Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 11, 2019 | |
Document Information [Line Items] | ||
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ | |
Entity Central Index Key | 0000946486 | |
Trading Symbol | wint | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding (in shares) | 32,188,855 | |
Entity Shell Company | false | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Title of 12(g) Security | Common Stock, $0.001 par value |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 4,437 | $ 11,187 |
Available-for-sale marketable securities | 13,959 | |
Prepaid expenses and other current assets | 826 | 507 |
Total current assets | 5,263 | 25,653 |
Property and equipment, net | 877 | 802 |
Restricted cash | 154 | 171 |
Operating lease right-of-use assets | 1,566 | |
Indefinite intangible asset | 77,090 | 77,090 |
Goodwill | 15,682 | 15,682 |
Total assets | 100,632 | 119,398 |
Current Liabilities: | ||
Accounts payable | 607 | 3,420 |
Collaboration and device development payable, net | 1,873 | 2,576 |
Accrued expenses | 5,235 | 6,465 |
Operating lease liabilities - current portion | 781 | |
Deferred revenue | 198 | |
Loans payable | 7,782 | 7,974 |
Total current liabilities | 16,278 | 20,633 |
Operating lease liabilities - non-current portion | 953 | |
Restructured debt liability - contingent milestone payments | 15,000 | 15,000 |
Deferred tax liabilities | 15,224 | 15,476 |
Other liabilities | 106 | 175 |
Total liabilities | 47,561 | 51,284 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2019 and December 31, 2018; 32,188,929 and 32,133,263 shares issued at September 30, 2019 and December 31, 2018, respectively; 32,188,855 and 32,133,189 shares outstanding at September 30, 2019 and December 31, 2018, respectively | 32 | 32 |
Additional paid-in capital | 733,840 | 728,783 |
Accumulated deficit | (677,747) | (657,647) |
Accumulated other comprehensive income | 0 | |
Treasury stock (at cost); 74 shares | (3,054) | (3,054) |
Total stockholders' equity | 53,071 | 68,114 |
Total liabilities & stockholders' equity | $ 100,632 | $ 119,398 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
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) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 32,188,929 | 32,133,263 |
Common stock, shares outstanding (in shares) | 32,188,855 | 32,133,189 |
Treasury stock, shares (in shares) | 74 | 74 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 229 | $ 198 | $ 1,484 | |
Expenses: | ||||
Research and development | 3,792 | 2,197 | 10,547 | 8,194 |
General and administrative | 3,395 | 1,500 | 9,990 | 4,634 |
Total operating expenses | 7,187 | 3,697 | 20,537 | 12,828 |
Operating loss | (7,187) | (3,468) | (20,339) | (11,344) |
Other income / (expense): | ||||
Interest income | 25 | 1 | 124 | 9 |
Interest expense | (105) | (460) | (358) | (642) |
Other income, net | 141 | 473 | 486 | |
Other income / (expense), net | 61 | (459) | 239 | (147) |
Net loss | $ (7,126) | $ (3,927) | $ (20,100) | $ (11,491) |
Net loss per common share | ||||
Basic and diluted (in dollars per share) | $ (0.22) | $ (1.04) | $ (0.62) | $ (3.21) |
Weighted average number of common shares outstanding | ||||
Basic and diluted (in shares) | 32,189 | 3,769 | 32,173 | 3,585 |
Grant [Member] | ||||
Revenues: | ||||
Revenues | $ 70 | $ 765 | ||
License [Member] | ||||
Revenues: | ||||
Revenues | $ 159 | $ 198 | $ 719 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Net loss | $ (7,126) | $ (3,927) | $ (20,100) | $ (11,491) |
Other comprehensive income: | ||||
Unrealized gain (loss) on marketable securities | (12) | |||
Comprehensive loss | $ (7,138) | $ (3,927) | $ (20,100) | $ (11,491) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Treasury Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2017 | 3 | 3,227 | |||||
Balance at Dec. 31, 2017 | $ 3 | $ 616,245 | $ (637,114) | $ (3,054) | $ (23,920) | ||
Net loss | (4,512) | (4,512) | |||||
Share Purchase Agreement, April 2018 | (52) | (52) | |||||
Stock-based compensation expense | 418 | 418 | |||||
Balance (in shares) at Mar. 31, 2018 | 3 | 3,227 | |||||
Balance at Mar. 31, 2018 | $ 3 | 616,611 | (641,626) | $ (3,054) | (28,066) | ||
Balance (in shares) at Dec. 31, 2017 | 3 | 3,227 | |||||
Balance at Dec. 31, 2017 | $ 3 | 616,245 | (637,114) | $ (3,054) | (23,920) | ||
Net loss | (11,491) | ||||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2018 | 3 | 3,769 | |||||
Balance at Sep. 30, 2018 | $ 4 | 620,322 | (648,605) | $ (3,054) | (31,333) | ||
Balance (in shares) at Mar. 31, 2018 | 3 | 3,227 | |||||
Balance at Mar. 31, 2018 | $ 3 | 616,611 | (641,626) | $ (3,054) | (28,066) | ||
Net loss | (3,052) | (3,052) | |||||
Stock-based compensation expense | 140 | 140 | |||||
Issuance of common stock, Share Purchase Agreement, April 2018 (in shares) | 542 | ||||||
Issuance of common stock, Share Purchase Agreement, April 2018 | $ 1 | 2,593 | 2,594 | ||||
Balance (in shares) at Jun. 30, 2018 | 3 | 3,769 | |||||
Balance at Jun. 30, 2018 | $ 4 | 619,344 | (644,678) | $ (3,054) | (28,384) | ||
