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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 US (US GAAP) for interim financial information in accordance with the instructions to Form

-Q and include accounts of Windtree 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. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. When necessary, the prior year interim unaudited condensed consolidated financial statements have been reclassified to conform to the current year presentation. Operating results for the

three

and

nine

months ended

September 30, 2019

are

not

necessarily indicative of the results that

may

be expected for the year ending

December

31,

2019.

There have been

changes to our critical accounting policies since

December 31, 2018.

The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with annual audited financial statements and related notes as of and for the year ended

December 31, 2018

contained in our

2018

Form

-K and our Quarterly Reports on Form

-Q filed thereafter.

Note

–

Basis of Presentation

The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. When necessary, prior year’s consolidated financial statements have been reclassified to conform to the current year presentation.

Consolidated Balance Sheets - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Current Assets:
Cash and cash equivalents	$ 11,187,000	$ 1,815,000
Available-for-sale marketable securities	13,959,000
Prepaid expenses and other current assets	507,000	422,000
Total current assets	25,653,000	2,237,000
Property and equipment, net	802,000	885,000
Restricted cash	171,000	225,000
Indefinite intangible asset	77,090,000
Goodwill	15,682,000
Total assets	119,398,000	3,347,000
Current Liabilities:
Accounts payable	3,420,000	2,324,000
Collaboration and device development payable, net	2,576,000	4,418,000
Accrued Liabilities, Current, Total	6,465,000	4,134,000
Deferred revenue - current portion	198,000	884,000
Loan payable	7,974,000
Total current liabilities	20,633,000	11,760,000
Restructured debt liability - contingent milestone payments	15,000,000	15,000,000
Deferred revenue - non-current portion		407,000
Deferred tax liabilities	15,476,000
Other liabilities	175,000	100,000
Total liabilities	51,284,000	27,267,000
Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares and 2,701 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively	0	0
Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2018 and December 31, 2017; 32,133,263 and 3,227,495 shares issued at December 31, 2018 and December 31, 2017, respectively; 32,133,189 shares and 3,227,421 shares outstanding at December 31, 2018 and December 31, 2017, respectively	32,000	3,000
Additional paid-in capital	728,783,000	616,245,000
Accumulated deficit	(657,647,000)	(637,114,000)
Treasury stock (at cost); 74 shares	(3,054,000)	(3,054,000)
Total stockholders' equity	68,114,000	(23,920,000)
Total liabilities & stockholders' equity	$ 119,398,000	$ 3,347,000

Consolidated Statements of Changes in Stockholders' Equity - USD ($)	Private Placement [Member] Preferred Stock [Member]	Private Placement [Member] Additional Paid-in Capital [Member]	Private Placement [Member]	Share Purchase Agreement [Member] Common Stock [Member]	Share Purchase Agreement [Member] Additional Paid-in Capital [Member]	Share Purchase Agreement [Member]	Share Purchase Agreement, April 2018 [Member] Common Stock [Member]	Share Purchase Agreement, April 2018 [Member] Additional Paid-in Capital [Member]	Share Purchase Agreement, April 2018 [Member]	Share Purchase Agreement, December 2018 [Member] Common Stock [Member]	Share Purchase Agreement, December 2018 [Member] Additional Paid-in Capital [Member]	Share Purchase Agreement, December 2018 [Member]	Placement Agent [Member] Common Stock [Member]	Warrants in Connection with Equity Consideration in Debt Issuance [Member] Additional Paid-in Capital [Member]	Warrants in Connection with Equity Consideration in Debt Issuance [Member]	Warrants in Connection with Equity Consideration in Payable Restructuring [Member] Additional Paid-in Capital [Member]	Warrants in Connection with Equity Consideration in Payable Restructuring [Member]	Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Treasury Stock [Member]	Total
Balance (in shares) at Dec. 31, 2016																			436,000
Balance at Dec. 31, 2016																				$ 592,892,000	$ (618,668,000)	$ (3,054,000)	$ (28,830,000)
Net loss																					(18,446,000)		(18,446,000)
Issuance of stock (in shares)	7,000			2,312,000															42,000
Issuance of stock		$ 10,433,000	$ 10,433,000	$ 2,000	$ 9,969,000	$ 9,971,000														1,030,000			1,030,000
Preferred stock conversions (in shares)																		(4,000)	217,000
Preferred stock conversions																				(2,000)			(2,000)
Issuance of common stock, 401(k) plan employer match (in shares)																			7,000
Issuance of common stock, 401(k) plan employer match																				95,000			95,000
Issuance of common stock, equity consideration in debt restructuring (in shares)																			71,000
Issuance of common stock, equity consideration in debt restructuring																				267,000			267,000
Exercise of prefunded common stock warrants (in shares)																			142,000
Exercise of prefunded common stock warrants
Stock-based compensation expense																			$ 1,000	1,561,000			1,562,000
Stock-based compensation expense																							$ 1,600,000
Balance (in shares) at Dec. 31, 2017																		3,000	3,227,000				3,227,421
Balance at Dec. 31, 2017																			$ 3,000	616,245,000	(637,114,000)	$ (3,054,000)	$ (23,920,000)
Net loss																					(4,512,000)		(4,512,000)
Stock-based compensation expense																				418,000			418,000
Balance at Mar. 31, 2018																			$ 3,000	616,611,000	(641,626,000)	$ (3,054,000)	$ (28,066,000)
Balance (in shares) at Dec. 31, 2017																		3,000	3,227,000				3,227,421
Balance at Dec. 31, 2017																			$ 3,000	616,245,000	(637,114,000)	$ (3,054,000)	$ (23,920,000)
Net loss																							(11,491,000)
Balance at Sep. 30, 2018																			$ 4,000	620,322,000	(648,605,000)	$ (3,054,000)	$ (31,333,000)
Balance (in shares) at Dec. 31, 2017																		3,000	3,227,000				3,227,421
Balance at Dec. 31, 2017																			$ 3,000	616,245,000	(637,114,000)	$ (3,054,000)	$ (23,920,000)
Net loss																					(20,533,000)		(20,533,000)
Issuance of stock (in shares)							542,000			11,786,000			114,000
Issuance of stock							$ 1,000	$ 2,540,000	$ 2,541,000	$ 12,000	$ 41,101,000	$ 41,113,000
Preferred stock conversions (in shares)																		(3,000)	135,000
Preferred stock conversions
Issuance of common stock, CVie Acquisition (in shares)																			16,265,000
Issuance of common stock, CVie Acquisition																			$ 16,000	67,484,000			67,500,000
Vesting of restricted stock units (in shares)																			95,000
Vesting of restricted stock units
Withholding tax payments related to net share settlements of restricted stock units (in shares)																			(31,000)
Withholding tax payments related to net share settlements of restricted stock units																				(155,000)			(155,000)
Issuance of warrants														$ 417,000	$ 417,000	$ 196,000	$ 196,000
Stock-based compensation expense																				955,000			$ 955,000
Balance (in shares) at Dec. 31, 2018																			32,133,000				32,133,189
Balance at Dec. 31, 2018																			$ 32,000	728,783,000	(657,647,000)	$ (3,054,000)	$ 68,114,000
Balance at Mar. 31, 2018																			3,000	616,611,000	(641,626,000)	(3,054,000)	(28,066,000)
Net loss																					(3,052,000)		(3,052,000)
Issuance of stock (in shares)																			542,000
Issuance of stock																			$ 1,000	2,593,000			2,594,000
Stock-based compensation expense																				140,000			140,000
Balance at Jun. 30, 2018																			4,000	619,344,000	(644,678,000)	(3,054,000)	(28,384,000)
Net loss																					(3,927,000)		(3,927,000)
Issuance of warrants																				833,000			833,000
Stock-based compensation expense																				145,000			145,000
Balance at Sep. 30, 2018																			$ 4,000	620,322,000	(648,605,000)	$ (3,054,000)	(31,333,000)
Net loss																							$ (9,042,000)
Balance (in shares) at Dec. 31, 2018																			32,133,000				32,133,189
Balance at Dec. 31, 2018																			$ 32,000	728,783,000	(657,647,000)	$ (3,054,000)	$ 68,114,000
Net loss																					(6,537,000)		(6,537,000)
Vesting of restricted stock units (in shares)																			56,000
Vesting of restricted stock units
Withholding tax payments related to net share settlements of restricted stock units (in shares)
Withholding tax payments related to net share settlements of restricted stock units																				(151,000)			(151,000)
Stock-based compensation expense																				1,530,000			1,530,000
Balance at Mar. 31, 2019																			$ 32,000	730,162,000	(664,184,000)	$ (3,054,000)	$ 62,996,000
Balance (in shares) at Dec. 31, 2018																			32,133,000				32,133,189
Balance at Dec. 31, 2018																			$ 32,000	728,783,000	(657,647,000)	$ (3,054,000)	$ 68,114,000
Net loss																							$ (20,100,000)
Balance (in shares) at Sep. 30, 2019																							32,188,855
Balance at Sep. 30, 2019																			32,000	733,840,000	(677,747,000)	(3,054,000)	$ 53,071,000
Balance at Mar. 31, 2019																			32,000	730,162,000	(664,184,000)	(3,054,000)	62,996,000
Net loss																					(6,437,000)		(6,437,000)
Stock-based compensation expense																				1,739,000			1,739,000
Balance at Jun. 30, 2019																			32,000	731,901,000	(670,621,000)	(3,054,000)	58,270,000
Net loss																					(7,126,000)		(7,126,000)
Stock-based compensation expense																				1,939,000			$ 1,938,000
Balance (in shares) at Sep. 30, 2019																							32,188,855
Balance at Sep. 30, 2019																			$ 32,000	$ 733,840,000	$ (677,747,000)	$ (3,054,000)	$ 53,071,000

Note 9 - Collaboration and Device Development Payable (Tables)

12 Months Ended

Dec. 31, 2018

Series E Warrants [Member]

Schedule of Assumptions Used for Warrant Valution [Table Text Block]

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.70	%

Note 6 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended									9 Months Ended		12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
License [Member]
License revenue with affiliate		$ 304	$ 159	$ 356	$ 204	$ 102				$ 198	$ 719	$ 1,023	$ 102

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017	Feb. 15, 2017
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0	2,701
Preferred stock, shares outstanding (in shares)	0	0	2,701
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	120,000,000	120,000,000	120,000,000
Common stock, shares issued (in shares)	32,188,929	32,133,263	3,227,495
Common stock, shares outstanding (in shares)	32,188,855	32,133,189	3,227,421
Treasury stock, shares (in shares)	74	74	74

Note 3 - Business Combination - Warrant Valuation Assumptions (Details) - Warrants Issued for CVie Acquisition [Member]	Dec. 21, 2018
Measurement Input, Price Volatility [Member]
Measurement input	1.16
Measurement Input, Expected Term [Member]
Measurement input	2.5
Measurement Input, Risk Free Interest Rate [Member]
Measurement input	0.0262

Note 9 - Collaboration and Device Development Payable - Significant Input Assumptions of Warrant Valuation (Details) - Series E Warrants [Member]	Dec. 07, 2018
Measurement Input, Price Volatility [Member]
Measurement input	1.03
Measurement Input, Expected Term [Member]
Measurement input	5
Measurement Input, Risk Free Interest Rate [Member]
Measurement input	0.027

Note 6 - License Revenue with Affiliate (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Disaggregation of Revenue [Table Text Block]

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

License revenue with affiliate	$	-	$	159	$	198	$	719

	Year Ended December 31,
(in thousands)	2018		2017

License revenue with affiliate	$	1,023	$	102

Note 3 - Business Combination

12 Months Ended

Dec. 31, 2018

Business Combination Disclosure [Text Block]

Note

–

Business Combination

December 21, 2018 (

the Acquisition Date), we completed the acquisition of all the capital stock of CVie Investments Limited (CVie Investments), an exempted company with limited liability incorporated under the laws of the Cayman Islands, by issuing

16,256,060

shares of its common stock (CVie Acquisition). The preliminary purchase price for the CVie Acquisition was approximately

$67.5

million. We plan to operate CVie and its wholly-owned subsidiary, CVie Therapeutics Limited (CVie Therapeutics, and together with CVie Investments, CVie), a Taiwan corporation organized under the laws of the Republic of China and CVie Investments' operating company, as a business division focused on development of drug product candidates in cardiovascular diseases. The CVie Acquisition was undertaken as part of a strategic initiative to create stockholder value and resulted from a multi-year process focused on identifying strategic opportunities, including potential strategic alliances, collaborations (primarily outside the United States), joint development opportunities, acquisitions, technology licensing arrangements, as well as potential combinations (including by merger or acquisition) or other corporate transactions.

In connection with the CVie Acquisition, our board of directors declared a dividend to the holders of record of outstanding shares of common stock, and holders of certain warrants to purchase common stock, that were outstanding on

December 20, 2018

0.6148

Series H AEROSURF Warrant, for each share of common stock held by a shareholder or each warrant held by a warrant holder, as applicable, on the record date (AEROSURF Warrants). The AEROSURF Warrants are exercisable for an aggregate of

2,963,167

shares of common stock. Each AEROSURF Warrant has a term of

five

years and provides for automatic exercise into

one

share of common stock, without any exercise price, upon our public announcement of the dosing of the

first

human subject enrolled in our phase

clinical trial for AEROSURF. The AEROSURF Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s own Equity, and have been classified as equity. The

$12.5

million fair value at issuance of the AEROSURF Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants of

two

and a half years based on the expected date of the

first

human subject enrollment in our phase

clinical trial for AEROSURF, and the risk-free interest rate based on the average

two

-year and

three

-year treasury bill rate in effect at the measurement date.

Significant Input Assumptions of Warrant Valuation
Historical volatility	116	%
Expected term (in years)	2.5
Risk-free interest rate	2.62	%

On the Acquisition Date, we entered into an indemnification letter agreement (the Indemnification Letter Agreement) with Lee’s Pharmaceutical Holdings Limited (Lee’s), pursuant to which Lee’s agreed to indemnify the holders of issued and outstanding shares of common stock on

December 20, 2018 (

the Indemnitees) for any loss, liability, damage or expense, including reasonable attorney’s fees and expenses incurred by us in connection with or, as a result of, any material inaccuracy in any representation or warranty made by CVie in the Merger Agreement (notwithstanding that the representations and warranties made by CVie do

not

survive after the closing of the merger). To secure Lee’s performance of this indemnity obligation,

984,000

of the shares issued to Lee’s affiliate in the Merger are being placed in escrow with our transfer agent, Continental Stock Transfer & Trust Company for

one

year. A portion of the escrowed shares will be transferred to the Indemnitees as the sole and exclusive remedy for a successful indemnity claim.

The aggregate purchase price has been allocated based on the fair value of assets acquired and liabilities assumed as of the acquisition date. The excess of the

$67.5

million acquisition consideration over the acquired net assets was recorded as goodwill. The goodwill recorded is

not

deductible for tax purposes. The following table summarizes the initial allocation of the purchase price to the estimated fair value of the net assets acquired and liabilities assumed.

(in thousands)
Cash and cash equivalents	$	193
Restricted cash		31
Prepaid expenses and other current assets		387
Property and equipment, net		76
Intangible assets		77,090
Total identifiable assets acquired	$	77,777

Current liabilities	$	(2,590	)
Loan payable, current		(3,453	)
Loan payable, non current		(4,491	)
Deferred tax liabilities, noncurrent		(15,418	)
Other liabilities, noncurrent		(7	)
Net identifiable assets acquired		51,818
Goodwill		15,682
Net assets acquired	$	67,500

The acquired identifiable intangible assets consist of in-process research and development (“IPR&D”) of approximately

$77.1

million with an indefinite useful life.

See,

Note

for further discussion.

From the Acquisition Date to

December 31, 2018,

we recorded net loss from the CVie Acquisition of approximately

$0.5

million.

The following table presents unaudited consolidated pro forma results of operations based on our historical financial statements and adjusted for the acquisition of CVie as if it occurred on

January 1, 2017.

The unaudited pro forma amounts were prepared for comparative purposes only and are

not

indicative of what actual consolidated results of our operations would have been, nor are they indicative of the consolidated results of operations in the future.

	Year Ended December 31,
(in thousands, except per share data)	2018			2017

Pro forma net loss attributable to common shareholders	$	(38,082	)	$	(34,616	)
Pro forma EPS - basic and diluted	$	(1.20	)	$	(1.19	)

For the year ended

December 31, 2018,

net loss excludes the impact of transaction costs related to the CVie Acquisition. For the years ended

December 31, 2018

and

2017,

net loss excludes the impact of interest expense related to liabilities that were converted into common stock as part of the private placement.

Note 10 - Leases (Tables)

9 Months Ended

Sep. 30, 2019

Lease, Cost [Table Text Block]

	Three Months Ended September 30,			Nine Months Ended September 30,
(in thousands)	2019			2019

Operating lease cost	$	212		$	677
Variable lease cost		5			17
Total lease cost	$	217		$	694

Other Information
Operating cash flows used for operating leases	$	227		$	721
Operating lease liabilities arising from obtaining right-of-use assets	$	232		$	364
Weighted average remaining lease term (in years)		2.4			2.4
Weighted average incremental borrowing rate		9.00	%		9.00	%

Lessee, Operating Lease, Liability, Maturity [Table Text Block]

	As of September 30,
(in thousands)	2019

2019 (excluding the nine months ended September 30, 2019)	$	230
2020		849
2021		638
2022		179
2023		23
Thereafter		-
Total lease payments		1,919
Less imputed interest		(184	)
Total operating lease liabilities at September 30, 2019		1,735

Note 13 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Nov. 01, 2017	Dec. 31, 2018	Dec. 31, 2017	Sep. 30, 2019
Repayments of Long-term Debt, Total			$ 2,500
Liability for Contingent Milestone Payment, Noncurrent		15,000	15,000	$ 15,000
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 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	25,000
Class of Warrant or Right, Exercise Price of Cancelled Warrants	$ 786.80
Repayments of Long-term Debt, Total	$ 2,500
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations	71,111
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

Note 15 - Stock Options and Stock-based Employee Compensation - Stock Options and Restricted Stock Units (RSUs) Outstanding and Available for Future Issuance (Details) - shares shares in Thousands	Dec. 31, 2018	Dec. 31, 2017
2011 Plan (in shares)	4,568	273
The 2011 Long-term Incentive Plan [Member]
2011 Plan (in shares)	4,558	263
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant	1,453	1,623
Non-Plan [Member]
2011 Plan (in shares)	10	10

Note 12 - Convertible Note Payable (Details Textual)				9 Months Ended		12 Months Ended
Note 12 - Convertible Note Payable (Details Textual)	Dec. 27, 2018 USD ($) $ / shares	Jul. 23, 2018 USD ($)	Jul. 02, 2018 USD ($) $ / shares shares	Sep. 30, 2019 USD ($)	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)	Dec. 26, 2018 $ / shares
Proceeds from Convertible Debt					$ 1,500,000	$ 1,500,000
Repayments of Convertible Debt						1,500,000
Gain (Loss) on Extinguishment of Debt, Total						(3,345,000)
Panacea [Member] \| Secured Convertible Promissory Note [Member]
Debt Instrument, Face Amount			$ 1,500,000
Debt Instrument, Convertible, Conversion Price \| $ / shares	$ 4							$ 4
Debt Instrument, Convertible, Beneficial Conversion Feature			$ 400,000
Repayments of Convertible Debt	$ 1,500,000
Gain (Loss) on Extinguishment of Debt, Total	$ 400,000
Share Price \| $ / shares	$ 5.11
Debt Instrument, Convertible, Number of Equity Instruments	375,000
Panacea [Member] \| Series D Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares			187,500
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares			$ 4
Class of Warrant or Right, Vesting Period			180 days
Warrants and Rights Outstanding, Term			5 years
Common Stock Maximum Ownership Percentage For Warrant Exercise			9.99%
Panacea [Member] \| Series D Warrants [Member] \| Warrant [Member]
Derivative Liability, Total						400,000
Convertible Notes Payable [Member] \| Panacea [Member]
Debt Instrument, Face Amount			$ 1,500,000
Proceeds from Convertible Debt		$ 500,000	$ 1,000,000
Debt Instrument, Interest Rate, Stated Percentage			15.00%
Debt Instrument, Convertible, Conversion Price \| $ / shares			$ 4
Debt Instrument, Convertible, Beneficial Conversion Feature						$ 400,000

Note 9 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Weighted average expected volatility	95.00%	93.00%	79.00%
Weighted average expected term (Year)	6 years 219 days	7 years	6 years 219 days
Weighted average risk-free interest rate	2.60%	2.70%	2.20%
Expected dividends

Note 11 - Subsequent Event (Details Textual) - LPH II Loan [Member] - Subsequent Event [Member] - LPH II [Member] - USD ($) $ in Millions	Oct. 24, 2019	Oct. 28, 2019
Proceeds from Issuance of Debt	$ 1.0
Debt Instrument, Interest Rate, Effective Percentage		6.00%

Note 10 - Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2018

Schedule of Accrued Liabilities [Table Text Block]

	December 31,
(in thousands)	2018		2017

Professional fees	$	2,473	$	412
Research and development		2,361		1,778
Salaries, bonus & benefits		815		1,008
Manufacturing operations		212		537
Other		604		399
Total accrued expenses	$	6,465	$	4,134

Note 3 - Business Combination - Pro Forma Information (Details) - CVie Investments [Member] - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Pro forma net loss attributable to common shareholders	$ (38,082)	$ (34,616)
Pro forma EPS - basic and diluted (in dollars per share)	$ (1.20)	$ (1.19)

Note 12 - Convertible Note Payable

12 Months Ended

Dec. 31, 2018

Convertible Note Payable Disclosure [Text Block]

Note

–

Convertible Note Payable

July 2, 2018,

we issued to Panacea Venture Management Company Ltd. (Panacea) a Secured Convertible Promissory Note (the Note) with respect to a loan facility in the aggregate amount of up to

$1.5

million, which was funded in

two

loans of,

$1.0

million on the date of the Note and

$0.5

million on

July 23, 2018.

The Note had a maturity date of

December 31, 2018

and accrued interest at a rate of

15%

per annum until the Note was paid in full or converted into shares of our common stock at a price per share of

$4.00.

In addition, in lieu of converting the Note, Panacea could deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea, participated. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets.

In connection with the Note, we issued to Panacea warrants (the “Series D Warrants”) to purchase

187,500

shares (the “Warrant Shares”) at an exercise price of

$4.00

per Warrant Share (the “Exercise Price”). The Warrants

may

be exercised at any time beginning

six

months after the date of issuance and through the

fifth

anniversary of the date of issuance. The Warrants

may

not

be exercised to the extent that the holder would, following such exercise, beneficially own more than

9.99%

of our outstanding shares of common stock, which percentage

may

be increased, decreased or waived by such holder upon

sixty-one

days’ notice to us. The Warrants also contain customary provisions that adjust the Exercise Price and the number of Warrant Shares in the event of a corporate transaction.

We recorded the Note as current debt at its face value of

$1.5

million less debt discounts consisting of (i)

$0.4

million fair value of the warrants issued in connection with the Note and (ii) a

$0.4

million beneficial conversion feature related to an embedded conversion option that had an effective conversion price that was less than the fair value of the underlying stock at the commitment date. The discount is being accreted to the

$1.5

million loan over its term using the effective interest method. The Panacea Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s Own Equity

, and have been classified as equity.

The fair value at issuance of the Panacea Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants, and the risk-free interest rate based on the

five

-year treasury bill rate in effect at the measurement date.

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.75	%

The following amounts comprise the convertible note interest expense for the periods presented:

	Year Ended December 31,
(in thousands)	2018

Non-cash amortization of debt discounts	$	833
Cash interest expense		106
Total convertible note interest expense	$	939

Extinguishment of Panacea Convertible Promissory Note

December 27, 2018,

we repaid the Note in its entirety in cash of

$1.5

million. As part of the extinguishment of debt, we recorded a gain on extinguishment of debt of approximately

$0.4

million, relating to the reacquisition of the beneficial conversion option. The gain was calculated using the intrinsic value of the beneficial conversion option, which is the product of: (i) the difference between the common stock price on the date of extinguishment of

$5.11

and the conversion price of

$4.00,

and (ii)

375,000

shares convertible into common stock.

Note 11 - Subsequent Event

9 Months Ended

Sep. 30, 2019

Subsequent Events [Text Block]

Note

–

Subsequent Event

Effective as of

October 24, 2019,

we entered into a Loan Agreement (“Loan Agreement”) with LPH II. Under the Loan Agreement, LPH II agreed to lend us

$1.0

million (the “Loan”) to support our operations while we seek to complete a financing or Strategic Transaction (as defined in the Loan Agreement). The Loan, which was funded in a single installment on

October 28, 2019,

will accrue interest at a rate of

per annum and will mature upon the earlier of (i) the closing date for the Strategic Transaction on terms defined in the Loan Agreement, or (ii)

December 31, 2019.

If we are unable to complete the Strategic Transaction for any reason, based on our resources currently available to us, we likely will have insufficient resources to repay the Loan and

may

be forced to curtail some or all of our activities, and, ultimately,

may

be compelled to cease operations.

Note 3 - Business Combination (Details Textual) - CVie Investments [Member] $ in Millions	Dec. 31, 2018 USD ($)	Dec. 21, 2018 USD ($) shares
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares \| shares		16,256,060
Business Combination, Consideration Transferred, Total \| $		$ 67.5
Indemnification Agreement, Shares Placed in Escrow \| shares		984,000
Business Combination, Pro Forma Information, Earnings or Loss of Acquiree since Acquisition Date, Actual \| $	$ 0.5
In Process Research and Development [Member]
Indefinite-lived Intangible Assets Acquired \| $		$ 77.1
Warrants Issued for CVie Acquisition [Member]
Business Combination, Ratio of Warrants Received for Each Share of Common Stock and Certain Warrants		0.6148
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		2,963,167
Warrants and Rights Outstanding, Term		5 years
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right \| shares		1
Warrants and Rights Outstanding \| $		$ 12.5

Note 11 - Loan Payable

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Short-term Debt [Text Block]

Note

–

Loan

Payable

January 2018

and

March 2018,

LPH Investments Limited (LPH), an affiliate of Lee’s, agreed to lend us

$1.5

million and

$1.0

million, respectively, to support our AEROSURF development activities and sustain our operations while we sought to identify and advance

one

or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrued interest at a rate of

per annum and would mature upon the earlier of the closing date of the Funding Event or

December 31, 2018.

To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement dated

March 1, 2018 (

LPH Security Agreement). Effective

December 5, 2018,

LPH assigned all outstanding loans to us to LPH II Investment Limited (LPH II), a subsidiary of Lee's. In connection with the Private Placement Financing, we converted to equity

$6.0

million of the then outstanding loan payable obligations to LPH II on the same terms as those of the investors in the private placement. Included in the conversion were the

$1.5

million and

$1.0

million loans and following this conversion of the loans into equity securities, the security interest granted under the LPH Security Agreement was discharged.

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 due in

March 2020.

September 2016,

CVie entered into a

-month revolving credit facility of approximately

$2.9

million with O-Bank Co., Ltd. (O-Bank) to finance operating activities. The facility was later renewed and increased to approximately

$5.8

million in

September 2017.

The credit facility was guaranteed by Lee’s, which pledged bank deposits in the amount of

110%

of the actual borrowing amount. The guaranty was part of the 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

-day TAIBOR (the Taipei Interbank Offer Rate) plus

0.91%.

The credit facility expired on

September 11, 2019

and the loans mature

six

months after the expiration date, on

March 11, 2020.

We have initiated a process with O-Bank potentially to extend the maturity date of the facility into

2021.

As of

September 30, 2019,

the outstanding principal was approximately

$4.5

million.

Assumption of

Lee's

debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$3.5

million of debt payable to Lee’s Pharmaceutical International Limited (Lee’s International).

From

April 24, 2018

November 16, 2018,

CVie entered into

four

separate agreements to borrow an aggregate of approximately

$3.5

million from Lee’s International. The terms of the loan agreements are identical with interest, payable in cash upon maturity, at a rate of

per annum and maturing

one

year from the effective date of the respective loan agreement as follows:

$0.5

million in

April 2019;

$0.3

million in

September 2019;

$0.2

million in

October 2019;

and

$2.5

million in

November 2019.

