0001437749-21-007493 | 10-K | XBRL Viewer | Windtree Therapeutics INC DE

Significant Accounting Policies [Text Block]

Note

- Accounting Policies and Recent Accounting Pronouncements

Principles of Consolidation

The consolidated financial statements are prepared in accordance with US GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.).

Intangible Assets and Goodwill

We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development, or IPR&D, assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is

not

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

may

be impaired.

Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is

not

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

may

be impaired.

The following table represents identifiable intangible assets and goodwill as of

December 31, 2020

and

2019

	December 31,
(in thousands)	2020		2019

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

Goodwill	$	15,682	$	15,682

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 assessment 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 assessment. When conducting our annual impairment test of goodwill and indefinite-lived intangible assets as of

December 1, 2020

, we elected to perform a quantitative assessment.

Our company consists of

one

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

further evaluation is required, and

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

may

not

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

December 1, 2020

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

impairment loss was recognized.

When performing the quantitative impairment assessment for our indefinite-lived IPR&D intangible assets, we estimate the fair values of the assets using the multi-period excess earnings method, or MPEEM. MPEEM is a variation of the income approach which estimates the fair value of an intangible asset based on the present value of the incremental after-tax cash flows attributable to the intangible asset. Significant factors considered in the calculation of IPR&D intangible assets include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for each project were estimated based on forecasted revenue and costs, taking into account the expected product life cycles, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D assets, (ii) the long-term growth rate, (iii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iv) the tax rate, which considers geographic diversity of the projected cash flows. While we use the best available information to prepare our cash flows and discount rate assumptions, actual future cash flows could differ significantly based on the commercial success of the related drug candidates and market conditions 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, 2020

, 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

Total other (expense), net

. Foreign currency transactions resulted in

losses

of approximately

$1.2

million and

$0.5

million, respectively, for the years ended

December 31, 2020

and

2019

Use of Estimates

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

Cash and Cash Equivalents

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

days or less that are readily convertible into cash.

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, 2020

and

2019

, 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

(see,

Note

- Commitments

, for further discussion on our leases).

Leases

Leases are accounted for under ASC Topic

842,

Leases

, or ASC

842.

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. It is our policy

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.

At the inception of a contract, we assess whether the contract is, or contains, a lease. The assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether we obtain the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) 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 property and equipment, 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, 2020

and

2019

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

Severance

July 2020,

we entered into separation agreements with

two

executives, which provide that the former employees are entitled to receive: (i) a severance amount equal to the sum of their respective base salaries then in effect and their respective annual target bonus amounts, payable in equal installments through

August 2021

and (ii) subject to certain exceptions, a pro rata bonus commensurate with the bonus of other contract executives for the year

2020,

prorated for the number of days of their respective employment during

2020,

and payable at the time that other contract executives are paid bonuses with respect to

2020.

The severance amount related to the departure of these executives is approximately

$0.9

million, was accrued at the date of the separations, and will be paid ratably through

August 2021.

During the year ended

December 31, 2020

$0.4

million was paid.

Restructured Debt Liability - Contingent Milestone Payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

see,

Note

- Restructured Debt Liability

), we have established a

$15.0

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

October 27, 2017,

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

not

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

Research and Development

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

, or 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

, or 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.

Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended

December 31, 2020

and

2019

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

9.1

million and

6.5

million shares, respectively. As of

December 31, 2020

and

2019

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

We do

not

have any components of other comprehensive (loss) income.

Concentration of Suppliers

We currently obtain the active pharmaceutical ingredients 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 and several are located outside the U.S. 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 cardiovascular and acute pulmonary 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 U.S. and Asia. License revenue with affiliate for the years ended

December 31, 2020

and

2019

are generated in the U.S. Long-lived assets, consisting of intangible assets of

$77.1

million and goodwill of

$15.7

million were located outside the U.S. at

December 31, 2020

and

2019

COVID-

The COVID-

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

-K, our operations, capital and financial resources and overall liquidity position and outlook have been impacted by COVID-

19,

primarily due to delays experienced in our operations, including in clinical study initiation and enrollment. The potentially extended timelines

may

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

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

pandemic will have, directly or indirectly, on our financial condition and operations, including ongoing and planned clinical trials, will depend on future developments that are highly uncertain and cannot be accurately predicted. These potential future developments include new information that

may

emerge concerning the severity of the COVID-

outbreak, the severity and transmissibility of new variants of the virus, such as the

B.1.1.7

strain

first

identified in the United Kingdom and the

B.1.351

strain

first

detected in South Africa, cases of which have been confirmed in the U.S., information about any regional resurgences in

one

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

may

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

measures in

one

or more markets where our clinical trial sites, principal executive offices, research and development laboratories or other facilities are located remains possible and we believe there could be further impact on the clinical development of our product candidates, which

may

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

2021.

We are

not

aware of any specific event or circumstance that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities as of the date of issuance of these consolidated financial statements. These estimates

may

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

may

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

may

be material.

Recent Accounting Pronouncements

December 2019,

the FASB issued Accounting Standards Update, or ASU,

2019

12,

Income Taxes

(Topic

740

): Simplifying the Accounting for Income Taxes

, or ASU

2019

12.

ASU

2019

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

740

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

December 15, 2020

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

not

believe there will be a material impact upon adoption.

Note 5 - License Revenue with Affiliate

12 Months Ended

Dec. 31, 2020

Revenue from Contract with Customer [Text Block]

Note

- License Revenue with Affiliate

	Year Ended December 31,
(in thousands)	2020		2019

License revenue with affiliate	$	-	$	198

License revenue with affiliate for the year ended

December 31, 2019

represents revenue from the Asia License Agreement with Lee

s (HK) and constitutes a contract with a customer accounted for in accordance with ASC Topic

606,

Revenue from Contracts with Customers

, or ASC Topic

606.

All revenue related to the

$1.0

million upfront payment under the Asia License Agreement was recognized as of the

second

quarter of

2019

and

future material performance obligations are due.

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

+ Details

Note 6 - Fair Value Measurements

12 Months Ended

Dec. 31, 2020

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

The tables below categorize assets measured at fair value on a recurring basis as of

December 31, 2020

and

2019

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

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

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

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

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 7 - Property and Equipment

12 Months Ended

Dec. 31, 2020

Property, Plant and Equipment Disclosure [Text Block]

Note

– Property and Equipment

Property and equipment is comprised of the following:

	December 31,
(in thousands)	2020			2019

Manufacturing, laboratory & office equipment	$	4,591		$	4,313
Leasehold improvements		2,482			2,469
Furniture & fixtures		390			390
Subtotal		7,463			7,172
Accumulated depreciation and amortization		(6,539	)		(6,374	)
Property and equipment, net	$	924		$	798

Depreciation expense on property and equipment was

$0.2

million for each of the years ended

December 31, 2020

and

2019

Note 8 - Collaboration and Device Development Payable	12 Months Ended
Note 8 - Collaboration and Device Development Payable	Dec. 31, 2020
Notes to Financial Statements
Accounts Payable and Accrued Liabilities Disclosure [Text Block]	Note 8 - Collaboration and Device Development Payable Collaboration and device development payable represents amounts due to Battelle Memorial Institute, or Battelle, under a collaboration agreement related to the development of our phase 3 ADS ( see , Note 14 - Collaboration, Licensing and Research Funding Agreements ) and a Research and Development Services Agreement, or RDSA, dated June 2012 for our phase 2 ADS. In March 2020, we entered into the first amendment to the December 2018 payment restructuring agreement, or the Amendment, with Battelle in which we agreed to amend the payment terms of two milestone payments previously due no later than January 2020. Under the Amendment, we agreed that (i) the first milestone payment would continue to be due upon enrollment of the first patient in the next AEROSURF clinical study but no later than April 15, 2020; and (ii) the second milestone payment would continue to be due upon completion of the technology transfer of our device manufacturing process for the phase 3 ADS to our new medical device manufacturer but no later than September 1, 2020. The Amendment was treated as a debt modification and, in accordance with debt modification accounting, no gain or loss was recognized. In April 2020, we made the first milestone payment of $0.8 million to Battelle and announced enrollment of the first patient into the AEROSURF phase 2 bridging study. In September 2020, we made the final milestone payment of $0.8 million to Battelle. As of December 31, 2020 , there are no remaining amounts outstanding to Battelle related to the collaboration and device development payable. As of December 31, 2019 , collaboration and device development payable was $2.0 million, including accrued interest.

