Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Apr. 06, 2018 | Jun. 30, 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) | 3,769,088 | ||
Entity Public Float | $ 3.4 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 1,815 | $ 5,588 |
Prepaid interest, current portion | 1,094 | |
Prepaid expenses and other current assets | 422 | 512 |
Total current assets | 2,237 | 7,194 |
Property and equipment, net | 885 | 1,054 |
Restricted cash | 225 | 225 |
Prepaid interest, non-current portion | 1,226 | |
Total assets | 3,347 | 9,699 |
Current Liabilities: | ||
Accounts payable | 3,048 | 1,813 |
Collaboration payable | 3,624 | 3,967 |
Accrued expenses | 4,204 | 7,611 |
Deferred revenue - current portion | 884 | |
Total current liabilities | 11,760 | 13,391 |
Long-term debt | 25,000 | |
Restructured debt liability - contingent milestone payments | 15,000 | |
Deferred revenue - non-current portion | 407 | |
Other liabilities | 100 | 138 |
Total liabilities | 27,267 | 38,529 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 2,701 and 0 shares issued and outstanding at December 31, 2017 and 2016, respectively | ||
Common stock, $0.001 par value; 120,000,000 and 60,000,000 shares authorized at December 31, 2017 and 2016, respectively; 3,227,495 and 436,253 shares issued at December 31, 2017 and 2016, respectively; 3,227,421 and 436,179 shares outstanding at December 31, 2017 and 2016, respectively | 3 | 4 |
Additional paid-in capital | 616,245 | 592,888 |
Accumulated deficit | (637,114) | (618,668) |
Treasury stock (at cost); 74 shares | (3,054) | (3,054) |
Total stockholders' equity | (23,920) | (28,830) |
Total liabilities & stockholders' equity | $ 3,347 | $ 9,699 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 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) | 2,701 | 0 |
Preferred stock, shares outstanding (in shares) | 2,701 | 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) | 3,227,495 | 436,253 |
Common stock, shares outstanding (in shares) | 3,227,421 | 436,179 |
Treasury stock, shares (in shares) | 74 | 74 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | ||
Grant revenue | $ 1,383 | $ 2,042 |
License revenue | 102 | |
Total revenues | 1,485 | 2,042 |
Expenses: | ||
Research and development | 17,376 | 31,705 |
General and administrative | 6,657 | 8,373 |
Total operating expense | 24,033 | 40,078 |
Operating loss | (22,548) | (38,036) |
Change in fair value of common stock warrant liability | 223 | |
Other income / (expense): | ||
Gain on debt restructuring | 5,824 | |
Interest income | 12 | 18 |
Interest expense | (1,863) | (2,518) |
Other income | 129 | 823 |
Other income / (expense), net | 4,102 | (1,677) |
Net loss | (18,446) | (39,490) |
Deemed dividend on Series A preferred stock | (6,370) | |
Net loss attributable to common shareholders | $ (24,816) | $ (39,490) |
Net loss per common share | ||
Basic and diluted (in dollars per share) | $ (24.14) | $ (94.84) |
Weighted average number of common shares outstanding | ||
Basic and diluted (in shares) | 1,028 | 416 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Private Placement [Member]Preferred Stock [Member] | Private Placement [Member]Common Stock [Member] | Private Placement [Member]Additional Paid-in Capital [Member] | Private Placement [Member]Retained Earnings [Member] | Private Placement [Member]Treasury Stock [Member] | Private Placement [Member] | Share Purchase Agreement [Member]Preferred Stock [Member] | Share Purchase Agreement [Member]Common Stock [Member] | Share Purchase Agreement [Member]Additional Paid-in Capital [Member] | Share Purchase Agreement [Member]Retained Earnings [Member] | Share Purchase Agreement [Member]Treasury Stock [Member] | Share Purchase Agreement [Member] | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Treasury Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2015 | 410,000 | |||||||||||||||||
Balance at Dec. 31, 2015 | $ 590,498 | $ (579,178) | $ (3,054) | $ 8,266 | ||||||||||||||
Net loss | (39,490) | (39,490) | ||||||||||||||||
Issuance of common stock, ATM Program (in shares) | 18,000 | |||||||||||||||||
Issuance of common stock, ATM Program | 709 | 709 | ||||||||||||||||
Issuance of common stock, 401(k) Plan employer match (in shares) | 8,000 | |||||||||||||||||
Issuance of common stock, 401(k) Plan employer match | 274 | 274 | ||||||||||||||||
Stock-based compensation expense | 1,411 | $ 1,411 | ||||||||||||||||
Balance (in shares) at Dec. 31, 2016 | 436,000 | 436,179 | ||||||||||||||||
Balance at Dec. 31, 2016 | 592,892 | (618,668) | $ (3,054) | $ (28,830) | ||||||||||||||
Net loss | (18,446) | (18,446) | ||||||||||||||||
Issuance of common stock, ATM Program (in shares) | 7,000 | 2,312,000 | 42,000 | |||||||||||||||
Issuance of common stock, ATM Program | $ 10,433 | $ 10,433 | $ 2 | $ 9,969 | $ 9,971 | 1,030 | 1,030 | |||||||||||
Issuance of common stock, 401(k) Plan employer match (in shares) | 7,000 | |||||||||||||||||
Issuance of common stock, 401(k) Plan employer match | 95 | 95 | ||||||||||||||||
Stock-based compensation expense | $ 1 | 1,561 | 1,562 | |||||||||||||||
Conversions of preferred stock (in shares) | (4,000) | 217,000 | ||||||||||||||||
Conversions of preferred stock | (2) | (2) | ||||||||||||||||
Issuance of common stock, equity consideration in debt restructuring (in shares) | 71,000 | |||||||||||||||||
Issuance of common stock, equity consideration in debt restructuring | 267 | 267 | ||||||||||||||||
Exercise of prefunded common stock warrants (in shares) | 143,000 | |||||||||||||||||
Exercise of prefunded common stock warrants | ||||||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 3,000 | 3,227,000 | 3,227,421 | |||||||||||||||
Balance at Dec. 31, 2017 | $ 3 | $ 616,245 | $ (637,114) | $ (3,054) | $ (23,920) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (18,446) | $ (39,490) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 192 | 255 |
Stock-based compensation and 401(k) plan employer match | 1,655 | 1,685 |
Fair value adjustment of common stock warrants | (223) | |
Amortization of prepaid interest | 912 | 1,709 |
Gain on debt restructuring | (5,824) | |
Loss on sale or disposal of equipment | (16) | |
Changes in: | ||
Prepaid expenses and other current assets | 90 | (150) |
Accounts payable | 2,433 | 1,444 |
Collaboration payable | (343) | 686 |
Accrued expenses | (2,995) | 387 |
Deferred revenue - current | 884 | |
Deferred revenue - non-current | 407 | |
Other liabilities | (10) | 124 |
Net cash used in operating activities | (21,045) | (33,589) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (24) | (281) |
Proceeds from sale of property and equipment | 27 | |
Net cash used in investing activities | (24) | (254) |
Cash flows from financing activities: | ||
Proceeds from private placement issuance of securities, net of expenses | 14,860 | |
Proceeds from ATM Program, net of expenses | 1,036 | 709 |
Proceeds from loan payable, net of expenses | 3,900 | |
Principal payments on debt restructuring | (2,500) | |
Net cash provided by financing activities | 17,296 | 709 |
Net increase/(decrease) in cash and cash equivalents | (3,773) | (33,134) |
Cash, cash equivalents and restricted cash - beginning of year | 5,813 | 38,947 |
Cash, cash equivalents and restricted cash - end of year | 2,040 | 5,813 |
Supplementary disclosure of cash flows information: | ||
Interest paid | $ 1,088 | $ 280 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 12 Months Ended |
Dec. 31, 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 4 4 may no Our lead development program is AEROSURF ® may not may may not first 72 may AEROSURF is designed to administer aerosolized KL 4 4 While we are focused primarily on AEROSURF, we are also assessing potential development pathways to potentially gain marketing approval for lyophilized KL 4 4 may We also believe that our KL 4 may 4 no may 4 The reader is referred to, and encouraged to read in its entirety “Item 1 10 4 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 Basis of Presentation The accompanying consolidated financial statements reflect a 1 20 December 22, 2017. |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 3 Liquidity Risks and Management’s Plans As of December 31, 2017, $1.8 $11.7 In January 2018 March 2018, $1.5 $1.0 one see, 17 In early April 2018, $2.6 $2.5 see, 17 April 15, 2018, May 2018. We expect to continue to incur significant losses and require significant additional capital to advance our AEROSURF clinical development program, support our operations and satisfy existing obligations beyond May 2018, not one To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to raise additional capital through one third no none not one The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not As of December 31, 2017, 120 5 114.1 5.0 not |