Due to our current cash position, Lee’s recently agreed in principle to defer payment of these loans until we have adequate cash resources to satisfy the outstanding obligations or

later than

April 30, 2021.

During the quarter ended

March 31, 2019,

we made payments of

$0.45

million against the

April 2018

loan and paid the remaining

$50,000

balance plus accrued interest in

April 2019.

As of

September 30, 2019,

the outstanding principal of the loans with Lee’s International was

$3.0

million.

Loan payable to Bank Direct Capital Finance

May 2019,

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

$0.7

million of certain premiums at a

5.35%

annual interest rate. Payments of approximately

$80,000

are due monthly through

March 2020.

As of

September 30, 2019,

the outstanding principal of the loan was

$0.4

million.

Note

–

Loan Payable

January 2018

and

March 2018,

LPH Investments Limited (“LPH”), an affiliate of Lee’s, agreed to lend us

$1.5

million and

$1.0

million, respectively, to support our AEROSURF development activities and sustain our operations while we sought to identify and advance

one

or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrue interest at a rate of

per annum and mature upon the earlier of the closing date of the Funding Event or

December 31, 2018.

To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement with LPH dated

March 1, 2018 (

LPH Security Agreement).

During the

third

and

fourth

quarters of

2018,

LPH agreed to lend us funds to sustain our operations while we continued to work on a strategic transaction. The initial loan was funded on

August 14, 2018

in the amount of

$0.3

million, and subsequent loans on the following dates and in the following amounts:

August 29, 2018,

in the amount of

$0.48

million;

September 12, 2018

in the amount of

$0.5

million;

September 27, 2018

in the amount of

$0.5

million;

October 19, 2018

in the amount of

$0.43

million;

November 2, 2018

in the amount of

$0.5

million;

November 19, 2018

in the amount of

$0.35

million; and

December 5, 2018

in the amount of

$0.6

million. The loans accrued interest at a rate of

per annum and matured upon the earlier of (i) the closing date for the strategic transaction (as defined in the related loan agreements), provided that the we were able to raise a minimum of

$30

million in connection with such transaction, or (ii)

March 31, 2019.

In each case, we granted to LPH a security interest in substantially all of our assets pursuant to the terms of the LPH Security Agreement.

Extinguishment of Loan Payable

December 21, 2018,

as part of the Private Placement Financing, we converted

$6.0

million of existing loan payable obligations to LPH on the same terms as those of the Investors of the private placement. In connection with the conversion of Lee’s debt, we issued: (i)

1,810,938

shares of common stock based at

$3.3132

per share, (ii) Series F Warrants to purchase

307,859

shares of common stock, at an exercise price equal to

$3.68

per share, and (iii) Series G Warrants to purchase

597,610

shares common stock, at an exercise price equal to

$4.05

per share. The Series F Warrants are exercisable at any time after the date of issuance and through the

-month anniversary of the date of issuance and the Series G Warrants

may

be exercised through the

-year anniversary of the date of issuance.

The conversion of the loan payable to LPH is treated as an extinguishment of debt and does

not

represent a capital transaction as the Private Placement Financing included

third

-party investors and all investors received identical terms. We recorded a loss on extinguishment of debt approximately

$3.2

million. The loss was calculated as the difference between: (i) the aggregate fair value of approximately

$9.2

million, based on the fair value of the common stock and Warrants on

December 21, 2018,

and (ii) the carrying value of the debt liabilities of

$6.0

million.

The balance of the loan payable to LPH of

$160,000

was paid along with accrued interest of

$182,000

December 27, 2018.

Assumption of bank debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$4.5

million (or NTD

$138.0

million) in a bank credit facility due in

March 2020.

September 2016,

CVie entered into a

-month revolving credit facility of approximately

$2.9

million (or NTD

$90.0

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

$5.84

million (or NTD

$180.0

million) in

September 2017.

The credit facility was guaranteed by Lee’s, which pledged bank deposits in the amount of

110%

of the actual borrowing amount. The guaranty was part of the 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

-day TAIBOR (the Taipei Interbank Offer Rate) plus

0.91%.

The credit facility will expire on

September 11, 2019

and matures

six

months after the expiration date, on

March 11, 2020.

Although we reached an understanding with Lee’s that it would maintain the bank deposits securing its guaranty obligation under the credit facility, we do

not

have a written agreement with Lee’s requiring it to do so; therefore, the

$4.5

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

As of

December 31, 2018,

the outstanding principal was approximately

$4.5

million (or NTD

$138.0

million), due to exchange rate fluctuations.

Assumption of Lee’s debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$3.5

million (or NTD

$106.2

million) of debt payable to Lee’s Pharmaceutical International Limited (Lee’s International).

From

April 24, 2018

November 16, 2018,

CVie entered into

four

separate agreements to borrow an aggregate of approximately

$3.5

million from Lee’s International. The terms of the loan agreements are identical where the interest, payable in cash upon maturity, is

per annum and each of the

four

separate loans will mature

one

year from the effective date as follows:

$0.5

million in

April 2019;

$0.3

million in

September 2019;

$0.2

million in

October 2019;

and

$2.5

million in

November 2019.

As of

December 31, 2018,

the outstanding principal was approximately

$3.5

million (or NTD

$106.2

million), due to exchange rate fluctuations.

Note 7 - Fair Value Measurements (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

	Fair Value		Fair value measurement using
	September 30,
(in thousands)	2019		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	4,437	$	4,437	$	-	$	-
U.S. Treasury notes		-		-		-		-
Certificate of deposit		154		154		-		-
Total Assets	$	4,591	$	4,591	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912		19,912		-		-
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912	$	19,912
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

Note 13 - Restructured Debt Liability (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Schedule of Long-term Debt Instruments [Table Text Block]

	September 30,		December 31,
(in thousands)	2019		2018

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

	December 31,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.22)
-URI http://asc.fasb.org/extlink&oid=6877327&loc=d3e13212-122682

Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 1A
-URI http://asc.fasb.org/extlink&oid=114775744&loc=d3e28541-108399

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 6
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21506-112644

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08.(e),(f))
-URI http://asc.fasb.org/extlink&oid=26873400&loc=d3e23780-122690

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 2
-URI http://asc.fasb.org/extlink&oid=114775744&loc=d3e28551-108399

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 7
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21521-112644

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21538-112644

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 470
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=75038535&loc=d3e64711-112823

Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 55
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=114775985&loc=d3e28878-108400

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21475-112644

+ Details

Note 16 - Collaboration, Licensing and Research Funding Agreements (Details Textual) € in Millions			1 Months Ended			3 Months Ended	9 Months Ended		12 Months Ended
	Nov. 01, 2017 USD ($)	Oct. 27, 2017 USD ($)	Aug. 31, 2017 USD ($)	Jun. 30, 2017 USD ($)	Oct. 31, 2014 USD ($)	Oct. 31, 2017 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2018 EUR (€)	Dec. 31, 2017 USD ($)	Dec. 31, 2016 USD ($)	Dec. 31, 2012 USD ($)
Proceeds from Short-term Debt, Total								$ 4,280,000	$ 6,160,000		$ 3,900,000
LPH [Member] \| Acquisition of Windtree [Member]
Business Combination, Consideration Transferred, Total	$ 10,000,000	$ 10,000,000
Maximum [Member] \| Lee's [Member] \| Lee's Loan to Support Operations [Member]
Proceeds from Short-term Debt, Total						$ 3,900,000
License Agreement With Lee’s [Member]
Proceeds from License Fees Received				$ 1,000,000					1,000,000
License Agreement, Contingent Receivable, Maximum			$ 35,800,000	$ 37,500,000
Fair Value of Royalties and Milestones Foregone									300,000
Revenue, Remaining Performance Obligation, Amount									1,300,000
Philip Morris USA Inc. - License Agreement [Member]
Payments for Royalties											300,000
Deferred Royalty Expense											300,000
Philip Morris Products S.A. - License Agreement [Member]
Payments for Royalties											$ 487,500
Deferred Royalty Expense									400,000			$ 187,500
Johnson and Johnson - License Agreement [Member]
Potential License Fee Payable									2,500,000
Payment of License Cost Subject to Regulatory Approval									$ 1,000,000				$ 500,000
Percent of Cash Upfront and Milestone Fees Payable to Esteve									10.00%
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve									$ 20,000,000
Universita Degli Studi Do Miano-Biocca [Member]
Payment of License Cost for New Compounds Modulating									100,000	€ 0.1
Payment of License Cost Upon Obtaining Marketing Authorization									1,700,000	€ 1.5
Payment of License Cost, Aggregation Fund									200,000
Battelle Applies [Member]
Maximum Royalty Paid on Completion of Activities Under the Agreement					$ 25,000,000				$ 35,000,000

Note 14 - Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2018

Common Shares Reserved for Future Issuance, Warrants [Table Text Block]

	December 31,						Expiration
(in thousands, except price per share data)	2018		2017		Exercise Price		Date

Investors - Aerosurf		2,963		-	$	-	02/14/24
Investors - December 2018 financing - long-term		3,889		-	$	4.05	12/04/23
Investors - December 2018 financing - short-term		2,004		-	$	3.68	06/24/20
Battelle - 2018 payables restructuring agreement (1)		75		-	$	6.50	12/07/23
Panacea Venture Management Company Ltd.		188		-	$	4.00	07/02/23
LPH II Investments Limited		135		-	$	5.52	04/04/25
Investors - February 2017 financing		352		352	$	27.40	02/15/24
Investors - July 2015 financing		240		240	$	196.00	07/22/22
Battelle - 2014 collaboration agreement (1)		4		4	$	1,400.00	10/10/24
Total		9,850		596

Note 3 - Business Combination (Tables)

12 Months Ended

Dec. 31, 2018

Schedule of Business Acquisitions, by Acquisition [Table Text Block]

(in thousands)
Cash and cash equivalents	$	193
Restricted cash		31
Prepaid expenses and other current assets		387
Property and equipment, net		76
Intangible assets		77,090
Total identifiable assets acquired	$	77,777

Current liabilities	$	(2,590	)
Loan payable, current		(3,453	)
Loan payable, non current		(4,491	)
Deferred tax liabilities, noncurrent		(15,418	)
Other liabilities, noncurrent		(7	)
Net identifiable assets acquired		51,818
Goodwill		15,682
Net assets acquired	$	67,500

Business Acquisition, Pro Forma Information [Table Text Block]

	Year Ended December 31,
(in thousands, except per share data)	2018			2017

Pro forma net loss attributable to common shareholders	$	(38,082	)	$	(34,616	)
Pro forma EPS - basic and diluted	$	(1.20	)	$	(1.19	)

Warrants Issued for CVie Acquisition [Member]

Schedule of Assumptions Used for Warrant Valution [Table Text Block]

Significant Input Assumptions of Warrant Valuation
Historical volatility	116	%
Expected term (in years)	2.5
Risk-free interest rate	2.62	%

Note 6 - Fair Value of Financial Instruments (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

	Fair Value		Fair value measurement using
	September 30,
(in thousands)	2019		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	4,437	$	4,437	$	-	$	-
U.S. Treasury notes		-		-		-		-
Certificate of deposit		154		154		-		-
Total Assets	$	4,591	$	4,591	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912		19,912		-		-
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912	$	19,912
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

Note 5 - Accounting Policies and Recent Accounting Pronouncements - Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Indefinite intangible asset	$ 77,090	$ 77,090
Istaroxime Drug Candidate [Member]
Indefinite intangible asset	22,340	22,340
Rostafuroxin Drug Candidate [Member]
Indefinite intangible asset	$ 54,750	$ 54,750

Note 4 - Summary of Significant Accounting Policies (Details Textual) - USD ($) shares in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017	Jan. 01, 2019	Dec. 01, 2017	Nov. 01, 2017
Foreign Currency Transaction Gain (Loss), before Tax, Total	$ 100,000	$ 0	$ 400,000	$ 0	$ 100,000	$ 0
Marketable Securities, Realized Gain (Loss), Total	14,000		75,000		0
Marketable Securities, Unrealized Gain (Loss), Total	(12,000)		0	$ 0	0
Liability for Contingent Milestone Payment, Noncurrent	15,000,000		$ 15,000,000		$ 15,000,000	$ 15,000,000
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants			15,600	1,300	14,400	1,000
Operating Lease, Right-of-Use Asset	1,566,000		$ 1,566,000
Operating Lease, Liability, Total	1,735,000		1,735,000
Accrued Liabilities, Current, Total	5,235,000		5,235,000		6,465,000	$ 4,134,000
Other Liabilities, Noncurrent, Total	106,000		106,000		175,000	100,000
Accounting Standards Update 2016-02 [Member]
Operating Lease, Right-of-Use Asset							$ 2,200,000
Operating Lease, Liability, Total							2,000,000
Accrued Liabilities, Current, Total							(72,000)
Other Liabilities, Noncurrent, Total							$ (139,000)
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000,000		$ 15,000,000		$ 15,000,000	$ 15,000,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent								$ 15,000,000	$ 15,000,000

Note 6 - License Revenue with Affiliate

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Revenue from Contract with Customer [Text Block]

Note

–

License Revenue with Affiliate

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

License revenue with affiliate	$	-	$	159	$	198	$	719

License revenue with affiliate represents revenue from a License Agreement with Lee’s Pharmaceutical (HK) Ltd. (Lee’s (HK)), an affiliate of our largest shareholder, Lee’s Pharmaceutical Holdings Limited (Lee’s), and constitutes a contract with a customer accounted for in accordance with ASC Topic

606.

As of

June 30, 2019,

all revenue related to the License Agreement was recognized and

future material performance obligations are due.

Note

–

License Revenue with Affiliate

	Year Ended December 31,
(in thousands)	2018		2017

License revenue with affiliate	$	1,023	$	102

License revenue with affiliate for years ended

December 31, 2018

and

2017

represents revenue from a License Agreement with Lee’s (HK) and constitutes a contract with a customer accounted for in accordance with ASC Topic

606,

which we adopted effective

January 1, 2018 (

see

, Note

– Accounting Policies and Recent Accounting Pronouncements, and Note

– Collaboration, Licensing and Research Funding Agreements). There was

impact to License revenue with affiliate previously recognized as a result of the adoption of ASC Topic

606.

Note 12 - Convertible Note Payable - Significant Input Assumptions of Warrant Valuation (Details) - Series D Warrants [Member]	Dec. 31, 2018
Measurement Input, Price Volatility [Member]
Measurement input	1.03
Measurement Input, Expected Term [Member]
Measurement input	5
Measurement Input, Risk Free Interest Rate [Member]
Measurement input	0.0275

Note 9 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Share-based Payment Arrangement, Expense	$ 1,939	$ 145	$ 5,208	$ 703	$ 955	$ 1,561
Research and Development Expense [Member]
Share-based Payment Arrangement, Expense	574	29	1,613	169	$ 232	$ 837
General and Administrative Expense [Member]
Share-based Payment Arrangement, Expense	$ 1,365	$ 116	$ 3,595	$ 534

Note 7 - Loans Payable (Details Textual) $ in Millions			1 Months Ended					3 Months Ended	9 Months Ended		12 Months Ended
Note 7 - Loans Payable (Details Textual) $ in Millions	Dec. 21, 2018 USD ($)	Dec. 05, 2018 USD ($)	May 30, 2019 USD ($)	Apr. 30, 2019 USD ($)	Mar. 31, 2018 USD ($)	Jan. 31, 2018 USD ($)	Sep. 30, 2017 USD ($)	Mar. 31, 2019 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)	Dec. 31, 2018 TWD ($)	Dec. 21, 2018 TWD ($)	Nov. 19, 2018 USD ($)	Nov. 16, 2018 USD ($)	Nov. 02, 2018 USD ($)	Oct. 19, 2018 USD ($)	Sep. 27, 2018 USD ($)	Sep. 12, 2018 USD ($)	Aug. 29, 2018 USD ($)	Aug. 14, 2018 USD ($)	Sep. 30, 2017 TWD ($)	Sep. 30, 2016 USD ($)	Sep. 30, 2016 TWD ($)
Repayments of Short-term Debt, Total									$ 820,000		$ 160,000
Short-term Debt, Total									7,782,000		$ 7,974,000
CVie Investments [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total	$ 2,590,000
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt	3,453,000
Debt Payable to Lee's International [Member]
Debt Instrument, Interest Rate, Stated Percentage																4.00%
Debt Instrument, Face Amount																$ 3,500,000
Repayments of Short-term Debt, Total				$ 50,000				$ 450,000
Short-term Debt, Total									3,000,000
Debt Payable to Lee's International [Member] \| Debt Maturing April 2019 [Member]
Debt Instrument, Face Amount																500,000
Debt Payable to Lee's International [Member] \| Debt Maturing September 2019 [Member]
Debt Instrument, Face Amount																300,000
Debt Payable to Lee's International [Member] \| Debt Maturing October 2019 [Member]
Debt Instrument, Face Amount																200,000
Debt Payable to Lee's International [Member] \| Debt Maturing November 2019 [Member]
Debt Instrument, Face Amount																$ 2,500,000
Debt Payable to Lee's International [Member] \| CVie Investments [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt	3,500,000													$ 106.2
Loan payable to Bank Direct Capital Finance [Member]
Loans Payable to Bank, Total									400,000
Loan payable to Bank Direct Capital Finance [Member] \| Loans Payable [Member]
Debt Instrument, Interest Rate, Stated Percentage			5.35%
Debt Instrument, Face Amount			$ 700,000
Debt Instrument, Periodic Payment, Total			$ 80,000
Loan Payable Obligation Converted to LPH II [Member]
Debt Conversion, Original Debt, Amount	6,000,000
LPH [Member]
Proceeds from Issuance of Debt					$ 1,000,000	$ 1,500,000
Debt Instrument, Interest Rate, Stated Percentage											6.00%		6.00%
Debt Instrument, Face Amount		$ 600,000													$ 350,000		$ 500,000	$ 430,000	$ 500,000	$ 500,000	$ 480,000	$ 300,000
Short-term Debt, Total	6,000,000
LPH [Member] \| Loan Payable Obligation Converted to LPH II [Member] \| Debt Issued on January 2018 [Member]
Debt Conversion, Original Debt, Amount		1,500,000
LPH [Member] \| Loan Payable Obligation Converted to LPH II [Member] \| Debt Issued on March 2018 [Member]
Debt Conversion, Original Debt, Amount		$ 1,000,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Percent of Pledged Deposits Required							110.00%				110.00%		110.00%										110.00%
Line of Credit, Current									$ 4,500,000		$ 4,500,000		$ 138.0
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate							0.91%				0.91%
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| CVie Investments [Member]
Line of Credit Facility, Maximum Borrowing Capacity							$ 5,840,000																$ 180.0	$ 2,900,000	$ 90.0
O-Bank Co., Ltd. [Member] \| CVie Investments [Member] \| Revolving Credit Facility [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total	$ 4,500,000				$ 4,500,000									$ 138.0

Note 5 - Accounting Policies and Recent Accounting Pronouncements (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

(in thousands)	Estimated Fair Value

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

Note 14 - Stockholders' Equity (Details Textual) - USD ($)									1 Months Ended	12 Months Ended
	Dec. 24, 2018	Dec. 21, 2018	Apr. 04, 2018	Nov. 01, 2017	Oct. 27, 2017	Oct. 25, 2017	Feb. 15, 2017	Feb. 11, 2013	Oct. 31, 2017	Dec. 31, 2018	Dec. 31, 2017	Sep. 30, 2019
Common Stock, Shares, Issued, Total										32,133,263	3,227,495	32,188,929
Proceeds from Issuance of Private Placement		$ 39,000,000								$ 32,893,000	$ 14,860,000
Preferred Stock, Par or Stated Value Per Share							$ 0.001			$ 0.001	$ 0.001	$ 0.001
Proceeds from Issuance of Common Stock											$ 1,036,000
Common Stock, Capital Shares Reserved for Future Issuance										9,850,000	596,000
The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized	4,200,000					1,750,000					37,500
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant										1,453,000	1,623,000
The 401(k) Plan [Member]
Common Stock, Capital Shares Reserved for Future Issuance											807
LPH [Member] \| Acquisition of Windtree [Member]
Business Combination, Consideration Transferred, Total				$ 10,000,000	$ 10,000,000
Business Acquisition, Shares Acquired, Number					2,311,604
Business Acquisition, Share Price					$ 4.326
Business Acquisition, Shares Acquired, Price Per Share, Percentage Premium					15.00%
Business Acquisition, Percentage of Voting Interests Acquired					73.00%
Business Combination, Consideration Transferred, Liabilities Cancelled					$ 3,900,000
Business Combination, Number of Individuals Acquirer May Appoint to the Acquiree's Board of Directors					2
Business Combination, Registration Rights Agreement, Maximum Rights Percentage in First 18 Months					25.00%
Battelle [Member] \| Series A Preferred Stock [Member]
Preferred Stock, Convertible, Shares, Liquidity Preference Waived									1,095
Private Placement [Member]
Common Stock, Shares, Issued, Total		11,785,540
Share Price		$ 3.3132
Proceeds from Issuance of Private Placement		$ 39,000,000
Debt Conversion, Original Debt, Amount		$ 6,000,000
Shares Issued, Price Per Share		$ 3.3132
Private Placement [Member] \| Series F Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		2,003,541
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 3.68
Warrants and Rights Outstanding, Term		1 year 180 days
Private Placement [Member] \| Series G Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		3,889,229
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 4.05
Warrants and Rights Outstanding, Term		5 years
Private Placement [Member] \| December 2018 Warrants [Member]
Common Stock Maximum Ownership Percentage For Warrant Exercise		9.99%
Private Placement [Member] \| Series A Units [Member]
Stock Issued During Period, Shares, New Issues							7,049
Convertible Preferred Stock Units, Price Per Unit							$ 1,495
Gross Proceeds From Issuance Of Units							$ 10,500,000
Non-cash Consideration Received							$ 1,600,000
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right							1
Private Placement [Member] \| Series A Warrant [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights							$ 27.40
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right							50
Class of Warrants May Not Exercise to Extent, Percentage							9.99%
Private Placement [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Debt Conversion, Original Debt, Amount		$ 6,000,000
Private Placement [Member] \| Lee’s Pharmaceutical Holdings Limited [Member] \| Series F Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		307,859
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 3.68
Warrants and Rights Outstanding, Term		1 year 180 days
Private Placement [Member] \| Lee’s Pharmaceutical Holdings Limited [Member] \| Series G Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		597,610
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 4.05
Warrants and Rights Outstanding, Term		5 years
Private Placement [Member] \| Battelle [Member]
Debt Conversion, Original Debt, Amount		$ 1,000,000
Private Placement [Member] \| LPH II [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights			135,417
Class of Warrant or Right, Exercise Price of Warrants or Rights			$ 5.52
Warrants and Rights Outstanding, Term			7 years
Private Placement, Purchase Price of Common Stock and Warrants			$ 2,600,000
Shares Issued, Price Per Share			$ 4.80
Stock Issued During Period, Shares, New Issues			541,667
Class of Warrant or Right, Vesting Period			180 days
Registration Rights Agreement, Rights Percentage			25.00%
Stifel ATM Program [Member]
Stock Issued During Period, Shares, New Issues											42,357
Agency Agreement Period								3 years
Maximum Potential Common Stock Available for Issue, Value								$ 25,000,000
Percentage Sales Commission on Shares								3.00%
Proceeds from Issuance of Common Stock											$ 1,100,000
Proceeds from Issuance of Common Stock, Net											$ 1,000,000
The 401(k) Plan [Member]
Stock Issued During Period, Shares, New Issues											7,561
Defined Contribution Plan, Cost										$ 0	$ 100,000

Note 15 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Weighted average expected volatility	95.00%	93.00%	79.00%
Weighted average expected term (Year)	6 years 219 days	7 years	6 years 219 days
Weighted average risk-free interest rate	2.60%	2.70%	2.20%
Expected dividends

Note 1 - The Company and Description of Business

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

Note

–

The Company and Description of Business

Windtree Therapeutics, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases. Through

2018,

we focused on the development of our proprietary

KL4

surfactant technology and aerosol delivery system (ADS) technology for the treatment and/or prevention of respiratory distress syndrome (RDS) in premature infants. In

December

2018,

we entered into an Agreement and Plan of Merger (the CVie Acquisition) with CVie Investments Limited (CVie Investments), an exempted company with limited liability incorporated under the laws of the Cayman Islands. We have operated CVie Investments, and its wholly-owned subsidiary, CVie Therapeutics Limited (CVie Therapeutics), a Taiwan corporation organized under the laws of the Republic of China, as a business division (these entities

may

be collectively referred to herein as CVie) focused on development of drug product candidates for cardiovascular diseases, including acute heart failure and hypertension and associated organ dysfunction.

Our

four

lead development programs are (

) istaroxime for treatment of (a) acute heart failure (AHF) and (b) early cardiogenic shock, (

) AEROSURF® (lucinactant for inhalation) for non-invasive delivery of our lyophilized

KL4

surfactant to treat RDS in premature infants, (

) lyophilized

KL4

surfactant intratracheal suspension for RDS, and (

) rostafuroxin for genetically associated hypertension. We are currently preparing for a study assessing the utility of istaroxime in early cardiogenic shock, as well as phase

clinical studies of istaroxime in acute heart failure and AEROSURF in RDS potentially to transition thereafter to phase

We also continue with our preclinical activities for follow-on oral and intravenous SERCA

heart failure compounds; however, we have slowed the pace of these activities while we seek the additional capital required to support our development activities and operations.

See

, “Note

– Liquidity Risks and Management’s Plans.”

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, 2018

that we filed with the Securities and Exchange Commission (SEC) on

April 16, 2019,

as amended by the Form

-K/A that we filed with the SEC on

April 23, 2019 (

collectively,

2018

Form

-K), and our Quarterly Reports on Form

-Q filed thereafter, which contain discussions of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs.

Note

–

The Company and Description of Business

KL4

surfactant technology and aerosol delivery system (ADS) technology for the treatment and or prevention of respiratory distress syndrome (RDS) in premature infants. Following our merger with CVie Investments Limited in

December 2018 (

see

, Note

– Business Combination), we are also focusing on therapies for acute heart failure and hypertension and associated organ dysfunction.

Our

four

lead development programs are (

) istaroxime for treatment of acute decompensated heart failure (ADHF), (

) AEROSURF® (lucinactant for inhalation) for non-invasive delivery of our lyophilized

KL4

surfactant to treat RDS in premature infants, (

) lyophilized

KL4

surfactant intratracheal suspension for RDS, and (

) rostafuroxin for genetically associated hypertension.

Heart failure is a chronic, progressive disease resulting from structural or functional cardiac abnormalities and is characterized by inadequate pumping function of the heart that results in fluid accumulation manifesting as pulmonary congestion, peripheral edema and congestion in other parts of the body. Insufficient cardiac output can result in inadequate peripheral perfusion that increases the risk of other organ dysfunction such as renal failure. Heart failure commonly but episodically worsens to a point of decompensation, a condition called ADHF. We are developing istaroxime for the treatment of ADHF. Istaroxime has a dual mechanism of action referred to as luso-inotropic, that

may

result in improvement in cardiac function to reduce congestion and edema and preserve other organ function while avoiding the side effects associated with other classes of heart failure therapies. Istaroxime has been evaluated in

two

phase

clinical trials, the results of which suggest that istaroxime

may

improve cardiovascular physiology as assessed by parameters of pump function, decreases in pulmonary capillary wedge pressure, decreases in heart rate, increases in blood pressure without adverse events such as arrhythmias, cardiac damage (as indicated by elevated troponin values) or adverse impact on kidney function. Based on preclinical and clinical studies performed to date, we believe that istaroxime, if approved, could potentially improve patients’ heart failure symptoms and reduce complications and the length of hospital stays when compared to current therapeutic regimens for ADHF. In

2019,

we plan to work with heart failure experts to review the program and engage with the FDA and regulators in the EU to determine next steps in clinical development for this potential novel therapy for ADHF.

