Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2019 | |
Document Information [Line Items] | |
Entity Registrant Name | WINDTREE THERAPEUTICS INC /DE/ |
Entity Central Index Key | 0000946486 |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | false |
Entity Small Business | true |
Document Type | S-1 |
Document Period End Date | Sep. 30, 2019 |
Document Fiscal Year Focus | 2019 |
Document Fiscal Period Focus | Q3 |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 11,187,000 | $ 1,815,000 |
Available-for-sale marketable securities | 13,959,000 | |
Prepaid expenses and other current assets | 507,000 | 422,000 |
Total current assets | 25,653,000 | 2,237,000 |
Property and equipment, net | 802,000 | 885,000 |
Restricted cash | 171,000 | 225,000 |
Indefinite intangible asset | 77,090,000 | |
Goodwill | 15,682,000 | |
Total assets | 119,398,000 | 3,347,000 |
Current Liabilities: | ||
Accounts payable | 3,420,000 | 2,324,000 |
Collaboration and device development payable, net | 2,576,000 | 4,418,000 |
Accrued Liabilities, Current, Total | 6,465,000 | 4,134,000 |
Deferred revenue - current portion | 198,000 | 884,000 |
Loan payable | 7,974,000 | |
Total current liabilities | 20,633,000 | 11,760,000 |
Restructured debt liability - contingent milestone payments | 15,000,000 | 15,000,000 |
Deferred revenue - non-current portion | 407,000 | |
Deferred tax liabilities | 15,476,000 | |
Other liabilities | 175,000 | 100,000 |
Total liabilities | 51,284,000 | 27,267,000 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares and 2,701 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2018 and December 31, 2017; 32,133,263 and 3,227,495 shares issued at December 31, 2018 and December 31, 2017, respectively; 32,133,189 shares and 3,227,421 shares outstanding at December 31, 2018 and December 31, 2017, respectively | 32,000 | 3,000 |
Additional paid-in capital | 728,783,000 | 616,245,000 |
Accumulated deficit | (657,647,000) | (637,114,000) |
Treasury stock (at cost); 74 shares | (3,054,000) | (3,054,000) |
Total stockholders' equity | 68,114,000 | (23,920,000) |
Total liabilities & stockholders' equity | $ 119,398,000 | $ 3,347,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Feb. 15, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 | |
Preferred stock, shares issued (in shares) | 0 | 0 | 2,701 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 2,701 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | 120,000,000 | |
Common stock, shares issued (in shares) | 32,188,929 | 32,133,263 | 3,227,495 | |
Common stock, shares outstanding (in shares) | 32,188,855 | 32,133,189 | 3,227,421 | |
Treasury stock, shares (in shares) | 74 | 74 | 74 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenues | $ 304 | $ 229 | $ 1,051 | $ 204 | $ 102 | $ 17 | $ 1,147 | $ 219 | $ 198 | $ 1,484 | $ 1,788 | $ 1,485 | |||
Expenses: | |||||||||||||||
Research and development | 3,792 | 2,368 | 2,197 | 2,879 | 3,118 | 2,418 | 3,062 | 5,483 | 6,413 | 10,547 | 8,194 | 10,562 | 17,376 | ||
General and administrative | 3,395 | 2,787 | 1,500 | 1,208 | 1,926 | 1,182 | 1,749 | 1,804 | 1,922 | 9,990 | 4,634 | 7,421 | 6,657 | ||
Total operating expenses | 7,187 | 5,155 | 3,697 | 4,087 | 5,044 | 3,600 | 4,811 | 7,287 | 8,335 | 20,537 | 12,828 | 17,983 | 24,033 | ||
Operating loss | (7,187) | (4,851) | (3,468) | (3,036) | (4,840) | (3,498) | (4,794) | (6,140) | (8,116) | (20,339) | (11,344) | (16,195) | (22,548) | ||
Other income / (expense): | |||||||||||||||
Net loss on debt extinguishment | (3,345) | ||||||||||||||
Gain on debt restructuring | 5,824 | ||||||||||||||
Interest income | 25 | 1 | 124 | 9 | 15 | 12 | |||||||||
Interest expense | (105) | (460) | (358) | (642) | (1,409) | (1,863) | |||||||||
Other income, net | 141 | 473 | 486 | 401 | 129 | ||||||||||
Other income / (expense), net | 61 | (459) | 239 | (147) | (4,338) | 4,102 | |||||||||
Net loss | $ (7,126) | $ (6,437) | $ (6,537) | (9,042) | (3,927) | (3,052) | (4,512) | 2,473 | (5,443) | (6,752) | (8,724) | $ (20,100) | $ (11,491) | (20,533) | (18,446) |
AEROSURF warrant dividend | (12,505) | (12,505) | |||||||||||||
Deemed dividend on Series A preferred stock | (1,718) | (2,234) | (532) | (3,604) | (1,718) | (6,370) | |||||||||
Net loss attributable to common shareholders | (23,265) | $ (3,927) | (3,052) | (4,512) | 2,473 | (7,677) | (7,284) | (12,328) | $ (34,756) | $ (24,816) | |||||
Net loss per common share | |||||||||||||||
Basic and diluted (in dollars per share) | $ (0.22) | $ (1.04) | $ (0.62) | $ (3.21) | $ (7.74) | $ (24.14) | |||||||||
Weighted average number of common shares outstanding | |||||||||||||||
Basic and diluted (in shares) | 32,189,000 | 3,769,000 | 32,173,000 | 3,585,000 | 4,493 | 1,028 | |||||||||
Grant [Member] | |||||||||||||||
License revenue with affiliate | $ 70 | $ 765 | $ 765 | $ 1,383 | |||||||||||
License [Member] | |||||||||||||||
License revenue with affiliate | $ 304 | $ 159 | $ 356 | $ 204 | $ 102 | $ 198 | $ 719 | $ 1,023 | $ 102 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | 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] | Share Purchase Agreement, April 2018 [Member]Preferred Stock [Member] | Share Purchase Agreement, April 2018 [Member]Common Stock [Member] | Share Purchase Agreement, April 2018 [Member]Additional Paid-in Capital [Member] | Share Purchase Agreement, April 2018 [Member]Retained Earnings [Member] | Share Purchase Agreement, April 2018 [Member]Treasury Stock [Member] | Share Purchase Agreement, April 2018 [Member] | Share Purchase Agreement, December 2018 [Member]Preferred Stock [Member] | Share Purchase Agreement, December 2018 [Member]Common Stock [Member] | Share Purchase Agreement, December 2018 [Member]Additional Paid-in Capital [Member] | Share Purchase Agreement, December 2018 [Member]Retained Earnings [Member] | Share Purchase Agreement, December 2018 [Member]Treasury Stock [Member] | Share Purchase Agreement, December 2018 [Member] | Placement Agent [Member]Preferred Stock [Member] | Placement Agent [Member]Common Stock [Member] | Placement Agent [Member]Additional Paid-in Capital [Member] | Placement Agent [Member]Retained Earnings [Member] | Placement Agent [Member]Treasury Stock [Member] | Placement Agent [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member]Preferred Stock [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member]Common Stock [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member]Additional Paid-in Capital [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member]Retained Earnings [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member]Treasury Stock [Member] | Warrants in Connection with Equity Consideration in Debt Issuance [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [Member]Preferred Stock [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [Member]Common Stock [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [Member]Additional Paid-in Capital [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [Member]Retained Earnings [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [Member]Treasury Stock [Member] | Warrants in Connection with Equity Consideration in Payable Restructuring [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, 2016 | 436,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2016 | $ 592,892,000 | $ (618,668,000) | $ (3,054,000) | $ (28,830,000) | ||||||||||||||||||||||||||||||||||||||||||||
Net loss | (18,446,000) | (18,446,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock (in shares) | 7,000 | 2,312,000 | 42,000 | |||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock | $ 10,433,000 | $ 10,433,000 | $ 2,000 | $ 9,969,000 | $ 9,971,000 | 1,030,000 | 1,030,000 | |||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions (in shares) | (4,000) | 217,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions | (2,000) | (2,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, 401(k) plan employer match (in shares) | 7,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, 401(k) plan employer match | 95,000 | 95,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, equity consideration in debt restructuring (in shares) | 71,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, equity consideration in debt restructuring | 267,000 | 267,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Exercise of prefunded common stock warrants (in shares) | 142,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Exercise of prefunded common stock warrants | ||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | $ 1,000 | 1,561,000 | 1,562,000 | |||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | $ 1,600,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 3,000 | 3,227,000 | 3,227,421 | |||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | $ (23,920,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (4,512,000) | (4,512,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 418,000 | 418,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2018 | $ 3,000 | 616,611,000 | (641,626,000) | $ (3,054,000) | $ (28,066,000) | |||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 3,000 | 3,227,000 | 3,227,421 | |||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | $ (23,920,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (11,491,000) | |||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2018 | $ 4,000 | 620,322,000 | (648,605,000) | $ (3,054,000) | $ (31,333,000) | |||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 3,000 | 3,227,000 | 3,227,421 | |||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | $ (23,920,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (20,533,000) | (20,533,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock (in shares) | 542,000 | 11,786,000 | 114,000 | |||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock | $ 1,000 | $ 2,540,000 | $ 2,541,000 | $ 12,000 | $ 41,101,000 | $ 41,113,000 | ||||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions (in shares) | (3,000) | 135,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions | ||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, CVie Acquisition (in shares) | 16,265,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, CVie Acquisition | $ 16,000 | 67,484,000 | 67,500,000 | |||||||||||||||||||||||||||||||||||||||||||||
