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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 purchase price for the CVie Acquisition was approximately

$67.5

million. We 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 subsidiary 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 were placed in escrow with our transfer agent, Continental Stock Transfer & Trust Company for

one

year. The shares were released from escrow as of

December 31, 2019.

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 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	)
Loans payable, current		(7,944	)
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, 2018.

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

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

For the year ended

December 31, 2018,

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

Note 4 - Liquidity Risks and Management's Plans	12 Months Ended
Note 4 - Liquidity Risks and Management's Plans	Dec. 31, 2019
Notes to Financial Statements
Liquidity Disclosures [Text Block]	Note 4 - Liquidity Risks and Management’s Plans We are subject to risks common to companies in the biotechnology industry, including but not limited to, the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, reliance on third party manufacturers. We have incurred net losses since inception. Our net loss was $27.5 million and $20.5 million for the years ended December 31, 2019 and 2018 respectively. We expect to continue to incur operating losses for at least the next several years. As of December 31, 2019, we had an accumulated deficit of $685.1 million. Our future success is dependent on our ability to identify and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans. In the future, we will need to raise additional capital to continue funding our operations. We plan to obtain funding through a combination of public or private equity offerings, or strategic transactions including collaborations, licensing arrangements or other strategic partnerships. There is inherent uncertainty associated with these fundraising activities and, other than the funding recently committed by Lee’s Pharmaceutical (HK) Ltd. (Lee’s (HK)) as discussed below, they are not considered probable. In the absence of such funding, we plan to strategically manage our uncommitted spend to execute our priorities and implement cost saving measures to reduce research and development expenditures which would include limiting or delaying or terminating preclinical and clinical studies or other development activities for our AEROSURF product candidates. We recently entered into a binding commitment with Lee’s (HK), pursuant to which Lee’s HK will provide financing for the development of AEROSURF beginning April 1, 2020 through September 30, 2020. We are in the process of negotiating a definitive agreement with Lee’s HK to set forth additional funding beyond September 30, 2020 through study completion. If we are unsuccessful at finalizing a definitive agreement with Lee’s HK or if we are successful but Lee’s HK subsequently terminates the agreement beyond September 30, 2020, our board of directors has approved a plan to suspend or terminate AEROSURF development until such time as we are able to secure the capital required to fund the program. Management considers the successful implementation of these plans and efforts to manage uncommitted spending, including AEROSURF development, and to carry out necessary cost saving measures to be probable. Therefore, we expect our plans will enable our cash and cash equivalents as of the filing of our Annual Report on Form 10 -K to be sufficient to fund operations through at least the next twelve months. Our funding requirements, however, are based on estimates that are subject to risks and uncertainties and may change as a result of many factors currently unknown. Although management continues to pursue the plans described above, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, including as a result of market volatility following the COVID- 19 outbreak. Until such time as we can generate substantial product revenues, if ever, we expect to finance our cash needs through a combination of equity offerings, strategic partnerships and licensing arrangements. The terms of any future financing may adversely affect the holdings or the rights of our existing stockholders.

Note 5 - Accounting Policies and Recent Accounting Pronouncements

12 Months Ended

Dec. 31, 2019

Significant Accounting Policies [Text Block]

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 Combinations

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 Intangible Assets

We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development (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, 2019

and

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

may

be impaired.

When testing our goodwill and indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than

not

that the fair values of our reporting unit and indefinite-lived intangible assets are less than the respective carrying values. Such qualitative factors can include, among others, industry and market conditions, overall financial performance, and relevant entity-specific events. If we conclude based on our qualitative assessments that it is more likely than

not

that the fair value of our reporting unit or indefinite-lived intangible assets are less than their respective carrying values, we perform a quantitative analysis. When conducting our annual impairment test of goodwill and indefinite-lived intangible assets as of

December 1, 2019,

we elected to perform quantitative assessments.

The Company consists of

one

reporting unit. In order to perform the quantitative goodwill impairment test, we compare the estimated fair value of our reporting unit to its carrying value. If the fair value exceeds the carrying value,

further evaluation is required, and

impairment exists. If the carrying amount exceeds the fair value, the difference between the carrying value and the fair value is recorded as an impairment loss, the amount of which

may

not

exceed the total amount of goodwill. When performing our annual goodwill impairment assessment as of

December 1, 2019,

we determined the fair value of our reporting unit based upon the quoted market price and related market capitalization of the Company’s common stock, adjusted for an estimated control premium. Based on the quantitative test performed, the fair value of our reporting unit exceeded its carrying value and

impairment loss was recognized.

When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method (“MPEEM”). MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include:

) the amount and timing of the projected net cash flows associated with the IPR&D assets,

) the long-term growth rate,

) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and

) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions resulting in future impairment charges related to our indefinite-lived intangible asset balances.

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

December 1, 2019,

we concluded that the assets were

not

impaired.

Foreign Currency Transactions

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

not

denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in other income (expense). Foreign currency transactions resulted in losses of approximately

$0.5

million and

$0.1

million, respectively, for the years ended

December 31, 2019

and

2018.

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 at domestic and foreign financial institutions and consist of liquid investments, money market funds, and US Treasury notes with a maturity from date of purchase of

days or less that are readily convertible into cash.

Marketable Securities

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 consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in other income (expense) on a specific-identification basis. For the year ended

December 31, 2019,

we recognized

$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 year ended

December 31, 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 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.

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, 2019

and

2018,

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 loans payable (including current installments) approximates fair value based on a comparison of interest rates on the loan to current market rates considering our credit risk.

Property and Equipment

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

three

ten

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

Restricted Cash

Restricted cash consists principally of a

$140,000

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

May 26, 2004

for our headquarters location in Warrington, Pennsylvania and

$14,000

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

(see, -

Note

- Commitments, for further discussion on our leases).

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.

For contracts entered into on or after the effective date of ASC

842,

at the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (

) whether the contract involves the use of a distinct identified asset, (

) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (

) whether we have the right to direct the use of the asset.

We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any

one

of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset, the present value of the lease payments equals or exceeds substantially all of the fair value of the asset, or the leased asset is of such a specialized nature that it is expected to have

alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does

not

meet any of these criteria. Currently, all of our leases are classified as operating leases.

Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are

not

included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of

months or less.

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, 2019

and

2018

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

$15.0

million long-term liability for contingent milestone payments 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.

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 - noncurrent 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 was recognized as our performance obligations under the contract were 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.

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 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 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.

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.

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

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 year ended

December 31, 2018,

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

$1.7

million 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

- Loans Payable - Current Portion and Non-current Portion). 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

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.

Net Loss per Common Share

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. For the years ended

December 31, 2019

and

2018,

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

19.6

million and

14.4

million shares, respectively. As of

December 31, 2019

and

2018,

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.

Segment and Geographic Information

We currently operate in

one

operating 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. We operate primarily in the US and Asia. License revenue with affiliate and grant revenue for the years ended

December 31, 2019

and

2018

are generated in the US. Long-lived assets, consisting of intangible assets and goodwill of

$77.1

million and

$15.7

million, respectively, were located outside the US at

December 31, 2019

and

2018.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

February 2016,

the FASB issued ASU

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 are 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 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 consolidated balance sheets. The adoption of the standard did

not

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

– Leases, for our current lease commitments.

January 2017,

the FASB issued ASU

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

December 31, 2019.

Recent Accounting Pronouncements

August 2018,

the FASB issued ASU

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 consolidated financial statements.

December 2019,

the FASB issued ASU

2019

12,

Income Taxes (Topic

740

): Simplifying the Accounting for Income Taxes

. ASU

2019

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

740

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

December 15, 2020

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

not

believe there will be a material impact upon adoption.

Note 6 - License Revenue with Affiliate

12 Months Ended

Dec. 31, 2019

Revenue from Contract with Customer [Text Block]

Note

- License Revenue with Affiliate

	Year Ended December 31,
(in thousands)	2019		2018

License revenue with affiliate	$	198	$	1,023

License revenue with affiliate for the years ended

December 31, 2019

and

2018

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.