Note 9 - Accrued Expenses

12 Months Ended

Dec. 31, 2020

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)	2020		2019

Salaries, bonus and benefits	$	1,214	$	696
Research and development		1,207		1,415
Severance		474		-
Professional fees		455		543
Manufacturing operations		41		183
Other		422		389
Total accrued expenses	$	3,813	$	3,226

Note 10 - Loans Payable	12 Months Ended
Note 10 - Loans Payable	Dec. 31, 2020
Notes to Financial Statements
Short-term Debt [Text Block]	Note 10 - Loans Payable Current Portion Loan Payable to Bank Direct Capital Finance In June 2020, we entered into an insurance premium financing and security agreement with Bank Direct Capital Finance, or Bank Direct. Under the agreement, we financed $1.1 million of certain premiums at a 4.26% annual interest rate. Payments of approximately $117,000 are due monthly from July 2020 through March 2021. As of December 31, 2020 , the outstanding principal of the loan was $0.4 million. The balance of the loan was repaid during the first quarter of 2021. In May 2019, we entered into an insurance premium financing and security agreement with 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 balance of the loan was repaid during the first quarter of 2020. 2019 LPH II Loans 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, or 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, or the December 2019 Private Placement Financing, 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 Financing. 2018 LPH II Loans From April 24, 2018 to November 16, 2018, our subsidiary, CVie Therapeutics Limited, 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 were 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, 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: 325,607 shares of common stock based at $9.06 per share and Series I Warrants to purchase 162,804 shares of common stock, at an exercise price equal to $12.09 per share. The Series I Warrants are exercisable at any time after the six -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 were no remaining amounts outstanding. Non-Current Portion O-Bank Co., Ltd. Credit Facility In September 2016, CVie Therapeutics Limited entered into a 12 -month revolving credit facility of approximately $2.9 million with O-Bank Co., Ltd., or O-Bank, to finance operating activities, or the O-Bank Facility. The O-Bank Facility was later renewed and increased to approximately $5.8 million in September 2017. The O-Bank Facility is guaranteed by Lee ' s Pharmaceutical Holdings Limited, or Lee ' s, which pledged bank deposits in the amount of 110% of the actual borrowing amount. Interest, payable in cash on a monthly basis, was determined based on 90 -day Taipei Interbank Offer Rate, or TAIBOR, plus 0.91%. The O-Bank Facility expired on September 11, 2019 and the loans were set to mature six months after the expiration date, on March 11, 2020. In March 2020, the O-Bank Facility was amended, among other things, to extend the maturity date to March 2022, to decrease the total amount of the O-Bank Facility to approximately $5.0 million, to change the applicable interest rate to the TAIBOR plus 1.17% and to adjust the term to 24 -month non-revolving. In the second quarter of 2020, we were informed by Lee ' s of their desire to reduce the amount of pledged bank deposits with O-Bank by 50% . To remain in compliance with the terms of the O-Bank Facility, we repaid approximately $2.3 million of the outstanding principal in August 2020. In November 2020, Lee ' s committed to maintain the required level of pledged bank deposits with O-Bank through the date of full repayment of the O-Bank Facility. As of December 31, 2020 and 2019 , the outstanding principal of the O-Bank Facility was approximately $2.4 million and $4.6 million, respectively.

Note 11 - Restructured Debt Liability	12 Months Ended
Note 11 - Restructured Debt Liability	Dec. 31, 2020
Notes to Financial Statements
Long-term Debt [Text Block]	Note 11 - Restructured Debt Liability On October 27, 2017, we and Deerfield entered into the Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P., or the Deerfield Loan, in the aggregate principal amount of $25.0 million and (ii) warrants to purchase up to 8,333 shares of our common stock at an exercise price of $2,360.40 per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of $2.5 million, (ii) 23,703 shares of common stock, representing 2% of fully-diluted shares outstanding (as defined in the Exchange and Termination Agreement) on the closing date, and (iii) the right to receive certain milestone payments based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to $15.0 million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a $15.0 million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement ( see , Note 4 - Accounting Policies and Recent Accounting Pronouncements ). The liability has been recorded at the full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or the milestones are not achieved and the liability is written off as a gain on debt restructuring. As of December 31, 2020 and 2019 , the restructured debt liability balance was $15.0 million.

Note 12 - Stockholders' Equity

12 Months Ended

Dec. 31, 2020

Stockholders' Equity Note Disclosure [Text Block]

Note

- Stockholders

Equity

May 2020

Public Offering

May 20, 2020,

we entered into an underwriting agreement, or the Underwriting Agreement, with Ladenburg as representative for the several underwriters named therein, or collectively, the Underwriters, relating to the

May 2020

Offering for an aggregate of

2,758,620

units with each unit consisting of

one

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

$7.975

per share and expire

five

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

May 2020

Offering.

In addition, we granted the Underwriters a

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

413,793

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

413,793

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

The closing of the

May 2020

Offering occurred on

May 22, 2020,

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

$7.25

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

$2.8

million payable by us, and excluding the proceeds, if any, from the exercise of the Warrants issued pursuant to this

May 2020

Offering, the net proceeds to us were approximately

$20.2

million.

We have determined that the appropriate accounting treatment under ASC

480,

Distinguishing Liabilities from Equity

, or ASC

480,

is to classify the common stock and the Warrants issued in the

May 2020

Offering as equity. We have also determined that the Warrants are

not

in their entirety a derivative under the scope of ASC

815,

Derivatives and Hedging

, or ASC

815,

due to the scope exception under ASC

815

74,

nor are there any material embedded derivatives that require separate accounting. We allocated the net proceeds from the

May 2020

Offering based on the relative fair value of the common stock and the Warrants.

At-The-Market Program

September 17, 2020,

we entered into an At-The-Market Offering Agreement with Ladenburg, pursuant to which we

may

offer and sell, from time to time at our sole discretion, up to a maximum of

$10.0

million of shares of our common stock through Ladenburg as agent and/or principal under the ATM Program. When we issue sales notices to Ladenburg, we designate the maximum amount of shares to be sold by Ladenburg daily and the minimum price per share at which shares

may

be sold. Ladenburg

may

sell shares by any method permitted by law deemed to be an

“

at-the-market offering

”

as defined in Rule

415

(a)(

) under the Securities Act of

1933,

as amended, or in privately negotiated transactions.

We agreed to pay Ladenburg a commission of

of the gross sales price of any shares sold pursuant to the ATM Program. The rate of compensation will

not

apply when Ladenburg acts as principal.

As of

December 31, 2020

, we had

not

sold any shares under the ATM Program. In

February 2021,

we sold

105,083

shares of our common stock under the ATM Program resulting in aggregate gross and net proceeds to us of approximately

$0.6

million.

Warrant Amendments

April 24, 2020,

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

December 24, 2018,

or the Series F Warrants, entered into Amendment

No.

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

June 24, 2020

December 24, 2020

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

not

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

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

December 24, 2020.

The lock-up provision commenced on

May 22, 2020

upon closing of the

May 2020

Offering discussed above and has expired.