Vesting of restricted stock units (in shares) | 95,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Vesting of restricted stock units | ||||||||||||||||||||||||||||||||||||||||||||||||
Withholding tax payments related to net share settlements of restricted stock units (in shares) | (31,000) | |||||||||||||||||||||||||||||||||||||||||||||||
Withholding tax payments related to net share settlements of restricted stock units | (155,000) | (155,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of warrants | $ 417,000 | $ 417,000 | $ 196,000 | $ 196,000 | ||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 955,000 | $ 955,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 32,133,000 | 32,133,189 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | $ 68,114,000 | |||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2018 | 3,000 | 616,611,000 | (641,626,000) | (3,054,000) | (28,066,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (3,052,000) | (3,052,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock (in shares) | 542,000 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of stock | $ 1,000 | 2,593,000 | 2,594,000 | |||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 140,000 | 140,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2018 | 4,000 | 619,344,000 | (644,678,000) | (3,054,000) | (28,384,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (3,927,000) | (3,927,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of warrants | 833,000 | 833,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 145,000 | 145,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2018 | $ 4,000 | 620,322,000 | (648,605,000) | $ (3,054,000) | (31,333,000) | |||||||||||||||||||||||||||||||||||||||||||
Net loss | $ (9,042,000) | |||||||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 32,133,000 | 32,133,189 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | $ 68,114,000 | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (6,537,000) | (6,537,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Vesting of restricted stock units (in shares) | 56,000 | |||||||||||||||||||||||||||||||||||||||||||||||
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 | (151,000) | (151,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,530,000 | 1,530,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2019 | $ 32,000 | 730,162,000 | (664,184,000) | $ (3,054,000) | $ 62,996,000 | |||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 32,133,000 | 32,133,189 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | $ 68,114,000 | |||||||||||||||||||||||||||||||||||||||||||
Net loss | $ (20,100,000) | |||||||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Sep. 30, 2019 | 32,188,855 | |||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2019 | 32,000 | 733,840,000 | (677,747,000) | (3,054,000) | $ 53,071,000 | |||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2019 | 32,000 | 730,162,000 | (664,184,000) | (3,054,000) | 62,996,000 | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (6,437,000) | (6,437,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,739,000 | 1,739,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2019 | 32,000 | 731,901,000 | (670,621,000) | (3,054,000) | 58,270,000 | |||||||||||||||||||||||||||||||||||||||||||
Net loss | (7,126,000) | (7,126,000) | ||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,939,000 | $ 1,938,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance (in shares) at Sep. 30, 2019 | 32,188,855 | |||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2019 | $ 32,000 | $ 733,840,000 | $ (677,747,000) | $ (3,054,000) | $ 53,071,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (20,533) | $ (18,446) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 160 | 192 |
Amortization of debt discount | 863 | |
Stock-based compensation | 955 | 1,655 |
Amortization of prepaid interest | 912 | |
Net loss on extinguishment of debt | 3,345 | |
Gain on debt restructuring | (5,824) | |
Gain on sale of equipment | (9) | |
Changes in: | ||
Prepaid expenses and other current assets | 302 | 90 |
Accounts payable | 997 | 2,433 |
Collaboration and device development payable | (510) | (343) |
Accrued expenses | (276) | (2,995) |
Deferred revenue - current | (686) | 884 |
Deferred revenue - non-current | (407) | 407 |
Other liabilities | 18 | (10) |
Net cash used in operating activities | (15,781) | (21,045) |
Cash flows from investing activities: | ||
Cash acquired in CVie acquisition | 223 | |
Purchase of marketable securities | (13,959) | |
Proceeds from sale of property and equipment | 9 | |
Purchase of property and equipment | (24) | |
Net cash used in investing activities | (13,727) | (24) |
Cash flows from financing activities: | ||
Proceeds from Issuance of Private Placement | 32,893 | 14,860 |
Proceeds from loan payable, net of expenses | 6,160 | 3,900 |
Repayment of loan payable | (160) | |
Proceeds from convertible note payable | 1,500 | |
Repayment of convertible note payable | (1,500) | |
Payment for taxes related to net share settlements of restricted stock units | (155) | |
Proceeds from ATM Program, net of expenses | 1,036 | |
Principal payments on debt restructuring | (2,500) | |
Net cash provided by financing activities | 38,738 | 17,296 |
Effect of exchange rates on cash | 88 | |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 9,318 | (3,773) |
Cash, cash equivalents and restricted cash - beginning of year | 2,040 | 5,813 |
Cash, cash equivalents and restricted cash - end of year | 11,358 | 2,040 |
Supplementary disclosure of cash flows information: | ||
Interest paid | $ 288 | $ 1,088 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 4,437,000 | $ 11,187,000 |
Available-for-sale marketable securities | 13,959,000 | |
Prepaid expenses and other current assets | 826,000 | 507,000 |
Total current assets | 5,263,000 | 25,653,000 |
Property and equipment, net | 877,000 | 802,000 |
Restricted cash | 154,000 | 171,000 |
Operating lease right-of-use assets | 1,566,000 | |
Indefinite intangible asset | 77,090,000 | 77,090,000 |
Goodwill | 15,682,000 | 15,682,000 |
Total assets | 100,632,000 | 119,398,000 |
Current Liabilities: | ||
Accounts payable | 607,000 | 3,420,000 |
Collaboration and device development payable, net | 1,873,000 | 2,576,000 |
Accrued expenses | 5,235,000 | 6,465,000 |
Operating lease liabilities - current portion | 781,000 | |
Deferred revenue - current portion | 198,000 | |
Loan payable | 7,782,000 | 7,974,000 |
Total current liabilities | 16,278,000 | 20,633,000 |
Operating lease liabilities - non-current portion | 953,000 | |
Restructured debt liability - contingent milestone payments | 15,000,000 | 15,000,000 |
Deferred tax liabilities | 15,224,000 | 15,476,000 |
Other liabilities | 106,000 | 175,000 |
Total liabilities | 47,561,000 | 51,284,000 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares and 2,701 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 0 | 0 |
Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2018 and December 31, 2017; 32,133,263 and 3,227,495 shares issued at December 31, 2018 and December 31, 2017, respectively; 32,133,189 shares and 3,227,421 shares outstanding at December 31, 2018 and December 31, 2017, respectively | 32,000 | 32,000 |
Additional paid-in capital | 733,840,000 | 728,783,000 |
Accumulated deficit | (677,747,000) | (657,647,000) |
Accumulated other comprehensive income | 0 | |
Treasury stock (at cost); 74 shares | (3,054,000) | (3,054,000) |
Total stockholders' equity | 53,071,000 | 68,114,000 |
Total liabilities & stockholders' equity | $ 100,632,000 | $ 119,398,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Feb. 15, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 | |
Preferred stock, shares issued (in shares) | 0 | 0 | 2,701 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 2,701 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | 120,000,000 | |
Common stock, shares issued (in shares) | 32,188,929 | 32,133,263 | 3,227,495 | |
Common stock, shares outstanding (in shares) | 32,188,855 | 32,133,189 | 3,227,421 | |
Treasury stock, shares (in shares) | 74 | 74 | 74 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | |||||||||||||||
Total revenues | $ 304 | $ 229 | $ 1,051 | $ 204 | $ 102 | $ 17 | $ 1,147 | $ 219 | $ 198 | $ 1,484 | $ 1,788 | $ 1,485 | |||
Expenses: | |||||||||||||||
Research and development | 3,792 | 2,368 | 2,197 | 2,879 | 3,118 | 2,418 | 3,062 | 5,483 | 6,413 | 10,547 | 8,194 | 10,562 | 17,376 | ||
General and administrative | 3,395 | 2,787 | 1,500 | 1,208 | 1,926 | 1,182 | 1,749 | 1,804 | 1,922 | 9,990 | 4,634 | 7,421 | 6,657 | ||
Total operating expenses | 7,187 | 5,155 | 3,697 | 4,087 | 5,044 | 3,600 | 4,811 | 7,287 | 8,335 | 20,537 | 12,828 | 17,983 | 24,033 | ||
Operating loss | (7,187) | (4,851) | (3,468) | (3,036) | (4,840) | (3,498) | (4,794) | (6,140) | (8,116) | (20,339) | (11,344) | (16,195) | (22,548) | ||
Other income / (expense): | |||||||||||||||
Interest income | 25 | 1 | 124 | 9 | 15 | 12 | |||||||||
Interest expense | (105) | (460) | (358) | (642) | (1,409) | (1,863) | |||||||||
Other income, net | 141 | 473 | 486 | 401 | 129 | ||||||||||
Other income / (expense), net | 61 | (459) | 239 | (147) | (4,338) | 4,102 | |||||||||
Net loss | $ (7,126) | $ (6,437) | $ (6,537) | (9,042) | $ (3,927) | (3,052) | (4,512) | 2,473 | (5,443) | (6,752) | (8,724) | $ (20,100) | $ (11,491) | $ (20,533) | $ (18,446) |
Net loss per common share | |||||||||||||||