Note 4 - Accounting Policies an
Note 4 - Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 4 Accounting Policies and Recent Accounting Pronouncements The consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the U. S. Consolidation The consolidated financial statements include all accounts of Windtree Therapeutics, Inc. and its inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). All intercompany transactions and balances have been eliminated in consolidation. Use of estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U. S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and cash equivalents Cash and cash equivalents are held in U.S. banks and consist of liquid investments and money market funds with a maturity from date of purchase of 90 Fair value of financial instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying amount of cash equivalents is equal to their respective fair values at December 31, 2017 2016, Property and equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten Restricted cash Restricted cash consists of a certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated May 26, 2004 See, 13 Long-lived assets Our long-lived assets, primarily consisting of equipment, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not No December 31, 2017 2016 no not Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, 11 Restructured debt liability – contingent milestone payment In conjunction with the November 2017 See, 8 $15 October 27, 2017 ( not Deferred revenue Deferred revenue represents amounts collected but not $1.0 July 2017 Revenue recognition We recognize grant revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Research and development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with Accounting Standards Codification (ASC) Topic 730, Research and Development Stock-based compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation 718 See 10 Warrant accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity 815 Income taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not Beneficial Conversion Feature The issuance of our Preferred Shares in the first 2017 see 9 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 December 31, 2017, $2.8 Net loss per common share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. For the years ended December 31, 2017 2016, 1.0 0.5 December 31, 2017 2016, In accordance with ASC Topic 260, Earnings per Share, December 31, 2016, February 2016, We do not Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL 4 third 4 one Business segments We currently operate in one one not Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2014, 2014 15, Presentation of Financial Statements – Going Concern (Subtopic 205 40 one 2014 15 December 31, 2016. one 3 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718 2016 09 three March 31, 2017 not 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230 2016 18 March 31, 2017 $0.2 December 30, 2017 2016. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 December 31, 2018 one two not January 1, 2018 may In February 2016, ASU 2016 02, 482 December 31, 2019 2016 02 may In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 may not |
Note 5 - Fair Value Measurement
Note 5 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 5 Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three first two ● Level 1 ● Level 2 1 not ● Level 3 no Fair Value on a Recurring Basis Assets and liabilities measured at fair value on a recurring basis are categorized in the table below as of December 31, 2017 2016: Fair Value Fair value measurement using December 31, (in thousands) 2017 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 1,815 $ 1,815 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 2,040 $ 2,040 $ - $ - 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 2016, 2011 February 2016. (in thousands) Balance at January 1, 2016 $ 223 Change in fair value of common stock warrant liability (223 ) Balance at December 31, 2016 $ - |
Note 6 - Property and Equipment
Note 6 - Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 6 Property and Equipment Property and equipment comprises the following: December 31, (in thousands) 2017 2016 Manufacturing, laboratory & office equipment $ 4,965 $ 4,940 Furniture & fixtures 615 615 Leasehold improvements 2,458 2,459 Subtotal 8,038 8,014 Accumulated depreciation and amortization (7,153 ) (6,960 ) Property and equipment, net $ 885 $ 1,054 Depreciation expense on property and equipment for the years ended December 31, 2017 2016 $0.2 $0.3 |
Note 7 - Collaborative Payable
Note 7 - Collaborative Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | Note 7 Collaboration Payable and Accrued Expenses Collaboration payable represents amounts due to Battelle under a collaboration agreement related to the development of a new version of our ADS ( See 11 December 31, 2017 2016, $3.6 $4.0 Accrued expenses comprise the following: December 31, (in thousands) 2017 2016 Salaries, bonus & benefits $ 1,008 $ 1,309 Research and development 1,848 5,174 Manufacturing operations 537 454 Professional fees 412 305 Other 399 369 Total accrued expenses $ 4,204 $ 7,611 |
Note 8 - Long-term Debt Restruc
Note 8 - Long-term Debt Restructured Debt Liability | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 8 Long-term Debt / Restructured Debt Liability As of December 31, 2016, December 31, (in thousands) 2017 2016 Deerfield Loan $ - $ 25,000 Restructured debt liability - contingent milestone payments $ 15,000 - Under the terms of the Deerfield Loan, Deerfield made two first February 2013 $10 second first ® December 2013 $20 8.75%, Upon execution of the Deerfield Loan, we issued to Deerfield warrants to purchase approximately 10,000 $786.80 second December 2013, 15,000 $786.80 six sixth February 13, 2019. In July 2015, two $5.0 February 2017, ( February 2018 February 2019 $12.5 $5 July 2015 $5 $5 8.25% On November 1, 2017, $25 25,000 $786.80 $2.5 71,111 ® $15 Contemporaneously with the execution of the Exchange and Termination Agreement, we and Deerfield entered into a registration rights agreement pursuant to which we agreed to provide certain registration rights with respect to the shares of common stock issued to Deerfield under the Exchange and Termination Agreement. We issued the shares of common stock to Deerfield pursuant to Rule 506 4 2 1933. The November 2017 470, Debt – Modifications and Extinguishments $5.8 $25 $15 $2.5 $1.4 $0.3 $15 see 4 The following amounts comprise the Deerfield Loan interest expense for the periods presented: Year Ended (in thousands) 2017 2016 Amortization of prepaid interest expense $ 911 $ 1,710 Cash interest expense 1,088 450 Total interest expense $ 1,999 $ 2,160 Amortization of prepaid interest expense represents non-cash amortization of $5 July 2015 $5 8.75% 8.25% |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 9 Stockholders’ Equity Private Placement Offerings February 2017 On February 15, 2017, 7,049 $1,495, $10.5 $1.6 December 31, 2016 first second 2017. one $0.001 1 50 $27.40 may 50 may February 15, 2024. may not 9.99% three February 13, 2018, may To facilitate consummation of the Share Purchase Agreement in October 2017 ( Share Purchase Agreement 1,095 $0.001 not not no As of December 31, 2017, 4,348 217,400 2,701 Share Purchase Agreement Effective October 27, 2017, $10 2,311,604 $4.326 15% 10 73% $3.9 August 14, 2017, two may 30th 24 2011 2017 2018 two March 15, 2018 March 15, 2019. Contemporaneously with the execution of the SPA, we and LPH entered into a registration rights agreement pursuant to which we agreed to provide certain registration rights with respect to the Shares under the SPA, which rights are limited to registration of up to 25% 18 506 4 2 1933. At-the-Market Program (ATM Program) Stifel ATM Program On February 11, 2013, may may three $25,000,000 February 11, 2016, three February 11, 2019. not If we issue a sale notice to Stifel, we may may 3.0% During 2017, 42,357 $1.1 $1.0 During 2016, 18,013 $0.7 Effective with our transition to the OTCQB ® May 2017, no 401 We have a voluntary 401 401 2017 2016 8 December 31, 2017 2016, 7,561 8,437 401 December 31, 2017 2016 $0.1 $0.3 Common Shares Reserved for Future Issuance Common shares reserved for potential future issuance upon exercise of warrants The chart below summarizes shares of our common stock reserved for future issuance upon the exercise of warrants: December 31, Expiration (in thousands, except price per share data) 2017 2016 Exercise Price Date Investors - February 2017 financing 352 - $ 27.40 2/15/2024 Investors - July 2015 financing 240 240 $ 196.00 7/22/2022 Investors - July 2015 financing (prefunded) - 143 $ - 7/22/2022 Battelle - 2014 collaboration agreement (1) 4 5 $ 1,400.00 10/10/2024 Deerfield - 2013 loan - 500 $ 786.80 2/13/2019 Total 596 888 ( 1 See 11 Common shares reserved for potential future issuance upon exercise of stock options or granting of additional equity incentive awards At the 2017 2011 “2011 37,500. October 25, 2017 1.75 November 13, 2017. As of December 31, 2017 2016, 1.6 0.1 2011 Common shares reserved for potential future issuance under our 401 As of December 31, 2017 2016, 807 8,368 401 |