May 6, 2020,

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

December 6, 2019,

or the Series I Warrants, entered into Amendment

No.

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

$12.09

$9.67

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

December 5, 2021.

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

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

December 24, 2020.

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

not

May 22, 2020

upon closing of the

May 2020

Offering discussed above and has expired.

While there is

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

718

20,

Compensation – Stock Compensation

, or ASC

718

20.

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

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

six

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

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

We have determined, based on the guidance in ASC

718

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

$1.1

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

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

2,916,666

shares of common stock at a price per share of

$9.06,

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

1,458,334

shares of common stock at an exercise price equal to

$12.09

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

2,916,666

shares of common stock sold and

1,458,334

shares of common stock underlying the Series I Warrants.

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)	2020		2019		Exercise Price		Date

Investors - May 2020 financing		3,155		-	$	7.98	05/22/25
Investors - December 2019 financing		1,458		1,458	$	12.09	12/06/24
Investors - AEROSURF		988		988	$	-	02/14/24
Investors - December 2018 financing - long-term		1,296		1,296	$	12.15	12/04/23
Investors - December 2018 financing - short-term		-		668	$	11.04	12/24/20
Battelle - 2018 payables restructuring agreement (1)		25		25	$	19.50	12/07/23
Panacea Venture Management Company Ltd.		63		63	$	12.00	07/02/23
LPH II Investments Limited		45		45	$	16.56	04/04/25
Investors - February 2017 financing		117		117	$	82.20	02/15/24
Investors - July 2015 financing		80		80	$	588.00	07/22/22
Battelle - 2014 collaboration agreement		1		1	$	4,200.00	10/10/24
Total		7,228		4,741

(

)

See,

Note

- Collaboration, Licensing and Research Funding Agreements

, for further details on the Battelle collaboration agreement.

Common shares reserved for potential future issuance upon granting of additional equity incentive awards

As of

December 31, 2020

and

2019

, we had

0.2

million and

0.1

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

2011

long-term incentive plan, or

2011

Plan.

The

2011

Plan was suspended upon the effective date of the

2020

Equity Incentive Plan, or the

2020

Plan, in

January 2021;

therefore,

shares are available for future grants under the

2011

Plan. The

2020

Plan allows for up to a maximum of

1,535,500

shares of common stock to be available for issuance pursuant to stock-based awards granted under the

2020

Plan.

See,

Note

- Stock Options and Stock-based Employee Compensation

Note 13 - Stock Options and Stock-based Employee Compensation

12 Months Ended

Dec. 31, 2020

Share-based Payment Arrangement [Text Block]

Note

- Stock Options and Stock-based Employee Compensation

Long-term Incentive Plans

November 23, 2020,

our Board of Directors adopted our

2020

Plan, which was subsequently approved by our majority stockholders by written consent on

December 24, 2020

and became effective on

January 20, 2021,

or the effective date. On the effective date, the

2020

Plan replaced our

2011

Plan and the

2020

Plan became our primary plan for providing equity-based compensation to our eligible employees, consultants, and non-employee directors. The

2020

Plan allows for up to a maximum of

1,535,500

shares of common stock to be available for issuance pursuant to stock-based awards granted under the

2020

Plan. The

2020

Plan continues many of the features of the

2011

Plan but is updated to reflect changes to Nasdaq rules regarding equity compensation, other regulatory changes, and market and corporate governance developments. Awards outstanding under the

2011

Plan will continue to be governed by the terms of that plan and the agreements under which they were granted, although any shares returnable to the

2011

Plan as a result of cancellations, expirations and forfeitures will be returned to, and become available for issuance under, the

2020

Plan.

There were

1.9

million shares of our common stock authorized under the

2011

Plan, of which

0.2

million shares remained available for issuance as of

December 31, 2020

. Awards under the Plan

may

include stock options, stock appreciation rights, or SARs, restricted stock awards, or RSAs, restricted stock units, or RSUs, other performance and stock-based awards, and dividend equivalents.

An administrative committee, or 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 RSUs outstanding and available for future issuance are as follows:

	December 31,
(in thousands)	2020		2019

Stock Options and RSUs Outstanding
2011 Plan		1,688		1,804
Non-Plan		215		3
Total Outstanding		1,903		1,807

Available for Future Grants under 2011 Plan		230		149

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 Financial Officer, Mr. Hamill, on

July 20, 2020,

and the hiring of our Chief Executive Officer, Mr. Fraser, on

February 1, 2016.

Inducement grants were awarded in accordance with Nasdaq Listing Rule

5635

(c)(

) and the inducement grants vest in a series of

three

successive, equal installments beginning with the

first

anniversary of the grant date and have 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, 2020		1,772		$	17.61
Granted		562			7.22
Forfeited or expired		(431	)		13.06
Outstanding at December 31, 2020		1,903		$	15.57		7.8

Vested and exercisable at December 31, 2020		1,057		$	20.12		7.0

Vested and expected to vest at December 31, 2020		1,828		$	15.56		7.8

During the year ended

December 31, 2020

35,000

RSUs vested at a weighted-average grant date fair value of

$11.85

. As of

December 31, 2020

, there were

unvested RSUs.

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, 2020

and

2019

was

$5.98

and

$10.02

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

December 31, 2019

was

$11.85

. There were

RSUs granted during the year ended

December 31, 2020.

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

December 31, 2020

are each

Stock-Based Compensation

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

718

$5.7

million and

$6.7

million, respectively, for each of the years ended

December 31, 2020

and

2019

Stock-based compensation expense was classified as follows:

	Year Ended December 31,
(in thousands)	2020		2019

Research and development	$	2,098	$	1,932
General and administrative		3,586		4,789
Total	$	5,684	$	6,721

The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant.

	Year Ended December 31,
	2020			2019

Weighted average expected volatility		103	%		95	%
Weighted average expected term		7.0			6.6
Weighted average risk-free interest rate		0.54	%		2.60	%
Expected dividends		-			-

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

2020

and

2019

equals

$7.1

million and

$5.6

million, respectively. As of

December 31, 2020

, there was

$5.2

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

1.8

years.