Basic and diluted (in dollars per share) | $ (0.22) | $ (1.04) | $ (0.62) | $ (3.21) | $ (7.74) | $ (24.14) | |||||||||
Weighted average number of common shares outstanding | |||||||||||||||
Basic and diluted (in shares) | 32,189,000 | 3,769,000 | 32,173,000 | 3,585,000 | 4,493 | 1,028 | |||||||||
Grant [Member] | |||||||||||||||
Revenues: | |||||||||||||||
License revenue with affiliate | $ 70 | $ 765 | $ 765 | $ 1,383 | |||||||||||
License [Member] | |||||||||||||||
Revenues: | |||||||||||||||
License revenue with affiliate | $ 304 | $ 159 | $ 356 | $ 204 | $ 102 | $ 198 | $ 719 | $ 1,023 | $ 102 |
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 | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Treasury Stock [Member] | Total |
Balance at Dec. 31, 2016 | $ 592,892,000 | $ (618,668,000) | $ (3,054,000) | $ (28,830,000) | |||
Net loss | (18,446,000) | (18,446,000) | |||||
Stock-based compensation expense | 1,600,000 | ||||||
Issuance of stock (in shares) | 42 | ||||||
Issuance of stock | 1,030,000 | 1,030,000 | |||||
Balance (in shares) at Dec. 31, 2017 | 3 | 3,227 | |||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | (23,920,000) | ||
Net loss | (4,512,000) | (4,512,000) | |||||
Share Purchase Agreement, April 2018 | (52,000) | (52,000) | |||||
Stock-based compensation expense | 418,000 | 418,000 | |||||
Balance (in shares) at Mar. 31, 2018 | 3 | 3,227 | |||||
Balance at Mar. 31, 2018 | $ 3,000 | 616,611,000 | (641,626,000) | $ (3,054,000) | (28,066,000) | ||
Balance (in shares) at Dec. 31, 2017 | 3 | 3,227 | |||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | (23,920,000) | ||
Net loss | (11,491,000) | ||||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2018 | 3 | 3,769 | |||||
Balance at Sep. 30, 2018 | $ 4,000 | 620,322,000 | (648,605,000) | $ (3,054,000) | (31,333,000) | ||
Balance (in shares) at Dec. 31, 2017 | 3 | 3,227 | |||||
Balance at Dec. 31, 2017 | $ 3,000 | 616,245,000 | (637,114,000) | $ (3,054,000) | (23,920,000) | ||
Net loss | (20,533,000) | (20,533,000) | |||||
Stock-based compensation expense | 955,000 | 955,000 | |||||
Vesting of restricted stock units (in shares) | 95 | ||||||
Vesting of restricted stock units | |||||||
Withholding tax payments related to net share settlements of restricted stock units (in shares) | (31) | ||||||
Withholding tax payments related to net share settlements of restricted stock units | (155,000) | (155,000) | |||||
Balance (in shares) at Dec. 31, 2018 | 32,133 | ||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | 68,114,000 | ||
Balance (in shares) at Mar. 31, 2018 | 3 | 3,227 | |||||
Balance at Mar. 31, 2018 | $ 3,000 | 616,611,000 | (641,626,000) | $ (3,054,000) | (28,066,000) | ||
Net loss | (3,052,000) | (3,052,000) | |||||
Stock-based compensation expense | 140,000 | 140,000 | |||||
Issuance of stock (in shares) | 542 | ||||||
Issuance of stock | $ 1,000 | 2,593,000 | 2,594,000 | ||||
Balance (in shares) at Jun. 30, 2018 | 3 | 3,769 | |||||
Balance at Jun. 30, 2018 | $ 4,000 | 619,344,000 | (644,678,000) | $ (3,054,000) | (28,384,000) | ||
Net loss | (3,927,000) | (3,927,000) | |||||
Stock-based compensation expense | 145,000 | 145,000 | |||||
Issuance of warrants | 833,000 | 833,000 | |||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2018 | 3 | 3,769 | |||||
Balance at Sep. 30, 2018 | $ 4,000 | 620,322,000 | (648,605,000) | $ (3,054,000) | (31,333,000) | ||
Net loss | (9,042,000) | ||||||
Balance (in shares) at Dec. 31, 2018 | 32,133 | ||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | 68,114,000 | ||
Net loss | (6,537,000) | (6,537,000) | |||||
Stock-based compensation expense | 1,530,000 | 1,530,000 | |||||
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 | (151,000) | (151,000) | |||||
Unrealized gain (loss) on marketable securities | 40,000 | 40,000 | |||||
Balance (in shares) at Mar. 31, 2019 | 32,189 | ||||||
Balance at Mar. 31, 2019 | $ 32,000 | 730,162,000 | (664,184,000) | 40,000 | $ (3,054,000) | 62,996,000 | |
Balance (in shares) at Dec. 31, 2018 | 32,133 | ||||||
Balance at Dec. 31, 2018 | $ 32,000 | 728,783,000 | (657,647,000) | $ (3,054,000) | 68,114,000 | ||
Net loss | (20,100,000) | ||||||
Unrealized gain (loss) on marketable securities | |||||||
Balance (in shares) at Sep. 30, 2019 | 32,189 | ||||||
Balance at Sep. 30, 2019 | $ 32,000 | 733,840,000 | (677,747,000) | $ (3,054,000) | 53,071,000 | ||
Balance (in shares) at Mar. 31, 2019 | 32,189 | ||||||
Balance at Mar. 31, 2019 | $ 32,000 | 730,162,000 | (664,184,000) | 40,000 | $ (3,054,000) | 62,996,000 | |
Net loss | (6,437,000) | (6,437,000) | |||||
Stock-based compensation expense | 1,739,000 | 1,739,000 | |||||
Unrealized gain (loss) on marketable securities | (28,000) | (28,000) | |||||
Balance (in shares) at Jun. 30, 2019 | 32,189 | ||||||
Balance at Jun. 30, 2019 | $ 32,000 | 731,901,000 | (670,621,000) | 12,000 | $ (3,054,000) | 58,270,000 | |
Net loss | (7,126,000) | (7,126,000) | |||||
Stock-based compensation expense | 1,939,000 | 1,938,000 | |||||
Unrealized gain (loss) on marketable securities | (12,000) | (12,000) | |||||
Balance (in shares) at Sep. 30, 2019 | 32,189 | ||||||
Balance at Sep. 30, 2019 | $ 32,000 | $ 733,840,000 | $ (677,747,000) | $ (3,054,000) | $ 53,071,000 |
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 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 used in 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 | |
Repayment of loan payable | (820) | |
Payment for taxes related to net share settlements of restricted stock units | (151) | |
Net cash 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 year | 11,358 | 2,040 |
Cash, cash equivalents and restricted cash - end of year | 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 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 pulmonary and cardiovascular diseases. Historically, our focus has been on the development of our proprietary KL4 December 2018 ( see 3 Our four 1 2 KL4 3 KL4 4 Heart failure is a chronic, progressive disease resulting from structural or functional cardiac abnormalities and is characterized by inadequate pumping function of the heart that results in fluid accumulation manifesting as pulmonary congestion, peripheral edema and congestion in other parts of the body. Insufficient cardiac output can result in inadequate peripheral perfusion that increases the risk of other organ dysfunction such as renal failure. Heart failure commonly but episodically worsens to a point of decompensation, a condition called ADHF. We are developing istaroxime for the treatment of ADHF. Istaroxime has a dual mechanism of action referred to as luso-inotropic, that may two 2 may 2019, AEROSURF (lucinactant for inhalation) is an investigational combination drug/device product that we are developing to improve the management of RDS in premature infants who may not may may KL4 2017, 2b not 72 24% 50 2 50 2019, 3 not 2b KL4 We are also assessing potential development pathways to secure marketing approval for lyophilized KL4 KL4 KL4 2012 second 2019. may not We also believe that our lyophilized KL4 may Our fourth 20% 25% may may may three 2b two one one no 2019, The reader is referred to, and encouraged to read in its entirety, “Item 1 10 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 2 Basis of Presentation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. When necessary, prior year’s consolidated financial statements have been reclassified to conform to the current year presentation. |
Note 3 - Business Combination
Note 3 - Business Combination | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Business Combination Disclosure [Text Block] | Note 3 Business Combination On December 21, 2018 ( 16,256,060 $67.5 In connection with the CVie Acquisition, our board of directors declared a dividend to the holders of record of outstanding shares of common stock, and holders of certain warrants to purchase common stock, that were outstanding on December 20, 2018 0.6148 2,963,167 five one first 3 815, $12.5 two first 3 two three Significant Input Assumptions of Warrant Valuation Historical volatility 116 % Expected term (in years) 2.5 Risk-free interest rate 2.62 % On the Acquisition Date, we entered into an indemnification letter agreement (the Indemnification Letter Agreement) with Lee’s Pharmaceutical Holdings Limited (Lee’s), pursuant to which Lee’s agreed to indemnify the holders of issued and outstanding shares of common stock on December 20, 2018 ( not 984,000 one The aggregate purchase price has been allocated based on the fair value of assets acquired and liabilities assumed as of the acquisition date. The excess of the $67.5 not (in thousands) Cash and cash equivalents $ 193 Restricted cash 31 Prepaid expenses and other current assets 387 Property and equipment, net 76 Intangible assets 77,090 Total identifiable assets acquired $ 77,777 Current liabilities $ (2,590 ) Loan payable, current (3,453 ) Loan payable, non current (4,491 ) Deferred tax liabilities, noncurrent (15,418 ) Other liabilities, noncurrent (7 ) Net identifiable assets acquired 51,818 Goodwill 15,682 Net assets acquired $ 67,500 The acquired identifiable intangible assets consist of in-process research and development (“IPR&D”) of approximately $77.1 See, 5 From the Acquisition Date to December 31, 2018, $0.5 The following table presents unaudited consolidated pro forma results of operations based on our historical financial statements and adjusted for the acquisition of CVie as if it occurred on January 1, 2017. not Year Ended December 31, (in thousands, except per share data) 2018 2017 Pro forma net loss attributable to common shareholders $ (38,082 ) $ (34,616 ) Pro forma EPS - basic and diluted $ (1.20 ) $ (1.19 ) For the year ended December 31, 2018, December 31, 2018 2017, |
Note 4 - Liquidity Risks and Ma
