View Filing Data

Print Document View Excel Document

Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Jun. 30, 2017	Aug. 15, 2017
Document Information [Line Items]
Entity Registrant Name	WINDTREE THERAPEUTICS INC /DE/
Entity Central Index Key	0000946486
Trading Symbol	wint
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
Entity Common Stock, Shares Outstanding (in shares)		13,994,960
Document Type	10-Q
Document Period End Date	Jun. 30, 2017
Document Fiscal Year Focus	2017
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Jun. 30, 2017	Dec. 31, 2016
Current Assets:
Cash and cash equivalents	$ 2,528	$ 5,588
Prepaid interest, current portion	1,094	1,094
Prepaid expenses and other current assets	318	512
Total current assets	3,940	7,194
Property and equipment, net	977	1,054
Restricted cash	225	225
Prepaid interest, non-current portion	683	1,226
Total assets	5,825	9,699
Current Liabilities:
Accounts payable	2,846	1,813
Collaboration payable	3,930	3,967
Accrued expenses	6,108	7,611
Long-term debt, current portion	12,500
Total current liabilities	25,384	13,391
Long-term debt, non-current portion	12,500	25,000
Other liabilities	124	138
Total liabilities	38,008	38,529
Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 6,213 and 0 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
Common stock, $0.001 par value; 120,00,000 and 60,000,000 shares authorized at June 30, 2017 and December 31, 2016, respectively; 10,569,452 and 8,725,069 shares issued at June 30, 2017 and December 31, 2016, respectively; 10,567,960 and 8,723,577 shares outstanding at June 30, 2017 and December 31, 2016, respectively	11	9
Additional paid-in capital	605,004	592,883
Accumulated deficit	(634,144)	(618,668)
Treasury stock (at cost); 1,492 shares	(3,054)	(3,054)
Total stockholders' equity	(32,183)	(28,830)
Total liabilities & stockholders' equity	$ 5,825	$ 9,699

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Jun. 30, 2017	Dec. 31, 2016
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	6,213	0
Preferred stock, shares outstanding (in shares)	6,213	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	120,000,000	60,000,000
Common stock, shares issued (in shares)	10,569,452	8,725,069
Common stock, shares outstanding (in shares)	10,567,960	8,723,577
Treasury stock, shares (in shares)	1,492	1,492

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2017	Jun. 30, 2016	Jun. 30, 2017	Jun. 30, 2016
Revenues:
Grant revenue	$ 1,147	$ 106	$ 1,366	$ 181
Expenses:
Research and development	5,483	8,316	11,896	18,676
General and administrative	1,804	1,783	3,726	5,440
Total operating expense	7,287	10,099	15,622	24,116
Operating loss	(6,140)	(9,993)	(14,256)	(23,935)
Change in fair value of common stock warrant liability				223
Other income / (expense):
Interest income	3	5	6	12
Interest expense	(615)	(637)	(1,226)	(1,259)
Other income		1		434
Other income / (expense), net	(612)	(631)	(1,220)	(813)
Net loss	(6,752)	(10,624)	(15,476)	(24,525)
Deemed dividend on Series A preferred stock	(532)		(4,136)
Net loss attributable to common shareholders	$ (7,284)	$ (10,624)	$ (19,612)	$ (24,525)
Net loss per common share
Basic and diluted (in dollars per share)	$ (0.76)	$ (1.29)	$ (2.10)	$ (2.99)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	9,634	8,238	9,317	8,215

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2017	Jun. 30, 2016
Cash flows from operating activities:
Net loss	$ (15,476,000)	$ (24,525,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	101,000	140,000
Stock-based compensation and 401(k) plan employer match	660,000	971,000
Fair value adjustment of common stock warrants		(223,000)
Amortization of prepaid interest	543,000	1,088,000
Changes in:
Prepaid expenses and other current assets	194,000	(92,000)
Accounts payable	2,231,000	3,101,000
Collaboration payable	(37,000)	1,226,000
Accrued expenses	(1,077,000)	(122,000)
Other liabilities		124,000
Net cash used in operating activities	(12,861,000)	(18,312,000)
Cash flows from investing activities:
Purchase of property and equipment	(24,000)	(149,000)
Net cash used in investing activities	(24,000)	(149,000)
Cash flows from financing activities:
Proceeds from Private Placement issuance of securities, net of expenses	8,789,000
Proceeds from ATM Program, net of expenses	1,036,000	69,000
Net cash provided by financing activities	9,825,000	69,000
Net increase/(decrease) in cash and cash equivalents	(3,060,000)	(18,392,000)
Cash, cash equivalents and restricted cash - beginning of year	5,813,000	38,947,000
Cash, cash equivalents and restricted cash - end of year	2,753,000	20,555,000
Supplementary disclosure of cash flows information:
Interest paid	$ 514,000	$ 61,000

Note 1 - The Company and Description of Business

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

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

Note

–

The Company and Description of Business

Windtree Therapeutics, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology company focused on developing novel KL

surfactant therapies for respiratory diseases and other potential applications. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. Our proprietary technology platform includes a synthetic, peptide-containing surfactant (

surfactant) that is structurally similar to endogenous pulmonary surfactant, and novel drug delivery technologies being developed to enable noninvasive administration of aerosolized

surfactant. We believe that our proprietary technology platform

may

make it possible to develop a pipeline of surfactant products to address a variety of respiratory diseases for which there are few or

approved therapies.

Our lead development program is AEROSURF

(lucinactant for inhalation), an investigational combination drug/device product that combines our

surfactant with our novel aerosol delivery system (ADS). We are developing AEROSURF to improve the management of respiratory distress syndrome (RDS) in premature infants. RDS is a serious respiratory condition caused by a deficiency of natural lung surfactant in lungs of premature infants, and the most prevalent respiratory disease in the neonatal intensive care unit. By enabling administration of aerosolized

surfactant, AEROSURF

may

reduce or eliminate the need for invasive endotracheal intubation and mechanical ventilation, which currently are required to administer life-saving surfactant therapy, but which are associated with serious respiratory conditions and other complications. To avoid the risks of surfactant administration, many neonatologists initially delay surfactant therapy and treat premature infants with noninvasive respiratory support (such as nasal continuous positive airway pressure (nCPAP)). We believe that AEROSURF, if approved, has the potential to address a serious unmet medical need by enabling earlier

surfactant therapy for infants receiving nCPAP alone, reducing the number of premature infants who are subjected to invasive surfactant administration, and potentially providing transformative clinical and pharmacoeconomic benefits.

We recently completed

an AEROSURF phase

clinical trial that was designed to evaluate aerosolized

surfactant administered to premature infants

week gestational age receiving nCPAP, in

two

dose groups (

and

minutes) with up to

two

potential repeat doses, compared to infants receiving nCPAP alone. This trial was conducted in approximately

clinical sites in the U.S., Canada, the European Union and Latin America.