Net loss | (3,927) | (3,927) | |||||
Stock-based compensation expense | 145 | 145 | |||||
Issuance of warrants, equity consideration in debt issuance | 833 | 833 | |||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2018 | 3 | 3,769 | |||||
Balance at Sep. 30, 2018 | $ 4 | 620,322 | (648,605) | $ (3,054) | (31,333) | ||
Balance (in shares) at Dec. 31, 2018 | 32,133 | ||||||
Balance at Dec. 31, 2018 | $ 32 | 728,783 | (657,647) | $ (3,054) | 68,114 | ||
Net loss | (6,537) | (6,537) | |||||
Stock-based compensation expense | 1,530 | 1,530 | |||||
Vesting of restricted stock units (in shares) | 56 | ||||||
Vesting of restricted stock units | |||||||
Withholding tax payments related to net share settlements of restricted stock units (in shares) | |||||||
Withholding tax payments related to net share settlements of restricted stock units | (151) | (151) | |||||
Unrealized gain (loss) on marketable securities | 40 | 40 | |||||
Balance (in shares) at Mar. 31, 2019 | 32,189 | ||||||
Balance at Mar. 31, 2019 | $ 32 | 730,162 | (664,184) | 40 | $ (3,054) | 62,996 | |
Balance (in shares) at Dec. 31, 2018 | 32,133 | ||||||
Balance at Dec. 31, 2018 | $ 32 | 728,783 | (657,647) | $ (3,054) | 68,114 | ||
Net loss | (20,100) | ||||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2019 | 32,189 | ||||||
Balance at Sep. 30, 2019 | $ 32 | 733,840 | (677,747) | $ (3,054) | 53,071 | ||
Balance (in shares) at Mar. 31, 2019 | 32,189 | ||||||
Balance at Mar. 31, 2019 | $ 32 | 730,162 | (664,184) | 40 | $ (3,054) | 62,996 | |
Net loss | (6,437) | (6,437) | |||||
Stock-based compensation expense | 1,739 | 1,739 | |||||
Unrealized gain (loss) on marketable securities | (28) | (28) | |||||
Balance (in shares) at Jun. 30, 2019 | 32,189 | ||||||
Balance at Jun. 30, 2019 | $ 32 | 731,901 | (670,621) | 12 | $ (3,054) | 58,270 | |
Net loss | (7,126) | (7,126) | |||||
Stock-based compensation expense | 1,939 | 1,938 | |||||
Unrealized gain (loss) on marketable securities | (12) | (12) | |||||
Balance (in shares) at Sep. 30, 2019 | 32,189 | ||||||
Balance at Sep. 30, 2019 | $ 32 | $ 733,840 | $ (677,747) | $ (3,054) | $ 53,071 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (20,100) | $ (11,491) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Recognition of deferred revenue | (198) | (789) |
Depreciation | 178 | 121 |
Amortization of operating lease right-of-use assets | 741 | |
Amortization of debt discount | 127 | 303 |
Stock-based compensation | 5,208 | 703 |
Realized gain on investments | (75) | |
Gain on sale of property and equipment | (9) | |
Changes in: | ||
Prepaid expenses and other current assets | 389 | 23 |
Accounts payable | (2,813) | 1,471 |
Collaboration and device development payable | (830) | 146 |
Accrued expenses | (1,166) | (68) |
Operating lease liabilities | (784) | |
Other liabilities | 119 | |
Net cash used in operating activities | (19,204) | (9,590) |
Cash flows from investing activities: | ||
Proceeds from sale of marketable securities | 13,988 | |
Purchase of property and equipment | (129) | |
Proceeds from sale of property and equipment | 9 | |
Net cash provided by investing activities | 13,859 | 9 |
Cash flows from financing activities: | ||
Proceeds from loan payable, net of expenses | 4,280 | |
Proceeds from private placement issuance of securities, net of expenses | 2,541 | |
Proceeds from convertible note payable | 1,500 | |
Principle payments on loans payable | (820) | |
Payment for taxes related to net share settlements of restricted stock units | (151) | |
Net cash (used in) / provided by financing activities | (971) | 8,321 |
Effect of exchange rate changes on cash and cash equivalents | (451) | |
Net decrease in cash and cash equivalents | (6,767) | (1,260) |
Cash, cash equivalents and restricted cash - beginning of period | 11,358 | 2,040 |
Cash, cash equivalents and restricted cash - end of period | 4,591 | 780 |
Supplementary disclosure of non-cash activity: | ||
Prepayment of director and officer insurance through 3rd party financing | $ 708 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 9 Months Ended |
Sep. 30, 2019 | |
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 and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases. Through 2018, KL4 December 2018, may Our four 1 2 KL4 3 KL4 4 2 3. 2a See 3 The reader is referred to, and encouraged to read in its entirety, Item 1 10 December 31, 2018 April 16, 2019, 10 April 23, 2019 ( 2018 10 10 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 Basis of Presentation These interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the US (US GAAP) for interim financial information in accordance with the instructions to Form 10 not three nine September 30, 2019 not may December 31, 2019. no December 31, 2018. December 31, 2018 2018 10 10 |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Liquidity Disclosures [Text Block] | Note 3 Liquidity Risks and Management’s Plans As of September 30, 2019, $4.4 $16.3 $7.8 see 7 October 24, 2019, $1.0 November 2019 We have an immediate need for additional capital to continue