All revenue related to the License Agreement was recognized as of the

second

quarter of

2019

and

future material performance obligations are due.

Note 7 - Fair Value Measurements

12 Months Ended

Dec. 31, 2019

Fair Value Disclosures [Text Block]

Note

- Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on

three

levels of inputs, of which the

first

two

are considered observable and the last unobservable, as follows:

●

Level

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

December 31, 2019

and

2018:

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

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

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

Cash equivalents:
Money market funds	$	103	$	103	$	-	$	-
U.S. Treasury notes		6,018		6,018
Available-for-sale marketable securities:
U.S. Treasury notes		13,959		13,959		-		-
Total Assets	$	20,080	$	20,080	$	-	$	-

- Definition

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

+ References + Details

Note 8 - Property and Equipment

12 Months Ended

Dec. 31, 2019

Property, Plant and Equipment Disclosure [Text Block]

Note

– Property and Equipment

Property and equipment is comprised of the following:

	December 31,
(in thousands)	2019			2018

Manufacturing, laboratory & office equipment	$	4,313		$	4,359
Furniture & fixtures		390			390
Leasehold improvements		2,469			2,469
Subtotal		7,172			7,218
Accumulated depreciation and amortization		(6,374	)		(6,416	)
Property and equipment, net	$	798		$	802

Depreciation expense on property and equipment was

$0.2

million in for each of the years ended

December 31, 2019

and

2018.

Note 9 - Collaboration and Device Development Payable

12 Months Ended

Dec. 31, 2019

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, 2019

and

2018,

collaboration and device development payable was

$2.0

million and

$2.6

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

$1.0

million and thereafter initiated payments totaling an aggregate

$1.25

million payable in

five

equal, consecutive monthly installments of

$0.25

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

$25.0

million to

$35.0

million. In addition, under the terms of the Battelle Payment Restructuring, we agreed to make

two

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

first

patient in the next AEROSURF clinical study (First Milestone), 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 (Second Milestone), an amount equal to the then-outstanding Battelle Payables, including unpaid interest. If any amounts of the Battelle Payables remained unpaid by

December 31, 2019,

then all unpaid Battelle Payables would be due on

January 7, 2020.

Neither milestone was achieved as of

December 31, 2019.

March 30, 2020,

we and Battelle entered into an amendment to the Battelle Payment Restructuring such that the First Milestone would be payable

later than

April 15, 2020

and the Second Milestone would be payable

later than

September 1, 2020.

Management determined the payment restructuring agreement of the Battelle Payables does

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, 2019,

we had accrued interest expense relating to the Battelle Payables of

$0.4

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

-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 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 10 - Accrued Expenses

12 Months Ended

Dec. 31, 2019

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)	2019		2018

Research and development	$	1,415		2,361
Professional fees		543	$	2,473
Salaries, bonus & benefits		696		815
Manufacturing operations		183		212
Other		389		604
Total accrued expenses	$	3,226	$	6,465

Note 11 - Loan Payable - Current Portion and Non-current Portion	12 Months Ended
	Dec. 31, 2019
Notes to Financial Statements
Short-term Debt [Text Block]	Note 11 - Loans Payable - Current Portion and Non-current Portion Loans Payable – Current Portion 2019 Loan On October 24, 2019, we entered into a loan agreement with LPH II. Under the loan agreement, LPH II agreed to lend us $1.0 million, the 2019 Loan, to support our operations while we sought to complete a strategic transaction (as defined in the loan agreement). The 2019 Loan, which was funded in a single installment by wire transfer on October 28, 2019, accrued interest at a rate of 6% per annum and matured upon the closing date of the December 2019 private placement, which qualified as the strategic transaction under terms defined in the loan agreement. We repaid the 2019 Loan and related accrued interest in full upon consummation of the December 2019 Private Placement. 201 8 Loan s In 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, or the First Quarter 2018 Loans, 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, or the Funding Event. The loans accrued interest at a rate of 6% 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, or the LPH Security Agreement. During the third and fourth quarters of 2018, LPH agreed to lend us funds, or the Third and Fourth Quarter 2018 Loans, to sustain our operations while we continued to work on a strategic transaction. Of the Third and Fourth Quarter 2018 Loans, the initial loan was funded on August 14, 2018 in the amount of $0.3 million, and subsequent Third and Fourth Quarter 2018 Loans were funded 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 6% 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 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. Effective December 5, 2018, LPH assigned all outstanding loans to us to LPH II. On December 21, 2018, as part of the December 2018 Private Placement Financing ( see , “Private Placement Offerings”), we converted $6.0 million of existing loan payable obligations comprised of $2.5 million of the First Quarter 2018 Loans and $3.5 million of the Third and Fourth Quarter 2018 Loans into equity securities on the same terms as those of the investors in the December 2018 Private Placement Financing. The conversion of the loan payable to LPH II was treated as an extinguishment of debt and does not represent a capital transaction as the December 2018 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 the aggregate fair value of the common stock and Series F and Series G Warrants on December 21, 2018 and the carrying value of the debt liabilities. The balance of the loans payable to LPH II of $160,000 was paid along with accrued interest of $182,000 on December 27, 2018. Following this conversion of the First Quarter 2018 Loans and the conversion and payoff of the Third and Fourth Quarter 2018 Loans into equity securities, the security interest granted under the LPH Security Agreement was discharged. Assumption of LPH II debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $3.5 million of debt payable to LPH II. From April 24, 2018 to November 16, 2018, CVie entered into four separate agreements to borrow an aggregate of approximately $3.5 million from LPH II on the following dates and in the following amounts $0.5 million in April 2018, or the April 2018 Loan; $0.3 million in September 2018, or the September 2018 Loan; $0.15 million in October 2018, or the October 2018 Loan; and $2.5 million in November 2018, or the November 2018 Loan. The April 2018 Loan, the September 2018 Loan, the October 2018 Loan and the September 2018 Loan were subsequently assigned to LPH II. The terms of the loan agreements are identical with interest, payable in cash upon maturity, at a rate of 4% per annum and maturing one year from the effective date of the respective loan agreement. 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. In December 2019, as part of the December 2019 Private Placement Financing ( see , “Private Placement Offerings”), we converted the remaining $2.95 million related to the September 2018 Loan, October 2018 Loan, and November 2018 Loan on the same terms as the Investors of the December 2019 Private Placement Financing. In connection with the conversion of the LPH II debt, we issued: 976,821 shares of common stock based at $3.02 per share and Series I Warrants to purchase 488,411 shares of common stock, at an exercise price equal to $4.03 per share. The Series I Warrants are exercisable at any time after the sixth -month anniversary of the date of issuance and through the 5 -year anniversary of the date of issuance. The conversion of the loan payable to LPH II is treated as an extinguishment of debt and does not represent a capital transaction as the December 2019 Private Placement Financing included third -party investors and all investors received identical terms. We recorded a loss on extinguishment of debt of approximately $1.8 million. The loss was calculated as the difference between the aggregate fair value of the common stock and Series I Warrants on December 6, 2019 and the carrying value of the debt liabilities. The accrued interest of $127,000 was paid in December 2019 and as of December 31, 2019 there are no remaining amounts outstanding. Loan payable to Bank Direct Capital Finance In May 2019, we entered into an insurance premium financing and security agreement with Bank Direct Capital Finance, or Bank Direct. Under the agreement, we have financed $0.7 million of certain premiums at a 5.35% annual interest rate. As of December 31, 2019, the outstanding principal of the loan was $0.2 million. The remaining payments were made during the first quarter of 2020. Loans Payable – Non-current Portion 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. In September 2016, CVie entered into a 12 -month revolving credit facility of approximately $2.9 million with O-Bank Co., Ltd., or O-Bank, to finance operating activities, or the O-Bank Facility. The O-Bank Facility was later renewed and increased to approximately $5.8 million in September 2017. The O-Bank Facility was guaranteed by Lee’s, which pledged bank deposits in the amount of 110% of the actual borrowing amount. The guaranty was part of the O-Bank Facility; however, we do not have a written commitment from Lee’s to maintain the collateral. Interest, payable in cash on a monthly basis, is determined based on 90 -day TAIBOR (the Taipei Interbank Offer Rate) plus 0.91%. The O-Bank Facility expired on September 11, 2019 and the loans were set to mature six months after the expiration date, on March 11, 2020. In March 2020, the O-Bank Facility was amended including the extension of the maturity date to March 2022. In addition to the extension of the maturity date, the total amount of the O-Bank Facility was decreased to approximately $5.0 million, and the interest rate was changed to the TAIBOR plus 1.17% and the term was changed to 24 -month non-revolving. All amounts due under the O-Bank Facility will be payable upon the earlier of (i) six months after the expiration date or (ii) two years after the drawdown date. As of December 31, 2019, the outstanding principal of the O-Bank Facility was approximately $4.6 million, and has subsequently been refinanced to mature in March 2022, therefore, the outstanding principal has been classified in Loans Payable - Non-current Portion.