Note 4 - Liquidity Risks and Management's Plans | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 Liquidity Risks and Management’s Plans As of December 31, 2018, $11.2 $14.0 $20.6 $8.0 see 11 April 5, 2019, October 2019. Although we believe that the December 2018 $39 may October 2019, 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 a combination of public or private equity offerings and strategic transactions, including but not none 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, 2018, 120 5 72.0 5.0 not |
Note 5 - Accounting Policies an
Note 5 - Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 Accounting Policies and Recent Accounting Pronouncements Principles of consolidation The 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 Limited and its wholly-owned subsidiary, CVie Therapeutics Limited; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, 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 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 December 31, 2018: (in thousands) Estimated Fair 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 assets acquired and liabilities assumed in a business combination and is not may not not Foreign c urrenc y transactions The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are not $0.1 December 31, 2018. no December 31, 2017. 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 at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of 90 Marketable securities 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, no December 31, 2018 2017. no December 31, 2018 2017. 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. 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, 2018 2017, 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 principally of a $140,000 May 26, 2004 $31,000 see, 18 Long-lived assets Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not No December 31, 2018 2017 no not Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, 16 Restructured debt liability – contingent milestone payment In conjunction with the November 2017 see, 13 $15 October 27, 2017 ( not Deferred revenue Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria ( see 12 not 12 Deferred revenue primarily consists of amounts related to an upfront license fee received in July 2017 see 16 Revenue recognition Effective January 1, 2018, 606, 606, In accordance with ASC Topic 606, 606, five (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five 606, We have concluded that our government grants are not 606 not 958 605, Not not In the absence of applicable guidance under US GAAP, effective January 1, 2018, We believe this policy is consistent with the overarching premise in ASC Topic 606, no 606. 606. Prior to January 1, 2018, not no 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 15 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, 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 A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date. Preferred Stock The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the first 2017 14 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 December 31, 2018 December 31, 2017, $1.7 $2.8 December 31, 2018, no Convertible Note The issuance on July 2, 2018 $1.5 $1.5 $0.4 $0.4 $1.5 see 11 December 27, 2018, $1.5 $0.4 $5.11 $4.00, 375,000 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, 2018 2017, 14.4 1.0 December 31, 2018 2017, We do not Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL4 third KL4 one Business segments We currently operate in one one not Recent Accounting Pronouncements Recently Adopted Accounting Standards In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 606 2014 09, January 1, 2018 June 2017, 2014 09 no no See, 16 In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 January 1, 2018 not 2018 In August 2016, 2016 15, Statement of Cash Flows (Topic 230 eight one December 31, 2018 2016 15 January 1, 2018 not 2018 In January 2017, 2017 01, Business Combinations (Topic 805 first not not December 31, 2018 2017 01 January 1, 2018 not 2018 Recent Accounting Pronouncements In February 2016, 2016 02, Leases 842 January 1, 2019. not In January 2017, 2017 04, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment 2017 04 second two not 2017 04 December 15, 2019; 2017 04 not |
Note 6 - License Revenue with A
Note 6 - License Revenue with Affiliate | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 License Revenue with Affiliate Year Ended December 31, (in thousands) 2018 2017 License revenue with affiliate $ 1,023 $ 102 License revenue with affiliate for years ended December 31, 2018 2017 606, January 1, 2018 ( see 5 16 no 606. |
Note 7 - Fair Value Measurement
Note 7 - Fair Value Measurements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 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, 2018 2017: 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 $ - $ - 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 $ - $ - |
Note 8 - Property and Equipment
Note 8 - Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 8 Property and Equipment Property and equipment is comprised of the following: December 31, (in thousands) 2018 2017 Manufacturing, laboratory & office equipment $ 4,359 $ 4,965 Furniture & fixtures 390 615 Leasehold improvements 2,469 2,458 Subtotal 7,218 8,038 Accumulated depreciation and amortization (6,416 ) (7,153 ) Property and equipment, net $ 802 $ 885 Depreciation expense on property and equipment for the years ended December 31, 2018 2017 $0.2 $0.2 |
Note 9 - Collaboration and Devi
Note 9 - Collaboration and Device Development Payable | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | Note 9 Collaboration and Device Development Payable Collaboration and device development payable represents amounts due to Battelle under a collaboration agreement related to the development of our phase 3 see 16 June 2012 2 December 31, 2018 2017, $2.6 $4.4 Restructuring of the Battelle Payables On December 7, 2018, 6.0% $3.0 30 December 2018 $1.0 see 14 $972,281, $1,250,000, five $250,000, $25.0 $35.0 two first one 3 December 31, 2019, January 7, 2020. Management determined the payment restructuring agreement of the Battelle Payables do not not not In connection with the payment restructuring agreement, we also issued to Battelle Series E Warrants (“Series E Warrants”) to purchase 75,000 $6.50 may 5 December 11, 2023. may not 9.99% The Series E Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic 815, five Significant Input Assumptions of Warrant Valuation Historical volatility 103 % Expected term (in years) 5 Risk-free interest rate 2.70 % As of December 31, 2018, $0.3 Extinguishment of Collaboration and Device Development Payable On December 21, 2018, $1.0 301,823 $3.3132 51,310 $3.68 99,602 $4.05 18th may 5 The conversion of the Battelle Payables is treated as an extinguishment of outstanding liabilities. We recorded a loss on extinguishment of debt of approximately $0.5 $1.5 December 21, 2018 $1.0 |
Note 10 - Accrued Expenses
Note 10 - Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | Note 10 Accrued Expenses Accrued expenses are comprised of the following: December 31, (in thousands) 2018 2017 Professional fees $ 2,473 $ 412 Research and development 2,361 1,778 Salaries, bonus & benefits 815 1,008 Manufacturing operations 212 537 Other 604 399 Total accrued expenses $ 6,465 $ 4,134 |
Note 11 - Loan Payable
Note 11 - Loan Payable | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 11 – Loan Payable In January 2018 March 2018, $1.5 $1.0 one 6% December 31, 2018. March 1, 2018 ( During the third fourth 2018, August 14, 2018 $0.3 August 29, 2018, $0.48 September 12, 2018 $0.5 September 27, 2018 $0.5 October 19, 2018 $0.43 November 2, 2018 $0.5 November 19, 2018 $0.35 December 5, 2018 $0.6 6% $30 March 31, 2019. Extinguishment of Loan Payable On December 21, 2018, $6.0 1,810,938 $3.3132 307,859 $3.68 597,610 $4.05 18 may 5 The conversion of the loan payable to LPH is treated as an extinguishment of debt and does not third $3.2 $9.2 December 21, 2018, $6.0 The balance of the loan payable to LPH of $160,000 $182,000 December 27, 2018. Assumption of bank debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $4.5 $138.0 March 2020. In September 2016, 12 $2.9 $90.0 $5.84 $180.0 September 2017. 110% not 90 0.91%. September 11, 2019 six March 11, 2020. not $4.5 As of December 31, 2018, $4.5 $138.0 Assumption of Lee’s debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $3.5 $106.2 From April 24, 2018 November 16, 2018, four $3.5 4% four one $0.5 April 2019; $0.3 September 2019; $0.2 October 2019; $2.5 November 2019. As of December 31, 2018, $3.5 $106.2 |
Note 12 - Convertible Note Paya
Note 12 - Convertible Note Payable | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Convertible Note Payable Disclosure [Text Block] | Note 12 Convertible Note Payable On July 2, 2018, $1.5 two $1.0 $0.5 July 23, 2018. December 31, 2018 15% $4.00. In connection with the Note, we issued to Panacea warrants (the “Series D Warrants”) to purchase 187,500 $4.00 may six fifth may not 9.99% may sixty-one We recorded the Note as current debt at its face value of $1.5 $0.4 $0.4 $1.5 815, Derivatives and Hedging – Contracts in Entity’s Own Equity The fair value at issuance of the Panacea Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants, and the risk-free interest rate based on the five Significant Input Assumptions of Warrant Valuation Historical volatility 103 % Expected term (in years) 5 Risk-free interest rate 2.75 % The following amounts comprise the convertible note interest expense for the periods presented: Year Ended (in thousands) 2018 Non-cash amortization of debt discounts $ 833 Cash interest expense 106 Total convertible note interest expense $ 939 Extinguishment of Panacea Convertible Promissory Note On December 27, 2018, $1.5 $0.4 $5.11 $4.00, 375,000 |
Note 13 - Restructured Debt Lia