our operations. Even if we are able to secure such additional capital in the near term, we expect to continue to incur significant losses and will require significant additional capital to support our operations, advance our clinical development programs, and satisfy existing obligations. We currently only have cash and cash equivalent resources to fund our business operations through late- November 2019, not one To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans, and is currently actively engaged in discussions with various parties, including our largest shareholders, seeking to secure additional capital, potentially through one none no may not none November 2019 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 September 30, 2019, 120.0 5.0 72.0 5.0 not |
Note 4 - Summary of Significant
Note 4 - Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 4 Summary of Significant Accounting Policies Principles of C onsolidation The condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree Therapeutics, Inc. and its wholly-owned subsidiaries, CVie Investments, CVie Therapeutics, and a presently inactive subsidiary, Discovery Laboratories, Inc. Business C ombinations We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value of the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results may Goodwill and I ntangible A ssets We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development (IPR&D) assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not may September 30, 2019 December 31, 2018: (in thousands) Carrying Value Istaroxime drug candidate $ 22,340 Rostafuroxin drug candidate 54,750 Total $ 77,090 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not may not not Foreign C urrency T ransactions The functional currency for our foreign subsidiaries is US dollars. We remeasure monetary assets and liabilities that are not $0.1 $0.4 three nine September 30, 2019. no three nine September 30, 2018. Use of E stimates The preparation of financial statements, in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Marketable S ecurities Marketable securities consist of investments in US Treasury securities. Management determines the appropriate classification of these securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. We classify investments as available-for-sale pursuant to Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 320, three September 30, 2019, $14,000 $12,000 nine September 30, 2019, $75,000 no three nine September 30, 2018. We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not not Available-for-sale marketable securities are classified as marketable securities, current or marketable securities, non-current depending on the contractual maturity date of the individual available-for-sale security. Leases Effective January 1, 2019, 842, Leases 842 not 840, Leases At the inception of an arrangement, we determine whether an arrangement is, or contains, a lease based on the unique facts and circumstances present in the arrangement. An arrangement is, or contains, a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than one not 12 not Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may not 842, Restructured D ebt L iability – Co ntingent M ilestone P ayment In conjunction with the November 2017 s ee, 8 $15 October 27, 2017 ( not Research and D evelopment We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development Net L oss per C ommon S hare 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 September 30, 2019 2018, 15.6 1.3 three nine September 30, 2019 2018, Income T axes 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 Recently A dopted A ccounting S tandards In February 2016, No. 2016 02, Leases 2016 02 2016 02 842 840, Leases 842 2018. January 1, 2019 not not January 1, 2019. 840 ASC 842 not 12 not The adoption of this standard resulted in the recognition of operating lease liabilities and related right-of-use assets on our condensed consolidated balance sheets of $2.2 $2.0 842 $72,000 $139,000 not 10 In January 2017, No. 2017 04, 350 second December 15, 2019 January 1, 2019 December 31, 2019. Recently Issued Accounting Standards In August 2018, No. 2018 13, 820 2018 13 820. no 1 2 3 3 3 2018 13 December 15, 2019. 2018 13 |
Note 5 - License Revenue with A
Note 5 - License Revenue with Affiliate | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | Note 5 License Revenue with Affiliate Three Months Ended Nine Months Ended (in thousands) 2019 2018 2019 2018 License revenue with affiliate $ - $ 159 $ 198 $ 719 License revenue with affiliate represents revenue from a License Agreement with Lee’s Pharmaceutical (HK) Ltd. (Lee’s (HK)), an affiliate of our largest shareholder, Lee’s Pharmaceutical Holdings Limited (Lee’s), and constitutes a contract with a customer accounted for in accordance with ASC Topic 606. June 30, 2019, no |
Note 6 - Fair Value of Financia
Note 6 - Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