AEROSURF (lucinactant for inhalation) is an investigational combination drug/device product that we are developing to improve the management of RDS in premature infants who

may

not

have fully developed natural lung surfactant and

may

require surfactant therapy to sustain life. Surfactants in the US are animal-derived and must be administered using endotracheal intubation, frequently with mechanical ventilation, invasive procedures that

may

result in serious respiratory conditions and other complications. AEROSURF is designed to deliver aerosolized

KL4

surfactant noninvasively using our proprietary aerosol delivery systems (ADS) technology, without invasive procedures. In

2017,

we completed a phase

clinical trial, which based on the planned top-line results, did

not

meet the primary endpoint of reduction in nCPAP failure at

hours, due in large part, we believe, to an unexpected rate of treatment interruptions, which occurred in about

24%

of active enrollments, predominantly in the

-minute dose group. We believe the interruptions were primarily related to certain of the prototype phase

ADS with specific lots of disposable cartridge filters that had a higher tendency to clog. After excluding patients in the

-minute dose group whose dose was interrupted, in accordance with the predesignated statistical plan, we observed a meaningful treatment effect in line with our desired targeted outcome. The overall data suggest that the safety and tolerability profile of AEROSURF was generally comparable to the control group. Reported adverse events and serious adverse events were those that are common and expected among premature infants with RDS and comparable to the control group. As a result of these events, in

2019,

we are planning to initiate an additional AEROSURF clinical bridging study that is designed, among other things, to clinically evaluate the design and performance of our new phase

ADS. This trial will

not

be powered to establish statistical significance but will generate additional higher dose treatment data to augment the higher dose data obtained in the phase

clinical trial. We believe that AEROSURF, if approved, has the potential to reduce the number of premature infants who are subjected to invasive surfactant administration, and potentially provide transformative clinical and pharmacoeconomic benefits. The FDA has granted Fast Track designation for our

KL4

surfactant (including AEROSURF) to treat RDS.

We are also assessing potential development pathways to secure marketing approval for lyophilized

KL4

surfactant as an intratracheal instillate for the treatment and/or prevention of RDS. Lyophilized

KL4

surfactant is the drug product component of AEROSURF and a lyophilized dosage form of a liquid

KL4

surfactant that was approved by the FDA in

2012

(SURFAXIN®). We previously discussed with the FDA a potential approach and plan potentially to re-engage with the FDA in the

second

half of

2019.

If we can define an acceptable development plan that is achievable from a cost, timing and resource perspective, we

may

seek approval to treat premature infants who, because they are unable to breathe on their own or other reason, are

not

candidates for AEROSURF.

We also believe that our lyophilized

KL4

surfactant

may

potentially support a product pipeline to address a broad range of serious respiratory conditions in children and adults. We are pursuing a number of early exploratory research efforts to identify potential product candidates, including a collaboration with Eleison Pharmaceuticals, Inc., a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, to assess the feasibility of using our ADS potentially to deliver Eleison’s inhaled lipid cisplatin (ILC), and with support from the National Institutes of Health (NIH), to address respiratory conditions.

Our

fourth

product candidate is rostafuroxin for the treatment of genetically associated hypertension. Rostafuroxin targets resistant hypertensive patients with a specific genetic profile, which is found in approximately

20%

–

25%

of the adult hypertensive population. We believe that rostafuroxin

may

reduce or normalize blood pressure in this genetically identified subset of patients and

may

reduce the risk of hypertension-related sequelae beyond the level normally associated with the absolute reduction of blood pressure, per se, because the molecular mechanism blocked by rostafuroxin

may

also be involved in organ damage. CVie Therapeutics completed

three

clinical trials assessing rostafuroxin, including a phase

clinical trial which was conducted in

two

parts,

one

in Caucasian patients in Italy and

one

in Chinese patients in Taiwan. While the blood pressure reduction in Caucasians was notable, there was

blood pressure response in Chinese patients. We are analyzing the results of these studies potentially to understand the reasons for the limited response in Chinese patients. In

2019,

we plan to focus on finalizing the drug formulation and defining drug product analytical methods. We then to engage in business development activities potentially to out-license rostafuroxin to a larger company that has interest in and/or operates in the very large and broad antihypertension market.

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

– Business – Company Overview” in this Annual Report on Form

-K, 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 14 - Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares
shares in Thousands

12 Months Ended

Dec. 31, 2018

Dec. 31, 2017

Common Stock, Capital Shares Reserved for Future Issuance

9,850

596

Investors - Aerosurf [Member]

Common Stock, Capital Shares Reserved for Future Issuance

2,963

Class of Warrant or Right, Exercise Price of Warrants or Rights

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

02/14/24

Common Stock, Capital Shares Reserved for Future Issuance

3,889

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 4.05

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

12/04/23

Common Stock, Capital Shares Reserved for Future Issuance

2,004

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 3.68

Battelle - 2018 Payables Restructuring Agreement [Member]

06/24/20

Common Stock, Capital Shares Reserved for Future Issuance

^[1]

Class of Warrant or Right, Exercise Price of Warrants or Rights

^[1]

$ 6.50

Panacea Venture Management Company Ltd. [Member]

^[1]

12/07/23

Common Stock, Capital Shares Reserved for Future Issuance

188

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 4

LPH II Investments Limited [Member]

07/02/23

Common Stock, Capital Shares Reserved for Future Issuance

135

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 5.52

Investors - February 2017 Financing [Member]

04/04/25

Common Stock, Capital Shares Reserved for Future Issuance

352

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 27.40

Investors - July 2015 Financing [Member]

02/15/24

Common Stock, Capital Shares Reserved for Future Issuance

240

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 196

Battelle 2014 Collaboration Agreement [Member]

07/22/22

Common Stock, Capital Shares Reserved for Future Issuance

^[1]

Class of Warrant or Right, Exercise Price of Warrants or Rights

^[1]

$ 1,400

^[1]

10/10/24

[1]	See, - Note 16 - Collaboration and Device Development Payment Restructuring, Licensing and Research Funding Agreements for further details on the Battelle collaboration agreement.

Note 11 - Loan Payable (Details Textual) $ / shares in Units, $ in Millions			1 Months Ended			12 Months Ended
	Dec. 27, 2018 USD ($)	Dec. 21, 2018 USD ($) $ / shares shares	Mar. 31, 2018 USD ($)	Jan. 31, 2018 USD ($)	Sep. 30, 2017 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)	Sep. 30, 2019 USD ($)	Dec. 31, 2018 TWD ($)	Dec. 21, 2018 TWD ($) shares	Dec. 05, 2018 USD ($)	Nov. 19, 2018 USD ($)	Nov. 16, 2018 USD ($)	Nov. 02, 2018 USD ($)	Oct. 19, 2018 USD ($)	Sep. 27, 2018 USD ($)	Sep. 12, 2018 USD ($)	Aug. 29, 2018 USD ($)	Aug. 14, 2018 USD ($)	Sep. 30, 2017 TWD ($)	Sep. 30, 2016 USD ($)	Sep. 30, 2016 TWD ($)
Gain (Loss) on Extinguishment of Debt, Total						$ (3,345,000)
Short-term Debt, Total						7,974,000		$ 7,782,000
Debt Payable to Lee's International [Member]
Debt Instrument, Interest Rate, Stated Percentage													4.00%
Debt Instrument, Face Amount													$ 3,500,000
Short-term Debt, Total								3,000,000
Long-term Debt, Current Maturities, Total						$ 3,500,000			$ 106.2
Debt Payable to Lee's International [Member] \| Debt Maturing April 2019 [Member]
Debt Instrument, Face Amount													500,000
Debt Payable to Lee's International [Member] \| Debt Maturing September 2019 [Member]
Debt Instrument, Face Amount													300,000
Debt Payable to Lee's International [Member] \| Debt Maturing October 2019 [Member]
Debt Instrument, Face Amount													200,000
Debt Payable to Lee's International [Member] \| Debt Maturing November 2019 [Member]
Debt Instrument, Face Amount													$ 2,500,000
CVie Investments [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total		$ 2,590,000
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt		3,453,000
CVie Investments [Member] \| Debt Payable to Lee's International [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt		3,500,000								$ 106.2
Private Placement [Member]
Debt Conversion, Original Debt, Amount		$ 6,000,000
Debt Conversion, Converted Instrument, Shares Issued \| shares		1,810,938
Shares Issued, Price Per Share \| $ / shares		$ 3.3132
Private Placement [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Debt Conversion, Original Debt, Amount		$ 6,000,000
Private Placement [Member] \| Series F Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		2,003,541								2,003,541
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares		$ 3.68
Warrants and Rights Outstanding, Term		1 year 180 days								1 year 180 days
Private Placement [Member] \| Series F Warrants [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		307,859								307,859
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares		$ 3.68
Warrants and Rights Outstanding, Term		1 year 180 days								1 year 180 days
Private Placement [Member] \| Series G Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		3,889,229								3,889,229
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares		$ 4.05
Warrants and Rights Outstanding, Term		5 years								5 years
Private Placement [Member] \| Series G Warrants [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		597,610								597,610
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares		$ 4.05
Warrants and Rights Outstanding, Term		5 years								5 years
LPH [Member]
Proceeds from Issuance of Debt			$ 1,000,000	$ 1,500,000
Debt Instrument, Interest Rate, Stated Percentage						6.00%			6.00%
Debt Instrument, Face Amount											$ 600,000	$ 350,000		$ 500,000	$ 430,000	$ 500,000	$ 500,000	$ 480,000	$ 300,000
Gain (Loss) on Extinguishment of Debt, Total		$ (3,200,000)
Common Stock and Warrants for Debt Settlement, Fair Value		9,200,000
Short-term Debt, Total		6,000,000
Repayments of Debt	$ 160,000
Interest Paid, Including Capitalized Interest, Operating and Investing Activities, Total	$ 182,000
LPH II [Member]
Debt Instrument Requirement For Minimum Amount Rise						$ 30,000,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Percent of Pledged Deposits Required					110.00%	110.00%			110.00%											110.00%
Line of Credit, Current						$ 4,500,000		$ 4,500,000	$ 138.0
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate					0.91%	0.91%
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| CVie Investments [Member]
Line of Credit Facility, Maximum Borrowing Capacity					$ 5,840,000															$ 180.0	$ 2,900,000	$ 90.0
O-Bank Co., Ltd. [Member] \| CVie Investments [Member] \| Revolving Credit Facility [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total		$ 4,500,000	$ 4,500,000							$ 138.0

Note 9 - Collaboration and Device Development Payable

12 Months Ended

Dec. 31, 2018

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

Note

–

Collaboration and Device Development Payable

Collaboration and device development payable represents amounts due to Battelle under a collaboration agreement related to the development of our phase

ADS (

see

, Note

– Collaboration, Licensing and Research Funding Agreements) and a Research and Development Services Agreement (RDSA) dated

June 2012

for our prototype phase

ADS. As of

December 31, 2018

and

2017,

collaboration and device development payable was

$2.6

million and

$4.4

million, respectively, including accrued interest.

Restructuring of the Battelle Payables

December 7, 2018,

we entered into a payment restructuring agreement with Battelle Memorial Institute (“Battelle”) in which we agreed to the following: (i) the outstanding amounts owing under the Collaboration Agreement and RDSA (such amounts, the Battelle Payables) will continue to accrue interest at a rate of

6.0%

per annum and shall be payable on a monthly basis or any unpaid interest shall be added to the balance of the Battelle Payables, (ii) we and Battelle will continue the development activities relating to AEROSURF under the RDSA, and we will prepay for services to be provided by Battelle until we have repaid

$3.0

million of the Battelle Payables, after which time, services incurred shall be payable upon

days of receipt of the invoice, (iii) Battelle participated in the

December 2018

Private Placement Financing for

$1.0

million in a debt-equity exchange for a like amount of Battelle Payables (

see

, Note

– Stockholders’ Equity), (iv) upon the closing of the Private Placement Financing, we paid Battelle cash in the amount of

$972,281,

and thereafter initiated payments totaling an aggregate

$1,250,000,

payable in

five

equal, consecutive monthly installments of

$250,000,

and (v) increased the royalty cap previously set forth in the collaboration agreement from

$25.0

million to

$35.0

million. In addition, we have agreed to make

two

milestone payments to Battelle as follow: (i) upon enrollment of the

first

patient in the next AEROSURF clinical study, an amount equal to

one

half of the then-outstanding Battelle Payables (including unpaid interest), and (ii) when we complete the device technology transfer for the phase

ADS to Mack, an amount equal to the then-outstanding Battelle Payables, including unpaid interest. If any amounts of the Battelle Payables remain unpaid by

December 31, 2019,

then all unpaid Battelle Payables will be due on

January 7, 2020.

Management determined the payment restructuring agreement of the Battelle Payables do

not

represent a troubled debt restructuring as Battelle did

not

grant us a concession. Further, the payment restructuring agreement constitutes a debt modification as the restructured terms do

not

result in a substantially different instrument.

In connection with the payment restructuring agreement, we also issued to Battelle Series E Warrants (“Series E Warrants”) to purchase

75,000

shares of common stock, at an exercise price equal to

$6.50

per share (“the Exercise Price”). The Series E Warrants

may

be exercised after the date of issuance through the

-year anniversary of the date of issuance on

December 11, 2023.

The Series E Warrants

may

not

be exercised to the extent that the holder thereof would, following such exercise or conversion, beneficially own more than

9.99%

(or other percent as designated by each holder) of our outstanding shares of common stock. The Series E Warrants contain customary provisions that adjust the Exercise Price and the number of shares of common stock into which the Series E Warrants are exercisable in the event of a corporate transaction.

The Series E Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s own Equity, and have been classified as equity. The fair value at issuance of the Series E Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants, and the risk-free interest rate based on the

five

-year treasury bill rate in effect at the measurement date.

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.70	%

As of

December 31, 2018,

we had accrued interest expense relating to the Battelle Payables of

$0.3

million.

Extinguishment of Collaboration and Device Development Payable

December 21, 2018,

as part of the Private Placement Financing, we converted

$1.0

million of existing Battelle Payables on the same terms as the Investors of the Private Placement Financing. In connection with the conversion of the Battelle Payables, we issued: (i)

301,823

shares of common stock based at

$3.3132

per share, (ii) Series F Warrants to purchase

51,310

shares of common stock, at an exercise price equal to

$3.68

per share, and (iii) Series G Warrants to purchase

99,602

shares common stock, at an exercise price equal to

$4.05

per share. The Series F Warrants are exercisable at any time after the date of issuance and through the

18th

month anniversary of the date of issuance and the Series G Warrants

may

be exercise through the

-year anniversary of the date of issuance.

The conversion of the Battelle Payables is treated as an extinguishment of outstanding liabilities. We recorded a loss on extinguishment of debt of approximately

$0.5

million. The loss was calculated as the difference between: (i) the aggregate fair value of approximately

$1.5

million, based on the fair value of the common stock and Warrants on

December 21, 2018

and (ii) the carrying value of the Battelle Payables of

$1.0

million.

Note 15 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Shares Outstanding, Beginning Balance (in shares)	4,417	84
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share)	$ 6.73	$ 163.20
Shares Granted (in shares)	1,144	4,337
Weighted Average Exercise Price, Granted (in dollars per share)	$ 4.20	$ 4.22
Shares Forfeited or Expired (in shares)	(5)	(4)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share)	$ 467.57	$ 617.75
Shares Outstanding, Ending Balance (in shares)	5,556	4,417
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share)	$ 5.80	$ 6.73
Weighted Average Remaining Contractual Life, Outstanding (Year)	9 years 73 days	9 years 328 days
Shares Vested and Exercisable (in shares)	70	63
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share)	$ 128.45	$ 171.87
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	6 years 109 days	6 years 182 days
Vested and expected to vest (in shares)	5,245	4,243
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share)	$ 5.79	$ 6.78
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	9 years 73 days	9 years 328 days

Note 2 - Basis of Presentation

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Basis of Accounting [Text Block]

Note

–

Basis of Presentation

-Q and include accounts of Windtree and its wholly-owned subsidiaries. Accordingly, they do

not

three

and

nine

months ended

September 30, 2019

are

not

necessarily indicative of the results that

may

be expected for the year ending

December

31,

2019.

There have been

changes to our critical accounting policies since

December 31, 2018.

The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with annual audited financial statements and related notes as of and for the year ended

December 31, 2018

contained in our

2018

Form

-K and our Quarterly Reports on Form

-Q filed thereafter.

Note

–

Basis of Presentation

Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Property and equipment, gross		$ 7,218	$ 8,038
Accumulated depreciation and amortization		(6,416)	(7,153)
Property and equipment, net	$ 877	802	885
Manufacturing, Laboratory, and Office Equipment [Member]
Property and equipment, gross		4,359	4,965
Furniture and Fixtures [Member]
Property and equipment, gross		390	615
Leasehold Improvements [Member]
Property and equipment, gross		$ 2,469	$ 2,458

Note 8 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000	$ 15,000
Deerfield Loan [Member]
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000	$ 15,000

Note 12 - Convertible Note Payable (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Convertible Note Interest Expense [Table Text Block]

	Year Ended December 31,
(in thousands)	2018

Non-cash amortization of debt discounts	$	833
Cash interest expense		106
Total convertible note interest expense	$	939

Series D Warrants [Member]

Schedule of Assumptions Used for Warrant Valution [Table Text Block]

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.75	%

Note 6 - Fair Value of Financial Instruments

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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
	September 30,
(in thousands)	2019		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	4,437	$	4,437	$	-	$	-
U.S. Treasury notes		-		-		-		-
Certificate of deposit		154		154		-		-
Total Assets	$	4,591	$	4,591	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912		19,912		-		-
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

Note

–

Fair Value Measurements

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

– Quoted prices in active markets for identical assets and liabilities.

●

Level

– Inputs other than Level

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

– Unobservable inputs that are supported by little or

market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

Assets and liabilities measured at fair value on a recurring basis are categorized in the table below as of

December

31,

2018

and

2017:

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912	$	19,912
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

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 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands	Oct. 24, 2019	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Cash and Cash Equivalents, at Carrying Value, Ending Balance		$ 4,437	$ 11,187	$ 1,815
Liabilities, Current, Total		16,278	20,633	$ 11,760
Loans Payable, Current, Total		$ 7,800	$ 8,000
Common Stock, Shares Authorized		120,000,000	120,000,000	120,000,000
Preferred Stock, Shares Authorized		5,000,000	5,000,000	5,000,000
Common Stock, Capital Shares Available for Issuance		72,000,000	72,000,000
Preferred Stock, Capital Shares Available for Issuance		5,000,000	5,000,000
Subsequent Event [Member] \| LPH II [Member] \| LPH II Loan [Member]
Proceeds from Issuance of Debt	$ 1,000

Note 1 - The Company and Description of Business

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

Note

–

The Company and Description of Business

2018,

we focused on the development of our proprietary

KL4

surfactant technology and aerosol delivery system (ADS) technology for the treatment and/or prevention of respiratory distress syndrome (RDS) in premature infants. In

December

2018,

may

Our

four

lead development programs are (

) istaroxime for treatment of (a) acute heart failure (AHF) and (b) early cardiogenic shock, (

) AEROSURF® (lucinactant for inhalation) for non-invasive delivery of our lyophilized

KL4

surfactant to treat RDS in premature infants, (

) lyophilized

KL4

surfactant intratracheal suspension for RDS, and (

) rostafuroxin for genetically associated hypertension. We are currently preparing for a study assessing the utility of istaroxime in early cardiogenic shock, as well as phase

clinical studies of istaroxime in acute heart failure and AEROSURF in RDS potentially to transition thereafter to phase

We also continue with our preclinical activities for follow-on oral and intravenous SERCA

heart failure compounds; however, we have slowed the pace of these activities while we seek the additional capital required to support our development activities and operations.

See

, “Note

– Liquidity Risks and Management’s Plans.”

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, 2018

that we filed with the Securities and Exchange Commission (SEC) on

April 16, 2019,

as amended by the Form

-K/A that we filed with the SEC on

April 23, 2019 (

collectively,

2018

Form

-K), and our Quarterly Reports on Form

-Q filed thereafter, which contain discussions of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs.

Note

–

The Company and Description of Business

KL4

December 2018 (

see

, Note

– Business Combination), we are also focusing on therapies for acute heart failure and hypertension and associated organ dysfunction.

Our

four

lead development programs are (

) istaroxime for treatment of acute decompensated heart failure (ADHF), (

) AEROSURF® (lucinactant for inhalation) for non-invasive delivery of our lyophilized

KL4

surfactant to treat RDS in premature infants, (

) lyophilized

KL4

surfactant intratracheal suspension for RDS, and (

) rostafuroxin for genetically associated hypertension.

may

two

phase

clinical trials, the results of which suggest that istaroxime

may

2019,

AEROSURF (lucinactant for inhalation) is an investigational combination drug/device product that we are developing to improve the management of RDS in premature infants who

may

not

have fully developed natural lung surfactant and

may

result in serious respiratory conditions and other complications. AEROSURF is designed to deliver aerosolized

KL4

surfactant noninvasively using our proprietary aerosol delivery systems (ADS) technology, without invasive procedures. In

2017,

we completed a phase

clinical trial, which based on the planned top-line results, did

not

meet the primary endpoint of reduction in nCPAP failure at

hours, due in large part, we believe, to an unexpected rate of treatment interruptions, which occurred in about

24%

of active enrollments, predominantly in the

-minute dose group. We believe the interruptions were primarily related to certain of the prototype phase

ADS with specific lots of disposable cartridge filters that had a higher tendency to clog. After excluding patients in the

2019,

we are planning to initiate an additional AEROSURF clinical bridging study that is designed, among other things, to clinically evaluate the design and performance of our new phase

ADS. This trial will

not

be powered to establish statistical significance but will generate additional higher dose treatment data to augment the higher dose data obtained in the phase

KL4

surfactant (including AEROSURF) to treat RDS.

We are also assessing potential development pathways to secure marketing approval for lyophilized

KL4

surfactant as an intratracheal instillate for the treatment and/or prevention of RDS. Lyophilized

KL4

surfactant is the drug product component of AEROSURF and a lyophilized dosage form of a liquid

KL4

surfactant that was approved by the FDA in

2012

(SURFAXIN®). We previously discussed with the FDA a potential approach and plan potentially to re-engage with the FDA in the

second

half of

2019.

If we can define an acceptable development plan that is achievable from a cost, timing and resource perspective, we

may

seek approval to treat premature infants who, because they are unable to breathe on their own or other reason, are

not

candidates for AEROSURF.

We also believe that our lyophilized

KL4

surfactant

may

Our

fourth

20%

–

25%

of the adult hypertensive population. We believe that rostafuroxin

may

reduce or normalize blood pressure in this genetically identified subset of patients and

may

reduce the risk of hypertension-related sequelae beyond the level normally associated with the absolute reduction of blood pressure, per se, because the molecular mechanism blocked by rostafuroxin

may

also be involved in organ damage. CVie Therapeutics completed

three

clinical trials assessing rostafuroxin, including a phase

clinical trial which was conducted in

two

parts,

one

in Caucasian patients in Italy and

one

in Chinese patients in Taiwan. While the blood pressure reduction in Caucasians was notable, there was

blood pressure response in Chinese patients. We are analyzing the results of these studies potentially to understand the reasons for the limited response in Chinese patients. In

2019,

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

– Business – Company Overview” in this Annual Report on Form

-K, 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 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Indefinite intangible asset	$ 77,090	$ 77,090
Istaroxime Drug Candidate [Member]
Indefinite intangible asset	22,340	22,340
Rostafuroxin Drug Candidate [Member]
Indefinite intangible asset	$ 54,750	$ 54,750

Note 12 - Convertible Note Payable - Convertible Note Interest Expense (Details) - Convertible Notes Payable [Member] $ in Thousands	12 Months Ended
	Dec. 31, 2018 USD ($)
Non-cash amortization of debt discounts	$ 833
Cash interest expense	106
Total convertible note interest expense	$ 939

Note 21 - Selected Quarterly Financial Data (Unaudited) - Schedule of Quarterly Financial Data (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended											9 Months Ended		12 Months Ended
	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Grant revenue					$ 70	$ 695			$ 17	$ 1,147	$ 219			$ 765	$ 1,383
Total revenues				304	229	1,051	204	102	17	1,147	219	$ 198	$ 1,484	1,788	1,485
Research and development	3,792			2,368	2,197	2,879	3,118	2,418	3,062	5,483	6,413	10,547	8,194	10,562	17,376
Selling, general and administrative	3,395			2,787	1,500	1,208	1,926	1,182	1,749	1,804	1,922	9,990	4,634	7,421	6,657
Total expenses	7,187			5,155	3,697	4,087	5,044	3,600	4,811	7,287	8,335	20,537	12,828	17,983	24,033
Operating loss	(7,187)			(4,851)	(3,468)	(3,036)	(4,840)	(3,498)	(4,794)	(6,140)	(8,116)	(20,339)	(11,344)	(16,195)	(22,548)
Other income / (expense), net				(4,191)	(459)	(16)	328	5,971	(649)	(612)	(608)			(4,338)	4,102
Net (loss) / income	(7,126)	$ (6,437)	$ (6,537)	(9,042)	(3,927)	(3,052)	(4,512)	2,473	(5,443)	(6,752)	(8,724)	(20,100)	(11,491)	(20,533)	(18,446)
AEROSURF warrant dividend				(12,505)										(12,505)
Deemed dividend on preferred stock				(1,718)					(2,234)	(532)	(3,604)			(1,718)	(6,370)
Net (loss) / income attributable to common shareholders				$ (23,265)	$ (3,927)	$ (3,052)	$ (4,512)	$ 2,473	$ (7,677)	$ (7,284)	$ (12,328)			$ (34,756)	$ (24,816)
Net (loss) / income per common share - basic (in dollars per share)				$ (3.24)	$ (1.04)	$ (0.81)	$ (1.40)	$ 1.03	$ (10.53)	$ (14.37)	$ (27.40)			$ (7.74)	$ (24.14)
Net (loss) / income per common share - diluted (in dollars per share)				$ (3.24)	$ (1.04)	$ (0.81)	$ (1.40)	$ 0.97	$ (10.53)	$ (14.37)	$ (27.40)			$ (7.74)	$ (24.14)
Weighted average number of common shares outstanding - basic (in shares)				7,191	3,769	3,751	3,227	2,405	729	507	450			4,493	1,028
Weighted average number of common shares outstanding - diluted (in shares)				7,191	3,769	3,751	3,227	2,540	729	507	450			4,493	1,028
License [Member]
License revenue with affiliate				$ 304	$ 159	$ 356	$ 204	$ 102				$ 198	$ 719	$ 1,023	$ 102

Note 20 - Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Income tax benefit, statutory rates	$ (4,312)	$ (6,272)
State taxes on income, net of federal benefit	(535)	(398)
Impact of tax reform	5	71,151
Research and development tax credit	(351)	(797)
Foreign rate differential	24
Employee related	2,875	953
Interest related	186	(147)
Income tax expense / (benefit), statutory rates	(2,108)	64,490
Valuation allowance	2,108	(64,490)
Income tax benefit, net

Note 8 - Restructured Debt Liability

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Long-term Debt [Text Block]

Note

–

Restructured Debt Liability

	September 30,		December 31,
(in thousands)	2019		2018

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

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. (Deerfield Loan) in the aggregate principal amount of

$25

million and (ii) warrants to purchase up to

25,000

shares of our common stock at an exercise price of

$786.80

per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of

$2.5

million, (ii)

71,111

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

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

million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement (

see

, Note

– 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.

Note

–

Restructured Debt Liability

	December 31,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

November 1, 2017,

$25

million and (ii) warrants to purchase up to

25,000

shares of our common stock at an exercise price of

$786.80

per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of

$2.5

million, (ii)

71,111

shares of common stock, representing

$15

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

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.

Document And Entity Information	9 Months Ended
Document And Entity Information	Sep. 30, 2019
Document Information [Line Items]
Entity Registrant Name	WINDTREE THERAPEUTICS INC /DE/
Entity Central Index Key	0000946486
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	true
Document Type	S-1
Document Period End Date	Sep. 30, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q3
Amendment Flag	false

Note 19 - Litigation

12 Months Ended

Dec. 31, 2018

Legal Matters and Contingencies [Text Block]

Note

–

Litigation

We are

not

aware of any pending or threatened legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.

We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if

not

resolved, could be time-consuming and result in costly litigation. There can be

assurance that an adverse result in any future proceeding would

not

have a potentially material adverse effect on our business, results of operations and financial condition.