Note 14 - Collaboration, Licensing and Research Funding Agreements	12 Months Ended
	Dec. 31, 2020
Notes to Financial Statements
Corporate Partnership, Licensing and Research Funding Agreements [Text Block]	Note 14 - Collaboration, Licensing and Research Funding Agreements Collaboration Agreement Battelle Memorial Institute In October 2014, we entered into a Collaboration Agreement with Battelle, or the Battelle Collaboration Agreement, for the development of our new ADS for use in our phase 3 program. 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 phase 2 ADS used in the AEROSURF phase 2b clinical trial. Under the Battelle Collaboration Agreement, we and Battelle shared the costs of development for a three -stage development plan that included planning, executing the project plan and testing and completing verification and documentation of a new phase 3 ADS, putting us in a position to manufacture a new phase 3 ADS for use in the remaining AEROSURF development activities, including a potential phase 3 clinical program, and, if approved, 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 the costs of the project plan equally. 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 $25.0 million, which under a payment restructuring agreement (discussed below), was increased to $35.0 million. The Battelle 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 entered into a payment restructuring agreement with Battelle, or the Battelle Payment Restructuring Agreement, in which we agreed, among other things, as follows: (i) the outstanding amounts then due to Battelle, or the Battelle Payables, under the RDSA and the Battelle Collaboration Agreement would continue to accrue interest at a rate of 6% per annum; (ii) AEROSURF development activities thereafter would be performed under the RDSA; (iii) Battelle would participate in a December 2018 private placement offering and exchange $1.0 million of the debt for shares of our common stock; and (iv) upon the closing of the December 2018 private placement, we paid Battelle cash in the amount of $1.0 million and thereafter initiated payments totaling an aggregate $1.25 million in 2019. In addition, we agreed to make two milestone payments to Battelle as follows: (i) upon enrollment of the first patient in the next AEROSURF clinical study, or the First Milestone, an amount equal to one half of the then-outstanding Battelle Payables, including unpaid interest, and (ii) upon completion of the device technology transfer for the new ADS to Mack, or the 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. On March 30, 2020, we and Battelle entered into an amendment to the Battelle Payment Restructuring Agreement such that the First Milestone and Second Milestone payments would be payable no later than April 15, 2020 and September 1, 2020, respectively. In April 2020, we made the First Milestone payment of $0.8 million to Battelle and announced enrollment of the first patient into the AEROSURF phase 2 bridging study. In September 2020, we made the final Second Milestone payment of $0.8 million to Battelle ( see, Note 8 - 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, or the Asia License Agreement, with Lee ' s (HK) and an affiliate of Lee ' s and thereafter amended it effective August 2017. Under the Asia License Agreement, as amended, we granted to Lee ' s (HK) and an affiliate an exclusive license with a right to sublicense (i) to develop, manufacture, and commercialize our KL4 surfactant products, including SURFAXIN, which was approved by the FDA in 2012 for RDS in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN, and AEROSURF, including the ADS, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the licensed territory, which includes the People ' s Republic of China, or China, Hong Kong, Thailand, Taiwan and 12 other countries. Under the Asia License Agreement, Lee ' s (HK) made an upfront payment to us of $1.0 million. We also may receive up to $35.8 million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee ' s (HK) may receive at a rate equal to low double digits. In addition, Lee ' s (HK) is responsible for all costs and expenses in and for the licensed territory related to development activities, including a planned AEROSURF phase 3 clinical program, regulatory activities, and commercialization activities. We will be eligible to receive tiered royalties based on a percent of Net Sales (as defined in the Asia License Agreement), 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 (i) the expiration of the last valid patent claim covering the product in the country of sale, (ii) the expiration or revocation of any applicable regulatory exclusivity in the country of sale, and (iii) 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 Asia License Agreement, Lee ' s (HK) is responsible for all activities related to development, regulatory approval and commercialization of KL4 surfactant and drug/medical device combination products in the licensed territory. Lee ' s (HK) 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 (HK) our exclusive agent and representative to develop and register AEROSURF and other aerosolized products in our name and on our behalf. Lee ' s (HK) also has agreed that, except as provided in the Asia 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 China, 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. The Asia License Agreement is accounted for in accordance with ASC Topic 606 and constitutes a contract with a customer. All revenue related to the $1.0 million upfront payment 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. 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. In March 2020, we entered into the Term Sheet with Lee ' s (HK), pursuant to which Lee ' s (HK) had agreed to provide financing for the development of AEROSURF. In August 2020, we entered into the PF Agreement with Lee ' s (HK), formalizing the terms of the Term Sheet, and under which we received payments totaling $2.8 million through October 2020. Pursuant to the PF Agreement, Lee ' s (HK) agreed to pay additional amounts to be set forth in an updated development budget to be agreed between the parties by September 1, 2020 and updated every six months thereafter, to fund the continued development of AEROSURF and to be paid with the payment schedule to be set forth in each updated development budget. In partial satisfaction of our obligations under the PF Agreement, we agreed to pay Lee ' s (HK) 50% of any Commercialization Net Revenues (as defined in the PF Agreement) up to an amount that is equal to 125% of the Project Expenses (as defined in the PF Agreement) funded by Lee ' s (HK). On November 12, 2020, Lee ' s (HK) provided notice of termination of additional funding under the PF Agreement. Thereafter, we and Lee ' s (HK) revised our plans for the continued development of AEROSURF. Lee ' s (HK) agreed to continue the development of AEROSURF in Asia at its cost. Lee ' s (HK) will fund an additional $1.0 million to us in 2021 for certain transition and analytical services to be provided by us with respect to the development of AEROSURF, which will be considered “ Project Expenses ” under the terms of the PF Agreement. To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid 125% of the amounts funded by Lee ' s (HK) for the development of AEROSURF, we will pay to Lee ' s (HK) 50% of all revenue amounts and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio, excluding (i) payments for bona fide research and development services; (ii) reimbursement of patent expenses and (iii) all amounts paid to us under the Asia License Agreement, minus certain deductions and certain reductions for any payments made by us with respect to third party intellectual property not previously funded by Lee ' s (HK). As of December 31, 2020 , the liability balance related to the payments under the PF Agreement was $2.8 million and is recorded in other liabilities. We have determined that the Term Sheet and the PF Agreement are within the scope of ASC 730 - 20, Research and Development Arrangements , or ASC 730 - 20. We concluded that there has not been a substantive and genuine transfer of risk related to the Term Sheet or the PF Agreement as there is a presumption that we are obligated to repay Lee ' s (HK) based on the significant related party relationship that exists at the time the parties entered into the Term Sheet and the PF Agreement, including Lee ' s (HK)'s approximate 29% ownership of the outstanding shares of our common stock as of December 31, 2020 . We have determined that the appropriate accounting treatment under ASC 730 - 20 is to record the proceeds received from Lee ' s (HK) as cash and cash equivalents, as we have the ability to direct the usage of funds, and a long-term liability on our consolidated balance sheet when received. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the KL4/AEROSURF patent portfolio. We have also determined that the Term Sheet and the PF Agreement are not in their entirety a derivative under the scope of ASC 815, due to the scope exception under ASC 815 - 10 - 15 - 59, nor are there any embedded derivatives that require separate accounting. Philip Morris USA Inc. and Philip Morris Products S.A. Under license agreements with Philip Morris USA Inc., or PMUSA, and Philip Morris Products S.A., or 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 specified respiratory indications in humans in designated hospital settings. 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 ADS 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 2020 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, or 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 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, the license agreement requires that we 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., or 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, or the Former Esteve Territories, we agreed to pay Esteve 10% of any cash up front and milestone fees (up to a maximum aggregate of $20.0 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, or Bicocca, in Milan, Italy, focused on defining the role of SERCA2a and phospholamban, or 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. 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. On March 19, 2021, we entered into an Agreement for Scientific Collaboration, or the New SERCA2a Agreement, with Bicocca, which extends our collaboration. The New SERCA2a Agreement amends and restates the recently expired terms of the prior collaboration agreement. Under the New SERCA2a Agreement, we will provide Bicocca with approximately € 0.2 million (approximately $0.2 million) for research activities and to cover laboratory space and operation costs. Results obtained from the collaboration will be jointly owned by the parties. However, Bicocca will assign to us its interest in patent applications and patents covering any new SERCA2a compounds and diagnostic products suitable for further clinical development. We have agreed to pay Bicocca (corresponding to stage of development): (i) € 25,000 (approximately $30,000 ) for execution of an assignment to the Company of Bicocca's interest in the patent at issue, (ii) € 75,000 (approximately $90,000 ) for new SERCA2a compounds developed up to phase 1 studies in humans upon the completion and availability of the proof of concept of biological efficacy of new compounds on modulating the SERCA2a activity in cell-free systems, or its functional counterpart in isolated cells and (iii) € 1.5 million (approximately $1.8 million) upon obtaining marketing authorization in the U.S., EU, or China of new compounds with the corresponding companion diagnostic assay. We have also agreed to pay royalties on products generated from the collaboration in the range of a fraction of a single digit to a low 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 or until the expiry of patent(s) covering the products.

Note 15 - Related Party Transactions

12 Months Ended

Dec. 31, 2020

Note

- Related Party Transactions

Lee

s Pharmaceutical Holdings Limited

As of

December 31, 2020

and

2019

, Lee

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

29%

and

35%

, respectively.