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 ● Level 2 1 not ● Level 3 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 September 30, (in thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 4,437 $ 4,437 $ - $ - U.S. Treasury notes - - - - Certificate of deposit 154 154 - - Total Assets $ 4,591 $ 4,591 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2018 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 5,234 $ 5,234 $ - $ - U.S. Treasury notes 19,912 19,912 - - Certificate of deposit 171 171 - - Total Assets $ 25,317 $ 25,317 $ - $ - |
Note 7 - Loans Payable
Note 7 - Loans Payable | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Short-term Debt [Text Block] | Note 7 Loan s Payable In January 2018 March 2018, $1.5 $1.0 one 6% December 31, 2018. March 1, 2018 ( December 5, 2018, $6.0 $1.5 $1.0 Assumption of bank debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $4.5 March 2020. In September 2016, 12 $2.9 $5.8 September 2017. 110% not 90 0.91%. September 11, 2019 six March 11, 2020. 2021. As of September 30, 2019, $4.5 Assumption of Lee's debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $3.5 From April 24, 2018 November 16, 2018, four $3.5 4% one $0.5 April 2019; $0.3 September 2019; $0.2 October 2019; $2.5 November 2019. no April 30, 2021. During the quarter ended March 31, 2019, $0.45 April 2018 $50,000 April 2019. September 30, 2019, $3.0 Loan payable to Bank Direct Capital Finance In May 2019, $0.7 5.35% $80,000 March 2020. September 30, 2019, $0.4 |
Note 8 - Restructured Debt Liab
Note 8 - Restructured Debt Liability | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | Note 8 Restructured Debt Liability September 30, December 31, (in thousands) 2019 2018 Restructured debt liability - contingent milestone payments $ 15,000 $ 15,000 On November 1, 2017, $25 25,000 $786.80 $2.5 71,111 2% $15 $15 see 4 not |
Note 9 - Stock Options and Stoc
Note 9 - Stock Options and Stock-based Employee Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | Note 9 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 six 18 A summary of activity under our long-term incentive plan is presented below: (in thousands, except for weighted-average data) Stock Options Shares Weighted- Weighted- Outstanding at January 1, 2019 4,417 $ 6.73 Granted 1,144 4.20 Forfeited or expired (5 ) 467.57 Outstanding at September 30, 2019 5,556 $ 5.80 9.2 Vested and exercisable at September 30, 2019 70 $ 128.45 6.3 Vested and expected to vest at September 30, 2019 5,245 $ 5.79 9.2 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2019 151 $ 4.29 Awarded 249 3.95 Vested (95 ) 3.95 Cancelled (144 ) 4.33 Unvested at September 30, 2019 161 $ 4.04 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: Nine Months Ended 2019 Weighted average expected volatility 95% Weighted average expected term (in years) 6.6 Weighted average risk-free interest rate 2.6% Expected dividends - The table below summarizes the total stock-based compensation expense included in the condensed consolidated statements of operations for the periods presented: Three Months Ended Nine Months Ended (in thousands) 2019 2018 2019 2018 Research and development $ 574 $ 29 $ 1,613 $ 169 General and administrative 1,365 116 3,595 534 Total $ 1,939 $ 145 $ 5,208 $ 703 |
Note 10 - Leases
Note 10 - Leases | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 10 Leases Our operating leases consist primarily of facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan. We maintain our corporate headquarters and operations in Warrington, Pennsylvania, with a remaining non-cancelable term of approximately three Throughout the term of our leases, we are responsible for paying certain variable lease costs, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities. The following table contains a summary of the lease costs recognized under ASC 842 three nine September 30, 2019: Three Months Ended Nine Months Ended (in thousands) 2019 2019 Operating lease cost $ 212 $ 677 Variable lease cost 5 17 Total lease cost $ 217 $ 694 Other Information Operating cash flows used for operating leases $ 227 $ 721 Operating lease liabilities arising from obtaining right-of-use assets $ 232 $ 364 Weighted average remaining lease term (in years) 2.4 2.4 Weighted average incremental borrowing rate 9.00 % 9.00 % Future minimum lease payments under our non-cancelable operating leases as of September 30, 2019, As of (in thousands) 2019 2019 (excluding the nine months ended September 30, 2019) $ 230 2020 849 2021 638 2022 179 2023 23 Thereafter - Total lease payments 1,919 Less imputed interest (184 ) Total operating lease liabilities at September 30, 2019 1,735 |
Note 11 - Subsequent Event
Note 11 - Subsequent Event | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 11 Subsequent Event Effective as of October 24, 2019, $1.0 October 28, 2019, 6% December 31, 2019. may may |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of C onsolidation The condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree Therapeutics, Inc. and its wholly-owned subsidiaries, CVie Investments, CVie Therapeutics, and a presently inactive subsidiary, Discovery Laboratories, Inc. |