Note 8 - Property and Equipment

12 Months Ended

Dec. 31, 2018

Property, Plant and Equipment Disclosure [Text Block]

Note

–

Property and Equipment

Property and equipment is comprised of the following:

	December 31,
(in thousands)	2018			2017

Manufacturing, laboratory & office equipment	$	4,359		$	4,965
Furniture & fixtures		390			615
Leasehold improvements		2,469			2,458
Subtotal		7,218			8,038
Accumulated depreciation and amortization		(6,416	)		(7,153	)
Property and equipment, net	$	802		$	885

Depreciation expense on property and equipment for the years ended

December 31, 2018

and

2017

was

$0.2

million and

$0.2

million, respectively.

Note 9 - Collaboration and Device Development Payable (Details Textual)			12 Months Ended
	Dec. 21, 2018 USD ($) $ / shares shares	Dec. 07, 2018 USD ($) $ / shares shares	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)	Sep. 30, 2019 USD ($)	Dec. 06, 2018 USD ($)
Collaboration and Device Development Payable, Current		$ 4,400,000	$ 2,576,000	$ 4,418,000	$ 1,873,000
Gain (Loss) on Extinguishment of Debt, Total			(3,345,000)
Conversion of Battelle Payables [Member]
Gain (Loss) on Extinguishment of Debt, Total	$ (500,000)
Debt Conversion, Converted Instrument, Amount	1,500,000
Debt Conversion, Original Debt, Amount	1,000,000
Private Placement [Member]
Debt Conversion, Original Debt, Amount	$ 6,000,000
Private Placement [Member] \| Series F Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	2,003,541
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares	$ 3.68
Warrants and Rights Outstanding, Term	1 year 180 days
Private Placement [Member] \| Series G Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	3,889,229
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares	$ 4.05
Warrants and Rights Outstanding, Term	5 years
Payment Restructuring of Battelle Payables [Member]
Collaboration and Device Development Payable, Interest Rate		6.00%
Collaboration and Device Development Payable, Repaid Payable Threshold to Qualify for Services on Credit		$ 3,000,000
Payments for Collaboration and Device Development Payable		972,281
Collaboration and Device Development Agreement, Aggregate Payments		$ 1,250,000
Collaboration and Device DevelopmentPayable, Number of Monthly Installments Payments Deferred		5
Collaboration and Device Development Payable, Periodic Payment, Total		$ 250,000
Royalty Guarantees, Commitments, Amount		$ 35,000,000				$ 25,000,000
Interest Payable, Current			$ 300,000
Payment Restructuring of Battelle Payables [Member] \| Series E Warrants [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares		$ 6.50
Warrants and Rights Outstanding, Term		5 years
Common Stock Maximum Ownership Percentage For Warrant Exercise		9.99%
Payment Restructuring of Battelle Payables [Member] \| Series E Warrants [Member] \| Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares		75,000
Payment Restructuring of Battelle Payables [Member] \| Private Placement [Member]
Collaboration and Device Development Payable, Converted Payable Amount into Equity	$ 1,000,000
Sale of Stock, Number of Shares Issued in Transaction \| shares	301,823
Sale of Stock, Price Per Share \| $ / shares	$ 3.3132
Payment Restructuring of Battelle Payables [Member] \| Private Placement [Member] \| Series F Warrants [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares	$ 3.68
Warrants and Rights Outstanding, Term	1 year 180 days
Payment Restructuring of Battelle Payables [Member] \| Private Placement [Member] \| Series F Warrants [Member] \| Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	51,310
Payment Restructuring of Battelle Payables [Member] \| Private Placement [Member] \| Series G Warrants [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares	$ 4.05
Warrants and Rights Outstanding, Term	5 years
Payment Restructuring of Battelle Payables [Member] \| Private Placement [Member] \| Series G Warrants [Member] \| Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	99,602

Note 20 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Net operating loss carryforwards (federal and state)	$ 176,759	$ 168,263
Research and development tax credit	16,718	16,813
Compensation expense on stock	1,121	1,191
Charitable contribution carryforward		5
Other accrued	1,016	2,547
Deferred revenue	57	317
Depreciation	309	297
Total long-term deferred tax assets	195,980	189,433
IPR&D	(15,476)
Total long-term deferred tax liabilities	(15,476)
Valuation allowance	(195,980)	(189,433)
Deferred tax liabilities, net	$ (15,476)

Note 10 - Leases - Lease Costs (Details) $ in Thousands	3 Months Ended	9 Months Ended
Note 10 - Leases - Lease Costs (Details) $ in Thousands	Sep. 30, 2019 USD ($)	Sep. 30, 2019 USD ($)
Operating lease cost	$ 212	$ 677
Variable lease cost	5	17
Total lease cost	217	694
Operating cash flows used for operating leases	227	721
Operating lease liabilities arising from obtaining right-of-use assets	$ 232	$ 364
Weighted average remaining lease term (in years) (Year)	2 years 146 days	2 years 146 days
Weighted average incremental borrowing rate	9.00%	9.00%

Consolidated Balance Sheets (Parentheticals) - $ / shares	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017	Feb. 15, 2017
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0	2,701
Preferred stock, shares outstanding (in shares)	0	0	2,701
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	120,000,000	120,000,000	120,000,000
Common stock, shares issued (in shares)	32,188,929	32,133,263	3,227,495
Common stock, shares outstanding (in shares)	32,188,855	32,133,189	3,227,421
Treasury stock, shares (in shares)	74	74	74

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Current Assets:
Cash and cash equivalents	$ 4,437,000	$ 11,187,000
Available-for-sale marketable securities		13,959,000
Prepaid expenses and other current assets	826,000	507,000
Total current assets	5,263,000	25,653,000
Property and equipment, net	877,000	802,000
Restricted cash	154,000	171,000
Operating lease right-of-use assets	1,566,000
Indefinite intangible asset	77,090,000	77,090,000
Goodwill	15,682,000	15,682,000
Total assets	100,632,000	119,398,000
Current Liabilities:
Accounts payable	607,000	3,420,000
Collaboration and device development payable, net	1,873,000	2,576,000
Accrued expenses	5,235,000	6,465,000
Operating lease liabilities - current portion	781,000
Deferred revenue - current portion		198,000
Loan payable	7,782,000	7,974,000
Total current liabilities	16,278,000	20,633,000
Operating lease liabilities - non-current portion	953,000
Restructured debt liability - contingent milestone payments	15,000,000	15,000,000
Deferred tax liabilities	15,224,000	15,476,000
Other liabilities	106,000	175,000
Total liabilities	47,561,000	51,284,000
Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares and 2,701 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively	0	0
Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2018 and December 31, 2017; 32,133,263 and 3,227,495 shares issued at December 31, 2018 and December 31, 2017, respectively; 32,133,189 shares and 3,227,421 shares outstanding at December 31, 2018 and December 31, 2017, respectively	32,000	32,000
Additional paid-in capital	733,840,000	728,783,000
Accumulated deficit	(677,747,000)	(657,647,000)
Accumulated other comprehensive income		0
Treasury stock (at cost); 74 shares	(3,054,000)	(3,054,000)
Total stockholders' equity	53,071,000	68,114,000
Total liabilities & stockholders' equity	$ 100,632,000	$ 119,398,000

Note 5 - License Revenue with Affiliate

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Revenue from Contract with Customer [Text Block]

Note

–

License Revenue with Affiliate

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

License revenue with affiliate	$	-	$	159	$	198	$	719

606.

As of

June 30, 2019,

all revenue related to the License Agreement was recognized and

future material performance obligations are due.

Note

–

License Revenue with Affiliate

	Year Ended December 31,
(in thousands)	2018		2017

License revenue with affiliate	$	1,023	$	102

License revenue with affiliate for years ended

December 31, 2018

and

2017

represents revenue from a License Agreement with Lee’s (HK) and constitutes a contract with a customer accounted for in accordance with ASC Topic

606,

which we adopted effective

January 1, 2018 (

see

, Note

– Accounting Policies and Recent Accounting Pronouncements, and Note

– Collaboration, Licensing and Research Funding Agreements). There was

impact to License revenue with affiliate previously recognized as a result of the adoption of ASC Topic

606.

Note 13 - Restructured Debt Liability

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Long-term Debt [Text Block]

Note

–

Restructured Debt Liability

	September 30,		December 31,
(in thousands)	2019		2018

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

November 1, 2017,

$25

million and (ii) warrants to purchase up to

25,000

shares of our common stock at an exercise price of

$786.80

per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of

$2.5

million, (ii)

71,111

shares of common stock, representing

$15

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

million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement (

see

, Note

not

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

Note

–

Restructured Debt Liability

	December 31,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

November 1, 2017,

$25

million and (ii) warrants to purchase up to

25,000

shares of our common stock at an exercise price of

$786.80

per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of

$2.5

million, (ii)

71,111

shares of common stock, representing

$15

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

million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement (

see

, Note

not

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

Note 21 - Selected Quarterly Financial Data (Unaudited)

12 Months Ended

Dec. 31, 2018

Quarterly Financial Information [Text Block]

Note

–

Selected Quarterly Financial Data (Unaudited)

The following tables contain unaudited statement of operations information for each quarter of

2018

and

2017.

The operating results for any quarter are

not

necessarily indicative of results for any future period.

2018 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	-		$	695		$	70		$	-		$	765
License revenue with affiliate		204			356			159			304			1,023
Total revenues		204			1,051			229			304			1,788
Expenses:
Research and development		3,118			2,879			2,197			2,368			10,562
Selling, general and administrative		1,926			1,208			1,500			2,787			7,421
Total expenses		5,044			4,087			3,697			5,155			17,983
Operating loss		(4,840	)		(3,036	)		(3,468	)		(4,851	)		(16,195	)
Other income / (expense), net		328			(16	)		(459	)		(4,191	)		(4,338	)
Net (loss) / income	$	(4,512	)	$	(3,052	)	$	(3,927	)	$	(9,042	)	$	(20,533	)
AEROSURF warrant dividend		-			-			-			(12,505	)		(12,505	)
Deemed dividend on preferred stock		-			-			-			(1,718	)		(1,718	)
Net (loss) / income attributable to common shareholders	$	(4,512	)	$	(3,052	)	$	(3,927	)	$	(23,265	)	$	(34,756	)
Net (loss) / income per common share - basic	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Net (loss) / income per common share - diluted	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Weighted average number of common shares outstanding - basic		3,227			3,751			3,769			7,191			4,493
Weighted average number of common shares outstanding - diluted		3,227			3,751			3,769			7,191			4,493

2017 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	219		$	1,147		$	17		$	-		$	1,383
License revenue with affiliate		-			-			-			102			102
Total revenues		219			1,147			17			102			1,485
Expenses:
Research and development		6,413			5,483			3,062			2,418			17,376
Selling, general and administrative		1,922			1,804			1,749			1,182			6,657
Total expenses		8,335			7,287			4,811			3,600			24,033
Operating loss		(8,116	)		(6,140	)		(4,794	)		(3,498	)		(22,548	)
Other income / (expense), net		(608	)		(612	)		(649	)		5,971			4,102
Net (loss) / income	$	(8,724	)	$	(6,752	)	$	(5,443	)	$	2,473		$	(18,446	)
Deemed dividend on preferred stock		(3,604	)		(532	)		(2,234	)		-			(6,370	)
Net (loss) / income attributable to common shareholders	$	(12,328	)	$	(7,284	)	$	(7,677	)	$	2,473		$	(24,816	)
Net (loss) / income per common share - basic	$	(27.40	)	$	(14.37	)	$	(10.53	)	$	1.03		$	(24.14	)
Net (loss) / income per common share - diluted	$	(27.40	)	$	(14.37	)	$	(10.53	)	$	0.97		$	(24.14	)
Weighted average number of common shares outstanding - basic		450			507			729			2,405			1,028
Weighted average number of common shares outstanding - diluted		450			507			729			2,540			1,028

F-

Note 5 - Accounting Policies and Recent Accounting Pronouncements

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Significant Accounting Policies [Text Block]

Note

–

Summary of Significant Accounting Policies

Principles of

onsolidation

The condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree Therapeutics, Inc. and its wholly-owned subsidiaries, CVie Investments, CVie Therapeutics, and a presently inactive subsidiary, Discovery Laboratories, Inc.

Business

ombinations

We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value of the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results

may

differ materially from estimates.

Goodwill and

ntangible

ssets

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 (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

September 30, 2019

and

December 31, 2018:

(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. We perform an annual impairment test for goodwill and evaluate the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such an assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Foreign

urrency

ransactions

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). Foreign currency transactions resulted in gains of approximately

$0.1

million and

$0.4

million for the

three

and

nine

months ended

September 30, 2019.

There were

foreign currency transaction gains or losses for the

three

and

nine

months ended

September 30, 2018.

Use of

stimates

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.

Marketable

ecurities

Marketable securities consist of investments in US Treasury securities. Management determines the appropriate classification of these securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. We classify investments as available-for-sale pursuant to Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC)

320,

Investments—Debt and Equity Securities. Investments are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in other income (expense) on a specific-identification basis. For the

three

months ended

September 30, 2019,

we had

$14,000

in realized gains and

$12,000

in unrealized losses on marketable securities. For the

nine

months ended

September 30, 2019,

we had

$75,000

in realized gains and our unrealized gains and losses on marketable securities netted to zero. There were

realized or unrealized gains or losses on investments for the

three

and

nine

months ended

September 30, 2018.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the condensed consolidated statements of operations if we have experienced a credit loss, have the intent to sell the investment, or if it is more likely than

not

that we will be required to sell the investment before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with our investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period.

Available-for-sale marketable securities are classified as marketable securities, current or marketable securities, non-current depending on the contractual maturity date of the individual available-for-sale security.

Leases

Effective

January 1, 2019,

we adopted ASC Topic

842,

Leases

(ASC

842

), using the modified retrospective transition approach and utilizing the effective date as the date of initial application. Consequently, prior period balances and disclosures have

not

been restated and are presented in accordance with the previous guidance in ASC Topic

840,

Leases

At the inception of an arrangement, we determine whether an arrangement is, or contains, a lease based on the unique facts and circumstances present in the arrangement. An arrangement is, or contains, a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than

one

year are generally recognized on the balance sheet as operating lease right-of-use assets and current and non-current operating lease liabilities, as applicable. We elected

not

to recognize on the balance sheet leases with terms of

months or less. We typically only include the initial lease term in our assessment of a lease arrangement. Options to extend a lease are

not

included in our assessment unless there is reasonable certainty that we will renew.

Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset

may

be required for items such as incentives received. The interest rate implicit in our leases is typically

not

readily determinable. As a result, we utilize our incremental borrowing rate, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. In transition to ASC

842,

we utilized the remaining lease term of our leases in determining the appropriate incremental borrowing rates.

Restructured

ebt

iability –

ntingent

ilestone

ayment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

ee,

Note

– Restructured Debt Liability), we established a

$15

million long-term liability for contingent AEROSURF regulatory and commercial milestone payments, beginning with the filing for marketing approval in the United States, potentially due under the Exchange and Termination Agreement dated as of

October 27, 2017 (

Exchange and Termination Agreement), between ourselves and affiliates of Deerfield Management Company L.P. (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

evelopment

We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical medical and regulatory operations, and (c) direct 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 ASC Topic

730,

Research and Development

Net

oss per

ommon

hare

Basic net loss per 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

September 30, 2019

and

2018,

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

15.6

million and

1.3

million shares, respectively. For the

three

and

nine

months ended

September 30, 2019

and

2018,

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

Income

axes

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.

Recently

dopted

ccounting

tandards

February 2016,

the FASB issued Accounting Standards Update (ASU)

No.

2016

02,

Leases

(ASU

2016

). ASU

2016

establishes ASC

842

which amends ASC

840,

Leases

, by introducing a lessee model that requires balance sheet recognition for most leases and the disclosure of key information about leasing arrangements. ASC

842

was subsequently amended during

2018.

Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. We adopted the new standard using the required modified retrospective approach on

January 1, 2019

and used the effective date as its date of initial application. Consequently, financial information is

not

updated and the disclosures required under the new standard are

not

provided for dates and periods prior to

January 1, 2019.

Instead, the requirements of ASC

840

are presented for these prior periods.

ASC

842

provides several optional practical expedients in transition. We elected the package of practical expedients which allowed us to

not

reassess our existing conclusions on lease identification, classification, and initial direct costs. Further, we elected to utilize the short-term lease exemption for all leases with an original term of

months or less, for purposes of applying the recognition and measurement requirements of the new standard. We also elected the practical expedient to

not

separate lease and non-lease components for all our leases.

The adoption of this standard resulted in the recognition of operating lease liabilities and related right-of-use assets on our condensed consolidated balance sheets of

$2.2

million and

$2.0

million, respectively, related to our operating leases. The adoption of ASC

842

also resulted in the elimination of deferred rent of approximately

$72,000

and

$139,000

in accrued expenses and other long-term liabilities, respectively, in our condensed consolidated balance sheets. The adoption of the standard did

not

have a material impact on our condensed consolidated statements of operations and comprehensive loss or condensed consolidated statements of cash flows. Refer to Note

– Leases, for our current lease commitments.

January 2017,

the FASB issued ASU

No.

2017

04,

"Intangibles-Goodwill and Other (Topic

350

): Simplifying the Test for Goodwill Impairment." The new standard simplifies the subsequent measurement of goodwill by eliminating the

second

step of the goodwill impairment test. This ASU will be applied prospectively and is effective for annual or interim goodwill impairment tests in fiscal years beginning after

December 15, 2019

with early adoption permitted. We adopted this guidance on

January 1, 2019

and will apply it to our annual impairment test, and any interim impairment tests during the year ending

December 31, 2019.

Recently Issued Accounting Standards

August 2018,

the FASB issued ASU

No.

2018

13,

"Fair Value Measurement (Topic

820

): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement" (ASU

2018

), which removes, adds and modifies certain disclosure requirements for fair value measurements in Topic

820.

Companies will

longer be required to disclose the amount of and reasons for transfers between Level

and Level

of the fair value hierarchy as well as the valuation processes of Level

fair value measurements. However, companies will be required to additionally disclose the changes in unrealized gains and losses included in other comprehensive income for recurring Level

fair value measurements and the range and weighted average of assumptions used to develop significant unobservable inputs for Level

fair value measurements. ASU

2018

is effective for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2019.

The amendments relating to additional disclosure requirements will be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. All other amendments will be applied retrospectively to all periods presented upon their effective date. We are currently evaluating the impact that the adoption of ASU

2018

will have on our condensed consolidated financial statements.

Note

–

Accounting Policies and Recent Accounting Pronouncements

Principles of consolidation

The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (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.).

Business

ombinations

We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results

may

differ materially from estimates.

Goodwill and

ntangible

ssets

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 (“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

December 31, 2018:

(in thousands)	Estimated Fair 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 assets acquired and liabilities assumed in a business combination and is

not

amortized. We perform an annual impairment test for goodwill and evaluates the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Foreign

urrenc

y transactions

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

not

$0.1

million for the year ended

December 31, 2018.

There were

foreign currency transaction gains or losses for the year ended

December 31, 2017.

Use of estimates

The preparation of financial statements, in conformity with accounting principles generally accepted in the U. S., 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 in at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of

days or less that are readily convertible into cash.

Marketable securities

320,

Investments—Debt and Equity Securities. Investments are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were

realized gains or losses on marketable securities for the years ended

December 31, 2018

and

2017.

There were

unrealized gains or losses on investments for the years ended

December 31, 2018

and

2017.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if we have experienced a credit loss, have the intent to sell the investment, or if it is more likely than

not

Fair value of financial instruments

Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying amount of cash equivalents is equal to their respective fair values at

December 31, 2018

and

2017,

respectively. We determine the fair value of marketable securities on quoted market prices or other relevant information generated by market transactions involving identical or comparable assets. Accounts payable and accrued expenses are carried at cost, which approximates fair value because of their short maturity. The carrying amount of loan payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk.

Property and equipment

Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally

three

ten

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

Restricted cash

Restricted cash consists principally of a

$140,000

certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated

May 26, 2004

for our headquarters location in Warrington, Pennsylvania and

$31,000

in deposits held by our landlord for our offices in Taipei, Taiwan, the former headquarters of CVie Therapeutics (

see,

– Note

– Commitments, for further discussion on our leases).

Long-lived assets

Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset

may

not

be recoverable, or its estimated useful life has changed significantly. When the undiscounted cash flows of an asset are less than its carrying value, an impairment is recorded and the asset is written down to estimated value.

impairment was recorded during the years ended

December 31, 2018

and

2017

as management believes there are

circumstances that indicate the carrying amount of the assets will

not

be recoverable.

Collaborative arrangements

We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic

808,

Collaborative Arrangements

See,

– Note

– Collaboration, Licensing and Research Funding Agreements.

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

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.

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (

see

, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – current portion. Amounts

not

expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in

July 2017

in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (

see

, Note

– Collaboration and Device Development Payment Restructuring, Licensing and Research Funding Agreements).

Revenue recognition

Effective

January 1, 2018,

we adopted Accounting Standards Codification (“ASC”) Topic

606,

Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic

606,

if any, as an adjustment to the opening balance of retained earnings. Additionally, under this method of adoption, we apply the guidance to all incomplete contracts in scope as of the date of initial application. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

In accordance with ASC Topic

606,

we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC Topic

606,

we perform the following

five

steps:

	(i)		identify the contract(s) with a customer;

	(ii)		identify the performance obligations in the contract;

	(iii)		determine the transaction price;

	(iv)		allocate the transaction price to the performance obligations in the contract; and

	(v)		recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the

five

-step model to contracts when we determine that it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic

606,

we assess the goods or services promised within a contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

We have concluded that our government grants are

not

within the scope of ASC Topic

606

as they do

not

meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic

958

605,

Not

-for-Profit-Entities-Revenue Recognition does

not

apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under US GAAP, effective

January 1, 2018,

we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic

606,

to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services, even though there is

exchange as defined in ASC Topic

606.

We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic

606.

Prior to

January 1, 2018,

we recognized revenue as related costs were incurred under the grants given that persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Recognized amounts reflected our performance under the grants and equal direct and indirect costs incurred. Revenue and expenses under these arrangements were presented gross. Revenue recognition under this new policy is

not

materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was

change to the amounts we have historically recorded in our financial statements.

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 Accounting Standards Codification (ASC) Topic

730,

Research and Development

Stock-based compensation

Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic

718,

Stock Compensation

(ASC Topic

718

See

, – Note

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

Warrant accounting

We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s Own Equity

(ASC Topic

815

), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement.

Income taxes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes, 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.

not

assured.

Beneficial Conversion Feature

A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date.

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the

first

quarter of

2017

(see, “– Note

– Stockholders’ Equity”) resulted in a beneficial conversion feature. We recognized this feature by allocating the intrinsic value of the beneficial conversion feature, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a

$3.6

million

one

-time, non-cash deemed dividend to the preferred shareholders during the

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted. For the years ended

December 31, 2018

and

December 31, 2017,

we recognized a non-cash deemed dividend to the preferred shareholders of

$1.7

million and

$2.8

million, respectively, related to the Preferred Shares converted during the period. As of

December 31, 2018,

there were

Preferred Shares remaining to be converted.

Convertible Note

The issuance on

July 2, 2018

of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of

$1.5

million resulted in a beneficial conversion feature. We recognized this feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, resulting in a discount on the Note. We recorded the Note as current debt at its face value of

$1.5

million less debt discount consisting of (i)

$0.4

million related to the beneficial conversion feature and (ii)

$0.4

million in fair value of the warrants issued in connection with the Note. The discount was accreted to the

$1.5

million loan over its term using the effective interest method (

see

, – Note

– Loan Payable). On

December 27, 2018,

we repaid the Note in its entirety in cash of

$1.5

million. As part of the extinguishment of debt, we recorded a gain on extinguishment of debt of approximately

$0.4

$5.11

and the conversion price of

$4.00,

and (ii)

375,000

shares convertible into common stock.

Net loss per common share

December 31, 2018

and

2017,

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

14.4

million and

1.0

million shares, respectively. As of

December 31, 2018

and

2017,

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 income (loss).

Concentration of Suppliers

We currently obtain the active pharmaceutical ingredients (APIs) of our

KL4

surfactant drug products from single-source suppliers. In addition, we rely on a number of

third

-party institutions and laboratories that perform various studies as well as quality control release and stability testing and other activities related to our

KL4

surfactant development and manufacturing activities. At the present time, several of these laboratories are single-source providers. The loss of

one

or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations.

Business segments

We currently operate in

one

business segment, which is the research and development of products focused on acute pulmonary and cardiovascular diseases, and the manufacture and commercial sales of approved products. We are managed and operated as

one

business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do

not

operate separate lines of business with respect to our product candidates.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

May 2014,

the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which was subsequently amended by several other ASUs related to Topic

606

to, among other things, defer the effective date and clarify various aspects of the new revenue guidance including principal versus agent considerations, identifying performance obligations, licensing, and other improvements and practical expedients. We adopted ASU

2014

09,

as amended, effective

January 1, 2018

using the modified retrospective transition method. In

June 2017,

we entered into a License Agreement with Lee’s Pharmaceutical (HK) Ltd. (Lee’s (HK)), granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory. The consideration we are eligible to receive under this agreement includes an upfront payment, contingent revenues in the form of regulatory and commercial milestones, and sales-based milestone and royalty payments. We evaluated the License Agreement under ASU

2014

and determined that there was

material impact to revenues for any of the years presented upon adoption. Additionally, there were

revisions to any balance sheet components of revenues such as deferred revenues or beginning retained earnings as a result of using the modified retrospective method. The primary impact on our financial statements is related to revised or additional disclosures with respect to revenues and cash flows arising from contracts with customers (

See,

“– Note

– Collaboration, Licensing and Research Funding Agreements).

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

), Scope of Modification Accounting

. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

), Classification of Certain Cash Receipts and Cash Payments

. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to

eight

specific cash flow issues, including debt prepayment or extinguishment costs, with the objective of reducing diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The ASU also clarifies how the predominance principle should be applied when cash receipts and cash payments have aspects of more than

one

class of cash flows. The ASU is effective retrospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2016

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

January 2017,

the FASB issued ASU

2017

01,

Business Combinations (Topic

805

), Clarifying the Definition of a Business

. The FASB changed its definition of a business in an effort to help entities determine whether a set of transferred assets and activities is a business. The guidance requires an entity to

first

evaluate whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this threshold is met, the set of transferred assets and activities is

not

a business. If the threshold is

not

met, the entity evaluates whether the set meets the requirements of a business, which includes, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. The ASU is effective for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

Recent Accounting Pronouncements

February 2016,

the FASB issued ASU

2016

02,

Leases

(Topic

842

). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective

January 1, 2019.

Early adoption is permitted. The standard requires a modified retrospective approach; however, the FASB recently added a transition option to the leases standard that allows entities to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. We have

not

elected to early adopt this standard. While we continue to assess all the effects of adoption, we believe the most significant effect relates to the recognition of right-of-use assets and corresponding liabilities on our consolidated balance sheet, primarily related to existing facility operating leases, and providing new disclosures with regards to our leasing activities.

January 2017,

the FASB issued ASU

2017

04,

Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment

. ASU

2017

simplifies the subsequent measurement of goodwill by removing the

second

step of the

two

-step impairment test and specifies that goodwill impairment should be measured by comparing the fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should

not

exceed the total amount of goodwill allocated to that reporting unit. An entity still has the option to perform the qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. ASU

2017

is effective for annual or interim goodwill impairment tests performed in fiscal years beginning after

December 15, 2019;

early adoption is permitted. We currently anticipate that the adoption of ASU

2017

will

not

have a material impact on our financial statements.