Note 12 - Convertible Note Payable

12 Months Ended

Dec. 31, 2019

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 was being accreted to the

$1.5

million loan over its term using the effective interest method. The Panacea Warrants were derivatives that qualified 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	%

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

$5.11

and the conversion price of

$4.00,

and (ii)

375,000

shares convertible into common stock.

Note 13 - Restructured Debt Liability

12 Months Ended

Dec. 31, 2019

Long-term Debt [Text Block]

Note

- Restructured Debt Liability

	December 31,		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

$15.0

million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a

$15.0

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

see

, Note

- Accounting Policies and Recent Accounting Pronouncements). The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are

not

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

Note 14 - Stockholders' Equity

12 Months Ended

Dec. 31, 2019

Stockholders' Equity Note Disclosure [Text Block]

Note

- Stockholders’ Equity

Private Placement Offerings

December 2019

Private Placement Financing

December 6, 2019

we completed the

December 2019

Private Placement Financing with select institutional investors, in which we issued and sold an aggregate of

8,749,999

shares of common stock at a price per share of

$3.02,

for an aggregate purchase price of approximately

$26.4

million. Included in the purchase price, LPH II converted

$2.95

million of existing debt obligations on the same terms as the other select institutional investors. In connection with this offering, we issued warrants, or the Series I Warrants, to purchase up to an aggregate of

4,375,002

shares of common stock at an exercise price equal to

$4.03

per share, which are exercisable on the

six

-month anniversary of date of issuance and through the

five

-year anniversary of the date of issuance. The Series I Warrants (i)

may

be exercised for cash or on a cashless basis if there is

effective registration statement registering the resale of the warrant shares, (ii)

may

not

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

4.99%

(or such other percent as designated by each holder

not

to exceed

19.99%

) of our outstanding shares of common stock, and (iii) contain customary provisions that adjust the exercise price and the number of shares of common stock into which the Series I Warrants are exercisable in the event of a corporate transaction. Our Registration Statement on Form S-

filed with the SEC on

January 21, 2020,

registered the

8,749,999

shares of common stock sold and

4,375,002

shares of common stock underlying the Series I Warrants.

December 2018

Private Placement Financing

December 21, 2018,

we completed a private placement offering with select institutional 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, or the

2018

Private Placement Financing. Included in the purchase price, each of LPH II, an affiliate of Lee’s, and Battelle converted

$6.0

million and

$1.0

million, respectively, of existing debt obligations on the same terms as the other select institutional investors. In connection with this 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, or 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, or 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.

April 2018

Private Placement Financing

April 2018,

we completed a private placement with LPH II for the purchase of

$2.6

million of our common stock and warrants to purchase our common stock at a purchase price per share of

$4.80.

In connection with this offering, we issued

541,667

shares of common stock and warrants to purchase

135,417

shares of 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.

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)	2019		2018		Exercise Price		Date

Investors - December 2019 financing		4,375		-	$	4.03	12/06/24
Investors - AEROSURF		2,963		2,963	$	-	02/14/24
Investors - December 2018 financing - long-term		3,889		3,889	$	4.05	12/04/23
Investors - December 2018 financing - short-term		2,004		2,004	$	3.68	06/24/20
Battelle - 2018 payables restructuring agreement (1)		75		75	$	6.50	12/07/23
Panacea Venture Management Company Ltd.		188		188	$	4.00	07/02/23
LPH II Investments Limited		135		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		4		4	$	1,400.00	10/10/24
Total		14,225		9,850

(

)

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

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, 2019

and

2018,

we had

0.4

million and

1.5

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

2011

Plan.

Note 15 - Stock Options and Stock-based Employee Compensation

12 Months Ended

Dec. 31, 2019

Share-based Payment Arrangement [Text Block]

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

0.4

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)	2019		2018

Stock Options and RSUs Outstanding
2011 Plan		5,412		4,558
Non-Plan		10		10
Total Outstanding		5,422		4,568

Available for Future Grants under 2011 Plan		448		1,453

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 vested 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:

(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		1,146			3.33
Forfeited or expired		(246	)		13.58
Outstanding at December 31, 2019		5,317		$	5.87		9.0

Vested and exercisable at December 31, 2019		1,564		$	9.78		8.9

Vested and expected to vest at December 31, 2019		5,075		$	5.85		9.0

(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
Cancelled		(144	)		4.33
Vested		(151	)		4.29
Unvested at December 31, 2019		105		$	3.95

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, 2019

and

2018

was

$3.34

and

$3.39,

respectively. The weighted-average grant-date fair value of RSUs granted during the years ended

December 31, 2019

and

2018

was

$3.95

and

$4.22,

respectively. The total intrinsic value of options outstanding, vested, and exercisable as of

December 31, 2019

are each

$0.

Stock-Based Compensation

We recognized stock-based compensation expense in accordance with ASC Topic

718

$6.7

million and

$1.0

million, respectively, for each of the years ended

December 31, 2019

and

2018.

Stock-based compensation expense was classified as follows:

	Year Ended December 31,
(in thousands)	2019		2018

Research and development	$	1,932	$	232
Selling, general and administrative		4,789		723
Total	$	6,721	$	955

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,
	2019			2018

Weighted average expected volatility		95	%		93	%
Weighted average expected term (years)		6.6			7.0
Weighted average risk-free interest rate		2.6	%		2.7	%
Expected dividends		-			-

The total fair value of the underlying shares of the options vested during

2019

and

2018

equals

$5.6

million and

$0.6

million, respectively. As of

December 31, 2019,

there was

$10.7

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

1.9

years.