Business Combinations Policy [Policy Text Block] | Business C ombinations We follow the acquisition method for an acquisition of a business where the purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values at the dates of acquisition. The excess of the fair value of purchase consideration over the fair value of the assets acquired and liabilities assumed is recorded as goodwill. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets. Management’s estimate of fair value is based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and as such, actual results may |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Goodwill and I ntangible A ssets We record acquired identified intangibles, which includes intangible assets (such as goodwill and other intangibles), based on estimated fair value. The acquired in-process research and development (IPR&D) assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not may September 30, 2019 December 31, 2018: (in thousands) Carrying Value Istaroxime drug candidate $ 22,340 Rostafuroxin drug candidate 54,750 Total $ 77,090 Goodwill represents the excess of the purchase price over the fair value of assets acquired and liabilities assumed in a business combination and is not may not not |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign C urrency T ransactions The functional currency for our foreign subsidiaries is US dollars. We remeasure monetary assets and liabilities that are not $0.1 $0.4 three nine September 30, 2019. no three nine September 30, 2018. |
Use of Estimates, Policy [Policy Text Block] | Use of E stimates The preparation of financial statements, in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Marketable Securities, Policy [Policy Text Block] | Marketable S ecurities Marketable securities consist of investments in US Treasury securities. Management determines the appropriate classification of these securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. We classify investments as available-for-sale pursuant to Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 320, three September 30, 2019, $14,000 $12,000 nine September 30, 2019, $75,000 no three nine September 30, 2018. We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not not Available-for-sale marketable securities are classified as marketable securities, current or marketable securities, non-current depending on the contractual maturity date of the individual available-for-sale security. |
Lessee, Leases [Policy Text Block] | Leases Effective January 1, 2019, 842, Leases 842 not 840, Leases At the inception of an arrangement, we determine whether an arrangement is, or contains, a lease based on the unique facts and circumstances present in the arrangement. An arrangement is, or contains, a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than one not 12 not Operating lease liabilities and their corresponding operating lease right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may not 842, |
Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block] | Restructured D ebt L iability – Co ntingent M ilestone P ayment In conjunction with the November 2017 s ee, 8 $15 October 27, 2017 ( not |
Research and Development Expense, Policy [Policy Text Block] | Research and D evelopment We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development |
Earnings Per Share, Policy [Policy Text Block] | Net L oss per C ommon S hare 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 September 30, 2019 2018, 15.6 1.3 three nine September 30, 2019 2018, |
Income Tax, Policy [Policy Text Block] | Income T axes 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 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently A dopted A ccounting S tandards In February 2016, No. 2016 02, Leases 2016 02 2016 02 842 840, Leases 842 2018. January 1, 2019 not not January 1, 2019. 840 ASC 842 not 12 not The adoption of this standard resulted in the recognition of operating lease liabilities and related right-of-use assets on our condensed consolidated balance sheets of $2.2 $2.0 842 $72,000 $139,000 not 10 In January 2017, No. 2017 04, 350 second December 15, 2019 January 1, 2019 December 31, 2019. Recently Issued Accounting Standards In August 2018, No. 2018 13, 820 2018 13 820. no 1 2 3 3 3 2018 13 December 15, 2019. 2018 13 |
Note 4 - Summary of Significa_2
Note 4 - Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Schedule of Indefinite-Lived Intangible Assets [Table Text Block] | (in thousands) Carrying Value Istaroxime drug candidate $ 22,340 Rostafuroxin drug candidate 54,750 Total $ 77,090 |
Note 5 - License Revenue with_2
Note 5 - License Revenue with Affiliate (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended Nine Months Ended (in thousands) 2019 2018 2019 2018 License revenue with affiliate $ - $ 159 $ 198 $ 719 |
Note 6 - Fair Value of Financ_2