Note 14 - Stockholders' Equity

12 Months Ended

Dec. 31, 2018

Stockholders' Equity Note Disclosure [Text Block]

Note

–

Stockholders’ Equity

Private Placement Offerings

December 2018

Private Placement

Financing

December 21, 2018,

we completed a private placement offering and entered into a Registration Rights Agreement with select institutional investors (Investors), for the purchase of an aggregate of

11,785,540

shares of common stock at a price per share of

$3.3132,

for an aggregate purchase price of approximately

$39.0

million (Private Placement Financing). Included in the purchase price, each of LPH II Investments Limited (LPH II), an affiliate of Lee’s Pharmaceutical Holdings Ltd. (Lee’s), and Battelle, converted

$6.0

million and

$1.0

million, respectively, of existing debt obligations on the same terms as the other Investors. In connection with the offering, we issued (i) Series F Warrants to purchase an aggregate of

2,003,541

shares of common stock at an exercise price equal to

$3.68

per share, which are exercisable through the

-month anniversary of the date of issuance (the Series F Warrants), and (ii) Series G Warrants to purchase an aggregate of

3,889,229

shares of common stock at an exercise price equal to

$4.05

per share, which are exercisable through the

-year anniversary of the date of issuance (the Series G Warrants and, together with the Series F Warrants, the

December 2018

Warrants). The

December 2018

Warrants (i)

may

not

be exercised to the extent that following such exercise, the holder would beneficially own more than

9.99%

(or other percent as designated by each holder) of our outstanding shares of common stock, and (ii) contain customary provisions that adjust the exercise price and the number of shares of common stock into which the

December 2018

Warrants are exercisable in the event of a corporate transaction.

Under the Registration Rights Agreement, we agreed to file by

May 1, 2019

a resale registration statement with the SEC to register for subsequent resale the shares of common stock issued in the Private Placement Financing and the shares of common stock to be issued upon exercise of the

December 2018

Warrants.

April 2018

Private Placement

April 4, 2018,

we completed a private placement offering and entered into a Registration Rights Agreement with LPH II for the purchase of

$2.6

million of our common stock at a purchase price per share of

$4.80,

and issued

541,667

shares of common stock and warrants to purchase

135,417

shares of our common stock at an exercise price of

$5.52

per share. The warrants are exercisable after

months and through the

seventh

anniversary of the issue date. Under the Registration Rights Agreement, we agreed to file an initial resale registration statement with the SEC to register for subsequent resale the shares and the warrant shares. We are required to seek registration of

25%

of the shares and warrant shares on such initial resale registration statement. From time to time, following the

180th

day from

March 30, 2018,

LPH II or a majority of the holders of the shares and warrant shares

may

require us to file additional registration statement(s) to register the resale of the balance of the shares and warrant shares, subject to certain limitations.

Share Purchase Agreement

Effective

October 27, 2017,

we entered into a Share Purchase Agreement (SPA) with LPH, an affiliate of Lee’s. Under the agreement, LPH invested

$10

million (the Investment) in our common stock and acquired

2,311,604

shares (the Shares), at a price of

$4.326

per share, which represented a

15%

premium over the average of the daily volume-weighted average price per share (VWAP) over the

-day trading period ending on and including the date of the SPA. Following the transactions described in the SPA, LPH beneficially owned

73%

of our issued and outstanding shares of common stock. The Investment included cancellation of

$3.9

million in outstanding loans that we borrowed from Lee’s (HK) under the Loan Agreement, effective

August 14, 2017,

between ourselves and Lee's (HK). Although the SPA granted LPH the right to appoint up to

two

individuals to serve on our Board of Directors, and LPH was permitted to designate such individuals on or prior to the

30th

day following the closing of the transactions contemplated by the SPA (the Closing)

such appointments were made. In addition, the SPA also amended the executive employment agreement of each of our President and Chief Executive Officer (Craig Fraser), Senior Vice President and Chief Financial Officer (John A. Tattory) and Senior Vice President and Chief Medical Officer (Steven G. Simonson, M.D.), such that the executives agreed to waive the guaranteed Annual Bonuses (as defined in each executive's employment agreement) that otherwise would have been payable to the executives during the

-month period following the change of control to Lee’s. Also under the SPA, each executive was awarded restricted stock units under our

2011

Long-Term Incentive Plan, as amended, having a value when issued equal to the combined total value of the

2017

and

2018

Target Bonus Amounts (as defined in each executive's employment agreement) and initially vesting in

two

equal installments on

March 15, 2018

and

March 15, 2019.

Under the terms of the SPA, we also granted to LPH a preemptive right to purchase in future offerings of equity securities up to that number of shares of our equity securities needed to maintain LPH's percentage of beneficial ownership of our outstanding voting stock immediately prior to each such offering, subject to certain limitations and exclusions.

Contemporaneously with the execution of the SPA, we and LPH entered into a registration rights agreement pursuant to which we agreed to provide certain registration rights with respect to the Shares under the SPA, which rights are limited to registration of up to

25%

of the Shares during the initial

-month period following the closing of the SPA. We issued the Shares to LPH pursuant to Rule

506

(b) of Regulation D and Regulation S under, and Section

(a)(

) of, the Securities Act of

1933.

February 2017

Private Placement

February 15, 2017,

we completed a private placement offering of

7,049

Series A Convertible Preferred Stock units at a price per unit of

$1,495,

for an aggregate purchase price of approximately

$10.5

million, including

$1.6

million of non-cash consideration representing a reduction in amounts due and accrued as of

December 31, 2016

for current development services that otherwise would have become payable in cash in the

first

and

second

quarters of

2017.

Each unit consisted of: (i)

one

share of Series A Convertible Preferred Stock, par value

$0.001

per share (Preferred Shares); and (ii) Series A-

Warrants to purchase

shares of common stock at an exercise price equal to

$27.40

per share. Each Preferred Share was convertible at the holder's option at any time into

shares of common stock. The Series A-

Warrants

may

be exercised through

February 15, 2024.

The Preferred Shares and Series A-

Warrants

may

not

be converted or exercised to the extent that the holder would, following such exercise or conversion, would beneficially own more than

9.99%

(or other lesser percent as designated by each holder) of our outstanding shares of common stock. In the event of a liquidation, including without limitation, the sale of substantially all of our assets and certain mergers and other corporate transactions (as defined in the Certificate of Designation of Preferences, Rights and Limitations relating to the Preferred Shares), the holder of Preferred Shares would have had a liquidation preference that could result in the holder receiving a return of its initial investment before any payments are made to holders of common stock, and then participating with other equity holders until it received in the aggregate up to

three

times its original investment. In addition to the offering, the securities purchase agreement also provided that, until

February 13, 2018,

the investors were entitled to participate in subsequent bona fide capital raising transactions.

To facilitate consummation of the Share Purchase Agreement in

October 2017 (

see – Share Purchase Agreement), Battelle, which held

1,095

Preferred Shares, executed a waiver wherein Battelle waived its right to the liquidation preference with respect to their Preferred Shares. We considered the relevant accounting guidance and concluded that the waiver did

not

remove a substantive term or otherwise fundamentally change the Preferred Shares. As a result, the Preferred Shares were modified rather than extinguished, and Battelle did

not

receive incremental fair value in the modification. There was, therefore,

incremental expense to be recognized related to the waiver. In addition, we and Battelle entered into a non-binding memorandum of understanding outlining the key terms for a potential restructuring of the amounts due to Battelle under development and collaboration agreements between ourselves and Battelle.

As of

December 31, 2018,

all outstanding Preferred Shares have been converted into shares of common stock.

At-the-Market Program (ATM Program)

Stifel ATM Program

February 11, 2013,

we entered into an At-the-Market Equity Sales Agreement (ATM Agreement) with Stifel, under which Stifel, as our exclusive agent, at our discretion and at such times that we

may

determine from time to time,

may

sell over a

three

-year period up to a maximum of

$25

million of shares of our common stock (ATM Program). We were

not

required to sell any shares at any time during the term of the ATM Program.

If we issued a sale notice to Stifel, we

may

have designated the minimum price per share at which shares

may

be sold and the maximum number of shares that Stifel is directed to sell during any selling period. We agreed to pay Stifel a commission equal to

3.0%

of the gross sales price of any shares sold pursuant to the ATM Agreement. With the exception of expenses related to the shares, Stifel was responsible for all of its own costs and expenses incurred in connection with the offering.

During

2017,

we completed registered offerings of our common stock under the ATM Program of

42,357

shares, resulting in aggregate gross and net proceeds to us of approximately

$1.1

million and

$1.0

million, respectively.

Effective with our transition to the OTCQB® Market (OTCQB) tier in early

May 2017,

the ATM Program was

longer available to us.

401

(k) Plan Employer Match

We have a voluntary

401

(k) savings plan (

401

(k) Plan) covering eligible employees that allows for periodic discretionary company matches equal to a percentage of each participant’s contributions (up to the maximum deduction allowed, including “catch up” amounts). During

2017,

we provided for the company match by issuing shares of common stock that are registered pursuant to a registration statement on Form S-

filed with the SEC. For the year ended

December 31, 2017,

the match resulted in the issuance of

7,561

shares of common stock. Expense associated with the

401

(k) match for the year ended

December 31, 2017

was

$0.1

million. During

2018,

we did

not

have a company match.

Common Shares Reserved for Future Issuance

Common shares reserved for potential future issuance upon exercise of warrants

The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants:

	December 31,						Expiration
(in thousands, except price per share data)	2018		2017		Exercise Price		Date

Investors - Aerosurf		2,963		-	$	-	02/14/24
Investors - December 2018 financing - long-term		3,889		-	$	4.05	12/04/23
Investors - December 2018 financing - short-term		2,004		-	$	3.68	06/24/20
Battelle - 2018 payables restructuring agreement (1)		75		-	$	6.50	12/07/23
Panacea Venture Management Company Ltd.		188		-	$	4.00	07/02/23
LPH II Investments Limited		135		-	$	5.52	04/04/25
Investors - February 2017 financing		352		352	$	27.40	02/15/24
Investors - July 2015 financing		240		240	$	196.00	07/22/22
Battelle - 2014 collaboration agreement (1)		4		4	$	1,400.00	10/10/24
Total		9,850		596

(

)

See

, – Note

– Collaboration, Licensing and Research Funding Agreements, for further details on the Battelle collaboration agreement.

Common shares reserved for potential future issuance upon exercise of stock options or granting of additional equity incentive awards

At the

2017

Annual Meeting of Stockholders, our stockholders approved an increase in the number of shares available for issuance under our Amended and Restated

2011

Long-Term Incentive Plan (the

“2011

Plan”) by

37,500.

October 25, 2017

the Board of Directors approved an increase to the number of shares available for issuance under the Plan by

1.75

million, which increase was approved by an action of the majority stockholder by written consent without a meeting of shareholders dated as of

November 13, 2017.

December 24,

2018,

the Compensation Committee of our Board of Directors approved an increase in the number of shares available for issuance under the Plan by approximately

4.2

million shares, which increase was also approved by an action by written consent without a meeting of holders of a majority of our outstanding shares of common stock.

As of

December 31, 2018

and

2017,

we had

1.5

million and

1.6

million shares, respectively, available for potential future issuance under the

2011

Plan.

Common shares reserved for potential future issuance under our

401

(k) Plan

As of

December 31, 2018

and

2017,

we had

807

common shares reserved for potential future issuance under the

401

(k) Plan.

Note 4 - Liquidity Risks and Management's Plans

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Liquidity Disclosures [Text Block]

Note

–

Liquidity Risks and Management’s Plans

As of

September 30, 2019,

we had cash and cash equivalents of

$4.4

million and current liabilities of

$16.3

million, including

$7.8

million of Loans payable (

see

, Note

- Loans Payable). On

October 24, 2019,

LPH II Investments Ltd. (LPH II), an affiliate of Lee’s Pharmaceutical Holdings Limited, agreed to lend the Company

$1.0

million to fund the Company’s operations, on an interim basis. We believe that, including the LPH II loan, we currently have cash and cash equivalent resources to fund our business operations through late-

November 2019

while maintaining minimum cash resources to provide for an orderly shutdown of operations, if required.

We have an immediate need for additional capital to continue our operations. Even if we are able to secure such additional capital in the near term, we expect to continue to incur significant losses and will require significant additional capital to support our operations, advance our clinical development programs, and satisfy existing obligations. We currently only have cash and cash equivalent resources to fund our business operations through late-

November 2019,

and we do

not

currently have sufficient cash and cash equivalents for at least the next year following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern within

one

year after the date that the financial statements are issued.

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans, and is currently actively engaged in discussions with various parties, including our largest shareholders, seeking to secure additional capital, potentially through

one

or a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations focused on specified geographic markets; however,

none

of these alternatives are committed at this time. There can be

assurance that we will be able to raise the required capital before our cash is exhausted, with acceptable terms and in an amount required to support our plans and operations, or identify and enter into any strategic transactions that would provide the capital that we will require or, if we do raise capital, it

may

not

be in an amount sufficient to support all of our planned activities and we would therefore need to prioritize and potentially curtail certain programs. If

none

of these alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, our current cash and cash equivalent resources is only adequate to fund our business operations through late-

November 2019

and we will

not

have sufficient cash resources and liquidity to fund our business operations for at least the next year following the date that the financial statements are issued. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through

one

year after the issuance of the accompanying financial statements.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do

not

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

As of

September 30, 2019,

there were

120.0

million shares of common stock and

5.0

million shares of preferred stock authorized under our Certificate of Incorporation, and approximately

72.0

million shares of common stock and

5.0

million shares of preferred stock available for issuance and

not

otherwise reserved.

Note

–

Liquidity Risks and Management’s Plans

As of

December 31, 2018,

we had cash and cash equivalents of

$11.2

million and available-for-sale, marketable securities of

$14.0

million, current liabilities of

$20.6

million, including

$8.0

million of Loan payable (

see

, Note

- Loan Payable). As of

April 5, 2019,

we believe that we have sufficient resources (including marketable securities) available to support our development activities, business operations and debt service through

October

2019.

Although we believe that the

December 2018

CVie Acquisition and

$39

million Private Placement Financing have improved our financial position and

may

better position us to raise the capital needed to fund our business plans, we expect to continue to incur significant losses and require significant additional capital to advance our istaroxime and AEROSURF clinical development programs, support our operations and business development efforts, and satisfy our obligations beyond

October 2019,

and we do

not

have sufficient cash and cash equivalents for at least the next year following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern within

one

year after the date that the financial statements are issued.

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to raise additional capital through a combination of public or private equity offerings and strategic transactions, including but

not

limited to potential alliances and collaborations focused on various individual markets; however,

none

of these alternatives are committed at this time. There can be

assurance that we will be able to complete any public or private equity offerings on acceptable terms, or in amounts required to support our operations, if at all, or identify and enter into any strategic transactions that will bring the capital that we will require. If

none

of these alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, we will

not

one

year after the issuance of the accompanying financial statements.

not

As of

December 31, 2018,

there were

120

million shares of common stock and

million shares of preferred stock authorized under our Certificate of Incorporation, and approximately

72.0

million shares of common stock and

5.0

million shares of preferred stock available for issuance and

not

otherwise reserved.

Note 10 - Accrued Expenses

12 Months Ended

Dec. 31, 2018

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

Note

–

Accrued Expenses

Accrued expenses are comprised of the following:

	December 31,
(in thousands)	2018		2017

Professional fees	$	2,473	$	412
Research and development		2,361		1,778
Salaries, bonus & benefits		815		1,008
Manufacturing operations		212		537
Other		604		399
Total accrued expenses	$	6,465	$	4,134

Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended											9 Months Ended		12 Months Ended
	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Total revenues				$ 304	$ 229	$ 1,051	$ 204	$ 102	$ 17	$ 1,147	$ 219	$ 198	$ 1,484	$ 1,788	$ 1,485
Expenses:
Research and development	3,792			2,368	2,197	2,879	3,118	2,418	3,062	5,483	6,413	10,547	8,194	10,562	17,376
General and administrative	3,395			2,787	1,500	1,208	1,926	1,182	1,749	1,804	1,922	9,990	4,634	7,421	6,657
Total operating expenses	7,187			5,155	3,697	4,087	5,044	3,600	4,811	7,287	8,335	20,537	12,828	17,983	24,033
Operating loss	(7,187)			(4,851)	(3,468)	(3,036)	(4,840)	(3,498)	(4,794)	(6,140)	(8,116)	(20,339)	(11,344)	(16,195)	(22,548)
Other income / (expense):
Net loss on debt extinguishment														(3,345)
Gain on debt restructuring															5,824
Interest income	25				1							124	9	15	12
Interest expense	(105)				(460)							(358)	(642)	(1,409)	(1,863)
Other income, net	141											473	486	401	129
Other income / (expense), net	61				(459)							239	(147)	(4,338)	4,102
Net loss	$ (7,126)	$ (6,437)	$ (6,537)	(9,042)	(3,927)	(3,052)	(4,512)	2,473	(5,443)	(6,752)	(8,724)	$ (20,100)	$ (11,491)	(20,533)	(18,446)
AEROSURF warrant dividend				(12,505)										(12,505)
Deemed dividend on Series A preferred stock				(1,718)					(2,234)	(532)	(3,604)			(1,718)	(6,370)
Net loss attributable to common shareholders				(23,265)	$ (3,927)	(3,052)	(4,512)	2,473	(7,677)	(7,284)	(12,328)			$ (34,756)	$ (24,816)
Net loss per common share
Basic and diluted (in dollars per share)	$ (0.22)				$ (1.04)							$ (0.62)	$ (3.21)	$ (7.74)	$ (24.14)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	32,189,000				3,769,000							32,173,000	3,585,000	4,493	1,028
Grant [Member]
License revenue with affiliate					$ 70								$ 765	$ 765	$ 1,383
License [Member]
License revenue with affiliate				$ 304	$ 159	$ 356	$ 204	$ 102				$ 198	$ 719	$ 1,023	$ 102

Note 20 - Income Taxes (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Schedule of Effective Income Tax Rate Reconciliation [Table Text Block]

	December 31,
(in thousands)	2018			2017

Income tax benefit, statutory rates	$	(4,312	)	$	(6,272	)
State taxes on income, net of federal benefit		(535	)		(398	)
Impact of tax reform		5			71,151
Research and development tax credit		(351	)		(797	)
Foreign rate differential		24			-
Employee related		2,875			953
Interest related		186			(147	)
Income tax expense / (benefit), statutory rates		(2,108	)		64,490
Valuation allowance		2,108			(64,490	)
Income tax benefit, net	$	-		$	-

Schedule of Deferred Tax Assets and Liabilities [Table Text Block]

	December 31,
(in thousands)	2018			2017

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	176,759		$	168,263
Research and development tax credit		16,718			16,813
Compensation expense on stock		1,121			1,191
Charitable contribution carryforward		-			5
Other accrued		1,016			2,547
Deferred revenue		57			317
Depreciation		309			297
Total long-term deferred tax assets		195,980			189,433
Long-term deferred liabilities:
IPR&D		(15,476	)		-
Total long-term deferred tax liabilities		(15,476	)		-
Valuation allowance		(195,980	)		(189,433	)
Deferred tax liabilities, net	$	(15,476	)	$	-

Note 10 - Leases (Details Textual)	Sep. 30, 2019
Operating Lease, Weighted Average Remaining Lease Term	2 years 146 days
Warrington, Pennsylvania [Member]
Operating Lease, Weighted Average Remaining Lease Term	3 years

Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Depreciation, Total	$ 178	$ 121	$ 160	$ 192

Note 4 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands		12 Months Ended
	Dec. 21, 2018	Dec. 31, 2018	Dec. 31, 2017	Sep. 30, 2019
Cash and Cash Equivalents, at Carrying Value, Ending Balance		$ 11,187	$ 1,815	$ 4,437
Debt Securities, Available-for-sale, Current, Total		13,959
Liabilities, Current, Total		20,633	11,760	16,278
Loans Payable, Current, Total		8,000		$ 7,800
Proceeds from Issuance of Private Placement	$ 39,000	$ 32,893	$ 14,860
Common Stock, Shares Authorized		120,000,000	120,000,000	120,000,000
Preferred Stock, Shares Authorized		5,000,000	5,000,000	5,000,000
Common Stock, Capital Shares Available for Issuance		72,000,000		72,000,000
Preferred Stock, Capital Shares Available for Issuance		5,000,000		5,000,000

Note 7 - Fair Value Measurements

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Fair Value Disclosures [Text Block]

Note

–

Fair Value of Financial Instruments

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
	September 30,
(in thousands)	2019		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	4,437	$	4,437	$	-	$	-
U.S. Treasury notes		-		-		-		-
Certificate of deposit		154		154		-		-
Total Assets	$	4,591	$	4,591	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912		19,912		-		-
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

Note

–

Fair Value Measurements

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

– Quoted prices in active markets for identical assets and liabilities.

●

Level

– Inputs other than Level

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

– Unobservable inputs that are supported by little or

market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

Assets and liabilities measured at fair value on a recurring basis are categorized in the table below as of

December

31,

2018

and

2017:

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,234	$	5,234	$	-	$	-
U.S. Treasury notes		19,912	$	19,912
Certificate of deposit		171		171		-		-
Total Assets	$	25,317	$	25,317	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

+ References + Details

Note 4 - Summary of Significant Accounting Policies (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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

(in thousands)	Estimated Fair Value

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

Note 16 - Collaboration, Licensing and Research Funding Agreements

12 Months Ended

Dec. 31, 2018

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

Note

–

Collaboration, Licensing and Research Funding Agreements

Collaboration

Agreement

Battelle Memorial Institute

October 2014,

we entered into a Collaboration Agreement with Battelle Memorial Institute (Battelle) for the development of our phase

ADS. We had previously worked with Battelle, which has expertise in developing and integrating aerosol devices using innovative and advanced technologies, in connection with development of our prototype phase

ADS used in the AEROSURF phase

clinical trial. Under the Collaboration Agreement, we and Battelle shared the costs of development for a

three

-stage development plan that included (i) defining the requirements and a detailed project plan for a phase

ADS, (ii) executing the project plan, and (iii) completing required testing, verification and documentation, putting us in a position to manufacture a phase

ADS for use in the remaining AEROSURF development activities and, if approved, the initial commercial activities. We retained final decision-making authority over all matters related to the design, registration, manufacture, packaging, marketing, distribution and sale of the phase

ADS. We and Battelle shared equally the costs of the

first

stage and the planned costs of the remaining

two

stages. Battelle agreed to bear the cost of any cost overruns associated with the project plan and we agreed to bear the cost of any increase in cost resulting from changes in the scope of the product requirements. We also agreed that, if Battelle successfully completed the project plan in a timely manner, we would pay Battelle royalties equal to a low single-digit percentage of the worldwide net sales and license royalties on sales of AEROSURF for the treatment of RDS in premature infants, up to an initial aggregate limit of

$25

million, which under the Battelle Payment Restructuring (discussed below) was increased to

$35

million. The Collaboration Agreement will end at the time we fulfill our payment obligations to Battelle, unless sooner terminated by a party as provided therein.

December 2018,

we and Battelle entered into a Payment Restructuring Agreement.

See

, Note

– Collaboration and Device Development Payable, regarding the

December 2018

Payment Restructuring Agreement.

Licensing and Research Funding Agreements

Lee’s Pharmaceutical (HK) Ltd.

June 2017,

we entered into a License, Development and Commercialization Agreement (License Agreement) with Lee’s Pharmaceutical (HK) Ltd., a company organized under the laws of Hong Kong (Lee’s (HK)) and an affiliate of Lee’s. Under the License Agreement, we granted to Lee’s (HK) an exclusive license with a right to sublicense (i) to develop and commercialize our

KL4

surfactant products, including SURFAXIN, which was approved by the FDA in

2012

for respiratory distress syndrome (RDS) in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN, and AEROSURF, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the licensed territory, which includes the People’s Republic of China (“PRC”), Hong Kong, Thailand, Taiwan and

other countries. In addition, we granted Lee’s (HK) options to potentially add Japan to the Licensed Territory, which was made effective in an

August 2017

amendment (License Amendment, discussed below) and to manufacture our ADS in the licensed territory, in each case subject to conditions set forth in the License Agreement.

Under the License Agreement, Lee’s made an upfront payment to us of

million. We also

may

receive up to

$37.5

million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee’s

may

receive at a rate equal to low double digits. In addition, Lee’s will be responsible for all costs and expenses in and for the Licensed Territory related to development activities, including a planned AEROSURF phase

clinical trial, regulatory activities, and commercialization activities.

August 2017,

we entered into a Loan Agreement, pursuant to which Lee’s (HK) agreed to lend us up to

$3.9

million to support our activities through

October 31, 2017,

while we and Lee’s worked to complete a

$10

million securities purchase agreement (Lee’s SPA) pursuant to which Lee’s acquired a controlling interest in our common stock on

November 1, 2017.

In connection with Lee’s SPA, we amended the License Agreement to expand certain of Lee’s (HK) rights, including by immediately adding Japan to the licensed territory, accelerating the right to manufacture the ADS in and for the licensed territory, reducing or eliminating certain of the milestone and royalty payments and adding an affiliate of Lee’s (HK) as a party to the License Agreement. As a result, the additional amounts for potential clinical, regulatory and commercial milestone were reduced to

$35.8

million.

We will be eligible to receive tiered royalties based on a percent of Net Sales, depending on the product, in the range of high single to low-to-mid double-digit percentages. Royalties are payable on a country-by-country basis until the latest of (A) the expiration of the last valid patent claim covering the product in the country of sale, (B) the expiration or revocation of any applicable regulatory exclusivity in the country of sale, and (C)

ten

(

) years after the

first

commercial sale in the country of sale. Thereafter, in consideration of licensed rights other than patent rights, royalties shall continue for the commercial life of each product and, for the initial

three

years, shall be in the range of low-to-mid single digits. In addition, in the event that

one

or more generic products are introduced, the royalty rates will be reduced, subject to certain minimums if we are subject to continuing obligations at the time to pay royalties under our in-license agreements.

Under the License Agreement, Lee’s will be responsible for all activities related to development, regulatory approval and commercialization of

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surfactant and combination drug / device products in the Licensed Territory. Lee’s will hold the product licenses for all non-aerosolized products in the Licensed Territory and will seek regulatory approval initially for SURFAXIN and SURFAXIN LS for RDS. We will hold the product license in the Licensed Territory (except where prohibited by law) for all aerosolized products and will designate Lee’s its exclusive agent and representative to develop and register AEROSURF and other aerosolized products in our name and on our behalf. Lee’s also has agreed that, except as provided in the License Agreement, for a period of

ten

(

) years beginning with the later of the

first

commercial sale of the

first

aerosolized product and the

first

commercial sale of the

first

non-aerosolized product in the PRC, it will

not

develop, register, manufacture, or commercialize any product for the prevention and/or treatment of RDS in premature infants or other diseases and conditions in humans, in either case that administers, utilizes or contains pulmonary surfactant without our prior written consent.

Accounting Analysis under ASC

606

In evaluating the License Agreement in accordance with ASC Topic

606,

we concluded that the contract counterparty, Lee’s (HK), is a customer. We identified the following performance obligations: (i) a bundled performance obligation consisting of licensing rights to develop and commercialize our

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surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS; and (ii) a technology transfer process for the manufacture of our ADS. We determined that participation in the Joint Steering Committee (and other committees under its authority) and our ongoing product development, regulatory, and commercialization activities under the License Agreement were deemed immaterial in the context of the contract. Consistent with the guidance under ASC

606

16A,

we disregarded immaterial promised goods and services when determining performance obligations.

We concluded that the licensing rights were

not

distinct within the context of the contract (i.e. separately identifiable) because the licensing rights do

not

have stand-alone value from other promised goods and services as Lee’s (HK) could

not

benefit from the licensing rights without the completion of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. The ADS manufacturing right and the technology transfer process for the manufacture of our ADS are distinct within the context of the contract because each has stand-alone value from other promised goods and services as Lee’s (HK) could benefit from each of these rights on a stand-alone basis. However, we determined that the ADS manufacturing right and the ADS technology transfer process have nominal stand-alone selling prices as the ADS is

not

yet verified and there is uncertainty with regard to the commercial value of the ADS given that the AEROSURF combination drug/device product is currently in clinical development.

With respect to Amendment

No.

we elected to use the practical expedient for contract modifications that occur prior to the adoption of ASU

2014

09,

and we determined that the impact was immaterial. Allocable arrangement consideration under the practical expedient comprised the upfront payment of

million and

$0.3

million related to reductions in royalties and milestones in connection with Amendment

No.

The

$1.3

million was attributed in its entirety to the bundled performance obligation of licensing rights to develop and commercialize our

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surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. Revenue associated with the bundled performance obligation was recognized beginning in

November 2017

with the initiation of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS and will be recognized over time as services are performed and based on the input method related to the level of effort expended. The expected completion date for the technology transfer is

June 2019.

Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. As part of our evaluation of the constraint, we considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors include: our financial position; ongoing delays in our development activities and with initiating our phase

clinical trial; our limited experience with successful drug development; our limited experience with clinical trials; our recent failure to achieve primary endpoints in our phase

clinical trial; our limited experience with commercialization; our decision in

2015

to cease manufacturing and commercializing of SURFAXIN; and the fact that the uncertainty about the related consideration is

not

expected to be resolved for a long period of time (

see

, Item

– Risk Factors).

Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have

remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

Philip Morris USA Inc. and Philip Morris Products S.A.

Under license agreements with Philip Morris USA Inc. (PMUSA) and Philip Morris Products S.A. (PMPSA), we hold exclusive worldwide licenses to the ADS technology for use with pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) for all respiratory diseases and conditions (the foregoing uses in each territory, the Exclusive Field), and an exclusive license in the US for use with certain non-surfactant drugs to treat a wide range of pediatric and adult respiratory indications in hospitals and other health care institutions. We generally are obligated to pay royalties at a rate equal to a low single-digit percent of sales of products sold in the Exclusive Field (as defined in the license agreements) in the territories, including sales of aerosol devices that are

not

based on the capillary aerosolization technology (unless we exercise our right to terminate the license with respect to a specific indication). We also agreed to pay minimum royalties quarterly beginning in

2014,

but are entitled to a reduction of future royalties in an amount equal to the excess of any minimum royalty paid over royalties actually earned in prior periods. For

2017,

we paid the minimum royalty of

$300,000

to PMUSA and paid

$487,500

to PMPSA, which included the minimum royalty of

$300,000

as well as the

$187,500

in deferred

2016

payments. For

2018,

we paid the minimum royalty of

$400,000

to each of PMUSA and to PMPSA.

Johnson & Johnson and Ortho Pharmaceutical Corporation

We, Johnson & Johnson (J&J) and its wholly-owned subsidiary, Ortho Pharmaceutical Corporation, are parties to a license agreement granting to us an exclusive worldwide license to the J&J proprietary

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surfactant technology. Under the license agreement, we are obligated to pay fees of up to

$2.5

million in the aggregate upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for certain designated products. We have paid

$1.0

million to date for milestones that have been achieved including a

$0.5

million milestone payment in

2012

that became due as a result of the FDA’s approval of SURFAXIN. In addition, we are required to make royalty payments at different rates, depending upon type of revenue and country, in amounts in the range of a high single-digit percent of net sales (as defined in the license agreement) of licensed products sold by us or sublicensees, or, if greater, a percentage of royalty income from sublicensees in the low double digits.

Laboratorios del Dr. Esteve, S.A.

We have a strategic alliance with Laboratorios del Dr. Esteve, S.A. (Esteve) for the development, marketing and sales of a broad portfolio of potential

KL4

surfactant products in Andorra, Greece, Italy, Portugal, and Spain. Antonio Esteve, Ph.D., a principal of Esteve, served as a member of our Board of Directors from

May 2002

until

January 2013.

Esteve will pay us a transfer price on sales of our

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surfactant products. We will be responsible for the manufacture and supply of all of the covered products and Esteve will be responsible for all sales and marketing in the territory. Esteve is obligated to make stipulated cash payments to us upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for the covered products. In addition, Esteve has agreed to contribute to phase

clinical trials for the covered products by conducting and funding development performed in the territory. As part of a

2004

restructuring in which Esteve returned certain rights to us in certain territories (Former Esteve Territories), we agreed to pay Esteve

10%

of any cash up front and milestone fees (up to a maximum aggregate of

$20

million) that we receive in connection with any strategic collaborations for the development and/or commercialization of certain of our

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surfactant products in the Former Esteve Territories.

Università degli Studi di Milano-Bicocca

Effective

April 13, 2015,

CVie Therapeutics, entered into an Agreement for Scientific Collaboration with the Università degli Studi di Milano-Bicocca (Bicocca) in Milan, Italy, focused on defining the role of sarco (endo) plasmic reticulum

Ca2

+ -ATPase

(

SERCA2a

) and phospholamban (PLN) in modulating cardiac contraction, and discovering new small molecules to modulate

SERCA2a

activity or new drugs for treating chronic and acute human heart failure. The term of the collaboration agreement would have expired after

three

years but was extended for approximately an additional year, with option for further renewal. We are currently in discussions potentially to extend this agreement, although there can be

assurance that we will be able to achieve an extension on acceptable terms, if at all.

Under the collaboration agreement, intellectual property resulting from the collaboration, including patents and know-how, will be jointly owned by the parties. For the development of any new

SERCA2a

compounds and diagnostic products suitable for further clinical development, we have the option to purchase Bicocca’s interest for up to

months after the filing of a patent application. If the option is

not

exercised, then the parties shall remain joint owners and each can use the intellectual property with consent of the other on terms to be defined. If we exercise an option, we have agreed to pay Bicocca (corresponding to stage of development): (i) €

0.1

million (approximately

$0.1

million) upon completion and the proof of concept of biological efficacy for new compounds modulating the

SERCA2a

activity caused by PLN mutations; and (ii) €

1.5

million (approximately

$1.7

million) upon obtaining marketing authorization in the US, EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties for any purchased intellectual property arising out of the collaboration in the range of a low- to mid-single digit percent of net sales for any products sold in any country for a period of

ten

years from the date of the

first

commercial sale.

Also, under the collaboration agreement, we have provided funds aggregating €

0.2

million (approximately

$0.2

million) to date to upgrade equipment and pay laboratory expenses for the renewal term expiring in

2019.

We also funded several related research contracts for the period covered by the collaboration agreement. In connection with our research activities, Bicocca agreed to provide us exclusive use of a research laboratory for the collaboration, and nonexclusive access to a physiology laboratory within the university. Bicocca serves as our primary location in Milan.

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended											9 Months Ended		12 Months Ended
	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Revenues:
Total revenues				$ 304	$ 229	$ 1,051	$ 204	$ 102	$ 17	$ 1,147	$ 219	$ 198	$ 1,484	$ 1,788	$ 1,485
Expenses:
Research and development	3,792			2,368	2,197	2,879	3,118	2,418	3,062	5,483	6,413	10,547	8,194	10,562	17,376
General and administrative	3,395			2,787	1,500	1,208	1,926	1,182	1,749	1,804	1,922	9,990	4,634	7,421	6,657
Total operating expenses	7,187			5,155	3,697	4,087	5,044	3,600	4,811	7,287	8,335	20,537	12,828	17,983	24,033
Operating loss	(7,187)			(4,851)	(3,468)	(3,036)	(4,840)	(3,498)	(4,794)	(6,140)	(8,116)	(20,339)	(11,344)	(16,195)	(22,548)
Other income / (expense):
Interest income	25				1							124	9	15	12
Interest expense	(105)				(460)							(358)	(642)	(1,409)	(1,863)
Other income, net	141											473	486	401	129
Other income / (expense), net	61				(459)							239	(147)	(4,338)	4,102
Net loss	$ (7,126)	$ (6,437)	$ (6,537)	(9,042)	$ (3,927)	(3,052)	(4,512)	2,473	(5,443)	(6,752)	(8,724)	$ (20,100)	$ (11,491)	$ (20,533)	$ (18,446)
Net loss per common share
Basic and diluted (in dollars per share)	$ (0.22)				$ (1.04)							$ (0.62)	$ (3.21)	$ (7.74)	$ (24.14)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	32,189,000				3,769,000							32,173,000	3,585,000	4,493	1,028
Grant [Member]
Revenues:
License revenue with affiliate					$ 70								$ 765	$ 765	$ 1,383
License [Member]
Revenues:
License revenue with affiliate				$ 304	$ 159	$ 356	$ 204	$ 102				$ 198	$ 719	$ 1,023	$ 102

Note 8 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Nov. 01, 2017	Dec. 31, 2018	Dec. 31, 2017	Sep. 30, 2019
Repayments of Long-term Debt, Total			$ 2,500
Liability for Contingent Milestone Payment, Noncurrent		15,000	15,000	$ 15,000
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 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	25,000
Class of Warrant or Right, Exercise Price of Cancelled Warrants	$ 786.80
Repayments of Long-term Debt, Total	$ 2,500
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations	71,111
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

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) shares in Thousands	Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Treasury Stock [Member]	Total
Balance at Dec. 31, 2016			$ 592,892,000	$ (618,668,000)		$ (3,054,000)	$ (28,830,000)
Net loss				(18,446,000)			(18,446,000)
Stock-based compensation expense							1,600,000
Issuance of stock (in shares)		42
Issuance of stock			1,030,000				1,030,000
Balance (in shares) at Dec. 31, 2017	3	3,227
Balance at Dec. 31, 2017		$ 3,000	616,245,000	(637,114,000)		$ (3,054,000)	(23,920,000)
Net loss				(4,512,000)			(4,512,000)
Share Purchase Agreement, April 2018			(52,000)				(52,000)
Stock-based compensation expense			418,000				418,000
Balance (in shares) at Mar. 31, 2018	3	3,227
Balance at Mar. 31, 2018		$ 3,000	616,611,000	(641,626,000)		$ (3,054,000)	(28,066,000)
Balance (in shares) at Dec. 31, 2017	3	3,227
Balance at Dec. 31, 2017		$ 3,000	616,245,000	(637,114,000)		$ (3,054,000)	(23,920,000)
Net loss							(11,491,000)
Unrealized gain (loss) on marketable securities
Balance (in shares) at Sep. 30, 2018	3	3,769
Balance at Sep. 30, 2018		$ 4,000	620,322,000	(648,605,000)		$ (3,054,000)	(31,333,000)
Balance (in shares) at Dec. 31, 2017	3	3,227
Balance at Dec. 31, 2017		$ 3,000	616,245,000	(637,114,000)		$ (3,054,000)	(23,920,000)
Net loss				(20,533,000)			(20,533,000)
Stock-based compensation expense			955,000				955,000
Vesting of restricted stock units (in shares)		95
Vesting of restricted stock units
Withholding tax payments related to net share settlements of restricted stock units (in shares)		(31)
Withholding tax payments related to net share settlements of restricted stock units			(155,000)				(155,000)
Balance (in shares) at Dec. 31, 2018		32,133
Balance at Dec. 31, 2018		$ 32,000	728,783,000	(657,647,000)		$ (3,054,000)	68,114,000
Balance (in shares) at Mar. 31, 2018	3	3,227
Balance at Mar. 31, 2018		$ 3,000	616,611,000	(641,626,000)		$ (3,054,000)	(28,066,000)
Net loss				(3,052,000)			(3,052,000)
Stock-based compensation expense			140,000				140,000
Issuance of stock (in shares)		542
Issuance of stock		$ 1,000	2,593,000				2,594,000
Balance (in shares) at Jun. 30, 2018	3	3,769
Balance at Jun. 30, 2018		$ 4,000	619,344,000	(644,678,000)		$ (3,054,000)	(28,384,000)
Net loss				(3,927,000)			(3,927,000)
Stock-based compensation expense			145,000				145,000
Issuance of warrants			833,000				833,000
Unrealized gain (loss) on marketable securities
Balance (in shares) at Sep. 30, 2018	3	3,769
Balance at Sep. 30, 2018		$ 4,000	620,322,000	(648,605,000)		$ (3,054,000)	(31,333,000)
Net loss							(9,042,000)
Balance (in shares) at Dec. 31, 2018		32,133
Balance at Dec. 31, 2018		$ 32,000	728,783,000	(657,647,000)		$ (3,054,000)	68,114,000
Net loss				(6,537,000)			(6,537,000)
Stock-based compensation expense			1,530,000				1,530,000
Vesting of restricted stock units (in shares)		56
Vesting of restricted stock units
Withholding tax payments related to net share settlements of restricted stock units (in shares)
Withholding tax payments related to net share settlements of restricted stock units			(151,000)				(151,000)
Unrealized gain (loss) on marketable securities					40,000		40,000
Balance (in shares) at Mar. 31, 2019		32,189
Balance at Mar. 31, 2019		$ 32,000	730,162,000	(664,184,000)	40,000	$ (3,054,000)	62,996,000
Balance (in shares) at Dec. 31, 2018		32,133
Balance at Dec. 31, 2018		$ 32,000	728,783,000	(657,647,000)		$ (3,054,000)	68,114,000
Net loss							(20,100,000)
Unrealized gain (loss) on marketable securities
Balance (in shares) at Sep. 30, 2019		32,189
Balance at Sep. 30, 2019		$ 32,000	733,840,000	(677,747,000)		$ (3,054,000)	53,071,000
Balance (in shares) at Mar. 31, 2019		32,189
Balance at Mar. 31, 2019		$ 32,000	730,162,000	(664,184,000)	40,000	$ (3,054,000)	62,996,000
Net loss				(6,437,000)			(6,437,000)
Stock-based compensation expense			1,739,000				1,739,000
Unrealized gain (loss) on marketable securities					(28,000)		(28,000)
Balance (in shares) at Jun. 30, 2019		32,189
Balance at Jun. 30, 2019		$ 32,000	731,901,000	(670,621,000)	12,000	$ (3,054,000)	58,270,000
Net loss				(7,126,000)			(7,126,000)
Stock-based compensation expense			1,939,000				1,938,000
Unrealized gain (loss) on marketable securities					(12,000)		(12,000)
Balance (in shares) at Sep. 30, 2019		32,189
Balance at Sep. 30, 2019		$ 32,000	$ 733,840,000	$ (677,747,000)		$ (3,054,000)	$ 53,071,000

Note 21 - Selected Quarterly Financial Data (Unaudited) (Tables)

12 Months Ended

Dec. 31, 2018

Quarterly Financial Information [Table Text Block]

2018 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	-		$	695		$	70		$	-		$	765
License revenue with affiliate		204			356			159			304			1,023
Total revenues		204			1,051			229			304			1,788
Expenses:
Research and development		3,118			2,879			2,197			2,368			10,562
Selling, general and administrative		1,926			1,208			1,500			2,787			7,421
Total expenses		5,044			4,087			3,697			5,155			17,983
Operating loss		(4,840	)		(3,036	)		(3,468	)		(4,851	)		(16,195	)
Other income / (expense), net		328			(16	)		(459	)		(4,191	)		(4,338	)
Net (loss) / income	$	(4,512	)	$	(3,052	)	$	(3,927	)	$	(9,042	)	$	(20,533	)
AEROSURF warrant dividend		-			-			-			(12,505	)		(12,505	)
Deemed dividend on preferred stock		-			-			-			(1,718	)		(1,718	)
Net (loss) / income attributable to common shareholders	$	(4,512	)	$	(3,052	)	$	(3,927	)	$	(23,265	)	$	(34,756	)
Net (loss) / income per common share - basic	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Net (loss) / income per common share - diluted	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Weighted average number of common shares outstanding - basic		3,227			3,751			3,769			7,191			4,493
Weighted average number of common shares outstanding - diluted		3,227			3,751			3,769			7,191			4,493

2017 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	219		$	1,147		$	17		$	-		$	1,383
License revenue with affiliate		-			-			-			102			102
Total revenues		219			1,147			17			102			1,485
Expenses:
Research and development		6,413			5,483			3,062			2,418			17,376
Selling, general and administrative		1,922			1,804			1,749			1,182			6,657
Total expenses		8,335			7,287			4,811			3,600			24,033
Operating loss		(8,116	)		(6,140	)		(4,794	)		(3,498	)		(22,548	)
Other income / (expense), net		(608	)		(612	)		(649	)		5,971			4,102
Net (loss) / income	$	(8,724	)	$	(6,752	)	$	(5,443	)	$	2,473		$	(18,446	)
Deemed dividend on preferred stock		(3,604	)		(532	)		(2,234	)		-			(6,370	)
Net (loss) / income attributable to common shareholders	$	(12,328	)	$	(7,284	)	$	(7,677	)	$	2,473		$	(24,816	)
Net (loss) / income per common share - basic	$	(27.40	)	$	(14.37	)	$	(10.53	)	$	1.03		$	(24.14	)
Net (loss) / income per common share - diluted	$	(27.40	)	$	(14.37	)	$	(10.53	)	$	0.97		$	(24.14	)
Weighted average number of common shares outstanding - basic		450			507			729			2,405			1,028
Weighted average number of common shares outstanding - diluted		450			507			729			2,540			1,028

Note 15 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Share-based Payment Arrangement, Expense	$ 1,939	$ 145	$ 5,208	$ 703	$ 955	$ 1,561
Research and Development Expense [Member]
Share-based Payment Arrangement, Expense	$ 574	$ 29	$ 1,613	$ 169	232	837
Selling, General and Administrative Expenses [Member]
Share-based Payment Arrangement, Expense					$ 723	$ 724

Significant Accounting Policies (Policies)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of

onsolidation

Principles of consolidation

Business Combinations Policy [Policy Text Block]

Business

ombinations

may

differ materially from estimates.

Business

ombinations

We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results

may

differ materially from estimates.

Goodwill and Intangible Assets, Policy [Policy Text Block]

Goodwill and

ntangible

ssets

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

September 30, 2019

and

December 31, 2018:

(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. We perform an annual impairment test for goodwill and evaluate the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such an assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Goodwill and

ntangible

ssets

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 (“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

December 31, 2018:

(in thousands)	Estimated Fair 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 assets acquired and liabilities assumed in a business combination and is

not

amortized. We perform an annual impairment test for goodwill and evaluates the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Foreign

urrency

ransactions

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

not

$0.1

million and

$0.4

million for the

three

and

nine

months ended

September 30, 2019.

There were

foreign currency transaction gains or losses for the

three

and

nine

months ended

September 30, 2018.

Foreign

urrenc

y transactions

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

not

$0.1

million for the year ended

December 31, 2018.

There were

foreign currency transaction gains or losses for the year ended

December 31, 2017.

Use of Estimates, Policy [Policy Text Block]

Use of

stimates

Use of estimates

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and cash equivalents

Cash and cash equivalents are held in at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of

days or less that are readily convertible into cash.

Marketable Securities, Policy [Policy Text Block]

Marketable

ecurities

320,

three

months ended

September 30, 2019,

we had

$14,000

in realized gains and

$12,000

in unrealized losses on marketable securities. For the

nine

months ended

September 30, 2019,

we had

$75,000

in realized gains and our unrealized gains and losses on marketable securities netted to zero. There were

realized or unrealized gains or losses on investments for the

three

and

nine

months ended

September 30, 2018.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

Marketable securities

320,

Investments—Debt and Equity Securities. Investments are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were

realized gains or losses on marketable securities for the years ended

December 31, 2018

and

2017.

There were

unrealized gains or losses on investments for the years ended

December 31, 2018

and

2017.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

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

Fair value of financial instruments

December 31, 2018

and

2017,

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

Property and equipment

Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally

three

ten

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

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

Restricted cash

Restricted cash consists principally of a

$140,000

certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated

May 26, 2004

for our headquarters location in Warrington, Pennsylvania and

$31,000

in deposits held by our landlord for our offices in Taipei, Taiwan, the former headquarters of CVie Therapeutics (

see,

– Note

– Commitments, for further discussion on our leases).

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

Long-lived assets

Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset

may

not

impairment was recorded during the years ended

December 31, 2018

and

2017

as management believes there are

circumstances that indicate the carrying amount of the assets will

not

be recoverable.

Collaborative Arrangement, Accounting Policy [Policy Text Block]

Collaborative arrangements

We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic

808,

Collaborative Arrangements

See,

– Note

– Collaboration, Licensing and Research Funding Agreements.

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

Restructured

ebt

iability –

ntingent

ilestone

ayment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

ee,

Note

– Restructured Debt Liability), we established a

$15

October 27, 2017 (

not

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

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

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.

Revenue [Policy Text Block]

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (

see

, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – current portion. Amounts

not

expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in

July 2017

in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (

see

, Note

– Collaboration and Device Development Payment Restructuring, Licensing and Research Funding Agreements).

Revenue from Contract with Customer [Policy Text Block]

Revenue recognition

Effective

January 1, 2018,

we adopted Accounting Standards Codification (“ASC”) Topic

606,

Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic

606,

In accordance with ASC Topic

606,

we perform the following

five

steps:

	(i)		identify the contract(s) with a customer;

	(ii)		identify the performance obligations in the contract;

	(iii)		determine the transaction price;

	(iv)		allocate the transaction price to the performance obligations in the contract; and

	(v)		recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the

five

606,

We have concluded that our government grants are

not

within the scope of ASC Topic

606

as they do

not

meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic

958

605,

Not

-for-Profit-Entities-Revenue Recognition does

not

apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under US GAAP, effective

January 1, 2018,

we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic

606,

exchange as defined in ASC Topic

606.

We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic

606.

Prior to

January 1, 2018,

not

materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was

change to the amounts we have historically recorded in our financial statements.

Research and Development Expense, Policy [Policy Text Block]

Research and

evelopment

730,

Research and Development

Research and development

730,

Research and Development

Share-based Payment Arrangement [Policy Text Block]

Stock-based compensation

Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic

718,

Stock Compensation

(ASC Topic

718

See

, – Note

Derivatives, Policy [Policy Text Block]

Warrant accounting

We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s Own Equity

(ASC Topic

815

), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement.

Income Tax, Policy [Policy Text Block]

Income

axes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes

not

assured.

Income taxes

We account for income taxes in accordance with ASC Topic

740,

not

assured.

Stockholders' Equity Note, Convertible Preferred Stock, Beneficial Conversion Feature, Policy [Policy Text Block]

Beneficial Conversion Feature

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the

first

quarter of

2017

(see, “– Note

$3.6

million

one

-time, non-cash deemed dividend to the preferred shareholders during the

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

December 31, 2018

and

December 31, 2017,

we recognized a non-cash deemed dividend to the preferred shareholders of

$1.7

million and

$2.8

million, respectively, related to the Preferred Shares converted during the period. As of

December 31, 2018,

there were

Preferred Shares remaining to be converted.

Convertible Note

The issuance on

July 2, 2018

of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of

$1.5

million less debt discount consisting of (i)

$0.4

million related to the beneficial conversion feature and (ii)

$0.4

million in fair value of the warrants issued in connection with the Note. The discount was accreted to the

$1.5

million loan over its term using the effective interest method (

see

, – Note

– Loan Payable). On

December 27, 2018,

we repaid the Note in its entirety in cash of

$1.5

million. As part of the extinguishment of debt, we recorded a gain on extinguishment of debt of approximately

$0.4

$5.11

and the conversion price of

$4.00,

and (ii)

375,000

shares convertible into common stock.

Earnings Per Share, Policy [Policy Text Block]

Net

oss per

ommon

hare

September 30, 2019

and

2018,

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

15.6

million and

1.3

million shares, respectively. For the

three

and

nine

months ended

September 30, 2019

and

2018,

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

Net loss per common share

December 31, 2018

and

2017,

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

14.4

million and

1.0

million shares, respectively. As of

December 31, 2018

and

2017,

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 income (loss).

Concentration of Suppliers [Policy Text Block]

Concentration of Suppliers

We currently obtain the active pharmaceutical ingredients (APIs) of our

KL4

surfactant drug products from single-source suppliers. In addition, we rely on a number of

third

-party institutions and laboratories that perform various studies as well as quality control release and stability testing and other activities related to our

KL4

surfactant development and manufacturing activities. At the present time, several of these laboratories are single-source providers. The loss of

one

or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations.

Segment Reporting, Policy [Policy Text Block]

Business segments

We currently operate in

one

business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do

not

operate separate lines of business with respect to our product candidates.

New Accounting Pronouncements, Policy [Policy Text Block]

Recently

dopted

ccounting

tandards

February 2016,

the FASB issued Accounting Standards Update (ASU)

No.

2016

02,

Leases

(ASU

2016

). ASU

2016

establishes ASC

842

which amends ASC

840,

Leases

, by introducing a lessee model that requires balance sheet recognition for most leases and the disclosure of key information about leasing arrangements. ASC

842

was subsequently amended during

2018.

January 1, 2019

and used the effective date as its date of initial application. Consequently, financial information is

not

updated and the disclosures required under the new standard are

not

provided for dates and periods prior to

January 1, 2019.

Instead, the requirements of ASC

840

are presented for these prior periods.

ASC

842

provides several optional practical expedients in transition. We elected the package of practical expedients which allowed us to

not

months or less, for purposes of applying the recognition and measurement requirements of the new standard. We also elected the practical expedient to

not

separate lease and non-lease components for all our leases.

The adoption of this standard resulted in the recognition of operating lease liabilities and related right-of-use assets on our condensed consolidated balance sheets of

$2.2

million and

$2.0

million, respectively, related to our operating leases. The adoption of ASC

842

also resulted in the elimination of deferred rent of approximately

$72,000

and

$139,000

in accrued expenses and other long-term liabilities, respectively, in our condensed consolidated balance sheets. The adoption of the standard did

not

have a material impact on our condensed consolidated statements of operations and comprehensive loss or condensed consolidated statements of cash flows. Refer to Note

– Leases, for our current lease commitments.

January 2017,

the FASB issued ASU

No.

2017

04,

"Intangibles-Goodwill and Other (Topic

350

): Simplifying the Test for Goodwill Impairment." The new standard simplifies the subsequent measurement of goodwill by eliminating the

second

step of the goodwill impairment test. This ASU will be applied prospectively and is effective for annual or interim goodwill impairment tests in fiscal years beginning after

December 15, 2019

with early adoption permitted. We adopted this guidance on

January 1, 2019

and will apply it to our annual impairment test, and any interim impairment tests during the year ending

December 31, 2019.

Recently Issued Accounting Standards

August 2018,

the FASB issued ASU

No.

2018

13,

"Fair Value Measurement (Topic

820

): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement" (ASU

2018

), which removes, adds and modifies certain disclosure requirements for fair value measurements in Topic

820.

Companies will

longer be required to disclose the amount of and reasons for transfers between Level

and Level

of the fair value hierarchy as well as the valuation processes of Level

fair value measurements. However, companies will be required to additionally disclose the changes in unrealized gains and losses included in other comprehensive income for recurring Level

fair value measurements and the range and weighted average of assumptions used to develop significant unobservable inputs for Level

fair value measurements. ASU

2018

is effective for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2019.

2018

will have on our condensed consolidated financial statements.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

May 2014,

the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which was subsequently amended by several other ASUs related to Topic

606

2014

09,

as amended, effective

January 1, 2018

using the modified retrospective transition method. In

June 2017,

2014

and determined that there was

material impact to revenues for any of the years presented upon adoption. Additionally, there were

See,

“– Note

– Collaboration, Licensing and Research Funding Agreements).

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

), Scope of Modification Accounting

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

), Classification of Certain Cash Receipts and Cash Payments

. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to

eight

one

class of cash flows. The ASU is effective retrospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2016

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

January 2017,

the FASB issued ASU

2017

01,

Business Combinations (Topic

805

), Clarifying the Definition of a Business

. The FASB changed its definition of a business in an effort to help entities determine whether a set of transferred assets and activities is a business. The guidance requires an entity to

first

not

a business. If the threshold is

not

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

Recent Accounting Pronouncements

February 2016,

the FASB issued ASU

2016

02,

Leases

(Topic

842

). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective

January 1, 2019.

not

January 2017,

the FASB issued ASU

2017

04,

Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment

. ASU

2017

simplifies the subsequent measurement of goodwill by removing the

second

step of the

two

not

2017

is effective for annual or interim goodwill impairment tests performed in fiscal years beginning after

December 15, 2019;

early adoption is permitted. We currently anticipate that the adoption of ASU

2017

will

not

have a material impact on our financial statements.

Lessee, Leases [Policy Text Block]

Leases

Effective

January 1, 2019,

we adopted ASC Topic

842,

Leases

(ASC

842

), using the modified retrospective transition approach and utilizing the effective date as the date of initial application. Consequently, prior period balances and disclosures have

not

been restated and are presented in accordance with the previous guidance in ASC Topic

840,

Leases

one

year are generally recognized on the balance sheet as operating lease right-of-use assets and current and non-current operating lease liabilities, as applicable. We elected

not

to recognize on the balance sheet leases with terms of

months or less. We typically only include the initial lease term in our assessment of a lease arrangement. Options to extend a lease are

not

included in our assessment unless there is reasonable certainty that we will renew.

may

be required for items such as incentives received. The interest rate implicit in our leases is typically

not

842,

we utilized the remaining lease term of our leases in determining the appropriate incremental borrowing rates.