Based on the planned top-line results, data show that AEROSURF did

not

meet the primary endpoint of a reduction in nCPAP failure at

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

Such interruptions occurred in about

24%

of active enrollments, predominantly in the

minute dose group, and were primarily related to specific lots of disposable cartridge filters in our proprietary ADS that had a tendency to clog. After excluding the patients whose dose was interrupted in the

minute dose group, the data show an nCPAP failure rate of

32%

compared to

44%

in the control group which is a

12%

absolute reduction or a

27%

relative reduction in nCPAP failure compared to control. These data suggest a meaningful treatment effect in line with our targeted outcome.

In addition, in

June 2017,

we and Lee

’s Pharmaceutical (HK), Ltd. (Lee’s) announced an exclusive license and collaboration agreement (License Agreement) for the development and commercialization of

surfactant products in China, Hong Kong and other select Asian markets,

with a future option to potentially add Japan

. The agreement includes AEROSURF as well as the non-aerosol products, SURFAXIN

(approved in the U.S. in

2012

) and SURFAXIN LS™ (an improved lyophilized formulation of SURFAXIN). We also granted Lee’s an exclusive license to manufacture

surfactant in China for use in non-aerosol surfactant products in the licensed territory and a future option to manufacture the device in the licensed territory. In connection with the Loan Agreement (

see,

“– Note

– Liquidity Risks and Management's Plans”), we amended the License Agreement to expand certain of Lee’s rights, including by

immediately adding Japan to the licensed territory,

accelerating the right to manufacture the ADS in and for the licensed territory, reducing or eliminating certain of the milestone and royalty payments and adding an affiliate of Lee’s as a party to the License Agreement. We are presently engaged in a technology transfer of our

surfactant manufacturing process to Lee’s.

Note 2 - Liquidity Risks and Management's Plans

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Liquidity Disclosures [Text Block]

Note

–

Liquidity Risks and Management

’s Plans

As of

June 30, 2017,

we had cash and cash equivalents of

$2.5

million, current liabilities of

$25.4

million (including

$12.5

million of long-term debt, current portion) and

$12.5

million of long-term debt, non-current portion.

Total long-term debt of

$25

million is with affiliates of Deerfield Management, L.P. (Deerfield), who hold a security interest in substantially all of our assets (Deerfield Loan).

We expect to continue to incur significant losses and require significant additional capital to

further advance our AEROSURF clinical development program, support our operations and meet our debt service obligations for the next several years, and we do

not

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

one

year after the date that these financial statements are issued.

potentially alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to seek additional capital through the following: (i) all or a combination of strategic transactions, and other potential alliances and collaborations focused on markets outside the U.S., as well as potential combinations (including by merger or acquisition) or other corporate transactions; and (ii) through public or private equity offerings. However, there can be

assurance that these alternatives will be available, or if available, that we will be able to raise sufficient capital through such transactions. If we are unable to raise the required capital, we will

not

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

one

year after the issuance of these financial statements.

In connection with the License Agreement with Lee

’s that we announced in

June 2017 (

see

, “– Note

– The Company and Description of Business”), we received an upfront license fee of

$1.0

million in

July 2017

and also are eligible to receive up to

$35.8

million in contingent clinical, regulatory and commercialization milestone payments, and royalties at an escalating high single digit to mid-teens percentage across all products. In addition, Lee’s will be responsible for all development costs in the licensed territory. In addition to the License Agreement, Lee’s also invested

million in our

February 2017

private placement offering.

Under a Loan Agreement dated as of

August 14, 2017,

Lee

’s agreed to lend us up to a potential

$3.9

million (Lee’s Loan) that will be funded in Lee’s sole discretion in

three

equal installments on

August 15,

September 10

and

October 10, 2017,

and will be used to support our AEROSURF development activities and sustain our operations through

October 31, 2017,

while we negotiate a potential share purchase agreement (Share Purchase) and related agreements. The Lee’s Loan will accrue interest at a rate of

12%

per annum. We received the initial installment of

$1.3

million from Lee's on

August 15, 2017.

Under the Share Purchase as currently contemplated, but subject to further negotiation, Lee’s would invest

$10

million and acquire a controlling interest in our Company. The outstanding principal balance of the Lee’s Loan would be applied to the Share Purchase and the Lee’s Loan would be discharged in full at the closing. In addition, to facilitate the Share Purchase, we are negotiating with Deerfield to restructure the Deerfield Loan (Loan Restructuring), effective as of the closing of the Share Purchase. Under the Loan Restructuring as currently contemplated, but subject to further negotiation, the notes issued in connection with the Deerfield Loan would be retired in exchange for (i)

$2.5

million of cash paid out of the proceeds of the Share Purchase, (ii) a number of newly-issued shares of our common stock equal to

of our outstanding common stock on a fully-diluted basis (to be defined) as of the closing date, and (iii) future regulatory and commercial milestones related to the development and commercialization of AEROSURF potentially totaling

$15

million. (S

, “– Note

– Subsequent Events”).

While we believe that we w

ill be able to reach agreement with Lee’s and Deerfield and close the Share Purchase and Loan Restructuring, there can be

assurance that we will be successful. At this time, we do

not

have an alternative source of funding available, such that, if we are unable to complete these transactions for any reason on or before

October 31, 2017,

may

be forced to curtail all of our activities and, ultimately, cease operations. In addition, if we are unable to finalize and close the Loan Restructuring and thereafter fail to make any required payment under the Deerfield Loan, or fail to comply with any commitments contained in the Deerfield Loan documents, Deerfield would be able to declare a default under the Deerfield Loan agreement, accelerate our payment obligations under all or a portion of our indebtedness, and, since we have pledged substantially all of our assets to secure the Deerfield Loan, foreclose on our assets, which could significantly diminish the market value and marketability of our assets and common stock and render us unable to continue as a going concern.

Moreover, e

ven if we are successful in completing these transactions, we will continue to require significant additional capital to support our research and development activities going forward, including the AEROSURF development program, and our operations.

As of

August 15, 2017,

after receipt of the initial advance under the Lee's Loan, we had cash and cash equivalents of

$2.9

million and believe that, assuming receipt of the

two

additional installments under the Lee's Loan, and before any additional financings, we will have sufficient cash resources to fund our operations through

November 2017.

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

not

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

Our ability to secure the needed capital through equity financings and other similar transactions is subject to regulatory and other constraints discussed in this Quarterly Report on Form

-Q and we cannot be certain that we will be able to raise a sufficient amount when needed, if at all, on favorable terms or otherwise. In the event that we cannot raise sufficient capital, we

may

be forced to consider

transactions on less-than-favorable terms, or limit or cease our development activities. If we are unable to raise the required capital, we

may

be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to raise sufficient capital, such financings

may

only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock

may

decline.