Note 16 - Collaboration, Licensing and Research Funding Agreements	12 Months Ended
	Dec. 31, 2019
Notes to Financial Statements
Corporate Partnership, Licensing and Research Funding Agreements [Text Block]	Note 16 - Collaboration, Licensing and Research Funding Agreements Collaboration Agreement Battelle Memorial Institute In October 2014, we entered into a Collaboration Agreement with Battelle Memorial Institute (Battelle) for the development of our phase 3 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 2 ADS used in the AEROSURF phase 2b 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 3 ADS, (ii) executing the project plan, and (iii) completing required testing, verification and documentation, putting us in a position to manufacture a phase 3 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 3 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. In December 2018, we and Battelle entered into a Payment Restructuring Agreement which was subsequently amended in March 2020. See, Note 9 - Collaboration and Device Development Payable. Licensing and Research Funding Agreements Lee’s Pharmaceutical (HK) Ltd. In 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 12 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 $1 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 3 clinical trial, regulatory activities, and commercialization activities. In 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 ( 10 ) years after the first commercial sale in the country of sale. Thereafter, in consideration of licensed rights other than patent rights, royalties shall continue for the commercial life of each product and, for the initial three years, shall be in the range of low-to-mid single digits. In addition, in the event that one or more generic products are introduced, the royalty rates will be reduced, subject to certain minimums if we are subject to continuing obligations at the time to pay royalties under our in-license agreements. Under the License Agreement, Lee’s will be responsible for all activities related to development, regulatory approval and commercialization of KL4 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 ( 10 ) years beginning with the later of the first commercial sale of the first aerosolized product and the first commercial sale of the first non-aerosolized product in 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 KL4 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 - 10 - 25 - 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. 1, 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 $1.0 million and $0.3 million related to reductions in royalties and milestones in connection with Amendment No. 1. The $1.3 million was attributed in its entirety to the bundled performance obligation of licensing rights to develop and commercialize our KL4 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 was recognized over time as services are performed and based on the input method related to the level of effort expended. All revenue related to the License Agreement was recognized as of the second quarter of 2019 and no future material performance obligations are due. Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. 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 3 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 2b 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 1A - 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 no remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. 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 2018 and 2019, 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 KL4 surfactant technology. Under the license agreement, we are obligated to pay fees of up to $2.5 million in the aggregate upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for certain designated products. We have paid $1.0 million to date for milestones that have been achieved 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 KL4 surfactant products. We will be responsible for the manufacture and supply of all of the covered products and Esteve will be responsible for all sales and marketing in the territory. Esteve is obligated to make stipulated cash payments to us upon our achievement of certain milestones, primarily upon receipt of marketing regulatory approvals for the covered products. In addition, Esteve has agreed to contribute to phase 3 clinical trials for the covered products by conducting and funding development performed in the territory. As part of a 2004 restructuring in which Esteve returned certain rights to us in certain territories (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 KL4 surfactant products in the Former Esteve Territories. Universita degli Studi di Milano-Bicocca Effective April 13, 2015, CVie Therapeutics, entered into an Agreement for Scientific Collaboration with the Universita degli Studi di Milano-Bicocca (Bicocca) in Milan, Italy, focused on defining the role of sarco (endo) plasmic reticulum Ca2 + -ATPase 2a ( 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 no 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 12 months after the filing of a patent application. If the option is not exercised, then the parties shall remain joint owners and each can use the intellectual property with consent of the other on terms to be defined. If we exercise an option, we have agreed to pay Bicocca (corresponding to stage of development): (i) € 0.1 million (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.

Note 17 - Related Party Transactions

12 Months Ended

Dec. 31, 2019

Note

- Related Party Transactions

Lee’s Pharmaceutical Holdings Limited

As of

December 31, 2019

and

2018,

Lee’s beneficial ownership of our issued and outstanding shares of common stock was

35%

and

40%,

respectively.

We entered into the following transactions with Lee’s during

2018

and

2019:

●

During

2018,

we entered into multiple loan agreements with an affiliate of Lee’s (

see

, Note

- Loans Payable - Current Portion and Non-current Portion);

●

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 Investments 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

- Loans Payable - Current Portion and Non-current Portion);

●

October 2019,

we entered into a loan agreement with an affiliate of Lee’s (

see

, Note

- Loans Payable - Current Portion and Non-current Portion);

●

December 2019,

an affiliate of Lee’s was an investor in the Private Placement Financing (

see

, Note

- Stockholders Equity);

●

December 2019,

as part of the Private Placement Financing, we converted

$2.95

million of existing loan payable obligations to the Lee’s affiliate on the same economic terms as those of the other investors (

see

, Note

- Loans Payable - Current Portion and Non-current Portion);

	●	Our $4.6 million bank credit facility is guaranteed by Lee’s ( see , Note 11 - Loans Payable – Current Portion and Non-Current Portion); and
	●	As of December 31, 2018 and 2019, we had approximately $0.5 million in accounts payable due to Lee’s for services provided by a Lee’s affiliate to our wholly-owned subsidiary, CVie Therapeutics; and, as of December 31, 2019 we had $0.8 million due from Lee’s for purchases of KL4 surfactant raw materials that we purchased from our supplier on behalf of Lee’s.

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

and

2019

we entered into the following transactions with Panacea and KPCB:

●

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,

in 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

and

December 2019,

Panacea was an investor in a Private Placement Financing (

see

, Note

- Stockholders Equity); and

●

December 2019,

we issued

96,429

shares of our common stock to Rui Jin (HK) Consulting Management Company Limited, an affiliate of Panacea, for services rendered.

As of

December 31, 2019,

Panacea and KPCB beneficially owned

15%

and

11%,

respectively, of our issued and outstanding shares of common stock. As of

December 31, 2018,

Panacea and KPCB each beneficially owned

14%

of our issued and outstanding shares of common stock.

Note 18 - Commitments	12 Months Ended
Note 18 - Commitments	Dec. 31, 2019
Notes to Financial Statements
Commitments Disclosure [Text Block]	Note 18 - Commitments We have no commitments other than the minimum lease payments commitment as disclosed in Note 21, Leases.

Note 19 - Litigation	12 Months Ended
Note 19 - Litigation	Dec. 31, 2019
Notes to Financial Statements
Legal Matters and Contingencies [Text Block]	Note 19 - Litigation We are not aware of any pending or threatened legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations. We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition.

Note 20 - Income Taxes

12 Months Ended

Dec. 31, 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, 2019

and

2018

is as follows:

	December 31,
(in thousands)	2019			2018

Income tax benefit, statutory rates	$	(5,770	)	$	(4,312	)
State taxes on income, net of federal benefit		(1,182	)		(535	)
Impact of tax reform		-			5
Research and development tax credit		(934	)		(351	)
Foreign rate differential		22			24
Employee related and other		1,983			2,875
Interest related		79			186
Income tax expense / (benefit), statutory rates		(5,802	)		(2,108	)
Valuation allowance		5,802			2,108
Income tax benefit, net	$	-		$	-

The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at

December 31, 2019

and

2018,

are as follows:

	December 31,
(in thousands)	2019			2018

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	180,979		$	176,759
Research and development tax credit		17,599			16,718
Compensation expense on stock		2,142			1,121
Charitable contribution carryforward		-			-
Other accrued		934			1,016
Deferred revenue		-			57
Depreciation		128			309
Total long-term deferred tax assets		201,782			195,980
Long-term deferred liabilities:
IPRD		(15,419	)		(15,476	)
Total long-term deferred tax liabilities		(15,419	)		(15,476	)
Valuation allowance		(201,782	)		(195,980	)
Deferred tax liabilities, net	$	(15,419	)	$	(15,476	)

We are in a net deferred tax liability position at

December 31, 2019

and

2018.

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, 2019

2018,

nor were any incurred in

2019

2018.

December 31, 2019

and

2018,

we had available carryforward net operating losses for federal tax purposes of

$618.9

million and

$606.6

million, respectively, research and development tax credit carryforward of

$16.9

million and

$16.7

million, respectively and orphan drug tax credit carryforwards of

$0.1

million. Of the of

$618.9

million of federal net operating loss carryforwards,

$35.9

million can be carried forward indefinitely. The remaining Federal net operating loss, research and development tax credit carryforwards and orphan drug credit carryforward will continue to expire through

2038.

December 31, 2019

and

2018,

we had available carryforward losses of approximately

$597.1

million and

$584.8

million, respectively, for state tax purposes. Of the

$597.1

million state tax carryforward losses,

$582.7

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 21 - Leases

12 Months Ended

Dec. 31, 2019

Lessee, Operating Leases [Text Block]

Note

- Leases

Our operating leases consist primarily of facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan.

We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. We also maintain offices in Taipei, Taiwan, 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.

April 2019,

we terminated our Taipei Taiwan lease and entered into a new lease to reduce the leased space from

2,635

square feet to

1,317

square feet. The total aggregate base rental payments remaining under the leases as of

December 31, 2019

are approximately

$1.5

million.

Throughout the term of our leases, we are responsible for paying certain variable lease costs, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities.