Note 17 - Related Party Transactions

12 Months Ended

Dec. 31, 2018

Note

–

Related Party Transactions

Lee’s Pharmaceutical Holdings Limited

As of

December 31, 2018

and

2017,

Lee’s beneficial ownership of our issued and outstanding shares of common stock was

40%

and

73%,

respectively.

From

June 2017

through

December 2018

we entered into transactions with Lee’s as follows:

●

June 2017,

we entered into a licensing agreement with an affiliate of Lee’s (

see

, Note

– Collaboration, Licensing and Research Funding Agreements)

●

October 2017,

we completed a

$10

million Share Purchase Agreement with an affiliate of Lee’s (

see

, Note

– Stockholders Equity)

●

During

2018,

we entered into multiple loan agreements with an affiliate of Lee’s (

see

, Note

– Loan Payable)

●

April 2018,

we completed a

$2.6

million private placement with an affiliate of Lee’s (

see

, Note

– Stockholders Equity)

●

In conjunction with the CVie Acquisition in

December 2018,

we issued shares of common stock to Lee’s as a

49%

shareholder in CVie Investment and entered into an indemnification letter agreement with Lee’s (

see

, Note

– Business Combination)

●

December 2018,

as part of the Private Placement Financing, we converted

$6.0

million of existing loan payable obligations to the Lee’s affiliate on the same economic terms as those of the other investors (

see

, Note

– Loan Payable)

●

Our

$4.5

million bank credit facility is guaranteed by Lee’s (

see

, Note

– Loan Payable)

Panacea Venture and KPCB-China

Mr. James Huang, who in connection with the CVie Acquisition in

December 2018

was appointed as a director and Chairman of our Board, is a founding and Managing Partner to Panacea Venture (Panacea) and, since

2011,

has served as a Managing Partner of Kleiner Perkins Caufield & Byers (KPCB) – China. During

2018

we had the following transactions with Panacea and KCPB:

●

July 2018,

we issued a

$1.5

million secured convertible promissory note (Note) to an affiliate of Panacea. The Note was paid in full in

December 2018 (

see

, Note

– Convertible Note Payable)

●

December 2018,

we issued

114,415

shares of our common stock to Rui Jin (HK) Consulting Management Company Limited, an affiliate of Panacea, for services rendered before Panacea and Mr. Huang became related parties to us.

●

December 2018,

conjunction with the CVie Acquisition, we issued shares of common stock to an investment fund managed by KPCB that was a

27%

shareholder in CVie (

see

, Note

– Business Combination). Mr. Huang disclaims any beneficial interest in this KPCB investment fund.

●

December 2018,

Panacea was an investor in the Private Placement Financing (

see

, Note

– Stockholders Equity)

As of

December 31, 2018,

Panacea and KPCB each had a

14%

beneficial ownership of our issued and outstanding shares of common stock.

Note 6 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Cash and cash equivalents	$ 4,437	$ 5,234	$ 1,815
Total Assets	4,591	25,317	2,040
Certificates of Deposit [Member]
Certificate of deposit	154	171	225
US Treasury Securities [Member]
Cash and cash equivalents		19,912
Cash and cash equivalents		19,912
Fair Value, Inputs, Level 1 [Member]
Cash and cash equivalents	4,437	5,234	1,815
Total Assets	4,591	25,317	2,040
Fair Value, Inputs, Level 1 [Member] \| Certificates of Deposit [Member]
Certificate of deposit	154	171	225
Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Cash and cash equivalents		19,912
Cash and cash equivalents		19,912
Fair Value, Inputs, Level 2 [Member]
Cash and cash equivalents
Total Assets
Fair Value, Inputs, Level 2 [Member] \| Certificates of Deposit [Member]
Certificate of deposit
Fair Value, Inputs, Level 2 [Member] \| US Treasury Securities [Member]
Cash and cash equivalents
Cash and cash equivalents
Fair Value, Inputs, Level 3 [Member]
Cash and cash equivalents
Total Assets
Fair Value, Inputs, Level 3 [Member] \| Certificates of Deposit [Member]
Certificate of deposit
Fair Value, Inputs, Level 3 [Member] \| US Treasury Securities [Member]
Cash and cash equivalents
Cash and cash equivalents

Note 15 - Stock Options and Stock-based Employee Compensation (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block]

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table style="margin-right: 15%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">December 31,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Stock Options and RSUs Outstanding</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 59.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,558</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">263</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Non-Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Total Outstanding</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,568</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">273</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Available for Future Grants under 2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,453</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,623</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> </table></div>

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, 2019		4,417		$	6.73
Granted		1,144			4.20
Forfeited or expired		(5	)		467.57
Outstanding at September 30, 2019		5,556		$	5.80		9.2

Vested and exercisable at September 30, 2019		70		$	128.45		6.3

Vested and expected to vest at September 30, 2019		5,245		$	5.79		9.2

						Weighted-
				Weighted-		Average
(in thousands, except for weighted-average data)				Average		Remaining
Stock Options	Shares			Exercise Price		Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		4,337			4.22
Forfeited or expired		(4	)		617.75
Outstanding at December 31, 2018		4,417		$	6.73		9.9

Vested and exercisable at December 31, 2018		63		$	171.87		6.5

Vested and expected to vest at December 31, 2018		4,243		$	6.78		9.9

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]

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

Unvested at January 1, 2019		151		$	4.29
Awarded		249			3.95
Vested		(95	)		3.95
Cancelled		(144	)		4.33
Unvested at September 30, 2019		161		$	4.04

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

Unvested at January 1, 2018		190		$	4.33
Awarded		56			4.22
Vested		(95	)		4.33
Unvested at December 31, 2018		151		$	4.29

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

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

Research and development	$	574	$	29	$	1,613	$	169
General and administrative		1,365		116		3,595		534
Total	$	1,939	$	145	$	5,208	$	703

	Year Ended December 31,
(in thousands)	2018		2017

Research and development	$	232	$	837
Selling, general and administrative		723		724
Total	$	955	$	1,561

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

	Nine Months Ended September 30,
	2019

Weighted average expected volatility		95%
Weighted average expected term (in years)		6.6
Weighted average risk-free interest rate		2.6%
Expected dividends		-

	Year Ended December 31,
	2018		2017

Weighted average expected volatility		93%		79%
Weighted average expected term (in years)		7.0		6.6
Weighted average risk-free interest rate		2.7%		2.2%
Expected dividends		-		-

Note 15 - Stock Options and Stock-based Employee Compensation

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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, 2019		4,417		$	6.73
Granted		1,144			4.20
Forfeited or expired		(5	)		467.57
Outstanding at September 30, 2019		5,556		$	5.80		9.2

Vested and exercisable at September 30, 2019		70		$	128.45		6.3

Vested and expected to vest at September 30, 2019		5,245		$	5.79		9.2

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

Unvested at January 1, 2019		151		$	4.29
Awarded		249			3.95
Vested		(95	)		3.95
Cancelled		(144	)		4.33
Unvested at September 30, 2019		161		$	4.04

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:

	Nine Months Ended September 30,
	2019

Weighted average expected volatility		95%
Weighted average expected term (in years)		6.6
Weighted average risk-free interest rate		2.6%
Expected dividends		-

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

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

Research and development	$	574	$	29	$	1,613	$	169
General and administrative		1,365		116		3,595		534
Total	$	1,939	$	145	$	5,208	$	703

Note

–

Stock Options and Stock-based Employee Compensation

Long-Term Incentive Plans

We have the

2011

Plan that provides for the grant of long-term equity and cash incentive compensation awards and replaced a

2007

Long-Term Incentive Plan.

There are

6.1

million shares of our common stock authorized under the

2011

Plan, of which

1.5

million shares remain available for issuance. Awards under the Plan

may

include stock options, stock appreciation rights (SARs), restricted stock awards (RSAs), restricted stock units, other performance and stock-based awards, and dividend equivalents.

An administrative committee (the Committee – currently the Compensation Committee of the Board of Directors) or Committee delegates

may

determine the types, the number of shares covered by, and the terms and conditions of, such awards. Eligible participants

may

include any of our employees, directors, advisors or consultants.

Stock options and restricted stock units (RSUs) outstanding and available for future issuance are as follows:

	December 31,
(in thousands)	2018		2017

Stock Options and RSUs Outstanding
2011 Plan		4,558		263
Non-Plan		10		10
Total Outstanding		4,568		273

Available for Future Grants under 2011 Plan		1,453		1,623

SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the

2011

Plan. Although individual grants

may

vary, option awards generally are exercisable upon vesting, vest in a series of

three

successive, equal installments beginning with the

first

anniversary of the grant date, and have a

-year term. Non-Plan stock options outstanding are in connection with the hiring of our Chief Executive Officer, Mr. Fraser, on

February 1, 2016.

Mr. Fraser was awarded an inducement grant in accordance with Nasdaq Listing Rule

5635

(c)(

) and this inducement grant vests in a series of

three

successive, equal installments beginning with the

first

anniversary of the grant date, and has a

-year term.

A summary of activity under our long-term incentive plans is presented below:

						Weighted-
				Weighted-		Average
(in thousands, except for weighted-average data)				Average		Remaining
Stock Options	Shares			Exercise Price		Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		4,337			4.22
Forfeited or expired		(4	)		617.75
Outstanding at December 31, 2018		4,417		$	6.73		9.9

Vested and exercisable at December 31, 2018		63		$	171.87		6.5

Vested and expected to vest at December 31, 2018		4,243		$	6.78		9.9

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

Unvested at January 1, 2018		190		$	4.33
Awarded		56			4.22
Vested		(95	)		4.33
Unvested at December 31, 2018		151		$	4.29

Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended

December 31, 2018

and

2017

was

$3.39

and

$17.44,

respectively. The weighted-average grant-date fair value of RSUs granted during the years ended

December 31, 2018

and

2017

was

$4.22

and

$4.33,

respectively. The total intrinsic value of options outstanding, vested, and exercisable as of

December 31, 2018

are each

$0.

Stock-Based Compensation

We recognized stock-based compensation expense in accordance with ASC Topic

718

$1.0

million and

$1.6

million, respectively, for each of the years ended

December 31, 2018

and

2017.

Stock-based compensation expense was classified as follows:

	Year Ended December 31,
(in thousands)	2018		2017

Research and development	$	232	$	837
Selling, general and administrative		723		724
Total	$	955	$	1,561

Under the

2011

Plan, except as

may

be provided in an award agreement or an employment agreement, outstanding awards fully vest upon a change in control. Concurrent with the execution of the share purchase agreement with LPH in

October 2017 (

see

, Note

– Stockholders’ Equity – Private Placement Offerings) and the resulting change in control, all outstanding awards under the

2011

Plan, except as provided for in agreements for certain executive officers, fully vested and resulted in a

$0.4

million charge to stock based compensation expense in

2017.

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 US Treasury yield curve in effect at the time of the grant.

	Year Ended December 31,
	2018		2017

Weighted average expected volatility		93%		79%
Weighted average expected term (in years)		7.0		6.6
Weighted average risk-free interest rate		2.7%		2.2%
Expected dividends		-		-

The total fair value of the underlying shares of the options vested during

2018

and

2017

equals

$0.6

million and

$1.9

million, respectively. As of

December 31, 2018,

there was

$13.9

million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the

2011

Plan. That cost is expected to be recognized over a weighted-average vesting period of

2.9

years.

Note 18 - Commitments (Details Textual)		12 Months Ended
Note 18 - Commitments (Details Textual)	Dec. 21, 2018 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)	Sep. 30, 2019 USD ($)	Nov. 30, 2018 USD ($)	Feb. 28, 2018 USD ($) ft²	Apr. 30, 2016 ft²
Operating Leases, Rent Expense, Net, Total		$ 800,000	$ 700,000
Eligible Transaction, Minimum Gross Proceeds from Financing					$ 30,000,000
Strategic and Retention Bonus, Maximum Bonus, Requirement, Eligible Transaction, Minimum Gross Proceeds					$ 45,000,000
Minimum Bonus Amount, Percentage of Maximum Bonus Amount					20.00%
Private Placement Financing, Value	$ 39,000,000
Eligible Participants, Total Bonus	$ 1,400,000
Eligible Participants, Bonus Installment		700,000
Forecast [Member]
Eligible Participants, Bonus Installment				$ 700,000
Headquarters [Member]
Area of Real Estate Property \| ft²						21,189	30,506
Security Deposit		140,000	$ 225,000			$ 140,000
Operating Leases, Future Minimum Payments Due, Total		$ 2,100,000

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Cash flows from operating activities:
Net loss	$ (20,533)	$ (18,446)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	160	192
Amortization of debt discount	863
Stock-based compensation	955	1,655
Amortization of prepaid interest		912
Net loss on extinguishment of debt	3,345
Gain on debt restructuring		(5,824)
Gain on sale of equipment	(9)
Changes in:
Prepaid expenses and other current assets	302	90
Accounts payable	997	2,433
Collaboration and device development payable	(510)	(343)
Accrued expenses	(276)	(2,995)
Deferred revenue - current	(686)	884
Deferred revenue - non-current	(407)	407
Other liabilities	18	(10)
Net cash used in operating activities	(15,781)	(21,045)
Cash flows from investing activities:
Cash acquired in CVie acquisition	223
Purchase of marketable securities	(13,959)
Proceeds from sale of property and equipment	9
Purchase of property and equipment		(24)
Net cash used in investing activities	(13,727)	(24)
Cash flows from financing activities:
Proceeds from Issuance of Private Placement	32,893	14,860
Proceeds from loan payable, net of expenses	6,160	3,900
Repayment of loan payable	(160)
Proceeds from convertible note payable	1,500
Repayment of convertible note payable	(1,500)
Payment for taxes related to net share settlements of restricted stock units	(155)
Proceeds from ATM Program, net of expenses		1,036
Principal payments on debt restructuring		(2,500)
Net cash provided by financing activities	38,738	17,296
Effect of exchange rates on cash	88
Net increase/(decrease) in cash, cash equivalents and restricted cash	9,318	(3,773)
Cash, cash equivalents and restricted cash - beginning of year	2,040	5,813
Cash, cash equivalents and restricted cash - end of year	11,358	2,040
Supplementary disclosure of cash flows information:
Interest paid	$ 288	$ 1,088

Note 7 - Loans Payable

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Short-term Debt [Text Block]

Note

–

Loan

Payable

January 2018

and

March 2018,

LPH Investments Limited (LPH), an affiliate of Lee’s, agreed to lend us

$1.5

million and

$1.0

million, respectively, to support our AEROSURF development activities and sustain our operations while we sought to identify and advance

one

or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrued interest at a rate of

per annum and would mature upon the earlier of the closing date of the Funding Event or

December 31, 2018.

To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement dated

March 1, 2018 (

LPH Security Agreement). Effective

December 5, 2018,

LPH assigned all outstanding loans to us to LPH II Investment Limited (LPH II), a subsidiary of Lee's. In connection with the Private Placement Financing, we converted to equity

$6.0

million of the then outstanding loan payable obligations to LPH II on the same terms as those of the investors in the private placement. Included in the conversion were the

$1.5

million and

$1.0

million loans and following this conversion of the loans into equity securities, the security interest granted under the LPH Security Agreement was discharged.

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 due in

March 2020.

September 2016,

CVie entered into a

-month revolving credit facility of approximately

$2.9

million with O-Bank Co., Ltd. (O-Bank) to finance operating activities. The facility was later renewed and increased to approximately

$5.8

million in

September 2017.

The credit facility was guaranteed by Lee’s, which pledged bank deposits in the amount of

110%

of the actual borrowing amount. The guaranty was part of the 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

-day TAIBOR (the Taipei Interbank Offer Rate) plus

0.91%.

The credit facility expired on

September 11, 2019

and the loans mature

six

months after the expiration date, on

March 11, 2020.

We have initiated a process with O-Bank potentially to extend the maturity date of the facility into

2021.

As of

September 30, 2019,

the outstanding principal was approximately

$4.5

million.

Assumption of

Lee's

debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$3.5

million of debt payable to Lee’s Pharmaceutical International Limited (Lee’s International).

From

April 24, 2018

November 16, 2018,

CVie entered into

four

separate agreements to borrow an aggregate of approximately

$3.5

million from Lee’s International. The terms of the loan agreements are identical with interest, payable in cash upon maturity, at a rate of

per annum and maturing

one

year from the effective date of the respective loan agreement as follows:

$0.5

million in

April 2019;

$0.3

million in

September 2019;

$0.2

million in

October 2019;

and

$2.5

million in

November 2019.

Due to our current cash position, Lee’s recently agreed in principle to defer payment of these loans until we have adequate cash resources to satisfy the outstanding obligations or

later than

April 30, 2021.

During the quarter ended

March 31, 2019,

we made payments of

$0.45

million against the

April 2018

loan and paid the remaining

$50,000

balance plus accrued interest in

April 2019.

As of

September 30, 2019,

the outstanding principal of the loans with Lee’s International was

$3.0

million.

Loan payable to Bank Direct Capital Finance

May 2019,

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

$0.7

million of certain premiums at a

5.35%

annual interest rate. Payments of approximately

$80,000

are due monthly through

March 2020.

As of

September 30, 2019,

the outstanding principal of the loan was

$0.4

million.

Note

–

Loan Payable

January 2018

and

March 2018,

LPH Investments Limited (“LPH”), an affiliate of Lee’s, agreed to lend us

$1.5

million and

$1.0

million, respectively, to support our AEROSURF development activities and sustain our operations while we sought to identify and advance

one

or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrue interest at a rate of

per annum and mature upon the earlier of the closing date of the Funding Event or

December 31, 2018.

To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement with LPH dated

March 1, 2018 (

LPH Security Agreement).

During the

third

and

fourth

quarters of

2018,

LPH agreed to lend us funds to sustain our operations while we continued to work on a strategic transaction. The initial loan was funded on

August 14, 2018

in the amount of

$0.3

million, and subsequent loans on the following dates and in the following amounts:

August 29, 2018,

in the amount of

$0.48

million;

September 12, 2018

in the amount of

$0.5

million;

September 27, 2018

in the amount of

$0.5

million;

October 19, 2018

in the amount of

$0.43

million;

November 2, 2018

in the amount of

$0.5

million;

November 19, 2018

in the amount of

$0.35

million; and

December 5, 2018

in the amount of

$0.6

million. The loans accrued interest at a rate of

per annum and matured upon the earlier of (i) the closing date for the strategic transaction (as defined in the related loan agreements), provided that the we were able to raise a minimum of

$30

million in connection with such transaction, or (ii)

March 31, 2019.

In each case, we granted to LPH a security interest in substantially all of our assets pursuant to the terms of the LPH Security Agreement.

Extinguishment of Loan Payable

December 21, 2018,

as part of the Private Placement Financing, we converted

$6.0

million of existing loan payable obligations to LPH on the same terms as those of the Investors of the private placement. In connection with the conversion of Lee’s debt, we issued: (i)

1,810,938

shares of common stock based at

$3.3132

per share, (ii) Series F Warrants to purchase

307,859

shares of common stock, at an exercise price equal to

$3.68

per share, and (iii) Series G Warrants to purchase

597,610

shares common stock, at an exercise price equal to

$4.05

per share. The Series F Warrants are exercisable at any time after the date of issuance and through the

-month anniversary of the date of issuance and the Series G Warrants

may

be exercised through the

-year anniversary of the date of issuance.

The conversion of the loan payable to LPH is treated as an extinguishment of debt and does

not

represent a capital transaction as the Private Placement Financing included

third

-party investors and all investors received identical terms. We recorded a loss on extinguishment of debt approximately

$3.2

million. The loss was calculated as the difference between: (i) the aggregate fair value of approximately

$9.2

million, based on the fair value of the common stock and Warrants on

December 21, 2018,

and (ii) the carrying value of the debt liabilities of

$6.0

million.

The balance of the loan payable to LPH of

$160,000

was paid along with accrued interest of

$182,000

December 27, 2018.

Assumption of bank debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$4.5

million (or NTD

$138.0

million) in a bank credit facility due in

March 2020.

September 2016,

CVie entered into a

-month revolving credit facility of approximately

$2.9

million (or NTD

$90.0

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

$5.84

million (or NTD

$180.0

million) in

September 2017.

The credit facility was guaranteed by Lee’s, which pledged bank deposits in the amount of

110%

of the actual borrowing amount. The guaranty was part of the 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

-day TAIBOR (the Taipei Interbank Offer Rate) plus

0.91%.

The credit facility will expire on

September 11, 2019

and matures

six

months after the expiration date, on

March 11, 2020.

Although we reached an understanding with Lee’s that it would maintain the bank deposits securing its guaranty obligation under the credit facility, we do

not

have a written agreement with Lee’s requiring it to do so; therefore, the

$4.5

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

As of

December 31, 2018,

the outstanding principal was approximately

$4.5

million (or NTD

$138.0

million), due to exchange rate fluctuations.

Assumption of Lee’s debt as part of the CVie Acquisition

As part of the CVie Acquisition, we assumed approximately

$3.5

million (or NTD

$106.2

million) of debt payable to Lee’s Pharmaceutical International Limited (Lee’s International).

From

April 24, 2018

November 16, 2018,

CVie entered into

four

separate agreements to borrow an aggregate of approximately

$3.5

million from Lee’s International. The terms of the loan agreements are identical where the interest, payable in cash upon maturity, is

per annum and each of the

four

separate loans will mature

one

year from the effective date as follows:

$0.5

million in

April 2019;

$0.3

million in

September 2019;

$0.2

million in

October 2019;

and

$2.5

million in

November 2019.

As of

December 31, 2018,

the outstanding principal was approximately

$3.5

million (or NTD

$106.2

million), due to exchange rate fluctuations.

Note 9 - Stock Options and Stock-based Employee Compensation (Details Textual) - The 2011 Long-term Incentive Plan [Member]	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period		3 years
Stock-based Awards [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period	3 years
Restricted Stock Units (RSUs) [Member] \| Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period	180 days
Restricted Stock Units (RSUs) [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period	1 year 180 days

Note 20 - Income Taxes

9 Months Ended

Sep. 30, 2019

Income Tax Disclosure [Text Block]

Note

–

Income Taxes

Since our inception, we have never recorded a provision or benefit for federal and state income taxes.

The reconciliation of the income tax benefit computed at the federal statutory rates to our recorded tax benefit for the years ended

December 31, 2018

and

2017

is as follows:

	December 31,
(in thousands)	2018			2017

Income tax benefit, statutory rates	$	(4,312	)	$	(6,272	)
State taxes on income, net of federal benefit		(535	)		(398	)
Impact of tax reform		5			71,151
Research and development tax credit		(351	)		(797	)
Foreign rate differential		24			-
Employee related		2,875			953
Interest related		186			(147	)
Income tax expense / (benefit), statutory rates		(2,108	)		64,490
Valuation allowance		2,108			(64,490	)
Income tax benefit, net	$	-		$	-

During

2017,

we recorded tax charges for the impact of the

2017

Tax Cuts and Jobs Act (the

2017

Tax Act) effects using the current available information and technical guidance on the interpretations of the

2017

Tax Act. As permitted by SEC Staff Accounting Bulletin

118,

Income Tax Accounting Implications of the Tax Cuts and Jobs Act, we recorded provisional estimates and have subsequently finalized our accounting analysis based on the guidance, interpretations, and data available as of

December 31, 2018.

Adjustments made in the

fourth

quarter of

2018

upon finalization of our accounting analysis were

not

material to our Consolidated Financial Statements.

The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at

December

31,

2018

and

2017,

are as follows:

	December 31,
(in thousands)	2018			2017

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	176,759		$	168,263
Research and development tax credit		16,718			16,813
Compensation expense on stock		1,121			1,191
Charitable contribution carryforward		-			5
Other accrued		1,016			2,547
Deferred revenue		57			317
Depreciation		309			297
Total long-term deferred tax assets		195,980			189,433
Long-term deferred liabilities:
IPR&D		(15,476	)		-
Total long-term deferred tax liabilities		(15,476	)		-
Valuation allowance		(195,980	)		(189,433	)
Deferred tax liabilities, net	$	(15,476	)	$	-

We are in a net deferred tax liability position at

December 31, 2018.

We are in a net deferred tax asset position at

December 31, 2017

before the consideration of a valuation allowance. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is

not

assured. It is our policy to classify interest and penalties recognized on uncertain tax positions as a component of income tax expense. There was neither interest nor penalties accrued as of

December 31, 2018

2017,

nor were any incurred in

2018

2017.

December 31, 2018

and

2017,

we had available carryforward net operating losses for federal tax purposes of

$606.6

million and

$590.0

million, respectively, and a research and development tax credit carryforward of

$16.7

million and

$16.8

million, respectively. The Federal net operating loss and research and development tax credit carryforwards will continue to expire through

2037.

December 31, 2018

and

2017,

we had available carryforward losses of approximately

$584.8

million and

$567.7

million , respectively, for state tax purposes. Of the

$583.9

million state tax carryforward losses,

$570.2

million is associated with the state of Pennsylvania, with the remainder associated with the other

states within which we have established tax nexus.

Utilization of net operating loss (NOL) and research and development (R&D) credit carryforwards

may

be subject to a substantial annual limitation under Section

382

of the Internal Revenue Code of

1986

due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes

may

limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. There also could be additional ownership changes in the future, which

may

result in additional limitations in the utilization of the carryforward NOLs and credits.

A full valuation allowance has been provided against our deferred tax assets and, if a future assessment requires an adjustment, an adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be

impact to the consolidated balance sheet or statement of operations if an adjustment were required.

Note 5 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended									9 Months Ended		12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
License [Member]
License revenue with affiliate		$ 304	$ 159	$ 356	$ 204	$ 102				$ 198	$ 719	$ 1,023	$ 102

Note 13 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000	$ 15,000
Deerfield Loan [Member]
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000	$ 15,000

Note 9 - Stock Options and Stock-based Employee Compensation

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Share-based Payment Arrangement [Text Block]

Note

–

Stock Options and Stock-Based Employee Compensation

three

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, 2019		4,417		$	6.73
Granted		1,144			4.20
Forfeited or expired		(5	)		467.57
Outstanding at September 30, 2019		5,556		$	5.80		9.2

Vested and exercisable at September 30, 2019		70		$	128.45		6.3

Vested and expected to vest at September 30, 2019		5,245		$	5.79		9.2

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

Unvested at January 1, 2019		151		$	4.29
Awarded		249			3.95
Vested		(95	)		3.95
Cancelled		(144	)		4.33
Unvested at September 30, 2019		161		$	4.04

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:

	Nine Months Ended September 30,
	2019

Weighted average expected volatility		95%
Weighted average expected term (in years)		6.6
Weighted average risk-free interest rate		2.6%
Expected dividends		-

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

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

Research and development	$	574	$	29	$	1,613	$	169
General and administrative		1,365		116		3,595		534
Total	$	1,939	$	145	$	5,208	$	703

Note

–

Stock Options and Stock-based Employee Compensation

Long-Term Incentive Plans

We have the

2011

Plan that provides for the grant of long-term equity and cash incentive compensation awards and replaced a

2007

Long-Term Incentive Plan.

There are

6.1

million shares of our common stock authorized under the

2011

Plan, of which

1.5

million shares remain available for issuance. Awards under the Plan

may

include stock options, stock appreciation rights (SARs), restricted stock awards (RSAs), restricted stock units, other performance and stock-based awards, and dividend equivalents.

An administrative committee (the Committee – currently the Compensation Committee of the Board of Directors) or Committee delegates

may

determine the types, the number of shares covered by, and the terms and conditions of, such awards. Eligible participants

may

include any of our employees, directors, advisors or consultants.

Stock options and restricted stock units (RSUs) outstanding and available for future issuance are as follows:

	December 31,
(in thousands)	2018		2017

Stock Options and RSUs Outstanding
2011 Plan		4,558		263
Non-Plan		10		10
Total Outstanding		4,568		273

Available for Future Grants under 2011 Plan		1,453		1,623

SARs, RSAs, other performance and stock-based awards, or dividend equivalents have been granted under the

2011

Plan. Although individual grants

may

vary, option awards generally are exercisable upon vesting, vest in a series of

three

successive, equal installments beginning with the

first

anniversary of the grant date, and have a

-year term. Non-Plan stock options outstanding are in connection with the hiring of our Chief Executive Officer, Mr. Fraser, on

February 1, 2016.