Note 13 - Restructured Debt Liability | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 13 Restructured Debt Liability December 31, December 31, (in thousands) 2018 2017 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 5 not |
Note 14 - Stockholders' Equity
Note 14 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 14 Stockholders’ Equity Private Placement Offerings December 2018 Financing On December 21, 2018, 11,785,540 $3.3132, $39.0 $6.0 $1.0 2,003,541 $3.68 18 3,889,229 $4.05 5 December 2018 December 2018 may not 9.99% December 2018 Under the Registration Rights Agreement, we agreed to file by May 1, 2019 December 2018 April 2018 On April 4, 2018, $2.6 $4.80, 541,667 135,417 $5.52 6 seventh 25% 180th March 30, 2018, may Share Purchase Agreement Effective October 27, 2017, $10 2,311,604 $4.326 15% 10 73% $3.9 August 14, 2017, two 30th no 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. 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 50 1 may February 15, 2024. 1 may not 9.99% three February 13, 2018, To facilitate consummation of the Share Purchase Agreement in October 2017 ( 1,095 not not no As of December 31, 2018, At-the-Market Program (ATM Program) Stifel ATM Program On February 11, 2013, may may three $25 not If we issued a sale notice to Stifel, we may may 3.0% During 2017, 42,357 $1.1 $1.0 Effective with our transition to the OTCQB® Market (OTCQB) tier in early May 2017, no 401 We have a voluntary 401 401 2017, 8 December 31, 2017, 7,561 401 December 31, 2017 $0.1 2018, not 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) 2018 2017 Exercise Price Date Investors - Aerosurf 2,963 - $ - 02/14/24 Investors - December 2018 financing - long-term 3,889 - $ 4.05 12/04/23 Investors - December 2018 financing - short-term 2,004 - $ 3.68 06/24/20 Battelle - 2018 payables restructuring agreement (1) 75 - $ 6.50 12/07/23 Panacea Venture Management Company Ltd. 188 - $ 4.00 07/02/23 LPH II Investments Limited 135 - $ 5.52 04/04/25 Investors - February 2017 financing 352 352 $ 27.40 02/15/24 Investors - July 2015 financing 240 240 $ 196.00 07/22/22 Battelle - 2014 collaboration agreement (1) 4 4 $ 1,400.00 10/10/24 Total 9,850 596 ( 1 See 16 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. December 24, 2018, 4.2 As of December 31, 2018 2017, 1.5 1.6 2011 Common shares reserved for potential future issuance under our 401 As of December 31, 2018 2017, 807 401 |
Note 15 - Stock Options and Sto
Note 15 - Stock Options and Stock-based Employee Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 15 Stock Options and Stock-based Employee Compensation Long-Term Incentive Plans We have the 2011 2007 There are 6.1 2011 1.5 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) 2018 2017 Stock Options and RSUs Outstanding 2011 Plan 4,558 263 Non-Plan 10 10 Total Outstanding 4,568 273 Available for Future Grants under 2011 Plan 1,453 1,623 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: Weighted- Weighted- Average (in thousands, except for weighted-average data) Average Remaining Stock Options Shares Exercise Contractual Outstanding at January 1, 2018 84 $ 163.20 Granted 4,337 4.22 Forfeited or expired (4 ) 617.75 Outstanding at December 31, 2018 4,417 $ 6.73 9.9 Vested and exercisable at December 31, 2018 63 $ 171.87 6.5 Vested and expected to vest at December 31, 2018 4,243 $ 6.78 9.9 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2018 190 $ 4.33 Awarded 56 4.22 Vested (95 ) 4.33 Unvested at December 31, 2018 151 $ 4.29 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, 2018 2017 $3.39 $17.44, December 31, 2018 2017 $4.22 $4.33, December 31, 2018 $0. Stock-Based Compensation We recognized stock-based compensation expense in accordance with ASC Topic 718 $1.0 $1.6 December 31, 2018 2017. Stock-based compensation expense was classified as follows: Year Ended (in thousands) 2018 2017 Research and development $ 232 $ 837 Selling, general and administrative 723 724 Total $ 955 $ 1,561 Under the 2011 may October 2017 ( see 14 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 US Treasury yield curve in effect at the time of the grant. Year Ended 2018 2017 Weighted average expected volatility 93% 79% Weighted average expected term (in years) 7.0 6.6 Weighted average risk-free interest rate 2.7% 2.2% Expected dividends - - The total fair value of the underlying shares of the options vested during 2018 2017 $0.6 $1.9 December 31, 2018, $13.9 2011 2.9 |
Note 16 - Collaboration, Licens
Note 16 - Collaboration, Licensing and Research Funding Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Corporate Partnership, Licensing and Research Funding Agreements [Text Block] | Note 16 Collaboration, Licensing and Research Funding Agreements Collaboration Agreement Battelle Memorial Institute In October 2014, 3 2 2b three 3 3 3 first two $25 $35 In December 2018, See 9 December 2018 Licensing and Research Funding Agreements Lee’s Pharmaceutical (HK) Ltd. In June 2017, KL4 2012 12 August 2017 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 KL4 ten 10 first first first first not Accounting Analysis under ASC 606 In evaluating the License Agreement in accordance with ASC Topic 606, KL4 606 10 25 16A, We concluded that the licensing rights were not not not not With respect to Amendment No. 1, 2014 09, $1 $0.3 No. 1. $1.3 KL4 November 2017 June 2019. Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. As part of our evaluation of the constraint, we considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors include: our financial position; ongoing delays in our development activities and with initiating our phase 3 2b 2015 not see 1A Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have no 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 US 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, 2017, $300,000 $487,500 $300,000 $187,500 2016 2018, $400,000 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 KL4 $2.5 $1.0 $0.5 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 KL4 May 2002 January 2013. KL4 3 2004 10% $20 KL4 Università degli Studi di Milano-Bicocca Effective April 13, 2015, Ca2 2a SERCA2a SERCA2a three no Under the collaboration agreement, intellectual property resulting from the collaboration, including patents and know-how, will be jointly owned by the parties. For the development of any new SERCA2a 12 not 0.1 $0.1 SERCA2a 1.5 $1.7 ten first Also, under the collaboration agreement, we have provided funds aggregating € 0.2 $0.2 2019. |
Note 17 - Related Party Transac
Note 17 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | Note 17 Related Party Transactions Lee’s Pharmaceutical Holdings Limited As of December 31, 2018 2017, 40% 73%, From June 2017 December 2018 ● In June 2017, see 16 ● In October 2017, $10 see 14 ● During 2018, see 11 ● In April 2018, $2.6 see 14 ● In conjunction with the CVie Acquisition in December 2018, 49% see 3 ● In December 2018, $6.0 see 11 ● Our $4.5 see 11 Panacea Venture and KPCB-China Mr. James Huang, who in connection with the CVie Acquisition in December 2018 2011, 2018 ● In July 2018, $1.5 December 2018 ( see 12 ● In December 2018, 114,415 ● In December 2018, 27% see 3 ● In December 2018, see 14 As of December 31, 2018, 14% |
Note 18 - Commitments
Note 18 - Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Commitments Disclosure [Text Block] | Note 18 Commitments Operating Leases Our operating leases consist primarily of a facility leases for our operations in Warrington, Pennsylvania and Taipei, Taiwan. We maintain our corporate headquarters and operations in Warrington, Pennsylvania. The facility serves as the main operating facility for drug and device development, regulatory, analytical technical services, research and development, and administration. We also maintain offices in Taipei, Taiwan, the former headquarters of CVie Therapeutics, where we perform certain manufacturing development and preclinical activities related to our cardiovascular drug product candidates. In February 2018, 30,506 21,189 $225,000 $140,000. December 31, 2018 $2.1 Rent expense under these leases was $0.8 $0.7 December 31, 2018 2017, Strategic and Retention Bonus In November 2018, Under the terms of the Strategic and Retention Bonus, an Eligible Transaction (as that term is defined under the program) means either (a) a strategic transaction consisting of a merger that would advance our strategic needs, including by potentially allowing for diversification of our product candidates, or (b) an acquisition; and, in addition, one nine $30 2018 $45 20% $30 two first five second nine With completion of the CVie Acquisition and the $39 December 21, 2018, $1.4 first $0.7 December 2018. $0.7 nine September 2019. |
Note 19 - Litigation
Note 19 - Litigation | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Legal Matters and Contingencies [Text Block] | Note 19 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 20 - Income Taxes
Note 20 - Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 20 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, 2018 2017 December 31, (in thousands) 2018 2017 Income tax benefit, statutory rates $ (4,312 ) $ (6,272 ) State taxes on income, net of federal benefit (535 ) (398 ) Impact of tax reform 5 71,151 Research and development tax credit (351 ) (797 ) Foreign rate differential 24 - Employee related 2,875 953 Interest related 186 (147 ) Income tax expense / (benefit), statutory rates (2,108 ) 64,490 Valuation allowance 2,108 (64,490 ) Income tax benefit, net $ - $ - During 2017, 2017 2017 2017 118, December 31, 2018. fourth 2018 not The tax effects of temporary differences that give rise to deferred tax assets and deferred tax liabilities, at December 31, 2018 2017, December 31, (in thousands) 2018 2017 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 176,759 $ 168,263 Research and development tax credit 16,718 16,813 Compensation expense on stock 1,121 1,191 Charitable contribution carryforward - 5 Other accrued 1,016 2,547 Deferred revenue 57 317 Depreciation 309 297 Total long-term deferred tax assets 195,980 189,433 Long-term deferred liabilities: IPR&D (15,476 ) - Total long-term deferred tax liabilities (15,476 ) - Valuation allowance (195,980 ) (189,433 ) Deferred tax liabilities, net $ (15,476 ) $ - We are in a net deferred tax liability position at December 31, 2018. December 31, 2017 not December 31, 2018 2017, 2018 2017. At December 31, 2018 2017, $606.6 $590.0 $16.7 $16.8 2037. At December 31, 2018 2017, $584.8 $567.7 $583.9 $570.2 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 21 - Selected Quarterly Fi