The following table contains a summary of the lease costs recognized under ASC

842

and other information pertaining to our operating leases for

twelve

months ended

December 31, 2019:

	Twelve Months Ended December 31,
(in thousands)	2019

Operating lease cost	$	889
Variable lease cost		22
Total lease cost	$	911

Other Information
Operating cash flows used for operating leases	$	951
Operating lease liabilities arising from obtaining right-of-use assets	$	364
Weighted average remaining lease term (in years)		2.2
Weighted average incremental borrowing rate		9.00	%

Rent expense under ASC

840

was

$0.8

million for the year ended

December 31, 2018.

Future minimum lease payments under our non-cancelable operating leases as of

December 31, 2019,

are as follows:

	As of December 31,
(in thousands)	2019

2020		850
2021		640
2022		180
2023		23
Thereafter		-
Total lease payments		1,693
Less imputed interest		(149	)
Total operating lease liabilities at December 31, 2019		1,544

Note 22 - Selected Quarterly Financial Data (Unaudited)

12 Months Ended

Dec. 31, 2019

Quarterly Financial Information [Text Block]

Note

- Selected Quarterly Financial Data (Unaudited)

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

2019

and

2018.

The operating results for any quarter are

not

necessarily indicative of results for any future period.

2019 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	-		$	-		$	-		$	-		$	-
License revenue with affiliate		40			158			-			-			198
Total revenues		40			158			-			-			198
Expenses:
Research and development		3,342			3,413			3,792			2,140			12,687
Selling, general and administrative		3,355			3,240			3,395			2,414			12,404
Total expenses		6,697			6,653			7,187			4,554			25,091
Operating loss		(6,657	)		(6,495	)		(7,187	)		(4,554	)		(24,893	)
Other income / (expense), net		120			58			61			(2,821	)		(2,582	)
Net (loss) / income	$	(6,537	)	$	(6,437	)	$	(7,126	)	$	(7,375	)	$	(27,475	)
Net (loss) / income per common share - basic and diluted	$	(0.20	)	$	(0.20	)	$	(0.22	)	$	(0.21	)	$	(0.84	)
Weighted average number of common shares outstanding - basic and diluted		32,142			32,189			32,189			34,597			32,784

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 and diluted	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Weighted average number of common shares outstanding - basic and diluted		3,227			3,751			3,769			7,191			4,493

Note 23 - Subsequent Events	12 Months Ended
Note 23 - Subsequent Events	Dec. 31, 2019
Notes to Financial Statements
Subsequent Events [Text Block]	Note 23 – Subsequent Events AEROSURF Funding Term Sheet On March 18, 2020, we entered into a binding term sheet (the “Term Sheet”) with Lee’s, pursuant to which the parties agreed that Lee’s would provide financing for the continued development of our product candidate, AEROSURF. The Term Sheet provides that in connection with the development of AEROSURF, Lee’s will make non-refundable payments to us in the amount of (i) $1.0 million no later than April 1, 2020; ( ii) $1.4 million no later than July 1, 2020; and (iii) $1.5 million no later than September 1, 2020; provided, however, that the amount of the last payment will be reduced to $0.4 million if on or prior to August 31, 2020, ( i) we receive net proceeds from the sale of our equity securities of at least $4.5 million and (ii) our common stock becomes listed on the Nasdaq National Market or the Nasdaq Global Market. The parties have agreed that they will negotiate in good faith to determine the terms of a definitive agreement prior to September 1, 2020. The definitive agreement will set forth additional semi-annual, non-refundable payments to fund the continued development of AEROSURF after September 30, 2020. The Term Sheet provides that, until such time as we have repaid 125% of the amounts funded by Lee’s for the development of AEROSURF, we will pay to Lee’s 50% of all revenue amounts and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio, excluding (i) payments for bona fide research and development services; (ii) reimbursement of patent expenses; and (iii) all amounts paid to us under the License, Development and Commercialization Agreement between us and Lee’s (HK) dated as of June 12, 2017 ( as amended, the “License Agreement”), and subject to reduction for any payments made by us with respect to third -party intellectual property not previously funded by Lee’s. The Term Sheet also provides that Lee’s and we will amend existing provisions of the License Agreement to reduce future royalty payments payable to us from Lee’s on net sales of certain licensed products, reducing the range of such royalty payment percentage from a range of high single to low mid-double digits to a range of mid-single to low-double digits. O-Bank Facility In March 2020, the O-Bank Facility was amended including the extension of the maturity date to March 2022. In addition to the extension of the maturity date, the total amount of the O-Bank Facility was decreased to approximately $5.0 million, and the interest rate was changed to the TAIBOR plus 1.17% and the term was changed to 24 -month non-revolving. All amounts due under the O-Bank Facility will be payable upon the earlier of (i) six months after the expiration date or (ii) two years after the drawdown date. As of December 31, 2019, the outstanding principal of the O-Bank Facility was approximately $4.6 million, and has subsequently been refinanced to mature in March 2022, therefore, the outstanding principal has been classified in Loans Payable - Non-current Portion. Coronavirus Outbreak In December 2019, a novel strain of coronavirus, or COVID- 19, was reported to have surfaced in Wuhan, China. As of March 2020, COVID- 19 has spread to other countries, including Europe and the United States, and has been declared to be a pandemic by the World Health Organization. Efforts to contain the spread of COVID- 19 have intensified and the U.S., Europe and Asia have implemented severe travel restrictions, social distancing and delays or cancellations of elective surgeries. As of April 1, 2020, our operations have not been significantly impacted by the COVID- 19 outbreak. However, we cannot at this time predict the specific extent, duration, or full impact that the COVID- 19 outbreak will have on our financial condition, operations, and business plans for 2020, including ongoing and planned clinical trials. Our clinical trials and next expected milestones of our product candidates may be impacted and we may experience delays in anticipated timelines and milestones.

Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2019

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

Business Combinations Policy [Policy Text Block]

Business Combinations

may

differ materially from estimates.

Goodwill and Intangible Assets, Policy [Policy Text Block]

Goodwill and Intangible Assets

not

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

may

be impaired. The following table represents identifiable intangible assets as of

December 31, 2019

and

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

may

be impaired.

When testing our goodwill and indefinite-lived intangible assets for impairment, we can elect to perform a qualitative assessment to determine if it is more likely than

not

December 1, 2019,

we elected to perform quantitative assessments.

The Company consists of

one

further evaluation is required, and

impairment exists. If the carrying amount exceeds the fair value, the difference between the carrying value and the fair value is recorded as an impairment loss, the amount of which

may

not

exceed the total amount of goodwill. When performing our annual goodwill impairment assessment as of

December 1, 2019,

impairment loss was recognized.

) the amount and timing of the projected net cash flows associated with the IPR&D assets,

) the long-term growth rate,

) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and

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

December 1, 2019,

we concluded that the assets were

not

impaired.

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Foreign Currency Transactions

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

not

$0.5

million and

$0.1

million, respectively, for the years ended

December 31, 2019

and

2018.

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

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

days or less that are readily convertible into cash.

Marketable Securities, Policy [Policy Text Block]

Marketable Securities

320,

Investments—Debt and Equity Securities

December 31, 2019,

we recognized

$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 year ended

December 31, 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

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

Fair Value of Financial Instruments

December 31, 2019

and

2018,

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

$14,000

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).

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.

For contracts entered into on or after the effective date of ASC

842,

at the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (

) whether the contract involves the use of a distinct identified asset, (

) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (

) whether we have the right to direct the use of the asset.

We evaluate the classification of our leases as either finance leases or operating leases. A lease is classified as a finance lease if any

one

alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does

not

meet any of these criteria. Currently, all of our leases are classified as operating leases.

Lease cost for our operating leases is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are

not

included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of

months or less.

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, 2019

and

2018

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 Debt Liability - Contingent Milestone Payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

see,

- Note

- Restructured debt liability), we have established a

$15.0

million long-term liability for contingent milestone payments potentially due under the Exchange and Termination Agreement dated as of

October 27, 2017 (

not

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

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 - noncurrent 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 was recognized as our performance obligations under the contract were 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.

Research and Development Expense, Policy [Policy Text Block]

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 equity instruments depending on the specific terms of the warrant agreement.