Note 10 - Stock Options and Sto
Note 10 - Stock Options and Stock-based Employee Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Note 10 Stock Options and Stock-based Employee Compensation Long-Term Incentive Plans We have the 2011 2007 2007 2007 1998 There are 1.9 2011 1.6 2007 2011 1998 not 1998 2011 may An administrative committee (the Committee – currently the Compensation Committee of the Board of Directors) or Committee delegates may may Stock options and restricted stock units (RSUs) outstanding and available for future issuance are as follows: December 31, (in thousands) 2017 2016 Stock Options and RSUs Outstanding 2011 Plan 263 47 2007 Plan - 1 1998 Plan - 0 Non-Plan 10 10 Total Outstanding 273 58 Available for Future Grants under 2011 Plan 1,623 52 No 2011 may three first 10 February 1, 2016. 5635 4 three first 10 A summary of activity under our long-term incentive plans is presented below: (in thousands, except for weighted-average data) Weighted- Weighted- Stock Options Shares Exercise Contractual Outstanding at January 1, 2017 57 $ 293.20 Granted 41 24.60 Forfeited or expired (14 ) 281.80 Outstanding at December 31, 2017 84 $ 163.20 7.8 Vested and exercisable at December 31, 2017 55 $ 228.60 7.3 Vested and expected to vest at December 31, 2017 82 $ 164.00 7.8 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2017 1 $ 36.80 Awarded 190 4.33 Vested (1 ) 36.80 Unvested at December 31, 2017 190 $ 4.33 Based upon application of the Black-Scholes option-pricing formula described below, the weighted-average grant-date fair value of options granted during the years ended December 31, 2017 2016 $17.44 $27.80, December 31, 2017 2016 $4.33 $36.80, December 31, 2017 $0. Stock-Based Compensation We recognized stock-based compensation expense in accordance with ASC Topic 718 $1.6 December 31, 2017 2016. Stock-based compensation expense was classified as follows: Year Ended (in thousands) 2017 2016 Research and development $ 837 $ 614 General and administrative 724 809 Total $ 1,561 $ 1,423 Under the 2011 9 2011 $0.4 2017. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant. Year Ended 2017 2016 Weighted average expected volatility 79% 78% Weighted average expected term (in years) 6.6 5.7 Weighted average risk-free interest rate 2.2% 1.4% Expected dividends - - The total fair value of the underlying shares of the options vested during 2017 2016 $3.1 $1.9 December 31, 2017, $0.9 2011 1.9 |
Note 11 - Collaboration, Licens
Note 11 - Collaboration, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Corporate Partnership, Licensing and Research Funding Agreements [Text Block] | Note 11 Collaboration, Licensing and Research Funding Agreements Collaboration Agreement Battelle Memorial Institute In October 2014, $1.2 $2.9 December 31, 2017 2016, In connection with the collaboration agreement, we issued to Battelle two $1,400 10 3,571 three 1786 no November 15, 2016). November 15, 2016 not 506. 815. If Battelle successfully completes their activities under the agreement, we have agreed to pay Battelle royalties equal to a low single-digit percentage of the worldwide net sales and license royalties on sales of AEROSURF for the treatment of RDS in premature infants, up to an aggregate limit of $25 On October 27, 2017, $0.6 $25 $35 Licensing and Research Funding Agreements Lee’s Pharmaceutical (HK) Ltd. In June 2017, “ 4 ® 2012 ® 4 12 Under the License Agreement, Lee’s made an upfront payment to us of $1 may $37.5 may 3 In August 2017, $3.9 October 31, 2017, $10 November 1, 2017. $35.8 We will be eligible to receive tiered royalties based on a percent of Net Sales, depending on the product, in the range of high single to low-to-mid double-digit percentages. Royalties are payable on a country-by-country basis until the latest of (A) the expiration of the last valid patent claim covering the product in the country of sale, (B) the expiration or revocation of any applicable regulatory exclusivity in the country of sale, and (C) ten 10 first three one Under the License Agreement, Lee’s will be responsible for all activities related to development, regulatory approval and commercialization of KL 4 ten 10 first first first first not Lee’s may may not third may not not may The term of the License Agreement commenced on the effective date of the License Agreement and will continue on a country-by-country basis for the commercial life of the products. Either party may sixty 60 may eighteen 18 Philip Morris USA Inc. and Philip Morris Products S.A. Under license agreements with Philip Morris USA Inc. (PMUSA) and Philip Morris Products S.A. (PMPSA), we hold exclusive worldwide licenses to the ADS technology for use with pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) for all respiratory diseases and conditions (the foregoing uses in each territory, the Exclusive Field), and an exclusive license in the U.S. for use with certain non-surfactant drugs to treat a wide range of pediatric and adult respiratory indications in hospitals and other health care institutions. We generally are obligated to pay royalties at a rate equal to a low single-digit percent of sales of products sold in the Exclusive Field (as defined in the license agreements) in the territories, including sales of aerosol devices that are not 2014, 2016, $250,000 $62,500 $187,500 July 2017. 2017, $300,000 $487,500 $300,000 $187,500 2016 Johnson & Johnson and Ortho Pharmaceutical Corporation We, Johnson & Johnson (J&J) and its wholly-owned subsidiary, Ortho Pharmaceutical Corporation, are parties to a license agreement granting to us an exclusive worldwide license to the J&J proprietary KL 4 $2.5 $950,000 $500,000 2012 Laboratorios del Dr. Esteve, S.A. We have a strategic alliance with Laboratorios del Dr. Esteve, S.A. (Esteve) for the development, marketing and sales of a broad portfolio of potential KL 4 May 2002 January 2013. 4 3 2004 10% $20 4 |
Note 12 - Commitments
Note 12 - Commitments | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Commitments Disclosure [Text Block] | Note 12 Commitments Operating Leases Our operating leases consist primarily of a facility lease for our operations in Pennsylvania. We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. In April 2016, 39,594 30,506 four February 2022. December 31, 2017 $3.9 In February 2018, 30,506 21,189 $225,000 $140,000. $2.5 Rent expense under these leases was $0.7 $0.8 December 31, 2017 2016, Severance Effective February 1, 2016, first 2016, $1.2 $0.2 August 1, 2017. $1.0 not $0.9 December 31, 2017. During the second 2016, $0.4 May 2016 On July 13, 2017, 20 42% 48 28 $0.2 third 2017. |
Note 13 - Litigation
Note 13 - Litigation | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Legal Matters and Contingencies [Text Block] | Note 13 Litigation We are not We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not no not |
Note 14 - Income Taxes
Note 14 - Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 14 Income Taxes Since our inception, we have never recorded a provision or benefit for Federal and state income taxes. The reconciliation of the income tax benefit computed at the Federal statutory rates to our recorded tax benefit for the years ended December 31, 2017 2016 December 31, (in thousands) 2017 2016 Income tax benefit, statutory rates $ (6,272 ) $ (13,426 ) State taxes on income, net of federal benefit (398 ) (2,599 ) Impact of tax reform 71,151 - Research and development tax credit (797 ) (1,305 ) Employee related 953 1,215 Interest related (147 ) (890 ) Warrant valuation related - (76 ) Income tax expense / (benefit), statutory rates 64,490 (17,081 ) Valuation allowance (64,490 ) 17,081 Income tax benefit, net $ - $ - On December 22, 2017, 2017 2017 21%, one December 31, 2017 $71.2 2017 one 1986 December 31, 2017. not not ASC 740, 2017 118, 2017 one 2017 not not 2017 2017 2017 may 2017 2018 The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2017 2016, December 31, (in thousands) 2017 2016 Long-term deferred assets: Net operating loss carryforwards (Federal and state) $ 168,263 $ 234,825 Research and development tax credit 16,813 15,700 Compensation expense on stock 1,191 2,157 Charitable contribution carryforward 5 6 Other accrued 2,547 342 Deferred revenue 317 - Depreciation 297 460 Total long-term deferred tax assets 189,433 253,490 Valuation allowance (189,433 ) (253,490 ) Deferred tax assets, net $ - $ - We are in a net deferred tax asset position at December 31, 2017 2016 not nor December 31, 2017 2016, nor 2017 2016. At December 31, 2017 2016, $590.0 $581.4 $16.8 $15.7 2037. At December 31, 2017, $5.2 $0.4 At December 31, 2017 2016, $567.7 $570.3 $567.7 $553.6 6 Utilization of net operating loss (NOL) and research and development (R&D) credit carryforwards may 382 1986 may may A full valuation allowance has been provided against our deferred tax assets and, if a future assessment requires an adjustment, an adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no |