We entered into the following transactions with Lee

s during

2020

and

2019

●

March 2020,

we entered into the Term Sheet, with Lee

s (HK), pursuant to which Lee

s (HK) had agreed to provide financing for the development of AEROSURF. In

August 2020,

we entered into the PF Agreement with Lee

s (HK), formalizing the terms of the Term Sheet, under which we received payments of

$2.8

million in

2020.

As of

December 31, 2020

, the liability balance related to the

$2.8

million in payments is recorded in other liabilities. The liability will remain on the balance sheet until we repay such amounts as a result of any revenues and payments received by us for any sale, divestiture, license or other development and/or commercialization of the

KL4/AEROSURF

patent portfolio. Lee

s (HK) will fund an additional

$1.0

million to us in

2021

for certain transition and analytical services to be provided by us with respect to the development of AEROSURF, which will be considered

“

Project Expenses

”

under the terms of the PF Agreement (

see

Note

- Collaboration, Licensing and Research Funding Agreements

- Lee

s Pharmaceutical (HK) Ltd.);


	●	Our $2.4 million bank credit facility is guaranteed by Lee ' s ( see , Note 10 - Loans Payable );


	●	We incurred $0.2 million in research and development expenses for services provided by a Lee ' s affiliate to our wholly owned subsidiary, CVie Therapeutics, or CVie, during each of 2020 and 2019 ;

	●	We incurred $0.2 million in interest expense in 2019 related to loan agreements between our wholly owned subsidiary, CVie, and an affiliate of Lee ' s ( see , Note 10 - Loans Payable - 2018 LPH II Loans);

	●	As of December 31, 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; 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;

	●	In October 2019, we entered into a loan agreement with an affiliate of Lee ' s and in December 2019, as part of the December 2019 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 10 - Loans Payable - 2019 LPH II Loans and see , Note 12 - Stockholders' Equity - December 2019 Private Placement Financing); and

	●	In December 2019, an affiliate of Lee ' s was an investor of $2.0 million in the December 2019 Private Placement Financing ( see , Note 12 - Stockholders' Equity - December 2019 Private Placement Financing).

Panacea Venture

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, or Panacea.

During

2020

and

2019

, we entered into the following transactions with Panacea:

	●	In May 2020, Panacea was an investor of $2.0 million in the May 2020 Offering ( see , Note 12 - Stockholders' Equity - May 2020 Public Offering);

	●	In December 2019, Panacea was an investor of $5.0 million in the December 2019 Private Placement Financing ( see , Note 12 - Stockholders' Equity - December 2019 Private Placement Financing); and

	●	In December 2019, we issued 32,143 shares of our common stock to Rui Jin (HK) Consulting Management Company Limited, an affiliate of Panacea, for services rendered.

As of

December 31, 2020

and

2019

, Panacea

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

14%

and

15%

, respectively.

Note 16 - Commitments	12 Months Ended
Note 16 - Commitments	Dec. 31, 2020
Notes to Financial Statements
Commitments Disclosure [Text Block]	Note 16 - Commitments We have no commitments other than the minimum lease payments commitment as disclosed in Note 19 - Leases .

Note 17 - Litigation	12 Months Ended
Note 17 - Litigation	Dec. 31, 2020
Notes to Financial Statements
Legal Matters and Contingencies [Text Block]	Note 17 - 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 18 - Income Taxes

12 Months Ended

Dec. 31, 2020

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, 2020

and

2019

is as follows:

	December 31,
(in thousands)	2020			2019

Income tax benefit, statutory rates	$	(6,837	)	$	(5,770	)
State taxes on income, net of federal benefit		(125	)		(1,182	)
Net operating loss expirations		1,835			-
Research and development tax credit		(1,213	)		(934	)
Foreign rate differential		22			22
Employee related and other		193			1,983
Interest related		34			79
Income tax expense / (benefit), statutory rates		(6,091	)		(5,802	)
Valuation allowance		6,091			5,802
Income tax benefit, net	$	-		$	-

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

December 31, 2020

and

2019

, are as follows:

	December 31,
(in thousands)	2020			2019

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	183,793		$	180,979
Research and development tax credit		18,632			17,599
Compensation expense on stock		3,525			2,142
Other accrued		1,811			934
Depreciation		112			128
Total long-term deferred tax assets		207,873			201,782
Long-term deferred liabilities:
IPR&D		(16,778	)		(15,419	)
Total long-term deferred tax liabilities		(16,778	)		(15,419	)
Valuation allowance		(207,873	)		(201,782	)
Deferred tax liabilities, net	$	(16,778	)	$	(15,419	)

We are in a net deferred tax liability position at

December 31, 2020

and

2019

. 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, 2020

and

2019

, nor were any incurred in

2020

2019

December 31, 2020

and

2019

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

$631.9

million and

$618.9

million, respectively, research and development tax credit carryforward of

$17.2

million and

$16.9

million, respectively and orphan drug tax credit carryforwards of

$1.4

million and

$0.1

million, respectively. Of the of

$631.9

million of federal net operating loss carryforwards,

$48.9

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

2039

December 31, 2020

and

2019

, we had available carryforward losses of approximately

$585.3

million and

$597.1

million, respectively, for state tax purposes. Of the

$585.3

million state tax carryforward losses,

$582.2

million is associated with the state of Pennsylvania, with the remainder associated with the other

three

(

) states within which we have established tax nexus.

Future realization of the tax benefits of existing temporary differences and net operating loss carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period. As of

December 31, 2020

and

2019

, the Company performed an evaluation to determine whether a valuation allowance was needed. The Company considered all available evidence, both positive and negative, which included the results of operations for the current and preceding years. The Company determined that it was

not

possible to reasonably quantify future taxable income and determined that it is more likely than

not

that all of the deferred tax assets will

not

be realized. Accordingly, the Company maintained a full valuation allowance as of

December 31, 2020

and

2019

Under Internal Revenue Code Section

382,

if a corporation undergoes an

“

ownership change,

”

the corporation

s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income

may

be limited. We have

not

completed a study to assess whether an

“

ownership change

”

has occurred or whether there have been multiple ownership changes since we became a

“

loss corporation

”

as defined in Section

382.

Future changes in our stock ownership, which

may

be outside of our control,

may

trigger an

“

ownership change.

”

In addition, future equity offerings or acquisitions that have equity as a component of the purchase price could result in an

“

ownership change.

”

If an

“

ownership change

”

has occurred or does occur in the future, utilization of the NOL carryforwards or other tax attributes

may

be limited, which could potentially result in increased future tax liability to us.

Utilization of net operating loss, or NOL, and research and development, or 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 sheets or statements of operations if an adjustment were required.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

Note 19 - Leases

12 Months Ended

Dec. 31, 2020

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 where we perform certain manufacturing development and preclinical activities related to our cardiovascular drug product candidates.

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. In

January 2021,

we entered into a lease amendment to extend the term of our Warrington, Pennsylvania lease for a period of

five

years commencing on

March 1, 2022

and expiring on

February 28, 2027.