Income Tax, Policy [Policy Text Block]

Income Taxes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes

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

$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,

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

$1.7

million 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

- Loans Payable - Current Portion and Non-current Portion). 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 Loss per Common Share

December 31, 2019

and

2018,

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

19.6

million and

14.4

million shares, respectively. As of

December 31, 2019

and

2018,

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]

Segment and Geographic Information

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. We operate primarily in the US and Asia. License revenue with affiliate and grant revenue for the years ended

December 31, 2019

and

2018

are generated in the US. Long-lived assets, consisting of intangible assets and goodwill of

$77.1

million and

$15.7

million, respectively, were located outside the US at

December 31, 2019

and

2018.

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

February 2016,

the FASB issued ASU

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

$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 consolidated balance sheets. The adoption of the standard did

not

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

– Leases, for our current lease commitments.

January 2017,

the FASB issued ASU

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

December 31, 2019.

Recent Accounting Pronouncements

August 2018,

the FASB issued ASU

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 consolidated financial statements.

December 2019,

the FASB issued ASU

2019

12,

Income Taxes (Topic

740

): Simplifying the Accounting for Income Taxes

. ASU

2019

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

740

December 15, 2020

not

believe there will be a material impact upon adoption.

Note 3 - Business Combination (Tables)

12 Months Ended

Dec. 31, 2019

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	)
Loans payable, current		(7,944	)
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

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

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 5 - Accounting Policies and Recent Accounting Pronouncements (Tables)

12 Months Ended

Dec. 31, 2019

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

(in thousands)	Carrying Value

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

Note 6 - License Revenue with Affiliate (Tables)

12 Months Ended

Dec. 31, 2019

Disaggregation of Revenue [Table Text Block]

	Year Ended December 31,
(in thousands)	2019		2018

License revenue with affiliate	$	198	$	1,023

Note 7 - Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2019

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

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

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

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

Cash equivalents:
Money market funds	$	103	$	103	$	-	$	-
U.S. Treasury notes		6,018		6,018
Available-for-sale marketable securities:
U.S. Treasury notes		13,959		13,959		-		-
Total Assets	$	20,080	$	20,080	$	-	$	-

Note 8 - Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2019

Property, Plant and Equipment [Table Text Block]

	December 31,
(in thousands)	2019			2018

Manufacturing, laboratory & office equipment	$	4,313		$	4,359
Furniture & fixtures		390			390
Leasehold improvements		2,469			2,469
Subtotal		7,172			7,218
Accumulated depreciation and amortization		(6,374	)		(6,416	)
Property and equipment, net	$	798		$	802

Note 9 - Collaboration and Device Development Payable (Tables)

12 Months Ended

Dec. 31, 2019

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 10 - Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2019

Schedule of Accrued Liabilities [Table Text Block]

	December 31,
(in thousands)	2019		2018

Research and development	$	1,415		2,361
Professional fees		543	$	2,473
Salaries, bonus & benefits		696		815
Manufacturing operations		183		212
Other		389		604
Total accrued expenses	$	3,226	$	6,465

Note 12 - Convertible Note Payable (Tables)

12 Months Ended

Dec. 31, 2019

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 13 - Restructured Debt Liability (Tables)

12 Months Ended

Dec. 31, 2019

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

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

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

- Definition

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 14 - Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2019

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

	December 31,						Expiration
(in thousands, except price per share data)	2019		2018		Exercise Price		Date

Investors - December 2019 financing		4,375		-	$	4.03	12/06/24
Investors - AEROSURF		2,963		2,963	$	-	02/14/24
Investors - December 2018 financing - long-term		3,889		3,889	$	4.05	12/04/23
Investors - December 2018 financing - short-term		2,004		2,004	$	3.68	06/24/20
Battelle - 2018 payables restructuring agreement (1)		75		75	$	6.50	12/07/23
Panacea Venture Management Company Ltd.		188		188	$	4.00	07/02/23
LPH II Investments Limited		135		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		4		4	$	1,400.00	10/10/24
Total		14,225		9,850

Note 15 - Stock Options and Stock-based Employee Compensation (Tables)

12 Months Ended

Dec. 31, 2019

Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block]

	December 31,
(in thousands)	2019		2018

Stock Options and RSUs Outstanding
2011 Plan		5,412		4,558
Non-Plan		10		10
Total Outstanding		5,422		4,568

Available for Future Grants under 2011 Plan		448		1,453

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		1,146			3.33
Forfeited or expired		(246	)		13.58
Outstanding at December 31, 2019		5,317		$	5.87		9.0

Vested and exercisable at December 31, 2019		1,564		$	9.78		8.9

Vested and expected to vest at December 31, 2019		5,075		$	5.85		9.0

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
Cancelled		(144	)		4.33
Vested		(151	)		4.29
Unvested at December 31, 2019		105		$	3.95

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

	Year Ended December 31,
(in thousands)	2019		2018

Research and development	$	1,932	$	232
Selling, general and administrative		4,789		723
Total	$	6,721	$	955

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

	Year Ended December 31,
	2019			2018

Weighted average expected volatility		95	%		93	%
Weighted average expected term (years)		6.6			7.0
Weighted average risk-free interest rate		2.6	%		2.7	%
Expected dividends		-			-

Note 20 - Income Taxes (Tables)

12 Months Ended

Dec. 31, 2019

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

	December 31,
(in thousands)	2019			2018

Income tax benefit, statutory rates	$	(5,770	)	$	(4,312	)
State taxes on income, net of federal benefit		(1,182	)		(535	)
Impact of tax reform		-			5
Research and development tax credit		(934	)		(351	)
Foreign rate differential		22			24
Employee related and other		1,983			2,875
Interest related		79			186
Income tax expense / (benefit), statutory rates		(5,802	)		(2,108	)
Valuation allowance		5,802			2,108
Income tax benefit, net	$	-		$	-

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

	December 31,
(in thousands)	2019			2018

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	180,979		$	176,759
Research and development tax credit		17,599			16,718
Compensation expense on stock		2,142			1,121
Charitable contribution carryforward		-			-
Other accrued		934			1,016
Deferred revenue		-			57
Depreciation		128			309
Total long-term deferred tax assets		201,782			195,980
Long-term deferred liabilities:
IPRD		(15,419	)		(15,476	)
Total long-term deferred tax liabilities		(15,419	)		(15,476	)
Valuation allowance		(201,782	)		(195,980	)
Deferred tax liabilities, net	$	(15,419	)	$	(15,476	)

Note 21 - Leases (Tables)

12 Months Ended

Dec. 31, 2019

Lease, Cost [Table Text Block]

	Twelve Months Ended December 31,
(in thousands)	2019

Operating lease cost	$	889
Variable lease cost		22
Total lease cost	$	911

Other Information
Operating cash flows used for operating leases	$	951
Operating lease liabilities arising from obtaining right-of-use assets	$	364
Weighted average remaining lease term (in years)		2.2
Weighted average incremental borrowing rate		9.00	%

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

	As of December 31,
(in thousands)	2019

2020		850
2021		640
2022		180
2023		23
Thereafter		-
Total lease payments		1,693
Less imputed interest		(149	)
Total operating lease liabilities at December 31, 2019		1,544

Note 22 - Selected Quarterly Financial Data (Unaudited) (Tables)

12 Months Ended

Dec. 31, 2019

Quarterly Financial Information [Table Text Block]

2019 Quarters Ended:
(in thousands, except per share data)	Mar. 31			June 30			Sept. 30			Dec. 31			Total Year
Revenues:
Grant revenue	$	-		$	-		$	-		$	-		$	-
License revenue with affiliate		40			158			-			-			198
Total revenues		40			158			-			-			198
Expenses:
Research and development		3,342			3,413			3,792			2,140			12,687
Selling, general and administrative		3,355			3,240			3,395			2,414			12,404
Total expenses		6,697			6,653			7,187			4,554			25,091
Operating loss		(6,657	)		(6,495	)		(7,187	)		(4,554	)		(24,893	)
Other income / (expense), net		120			58			61			(2,821	)		(2,582	)
Net (loss) / income	$	(6,537	)	$	(6,437	)	$	(7,126	)	$	(7,375	)	$	(27,475	)
Net (loss) / income per common share - basic and diluted	$	(0.20	)	$	(0.20	)	$	(0.22	)	$	(0.21	)	$	(0.84	)
Weighted average number of common shares outstanding - basic and diluted		32,142			32,189			32,189			34,597			32,784