Note 15 - Selected Quarterly Fi
Note 15 - Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | Note 15 Selected Quarterly Financial Data (Unaudited) The following tables contain unaudited statement of operations information for each quarter of 2017 2016. not 2017 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 (1) Sept. 30 (1) Dec. 31 Total Year Revenues: Grant revenue $ 219 $ 1,147 $ 17 $ - $ 1,383 License revenue - - - 102 102 Total revenues 219 1,147 17 102 1,485 Expenses: Research and Development 6,413 5,483 3,062 2,418 17,376 Selling, general and administrative 1,922 1,804 1,749 1,182 6,657 Total expenses 8,335 7,287 4,811 3,600 24,033 Operating loss (8,116 ) (6,140 ) (4,794 ) (3,498 ) (22,548 ) Change in fair value of common stock warrant liability - - - - - Other income / (expense), net (608 ) (612 ) (649 ) 5,971 4,102 Net (loss) / income $ (8,724 ) $ (6,752 ) $ (5,443 ) $ 2,473 $ (18,446 ) Deemed dividend on preferred stock (3,604 ) (532 ) (2,234 ) - (6,370 ) Net (loss) / income attributable to common shareholders $ (12,328 ) $ (7,284 ) $ (7,677 ) $ 2,473 $ (24,816 ) Net (loss) / income per common share - basic $ (27.40 ) $ (14.37 ) $ (10.53 ) $ 1.03 $ (24.14 ) Net (loss) / income per common share - diluted $ (27.40 ) $ (14.37 ) $ (10.53 ) $ 0.97 $ (24.14 ) Weighted average number of common shares outstanding - basic 450 507 729 2,405 1,028 Weighted average number of common shares outstanding - diluted 450 507 729 2,540 1,028 2016 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue 75 106 961 900 2,042 License revenue - - - - - Total revenues 75 106 961 900 2,042 Expenses: Research and Development 10,360 8,316 7,081 5,948 31,705 Selling, general and administrative 3,657 1,783 1,613 1,320 8,373 Total expenses 14,017 10,099 8,694 7,268 40,078 Operating loss (13,942 ) (9,993 ) (7,733 ) (6,368 ) (38,036 ) Change in fair value of common stock warrant liability 223 - - - 223 Other expense, net (182 ) (631 ) (630 ) (234 ) (1,677 ) Net loss $ (13,901 ) $ (10,624 ) $ (8,363 ) $ (6,602 ) $ (39,490 ) Net loss per common share - basic and diluted $ (34.00 ) $ (25.80 ) $ (20.00 ) $ (15.40 ) $ (94.84 ) Weighted average number of common shares outstanding - basic and diluted 410 412 418 426 416 ( 1 Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the quarters ended June 30, 2017 September 30, 2017 9 February 2017 three six June 30, 2017 $ 0.80 three nine September 30, 2017 $3.40 |
Note 16 - Subsequent Events
Note 16 - Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 16 Subsequent Events We evaluated all events or transactions that occurred after December 31, 2017 In January 2018 March 2018, $1.5 $1.0 one 6% December 31, 2018. In April 2018, $2.6 $4.80. 541,667 135,417 $5.52 6 seventh 90 March 30, 2018, 25% 180th March 30, 2018, may |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Consolidation The consolidated financial statements include all accounts of Windtree Therapeutics, Inc. and its inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.). All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of estimates The preparation of financial statements, in conformity with accounting principles generally accepted in the U. S., requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and cash equivalents Cash and cash equivalents are held in U.S. banks and consist of liquid investments and money market funds with a maturity from date of purchase of 90 |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair value of financial instruments Our financial instruments consist principally of cash and cash equivalents and restricted cash. The fair values of our cash equivalents are based on quoted market prices. The carrying amount of cash equivalents is equal to their respective fair values at December 31, 2017 2016, |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three ten |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted cash Restricted cash consists of a certificate of deposit held by our bank as collateral for a letter of credit in the same notional amount held by our landlord to secure our obligations under our Lease Agreement dated May 26, 2004 See, 13 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-lived assets Our long-lived assets, primarily consisting of equipment, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not No December 31, 2017 2016 no not |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, 11 |
Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block] | Restructured debt liability – contingent milestone payment In conjunction with the November 2017 See, 8 $15 October 27, 2017 ( not |
Revenue Recognition, Deferred Revenue [Policy Text Block] | Deferred revenue Deferred revenue represents amounts collected but not $1.0 July 2017 |
Revenue Recognition, Multiple-deliverable Arrangements, Description [Policy Text Block] | Revenue recognition We recognize grant revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. |
Research and Development Expense, Policy [Policy Text Block] | Research and development We account for research and development expense by the following categories: (a) product development and manufacturing, (b) medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with Accounting Standards Codification (ASC) Topic 730, Research and Development |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-based compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation 718 See 10 |
Derivatives, Policy [Policy Text Block] | Warrant accounting We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity 815 |
Income Tax, Policy [Policy Text Block] | Income taxes We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not |
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 9 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 December 31, 2017, $2.4 |
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. For the years ended December 31, 2017 2016, 1.0 0.5 December 31, 2017 2016, In accordance with ASC Topic 260, Earnings per Share, December 31, 2016, February 2016, We do not |
Concentration of Suppliers [Policy Text Block] | Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL 4 third 4 one |
Segment Reporting, Policy [Policy Text Block] | Business segments We currently operate in one one not |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2014, 2014 15, Presentation of Financial Statements – Going Concern (Subtopic 205 40 one 2014 15 December 31, 2016. one 3 In March 2016, 2016 09, Compensation - Stock Compensation (Topic 718 2016 09 three March 31, 2017 not 2017 In November 2016, 2016 18, Statement of Cash Flows (Topic 230 2016 18 March 31, 2017 $0.2 December 30, 2017 2016. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 December 31, 2018 one two not January 1, 2018 may In February 2016, ASU 2016 02, 482 December 31, 2019 2016 02 may In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 may not |
Note 5 - Fair Value Measureme24
Note 5 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using December 31, (in thousands) 2017 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 1,815 $ 1,815 $ - $ - Certificate of deposit 225 225 - - Total Assets $ 2,040 $ 2,040 $ - $ - 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 December 31, 2016 $ - |
Note 6 - Property and Equipme25
Note 6 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, (in thousands) 2017 2016 Manufacturing, laboratory & office equipment $ 4,965 $ 4,940 Furniture & fixtures 615 615 Leasehold improvements 2,458 2,459 Subtotal 8,038 8,014 Accumulated depreciation and amortization (7,153 ) (6,960 ) Property and equipment, net $ 885 $ 1,054 |
Note 7 - Collaborative Payabl26
Note 7 - Collaborative Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, (in thousands) 2017 2016 Salaries, bonus & benefits $ 1,008 $ 1,309 Research and development 1,848 5,174 Manufacturing operations 537 454 Professional fees 412 305 Other 399 369 Total accrued expenses $ 4,204 $ 7,611 |
Note 8 - Long-term Debt Restr27
Note 8 - Long-term Debt Restructured Debt Liability (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Long-term Debt Instruments [Table Text Block] | December 31, (in thousands) 2017 2016 Deerfield Loan $ - $ 25,000 Restructured debt liability - contingent milestone payments $ 15,000 - |