In addition, our ability to secure additional capital at a time when we would like or require

may

be affected by the following factors: (i)

our common stock is currently

trading on the OTCQB

Market (OTCQB), which is operated by OTC Markets Group Inc., under the symbol “WINT” and

may

experience periods of illiquidity; (ii)

our common stock is currently considered a “penny stock,” such that brokers are required to adhere to more stringent market rules, which could result in reduced trading activity and trading levels in our common stock and limited or

analyst coverage; (iii) we are

longer eligible to use a Form S-

registration statement; (iv) we are

longer able to use our ATM Program; (v) our stockholders

may

not

approve proposals to increase the number of shares of common stock authorized under our Amended and Restated Certificate of Incorporation, as amended, which could impair our ability to conduct equity financings or enter into certain strategic transactions; (vi) our stockholders

may

not

approve, to the extent required under Delaware law, strategic transactions (mergers and acquisitions) recommended by our Board; (vii) our capital structure, which currently consists of common stock, convertible preferred stock, pre-funded warrants and warrants to purchase common stock, and

$25

million of debt,

may

make it difficult to conduct equity-based financings; and (viii) negative conditions in the broader financial and geopolitical markets. In light of the foregoing restrictions, we will be required to seek other methods of completing primary offerings, including, for example, under a registration statement on Form S-

the preparation and maintenance of which would be more time-consuming and costly, and private placements, potentially with registration rights or priced at a discount to the market value of our stock, or other transactions, any of which could result in substantial equity dilution of stockholders’ interests.

We have from time to time collaborated with research organizations and universities to assess the potential utility of our KL

surfactant in studies funded in part through non-dilutive grants issued by U.S. Government-sponsored drug development programs, including grants in support of initiatives related to our AEROSURF clinical development program. In late

May 2017,

we announced that we have been awarded

$0.9

million under a previously announced Phase II Small Business Innovation Research Grant (SBIR) valued at up to

$2.6

million from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support the AEROSURF phase

clinical trial. We also have received from time to time grants that support medical and biodefense-related initiatives under programs that encourage private sector development of medical countermeasures against chemical, biological, radiological and nuclear terrorism threat agents, and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures. Although there can be

assurance, we expect to pursue potential additional funding opportunities as they arise and expect that we

may

qualify for similar programs in the future.

As of

June 30, 2017,

we had outstanding

2.9

million pre-funded warrants issued in a

July 2015

public offering, of which the entire exercise price was prepaid upon issuance, and

6,213

convertible preferred shares issued in the

February 2017

private placement offering

Each preferred share

is convertible into

1,000

shares of common stock. Upon exercise of the pre-funded warrants and conversion of the convertible preferred shares, we would issue common shares to the holders and receive

additional proceeds.

As of

August 15, 2017,

2.5

million pre-funded warrants and

3,203

convertible preferred shares, convertible into

3.2

million shares of common stock, remained outstanding

In addition, as of

June 30, 2017,

there were

120

million shares of common stock and

million shares of preferred stock authorized under our Amended and Restated Certificate of Incorporation, as amended, and approximately

85.7

million shares of common stock and approximately

million shares of preferred stock available for issuance and

not

otherwise reserved.

Note 3 - Basis of Presentation

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Basis of Accounting [Text Block]

Note

–

Basis of Presentation

These interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (

U.S. GAAP

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

-Q. Accordingly, they do

not

include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the

three

and

six

months ended

June 30, 2017

are

not

necessarily indicative of the results that

may

be expected for the year ending

December

31,

2017.

There have been

changes to our critical accounting policies since

December 31, 2016.

For a discussion of our accounting policies,

see

, “Note

– Accounting Policies and Recent Accounting Pronouncements” in the Notes to Consolidated Financial Statements in our

2016

Form

-K. Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form

-Q.

Note 4 - Stockholders' Equity

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note

–

Stockholders

’ Equity

February 2017

Private Placement

February 15, 2017,

we completed a private placement offering of

7,049

Series A Convertible Preferred Stock units

at a price per unit of

$1,495,

for an aggregate purchase price of approximately

$10.5

million, including

$1.6

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

December 31, 2016

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

first

and

second

quarters of

2017.

Each unit consists of: (i)

one

share of Series A Convertible Preferred Stock, par value

$0.001

per share (Preferred Shares); and (ii)

1,000

Series A-

Warrants (Warrants) to purchase

one

share of common stock at an exercise price equal to

$1.37

per share. Each Preferred Share

may

be converted at the holder's option at any time into

1,000

shares of common stock at a conversion price of

$1.37

per share. The Warrants

may

be exercised beginning

August 15, 2017

and through

February 15, 2024.

The Preferred Shares and the Warrants

may

not

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

9.99%

(or other lesser percent as designated by each holder) of our outstanding shares of common stock. In addition to the offering, the securities purchase agreement also provides that, until

February 13, 2018,

the investors are entitled to participate in subsequent bona fide capital raising transactions that we

may

conduct.

As of

August 15, 2017,

3,846

Preferred Shares have been converted into

3,846,000

shares of common stock and

3,203

Preferred Shares remain outstanding.

At-the-Market (ATM) Program

During the

three

and

six

months ended

June 30, 2017,

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

41,231

shares and

847,147

shares, respectively. This resulted in an aggregate purchase price of approximately

$48,000

(

$46,000

net) and

$1,082,000

(

$1,036,000

net), respectively, for the

three

and

six

month periods ended

June 30, 2017.

During the

three

months ended

June 30, 2016,

there were

offerings under our ATM Program. During the

six

months ended

June 30, 2016,

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

27,971

shares for an aggregate purchase price of approximately

$71,000

(

$69,000

net).

Effective

May 5, 2017,

were

longer able to make use of our ATM Program (

see

, “–Note

– Liquidity Risks and Management’s Plans”).

Note 5 - Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Significant Accounting Policies [Text Block]

Note

–

Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements, in conformity with U.S. 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.

Severance

Effective

February 1, 2016,

we terminated the Employment Agreement

between ourselves and our then-President and Chief Executive Officer (Former CEO). During the

first

quarter of

2016,

we incurred a severance charge of

$1.2

million in general and administrative expense under the terms of the Former CEO’s employment agreement, including

$0.2

million related to stock option expense for certain options that will continue to vest through

August 1, 2017.

Of the

$1.0

million in severance

not

related to stock-based compensation,

$0.9

million was paid as of

June 30, 2017.

During the

second

quarter of

2016,

we incurred a severance charge of

$0.4

million related to a

May 2016

workforce reduction that was a component of a broader effort to initiate cash conservation and other cost reduction measures.

Research and Development Expense

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 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.