The total aggregate base rental payments related to the lease amendment are approximately

$3.4

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 the years ended

December 31, 2020

and

2019

	Year Ended December 31,
(in thousands)	2020			2019

Operating lease cost	$	826		$	889
Variable lease cost		29			22
Total lease cost	$	855		$	911

Other Information
Operating cash flows used for operating leases	$	895		$	951
Operating lease liabilities arising from obtaining right-of-use assets	$	249		$	364
Weighted average remaining lease term (in years)		1.3			2.2
Weighted average incremental borrowing rate		9.00	%		9.00	%

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

December 31, 2020

, are as follows:

(in thousands)	December 31, 2020

2021	$	855
2022		184
2023		24
Total lease payments		1,063
Less imputed interest		(57	)
Total operating lease liabilities at December 31, 2020	$	1,006

Note 20 - Subsequent Event	12 Months Ended
Note 20 - Subsequent Event	Dec. 31, 2020
Notes to Financial Statements
Subsequent Events [Text Block]	Note 20 - Subsequent Event On March 23, 2021, we entered into an underwriting agreement with Oppenheimer & Co. Inc. as representative for the several underwriters named therein, relating to the public offering, or the Offering, of 9,230,500 shares of our common stock, or the Common Stock, and warrants to purchase 9,230,500 shares of our Common Stock, or the Warrants. The shares of Common Stock and Warrants were sold together as a fixed combination, consisting of one share of Common Stock and a Warrant to purchase one share of Common Stock, but are immediately separable and were issued separately in the offering. Each Warrant is exercisable to purchase one share of Common Stock at a price of $3.60 per share and expires five years from the date of issuance. The Company does not plan to apply to list the Warrants on The Nasdaq Capital Market, any other national securities exchange or any other nationally recognized trading system. The closing of the Offering occurred on March 25, 2021. The combined price to the public in the Offering for each share of Common Stock and accompanying Warrant was $3.25 resulting in gross proceeds of $30.0 million. After deducting underwriting discounts and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the Warrants issued pursuant to this Offering, the net proceeds to the Company are expected to be approximately $27.3 million.

Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2020

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

Goodwill and Intangible Assets, Policy [Policy Text Block]

Intangible Assets and Goodwill

not

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

may

be impaired.

Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is

not

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

may

be impaired.

The following table represents identifiable intangible assets and goodwill as of

December 31, 2020

and

2019

	December 31,
(in thousands)	2020		2019

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

Goodwill	$	15,682	$	15,682

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, 2020

, we elected to perform a quantitative assessment.

Our 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, 2020

impairment loss was recognized.

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

December 1, 2020

, 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

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

Total other (expense), net

. Foreign currency transactions resulted in

losses

of approximately

$1.2

million and

$0.5

million, respectively, for the years ended

December 31, 2020

and

2019

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

days or less that are readily convertible into cash.

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

Fair Value of Financial Instruments

December 31, 2020

and

2019

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

(see,

Note

- Commitments

, for further discussion on our leases).

Lessee, Leases [Policy Text Block]

Leases

Leases are accounted for under ASC Topic

842,

Leases

, or ASC

842.

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. It is our policy

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

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 property and equipment, 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, 2020

and

2019

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

Severance Cost [Policy Text Block]

Severance

July 2020,

we entered into separation agreements with

two

August 2021

and (ii) subject to certain exceptions, a pro rata bonus commensurate with the bonus of other contract executives for the year

2020,

prorated for the number of days of their respective employment during

2020,

and payable at the time that other contract executives are paid bonuses with respect to

2020.

The severance amount related to the departure of these executives is approximately

$0.9

million, was accrued at the date of the separations, and will be paid ratably through

August 2021.

During the year ended

December 31, 2020

$0.4

million was paid.

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

Restructured Debt Liability - Contingent Milestone Payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

see,

Note

- Restructured Debt Liability

), we have established a

$15.0

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

October 27, 2017,

not

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

Research and Development Expense, Policy [Policy Text Block]

Research and Development

730,

Research and Development

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

, or ASC Topic

718.

See,

Note

- Stock Options and Stock-based Employee Compensation

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

, or 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.

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

December 31, 2020

and

2019

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

9.1

million and

6.5

million shares, respectively. As of

December 31, 2020

and

2019

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

We do

not

have any components of other comprehensive (loss) income.

Concentration of Suppliers [Policy Text Block]

Concentration of Suppliers

We currently obtain the active pharmaceutical ingredients 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 and several are located outside the U.S. 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 U.S. and Asia. License revenue with affiliate for the years ended

December 31, 2020

and

2019

are generated in the U.S. Long-lived assets, consisting of intangible assets of

$77.1

million and goodwill of

$15.7

million were located outside the U.S. at

December 31, 2020

and

2019

Effect of COVID-19 Pandemic [Policy Text Block]

COVID-

The COVID-

-K, our operations, capital and financial resources and overall liquidity position and outlook have been impacted by COVID-

19,

primarily due to delays experienced in our operations, including in clinical study initiation and enrollment. The potentially extended timelines

may

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

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

may

emerge concerning the severity of the COVID-

outbreak, the severity and transmissibility of new variants of the virus, such as the

B.1.1.7

strain

first

identified in the United Kingdom and the

B.1.351

strain

first

detected in South Africa, cases of which have been confirmed in the U.S., information about any regional resurgences in

one

may

measures in

one

may

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

2021.

We are

not

may

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

may

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

may

be material.

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

December 2019,

the FASB issued Accounting Standards Update, or ASU,

2019

12,

Income Taxes

(Topic

740

): Simplifying the Accounting for Income Taxes

, or ASU

2019

12.

ASU

2019

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

740

December 15, 2020

not

believe there will be a material impact upon adoption.

Note 4 - Accounting Policies and Recent Accounting Pronouncements (Tables)

12 Months Ended

Dec. 31, 2020

Schedule of Intangible Assets and Goodwill [Table Text Block]

	December 31,
(in thousands)	2020		2019

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

Goodwill	$	15,682	$	15,682

Note 5 - License Revenue with Affiliate (Tables)

12 Months Ended

Dec. 31, 2020

Disaggregation of Revenue [Table Text Block]

	Year Ended December 31,
(in thousands)	2020		2019

License revenue with affiliate	$	-	$	198

Note 6 - Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2020

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

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

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

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

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

Note 7 - Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2020

Property, Plant and Equipment [Table Text Block]

	December 31,
(in thousands)	2020			2019

Manufacturing, laboratory & office equipment	$	4,591		$	4,313
Leasehold improvements		2,482			2,469
Furniture & fixtures		390			390
Subtotal		7,463			7,172
Accumulated depreciation and amortization		(6,539	)		(6,374	)
Property and equipment, net	$	924		$	798

Note 9 - Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2020

Schedule of Accrued Liabilities [Table Text Block]

	December 31,
(in thousands)	2020		2019

Salaries, bonus and benefits	$	1,214	$	696
Research and development		1,207		1,415
Severance		474		-
Professional fees		455		543
Manufacturing operations		41		183
Other		422		389
Total accrued expenses	$	3,813	$	3,226

Note 12 - Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2020

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

	December 31,						Expiration
(in thousands, except price per share data)	2020		2019		Exercise Price		Date

Investors - May 2020 financing		3,155		-	$	7.98	05/22/25
Investors - December 2019 financing		1,458		1,458	$	12.09	12/06/24
Investors - AEROSURF		988		988	$	-	02/14/24
Investors - December 2018 financing - long-term		1,296		1,296	$	12.15	12/04/23
Investors - December 2018 financing - short-term		-		668	$	11.04	12/24/20
Battelle - 2018 payables restructuring agreement (1)		25		25	$	19.50	12/07/23
Panacea Venture Management Company Ltd.		63		63	$	12.00	07/02/23
LPH II Investments Limited		45		45	$	16.56	04/04/25
Investors - February 2017 financing		117		117	$	82.20	02/15/24
Investors - July 2015 financing		80		80	$	588.00	07/22/22
Battelle - 2014 collaboration agreement		1		1	$	4,200.00	10/10/24
Total		7,228		4,741

Note 13 - Stock Options and Stock-based Employee Compensation (Tables)

12 Months Ended

Dec. 31, 2020

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)	2020		2019

Stock Options and RSUs Outstanding
2011 Plan		1,688		1,804
Non-Plan		215		3
Total Outstanding		1,903		1,807

Available for Future Grants under 2011 Plan		230		149

Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block]

(in thousands, except for weighted-average data)
Stock Options	Shares			Weighted-Average Exercise Price		Weighted-Average Remaining Contractual Term (In Yrs)

