Early adoption is permitted. We are still evaluating the impact this standard will have on our consolidated financial statements and related disclosures, but do

not

believe there will be a material impact upon adoption.

Note 5 - Fair Value of Financial Instruments

6 Months Ended

Jun. 30, 2020

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
	June 30,
(in thousands)	2020		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	5,355	$	5,355	$	-	$	-
U.S. Treasury notes		25,243		25,243		-		-
Total Assets	$	30,598	$	30,598	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2019		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	1,819	$	1,819	$	-	$	-
U.S. Treasury notes		18,230		18,230		-		-
Total Assets	$	20,049	$	20,049	$	-	$	-

- 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 - Collaboration and Device Development Payable

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

Note

–

Collaboration and Device Development Payable

Restructuring of the Battelle Payables

March 2020,

we entered into the

first

amendment to the

December 2018

payment restructuring agreement, or the Amendment, with Battelle Memorial Institute, or Battelle, in which we agreed to amend the payment terms of

two

milestone payments previously due

later than

January 2020.

Under the Amendment, we agreed that (i) the

first

milestone payment would continue to be due upon enrollment of the

first

patient in the next AEROSURF clinical study but

later than

April 15, 2020;

and, (ii) the

second

milestone payment would continue to be due upon completion of technology transfer of our device manufacturing process for the phase

ADS to our new medical device manufacturer but

later than

September 1, 2020.

The Amendment is treated as a debt modification and, in accordance with debt modification accounting,

gain or loss was recognized.

April 2020,

we made the

first

milestone payment of

$0.8

million to Battelle and announced enrollment of the

first

patient into the AEROSURF phase

bridging study. As of

June 30, 2020,

the remaining liability of

$0.8

million is included in the balance of collaboration and device development payable, net.

Note 7 - Loans Payable

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Short-term Debt [Text Block]

Note

–

Loans Payable

Assumption of bank debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$4.5

million in a bank credit facility.

September 2016,

CVie Therapeutics Limited entered into a

-month revolving credit facility of approximately

$2.9

million with O-Bank Co., Ltd., or O-Bank, to finance operating activities, or the O-Bank Facility. The O-Bank Facility was later renewed and increased to approximately

$5.8

million in

September 2017.

The O-Bank Facility was guaranteed by Lee's Pharmaceutical Holdings Limited, or Lee's, which pledged bank deposits in the amount of

110%

of the actual borrowing amount. The guaranty was part of the O-Bank Facility; however, we do

not

have a written commitment from Lee's to maintain the collateral. Interest, payable in cash on a monthly basis, is determined based on the

-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.

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

-month non-revolving.

As of

June 30, 2020

and

December 31, 2019,

the outstanding principal of the O-Bank Facility was approximately

$4.7

million and

$4.6

million, respectively. 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.

The

$4.7

million outstanding under the facility has been classified as a current liability on the balance sheet as of

June 30, 2020

given the uncertainty of Lee's commitment to maintain the required collateral.

Loan payable to Bank Direct Capital Finance

May 2019,

we entered into an insurance premium financing and security agreement with Bank Direct Capital Finance, or Bank Direct. Under the agreement, we financed

$0.7

million of certain premiums at a

5.35%

annual interest rate. As of

December 31, 2019,

the outstanding principal of the loan was

$0.2

million. The balance of the loan was repaid during the quarter ended

March 31, 2020.

June 2020,

we entered into an insurance premium financing and security agreement with 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

are due monthly from

July 2020

through

March 2021.

As of

June 30, 2020,

the outstanding principal of the loan was

$1.1

million.

Note 8 - Restructured Debt Liability

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Long-term Debt [Text Block]

Note

–

Restructured Debt Liability

November 1, 2017,

we and Deerfield entered into an Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P., or 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

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

- Accounting Policies and Recent Accounting Pronouncements). 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

June 30, 2020

and

December 31, 2019,

the restructured debt liability balance was

$15.0

million.

Note 9 - Stockholders' Equity

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note

–

Stockholders' Equity

Warrant Amendments

April 24, 2020,

we and each of the holders of our Series F Warrants dated as of

December 24, 2018,

or the Series F Warrants, entered into Amendment

No.

to the Series F Warrant to Purchase Common Stock whereby the expiration date of the Series F Warrants was extended from

June 24, 2020

December 24, 2020

in consideration for the holders agreeing to be bound by a lock-up provision with respect to any shares of our common stock or securities convertible, exchangeable or exercisable into shares of our common stock that are beneficially owned, held or acquired by the holders. The lock-up provision provides that the holders will

not

offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of any shares of our common stock or securities convertible, exchangeable or exercisable into shares of our common stock that are beneficially owned, held or acquired by the holders for a period of

days following the earlier of (i) the closing date of our next public offering of securities, or (ii)

December 24, 2020.