Net Loss per Common Share

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

As of

June 30, 2017

and

2016,

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

23.4

million and

9.1

million shares, respectively. For the

three

and

six

months ended

June 30, 2017

and

2016,

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

In accordance with Accounting Standards Codification Topic

260,

Earnings per Share,

when calculating diluted net loss per common share, a gain associated with the decrease in the fair value of warrants classified as derivative liabilities results in an adjustment to the net loss; and the dilutive impact of the assumed exercise of these warrants results in an adjustment to the weighted average common shares outstanding. We utilize the treasury stock method to calculate the dilutive impact of the assumed exercise of warrants classified as derivative liabilities. For the

three

and

six

months ended

June 30, 2017

and

2016,

the effect of the adjustments for warrants classified as derivative liabilities was anti-dilutive.

We do

not

have any components of other comprehensive income (loss).

Beneficial Conversion Feature

The issuance of

our Preferred Shares in the

first

quarter of

2017

(

see

, “– Note

– Stockholders’ Equity”) resulted in a beneficial conversion feature, which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date. We recognized the beneficial conversion feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a

$3.6

million

one

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

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares.

This discount is amortized proportionately as the Preferred Shares are converted. For the

three

months ended

June 30, 2017,

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

$0.5

million related to the Preferred Shares converted during the period.

Rece

Adopted

Accounting

Standards

August 2014,

the Financial Accounting Standards Board (FASB

)

issued Accounting Standards Update (ASU

)

2014

15,

Presentation of Financial Statements

–

Going Concern

(Subtopic

205

Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern

, which defines management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. Substantial doubt about an entity's ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within

one

year after the date that the financial statements are issued (or are available to be issued). We adopted ASU

2014

effective

December 31, 2016.

Management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through

one

year after the issuance of these financial statements (s

, “ – Note

– Liquidity Risks and Management's Plans”).

March 2016,

the FASB issued ASU

2016

09,

Compensation - Stock Compensation (Topic

718

): Improvements to Employee Share-Based Payment Accounting

. This update addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. We adopted ASU

2016

during the

three

months ended

March 31, 2017

and will continue to recognize stock compensation expense with estimated forfeitures. The adoption did

not

have a material impact on our unaudited condensed consolidated financial statements and is

not

expected to have an impact on the annual

2017

financial statements.

November 2016,

the FASB issued ASU

2016

18,

Statement of Cash Flows (Topic

230

): Restricted Cash

. The new standard requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total to amounts on the balance sheet and disclose the nature of the restrictions. We adopted ASU

2016

March 31, 2017

on a retrospective basis. As a result, beginning-of-period cash, cash equivalents and restricted cash in the statement of cash flows increased by

$0.2

million for each of the

six

-month periods ended

June 30, 2017

and

2016.

Recent Accounting Pronouncements

May 2014,

the FASB issued ASU

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which requires an entity to recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the annual period ending

December 31, 2018

and interim periods within that annual period. An entity can elect to apply the guidance under

one

of the following

two

methods: (i) retrospectively to each prior reporting period presented,

referred to as the full retrospective method or (ii) retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial application in retained earnings,

referred to as the modified retrospective method. The Company has

not

yet completed its final review of the impact of this guidance including the new disclosure requirements, as it is continuing to evaluate the impacts of adoption and the implementation approach to be used. The Company plans to adopt the new standard effective

January 1, 2018.

The Company continues to monitor additional changes, modifications, clarifications or interpretations being undertaken by the FASB, which

may

impact its current conclusions.

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

): Scope of Modification Accounting

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

December 31, 2018

and interim periods within that annual period. Early adoption is permitted. We are currently evaluating the effect that ASU

2017

may

have on our consolidated financial statements and related disclosures.

Note 6 - Fair Value of Financial Instruments

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Fair Value Disclosures [Text Block]

Note

–

Fair Value of Financial Instruments

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

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

three

levels of inputs, of which the

first

two

are considered observable and the last unobservable, as follows:

	●	Level 1 – Quoted prices in active markets for identical assets and liabilities.
	●	Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
	●	Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented:

	Fair Value		Fair value measurement using
	June 30,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	2,528	$	2,528	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,753	$	2,753	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2016		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,588	$	5,588	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	5,813	$	5,813	$	-	$	-

The following table summarizes changes in the fair value of common stock warrant liability

measured on a recurring basis using Level

inputs for the

six

months ended

June 30, 2016

representing the write-off of the remaining liability upon expiration of the underlying warrants in

February 2016.

(in thousands)

Balance at January 1, 2016	$	223
Change in fair value of common stock warrant liability		(223	)
Balance at June 30, 2016	$	-

Fair Value of Long-Term Debt

June 30, 2017,

the estimated fair value of the Deerfield Loan (

see,

“– Note

– Long-term Debt”) was

$22.4

million, compared to a carrying value for current and non-current portions of

$25.0

million. The estimated fair value of the Deerfield Loan is based on discounting the future contractual cash flows to the present value at the valuation date. This analysis utilizes certain Level

unobservable inputs, including current cost of capital. Considerable judgment is required to interpret market data and to develop estimates of fair value. The estimates presented are

not

necessarily indicative of amounts that could be realized in a current market exchange. The use of alternative market assumptions and estimation methodologies could have a material effect on these estimates of fair value.

The methodology and assumptions do

not

take into consideration the potential restructuring of the Deerfield Loan (

see

, “– Note

– Subsequent Events”).

- Definition

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

+ References + Details

Note 7 - Long-term Debt

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Long-term Debt [Text Block]

Note

–

Long-term Debt

Long-term debt consists solely of amounts due under the Deerfield Loan for the periods presented:

	June 30,		December 31,
(in thousands)	2017		2016

Current portion	$	12,500	$	-
Non-current portion		12,500		25,000
Total Deerfield Loan	$	25,000	$	25,000

The principal amount of the loan is payable in

two

equal annual installments of

$12.5

million, payable in each of

February 2018

and

2019.

See

, “Note

– Long-term Debt” in the Notes to Consolidated Financial Statements in our

2016

Form

-K.

The following amounts comprise the Deerfield Loan interest expense for the periods presented:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2017		2016		2017		2016

Amortization of prepaid interest expense	$	273	$	544	$	543	$	1,088
Cash interest expense		257		-		511		-
Total interest expense	$	530	$	544	$	1,054	$	1,088

Amortization of prepaid interest expense represents non-cash amortization of

million of units

purchased by Deerfield in our

July 2015

public offering and accepted in satisfaction of

million of future interest payments calculated at an interest rate of

8.75%

under the Deerfield Loan. Cash interest expense represents interest at an annual rate of

8.25%

on the outstanding principal amount, paid in cash on a quarterly basis.

Note 8 - Stock Options and Stock-based Employee Compensation

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Disclosure of Compensation Related Costs, Share-based Payments [Text Block]

Note

–

Stock Options and Stock-Based Employee Compensation

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

three

years.