Outstanding at January 1, 2020		1,772		$	17.61
Granted		562			7.22
Forfeited or expired		(431	)		13.06
Outstanding at December 31, 2020		1,903		$	15.57		7.8

Vested and exercisable at December 31, 2020		1,057		$	20.12		7.0

Vested and expected to vest at December 31, 2020		1,828		$	15.56		7.8

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

	Year Ended December 31,
(in thousands)	2020		2019

Research and development	$	2,098	$	1,932
General and administrative		3,586		4,789
Total	$	5,684	$	6,721

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

	Year Ended December 31,
	2020			2019

Weighted average expected volatility		103	%		95	%
Weighted average expected term		7.0			6.6
Weighted average risk-free interest rate		0.54	%		2.60	%
Expected dividends		-			-

Note 18 - Income Taxes (Tables)

12 Months Ended

Dec. 31, 2020

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

	December 31,
(in thousands)	2020			2019

Income tax benefit, statutory rates	$	(6,837	)	$	(5,770	)
State taxes on income, net of federal benefit		(125	)		(1,182	)
Net operating loss expirations		1,835			-
Research and development tax credit		(1,213	)		(934	)
Foreign rate differential		22			22
Employee related and other		193			1,983
Interest related		34			79
Income tax expense / (benefit), statutory rates		(6,091	)		(5,802	)
Valuation allowance		6,091			5,802
Income tax benefit, net	$	-		$	-

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

	December 31,
(in thousands)	2020			2019

Long-term deferred assets:
Net operating loss carryforwards (federal and state)	$	183,793		$	180,979
Research and development tax credit		18,632			17,599
Compensation expense on stock		3,525			2,142
Other accrued		1,811			934
Depreciation		112			128
Total long-term deferred tax assets		207,873			201,782
Long-term deferred liabilities:
IPR&D		(16,778	)		(15,419	)
Total long-term deferred tax liabilities		(16,778	)		(15,419	)
Valuation allowance		(207,873	)		(201,782	)
Deferred tax liabilities, net	$	(16,778	)	$	(15,419	)

Note 19 - Leases (Tables)

12 Months Ended

Dec. 31, 2020

Lease, Cost [Table Text Block]

	Year Ended December 31,
(in thousands)	2020			2019

Operating lease cost	$	826		$	889
Variable lease cost		29			22
Total lease cost	$	855		$	911

Other Information
Operating cash flows used for operating leases	$	895		$	951
Operating lease liabilities arising from obtaining right-of-use assets	$	249		$	364
Weighted average remaining lease term (in years)		1.3			2.2
Weighted average incremental borrowing rate		9.00	%		9.00	%

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

(in thousands)	December 31, 2020

2021	$	855
2022		184
2023		24
Total lease payments		1,063
Less imputed interest		(57	)
Total operating lease liabilities at December 31, 2020	$	1,006

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

Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ / shares in Units, $ in Thousands			1 Months Ended	3 Months Ended	12 Months Ended
	Mar. 25, 2021	Sep. 17, 2020	Feb. 28, 2021	Mar. 29, 2021	Dec. 31, 2020	Dec. 31, 2019
Cash and Cash Equivalents, at Carrying Value, Ending Balance					$ 16,930	$ 22,578
Liabilities, Current, Total					6,131	7,817
Net Income (Loss) Attributable to Parent, Total					(32,566)	(27,475)
Retained Earnings (Accumulated Deficit), Ending Balance					$ (717,688)	$ (685,122)
September 2020 At The Market Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)		0
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value		$ 10,000
Subsequent Event [Member]
Stock Issued During Period, Shares, New Issues (in shares)	9,230,500
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	9,230,500
Stock and Warrants Issued, Price Per Share (in dollars per share)	$ 3.25
Proceeds from Issuance or Sale of Equity, Total	$ 27,300
Subsequent Event [Member] \| September 2020 At The Market Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)			105,083	105,083
Proceeds from Issuance or Sale of Equity, Total			$ 600

Note 4 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) shares in Millions		12 Months Ended
	Jul. 20, 2020 USD ($)	Dec. 31, 2020 USD ($) shares	Dec. 31, 2019 USD ($) shares	Nov. 01, 2017 USD ($)
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		1,200,000	$ 500,000
Asset Impairment Charges, Total		0	0
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000,000	$ 15,000,000
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants (in shares) \| shares		9.1	6.5
Number of Operating Segments		1
Intangible Assets, Net (Excluding Goodwill), Total		$ 77,100,000
Goodwill, Ending Balance		15,682,000	$ 15,682,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent				$ 15,000,000
John A. Tattory and Kathryn Cole [Member]
Severance Costs	$ 900,000
Payments for Severance Costs		400,000
Restricted Cash for Offices in Taipei, Taiwan [Member]
Security Deposit		14,000
Restricted Cash for Headquarters in Warrington, Pennsylvania [Member]
Security Deposit		$ 140,000
Minimum [Member]
Property, Plant and Equipment, Useful Life (Year)		3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life (Year)		10 years

Note 4 - Accounting Policies and Recent Accounting Pronouncements - Intangible Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019
Intangible assets	$ 77,090	$ 77,090
Goodwill, Ending Balance	15,682	15,682
Istaroxime Drug Candidate [Member]
Intangible assets	$ 22,340	$ 22,340

Note 5 - License Revenue with Affiliate (Details Textual) - USD ($)	1 Months Ended	12 Months Ended
	Jun. 30, 2017	Dec. 31, 2019
License Agreement With Lee’s [Member]
Proceeds from License Fees Received	$ 1,000,000	$ 1,000,000

Note 5 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
License revenue with affiliate		$ 198

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

Amount, including tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value-added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130543-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019
Total Assets	$ 15,619	$ 20,049
Fair Value, Inputs, Level 1 [Member]
Total Assets	15,619	20,049
Fair Value, Inputs, Level 2 [Member]
Total Assets
Fair Value, Inputs, Level 3 [Member]
Total Assets
US Treasury Securities [Member]
Cash equivalents	9,101	18,230
US Treasury Securities [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	9,101	18,230
US Treasury Securities [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
US Treasury Securities [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents
Money Market Funds [Member]
Cash equivalents	6,518	1,819
Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents	6,518	$ 1,819
Money Market Funds [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents
Money Market Funds [Member] \| Fair Value, Inputs, Level 3 [Member]
Cash equivalents

Note 7 - Property and Equipment (Details Textual) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Depreciation, Total	$ 165	$ 195

Note 7 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019
Property and equipment, gross	$ 7,463	$ 7,172
Accumulated depreciation and amortization	(6,539)	(6,374)
Property and equipment, net	924	798
Manufacturing, Laboratory, and Office Equipment [Member]
Property and equipment, gross	4,591	4,313
Leasehold Improvements [Member]
Property and equipment, gross	2,482	2,469
Furniture and Fixtures [Member]
Property and equipment, gross	$ 390	$ 390

Note 8 - Collaboration and Device Development Payable (Details Textual) - USD ($) $ in Thousands	1 Months Ended
	Sep. 30, 2020	Apr. 30, 2020	Dec. 31, 2020	Dec. 31, 2019
Collaboration and Device Development Payable, Current				$ 1,972
Battelle Applies [Member]
Payments for Collaboration and Device Development Payable	$ 800	$ 800
Collaboration and Device Development Payable, Current			$ 0	$ 2,000

Note 9 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2020	Dec. 31, 2019
Salaries, bonus and benefits	$ 1,214	$ 696
Research and development	1,207	1,415
Severance	474
Professional fees	455	543
Manufacturing operations	41	183
Other	422	389
Total accrued expenses	$ 3,813	$ 3,226