Note 21 - Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | Note 21 Selected Quarterly Financial Data (Unaudited) The following tables contain unaudited statement of operations information for each quarter of 2018 2017. not 2018 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue $ - $ 695 $ 70 $ - $ 765 License revenue with affiliate 204 356 159 304 1,023 Total revenues 204 1,051 229 304 1,788 Expenses: Research and development 3,118 2,879 2,197 2,368 10,562 Selling, general and administrative 1,926 1,208 1,500 2,787 7,421 Total expenses 5,044 4,087 3,697 5,155 17,983 Operating loss (4,840 ) (3,036 ) (3,468 ) (4,851 ) (16,195 ) Other income / (expense), net 328 (16 ) (459 ) (4,191 ) (4,338 ) Net (loss) / income $ (4,512 ) $ (3,052 ) $ (3,927 ) $ (9,042 ) $ (20,533 ) AEROSURF warrant dividend - - - (12,505 ) (12,505 ) Deemed dividend on preferred stock - - - (1,718 ) (1,718 ) Net (loss) / income attributable to common shareholders $ (4,512 ) $ (3,052 ) $ (3,927 ) $ (23,265 ) $ (34,756 ) Net (loss) / income per common share - basic $ (1.40 ) $ (0.81 ) $ (1.04 ) $ (3.24 ) $ (7.74 ) Net (loss) / income per common share - diluted $ (1.40 ) $ (0.81 ) $ (1.04 ) $ (3.24 ) $ (7.74 ) Weighted average number of common shares outstanding - basic 3,227 3,751 3,769 7,191 4,493 Weighted average number of common shares outstanding - diluted 3,227 3,751 3,769 7,191 4,493 2017 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue $ 219 $ 1,147 $ 17 $ - $ 1,383 License revenue with affiliate - - - 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 ) 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 F- 33 |
Note 1 - The Company and Desc_2
Note 1 - The Company and Description of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 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 pulmonary and cardiovascular diseases. Historically, our focus has been on the development of our proprietary KL4 December 2018 ( see 3 Our four 1 2 KL4 3 KL4 4 Heart failure is a chronic, progressive disease resulting from structural or functional cardiac abnormalities and is characterized by inadequate pumping function of the heart that results in fluid accumulation manifesting as pulmonary congestion, peripheral edema and congestion in other parts of the body. Insufficient cardiac output can result in inadequate peripheral perfusion that increases the risk of other organ dysfunction such as renal failure. Heart failure commonly but episodically worsens to a point of decompensation, a condition called ADHF. We are developing istaroxime for the treatment of ADHF. Istaroxime has a dual mechanism of action referred to as luso-inotropic, that may two 2 may 2019, AEROSURF (lucinactant for inhalation) is an investigational combination drug/device product that we are developing to improve the management of RDS in premature infants who may not may may KL4 2017, 2b not 72 24% 50 2 50 2019, 3 not 2b KL4 We are also assessing potential development pathways to secure marketing approval for lyophilized KL4 KL4 KL4 2012 second 2019. may not We also believe that our lyophilized KL4 may Our fourth 20% 25% may may may three 2b two one one no 2019, The reader is referred to, and encouraged to read in its entirety, “Item 1 10 |
Note 2 - Basis of Presentatio_2
Note 2 - Basis of Presentation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 2 Basis of Presentation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the US (US GAAP) and include accounts of Windtree and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. When necessary, prior year’s consolidated financial statements have been reclassified to conform to the current year presentation. |
Note 3 - Liquidity Risks and Ma
Note 3 - Liquidity Risks and Management's Plans | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 Liquidity Risks and Management’s Plans As of December 31, 2018, $11.2 $14.0 $20.6 $8.0 see 11 April 5, 2019, October 2019. Although we believe that the December 2018 $39 may October 2019, 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 a combination of public or private equity offerings and strategic transactions, including but not none 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, 2018, 120 5 72.0 5.0 not |
Note 4 - Summary of Significant
Note 4 - Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 Accounting Policies and Recent Accounting Pronouncements Principles of consolidation The 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 Limited and its wholly-owned subsidiary, CVie Therapeutics Limited; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, 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 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 December 31, 2018: (in thousands) Estimated Fair 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 assets acquired and liabilities assumed in a business combination and is not may not not Foreign c urrenc y transactions The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are not $0.1 December 31, 2018. no December 31, 2017. 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 at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of 90 Marketable securities 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, no December 31, 2018 2017. no December 31, 2018 2017. 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. 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, 2018 2017, 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 principally of a $140,000 May 26, 2004 $31,000 see, 18 Long-lived assets Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not No December 31, 2018 2017 no not Collaborative arrangements We account for collaborative arrangements in accordance with applicable accounting guidance provided in ASC Topic 808, Collaborative Arrangements See, 16 Restructured debt liability – contingent milestone payment In conjunction with the November 2017 see, 13 $15 October 27, 2017 ( not Deferred revenue Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria ( see 12 not 12 Deferred revenue primarily consists of amounts related to an upfront license fee received in July 2017 see 16 Revenue recognition Effective January 1, 2018, 606, 606, In accordance with ASC Topic 606, 606, five (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five 606, We have concluded that our government grants are not 606 not 958 605, Not not In the absence of applicable guidance under US GAAP, effective January 1, 2018, We believe this policy is consistent with the overarching premise in ASC Topic 606, no 606. 606. Prior to January 1, 2018, not no 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 15 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, 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 A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date. Preferred Stock The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the first 2017 14 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 December 31, 2018 December 31, 2017, $1.7 $2.8 December 31, 2018, no Convertible Note The issuance on July 2, 2018 $1.5 $1.5 $0.4 $0.4 $1.5 see 11 December 27, 2018, $1.5 $0.4 $5.11 $4.00, 375,000 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, 2018 2017, 14.4 1.0 December 31, 2018 2017, We do not Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL4 third KL4 one Business segments We currently operate in one one not Recent Accounting Pronouncements Recently Adopted Accounting Standards In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 606 2014 09, January 1, 2018 June 2017, 2014 09 no no See, 16 In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 January 1, 2018 not 2018 In August 2016, 2016 15, Statement of Cash Flows (Topic 230 eight one December 31, 2018 2016 15 January 1, 2018 not 2018 In January 2017, 2017 01, Business Combinations (Topic 805 first not not December 31, 2018 2017 01 January 1, 2018 not 2018 Recent Accounting Pronouncements In February 2016, 2016 02, Leases 842 January 1, 2019. not In January 2017, 2017 04, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment 2017 04 second two not 2017 04 December 15, 2019; 2017 04 not |
Note 5 - License Revenue with A
Note 5 - License Revenue with Affiliate | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 License Revenue with Affiliate Year Ended December 31, (in thousands) 2018 2017 License revenue with affiliate $ 1,023 $ 102 License revenue with affiliate for years ended December 31, 2018 2017 606, January 1, 2018 ( see 5 16 no 606. |
Note 6 - Fair Value of Financia
Note 6 - Fair Value of Financial Instruments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 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, 2018 2017: 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 $ - $ - 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 $ - $ - |
Note 7 - Loans Payable