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, 2017		1,142		$	14.66
Granted		822			1.23
Forfeited or expired		(53	)		33.52
Outstanding at June 30, 2017		1,911		$	8.36		7.4

Vested and exercisable at June 30, 2017		488		$	26.89		5.4

Vested and expected to vest at June 30, 2017		1,257		$	8.45		8.3

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

	Six Months Ended June 30,
	2017	2016

Weighted average expected volatility	79%	79%
Weighted average expected term (years)	6.6	5.7
Weighted average risk-free interest rate	2.22	1.4
Expected dividends	-	-

The table below summarizes the total stock-based compensation expense included in the statements of operations for the periods presented:

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2017		2016		2017		2016

Research and development	$	124	$	140	$	283	$	322
General and administrative		130		110		271		531
Total	$	254	$	250	$	554	$	853

Note 9 - Subsequent Events

6 Months Ended

Jun. 30, 2017

Notes to Financial Statements

Subsequent Events [Text Block]

Note

–

Subsequent Events

July 13, 2017,

we implemented a reduction in workforce by

employees, representing approximately

42%

of our total workforce, from

employees. The reduction was across all functions of the Company. Affected employees are eligible for certain severance and other benefits. In addition, the Company expects to record a

one

-time charge of approximately

$0.2

million in the

third

quarter of

2017.

Effective as of

August 14, 2017,

we entered into a loan agreement with Lee

’s, pursuant to which Lee’s has agreed to lend us up to a potential

$3.9

million that will be funded in Lee’s sole discretion in

three

equal installments on

August 15,

September 10

and

October 10, 2017,

and will be used to support our AEROSURF development activities and sustain our operations through

October 31, 2017,

while we negotiate the potential Share Purchase and related agreements. The Lee's Loan will accrue interest at a rate of

12%

per annum. We received the initial installment of

$1.3

million from Lee's on

August 15, 2017.

Under the Share Purchase as currently contemplated, but subject to further negotiation, Lee’s would invest

$10

million in our Company and acquire a controlling interest of a majority of the outstanding shares of our common stock at a price per share based on the average

-day volume-weighted average price per share (VWAP) up to and including the closing date, plus a premium up to, but

not

exceeding

15%,

but in

event greater than

$0.25

per share. As partial consideration for the Share Purchase, the outstanding principal balance of the Lee's Loan would be applied in full satisfaction of a like amount of cash consideration payable by Lee’s at the closing of such Share Purchase, and the Lee's Loan would be discharged in full. In connection with the Lee's Loan, Deerfield, which holds a security interest in substantially all of our assets to secure its

$25

million Deerfield Loan, entered into a Subordination Agreement, dated as of

August 14, 2017,

with us and Lee’s generally granting Lee’s a

first

right through

October 31, 2017,

to any cash payments (other than regularly scheduled interest payments under the Deerfield Loan) and to the proceeds of sales of assets in a bankruptcy proceeding for up to

$3.9

million principal amount plus related interest and expenses, subject to the exceptions set forth in the Subordination Agreement.

As partial consideration for the Lee's Loan, we and Lee

’s also entered into Amendment

No.

to the License Agreement (Amendment) pursuant to which reductions have been made to certain of the milestone and royalty payments. As a result, we

may

receive up to

$35.8

million (previously,

$37.5

million) in potential clinical, regulatory and commercial milestone payments. The options to add Japan to the Licensed Territory (as defined in the License Agreement) and to manufacture our aerosol delivery device in and for the Licensed Territory have been made effective immediately. In addition, Zhaoke Pharmaceutical (Hefei) Co. Ltd., an affiliate of Lee’s, has been made a party to the License Agreement. Except as set forth in the Amendment, all other terms and conditions of the License Agreement shall remain in full force and effect.

In addition, to facilitate the Share Purchase, we are negotiating with Deerfield to restructure the Deerfield Loan

(Loan Restructuring), effective as of the closing of the Share Purchase. Under the Loan Restructuring as currently contemplated, but subject to further negotiation, the notes issued in connection with the Deerfield Loan would be retired in exchange for (i)

$2.5

million of cash, which would be paid out of the proceeds of the Share Purchase, and (ii) a number of newly-issued shares of our common stock that equals

of our outstanding common stock on a fully-diluted basis (to be defined) as of the closing of the Share Purchase and Loan Restructuring. In addition, Deerfield would be entitled to receive future regulatory and commercial milestones related to the development and commercialization of AEROSURF potentially totaling

$15

million.

The Share Purchase and Loan Restructuring agreements are expected to include such customary representations, warranties, covenants, conditions and indemnities for certain losses and other terms as are acceptable to the parties.

While we believe that we will be able to reach agreement with Lee’s and Deerfield and close the Share Purchase and Loan Restructuring agreements in a timely manner, there can be

assurance that we will be successful.

