Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 15, 2017 | |
Document Information [Line Items] | ||
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ | |
Entity Central Index Key | 946,486 | |
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 | 2,017 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
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 Balance3
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 Statemen
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 Stateme5
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 Descri
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 1 – 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 4 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 ( 4 surfactant) that is structurally similar to endogenous pulmonary surfactant, and novel drug delivery technologies being developed to enable noninvasive administration of aerosolized 4 surfactant. We believe that our proprietary technology platform may no Our lead development program is AEROSURF ® (lucinactant for inhalation), an investigational combination drug/device product that combines our 4 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 4 surfactant, AEROSURF may 4 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 2b 4 surfactant administered to premature infants 28 32 two 25 50 two 50 not 72 Such interruptions occurred in about 24% 50 50 32% 44% 12% 27% In addition, in June 2017, ’s Pharmaceutical (HK), Ltd. (Lee’s) announced an exclusive license and collaboration agreement (License Agreement) for the development and commercialization of 4 surfactant products in China, Hong Kong and other select Asian markets, . The agreement includes AEROSURF as well as the non-aerosol products, SURFAXIN ® (approved in the U.S. in 2012 4 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, 2 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 4 surfactant manufacturing process to Lee’s. |
Note 2 - Liquidity Risks and Ma
Note 2 - Liquidity Risks and Management's Plans | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 2 – Liquidity Risks and Management ’s Plans As of June 30, 2017, $2.5 $25.4 $12.5 $12.5 $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 one To 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 no not one In connection with the License Agreement with Lee ’s that we announced in June 2017 ( see 1 $1.0 July 2017 $35.8 $2 February 2017 Under a Loan Agreement dated as of August 14, 2017, ’s agreed to lend us up to a potential $3.9 three August 15, September 10 October 10, 2017, October 31, 2017, 12% $1.3 August 15, 2017. $10 $2.5 2% $15 ee 9 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 no not October 31, 2017, may 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, $2.9 two 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 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 10 may transactions on less-than-favorable terms, or limit or cease our development activities. If we are unable to raise the required capital, we may may may In addition, our ability to secure additional capital at a time when we would like or require may 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 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 no no 3 no may not may not $25 may 1, We have from time to time collaborated with research organizations and universities to assess the potential utility of our KL 4 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, $0.9 $2.6 2b no may As of June 30, 2017, 2.9 July 2015 6,213 February 2017 Each preferred share is convertible into 1,000 no As of August 15, 2017, 2.5 3,203 3.2 In addition, as of June 30, 2017, 120 million shares of common stock and 5 85.7 5 not |
Note 3 - Basis of Presentation
Note 3 - Basis of Presentation | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 3 – 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 10 not three six June 30, 2017 not may December 31, 2017. no December 31, 2016. see 4 2016 10 10 |
Note 4 - Stockholders' Equity
Note 4 - Stockholders' Equity | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 4 – Stockholders ’ Equity February 2017 On February 15, 2017, 7,049 at a price per unit of $1,495, $10.5 $1.6 December 31, 2016 first second 2017. one $0.001 1,000 1 one $1.37 may 1,000 $1.37 may August 15, 2017 February 15, 2024. may not 9.99% February 13, 2018, may As of August 15, 2017, 3,846 3,846,000 3,203 At-the-Market (ATM) Program During the three and six June 30, 2017, 41,231 847,147 $48,000 $46,000 $1,082,000 $1,036,000 three six June 30, 2017. three June 30, 2016, no six June 30, 2016, 27,971 $71,000 $69,000 Effective May 5, 2017, were no see 2 |
Note 5 - Summary of Significant
Note 5 - Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 5 – 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, between ourselves and our then-President and Chief Executive Officer (Former CEO). During the first 2016, $1.2 $0.2 August 1, 2017. $1.0 not $0.9 June 30, 2017. During the second 2016, $0.4 May 2016 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 2016, 23.4 9.1 three six June 30, 2017 2016, In accordance with Accounting Standards Codification Topic 260, Earnings per Share, three six June 30, 2017 2016, We do not Beneficial Conversion Feature The issuance of our Preferred Shares in the first 2017 see 4 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 This discount is amortized proportionately as the Preferred Shares are converted. For the three June 30, 2017, $0.5 Rece nt ly Adopted Accounting Standards In August 2014, ) ) 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 one 2014 15 December 31, 2016. one ee 2 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718 2016 09 three March 31, 2017 not not 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230 2016 18 March 31, 2017 $0.2 six June 30, 2017 2016. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 December 31, 2018 one two 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 January 1, 2018. may In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 may |