Note 7 - Loans Payable | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 11 – Loan Payable In January 2018 March 2018, $1.5 $1.0 one 6% December 31, 2018. March 1, 2018 ( During the third fourth 2018, August 14, 2018 $0.3 August 29, 2018, $0.48 September 12, 2018 $0.5 September 27, 2018 $0.5 October 19, 2018 $0.43 November 2, 2018 $0.5 November 19, 2018 $0.35 December 5, 2018 $0.6 6% $30 March 31, 2019. Extinguishment of Loan Payable On December 21, 2018, $6.0 1,810,938 $3.3132 307,859 $3.68 597,610 $4.05 18 may 5 The conversion of the loan payable to LPH is treated as an extinguishment of debt and does not third $3.2 $9.2 December 21, 2018, $6.0 The balance of the loan payable to LPH of $160,000 $182,000 December 27, 2018. Assumption of bank debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $4.5 $138.0 March 2020. In September 2016, 12 $2.9 $90.0 $5.84 $180.0 September 2017. 110% not 90 0.91%. September 11, 2019 six March 11, 2020. not $4.5 As of December 31, 2018, $4.5 $138.0 Assumption of Lee’s debt as part of the CVie Acquisition As part of the CVie Acquisition, we assumed approximately $3.5 $106.2 From April 24, 2018 November 16, 2018, four $3.5 4% four one $0.5 April 2019; $0.3 September 2019; $0.2 October 2019; $2.5 November 2019. As of December 31, 2018, $3.5 $106.2 |
Note 8 - Restructured Debt Liab
Note 8 - Restructured Debt Liability | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 13 Restructured Debt Liability December 31, December 31, (in thousands) 2018 2017 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 5 not |
Note 9 - Stock Options and Stoc
Note 9 - Stock Options and Stock-based Employee Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 15 Stock Options and Stock-based Employee Compensation Long-Term Incentive Plans We have the 2011 2007 There are 6.1 2011 1.5 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) 2018 2017 Stock Options and RSUs Outstanding 2011 Plan 4,558 263 Non-Plan 10 10 Total Outstanding 4,568 273 Available for Future Grants under 2011 Plan 1,453 1,623 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: Weighted- Weighted- Average (in thousands, except for weighted-average data) Average Remaining Stock Options Shares Exercise Contractual Outstanding at January 1, 2018 84 $ 163.20 Granted 4,337 4.22 Forfeited or expired (4 ) 617.75 Outstanding at December 31, 2018 4,417 $ 6.73 9.9 Vested and exercisable at December 31, 2018 63 $ 171.87 6.5 Vested and expected to vest at December 31, 2018 4,243 $ 6.78 9.9 (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2018 190 $ 4.33 Awarded 56 4.22 Vested (95 ) 4.33 Unvested at December 31, 2018 151 $ 4.29 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, 2018 2017 $3.39 $17.44, December 31, 2018 2017 $4.22 $4.33, December 31, 2018 $0. Stock-Based Compensation We recognized stock-based compensation expense in accordance with ASC Topic 718 $1.0 $1.6 December 31, 2018 2017. Stock-based compensation expense was classified as follows: Year Ended (in thousands) 2018 2017 Research and development $ 232 $ 837 Selling, general and administrative 723 724 Total $ 955 $ 1,561 Under the 2011 may October 2017 ( see 14 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 US Treasury yield curve in effect at the time of the grant. Year Ended 2018 2017 Weighted average expected volatility 93% 79% Weighted average expected term (in years) 7.0 6.6 Weighted average risk-free interest rate 2.7% 2.2% Expected dividends - - The total fair value of the underlying shares of the options vested during 2018 2017 $0.6 $1.9 December 31, 2018, $13.9 2011 2.9 |
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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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. | Principles of consolidation The 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 Limited and its wholly-owned subsidiary, CVie Therapeutics Limited; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, 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 | 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 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 | 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 December 31, 2018: (in thousands) Estimated Fair 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 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. | Foreign c urrenc y transactions The functional currency for our foreign subsidiaries is US Dollars. We remeasure monetary assets and liabilities that are not $0.1 December 31, 2018. no December 31, 2017. |
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. | 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 at domestic and foreign financial institutions and consist of liquid investments and money market funds with a maturity from date of purchase of 90 | |
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. | Marketable securities 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, no December 31, 2018 2017. no December 31, 2018 2017. 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. |
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, 2018 2017, | |
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 principally of a $140,000 May 26, 2004 $31,000 see, 18 | |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-lived assets Our long-lived assets, primarily consisting of intangible assets, are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not No December 31, 2018 2017 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, 16 | |
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 | Restructured debt liability – contingent milestone payment In conjunction with the November 2017 see, 13 $15 October 27, 2017 ( not |
Revenue [Policy Text Block] | Deferred revenue Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria ( see 12 not 12 Deferred revenue primarily consists of amounts related to an upfront license fee received in July 2017 see 16 | |
Revenue from Contract with Customer [Policy Text Block] | Revenue recognition Effective January 1, 2018, 606, 606, In accordance with ASC Topic 606, 606, five (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five 606, We have concluded that our government grants are not 606 not 958 605, Not not In the absence of applicable guidance under US GAAP, effective January 1, 2018, We believe this policy is consistent with the overarching premise in ASC Topic 606, no 606. 606. Prior to January 1, 2018, not no | |
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 | 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 Payment Arrangement [Policy Text Block] | Stock-based compensation Stock-based compensation is accounted for under the fair value recognition provisions of ASC Topic 718, Stock Compensation 718 See 15 | |
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 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 | Income taxes We account for income taxes in accordance with ASC Topic 740, 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 A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date. Preferred Stock The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the first 2017 14 $3.6 one first 2017. An additional discount to the Preferred Shares of $4.5 December 31, 2018 December 31, 2017, $1.7 $2.8 December 31, 2018, no Convertible Note The issuance on July 2, 2018 $1.5 $1.5 $0.4 $0.4 $1.5 see 11 December 27, 2018, $1.5 $0.4 $5.11 $4.00, 375,000 | |
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, | 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, 2018 2017, 14.4 1.0 December 31, 2018 2017, We do not |
Concentration of Suppliers [Policy Text Block] | Concentration of Suppliers We currently obtain the active pharmaceutical ingredients (APIs) of our KL4 third KL4 one | |
Segment Reporting, Policy [Policy Text Block] | Business segments We currently operate in one one 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 | Recent Accounting Pronouncements Recently Adopted Accounting Standards In May 2014, 2014 09, Revenue from Contracts with Customers (Topic 606 606 2014 09, January 1, 2018 June 2017, 2014 09 no no See, 16 In May 2017, 2017 09, Compensation—Stock Compensation (Topic 718 December 31, 2018 2017 09 January 1, 2018 not 2018 In August 2016, 2016 15, Statement of Cash Flows (Topic 230 eight one December 31, 2018 2016 15 January 1, 2018 not 2018 In January 2017, 2017 01, Business Combinations (Topic 805 first not not December 31, 2018 2017 01 January 1, 2018 not 2018 Recent Accounting Pronouncements In February 2016, 2016 02, Leases 842 January 1, 2019. not In January 2017, 2017 04, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment 2017 04 second two not 2017 04 December 15, 2019; 2017 04 not |
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, |
Note 3 - Business Combination (
Note 3 - Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Business Acquisitions, by Acquisition [Table Text Block] | (in thousands) Cash and cash equivalents $ 193 Restricted cash 31 Prepaid expenses and other current assets 387 Property and equipment, net 76 Intangible assets 77,090 Total identifiable assets acquired $ 77,777 Current liabilities $ (2,590 ) Loan payable, current (3,453 ) Loan payable, non current (4,491 ) Deferred tax liabilities, noncurrent (15,418 ) Other liabilities, noncurrent (7 ) Net identifiable assets acquired 51,818 Goodwill 15,682 Net assets acquired $ 67,500 |
Business Acquisition, Pro Forma Information [Table Text Block] | Year Ended December 31, (in thousands, except per share data) 2018 2017 Pro forma net loss attributable to common shareholders $ (38,082 ) $ (34,616 ) Pro forma EPS - basic and diluted $ (1.20 ) $ (1.19 ) |
Warrants Issued for CVie Acquisition [Member] | |
Notes Tables | |
Schedule of Assumptions Used for Warrant Valution [Table Text Block] | Significant Input Assumptions of Warrant Valuation Historical volatility 116 % Expected term (in years) 2.5 Risk-free interest rate 2.62 % |
Note 5 - Accounting Policies _2
Note 5 - Accounting Policies and Recent Accounting Pronouncements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | (in thousands) Estimated Fair Value Istaroxime drug candidate $ 22,340 Rostafuroxin drug candidate 54,750 Total $ 77,090 |
Note 6 - License Revenue with_2
Note 6 - License Revenue with Affiliate (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | Year Ended December 31, (in thousands) 2018 2017 License revenue with affiliate $ 1,023 $ 102 |