Significant Accounting Policies (Policies)	6 Months Ended
Significant Accounting Policies (Policies)	Jun. 30, 2017
Accounting Policies [Abstract]
Use of Estimates, Policy [Policy Text Block]	Use of Estimates The preparation of financial statements, in conformity with U.S. 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.
Severance Cost [Policy Text Block]	Severance Effective February 1, 2016, we terminated the Employment Agreement between ourselves and our then-President and Chief Executive Officer (Former CEO). During the first quarter of 2016, we incurred a severance charge of $1.2 million in general and administrative expense under the terms of the Former CEO’s employment agreement, including $0.2 million related to stock option expense for certain options that will continue to vest through August 1, 2017. Of the $1.0 million in severance not related to stock-based compensation, $0.9 million was paid as of June 30, 2017. During the second quarter of 2016, we incurred a severance charge of $0.4 million related to a May 2016 workforce reduction that was a component of a broader effort to initiate cash conservation and other cost reduction measures.
Research and Development Expense, Policy [Policy Text Block]	Research and Development Expense 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 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.
Earnings Per Share, Policy [Policy Text Block]	Net Loss per Common Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of June 30, 2017 and 2016, the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of stock options and warrants was 23.4 million and 9.1 million shares, respectively. For the three and six months ended June 30, 2017 and 2016, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share. In accordance with Accounting Standards Codification Topic 260, Earnings per Share, when calculating diluted net loss per common share, a gain associated with the decrease in the fair value of warrants classified as derivative liabilities results in an adjustment to the net loss; and the dilutive impact of the assumed exercise of these warrants results in an adjustment to the weighted average common shares outstanding. We utilize the treasury stock method to calculate the dilutive impact of the assumed exercise of warrants classified as derivative liabilities. For the three and six months ended June 30, 2017 and 2016, the effect of the adjustments for warrants classified as derivative liabilities was anti-dilutive. We do not have any components of other comprehensive income (loss).
Stockholders' Equity Note, Convertible Preferred Stock, Beneficial Conversion Feature, Policy [Policy Text Block]	Beneficial Conversion Feature The issuance of our Preferred Shares in the first quarter of 2017 ( see , “– Note 4 – Stockholders’ Equity”) resulted in a beneficial conversion feature, which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date. We recognized the beneficial conversion feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a $3.6 million one -time, non-cash deemed dividend to the preferred shareholders during the first quarter of 2017. An additional discount to the Preferred Shares of $4.5 million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted. For the three months ended June 30, 2017, we recognized a non-cash deemed dividend to the preferred shareholders of $0.5 million related to the Preferred Shares converted during the period.
New Accounting Pronouncements, Policy [Policy Text Block]	Rece nt ly Adopted Accounting Standards In August 2014, the Financial Accounting Standards Board (FASB ) issued Accounting Standards Update (ASU ) 2014 - 15, Presentation of Financial Statements – Going Concern (Subtopic 205 - 40 ): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern , which defines management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. Substantial doubt about an entity's ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued (or are available to be issued). We adopted ASU 2014 - 15 effective December 31, 2016. Management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through one year after the issuance of these financial statements (s ee , “ – Note 2 – Liquidity Risks and Management's Plans”). In March 2016, the FASB issued ASU 2016 - 09, Compensation - Stock Compensation (Topic 718 ): Improvements to Employee Share-Based Payment Accounting . This update addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. We adopted ASU 2016 - 09 during the three months ended March 31, 2017 and will continue to recognize stock compensation expense with estimated forfeitures. The adoption did not have a material impact on our unaudited condensed consolidated financial statements and is not expected to have an impact on the annual 2017 financial statements. In November 2016, the FASB issued ASU 2016 - 18, Statement of Cash Flows (Topic 230 ): Restricted Cash . The new standard requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total to amounts on the balance sheet and disclose the nature of the restrictions. We adopted ASU 2016 - 18 on March 31, 2017 on a retrospective basis. As a result, beginning-of-period cash, cash equivalents and restricted cash in the statement of cash flows increased by $0.2 million for each of the six -month periods ended June 30, 2017 and 2016. Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014 - 09, Revenue from Contracts with Customers (Topic 606 ) , which requires an entity to recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the annual period ending December 31, 2018 and interim periods within that annual period. An entity can elect to apply the guidance under one of the following two methods: (i) retrospectively to each prior reporting period presented, referred to as the full retrospective method or (ii) retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial application in retained earnings, referred to as the modified retrospective method. The Company has not yet completed its final review of the impact of this guidance including the new disclosure requirements, as it is continuing to evaluate the impacts of adoption and the implementation approach to be used. The Company plans to adopt the new standard effective January 1, 2018. The Company continues to monitor additional changes, modifications, clarifications or interpretations being undertaken by the FASB, which may impact its current conclusions. In May 2017, the FASB issued ASU 2017 - 09, Compensation—Stock Compensation (Topic 718 ): Scope of Modification Accounting . This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. Early adoption is permitted. We are currently evaluating the effect that ASU 2017 - 09 may have on our consolidated financial statements and related disclosures.

Note 6 - Fair Value of Financial Instruments (Tables)

6 Months Ended

Jun. 30, 2017

Notes Tables

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

	Fair Value		Fair value measurement using
	June 30,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	2,528	$	2,528	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,753	$	2,753	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2016		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	5,588	$	5,588	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	5,813	$	5,813	$	-	$	-

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

(in thousands)

Balance at January 1, 2016	$	223
Change in fair value of common stock warrant liability		(223	)
Balance at June 30, 2016	$	-

Note 7 - Long-term Debt (Tables)

6 Months Ended

Jun. 30, 2017

Notes Tables

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

	June 30,		December 31,
(in thousands)	2017		2016

Current portion	$	12,500	$	-
Non-current portion		12,500		25,000
Total Deerfield Loan	$	25,000	$	25,000

Schedule of Debt Instrument Interest Expense [Table Text Block]

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2017		2016		2017		2016

Amortization of prepaid interest expense	$	273	$	544	$	543	$	1,088
Cash interest expense		257		-		511		-
Total interest expense	$	530	$	544	$	1,054	$	1,088

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.22)
-URI http://asc.fasb.org/extlink&oid=6877327&loc=d3e13212-122682

Reference 2: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=84159872&loc=d3e21475-112644

Reference 3: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 470
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=75038535&loc=d3e64711-112823

Reference 4: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08.(e),(f))
-URI http://asc.fasb.org/extlink&oid=26873400&loc=d3e23780-122690

Reference 5: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 55
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=64930739&loc=d3e28878-108400

Reference 6: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=84159872&loc=d3e21538-112644

Reference 7: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 6
-URI http://asc.fasb.org/extlink&oid=84159872&loc=d3e21506-112644

Reference 8: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 1A
-URI http://asc.fasb.org/extlink&oid=64930785&loc=d3e28541-108399

Reference 9: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 2
-URI http://asc.fasb.org/extlink&oid=64930785&loc=d3e28551-108399

Reference 10: http://www.xbrl.org/2003/role/presentationRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 7
-URI http://asc.fasb.org/extlink&oid=84159872&loc=d3e21521-112644

+ Details

Note 8 - Stock Options and Stock-based Employee Compensation (Tables)

6 Months Ended

Jun. 30, 2017

Notes Tables

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

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

Outstanding at January 1, 2017		1,142		$	14.66
Granted		822			1.23
Forfeited or expired		(53	)		33.52
Outstanding at June 30, 2017		1,911		$	8.36		7.4

Vested and exercisable at June 30, 2017		488		$	26.89		5.4

Vested and expected to vest at June 30, 2017		1,257		$	8.45		8.3

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

	Six Months Ended June 30,
	2017	2016

Weighted average expected volatility	79%	79%
Weighted average expected term (years)	6.6	5.7
Weighted average risk-free interest rate	2.22	1.4
Expected dividends	-	-

Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block]

	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2017		2016		2017		2016

Research and development	$	124	$	140	$	283	$	322
General and administrative		130		110		271		531
Total	$	254	$	250	$	554	$	853