Schedule of Debt Instrument Interest Expense [Table Text Block] | Year Ended (in thousands) 2017 2016 Amortization of prepaid interest expense $ 911 $ 1,710 Cash interest expense 1,088 450 Total interest expense $ 1,999 $ 2,160 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Common Shares Reserved for Future Issuance, Warrants [Table Text Block] | December 31, Expiration (in thousands, except price per share data) 2017 2016 Exercise Price Date Investors - February 2017 financing 352 - $ 27.40 2/15/2024 Investors - July 2015 financing 240 240 $ 196.00 7/22/2022 Investors - July 2015 financing (prefunded) - 143 $ - 7/22/2022 Battelle - 2014 collaboration agreement (1) 4 5 $ 1,400.00 10/10/2024 Deerfield - 2013 loan - 500 $ 786.80 2/13/2019 Total 596 888 |
Note 10 - Stock Options and S29
Note 10 - Stock Options and Stock-based Employee Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block] | December 31, (in thousands) 2017 2016 Stock Options and RSUs Outstanding 2011 Plan 263 47 2007 Plan - 1 1998 Plan - 0 Non-Plan 10 10 Total Outstanding 273 58 Available for Future Grants under 2011 Plan 1,623 52 |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | (in thousands, except for weighted-average data) Weighted- Weighted- Stock Options Shares Exercise Contractual Outstanding at January 1, 2017 57 $ 293.20 Granted 41 24.60 Forfeited or expired (14 ) 281.80 Outstanding at December 31, 2017 84 $ 163.20 7.8 Vested and exercisable at December 31, 2017 55 $ 228.60 7.3 Vested and expected to vest at December 31, 2017 82 $ 164.00 7.8 |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2017 1 $ 36.80 Awarded 190 4.33 Vested (1 ) 36.80 Unvested at December 31, 2017 190 $ 4.33 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Year Ended (in thousands) 2017 2016 Research and development $ 837 $ 614 General and administrative 724 809 Total $ 1,561 $ 1,423 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended 2017 2016 Weighted average expected volatility 79% 78% Weighted average expected term (in years) 6.6 5.7 Weighted average risk-free interest rate 2.2% 1.4% Expected dividends - - |
Note 14 - Income Taxes (Tables)
Note 14 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, (in thousands) 2017 2016 Income tax benefit, statutory rates $ (6,272 ) $ (13,426 ) State taxes on income, net of federal benefit (398 ) (2,599 ) Impact of tax reform 71,151 - Research and development tax credit (797 ) (1,305 ) Employee related 953 1,215 Interest related (147 ) (890 ) Warrant valuation related - (76 ) Income tax expense / (benefit), statutory rates 64,490 (17,081 ) Valuation allowance (64,490 ) 17,081 Income tax benefit, net $ - $ - |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, (in thousands) 2017 2016 Long-term deferred assets: Net operating loss carryforwards (Federal and state) $ 168,263 $ 234,825 Research and development tax credit 16,813 15,700 Compensation expense on stock 1,191 2,157 Charitable contribution carryforward 5 6 Other accrued 2,547 342 Deferred revenue 317 - Depreciation 297 460 Total long-term deferred tax assets 189,433 253,490 Valuation allowance (189,433 ) (253,490 ) Deferred tax assets, net $ - $ - |
Note 15 - Selected Quarterly 31
Note 15 - Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | 2017 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 (1) Sept. 30 (1) Dec. 31 Total Year Revenues: Grant revenue $ 219 $ 1,147 $ 17 $ - $ 1,383 License revenue - - - 102 102 Total revenues 219 1,147 17 102 1,485 Expenses: Research and Development 6,413 5,483 3,062 2,418 17,376 Selling, general and administrative 1,922 1,804 1,749 1,182 6,657 Total expenses 8,335 7,287 4,811 3,600 24,033 Operating loss (8,116 ) (6,140 ) (4,794 ) (3,498 ) (22,548 ) Change in fair value of common stock warrant liability - - - - - Other income / (expense), net (608 ) (612 ) (649 ) 5,971 4,102 Net (loss) / income $ (8,724 ) $ (6,752 ) $ (5,443 ) $ 2,473 $ (18,446 ) Deemed dividend on preferred stock (3,604 ) (532 ) (2,234 ) - (6,370 ) Net (loss) / income attributable to common shareholders $ (12,328 ) $ (7,284 ) $ (7,677 ) $ 2,473 $ (24,816 ) Net (loss) / income per common share - basic $ (27.40 ) $ (14.37 ) $ (10.53 ) $ 1.03 $ (24.14 ) Net (loss) / income per common share - diluted $ (27.40 ) $ (14.37 ) $ (10.53 ) $ 0.97 $ (24.14 ) Weighted average number of common shares outstanding - basic 450 507 729 2,405 1,028 Weighted average number of common shares outstanding - diluted 450 507 729 2,540 1,028 2016 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue 75 106 961 900 2,042 License revenue - - - - - Total revenues 75 106 961 900 2,042 Expenses: Research and Development 10,360 8,316 7,081 5,948 31,705 Selling, general and administrative 3,657 1,783 1,613 1,320 8,373 Total expenses 14,017 10,099 8,694 7,268 40,078 Operating loss (13,942 ) (9,993 ) (7,733 ) (6,368 ) (38,036 ) Change in fair value of common stock warrant liability 223 - - - 223 Other expense, net (182 ) (631 ) (630 ) (234 ) (1,677 ) Net loss $ (13,901 ) $ (10,624 ) $ (8,363 ) $ (6,602 ) $ (39,490 ) Net loss per common share - basic and diluted $ (34.00 ) $ (25.80 ) $ (20.00 ) $ (15.40 ) $ (94.84 ) Weighted average number of common shares outstanding - basic and diluted 410 412 418 426 416 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) | Dec. 22, 2017 |
Reverse Stock Split [Member] | |
Stockholders' Equity Note, Stock Split, Conversion Ratio | 20 |
Note 3 - Liquidity Risks and 33
Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | ||||
Apr. 16, 2018 | Mar. 31, 2018 | Jan. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash and Cash Equivalents, at Carrying Value | $ 1,815 | $ 5,588 | |||
Accounts Payable and Accrued Liabilities, Current | $ 11,700 | ||||
Common Stock, Shares Authorized | 120,000,000 | 60,000,000 | |||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | |||
Common Stock Capital Shares Available for Issuance | 114,100,000 | ||||
Preferred Stock Capital Shares Available for Issuance | 5,000,000 | ||||
Subsequent Event [Member] | |||||
Proceeds from Issuance of Private Placement | $ 2,500 | ||||
Subsequent Event [Member] | Private Placement [Member] | LPH II [Member] | |||||
Private Placement, Purchase Price of Common Stock and Warrants | $ 2,600 | ||||
LPH [Member] | Subsequent Event [Member] | |||||
Proceeds from Issuance of Debt | $ 1,000 | $ 1,500 |
Note 4 - Accounting Policies 34
Note 4 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Jul. 31, 2017USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | [1] | Jun. 30, 2017USD ($) | [1] | Mar. 31, 2017USD ($) | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)shares | Nov. 01, 2017USD ($) | |
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | ||||||||
Preferred Stock Dividends, Income Statement Impact | $ 2,234 | $ 532 | $ 3,604 | 6,370 | ||||||
Preferred Stock, Discount on Shares | 4,500 | $ 4,500 | ||||||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants | shares | 1 | 0.5 | ||||||||
Number of Operating Segments | 1 | |||||||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect | $ (3,773) | $ (33,134) | ||||||||
Impairment of Long-Lived Assets Held-for-use | 0 | 0 | ||||||||
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 | |||||||||
Conversion of Preferred Stock [Member] | ||||||||||
Preferred Stock Dividends, Income Statement Impact | 2,800 | |||||||||
License Agreement With Lee’s [Member] | ||||||||||
Deferred Revenue, Additions | $ 1,000 | |||||||||
Deerfield Loan [Member] | ||||||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | ||||||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | ||||||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | |||||||||
Minimum [Member] | ||||||||||
Property, Plant and Equipment, Useful Life | 3 years | |||||||||
Maximum [Member] | ||||||||||
Property, Plant and Equipment, Useful Life | 10 years | |||||||||
[1] | Net loss per common share - basic and diluted and weighted average number of common shares outstanding for the quarters ended June 30, 2017 and September 30, 2017 have been restated to correct immaterial calculation errors related to the conversion of preferred stock to common stock during those periods (See, " - Note 9 - Stockholders' Equity - Private Placement Offerings - February 2017 Private Placement, " for further discussion of our preferred stock). The loss per share for the three and six months ended June 30, 2017 was reduced by $0.80. The loss per share for the three and nine months ended September 30, 2017 was reduced by $3.40. |
Note 5 - Fair Value Measureme35
Note 5 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Assets: | ||
Cash and cash equivalents | $ 1,815 | $ 5,588 |