The lock-up provision commenced on

May 22, 2020

upon closing of the public offering discussed below.

May 6, 2020,

we and certain holders of our Series I Warrants dated as of

December 6, 2019,

or the Series I Warrants, entered into Amendment

No.

to the Series I Warrant to Purchase Common Stock pursuant to which the exercise price of the Series I Warrants was amended from

$12.09

$9.67

if the Series I Warrants are exercised, in whole or in part, prior to

December 5, 2021.

In addition, the certain holders of the Series I Warrants agreed to be bound by a lockup provision with respect to any shares of our common stock or securities convertible, exchangeable or exercisable into shares of our common stock that are beneficially owned, held or acquired by such holders for a period of

days following the earlier of (i) the closing date of our next public offering of securities, or (ii)

December 24, 2020.

During the lock-up period, the certain holders of the Series I Warrants will

not

May 22, 2020

upon closing of the public offering discussed below.

While there is

specific guidance that addresses the modification of an equity-classified contract, such as the amendments to the Series F Warrants and the Series I Warrants, it is the practice to determine the accounting for such modifications based on analogy to the share-based compensation guidance. The model for a modified share-based payment award that is classified as equity and remains classified in equity after the modification is addressed in ASC

718

20,

Compensation – Stock Compensation

, or ASC

718

20.

Pursuant to that guidance, the incremental fair value from the modification (the change in the fair value of the instrument before and after the modification) is recognized as an expense in the income statement to the extent the modified instrument has a higher fair value.

For the Series F Warrants, the amendment to the terms related to a

six

-month extension of the expiration date and the incremental fair value from the modification was determined by comparing the Black Scholes value before and after the modification. The amendment to the Series I Warrants related to a reduced exercise price for an

-month period and the reversion after that period to the initial exercise price. As a result, the incremental fair value was determined by comparing the Black Scholes value before the modification to a Monte Carlo valuation after the modification.

We have determined, based on the guidance in ASC

718

and our valuation of the Series F Warrants and the Series I Warrants, that the incremental fair value resulting from the modifications is

$1.1

million, which was recorded as an increase to equity, with a corresponding expense recognized in the interim unaudited condensed consolidated statement of operations as other expense.

May 2020

Public Offering

May 20, 2020,

we entered into an underwriting agreement, or the Underwriting Agreement, with Ladenburg Thalmann & Co. Inc., as representative for the several underwriters named therein, or collectively, the Underwriters, relating to the public offering of an aggregate of

2,758,620

units, or the Offering, with each unit consisting of

one

share of our common stock and a Warrant. The Warrants are immediately exercisable for shares of common stock at a price of

$7.975

per share and expire

five

years from the date of issuance. The shares of common stock and the Warrants were immediately separable and were issued separately in the offering.

In addition, we granted the Underwriters a

-day option, or the Overallotment Option, to purchase up to

413,793

additional shares of common stock and/or Warrants to purchase up to

413,793

additional shares of common stock, which such Overallotment Option was exercised in full.

The closing of the Offering occurred on

May 22, 2020,

inclusive of the Overallotment Option. The offering price to the public was

$7.25

per unit. After deducting underwriting discounts and commissions and offering expenses of

$2.8

million payable by us, and excluding the proceeds, if any, from the exercise of the Warrants issued pursuant to this Offering, the net proceeds to the Company were approximately

$20.2

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 Warrants issued in the Offering as equity. We have also determined that the 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

74,

nor are there any material embedded derivatives that require separate accounting. We allocated the net proceeds from the Offering based on the relative fair value of the common stock and the Warrants.

Note 10 - Stock Options and Stock-based Employee Compensation

6 Months Ended

Jun. 30, 2020

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 plan 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, 2020		1,772		$	17.61
Granted		5			9.74
Forfeited or expired		(15	)		38.12
Outstanding at June 30, 2020		1,762		$	17.41		8.5

Vested and exercisable at June 30, 2020		645		$	25.72		8.4

Vested and expected to vest at June 30, 2020		1,696		$	17.37		8.5

As of

June 30, 2020,

there were

35,000

unvested restricted stock units. There was

activity with respect to restricted stock units during the

six

months ended

June 30, 2020.