Note 2 - Liquidity Risks and Management's Plans (Details Textual) $ in Thousands				1 Months Ended		2 Months Ended	3 Months Ended		5 Months Ended	6 Months Ended
	Aug. 15, 2017 USD ($) shares	Aug. 14, 2017 USD ($)	Feb. 15, 2017 USD ($)	Jul. 31, 2017 USD ($)	May 31, 2017 USD ($)	Oct. 10, 2017 USD ($)	Jun. 30, 2017 USD ($) shares	Jun. 30, 2016 USD ($)	Dec. 31, 2017 USD ($)	Jun. 30, 2017 USD ($) shares	Jun. 30, 2016 USD ($)	Dec. 31, 2016 USD ($) shares
Cash and Cash Equivalents, at Carrying Value							$ 2,528			$ 2,528		$ 5,588
Accounts Payable and Accrued Liabilities, Current							25,400			25,400
Long-term Debt, Current Maturities							12,500			12,500
Long-term Debt, Excluding Current Maturities							12,500			12,500		$ 25,000
Revenue from Grants							$ 1,147	$ 106		$ 1,366	$ 181
Preferred Stock, Shares Outstanding \| shares							6,213			6,213		0
Common Stock, Shares Authorized \| shares							120,000,000			120,000,000		60,000,000
Preferred Stock, Shares Authorized \| shares							5,000,000			5,000,000		5,000,000
Common Stock Capital Shares Available for Issuance \| shares							85,700,000			85,700,000
Preferred Stock Capital Shares Available for Issuance \| shares							5,000,000			5,000,000
Prefunded Warrants [Member] \| July 2015 Public Offering [Member]
Class of Warrant or Right, Outstanding \| shares							2,900,000			2,900,000
Series A Units [Member] \| Private Placement [Member]
Convertible Preferred Stock Units, Shares Outstanding \| shares							6,213			6,213
Series A Warrant [Member] \| Private Placement [Member]
Preferred Stock Units, Number of Warrants										1,000
Phase II Small Business Innovation Research Grant from the NHLBI [Member]
Revenue from Grants					$ 900
Grant Award					$ 2,600
Scenario, Forecast [Member] \| Maximum [Member] \| Lee's [Member] \| Lee's Loan to Support Operations [Member]
Proceeds from Short-term Debt						$ 3,900
Lee's [Member]
Proceeds from Issuance of Private Placement			$ 2,000
Share Purchase, Consideration Transferred to The Company to Acquire Controlling interest	$ 10,000
Subsequent Event [Member]
Cash and Cash Equivalents, at Carrying Value	$ 2,900
Preferred Stock, Shares Outstanding \| shares	3,203
Convertible Preferred Stock, Number of Shares of Common Stock Upon Conversion \| shares	3,200,000
Subsequent Event [Member] \| Series A Warrant [Member]
Class of Warrant or Right, Outstanding \| shares	2,500,000
Subsequent Event [Member] \| Lee's [Member]
Debt Instrument, Interest Rate, Stated Percentage		12.00%
Subsequent Event [Member] \| Lee's [Member] \| Lee's Loan to Support Operations [Member]
Debt Instrument, Interest Rate, Stated Percentage		12.00%
Proceeds from Short-term Debt	$ 1,300
License Agreement With Lee’s [Member]
License Agreement, Contingent Receivable, Maximum							$ 37,500
License Agreement With Lee’s [Member] \| Subsequent Event [Member]
Proceeds from License Fees Received				$ 1,000
License Agreement, Contingent Receivable, Maximum		$ 35,800
Deerfield Loan [Member]
Debt Instrument, Interest Rate, Stated Percentage							8.75%			8.75%
Long-term Debt, Current Maturities							$ 12,500			$ 12,500
Long-term Debt, Excluding Current Maturities							12,500			12,500		25,000
Long-term Debt							$ 25,000			$ 25,000		$ 25,000
Deerfield Loan [Member] \| Scenario, Forecast [Member]
Percentage of Common Stock Issue For Debt Extinguishment									2.00%
Future Regulatory and Commercial Milestones Related to Development and Commercialization of AEROSURF, Potentially Value									$ 15,000
Repayments of Long-term Debt									$ 2,500

Note 4 - Stockholders' Equity (Details Textual) - USD ($)			3 Months Ended	6 Months Ended
	Aug. 15, 2017	Feb. 15, 2017	Jun. 30, 2017	Jun. 30, 2017	Jun. 30, 2016	Dec. 31, 2016
Preferred Stock, Par or Stated Value Per Share		$ 0.001	$ 0.001	$ 0.001		$ 0.001
Preferred Stock, Shares Outstanding			6,213	6,213		0
Stock Issued During Period, Shares, New Issues					27,971
Stock Issued During Period, Value, New Issues					$ 71,000
Proceeds from Issuance of Common Stock				$ 1,036,000	$ 69,000
Subsequent Event [Member]
Preferred Stock, Shares Outstanding	3,203
Conversion of Series A Convertible Preferred Stock into Common Stock [Member] \| Subsequent Event [Member]
Conversion of Stock, Shares Converted	3,846
Conversion of Stock, Shares Issued	3,846,000
Private Placement [Member]
Convertible Preferred Stock Units, Price Per Unit		$ 1,495
Private Placement [Member] \| Series A Units [Member]
Gross Proceeds From Issuance Of Units		$ 10,500,000
Non-cash Consideration Received		$ 1,600,000
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right		1
Stock Issued During Period, Shares, New Issues		7,049
Private Placement [Member] \| Series A Warrant [Member]
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right		1,000
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 1.37
Class of Warrants, May Not Exercise To Extent, Percentage		9.99%
Stifel ATM Program [Member]
Stock Issued During Period, Shares, New Issues			41,231	847,147
Stock Issued During Period, Value, New Issues			$ 48,000	$ 1,082,000
Proceeds from Issuance of Common Stock			$ 46,000	$ 1,036,000

Note 5 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands, shares in Millions		3 Months Ended			6 Months Ended
	Feb. 01, 2016	Jun. 30, 2017	Mar. 31, 2017	Jun. 30, 2016	Jun. 30, 2017	Jun. 30, 2016
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants					23.4	9.1
Preferred Stock, Discount on Shares		$ 4,500			$ 4,500
Preferred Stock Dividends, Income Statement Impact		$ 532	$ 3,600		4,136
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect					(3,060)	$ (18,392)
Accounting Standards Update 2016-18 [Member]
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect			200
Reclassification of Cash and Cash Equivalents to Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents [Member] \| Quarter Ended March 31, 2016 [Member]
Prior Period Reclassification Adjustment			$ 200
The 2016 Restructuring Plan [Member]
Severance Costs				$ 400
Former CEO's Employment Agreement [Member]
Payments for Restructuring					$ 900
Former CEO's Employment Agreement [Member] \| Stock Option Expense [Member]
Severance Costs	$ 200
Former CEO's Employment Agreement [Member] \| Not Related to Stock-based Compensation [Member]
Severance Costs	1,000
Selling, General and Administrative Expenses [Member] \| Former CEO's Employment Agreement [Member]
Severance Costs	$ 1,200

Note 6 - Fair Value of Financial Instruments (Details Textual) - Deerfield Loan [Member] $ in Millions	Jun. 30, 2017 USD ($)
Estimate of Fair Value Measurement [Member]
Long-term Debt, Fair Value	$ 22.4
Reported Value Measurement [Member]
Long-term Debt, Fair Value	$ 25.0