Total Assets | 2,040 | 5,813 |
Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | 225 | 225 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets: | ||
Cash and cash equivalents | 1,815 | 5,588 |
Total Assets | 2,040 | 5,813 |
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | 225 | 225 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit | ||
Fair Value, Inputs, Level 3 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Certificate of deposit |
Note 5 - Fair Value Measureme36
Note 5 - Fair Value Measurements - Level 3 Rollforward (Details) - Fair Value, Inputs, Level 3 [Member] - Derivative Financial Instruments, Liabilities [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Balance | $ 223 |
Change in fair value of common stock warrant liability | (223) |
Balance |
Note 6 - Property and Equipme37
Note 6 - Property and Equipment (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Depreciation | $ 0.2 | $ 0.3 |
Note 6 - Property and Equipme38
Note 6 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property and equipment, gross | $ 8,038 | $ 8,014 |
Accumulated depreciation and amortization | (7,153) | (6,960) |
Property and equipment, net | 885 | 1,054 |
Manufacturing, Laboratory, and Office Equipment [Member] | ||
Property and equipment, gross | 4,965 | 4,940 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 615 | 615 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | $ 2,458 | $ 2,459 |
Note 7 - Collaborative Payabl39
Note 7 - Collaborative Payable and Accrued Expenses (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Collaboration Payable, Current | $ 3,624 | $ 3,967 |
Note 7 - Collaboration Payable
Note 7 - Collaboration Payable and Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Salaries, bonus & benefits | $ 1,008 | $ 1,309 |
Research and development | 1,848 | 5,174 |
Manufacturing operations | 537 | 454 |
Professional fees | 412 | 305 |
Other | 399 | 369 |
Total accrued expenses | $ 4,204 | $ 7,611 |
Note 8 - Long-term Debt Restr41
Note 8 - Long-term Debt Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Nov. 01, 2017 | Jul. 22, 2015 | Dec. 03, 2013 | Feb. 13, 2013 | Dec. 31, 2017 | Dec. 31, 2016 | Feb. 15, 2017 |
Number of Advances | 2 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | ||||||
Repayments of Long-term Debt | $ 2,500 | ||||||
Gains (Losses) on Restructuring of Debt | 5,824 | ||||||
Stock Issued During Period, Value, Equity Consideration in Debt Restructuring | 267 | ||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | ||||||
Deerfield Loan [Member] | |||||||
Debt Instrument, Interest Rate During Period | 8.25% | ||||||
Debt Instrument, Periodic Payment, Principal | $ 5,000 | $ 5,000 | |||||
Long-term Debt, Maturities, Repayments of Principal in Year Two | 12,500 | ||||||
Debt Instrument, Prepaid Interest | 5,000 | ||||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000 | ||||||
Debt Instrument, Periodic Payment, Interest | $ 5,000 | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.75% | ||||||
Long-term Debt, Maturities, Repayments of Principal in Year Three | $ 12,500 | ||||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||||||
Extinguishment of Debt, Amount | $ 25,000 | ||||||
Repayments of Long-term Debt | $ 2,500 | ||||||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations | 71,111 | ||||||
Gains (Losses) on Restructuring of Debt | $ 5,800 | ||||||
Extinguishment of Debt, Write-off of Prepaid Interest | 1,400 | ||||||
Stock Issued During Period, Value, Equity Consideration in Debt Restructuring | 300 | ||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | ||||||
First Advance [Member] | |||||||
Class of Warrant or Right, Issued During Period | 10,000 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 786.80 | ||||||
Second Advance [Member] | |||||||
Class of Warrant or Right, Issued During Period | 15,000 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 786.80 | ||||||
Deerfield Loan Warrants [Member] | |||||||
Class of Warrants or Rights, Term of Warrants | 6 years | ||||||
Deerfield Loan Warrants [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||||||
Class of Warrant or Right, Number of Warrants Cancelled | 25,000 | ||||||
Class of Warrant or Right, Exercise Price of Cancelled Warrants | $ 786.80 | ||||||
First Advance [Member] | |||||||
Proceeds from Lines of Credit | $ 10,000 | ||||||
Second Advance [Member] | |||||||
Proceeds from Lines of Credit | $ 20,000 | ||||||
Deerfield Debt Restructuring [Member] | |||||||
Debt Instrument, Interest Rate During Period | 8.75% |
Note 8 - Long-term Debt Restr42
Note 8 - Long-term Debt Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Restructured debt liability - contingent milestone payments | $ 15,000 | |
Deerfield Loan [Member] | ||
Deerfield Loan | 25,000 | |
Restructured debt liability - contingent milestone payments | $ 15,000 |
Note 8 - Long-term Debt Restr43
Note 8 - Long-term Debt Restructured Debt Liability - Long-term Debt Interest Expense (Details) - Deerfield Loan [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Amortization of prepaid interest expense | $ 911 | $ 1,710 |
Cash interest expense | 1,088 | 450 |
Total interest expense | $ 1,999 | $ 2,160 |
Note 9 - Stockholders' Equity44
Note 9 - Stockholders' Equity (Details Textual) - USD ($) | Nov. 01, 2017 | Oct. 27, 2017 | Oct. 25, 2017 | Feb. 15, 2017 | Feb. 11, 2013 | Oct. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 08, 2017 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 27.40 | ||||||||
Preferred Stock, Shares Outstanding | 2,701 | 0 | 2,701 | ||||||
Proceeds from Issuance of Common Stock | $ 1,036,000 | $ 709,000 | |||||||
Common Stock, Capital Shares Reserved for Future Issuance | 596,000 | 888,000 | |||||||
The 2011 Long-term Incentive Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,750,000 | 37,500 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,623,000 | 52,000 | |||||||
The 401(k) Plan [Member] | |||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 807 | 8,368 | |||||||
LPH [Member] | Acquisition of Windtree [Member] | |||||||||
Business Combination, Consideration Transferred | $ 10,000,000 | $ 10,000,000 | |||||||
Business Acquisition, Shares Acquired, Number | 2,311,604 | ||||||||
Business Acquisition, Share Price | $ 4.326 | ||||||||
Business Acquisition, Shares Acquired, Price Per Share, Percentage Premium | 15.00% | ||||||||
Business Acquisition, Percentage of Voting Interests Acquired | 73.00% | ||||||||
Business Combination, Consideration Transferred, Liabilities Cancelled | $ 3,900,000 | ||||||||
Business Combination, Number of Individuals Acquirer May Appoint to the Acquiree's Board of Directors | 2 | ||||||||
Business Combination, Registration Rights Agreement, Maximum Rights Percentage in First 18 Months | 25.00% | ||||||||
Conversion of Series A Convertible Preferred Stock into Common Stock [Member] | |||||||||
Conversion of Stock, Shares Converted | 4,348 | ||||||||
Conversion of Stock, Shares Issued | 217,400 | ||||||||
Series A Preferred Stock [Member] | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | ||||||||
Series A Preferred Stock [Member] | Battelle [Member] | |||||||||
Preferred Stock, Convertible, Shares, Liquidity Preference Waived | 1,095 | ||||||||
Private Placement [Member] | |||||||||
Convertible Preferred Stock Units, Price Per Unit | $ 1,495 | ||||||||
Private Placement [Member] | Series A Units [Member] | |||||||||
Stock Issued During Period, Shares, New Issues | 7,049 | ||||||||
Gross Proceeds From Issuance Of Units | $ 10,500,000 | ||||||||
Non-cash Consideration Received | $ 1,600,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | ||||||||
Private Placement [Member] | Series A Warrant [Member] | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 50 | ||||||||
Class of Warrants, May Not Exercise To Extent, Percentage | 9.99% | ||||||||
Stifel ATM Program [Member] | |||||||||
Stock Issued During Period, Shares, New Issues | 42,357 | 18,013 | |||||||
Agency Agreement Period | 3 years | ||||||||
Maximum Potential Common Stock Available for Issue, Value | $ 25,000,000 | ||||||||
Percentage Sales Commission on Shares | 3.00% | ||||||||
Proceeds from Issuance of Common Stock | $ 1,100,000 | $ 700,000 | |||||||
Proceeds from Issuance of Common Stock, Net | $ 1,000,000 | ||||||||
The 401(k) Plan [Member] | |||||||||
Stock Issued During Period, Shares, New Issues | 7,561 | 8,437 | |||||||
Defined Contribution Plan, Cost | $ 100,000 | $ 300,000 |
Note 9 - Stockholders' Equity -
Note 9 - Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares shares in Thousands | 12 Months Ended | |||
Dec. 31, 2017 | Feb. 15, 2017 | Dec. 31, 2016 | ||
Common Stock, Capital Shares Reserved for Future Issuance | 596 | 888 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | |||