The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula based on the following weighted average assumptions:

	Six Months Ended June 30,
	2020	2019

Weighted average expected volatility	98%	95%
Weighted average expected term (in years)	6.0	6.6
Weighted average risk-free interest rate	2.60%	2.60%
Expected dividends	-	-

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 June 30,				Six Months Ended June 30,
(in thousands)	2020		2019		2020		2019

Research and development	$	596	$	550	$	1,310	$	1,039
General and administrative		970		1,189		1,945		2,230
Total	$	1,566	$	1,739	$	3,255	$	3,269

Note 11 - Collaboration, Licensing and Research Funding Agreements

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

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

Note

–

Collaboration, Licensing and Research Funding Agreements

March 2020,

we entered into the Term Sheet with Lee's (HK), pursuant to which Lee's (HK) will provide financing for the development of AEROSURF and in

August 2020,

we entered into the PF Agreement with Lee's (HK). In

April 2020,

we received the

first

non-refundable payment of

$1.0

million. In

August 2020,

we received the

second

non-refundable payment of

$1.4

million. The

third

non-refundable payment of

$0.4

million is due by

September 15, 2020.

In addition, Lee's (HK) will pay additional amounts to be set forth in an updated development budget to be agreed between the parties by

September 1, 2020

and updated every

six

may

The PF Agreement also provides that, 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 License, Development and Commercialization Agreement between us and Lee's (HK) dated as of

June 12, 2017,

as amended, or the 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).

We retain the right to develop and commercialize AEROSURF, Surfaxin, Surfaxin LS and any

KL4

Surfactant-containing product as a mono-substance or combination with any other active ingredient, or collectively, the Products, outside of the Licensed Territory (as defined in the License Agreement, which includes China, Japan, Hong Kong, South Korea, Thailand and other countries), including, without limitation, determining marketing and regulatory strategies for the approval to use and commercialize the Products. Pursuant to the PF Agreement, we will be responsible for all costs and expenses incurred by us in connection with the development and commercialization of the Products outside of the Licensed Territory.

Either party

may

terminate the PF Agreement for any material breach by the other party that is

not

cured within certain specified time periods.

We have determined that the Term Sheet is within the scope of ASC

730

20,

Research and Development Arrangements

, or ASC

730

20.

We concluded that there has

not

been a substantive and genuine transfer of risk related to the Term Sheet as there is a presumption that we are obligated to repay Lee's (HK) based on the significant related party relationship that exists at the time the parties entered into the Term Sheet, including Lee's (HK)'s approximate

29%

ownership of the outstanding shares of our common stock.

We have determined that the appropriate accounting treatment under ASC

730

is to record the proceeds received from Lee's (HK) as cash and cash equivalents, as we have the ability to direct the usage of funds, and a long-term liability on our condensed consolidated balance sheet when received. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the

KL4/AEROSURF

patent portfolio, as defined in the Term Sheet, or through the reduction of future milestone payments or royalties payable by Lee's (HK) to us under the existing License Agreement, as amended by the Term Sheet.

We have also determined that the Term Sheet is

not

in its entirety a derivative under the scope of ASC

815,

due to the scope exception under ASC

815

59,

nor are there any embedded derivatives that require separate accounting.

As of

June 30, 2020,

the liability balance related to the non-refundable payment was

$1.0

million and is recorded in other liabilities.

Note 12 - Subsequent Events

6 Months Ended

Jun. 30, 2020

Notes to Financial Statements

Subsequent Events [Text Block]

Note

–

Subsequent Events

O-Bank Facility Debt Repayment

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.

Executive Severance

July 2020,

John A. Tattory and the Company mutually agreed that he would cease serving as our Senior Vice President and Chief Financial Officer effective

July 20, 2020.

Also in

July 2020,

Kathryn Cole and the Company mutually agreed that she would cease serving as our Senior Vice President, Human Resources effective

July 20, 2020.

In connection with these departures, Mr. Tattory and Ms. Cole each entered into a separation agreement with the Company, which provide that the former employee will be 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,

or the Severance Period and (ii) a pro rata bonus, or the 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.

If at the time the Pro Rata Bonus is paid Mr. Tattory is employed or providing services on a full-time basis as a chief financial officer or principal financial officer of any entity, the Pro Rata Bonus shall

not

be paid to Mr. Tattory. The severance amount related the departure of Mr. Tattory and Ms. Cole is approximately

$0.9

million and will be paid ratably through

August 2021.