Mr. Fraser was awarded an inducement grant in accordance with Nasdaq Listing Rule

5635

(c)(

) and this inducement grant vests in a series of

three

successive, equal installments beginning with the

first

anniversary of the grant date, and has a

-year term.

A summary of activity under our long-term incentive plans is presented below:

						Weighted-
				Weighted-		Average
(in thousands, except for weighted-average data)				Average		Remaining
Stock Options	Shares			Exercise Price		Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		4,337			4.22
Forfeited or expired		(4	)		617.75
Outstanding at December 31, 2018		4,417		$	6.73		9.9

Vested and exercisable at December 31, 2018		63		$	171.87		6.5

Vested and expected to vest at December 31, 2018		4,243		$	6.78		9.9

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

Unvested at January 1, 2018		190		$	4.33
Awarded		56			4.22
Vested		(95	)		4.33
Unvested at December 31, 2018		151		$	4.29

Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended

December 31, 2018

and

2017

was

$3.39

and

$17.44,

respectively. The weighted-average grant-date fair value of RSUs granted during the years ended

December 31, 2018

and

2017

was

$4.22

and

$4.33,

respectively. The total intrinsic value of options outstanding, vested, and exercisable as of

December 31, 2018

are each

$0.

Stock-Based Compensation

We recognized stock-based compensation expense in accordance with ASC Topic

718

$1.0

million and

$1.6

million, respectively, for each of the years ended

December 31, 2018

and

2017.

Stock-based compensation expense was classified as follows:

	Year Ended December 31,
(in thousands)	2018		2017

Research and development	$	232	$	837
Selling, general and administrative		723		724
Total	$	955	$	1,561

Under the

2011

Plan, except as

may

be provided in an award agreement or an employment agreement, outstanding awards fully vest upon a change in control. Concurrent with the execution of the share purchase agreement with LPH in

October 2017 (

see

, Note

– Stockholders’ Equity – Private Placement Offerings) and the resulting change in control, all outstanding awards under the

2011

Plan, except as provided for in agreements for certain executive officers, fully vested and resulted in a

$0.4

million charge to stock based compensation expense in

2017.

	Year Ended December 31,
	2018		2017

Weighted average expected volatility		93%		79%
Weighted average expected term (in years)		7.0		6.6
Weighted average risk-free interest rate		2.7%		2.2%
Expected dividends		-		-

The total fair value of the underlying shares of the options vested during

2018

and

2017

equals

$0.6

million and

$1.9

million, respectively. As of

December 31, 2018,

there was

$13.9

million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the

2011

Plan. That cost is expected to be recognized over a weighted-average vesting period of

2.9

years.

Note 10 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Professional fees		$ 2,473	$ 412
Research and development		2,361	1,778
Salaries, bonus & benefits		815	1,008
Manufacturing operations		212	537
Other		604	399
Total accrued expenses	$ 5,235	$ 6,465	$ 4,134

Note 17 - Related Party Transactions (Details Textual) - USD ($) $ in Millions	1 Months Ended				12 Months Ended
	Dec. 31, 2018	Jul. 31, 2018	Apr. 30, 2018	Oct. 31, 2017	Dec. 31, 2018	Dec. 31, 2017
Affiliate of Lee’s [Member] \| Share Purchase Agreement [Member]
Related Party Transaction, Amounts of Transaction				$ 10.0
Affiliate of Lee’s [Member] \| Private Placement in a related Party Transaction [Member]
Related Party Transaction, Amounts of Transaction			$ 2.6
Affiliate of Lee’s [Member] \| Converting Existing Loans Payable [Member]
Related Party Transaction, Amounts of Transaction	$ 6.0
Lee’s Pharmaceutical Holdings Limited [Member] \| Bank Credit Facility is Guaranteed [Member]
Related Party Transaction, Amounts of Transaction					$ 4.5
Affiliate of Panacea [Member] \| Secured Convertible Promissory Note [Member]
Related Party Transaction, Amounts of Transaction		$ 1.5
Rui Jin (HK) Consulting Management Company Limited, an affiliate of Panacea [Member]
Related Party Transaction, Shares Issued					114,415
Lee’s Pharmaceutical Holdings Limited [Member] \| Windtree Therapeutics [Member]
Ownership Percentage	40.00%				40.00%	73.00%
Lee’s Pharmaceutical Holdings Limited [Member] \| CVie Investment [Member]
Ownership Percentage	49.00%				49.00%
KPCB [Member] \| Windtree Therapeutics [Member]
Ownership Percentage	14.00%				14.00%
KPCB [Member] \| CVie [Member]
Ownership Percentage	27.00%				27.00%

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

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

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, 2019		4,417		$	6.73
Granted		1,144			4.20
Forfeited or expired		(5	)		467.57
Outstanding at September 30, 2019		5,556		$	5.80		9.2

Vested and exercisable at September 30, 2019		70		$	128.45		6.3

Vested and expected to vest at September 30, 2019		5,245		$	5.79		9.2

						Weighted-
				Weighted-		Average
(in thousands, except for weighted-average data)				Average		Remaining
Stock Options	Shares			Exercise Price		Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		4,337			4.22
Forfeited or expired		(4	)		617.75
Outstanding at December 31, 2018		4,417		$	6.73		9.9

Vested and exercisable at December 31, 2018		63		$	171.87		6.5

Vested and expected to vest at December 31, 2018		4,243		$	6.78		9.9

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]

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

Unvested at January 1, 2019		151		$	4.29
Awarded		249			3.95
Vested		(95	)		3.95
Cancelled		(144	)		4.33
Unvested at September 30, 2019		161		$	4.04

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

Unvested at January 1, 2018		190		$	4.33
Awarded		56			4.22
Vested		(95	)		4.33
Unvested at December 31, 2018		151		$	4.29

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

	Nine Months Ended September 30,
	2019

Weighted average expected volatility		95%
Weighted average expected term (in years)		6.6
Weighted average risk-free interest rate		2.6%
Expected dividends		-

	Year Ended December 31,
	2018		2017

Weighted average expected volatility		93%		79%
Weighted average expected term (in years)		7.0		6.6
Weighted average risk-free interest rate		2.7%		2.2%
Expected dividends		-		-

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

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

Research and development	$	574	$	29	$	1,613	$	169
General and administrative		1,365		116		3,595		534
Total	$	1,939	$	145	$	5,208	$	703

	Year Ended December 31,
(in thousands)	2018		2017

Research and development	$	232	$	837
Selling, general and administrative		723		724
Total	$	955	$	1,561

Note 20 - Income Taxes (Details Textual) - USD ($) $ in Millions	Dec. 31, 2018	Dec. 31, 2017
Operating Loss Carryforwards, Total	$ 606.6	$ 590.0
State and Local Jurisdiction [Member]
Operating Loss Carryforwards, Total	584.8	567.7
State and Local Jurisdiction [Member] \| Pennsylvania [Member]
Operating Loss Carryforwards, Total	570.2
Research Tax Credit Carryforward [Member]
Tax Credit Carryforward, Amount	$ 16.7	$ 16.8

Note 3 - Liquidity Risks and Management's Plans

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Liquidity Disclosures [Text Block]

Note

–

Liquidity Risks and Management’s Plans

As of

September 30, 2019,

we had cash and cash equivalents of

$4.4

million and current liabilities of

$16.3

million, including

$7.8

million of Loans payable (

see

, Note

- Loans Payable). On

October 24, 2019,

LPH II Investments Ltd. (LPH II), an affiliate of Lee’s Pharmaceutical Holdings Limited, agreed to lend the Company

$1.0

November 2019

while maintaining minimum cash resources to provide for an orderly shutdown of operations, if required.

November 2019,

and we do

not

one

year after the date that the financial statements are issued.

one

or a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations focused on specified geographic markets; however,

none

of these alternatives are committed at this time. There can be

may

not

be in an amount sufficient to support all of our planned activities and we would therefore need to prioritize and potentially curtail certain programs. If

none

November 2019

and we will

not

one

year after the issuance of the accompanying financial statements.

not

As of

September 30, 2019,

there were

120.0

million shares of common stock and

5.0

million shares of preferred stock authorized under our Certificate of Incorporation, and approximately

72.0

million shares of common stock and

5.0

million shares of preferred stock available for issuance and

not

otherwise reserved.

Note

–

Liquidity Risks and Management’s Plans

As of

December 31, 2018,

we had cash and cash equivalents of

$11.2

million and available-for-sale, marketable securities of

$14.0

million, current liabilities of

$20.6

million, including

$8.0

million of Loan payable (

see

, Note

- Loan Payable). As of

April 5, 2019,

we believe that we have sufficient resources (including marketable securities) available to support our development activities, business operations and debt service through

October

2019.

Although we believe that the

December 2018

CVie Acquisition and

$39

million Private Placement Financing have improved our financial position and

may

October 2019,

and we do

not

one

year after the date that the financial statements are issued.

not

limited to potential alliances and collaborations focused on various individual markets; however,

none

of these alternatives are committed at this time. There can be

none

of these alternatives is available, or if available, we are unable to raise sufficient capital through such transactions, we will

not

one

year after the issuance of the accompanying financial statements.

not

As of

December 31, 2018,

there were

120

million shares of common stock and

million shares of preferred stock authorized under our Certificate of Incorporation, and approximately

72.0

million shares of common stock and

5.0

million shares of preferred stock available for issuance and

not

otherwise reserved.

Note 8 - Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2018

Property, Plant and Equipment [Table Text Block]

	December 31,
(in thousands)	2018			2017

Manufacturing, laboratory & office equipment	$	4,359		$	4,965
Furniture & fixtures		390			615
Leasehold improvements		2,469			2,458
Subtotal		7,218			8,038
Accumulated depreciation and amortization		(6,416	)		(7,153	)
Property and equipment, net	$	802		$	885

Note 5 - License Revenue with Affiliate (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Disaggregation of Revenue [Table Text Block]

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2019		2018		2019		2018

License revenue with affiliate	$	-	$	159	$	198	$	719

	Year Ended December 31,
(in thousands)	2018		2017

License revenue with affiliate	$	1,023	$	102

Note 9 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Shares Outstanding, Beginning Balance (in shares)	4,417	84
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share)	$ 6.73	$ 163.20
Shares Granted (in shares)	1,144	4,337
Weighted Average Exercise Price, Granted (in dollars per share)	$ 4.20	$ 4.22
Shares Forfeited or Expired (in shares)	(5)	(4)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share)	$ 467.57	$ 617.75
Shares Outstanding, Ending Balance (in shares)	5,556	4,417
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share)	$ 5.80	$ 6.73
Weighted Average Remaining Contractual Life, Outstanding (Year)	9 years 73 days	9 years 328 days
Shares Vested and Exercisable (in shares)	70	63
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share)	$ 128.45	$ 171.87
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	6 years 109 days	6 years 182 days
Vested and expected to vest (in shares)	5,245	4,243
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share)	$ 5.79	$ 6.78
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	9 years 73 days	9 years 328 days

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Net loss	$ (7,126)	$ (3,927)	$ (20,100)	$ (11,491)
Other comprehensive income:
Unrealized gain (loss) on marketable securities	(12)
Comprehensive loss	$ (7,138)	$ (3,927)	$ (20,100)	$ (11,491)

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

+ References + Details

Note 4 - Summary of Significant Accounting Policies

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Significant Accounting Policies [Text Block]

Note

–

Summary of Significant Accounting Policies

Principles of

onsolidation

Business

ombinations

may

differ materially from estimates.

Goodwill and

ntangible

ssets

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

September 30, 2019

and

December 31, 2018:

(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. We perform an annual impairment test for goodwill and evaluate the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such an assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Foreign

urrency

ransactions

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

not

$0.1

million and

$0.4

million for the

three

and

nine

months ended

September 30, 2019.

There were

foreign currency transaction gains or losses for the

three

and

nine

months ended

September 30, 2018.

Use of

stimates

Marketable

ecurities

320,

three

months ended

September 30, 2019,

we had

$14,000

in realized gains and

$12,000

in unrealized losses on marketable securities. For the

nine

months ended

September 30, 2019,

we had

$75,000

in realized gains and our unrealized gains and losses on marketable securities netted to zero. There were

realized or unrealized gains or losses on investments for the

three

and

nine

months ended

September 30, 2018.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

Leases

Effective

January 1, 2019,

we adopted ASC Topic

842,

Leases

(ASC

842

), using the modified retrospective transition approach and utilizing the effective date as the date of initial application. Consequently, prior period balances and disclosures have

not

been restated and are presented in accordance with the previous guidance in ASC Topic

840,

Leases

one

year are generally recognized on the balance sheet as operating lease right-of-use assets and current and non-current operating lease liabilities, as applicable. We elected

not

to recognize on the balance sheet leases with terms of

months or less. We typically only include the initial lease term in our assessment of a lease arrangement. Options to extend a lease are

not

included in our assessment unless there is reasonable certainty that we will renew.

may

be required for items such as incentives received. The interest rate implicit in our leases is typically

not

842,

we utilized the remaining lease term of our leases in determining the appropriate incremental borrowing rates.

Restructured

ebt

iability –

ntingent

ilestone

ayment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

ee,

Note

– Restructured Debt Liability), we established a

$15

October 27, 2017 (

not

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

Research and

evelopment

730,

Research and Development

Net

oss per

ommon

hare

September 30, 2019

and

2018,

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

15.6

million and

1.3

million shares, respectively. For the

three

and

nine

months ended

September 30, 2019

and

2018,

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

Income

axes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes

not

assured.

Recently

dopted

ccounting

tandards

February 2016,

the FASB issued Accounting Standards Update (ASU)

No.

2016

02,

Leases

(ASU

2016

). ASU

2016

establishes ASC

842

which amends ASC

840,

Leases

, by introducing a lessee model that requires balance sheet recognition for most leases and the disclosure of key information about leasing arrangements. ASC

842

was subsequently amended during

2018.

January 1, 2019

and used the effective date as its date of initial application. Consequently, financial information is

not

updated and the disclosures required under the new standard are

not

provided for dates and periods prior to

January 1, 2019.

Instead, the requirements of ASC

840

are presented for these prior periods.

ASC

842

provides several optional practical expedients in transition. We elected the package of practical expedients which allowed us to

not

months or less, for purposes of applying the recognition and measurement requirements of the new standard. We also elected the practical expedient to

not

separate lease and non-lease components for all our leases.

The adoption of this standard resulted in the recognition of operating lease liabilities and related right-of-use assets on our condensed consolidated balance sheets of

$2.2

million and

$2.0

million, respectively, related to our operating leases. The adoption of ASC

842

also resulted in the elimination of deferred rent of approximately

$72,000

and

$139,000

in accrued expenses and other long-term liabilities, respectively, in our condensed consolidated balance sheets. The adoption of the standard did

not

have a material impact on our condensed consolidated statements of operations and comprehensive loss or condensed consolidated statements of cash flows. Refer to Note

– Leases, for our current lease commitments.

January 2017,

the FASB issued ASU

No.

2017

04,

"Intangibles-Goodwill and Other (Topic

350

): Simplifying the Test for Goodwill Impairment." The new standard simplifies the subsequent measurement of goodwill by eliminating the

second

step of the goodwill impairment test. This ASU will be applied prospectively and is effective for annual or interim goodwill impairment tests in fiscal years beginning after

December 15, 2019

with early adoption permitted. We adopted this guidance on

January 1, 2019

and will apply it to our annual impairment test, and any interim impairment tests during the year ending

December 31, 2019.

Recently Issued Accounting Standards

August 2018,

the FASB issued ASU

No.

2018

13,

"Fair Value Measurement (Topic

820

): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement" (ASU

2018

), which removes, adds and modifies certain disclosure requirements for fair value measurements in Topic

820.

Companies will

longer be required to disclose the amount of and reasons for transfers between Level

and Level

of the fair value hierarchy as well as the valuation processes of Level

fair value measurements. However, companies will be required to additionally disclose the changes in unrealized gains and losses included in other comprehensive income for recurring Level

fair value measurements and the range and weighted average of assumptions used to develop significant unobservable inputs for Level

fair value measurements. ASU

2018

is effective for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2019.

2018

will have on our condensed consolidated financial statements.

Note

–

Accounting Policies and Recent Accounting Pronouncements

Principles of consolidation

Business

ombinations

We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results

may

differ materially from estimates.

Goodwill and

ntangible

ssets

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 (“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

December 31, 2018:

(in thousands)	Estimated Fair 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 assets acquired and liabilities assumed in a business combination and is

not

amortized. We perform an annual impairment test for goodwill and evaluates the recoverability whenever events or changes in circumstances indicate that the carrying value of goodwill

may

not

be fully recoverable. In making such assessment, qualitative factors are used to determine whether it is more likely than

not

that our fair value is less than our carrying value. If the estimated fair value is less than our carrying value, then an impairment loss is recorded.

Foreign

urrenc

y transactions

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

not

$0.1

million for the year ended

December 31, 2018.

There were

foreign currency transaction gains or losses for the year ended

December 31, 2017.

Use of estimates

Cash and cash equivalents

Cash and cash equivalents are held in at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of

days or less that are readily convertible into cash.

Marketable securities

320,

Investments—Debt and Equity Securities. Investments are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were

realized gains or losses on marketable securities for the years ended

December 31, 2018

and

2017.

There were

unrealized gains or losses on investments for the years ended

December 31, 2018

and

2017.

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is

not

Fair value of financial instruments

December 31, 2018

and

2017,

Property and equipment

Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally

three

ten

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

Restricted cash

Restricted cash consists principally of a

$140,000

certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated

May 26, 2004

for our headquarters location in Warrington, Pennsylvania and

$31,000

in deposits held by our landlord for our offices in Taipei, Taiwan, the former headquarters of CVie Therapeutics (

see,

– Note

– Commitments, for further discussion on our leases).

Long-lived assets

Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset

may

not

impairment was recorded during the years ended

December 31, 2018

and

2017

as management believes there are

circumstances that indicate the carrying amount of the assets will

not

be recoverable.

Collaborative arrangements

We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic

808,

Collaborative Arrangements

See,

– Note

– Collaboration, Licensing and Research Funding Agreements.

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

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.

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (

see

, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – current portion. Amounts

not

expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in

July 2017

in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (

see

, Note

– Collaboration and Device Development Payment Restructuring, Licensing and Research Funding Agreements).

Revenue recognition

Effective

January 1, 2018,

we adopted Accounting Standards Codification (“ASC”) Topic

606,

Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic

606,

In accordance with ASC Topic

606,

we perform the following

five

steps:

	(i)		identify the contract(s) with a customer;

	(ii)		identify the performance obligations in the contract;

	(iii)		determine the transaction price;

	(iv)		allocate the transaction price to the performance obligations in the contract; and

	(v)		recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the

five

606,

We have concluded that our government grants are

not

within the scope of ASC Topic

606

as they do

not

meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic

958

605,

Not

-for-Profit-Entities-Revenue Recognition does

not

apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under US GAAP, effective

January 1, 2018,

we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic

606,

exchange as defined in ASC Topic

606.

We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic

606.

Prior to

January 1, 2018,

not

materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was

change to the amounts we have historically recorded in our financial statements.

Research and development

730,

Research and Development

Stock-based compensation

Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic

718,

Stock Compensation

(ASC Topic

718

See

, – Note

Warrant accounting

We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s Own Equity

(ASC Topic

815

), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement.

Income taxes

We account for income taxes in accordance with ASC Topic

740,

not

assured.

Beneficial Conversion Feature

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the

first

quarter of

2017

(see, “– Note

$3.6

million

one

-time, non-cash deemed dividend to the preferred shareholders during the

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

December 31, 2018

and

December 31, 2017,

we recognized a non-cash deemed dividend to the preferred shareholders of

$1.7

million and

$2.8

million, respectively, related to the Preferred Shares converted during the period. As of

December 31, 2018,

there were

Preferred Shares remaining to be converted.

Convertible Note

The issuance on

July 2, 2018

of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of

$1.5

million less debt discount consisting of (i)

$0.4

million related to the beneficial conversion feature and (ii)

$0.4

million in fair value of the warrants issued in connection with the Note. The discount was accreted to the

$1.5

million loan over its term using the effective interest method (

see

, – Note

– Loan Payable). On

December 27, 2018,

we repaid the Note in its entirety in cash of

$1.5

million. As part of the extinguishment of debt, we recorded a gain on extinguishment of debt of approximately

$0.4

$5.11

and the conversion price of

$4.00,

and (ii)

375,000

shares convertible into common stock.

Net loss per common share

December 31, 2018

and

2017,

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

14.4

million and

1.0

million shares, respectively. As of

December 31, 2018

and

2017,

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 income (loss).

Concentration of Suppliers

We currently obtain the active pharmaceutical ingredients (APIs) of our

KL4

surfactant drug products from single-source suppliers. In addition, we rely on a number of

third

-party institutions and laboratories that perform various studies as well as quality control release and stability testing and other activities related to our

KL4

surfactant development and manufacturing activities. At the present time, several of these laboratories are single-source providers. The loss of

one

or more of our single-source suppliers or testing laboratories could have a material adverse effect upon our operations.

Business segments

We currently operate in

one

business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. We do

not

operate separate lines of business with respect to our product candidates.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

May 2014,

the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which was subsequently amended by several other ASUs related to Topic

606

2014

09,

as amended, effective

January 1, 2018

using the modified retrospective transition method. In

June 2017,

2014

and determined that there was

material impact to revenues for any of the years presented upon adoption. Additionally, there were

See,

“– Note

– Collaboration, Licensing and Research Funding Agreements).

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

), Scope of Modification Accounting

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

), Classification of Certain Cash Receipts and Cash Payments

. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to

eight

one

class of cash flows. The ASU is effective retrospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2016

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

January 2017,

the FASB issued ASU

2017

01,

Business Combinations (Topic

805

), Clarifying the Definition of a Business

. The FASB changed its definition of a business in an effort to help entities determine whether a set of transferred assets and activities is a business. The guidance requires an entity to

first

not

a business. If the threshold is

not

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our annual

2018

financial statements.

Recent Accounting Pronouncements

February 2016,

the FASB issued ASU

2016

02,

Leases

(Topic

842

). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective

January 1, 2019.

not

January 2017,

the FASB issued ASU

2017

04,

Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment

. ASU

2017

simplifies the subsequent measurement of goodwill by removing the

second

step of the

two

not

2017

is effective for annual or interim goodwill impairment tests performed in fiscal years beginning after

December 15, 2019;

early adoption is permitted. We currently anticipate that the adoption of ASU

2017

will

not

have a material impact on our financial statements.

Note 3 - Business Combination - Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018	Dec. 21, 2018
Goodwill	$ (15,682)	$ (15,682)
CVie Investments [Member]
Cash and cash equivalents			$ 193
Restricted cash			31
Prepaid expenses and other current assets			387
Property and equipment, net			76
Intangible assets			77,090
Total identifiable assets acquired			77,777
Current liabilities			(2,590)
Loan payable, current			(3,453)
Loan payable, non current			(4,491)
Deferred tax liabilities, noncurrent			(15,418)
Other liabilities, noncurrent			(7)
Net identifiable assets acquired			51,818
Goodwill			(15,682)
Net assets acquired			$ 67,500

Note 8 - Restructured Debt Liability (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Schedule of Long-term Debt Instruments [Table Text Block]

	September 30,		December 31,
(in thousands)	2019		2018

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

	December 31,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

+ References

+ Details

Note 18 - Commitments

12 Months Ended

Dec. 31, 2018

Commitments Disclosure [Text Block]

Note

–

Commitments

Operating Leases

Our operating leases consist primarily of a facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan.

We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. We also maintain offices in Taipei, Taiwan, the former headquarters of CVie Therapeutics, where we perform certain manufacturing development and preclinical activities related to our cardiovascular drug product candidates.

February 2018,

we amended our Warrington, Pennsylvania lease to (i) reduce the leased space from

30,506

square feet to

21,189

square feet and (ii) reduce the security deposit under the lease in the form of a letter of credit from

$225,000

$140,000.

The total aggregate base rental payments remaining under the leases as of

December 31, 2018

are approximately

$2.1

million.

Rent expense under these leases was

$0.8

million and

$0.7

million for the years ended

December 31, 2018

and

2017,

respectively.

Strategic and Retention Bonus

November 2018,

the Compensation Committee of our Board of Directors approved an Executive Strategic and Retention Bonus Program (“Strategic and Retention Bonus”) that was intended to provide incentives to, and retain, certain key personnel while they focused on completing the CVie Acquisition and, if successful, integrating and executing an expanded business plan.

Under the terms of the Strategic and Retention Bonus, an Eligible Transaction (as that term is defined under the program) means either (a) a strategic transaction consisting of a merger that would advance our strategic needs, including by potentially allowing for diversification of our product candidates, or (b) an acquisition; and, in addition,

one

or more financings within a

nine

-month period that in the aggregate results in gross proceeds to us of at least

$30

million. The Strategic and Retention Bonus payments could vary depending upon the aggregate amount raised in the financings. The maximum bonus amount would be determined by application of a multiplier to participants’

2018

base salary and would be payable only if we were to complete an Eligible Transaction with gross proceeds of at least

$45

million, while the minimum bonus amount would equal

20%

of the maximum bonus amount and would be payable if we were to raise at least

$30

million. For other amounts raised, the maximum bonus amount would be reduced in a stepped-down fashion as provided under the program. The bonus payments, if earned, would be paid in

two

equal installments to support retention with the

first

installment due within

five

business days after the closing of the Eligible Transaction, and the

second

installment due on the

nine

-month anniversary of the closing of the Eligible Transaction, provided that the recipient is actively employed by us at the time of payment.

With completion of the CVie Acquisition and the

$39

million Private Placement Financing on

December 21, 2018,

the participants became eligible to receive a total bonus of

$1.4

million, of which the

first

installment of

$0.7

million was paid in

December 2018.

The balance of

$0.7

million will be due on the

nine

-month anniversary of the closing of the Eligible Transaction in

September 2019.

Note 9 - Stock Options and Stock-based Employee Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares shares in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Unvested, Beginning Balance (in shares)	151	190
Unvested, Beginning Balance (in dollars per share)	$ 4.29	$ 4.33
Awarded (in shares)	249	56
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value	$ 3.95	$ 4.22	$ 4.33
Vested (in shares)	(95)	(95)
Vested (in dollars per share)	$ 3.95	$ 4.33
Cancelled (in shares)	(144)
Cancelled (in dollars per share)	$ 4.33
Unvested, Ending Balance (in shares)	161	151	190
Unvested, Ending Balance (in dollars per share)	$ 4.04	$ 4.29	$ 4.33

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Cash flows from operating activities:
Net loss	$ (20,100)	$ (11,491)
Adjustments to reconcile net loss to net cash used in operating activities:
Recognition of deferred revenue	(198)	(789)
Depreciation	178	121
Amortization of operating lease right-of-use assets	741
Amortization of debt discount	127	303
Stock-based compensation	5,208	703
Realized gain on investments	(75)
Gain on sale of equipment		(9)
Changes in:
Prepaid expenses and other current assets	389	23
Accounts payable	(2,813)	1,471
Collaboration and device development payable	(830)	146
Accrued expenses	(1,166)	(68)
Operating lease liabilities	(784)
Other liabilities	119
Net cash used in operating activities	(19,204)	(9,590)
Cash flows from investing activities:
Proceeds from sale of marketable securities	13,988
Purchase of property and equipment	(129)
Proceeds from sale of property and equipment		9
Net cash used in investing activities	13,859	9
Cash flows from financing activities:
Proceeds from loan payable, net of expenses		4,280
Proceeds from private placement issuance of securities, net of expenses		2,541
Proceeds from convertible note payable		1,500
Repayment of loan payable	(820)
Payment for taxes related to net share settlements of restricted stock units	(151)
Net cash provided by financing activities	(971)	8,321
Effect of exchange rate changes on cash and cash equivalents	(451)
Net decrease in cash and cash equivalents	(6,767)	(1,260)
Cash, cash equivalents and restricted cash - beginning of year	11,358	2,040
Cash, cash equivalents and restricted cash - end of year	4,591	780
Supplementary disclosure of non-cash activity:
Prepayment of director and officer insurance through 3rd party financing	$ 708

Note 10 - Leases

9 Months Ended

Sep. 30, 2019