Investors - February 2017 Financing [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 352 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | |||
Expiration date | 2/15/2024 | |||
Investors - July 2015 Financing [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 240 | 240 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 196 | |||
Expiration date | 7/22/2022 | |||
Investors - July 2015 Financing (Prefunded) [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 143 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | ||||
Expiration date | 7/22/2022 | |||
Battelle 2014 Collaboration Agreement [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | [1] | 4 | 5 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | [1] | $ 1,400 | ||
Expiration date | [1] | 10/10/2024 | ||
Deerfield - 2013 Loan [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 500 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 786.80 | |||
Expiration date | 2/13/2019 | |||
[1] | See, "- Note 11 - Collaboration, Licensing and Research Funding Agreements" for further details on the Battelle collaboration agreement |
Note 10 - Stock Options and S46
Note 10 - Stock Options and Stock-based Employee Compensation (Details Textual) - USD ($) $ / shares in Units, shares in Thousands | Feb. 01, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 17.44 | $ 27.80 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 0 | ||
Adjustments to Additional Paid in Capital, Share-based Compensation, Requisite Service Period Recognition | 1,562,000 | $ 1,411,000 | |
Allocated Share-based Compensation Expense | 1,561,000 | 1,423,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 3,100,000 | $ 1,900,000 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 900,000 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 328 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 0 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 0 | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 4.33 | $ 36.80 | |
Chief Executive Officer [Member] | Non-plan Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 3 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||
The 2011 Long-term Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,900 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,623 | 52 | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 3 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||
Allocated Share-based Compensation Expense | $ 400,000 |
Note 10 - Stock Options and S47
Note 10 - Stock Options and Stock-based Employee Compensation - Stock Options and Restricted Stock Units (RSUs) Outstanding and Available for Future Issuance (Details) - shares shares in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
2011 Plan (in shares) | 273 | 58 |
The 2011 Long-term Incentive Plan [Member] | ||
2011 Plan (in shares) | 263 | 47 |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,623 | 52 |
The 2007 Equity Incentive Plan [Member] | ||
2011 Plan (in shares) | 1 | |
The 1998 Equity Incentive Plan [Member] | ||
2011 Plan (in shares) | 0 | |
Non-Plan [Member] | ||
2011 Plan (in shares) | 10 | 10 |
Note 10 - Stock Options and S48
Note 10 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Shares Outstanding, Beginning Balance (in shares) | 57 | |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ 293.20 | |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 7 years 292 days | |
Shares Granted (in shares) | 41 | |
Weighted Average Exercise Price, Granted (in dollars per share) | $ 24.60 | |
Shares Forfeited or Expired (in shares) | (14) | |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ 281.80 | |
Shares Outstanding, Ending Balance (in shares) | 84 | 57 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ 163.20 | $ 293.20 |
Shares Vested and Exercisable (in shares) | 55 | |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ 228.60 | |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 7 years 109 days | |
Vested and expected to vest (in shares) | 82 | |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ 164 | |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 7 years 292 days |
Note 10 - Stock Options and S49
Note 10 - Stock Options and Stock-based Employee Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Unvested, Beginning Balance (in shares) | 1 | |
Unvested, Beginning Balance (in dollars per share) | $ 36.80 | |
Awarded (in shares) | 190 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 4.33 | $ 36.80 |
Vested (in shares) | (1) | |
Vested (in dollars per share) | $ 36.80 | |
Unvested, Ending Balance (in shares) | 190 | 1 |
Unvested, Ending Balance (in dollars per share) | $ 4.33 | $ 36.80 |
Note 10 - Stock Options and S50
Note 10 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Allocated Share-based Compensation Expense | $ 1,561 | $ 1,423 |
Research and Development Expense [Member] | ||
Allocated Share-based Compensation Expense | 837 | 614 |
Selling, General and Administrative Expenses [Member] | ||
Allocated Share-based Compensation Expense | $ 724 | $ 809 |
Note 10 - Stock Options and S51
Note 10 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Weighted average expected volatility | 79.00% | 78.00% |
Weighted average expected term (in years) (Year) | 6 years 219 days | 5 years 255 days |
Weighted average risk-free interest rate | 2.20% | 1.40% |
Expected dividends |
Note 11 - Collaboration, Lice52
Note 11 - Collaboration, Licensing and Research Funding Agreements (Details Textual) - USD ($) | Nov. 01, 2017 | Oct. 27, 2017 | Aug. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2017 | Oct. 31, 2017 | Sep. 30, 2017 | [1] | Jun. 30, 2017 | [1] | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Oct. 26, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2012 | Feb. 15, 2017 |
Research and Development Expense | $ 2,418,000 | $ 3,062,000 | $ 5,483,000 | $ 6,413,000 | $ 5,948,000 | $ 7,081,000 | $ 8,316,000 | $ 10,360,000 | $ 17,376,000 | $ 31,705,000 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | |||||||||||||||||||
Proceeds from Short-term Debt | $ 3,900,000 | |||||||||||||||||||
Percent of Cash Upfront and Milestone Fees Payable to Esteve | 10.00% | 10.00% | ||||||||||||||||||
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve | $ 20,000,000 | $ 20,000,000 | ||||||||||||||||||
LPH [Member] | Acquisition of Windtree [Member] | ||||||||||||||||||||
Business Combination, Consideration Transferred | $ 10,000,000 | $ 10,000,000 | ||||||||||||||||||
Maximum [Member] | Lee's [Member] | Lee's Loan to Support Operations [Member] | ||||||||||||||||||||
Proceeds from Short-term Debt | $ 3,900,000 | |||||||||||||||||||
Battelle Applies [Member] | ||||||||||||||||||||
Class of Warrants or Right, Number of Warrants Issued | 2 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1,400 | $ 1,400 | ||||||||||||||||||
Class of Warrants or Rights, Term of Warrants | 10 years | |||||||||||||||||||
Maximum Royalty Paid on Completion of Activities Under the Agreement | 35,000,000 | $ 25,000,000 | ||||||||||||||||||
Write-off of Previously Accrued Interest of Collaboration Invoices | $ 600,000 | |||||||||||||||||||
Battelle Applies [Member] | Initial Warrants [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 3,571 | 3,571 | ||||||||||||||||||
Battelle Applies [Member] | Additional Warrants [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1,786 | 1,786 | ||||||||||||||||||
Battelle 2014 Collaboration Agreement [Member] | ||||||||||||||||||||
Research and Development Expense | $ 1,200,000 | 2,900,000 | ||||||||||||||||||
License Agreement With Lee’s [Member] | ||||||||||||||||||||
Proceeds from License Fees Received | $ 1,000,000 | |||||||||||||||||||
License Agreement, Contingent Receivable, Maximum | $ 35,800,000 | $ 37,500,000 | ||||||||||||||||||
Philip Morris USA Inc. - License Agreement [Member] | ||||||||||||||||||||
Payments for Royalties | 300,000 | 250,000 | ||||||||||||||||||
Deferred Royalty Expense | 300,000 | |||||||||||||||||||
Philip Morris Products S.A. - License Agreement [Member] | ||||||||||||||||||||
Payments for Royalties | 487,500 | 62,500 | ||||||||||||||||||
Deferred Royalty Expense | 187,500 | $ 187,500 | ||||||||||||||||||
Johnson and Johnson - License Agreement [Member] | ||||||||||||||||||||
Potential License Fee Payable | $ 2,500,000 | 2,500,000 | ||||||||||||||||||
License Costs | $ 950,000 | |||||||||||||||||||
Payment of License Cost Subject to Regulatory Approval | $ 500,000 | |||||||||||||||||||