AEROSURF Project Financing Agreement

August 2020,

we and Lee's (HK) entered into the PF Agreement dated and effective as of

August 12, 2020,

formalizing the terms of the Term Sheet. Refer to Note

– Collaboration, Licensing and Research Funding Agreements for further discussion of the PF Agreement.

Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2020

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. The following table represents identifiable intangible assets as of

June 30, 2020

and

December 31, 2019:

(in thousands)	Carrying Value

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

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 its carrying value

may

be impaired.

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

$0.5

million and gains of approximately

$0.1

million for the

three

-month periods ended

June 30, 2020

and

2019.

Foreign currency transactions resulted in losses of approximately

$0.3

million and gains of approximately

$0.3

million for the

six

-month periods ended

June 30, 2020

and

2019.

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.

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

730,

Research and Development

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

June 30, 2020

and

2019,

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

9.7

million and

5.2

million shares, respectively. For the

three

and

six

months ended

June 30, 2020

and

2019,

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

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.

Effect of COVID-19 Pandemic [Policy Text Block]

COVID-

We are subject to risks and uncertainties as a result of the COVID-

not

been materially impacted by COVID-

while our operations have experienced some delays in clinical study initiation and early productivity. The full extent, duration, or full impact that the COVID-

may

emerge concerning the severity of the COVID-

outbreak, including any regional outbreaks in

one

or more markets where 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

measures in

one

may

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

third

quarter of

2020

and beyond.

We are

not

may

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

may

differ from these estimates under different assumptions or conditions and such differences

may

be material.

New Accounting Pronouncements, Policy [Policy Text Block]

Recently Issued Accounting Standards

Recent Accounting Pronouncements

December 2019,

the FASB issued ASU

2019

12,

Income Taxes

(Topic

740

): Simplifying the Accounting for Income Taxes

, or ASU

2019

12.

ASU

2019

simplifies the accounting for income taxes by removing exceptions within the general principles of Topic

740

December 15, 2020

not

believe there will be a material impact upon adoption.

Note 4 - Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2020

Notes Tables

Schedule of Indefinite-Lived Intangible Assets [Table Text Block]

(in thousands)	Carrying Value

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

Note 5 - Fair Value of Financial Instruments (Tables)

6 Months Ended

Jun. 30, 2020

Notes Tables

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

	Fair Value		Fair value measurement using
	June 30,
(in thousands)	2020		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	5,355	$	5,355	$	-	$	-
U.S. Treasury notes		25,243		25,243		-		-
Total Assets	$	30,598	$	30,598	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2019		Level 1		Level 2		Level 3

Cash equivalents:
Money market funds	$	1,819	$	1,819	$	-	$	-
U.S. Treasury notes		18,230		18,230		-		-
Total Assets	$	20,049	$	20,049	$	-	$	-

Note 10 - Stock Options and Stock-based Employee Compensation (Tables)

6 Months Ended

Jun. 30, 2020

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, 2020		1,772		$	17.61
Granted		5			9.74
Forfeited or expired		(15	)		38.12
Outstanding at June 30, 2020		1,762		$	17.41		8.5

Vested and exercisable at June 30, 2020		645		$	25.72		8.4

Vested and expected to vest at June 30, 2020		1,696		$	17.37		8.5

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

	Six Months Ended June 30,
	2020	2019

Weighted average expected volatility	98%	95%
Weighted average expected term (in years)	6.0	6.6
Weighted average risk-free interest rate	2.60%	2.60%
Expected dividends	-	-

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

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2020		2019		2020		2019

Research and development	$	596	$	550	$	1,310	$	1,039
General and administrative		970		1,189		1,945		2,230
Total	$	1,566	$	1,739	$	3,255	$	3,269

Note 2 - Basis of Presentation (Details Textual)	Apr. 29, 2020
Reverse Stock Split [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	3

Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands			1 Months Ended		3 Months Ended				6 Months Ended
	Sep. 01, 2020	May 22, 2020	Aug. 31, 2020	Apr. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Jun. 30, 2019	Mar. 31, 2019	Jun. 30, 2020	Jun. 30, 2019	Dec. 31, 2019
Net Income (Loss) Attributable to Parent, Total					$ (9,558)	$ (6,534)	$ (6,437)	$ (6,537)	$ (16,092)	$ (12,974)
Retained Earnings (Accumulated Deficit), Ending Balance					$ (701,214)				$ (701,214)		$ (685,122)
Proceeds from Issuance or Sale of Equity, Total		$ 20,200
Equity Issued During Period, Units, New Issues (in shares)		3,172,413
Units Issued, Price Per Unit (in dollars per share)		$ 7.25
Units, Number of Securities Called by Each Unit (in shares)		1
AEROSURF Funding Term Sheet [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Nonrefundable Payments, Tranche One				$ 1,000
AEROSURF Funding Term Sheet [Member] \| Lee’s Pharmaceutical Holdings Limited [Member] \| Forecast [Member]
Nonrefundable Payments, Tranche Two			$ 1,400
Nonrefundable Payments, Tranche Three	$ 400
Warrants Issued in Units [Member]
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)		1
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 7.975
Warrants and Rights Outstanding, Term (Year)		5 years
Over-Allotment Option [Member]
Equity Issued During Period, Units, New Issues (in shares)		413,793
Units Issued, Price Per Unit (in dollars per share)		$ 7.25