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 and diluted	$	(1.40	)	$	(0.81	)	$	(1.04	)	$	(3.24	)	$	(7.74	)
Weighted average number of common shares outstanding - basic and diluted		3,227			3,751			3,769			7,191			4,493

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 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 3 - Business Combination - Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands	Dec. 31, 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)
Loans payable, current			(7,944)
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 3 - Business Combination - Pro Forma Information (Details) - CVie Investments [Member] $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2018 USD ($) $ / shares
Pro forma net loss attributable to common shareholders \| $	$ (38,082)
Pro forma EPS - basic and diluted (in dollars per share) \| $ / shares	$ (1.20)

Note 4 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands	3 Months Ended								12 Months Ended
	Dec. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2019	Dec. 31, 2018
Net Income (Loss) Attributable to Parent, Total	$ (7,375)	$ (7,126)	$ (6,437)	$ (6,537)	$ (9,042)	$ (3,927)	$ (3,052)	$ (4,512)	$ (27,475)	$ (20,533)
Retained Earnings (Accumulated Deficit), Ending Balance	$ (685,122)				$ (657,647)				$ (685,122)	$ (657,647)

- Definition

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

+ References + Details

Note 5 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) $ / shares in Units, shares in Thousands			3 Months Ended					12 Months Ended
	Dec. 27, 2018 USD ($) $ / shares	Jul. 02, 2018 USD ($)	Dec. 31, 2018 USD ($) shares	Sep. 30, 2018 USD ($)	Jun. 30, 2018 USD ($)	Mar. 31, 2018 USD ($)	Mar. 31, 2017 USD ($)	Dec. 31, 2019 USD ($) shares	Dec. 31, 2018 USD ($) shares	Jan. 01, 2019 USD ($)	Dec. 26, 2018 $ / shares	Feb. 28, 2018 USD ($)	Dec. 31, 2017 USD ($)	Nov. 01, 2017 USD ($)
Number of Reporting Units								1
Goodwill, Impairment Loss								$ 0
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill)								0
Foreign Currency Transaction Gain (Loss), before Tax, Total								500,000	$ 100,000
Marketable Securities, Realized Gain (Loss), Total								75,000	0
Asset Impairment Charges, Total								0	0
Liability for Contingent Milestone Payment, Noncurrent			$ 15,000,000					15,000,000	15,000,000
Preferred Stock Dividends, Income Statement Impact			$ 1,718,000				$ 3,600,000		$ 1,718,000
Preferred Stock, Discount on Shares													$ 4,500,000
Preferred Stock, Shares Remaining to Be Converted \| shares			0						0
Repayments of Convertible Debt									$ 1,500,000
Gain (Loss) on Extinguishment of Debt, Total								$ (1,794,000)	$ (3,345,000)
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants \| shares								19,600	14,400
Number of Operating Segments								1
Intangible Assets, Net (Excluding Goodwill), Total			$ 77,100,000					$ 77,100,000	$ 77,100,000
Goodwill, Ending Balance			15,682,000					15,682,000	15,682,000
Operating Lease, Liability, Total								1,544,000
Operating Lease, Right-of-Use Asset								1,390,000
Accrued Liabilities, Current, Total			6,465,000					3,226,000	6,465,000
Other Liabilities, Noncurrent, Total			175,000						175,000
Marketable Securities, Unrealized Gain (Loss), Total								0	0
Accounting Standards Update 2016-02 [Member]
Operating Lease, Liability, Total										$ 2,200,000
Operating Lease, Right-of-Use Asset										2,000,000
Accrued Liabilities, Current, Total										(72,000)
Other Liabilities, Noncurrent, Total										$ (139,000)
Conversion of Preferred Stock [Member]
Preferred Stock Dividends, Income Statement Impact									1,700,000
Panacea [Member] \| Warrant Issued Related to Secured Convertible Promissory Note [Member]
Warrants and Rights Outstanding		$ 400,000
Panacea [Member] \| Secured Convertible Promissory Note [Member]
Debt Instrument, Face Amount		1,500,000
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, Conversion Price \| $ / shares	$ 4										$ 4
Debt Instrument, Convertible, Number of Equity Instruments	375,000
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent			$ 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
Headquarters [Member]
Security Deposit								140,000				$ 140,000	$ 225,000
Offices, Taipei, Taiwan [Member]
Security Deposit								$ 14,000
Minimum [Member]
Property, Plant and Equipment, Useful Life								3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life								10 years

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

Note 6 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended								12 Months Ended
	Dec. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2019	Dec. 31, 2018
License [Member]
License revenue with affiliate			$ 158	$ 40	$ 304	$ 159	$ 356	$ 204	$ 198	$ 1,023

Note 7 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands	Dec. 31, 2019	Dec. 31, 2018
US Treasury Note [Member]
Available-for-sale marketable securities		$ 13,959
Fair Value, Inputs, Level 1 [Member] \| US Treasury Note [Member]
Available-for-sale marketable securities		13,959
Fair Value, Inputs, Level 2 [Member] \| US Treasury Note [Member]
Available-for-sale marketable securities
Fair Value, Inputs, Level 3 [Member] \| US Treasury Note [Member]
Available-for-sale marketable securities
Fair Value, Recurring [Member]
Total Assets	$ 20,049	20,080
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member]
Total Assets	20,049	20,080
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member]
Total Assets
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 3 [Member]
Total Assets
Fair Value, Recurring [Member] \| Money Market Funds [Member]
Cash equivalents	1,819	103
Fair Value, Recurring [Member] \| Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	1,819	103
Fair Value, Recurring [Member] \| Money Market Funds [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
Fair Value, Recurring [Member] \| Money Market Funds [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents
Fair Value, Recurring [Member] \| US Treasury Securities [Member]
Cash equivalents	18,230	6,018
Fair Value, Recurring [Member] \| US Treasury Securities [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	18,230	6,018
Fair Value, Recurring [Member] \| US Treasury Securities [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
Fair Value, Recurring [Member] \| US Treasury Securities [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents

Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Depreciation, Total	$ 195	$ 160

Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2019	Dec. 31, 2018
Property and equipment, gross	$ 7,172	$ 7,218
Accumulated depreciation and amortization	(6,374)	(6,416)
Property and equipment, net	798	802
Manufacturing, Laboratory, and Office Equipment [Member]
Property and equipment, gross	4,313	4,359
Furniture and Fixtures [Member]
Property and equipment, gross	390	390
Leasehold Improvements [Member]
Property and equipment, gross	$ 2,469	$ 2,469

Note 9 - Collaboration and Device Development Payable (Details Textual) $ / shares in Units, $ in Thousands			12 Months Ended
	Dec. 21, 2018 USD ($) $ / shares shares	Dec. 07, 2018 USD ($) $ / shares shares	Dec. 31, 2019 USD ($)	Dec. 31, 2018 USD ($)	Dec. 06, 2018 USD ($)
Collaboration and Device Development Payable, Current			$ 1,972	$ 2,576
Gain (Loss) on Extinguishment of Debt, Total			(1,794)	$ (3,345)
Conversion of Battelle Payables [Member]
Gain (Loss) on Extinguishment of Debt, Total	$ (500)
Debt Conversion, Converted Instrument, Amount	1,500
Debt Conversion, Original Debt, Amount	$ 1,000
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
Payments for Collaboration and Device Development Payable		1,000
Collaboration and Device Development Agreement, Aggregate Payments		$ 1,250
Collaboration and Device DevelopmentPayable, Number of Monthly Installments Payments Deferred		5
Collaboration and Device Development Payable, Periodic Payment, Total		$ 250
Royalty Guarantees, Commitments, Amount		$ 35,000			$ 25,000
Interest Payable, Current			$ 400
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
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 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 10 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2019	Dec. 31, 2018
Research and development	$ 1,415	$ 2,361
Professional fees	543	2,473
Salaries, bonus & benefits	696	815
Manufacturing operations	183	212
Other	389	604
Total accrued expenses	$ 3,226	$ 6,465