Note 10 - Loans Payable (Details Textual) - USD ($)					1 Months Ended									3 Months Ended		12 Months Ended
Note 10 - Loans Payable (Details Textual) - USD ($)	Mar. 20, 2020	Dec. 06, 2019	Oct. 24, 2019	Dec. 21, 2018	Aug. 31, 2020	Jun. 30, 2020	Dec. 31, 2019	Apr. 30, 2019	Nov. 30, 2018	Oct. 30, 2018	Sep. 30, 2018	Apr. 30, 2018	Sep. 30, 2017	Jun. 30, 2020	Mar. 31, 2019	Dec. 31, 2020	Dec. 31, 2019	Oct. 28, 2019	May 31, 2019	Nov. 16, 2018	Sep. 30, 2016
Proceeds from Short-term Debt, Total																	$ 1,000,000
Repayments of Short-term Debt, Total																3,229,000	2,063,000
Gain (Loss) on Extinguishment of Debt, Total																	(1,794,000)
Loans Payable, Noncurrent, Total							$ 4,608,000									2,423,000	$ 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 (in shares)							162,804										162,804
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)							$ 12.09										$ 12.09
Warrants and Rights Outstanding, Term (Year)							5 years										5 years
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 (in shares)								325,607
Shares Issued, Price Per Share (in dollars per share)								$ 9.06
O-Bank Co., Ltd. [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Percent of Pledged Deposits Required													110.00%
Line of Credit Facility, Percent of Pledged Deposits Increase (Decrease)														(50.00%)
Repayments of Lines of Credit					$ 2,300,000
Loans Payable, Noncurrent, Total							4,600,000									2,400,000	$ 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] \| Nonrevolving Credit Facility [Member]
Line of Credit Facility, Maximum Borrowing Capacity	$ 5,000,000
Debt Instrument, Term (Month)	2 years
O-Bank Co., Ltd. [Member] \| Nonrevolving Credit Facility [Member] \| Taipei Interbank Offer Rate (TAIBOR) [Member]
Debt Instrument, Basis Spread on Variable Rate	1.17%
O-Bank Co., Ltd. [Member] \| CVie Investments [Member] \| Revolving Credit Facility [Member]
Line of Credit Facility, Maximum Borrowing Capacity													$ 5,800,000								$ 2,900,000
Loan payable to Bank Direct Capital Finance [Member] \| Loans Payable [Member]
Debt Instrument, Face Amount						$ 1,100,000								$ 1,100,000
Debt Instrument, Interest Rate, Stated Percentage						4.26%								4.26%
Debt Instrument, Periodic Payment, Total						$ 117,000
Loans Payable to Bank, Total																$ 400,000
Insurance Premium Financing and Security Agreement with Bank Direct [Member] \| Loans Payable [Member]
Debt Instrument, Face Amount																			$ 700,000
Debt Instrument, Interest Rate, Stated Percentage																			5.35%
Loans Payable to Bank, Total																			$ 200,000
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%
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
Gain (Loss) on Extinguishment of Debt, Total																	(1,800,000)
Interest Paid, Excluding Capitalized Interest, Operating Activities																	127,000
Short-term Debt, Total							$ 0										$ 0

Note 11 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Oct. 27, 2017	Dec. 31, 2020	Dec. 31, 2019
Repayments of Long-term Debt, Total		$ 547
Liability for Contingent Milestone Payment, Noncurrent		15,000	15,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Extinguishment of Debt, Amount	$ 25,000
Class of Warrant or Right, Number of Warrants Cancelled (in shares)	8,333
Class of Warrant or Right, Exercise Price of Cancelled Warrants (in dollars per share)	$ 2,360.40
Repayments of Long-term Debt, Total	$ 2,500
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations (in shares)	23,703
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding	2.00%
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000	$ 15,000	$ 15,000

Note 12 - Stockholders' Equity (Details Textual) - USD ($)					1 Months Ended		3 Months Ended	12 Months Ended
	Mar. 25, 2021	Sep. 17, 2020	May 22, 2020	Dec. 06, 2019	Feb. 28, 2021	Dec. 31, 2019	Mar. 29, 2021	Dec. 31, 2020	Dec. 31, 2019	Jan. 31, 2021	Nov. 23, 2020	May 06, 2020
Fair Value Adjustment of Warrants								$ 1,112,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)								200,000
The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)						149,000		230,000	149,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)								1,900,000
The 2020 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)											1,535,500
Conversion of Loan Payable as Part of Private Placement Financing [Member]
Debt Conversion, Original Debt, Amount				$ 2,950,000		$ 2,950,000
Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 3.60
Warrants and Rights Outstanding, Term (Year)	5 years
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	9,230,500
Proceeds from Issuance or Sale of Equity, Total	$ 27,300,000
Stock Issued During Period, Shares, New Issues (in shares)	9,230,500
Subsequent Event [Member] \| The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)										0
Over Allotment Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)			413,793
Series I Warrants Issued with Offering [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)				$ 12.09								$ 9.67
Warrants and Rights Outstanding, Term (Year)				5 years
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)				1,458,334
Common Stock Maximum Ownership Percentage For Warrant Exercise				4.99%
Common Stock Maximum Ownership Percentage For Warrant Exercise, Per Each Holder				19.99%
Series I and F Warrants Issued with Offering [Member]
Fair Value Adjustment of Warrants								$ 1,100,000
Public Offering [Member]
Equity Issued During Period, Units, New Issues (in shares)			2,758,620
Units, Number of Securities Called by Each Unit (in shares)			1
Units Issued, Price Per Unit (in dollars per share)			$ 7.25
Payments of Stock Issuance Costs			$ 2,800,000
Proceeds from Issuance or Sale of Equity, Total			$ 20,200,000
Units, Number of Warrants Called by Each Unit (in shares)			1
Public Offering [Member] \| Warrants Issued in Units [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)			$ 7.975
Warrants and Rights Outstanding, Term (Year)			5 years
Over-Allotment Option [Member]
Equity Issued During Period, Units, New Issues (in shares)			413,793
September 2020 At The Market Offering [Member]
Shares Authorized to Be Offered and Sold Under Offering Agreement, Value		$ 10,000,000
Stock Issued During Period, Shares, New Issues (in shares)		0
September 2020 At The Market Offering [Member] \| Subsequent Event [Member]
Proceeds from Issuance or Sale of Equity, Total					$ 600,000
Stock Issued During Period, Shares, New Issues (in shares)					105,083		105,083
Proceeds from Issuance of Common Stock							$ 600,000
September 2020 At The Market Offering [Member] \| Ladenburg [Member]
Commission Fee, Percent Fee		3.00%
Private Placement [Member]
Stock Issued During Period, Shares, New Issues (in shares)				2,916,666
Proceeds from Issuance of Common Stock				$ 26,400,000
Shares Issued, Price Per Share (in dollars per share)				$ 9.06

Note 12 - Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares
shares in Thousands

12 Months Ended

Dec. 31, 2020

Dec. 31, 2019

7,228

4,741

Investors - May 2020 Financing [Member]

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

3,155

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 7.98

Investors - December 2019 Financing [Member]

05/22/25

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

1,458

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12.09

Investors - Aerosurf [Member]

12/06/24

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

988

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

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

02/14/24

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

1,296

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12.15

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

12/04/23

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

668

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 11.04

Battelle - 2018 Payables Restructuring Agreement [Member]

12/24/20

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

^[1]

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

^[1]

$ 19.50

Panacea Venture Management Company Ltd. [Member]

^[1]

12/07/23

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

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 12

LPH II Investments Limited [Member]

07/02/23

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

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 16.56

Investors - February 2017 Financing [Member]

04/04/25

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

117

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 82.20

Investors - July 2015 Financing [Member]

02/15/24

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

Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)

$ 588

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 (in dollars per share)

$ 4,200