Note 6 - Fair Value of Financia
Note 6 - Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 6 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 first two ● Level 1 – Quoted prices in active markets for identical assets and liabilities. ● Level 2 – Inputs other than Level 1 not ● Level 3 – Unobservable inputs that are supported by little or no 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 3 six June 30, 2016 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 At June 30, 2017, see, 7 $22.4 $25.0 3 not not see 9 |
Note 7 - Long-term Debt
Note 7 - Long-term Debt | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 7 – 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 $12.5 February 2018 2019. See 9 2016 10 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 $5 purchased by Deerfield in our July 2015 $5 8.75% 8.25% |
Note 8 - Stock Options and Stoc
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 8 – 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 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 Weighted- Average 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
Note 9 - Subsequent Events | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 9 – Subsequent Events On July 13, 2017, we implemented a reduction in workforce by 20 42% 48 28 one $0.2 third 2017. Effective as of August 14, 2017, ’s, pursuant to which Lee’s has agreed to lend us up to a potential $3.9 three August 15, September 10 October 10, 2017, October 31, 2017, 12% $1.3 August 15, 2017. $10 10 not 15%, no $0.25 $25 August 14, 2017, first October 31, 2017, $3.9 As partial consideration for the Lee's Loan, we and Lee ’s also entered into Amendment No. 1 may $35.8 $37.5 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 2% $15 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 no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
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, between ourselves and our then-President and Chief Executive Officer (Former CEO). During the first 2016, $1.2 $0.2 August 1, 2017. $1.0 not $0.9 June 30, 2017. During the second 2016, $0.4 May 2016 |
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 2016, 23.4 9.1 three six June 30, 2017 2016, In accordance with Accounting Standards Codification Topic 260, Earnings per Share, three six June 30, 2017 2016, We do not |
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 2017 see 4 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 This discount is amortized proportionately as the Preferred Shares are converted. For the three June 30, 2017, $0.5 |
New Accounting Pronouncements, Policy [Policy Text Block] | Rece nt ly Adopted Accounting Standards In August 2014, ) ) 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 one 2014 15 December 31, 2016. one ee 2 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718 2016 09 three March 31, 2017 not not 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230 2016 18 March 31, 2017 $0.2 six June 30, 2017 2016. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 December 31, 2018 one two 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 January 1, 2018. may In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 may |
Note 6 - Fair Value of Financ16
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
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 |
Note 8 - Stock Options and St18
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 Weighted- Average 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 19
Note 2 - Liquidity Risks and Management's Plans (Details Textual) $ in Thousands | Aug. 15, 2017USD ($)shares | Aug. 14, 2017USD ($) | Feb. 15, 2017USD ($) | Jul. 31, 2017USD ($) | May 31, 2017USD ($) | Oct. 10, 2017USD ($) | Jun. 30, 2017USD ($)shares | Jun. 30, 2016USD ($) | Dec. 31, 2017USD ($) | Jun. 30, 2017USD ($)shares | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($)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 (
Note 4 - Stockholders' Equity (Details Textual) - USD ($) | 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 Significa21
Note 5 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands, shares in Millions | 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 Financ22
Note 6 - Fair Value of Financial Instruments (Details Textual) - Deerfield Loan [Member] $ in Millions | Jun. 30, 2017USD ($) |
Estimate of Fair Value Measurement [Member] | |
Long-term Debt, Fair Value | $ 22.4 |
Reported Value Measurement [Member] | |
Long-term Debt, Fair Value | $ 25 |
Note 6 - Fair Value of Financ23
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 Financ24
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, 2016USD ($) | |
Balance | $ 223 |
Change in fair value of common stock warrant liability | (223) |
Balance |
Note 7 - Long-term Debt (Detail
Note 7 - Long-term Debt (Details Textual) - Deerfield Loan [Member] $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($) | |
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 |
Debt Instrument, Periodic Payment, Interest | $ 5 |
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-
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 - Lon27
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 St28
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 St29
Note 8 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
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 St30
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 St31
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 (Det
Note 9 - Subsequent Events (Details Textual) $ / shares in Units, $ in Millions | Aug. 15, 2017USD ($)$ / shares | Aug. 14, 2017USD ($) | Jul. 13, 2017 | Oct. 10, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
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 | $ 25 | ||||||
Lee's [Member] | ||||||||
Share Purchase, Consideration Transferred to The Company to Acquire Controlling interest | $ 10 | |||||||
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 | |||||||
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 |