Note 4 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands, shares in Millions	3 Months Ended		6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019	Dec. 31, 2019	Nov. 01, 2017
Foreign Currency Transaction Gain (Loss), before Tax, Total	$ (500)	$ 100	$ (300)	$ 300
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000		$ 15,000		$ 15,000
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares)			9.7	5.2
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent						$ 15,000

Note 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2020	Dec. 31, 2019
Indefinite intangible asset	$ 77,090	$ 77,090
Istaroxime Drug Candidate [Member]
Indefinite intangible asset	22,340
Rostafuroxin Drug Candidate [Member]
Indefinite intangible asset	$ 54,750

Note 5 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Jun. 30, 2020	Dec. 31, 2019
Total Assets	$ 30,598	$ 20,049
Fair Value, Inputs, Level 1 [Member]
Total Assets	30,598	20,049
Fair Value, Inputs, Level 2 [Member]
Total Assets
Fair Value, Inputs, Level 3 [Member]
Total Assets
Money Market Funds [Member]
Cash equivalents	5,355	1,819
Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	5,355	1,819
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	25,243	18,230
US Treasury Securities [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	25,243	18,230
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 - Collaboration and Device Development Payable (Details Textual) - USD ($) $ in Millions	1 Months Ended
	Apr. 30, 2020	Jun. 30, 2020
Payments for Collaboration and Device Development Payable	$ 0.8
Contractual Obligation, Total		$ 0.8

Note 7 - Loans Payable (Details Textual) - USD ($)		1 Months Ended			3 Months Ended
Note 7 - Loans Payable (Details Textual) - USD ($)	Mar. 20, 2020	Aug. 31, 2020	Jun. 30, 2020	Sep. 30, 2017	Jun. 30, 2020	Dec. 31, 2019	May 30, 2019	Dec. 21, 2018	Sep. 30, 2016
Loans Payable, Current, Total			$ 5,714,000		$ 5,714,000	$ 161,000
Loan payable to Bank Direct Capital Finance [Member]
Loans Payable to Bank, Total						200,000
Loan payable to Bank Direct Capital Finance [Member] \| Loans Payable [Member]
Debt Instrument, Face Amount			$ 1,100,000		$ 1,100,000		$ 700,000
Debt Instrument, Interest Rate, Stated Percentage			4.26%		4.26%		5.35%
Loans Payable to Bank, Total			$ 1,100,000		$ 1,100,000
Debt Instrument, Periodic Payment, Total			117,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Percent of Pledged Deposits Required				110.00%
Loans Payable, Current, Total			$ 4,700,000		$ 4,700,000
Loans Payable, Total						$ 4,600,000
Line of Credit Facility, Percent of Pledged Deposits Increase (Decrease)					(50.00%)
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| Subsequent Event [Member]
Repayments of Lines of Credit		$ 2,300,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate				0.91%
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| CVie Investments [Member]
Line of Credit Facility, Maximum Borrowing Capacity				$ 5,800,000					$ 2,900,000
O-Bank Co., Ltd. [Member] \| Nonrevolving Credit Facility [Member]
Line of Credit Facility, Maximum Borrowing Capacity	$ 5,000,000
Debt Instrument, Term (Month)	2 years
O-Bank Co., Ltd. [Member] \| Nonrevolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate	1.17%
CVie Investments [Member] \| O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total								$ 4,500,000

Note 8 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		6 Months Ended
	Nov. 01, 2017	Jun. 30, 2020	Jun. 30, 2019	Dec. 31, 2019
Repayments of Long-term Debt, Total		$ 547
Liability for Contingent Milestone Payment, Noncurrent		15,000		$ 15,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Extinguishment of Debt, Amount	$ 25,000
Class of Warrant or Right, Number of Warrants Cancelled (in shares)	8,333
Class of Warrant or Right, Exercise Price of Cancelled Warrants (in dollars per share)	$ 2,360.40
Repayments of Long-term Debt, Total	$ 2,500
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations (in shares)	23,703
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding	2.00%
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000	$ 15,000		$ 15,000