Note 6 - Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Fair value measurement using September 30, (in thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 4,437 $ 4,437 $ - $ - U.S. Treasury notes - - - - Certificate of deposit 154 154 - - Total Assets $ 4,591 $ 4,591 $ - $ - Fair Value Fair value measurement using December 31, (in thousands) 2018 Level 1 Level 2 Level 3 Assets: Cash and cash equivalents $ 5,234 $ 5,234 $ - $ - U.S. Treasury notes 19,912 19,912 - - Certificate of deposit 171 171 - - Total Assets $ 25,317 $ 25,317 $ - $ - |
Note 8 - Restructured Debt Li_2
Note 8 - Restructured Debt Liability (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Schedule of Long-term Debt Instruments [Table Text Block] | September 30, December 31, (in thousands) 2019 2018 Restructured debt liability - contingent milestone payments $ 15,000 $ 15,000 |
Note 9 - Stock Options and St_2
Note 9 - Stock Options and Stock-based Employee Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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- Weighted- Outstanding at January 1, 2019 4,417 $ 6.73 Granted 1,144 4.20 Forfeited or expired (5 ) 467.57 Outstanding at September 30, 2019 5,556 $ 5.80 9.2 Vested and exercisable at September 30, 2019 70 $ 128.45 6.3 Vested and expected to vest at September 30, 2019 5,245 $ 5.79 9.2 |
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, 2019 151 $ 4.29 Awarded 249 3.95 Vested (95 ) 3.95 Cancelled (144 ) 4.33 Unvested at September 30, 2019 161 $ 4.04 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Nine Months Ended 2019 Weighted average expected volatility 95% Weighted average expected term (in years) 6.6 Weighted average risk-free interest rate 2.6% Expected dividends - |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Nine Months Ended (in thousands) 2019 2018 2019 2018 Research and development $ 574 $ 29 $ 1,613 $ 169 General and administrative 1,365 116 3,595 534 Total $ 1,939 $ 145 $ 5,208 $ 703 |
Note 10 - Leases (Tables)
Note 10 - Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three Months Ended Nine Months Ended (in thousands) 2019 2019 Operating lease cost $ 212 $ 677 Variable lease cost 5 17 Total lease cost $ 217 $ 694 Other Information Operating cash flows used for operating leases $ 227 $ 721 Operating lease liabilities arising from obtaining right-of-use assets $ 232 $ 364 Weighted average remaining lease term (in years) 2.4 2.4 Weighted average incremental borrowing rate 9.00 % 9.00 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | As of (in thousands) 2019 2019 (excluding the nine months ended September 30, 2019) $ 230 2020 849 2021 638 2022 179 2023 23 Thereafter - Total lease payments 1,919 Less imputed interest (184 ) Total operating lease liabilities at September 30, 2019 1,735 |
Note 3 - Liquidity Risks and _2
Note 3 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands | Oct. 24, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Cash and Cash Equivalents, at Carrying Value, Ending Balance | $ 4,437 | $ 11,187 | |
Liabilities, Current, Total | 16,278 | $ 20,633 | |
Loans Payable, Current, Total | $ 7,800 | ||
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 | |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | |
Common Stock, Capital Shares Available for Issuance | 72,000,000 | ||
Preferred Stock, Capital Shares Available for Issuance | 5,000,000 | ||
Subsequent Event [Member] | LPH II [Member] | LPH II Loan [Member] | |||
Proceeds from Issuance of Debt | $ 1,000 |
Note 4 - Summary of Significa_3
Note 4 - Summary of Significant Accounting Policies (Details Textual) - USD ($) shares in Millions | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 01, 2017 | |
Foreign Currency Transaction Gain (Loss), before Tax, Total | $ 100,000 | $ 0 | $ 400,000 | $ 0 | |||
Marketable Securities, Realized Gain (Loss), Total | 14,000 | 75,000 | |||||
Marketable Securities, Unrealized Gain (Loss), Total | (12,000) | 0 | $ 0 | ||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000,000 | $ 15,000,000 | $ 15,000,000 | ||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants | 15.6 | 1.3 | |||||
Operating Lease, Right-of-Use Asset | 1,566,000 | $ 1,566,000 | |||||
Operating Lease, Liability, Total | 1,735,000 | 1,735,000 | |||||
Accrued Liabilities, Current, Total | 5,235,000 | 5,235,000 | 6,465,000 | ||||
Other Liabilities, Noncurrent, Total | 106,000 | 106,000 | 175,000 | ||||
Accounting Standards Update 2016-02 [Member] | |||||||
Operating Lease, Right-of-Use Asset | $ 2,200,000 | ||||||
Operating Lease, Liability, Total | 2,000,000 | ||||||
Accrued Liabilities, Current, Total | (72,000) | ||||||
Other Liabilities, Noncurrent, Total | $ (139,000) | ||||||
Deerfield Loan [Member] | |||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000,000 | $ 15,000,000 | $ 15,000,000 | ||||
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000,000 |
Note 4 - Summary of Significa_4
Note 4 - Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Indefinite intangible asset | $ 77,090 | $ 77,090 |
Istaroxime Drug Candidate [Member] | ||
Indefinite intangible asset | 22,340 | |
Rostafuroxin Drug Candidate [Member] | ||
Indefinite intangible asset | $ 54,750 |
Note 5 - License Revenue with_3