Note 11 - Loan Payable - Current Portion and Non-current Portion (Details Textual) - USD ($)						1 Months Ended									3 Months Ended	12 Months Ended
	Mar. 20, 2020	Dec. 06, 2019	Oct. 24, 2019	Dec. 27, 2018	Dec. 21, 2018	Dec. 31, 2019	Apr. 30, 2019	Nov. 30, 2018	Oct. 30, 2018	Sep. 30, 2018	Apr. 30, 2018	Mar. 31, 2018	Jan. 31, 2018	Sep. 30, 2017	Mar. 31, 2019	Dec. 31, 2019	Dec. 31, 2018	Oct. 28, 2019	May 30, 2019	Dec. 05, 2018	Nov. 19, 2018	Nov. 16, 2018	Nov. 02, 2018	Oct. 19, 2018	Sep. 27, 2018	Sep. 12, 2018	Aug. 29, 2018	Aug. 14, 2018	Sep. 30, 2016
Gain (Loss) on Extinguishment of Debt, Total																$ (1,794,000)	$ (3,345,000)
Proceeds from Short-term Debt, Total																1,000,000	6,160,000
Repayments of Short-term Debt, Total																2,063,000	160,000
Loans Payable, Noncurrent, Total						$ 4,608,000										$ 4,608,000
Series I Warrants Issued with Conversion of Lee's International Debt [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights						488,411										488,411
Class of Warrant or Right, Exercise Price of Warrants or Rights						$ 4.03										$ 4.03
Warrants and Rights Outstanding, Term						5 years										5 years
CVie Investments [Member]
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total					$ 2,590,000
Loan Payable Obligation Converted to LPH II [Member]
Debt Conversion, Original Debt, Amount					6,000,000
First Quarter 2018 Loans Converted to LPH II [Member]
Debt Conversion, Original Debt, Amount					2,500,000
Third and Fourth Quarter 2018 Loans Converted to LPH II [Member]
Debt Conversion, Original Debt, Amount					3,500,000
Conversion of Loan Payable as Part of Private Placement Financing [Member]
Debt Conversion, Original Debt, Amount		$ 2,950,000				$ 2,950,000
Conversion of Loan Payable as Part of Private Placement Financing [Member] \| Common Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued						976,821
Shares Issued, Price Per Share						$ 3.02										$ 3.02
LPH II [Member]
Debt Instrument Requirement For Minimum Amount Rise																	$ 30,000,000
LPH [Member]
Proceeds from Issuance of Debt												$ 1,000,000	$ 1,500,000
Debt Instrument, Interest Rate, Stated Percentage																	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)
Repayments of Debt				$ 160,000
Interest Paid, Including Capitalized Interest, Operating and Investing Activities, Total				$ 182,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Percent of Pledged Deposits Required														110.00%
Loans Payable, Noncurrent, Total						$ 4,600,000										$ 4,600,000
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate														0.91%
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member] \| CVie Investments [Member]
Line of Credit Facility, Maximum Borrowing Capacity														$ 5,800,000															$ 2,900,000
O-Bank Co., Ltd. [Member] \| Nonrevolving Credit Facility [Member] \| Subsequent Event [Member]
Line of Credit Facility, Maximum Borrowing Capacity	$ 5,000,000
Debt Instrument, Term	2 years
O-Bank Co., Ltd. [Member] \| Nonrevolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member] \| Subsequent Event [Member]
Debt Instrument, Basis Spread on Variable Rate	1.17%
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							$ 3,500,000
LPH II Loan [Member] \| LPH II [Member]
Proceeds from Issuance of Debt			$ 1,000,000
Debt Instrument, Interest Rate, Effective Percentage																		6.00%
Debt Payable to LPH II [Member]
Debt Instrument, Interest Rate, Stated Percentage																						4.00%
Debt Instrument, Face Amount																						$ 3,500,000
Gain (Loss) on Extinguishment of Debt, Total																(1,800,000)
Proceeds from Short-term Debt, Total								$ 2,500,000	$ 150,000	$ 300,000	$ 500,000
Repayments of Short-term Debt, Total							$ 50,000								$ 450,000
Interest Paid, Excluding Capitalized Interest, Operating Activities																127,000
Short-term Debt, Total						0										0
Loan payable to Bank Direct Capital Finance [Member]
Loans Payable to Bank, Total						$ 200,000										$ 200,000
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

Note 12 - Convertible Note Payable (Details Textual)				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	Dec. 31, 2019 USD ($)	Dec. 31, 2018 USD ($)	Dec. 26, 2018 $ / shares
Proceeds from Convertible Debt					$ 1,500,000
Repayments of Convertible Debt					1,500,000
Gain (Loss) on Extinguishment of Debt, Total				$ (1,794,000)	$ (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 12 - Convertible Note Payable - Significant Input Assumptions of Warrant Valuation (Details) - Series D Warrants [Member]	Dec. 31, 2019
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 13 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands	Nov. 01, 2017	Dec. 31, 2019	Dec. 31, 2018
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 15,000
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 15,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Extinguishment of Debt, Amount	$ 25,000
Class of Warrant or Right, Number of Warrants Cancelled	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 13 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands	Dec. 31, 2019	Dec. 31, 2018
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000
Deerfield Loan [Member]
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000

Note 14 - Stockholders' Equity (Details Textual) - USD ($)					1 Months Ended	12 Months Ended
	Dec. 06, 2019	Dec. 24, 2018	Dec. 21, 2018	Apr. 04, 2018	Dec. 31, 2019	Dec. 31, 2019	Dec. 31, 2018
Common Stock, Shares, Issued, Total					41,091,606	41,091,606	32,133,263
Proceeds from Issuance of Private Placement						$ 22,982,000	$ 32,893,000
The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized		4,200,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant					448,000	448,000	1,453,000
Series I Warrants Issued with Offering [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	4,375,002
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 4.03
Warrants and Rights Outstanding, Term	5 years
Common Stock Maximum Ownership Percentage For Warrant Exercise	4.99%
Common Stock Maximum Ownership Percentage For Warrant Exercise, Per Each Holder	19.99%
Conversion of Loan Payable as Part of Private Placement Financing [Member]
Debt Conversion, Original Debt, Amount	$ 2,950,000				$ 2,950,000
Private Placement [Member]
Stock Issued During Period, Shares, New Issues	8,749,999
Shares Issued, Price Per Share	$ 3.02
Proceeds from Issuance of Common Stock	$ 26,400,000
Common Stock, Shares, Issued, Total			11,785,540
Share Price			$ 3.3132
Proceeds from Issuance of Private Placement			$ 39,000,000
Private Placement [Member] \| Lee’s Pharmaceutical Holdings Limited [Member]
Debt Conversion, Original Debt, Amount			6,000,000
Private Placement [Member] \| Battelle [Member]
Debt Conversion, Original Debt, Amount			$ 1,000,000
Private Placement [Member] \| LPH II [Member]
Stock Issued During Period, Shares, New Issues				541,667
Shares Issued, Price Per Share				$ 4.80
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
Class of Warrant or Right, Vesting Period				180 days
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%

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

12 Months Ended

Dec. 31, 2019

Dec. 31, 2018

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

14,225

9,850

Investors - December 2019 Financing [Member]

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

4,375

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

$ 4.03

Investors - Aerosurf [Member]

12/06/24

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

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 (in shares)

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 (in shares)

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 (in shares)

^[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 (in shares)

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 (in shares)

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 (in shares)

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 (in shares)

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 (in shares)

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

$ 1,400