[1] | Net loss per common share - basic and diluted and weighted average number of common shares outstanding for the quarters ended June 30, 2017 and September 30, 2017 have been restated to correct immaterial calculation errors related to the conversion of preferred stock to common stock during those periods (See, " - Note 9 - Stockholders' Equity - Private Placement Offerings - February 2017 Private Placement, " for further discussion of our preferred stock). The loss per share for the three and six months ended June 30, 2017 was reduced by $0.80. The loss per share for the three and nine months ended September 30, 2017 was reduced by $3.40. |
Note 12 - Commitments (Details
Note 12 - Commitments (Details Textual) | Jul. 13, 2017 | Feb. 01, 2016USD ($) | Apr. 30, 2016ft² | Sep. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Feb. 28, 2018USD ($)ft² | Jun. 30, 2017 | Mar. 31, 2016ft² |
Operating Leases, Rent Expense, Net | $ 700,000 | $ 800,000 | ||||||||
Severance Costs | $ 200,000 | |||||||||
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 | 48 | ||||||||
The 2016 Restructuring Plan [Member] | ||||||||||
Severance Costs | $ 400,000 | |||||||||
Former CEO's Employment Agreement [Member] | ||||||||||
Payments for Restructuring | 900,000 | |||||||||
Former CEO's Employment Agreement [Member] | Stock Option Expense [Member] | ||||||||||
Severance Costs | $ 200,000 | |||||||||
Former CEO's Employment Agreement [Member] | Not Related to Stock-based Compensation [Member] | ||||||||||
Severance Costs | 1,000,000 | |||||||||
Selling, General and Administrative Expenses [Member] | Former CEO's Employment Agreement [Member] | ||||||||||
Severance Costs | $ 1,200,000 | |||||||||
Headquarters [Member] | ||||||||||
Area of Real Estate Property | ft² | 30,506 | 39,594 | ||||||||
Lessee, Operating Lease, Renewal Term | 4 years | |||||||||
Operating Leases, Future Minimum Payments Due | 3,900,000 | |||||||||
Security Deposit | $ 225,000 | |||||||||
Headquarters [Member] | Subsequent Event [Member] | ||||||||||
Area of Real Estate Property | ft² | 21,189 | |||||||||
Operating Leases, Future Minimum Payments Due | $ 2,500,000 | |||||||||
Security Deposit | $ 140,000 |
Note 14 - Income Taxes (Details
Note 14 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Provisional Expense (Benefit) Due to Revaluation of Deferred Tax Assets (Liabilities) Offset by Change in Valuation Allowance | $ (71,200) | ||
Provisional Tax Expense Related to Deemed Repatriation of Foreign Income | 0 | ||
Operating Loss Carryforwards | 590,000 | $ 581,400 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | 0 | 0 | |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Expense | 0 | 0 | |
Federal Net Operating Loss Stock-Based Compensation [Member] | |||
Operating Loss Carryforwards | 5,200 | ||
State Net Operating Loss Stock-Based Compensation [Member] | |||
Operating Loss Carryforwards | 400 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards | 567,700 | 570,300 | |
Pennsylvania [Member] | |||
Operating Loss Carryforwards | 553,600 | ||
Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | $ 16,800 | $ 15,700 | |
Scenario, Forecast [Member] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% |
Note 14 - Income Taxes - Income
Note 14 - Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | 24 Months Ended |
Dec. 31, 2017 | Dec. 31, 2017 | |
Income tax benefit, statutory rates | $ (6,272) | $ (13,426) |
State taxes on income, net of federal benefit | (398) | (2,599) |
Impact of tax reform | 71,151 | |
Research and development tax credit | (797) | (1,305) |
Employee related | 953 | 1,215 |
Interest related | (147) | (890) |
Warrant valuation related | (76) | |
Income tax expense / (benefit), statutory rates | 64,490 | (17,081) |
Valuation allowance | (64,490) | 17,081 |
Income tax benefit, net |
Note 14 - Income Taxes - Deferr
Note 14 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Long-term deferred assets: | ||
Net operating loss carryforwards (Federal and state) | $ 168,263 | $ 234,825 |
Research and development tax credit | 16,813 | 15,700 |
Compensation expense on stock | 1,191 | 2,157 |
Charitable contribution carryforward | 5 | 6 |
Other accrued | 2,547 | 342 |
Deferred revenue | 317 | |
Depreciation | 297 | 460 |
Total long-term deferred tax assets | 189,433 | 253,490 |
Valuation allowance | (189,433) | (253,490) |
Deferred tax assets, net |
Note 15 - Selected Quarterly 57
Note 15 - Selected Quarterly Financial Data (Unaudited) (Details Textual) - $ / shares | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Jun. 30, 2017 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Earnings Per Share, Basic and Diluted | $ (15.40) | $ (20) | $ (25.80) | $ (34) | $ (24.14) | $ (94.84) | ||||
Restatement Adjustment [Member] | Immaterial Calculation Errors Related to Conversion of Preferred Stock to Common Stock [Member] | ||||||||||
Earnings Per Share, Basic and Diluted | $ 3.40 | $ 0.80 | $ 0.80 | $ 3.40 |
Note 15 - Selected Quarterly 58
Note 15 - Selected Quarterly Financial Data (Unaudited) - Schedule of Quarterly Financial Data (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |||
Revenues: | ||||||||||||
Grant revenue | $ 17 | [1] | $ 1,147 | [1] | $ 219 | $ 900 | $ 961 | $ 106 | $ 75 | $ 1,383 | $ 2,042 | |
License revenue | 102 | [1] | [1] | 102 | ||||||||
Total revenues | 102 | 17 | [1] | 1,147 | [1] | 219 | 900 | 961 | 106 | 75 | 1,485 | 2,042 |
License revenue | 102 | [1] | [1] | 102 | ||||||||
Expenses: | ||||||||||||
Research and Development Expense | 2,418 | 3,062 | [1] | 5,483 | [1] | 6,413 | 5,948 | 7,081 | 8,316 | 10,360 | 17,376 | 31,705 |
Selling, general and administrative | 1,182 | 1,749 | [1] | 1,804 | [1] | 1,922 | 1,320 | 1,613 | 1,783 | 3,657 | 6,657 | 8,373 |
Total expenses | 3,600 | 4,811 | [1] | 7,287 | [1] | 8,335 | 7,268 | 8,694 | 10,099 | 14,017 | 24,033 | 40,078 |
Operating loss | (3,498) | (4,794) | [1] | (6,140) | [1] | (8,116) | (6,368) | (7,733) | (9,993) | (13,942) | (22,548) | (38,036) |
Change in fair value of common stock warrant liability | [1] | [1] | 223 | 223 | ||||||||
Other income / (expense), net | 5,971 | (649) | [1] | (612) | [1] | (608) | (234) | (630) | (631) | (182) | 4,102 | (1,677) |
Net (loss) / income | 2,473 | (5,443) | [1] | (6,752) | [1] | (8,724) | $ (6,602) | $ (8,363) | $ (10,624) | $ (13,901) | (18,446) | (39,490) |
Deemed dividend on preferred stock | (2,234) | [1] | (532) | [1] | (3,604) | (6,370) | ||||||
Net (loss) / income attributable to common shareholders | $ 2,473 | $ (7,677) | [1] | $ (7,284) | [1] | $ (12,328) | $ (24,816) | $ (39,490) | ||||
Net (loss) / income per common share - basic (in dollars per share) | $ 1.03 | $ (10.53) | [1] | $ (14.37) | [1] | $ (27.40) | $ (24.14) | |||||
Net (loss) / income per common share - diluted (in dollars per share) | $ 0.97 | $ (10.53) | [1] | $ (14.37) | [1] | $ (27.40) | $ (24.14) | |||||
Weighted average number of common shares outstanding - basic (in shares) | 2,405 | 729 | 507 | 450 | 1,028 | |||||||
Weighted average number of common shares outstanding - diluted (in shares) | 2,540 | 729 | 507 | 450 | 1,028 | |||||||
Earnings Per Share, Basic and Diluted | $ (15.40) | $ (20) | $ (25.80) | $ (34) | $ (24.14) | $ (94.84) | ||||||
Weighted average number of common shares outstanding - basic and diluted (in shares) | 426 | 418 | 412 | 410 | 1,028 | 416 | ||||||
[1] | Net loss per common share - basic and diluted and weighted average number of common shares outstanding for the quarters ended June 30, 2017 and September 30, 2017 have been restated to correct immaterial calculation errors related to the conversion of preferred stock to common stock during those periods (See, " - Note 9 - Stockholders' Equity - Private Placement Offerings - February 2017 Private Placement, " for further discussion of our preferred stock). The loss per share for the three and six months ended June 30, 2017 was reduced by $0.80. The loss per share for the three and nine months ended September 30, 2017 was reduced by $3.40. |
Note 16 - Subsequent Events (De
Note 16 - Subsequent Events (Details Textual) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||
Apr. 16, 2018 | Mar. 31, 2018 | Jan. 31, 2018 | Feb. 15, 2017 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | |||
Subsequent Event [Member] | Private Placement [Member] | LPH II [Member] | ||||
Private Placement, Purchase Price of Common Stock and Warrants | $ 2.6 | |||
Private Placement, Common Stock and Warrant, Purchase Price per Share | $ 4.80 | |||
Stock Issued During Period, Shares, New Issues | 541,667 | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 135,417 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5.52 | |||
Class of Warrant or Right, Vesting Period | 6 years | |||
Class of Warrant or Right, Expiration Period | 7 years | |||
Registration Rights Agreement, Rights Percentage | 25.00% | |||
LPH [Member] | Subsequent Event [Member] | ||||
Proceeds from Issuance of Debt | $ 1 | $ 1.5 | ||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% |