Note 6 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands	Jun. 30, 2017	Dec. 31, 2016
Total Assets	$ 2,753	$ 5,813
Assets:
Cash and cash equivalents	2,528	5,588
Certificates of Deposit [Member]
Certificate of deposit	225	225
Fair Value, Inputs, Level 1 [Member]
Total Assets	2,753	5,813
Assets:
Cash and cash equivalents	2,528	5,588
Fair Value, Inputs, Level 1 [Member] \| Certificates of Deposit [Member]
Certificate of deposit	225	225
Fair Value, Inputs, Level 2 [Member]
Total Assets
Assets:
Cash and cash equivalents
Fair Value, Inputs, Level 2 [Member] \| Certificates of Deposit [Member]
Certificate of deposit
Fair Value, Inputs, Level 3 [Member]
Total Assets
Assets:
Cash and cash equivalents
Fair Value, Inputs, Level 3 [Member] \| Certificates of Deposit [Member]
Certificate of deposit

Note 6 - Fair Value of Financial Instruments - Level 3 Rollforward (Details) - Fair Value, Inputs, Level 3 [Member] - Derivative Financial Instruments, Liabilities [Member] $ in Thousands	6 Months Ended
	Jun. 30, 2016 USD ($)
Balance	$ 223
Change in fair value of common stock warrant liability	(223)
Balance

Note 7 - Long-term Debt (Details Textual) - Deerfield Loan [Member] $ in Millions	6 Months Ended
	Jun. 30, 2017 USD ($)
Debt Instrument Repayment of Principal Portion Number of Installments	2
Long-term Debt, Maturities, Repayments of Principal in Year Two	$ 12.5
Debt Instrument, Periodic Payment, Principal	5.0
Debt Instrument, Periodic Payment, Interest	$ 5.0
Debt Instrument, Interest Rate, Stated Percentage	8.75%
Debt Instrument, Interest Rate During Period	8.25%
Long-term Debt, Maturities, Repayments of Principal in Year Three	$ 12.5

Note 7 - Long-term Debt - Long-term Debt (Details) - USD ($) $ in Thousands	Jun. 30, 2017	Dec. 31, 2016
Long-term debt, current portion	$ 12,500
Long-term debt, non-current portion	12,500	25,000
Deerfield Loan [Member]
Long-term debt, current portion	12,500
Long-term debt, non-current portion	12,500	25,000
Total Deerfield Loan	$ 25,000	$ 25,000

Note 7 - Long-term Debt - Long-term Debt Interest Expense (Details) - Deerfield Loan [Member] - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2017	Jun. 30, 2016	Jun. 30, 2017	Jun. 30, 2016
Amortization of prepaid interest expense	$ 273	$ 544	$ 543	$ 1,088
Cash interest expense	257		511
Total interest expense	$ 530	$ 544	$ 1,054	$ 1,088

Note 8 - Stock Options and Stock-based Employee Compensation (Details Textual)	6 Months Ended
	Jun. 30, 2017
2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period	3 years

Note 8 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	6 Months Ended
	Jun. 30, 2017 $ / shares shares
Shares Outstanding, Beginning Balance (in shares) \| shares	1,142
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) \| $ / shares	$ 14.66
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) \| $ / shares	$ 8.36
Weighted Average Remaining Contractual Life, Outstanding (Year)	7 years 146 days
Shares Vested and Exercisable (in shares) \| shares	488
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) \| $ / shares	$ 26.89
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	5 years 146 days
Vested and expected to vest (in shares) \| shares	1,257
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) \| $ / shares	$ 8.45
Shares Granted (in shares) \| shares	822
Weighted Average Exercise Price, Granted (in dollars per share) \| $ / shares	$ 1.23
Shares Forfeited or Expired (in shares) \| shares	(53)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) \| $ / shares	$ 33.52
Shares Outstanding, Ending Balance (in shares) \| shares	1,911
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	8 years 109 days

Note 8 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	6 Months Ended
	Jun. 30, 2017	Jun. 30, 2016
Weighted average expected volatility	79.00%	79.00%
Weighted average expected term (years) (Year)	6 years 219 days	5 years 255 days
Weighted average risk-free interest rate	2.22%	1.40%
Expected dividends

Note 8 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2017	Jun. 30, 2016	Jun. 30, 2017	Jun. 30, 2016
Stock-based compensation expense	$ 254	$ 250	$ 554	$ 853
Research and Development Expense [Member]
Stock-based compensation expense	124	140	283	322
Selling, General and Administrative Expenses [Member]
Stock-based compensation expense	$ 130	$ 110	$ 271	$ 531

Note 9 - Subsequent Events (Details Textual) $ / shares in Units, $ in Millions				2 Months Ended	3 Months Ended		5 Months Ended
	Aug. 15, 2017 USD ($) $ / shares	Aug. 14, 2017 USD ($)	Jul. 13, 2017	Oct. 10, 2017 USD ($)	Sep. 30, 2017 USD ($)	Jun. 30, 2017 USD ($)	Dec. 31, 2017 USD ($)	Dec. 31, 2016 USD ($)
Entity Number of Employees						48
License Agreement With Lee’s [Member]
License Agreement, Contingent Receivable, Maximum						$ 37.5
Deerfield Loan [Member]
Debt Instrument, Interest Rate, Stated Percentage						8.75%
Long-term Debt						$ 25.0		$ 25.0
Lee's [Member]
Share Purchase, Consideration Transferred to The Company to Acquire Controlling interest	$ 10.0
Value Input, Premium, Percentage, Maximum	15.00%
Share Purchase, Premium, Price Per Share, Maximum \| $ / shares	$ 0.25
Scenario, Forecast [Member]
Severance Costs					$ 0.2
Scenario, Forecast [Member] \| Deerfield Loan [Member]
Repayments of Long-term Debt							$ 2.5
Percentage of Common Stock Issue For Debt Extinguishment							2.00%
Future Regulatory and Commercial Milestones Related to Development and Commercialization of AEROSURF, Potentially Value							$ 15.0
Scenario, Forecast [Member] \| Maximum [Member] \| Lee's [Member]
Proceeds from Issuance of Long-term Debt				$ 3.9
Subsequent Event [Member]
Restructuring and Related Cost, Number of Positions Eliminated			20
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent			42.00%
Entity Number of Employees			28
Subsequent Event [Member] \| License Agreement With Lee’s [Member]
License Agreement, Contingent Receivable, Maximum		$ 35.8
Subsequent Event [Member] \| Lee's [Member]
Debt Instrument, Interest Rate, Stated Percentage		12.00%
Proceeds from Issuance of Long-term Debt	$ 1.3