Note 5 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
License [Member] | ||||
License revenue with affiliate | $ 159 | $ 198 | $ 719 |
Note 6 - Fair Value of Financ_3
Note 6 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Cash and cash equivalents | $ 4,437 | $ 5,234 |
Total Assets | 4,591 | 25,317 |
Certificates of Deposit [Member] | ||
Certificate of deposit | 154 | 171 |
US Treasury Securities [Member] | ||
Cash and cash equivalents | 19,912 | |
U.S. Treasury notes | ||
Fair Value, Inputs, Level 1 [Member] | ||
Cash and cash equivalents | 4,437 | 5,234 |
Total Assets | 4,591 | 25,317 |
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | ||
Certificate of deposit | 154 | 171 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Cash and cash equivalents | 19,912 | |
U.S. Treasury notes | ||
Fair Value, Inputs, Level 2 [Member] | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | ||
Certificate of deposit | ||
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Cash and cash equivalents | ||
U.S. Treasury notes | ||
Fair Value, Inputs, Level 3 [Member] | ||
Cash and cash equivalents | ||
Total Assets | ||
Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | ||
Certificate of deposit | ||
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Cash and cash equivalents | ||
U.S. Treasury notes |
Note 7 - Loans Payable (Details
Note 7 - Loans Payable (Details Textual) $ in Millions | Dec. 21, 2018USD ($) | Dec. 05, 2018USD ($) | May 30, 2019USD ($) | Apr. 30, 2019USD ($) | Mar. 31, 2018USD ($) | Jan. 31, 2018USD ($) | Sep. 30, 2017TWD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Nov. 16, 2018USD ($) | Sep. 30, 2016USD ($) |
Repayments of Short-term Debt, Total | $ 820,000 | ||||||||||||
Short-term Debt, Total | 7,782,000 | $ 7,974,000 | |||||||||||
Debt Payable to Lee's International [Member] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||||||||||
Debt Instrument, Face Amount | $ 3,500,000 | ||||||||||||
Repayments of Short-term Debt, Total | $ 50,000 | $ 450,000 | |||||||||||
Short-term Debt, Total | 3,000,000 | ||||||||||||
Debt Payable to Lee's International [Member] | Debt Maturing April 2019 [Member] | |||||||||||||
Debt Instrument, Face Amount | 500,000 | ||||||||||||
Debt Payable to Lee's International [Member] | Debt Maturing September 2019 [Member] | |||||||||||||
Debt Instrument, Face Amount | 300,000 | ||||||||||||
Debt Payable to Lee's International [Member] | Debt Maturing October 2019 [Member] | |||||||||||||
Debt Instrument, Face Amount | 200,000 | ||||||||||||
Debt Payable to Lee's International [Member] | Debt Maturing November 2019 [Member] | |||||||||||||
Debt Instrument, Face Amount | $ 2,500,000 | ||||||||||||
Debt Payable to Lee's International [Member] | CVie Investments [Member] | |||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt | $ 3,500,000 | ||||||||||||
Loan payable to Bank Direct Capital Finance [Member] | |||||||||||||
Loans Payable to Bank, Total | 400,000 | ||||||||||||
Loan payable to Bank Direct Capital Finance [Member] | Loans Payable [Member] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.35% | ||||||||||||
Debt Instrument, Face Amount | $ 700,000 | ||||||||||||
Debt Instrument, Periodic Payment, Total | $ 80,000 | ||||||||||||
Loan Payable Obligation Converted to LPH II [Member] | |||||||||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | ||||||||||||
LPH [Member] | |||||||||||||
Proceeds from Issuance of Debt | $ 1,000,000 | $ 1,500,000 | |||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% | ||||||||||||
LPH [Member] | Loan Payable Obligation Converted to LPH II [Member] | Debt Issued on January 2018 [Member] | |||||||||||||
Debt Conversion, Original Debt, Amount | $ 1,500,000 | ||||||||||||
LPH [Member] | Loan Payable Obligation Converted to LPH II [Member] | Debt Issued on March 2018 [Member] | |||||||||||||
Debt Conversion, Original Debt, Amount | $ 1,000,000 | ||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | |||||||||||||
Line of Credit Facility, Percent of Pledged Deposits Required | 110.00% | ||||||||||||
Line of Credit, Current | $ 4,500,000 | ||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | Taipei Interbank Offer Rate (TAIBOR) [Member] | |||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.91% | ||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | CVie Investments [Member] | |||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5.8 | $ 2,900,000 | |||||||||||
O-Bank Co., Ltd. [Member] | CVie Investments [Member] | Revolving Credit Facility [Member] | |||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total | $ 4,500,000 |
Note 8 - Restructured Debt Li_3
Note 8 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Nov. 01, 2017 | Sep. 30, 2019 | Dec. 31, 2018 |
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | |
Deerfield Loan [Member] | |||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 15,000 | |
Deerfield Loan [Member] | Exchange and Termination Agreement [Member] | Deerfield Management, L.P. [Member] | |||
Extinguishment of Debt, Amount | $ 25,000 | ||