Note 9 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		6 Months Ended
	May 22, 2020	Jun. 30, 2020	Jun. 30, 2019	May 06, 2020	Dec. 06, 2019
Fair Value Adjustment of Warrants		$ 1,112
Equity Issued During Period, Units, New Issues (in shares)	3,172,413
Units, Number of Securities Called by Each Unit (in shares)	1
Units Issued, Price Per Unit (in dollars per share)	$ 7.25
Payments of Stock Issuance Costs	$ 2,800
Proceeds from Issuance or Sale of Equity, Total	$ 20,200
Public Offering [Member]
Equity Issued During Period, Units, New Issues (in shares)	2,758,620
Over-Allotment Option [Member]
Equity Issued During Period, Units, New Issues (in shares)	413,793
Units Issued, Price Per Unit (in dollars per share)	$ 7.25
Series I Warrants Issued with Offering [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)				$ 9.67	$ 12.09
Series I and F Warrants Issued with Offering [Member]
Fair Value Adjustment of Warrants		$ 1,100
Warrants Issued in Units [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 7.975
Warrants and Rights Outstanding, Term (Year)	5 years
Over Allotment Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	413,793

Note 10 - Stock Options and Stock-based Employee Compensation (Details Textual)	6 Months Ended
	Jun. 30, 2020 shares
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Ending Balance (in shares)	35,000
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 10 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	6 Months Ended
	Jun. 30, 2020 $ / shares shares
Shares Outstanding, Beginning Balance (in shares) \| shares	1,772
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) \| $ / shares	$ 17.61
Shares Granted (in shares) \| shares	5
Weighted Average Exercise Price, Granted (in dollars per share) \| $ / shares	$ 9.74
Shares Forfeited or Expired (in shares) \| shares	(15)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) \| $ / shares	$ 38.12
Shares Outstanding, Ending Balance (in shares) \| shares	1,762
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) \| $ / shares	$ 17.41
Weighted Average Remaining Contractual Life, Outstanding (Year)	8 years 182 days
Shares Vested and Exercisable (in shares) \| shares	645
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) \| $ / shares	$ 25.72
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	8 years 146 days
Vested and expected to vest (in shares) \| shares	1,696
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) \| $ / shares	$ 17.37
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	8 years 182 days

Note 10 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019
Weighted average expected volatility	98.00%	95.00%
Weighted average expected term (Year)	6 years	6 years 219 days
Weighted average risk-free interest rate	2.60%	2.60%
Expected dividends

Note 10 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Stock-based compensation expense	$ 1,566	$ 1,739	$ 3,255	$ 3,269
Research and Development Expense [Member]
Stock-based compensation expense	596	550	1,310	1,039
General and Administrative Expense [Member]
Stock-based compensation expense	$ 970	$ 1,189	$ 1,945	$ 2,230

Note 11 - Collaboration, Licensing and Research Funding Agreements (Details Textual) - USD ($) $ in Millions		1 Months Ended
	Sep. 01, 2020	Aug. 31, 2020	Apr. 30, 2020	Jun. 30, 2020	Mar. 18, 2020
Contractual Obligation, Total				$ 0.8
Lee’s Pharmaceutical Holdings Limited [Member] \| Windtree Therapeutics [Member]
Equity Method Investment, Ownership Percentage					29.00%
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%
Term Sheet With Lee [Member] \| Other Liabilities [Member]
Contractual Obligation, Total				$ 1.0
Term Sheet With Lee [Member] \| Forecast [Member]
Proceeds for Payments to Develop Product	$ 0.4	$ 1.4

Note 12 - Subsequent Events (Details Textual) - USD ($)		1 Months Ended	3 Months Ended
Note 12 - Subsequent Events (Details Textual) - USD ($)	Jul. 20, 2020	Aug. 31, 2020	Jun. 30, 2020
Subsequent Event [Member] \| John A. Tattory and Kathryn Cole [Member]
Severance Costs	$ 900,000
Revolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member]
Line of Credit Facility, Percent of Pledged Deposits Increase (Decrease)			(50.00%)
Revolving Credit Facility [Member] \| O-Bank Co., Ltd. [Member] \| Subsequent Event [Member]
Repayments of Lines of Credit		$ 2,300,000