Class of Warrant or Right, Number of Warrants Cancelled | 25,000 | ||
Class of Warrant or Right, Exercise Price of Cancelled Warrants | $ 786.80 | ||
Repayments of Long-term Debt, Total | $ 2,500 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations | 71,111 | ||
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding | 2.00% | ||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 |
Note 8 - Restructured Debt Li_4
Note 8 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 15,000 |
Deerfield Loan [Member] | ||
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 15,000 |
Note 9 - Stock Options and St_3
Note 9 - Stock Options and Stock-based Employee Compensation (Details Textual) - The 2011 Long-term Incentive Plan [Member] | 9 Months Ended |
Sep. 30, 2019 | |
Stock-based Awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 3 years |
Restricted Stock Units (RSUs) [Member] | Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 180 days |
Restricted Stock Units (RSUs) [Member] | Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 1 year 180 days |
Note 9 - Stock Options and St_4
Note 9 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Shares Outstanding, Beginning Balance (in shares) | shares | 4,417 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ / shares | $ 6.73 |
Shares Granted (in shares) | shares | 1,144 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ / shares | $ 4.20 |
Shares Forfeited or Expired (in shares) | shares | (5) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ / shares | $ 467.57 |
Shares Outstanding, Ending Balance (in shares) | shares | 5,556 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ / shares | $ 5.80 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 9 years 73 days |
Shares Vested and Exercisable (in shares) | shares | 70 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ / shares | $ 128.45 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 6 years 109 days |
Vested and expected to vest (in shares) | shares | 5,245 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ / shares | $ 5.79 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 9 years 73 days |
Note 9 - Stock Options and St_5
Note 9 - Stock Options and Stock-based Employee Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Unvested, Beginning Balance (in shares) | shares | 151 |
Unvested, Beginning Balance (in dollars per share) | $ / shares | $ 4.29 |
Awarded (in shares) | shares | 249 |
Awarded (in dollars per share) | $ / shares | $ 3.95 |
Vested (in shares) | shares | (95) |
Vested (in dollars per share) | $ / shares | $ 3.95 |
Cancelled (in shares) | shares | (144) |
Cancelled (in dollars per share) | $ / shares | $ 4.33 |
Unvested, Ending Balance (in shares) | shares | 161 |
Unvested, Ending Balance (in dollars per share) | $ / shares | $ 4.04 |
Note 9 - Stock Options and St_6
Note 9 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 9 Months Ended |
Sep. 30, 2019 | |
Weighted average expected volatility | 95.00% |
Weighted average expected term (Year) | 6 years 219 days |
Weighted average risk-free interest rate | 2.60% |
Expected dividends |
Note 9 - Stock Options and St_7
Note 9 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-based compensation expense | $ 1,939 | $ 145 | $ 5,208 | $ 703 |
Research and Development Expense [Member] | ||||
Stock-based compensation expense | 574 | 29 | 1,613 | 169 |
General and Administrative Expense [Member] | ||||
Stock-based compensation expense | $ 1,365 | $ 116 | $ 3,595 | $ 534 |
Note 10 - Leases (Details Textu
Note 10 - Leases (Details Textual) - USD ($) $ in Millions | Apr. 01, 2019 | Sep. 30, 2019 |
Operating Lease, Weighted Average Remaining Lease Term | 2 years 146 days | |
Reduction in Operating Lease Liability | $ 0.2 | |
Warrington, Pennsylvania [Member] | ||
Operating Lease, Weighted Average Remaining Lease Term | 3 years |
Note 10 - Leases - Lease Costs
Note 10 - Leases - Lease Costs (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Operating lease cost | $ 212 | $ 677 |
Variable lease cost | 5 | 17 |
Total lease cost | 217 | 694 |
Operating cash flows used for operating leases | 227 | 721 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 232 | $ 364 |
Weighted average remaining lease term (in years) (Year) | 2 years 146 days | 2 years 146 days |
Weighted average incremental borrowing rate | 9.00% | 9.00% |
Note 10 - Leases - Future Minim
Note 10 - Leases - Future Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2019USD ($) |
2019 (excluding the nine months ended September 30, 2019) | $ 230 |
2020 | 849 |
2021 | 638 |
2022 | 179 |
2023 | 23 |
Thereafter | |
Total lease payments | 1,919 |
Less imputed interest | (184) |
Total operating lease liabilities at September 30, 2019 | $ 1,735 |
Note 11 - Subsequent Event (Det
Note 11 - Subsequent Event (Details Textual) - LPH II Loan [Member] - Subsequent Event [Member] - LPH II [Member] - USD ($) $ in Millions | Oct. 24, 2019 | Oct. 28, 2019 |
Proceeds from Issuance of Debt | $ 1 | |
Debt Instrument, Interest Rate, Effective Percentage | 6.00% |