Note 7 - Fair Value Measureme_2
Note 7 - Fair Value Measurements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 $ - $ - | 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 $ - $ - 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 $ - $ - |
Note 8 - Property and Equipme_2
Note 8 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, (in thousands) 2018 2017 Manufacturing, laboratory & office equipment $ 4,359 $ 4,965 Furniture & fixtures 390 615 Leasehold improvements 2,469 2,458 Subtotal 7,218 8,038 Accumulated depreciation and amortization (6,416 ) (7,153 ) Property and equipment, net $ 802 $ 885 |
Note 9 - Collaboration and De_2
Note 9 - Collaboration and Device Development Payable (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Series E Warrants [Member] | |
Notes Tables | |
Schedule of Assumptions Used for Warrant Valution [Table Text Block] | Significant Input Assumptions of Warrant Valuation Historical volatility 103 % Expected term (in years) 5 Risk-free interest rate 2.70 % |
Note 10 - Accrued Expenses (Tab
Note 10 - Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, (in thousands) 2018 2017 Professional fees $ 2,473 $ 412 Research and development 2,361 1,778 Salaries, bonus & benefits 815 1,008 Manufacturing operations 212 537 Other 604 399 Total accrued expenses $ 6,465 $ 4,134 |
Note 12 - Convertible Note Pa_2
Note 12 - Convertible Note Payable (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Convertible Note Interest Expense [Table Text Block] | Year Ended (in thousands) 2018 Non-cash amortization of debt discounts $ 833 Cash interest expense 106 Total convertible note interest expense $ 939 | |
Series D Warrants [Member] | ||
Notes Tables | ||
Schedule of Assumptions Used for Warrant Valution [Table Text Block] | Significant Input Assumptions of Warrant Valuation Historical volatility 103 % Expected term (in years) 5 Risk-free interest rate 2.75 % |
Note 13 - Restructured Debt L_2
Note 13 - Restructured Debt Liability (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | December 31, December 31, (in thousands) 2018 2017 Restructured debt liability - contingent milestone payments $ 15,000 $ 15,000 |
Note 14 - Stockholders' Equity
Note 14 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Common Shares Reserved for Future Issuance, Warrants [Table Text Block] | December 31, Expiration (in thousands, except price per share data) 2018 2017 Exercise Price Date Investors - Aerosurf 2,963 - $ - 02/14/24 Investors - December 2018 financing - long-term 3,889 - $ 4.05 12/04/23 Investors - December 2018 financing - short-term 2,004 - $ 3.68 06/24/20 Battelle - 2018 payables restructuring agreement (1) 75 - $ 6.50 12/07/23 Panacea Venture Management Company Ltd. 188 - $ 4.00 07/02/23 LPH II Investments Limited 135 - $ 5.52 04/04/25 Investors - February 2017 financing 352 352 $ 27.40 02/15/24 Investors - July 2015 financing 240 240 $ 196.00 07/22/22 Battelle - 2014 collaboration agreement (1) 4 4 $ 1,400.00 10/10/24 Total 9,850 596 |
Note 15 - Stock Options and S_2
Note 15 - Stock Options and Stock-based Employee Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Schedule of Share Based Compensation Arrangement by Stock Options and Restricted Stock Units Outstanding and Available for Future Issuance [Table Text Block] | <table style="margin-right: 15%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">December 31,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Stock Options and RSUs Outstanding</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 59.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,558</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">263</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Non-Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Total Outstanding</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,568</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">273</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Available for Future Grants under 2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,453</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,623</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> </table></div>" id="sjs-C4"><div style="display: inline; font-family: times new roman; font-size: 10pt"><table style="margin-right: 15%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">December 31,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Stock Options and RSUs Outstanding</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 59.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,558</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">263</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Non-Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Total Outstanding</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4,568</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">273</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Available for Future Grants under 2011 Plan</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,453</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,623</div></td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap"> </td> </tr> </table></div> | |
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 | Weighted- Weighted- Average (in thousands, except for weighted-average data) Average Remaining Stock Options Shares Exercise Contractual Outstanding at January 1, 2018 84 $ 163.20 Granted 4,337 4.22 Forfeited or expired (4 ) 617.75 Outstanding at December 31, 2018 4,417 $ 6.73 9.9 Vested and exercisable at December 31, 2018 63 $ 171.87 6.5 Vested and expected to vest at December 31, 2018 4,243 $ 6.78 9.9 |
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 | (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2018 190 $ 4.33 Awarded 56 4.22 Vested (95 ) 4.33 Unvested at December 31, 2018 151 $ 4.29 |
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 | Year Ended (in thousands) 2018 2017 Research and development $ 232 $ 837 Selling, general and administrative 723 724 Total $ 955 $ 1,561 |
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 - | Year Ended 2018 2017 Weighted average expected volatility 93% 79% Weighted average expected term (in years) 7.0 6.6 Weighted average risk-free interest rate 2.7% 2.2% Expected dividends - - |
Note 20 - Income Taxes (Tables)
Note 20 - Income Taxes (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, (in thousands) 2018 2017 Income tax benefit, statutory rates $ (4,312 ) $ (6,272 ) State taxes on income, net of federal benefit (535 ) (398 ) Impact of tax reform 5 71,151 Research and development tax credit (351 ) (797 ) Foreign rate differential 24 - Employee related 2,875 953 Interest related 186 (147 ) Income tax expense / (benefit), statutory rates (2,108 ) 64,490 Valuation allowance 2,108 (64,490 ) Income tax benefit, net $ - $ - | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, (in thousands) 2018 2017 Long-term deferred assets: Net operating loss carryforwards (federal and state) $ 176,759 $ 168,263 Research and development tax credit 16,718 16,813 Compensation expense on stock 1,121 1,191 Charitable contribution carryforward - 5 Other accrued 1,016 2,547 Deferred revenue 57 317 Depreciation 309 297 Total long-term deferred tax assets 195,980 189,433 Long-term deferred liabilities: IPR&D (15,476 ) - Total long-term deferred tax liabilities (15,476 ) - Valuation allowance (195,980 ) (189,433 ) Deferred tax liabilities, net $ (15,476 ) $ - |
Note 21 - Selected Quarterly _2
Note 21 - Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | 2018 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue $ - $ 695 $ 70 $ - $ 765 License revenue with affiliate 204 356 159 304 1,023 Total revenues 204 1,051 229 304 1,788 Expenses: Research and development 3,118 2,879 2,197 2,368 10,562 Selling, general and administrative 1,926 1,208 1,500 2,787 7,421 Total expenses 5,044 4,087 3,697 5,155 17,983 Operating loss (4,840 ) (3,036 ) (3,468 ) (4,851 ) (16,195 ) Other income / (expense), net 328 (16 ) (459 ) (4,191 ) (4,338 ) Net (loss) / income $ (4,512 ) $ (3,052 ) $ (3,927 ) $ (9,042 ) $ (20,533 ) AEROSURF warrant dividend - - - (12,505 ) (12,505 ) Deemed dividend on preferred stock - - - (1,718 ) (1,718 ) Net (loss) / income attributable to common shareholders $ (4,512 ) $ (3,052 ) $ (3,927 ) $ (23,265 ) $ (34,756 ) Net (loss) / income per common share - basic $ (1.40 ) $ (0.81 ) $ (1.04 ) $ (3.24 ) $ (7.74 ) Net (loss) / income per common share - diluted $ (1.40 ) $ (0.81 ) $ (1.04 ) $ (3.24 ) $ (7.74 ) Weighted average number of common shares outstanding - basic 3,227 3,751 3,769 7,191 4,493 Weighted average number of common shares outstanding - diluted 3,227 3,751 3,769 7,191 4,493 2017 Quarters Ended: (in thousands, except per share data) Mar. 31 June 30 Sept. 30 Dec. 31 Total Year Revenues: Grant revenue $ 219 $ 1,147 $ 17 $ - $ 1,383 License revenue with affiliate - - - 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 ) 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 |
Note 4 - Summary of Significa_2
Note 4 - Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | (in thousands) Estimated Fair 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | Year Ended December 31, (in thousands) 2018 2017 License revenue with affiliate $ 1,023 $ 102 |
Note 6 - Fair Value of Financ_2
Note 6 - Fair Value of Financial Instruments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 $ - $ - | 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 $ - $ - 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 $ - $ - |
Note 8 - Restructured Debt Li_2
Note 8 - Restructured Debt Liability (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | December 31, December 31, (in thousands) 2018 2017 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 | Weighted- Weighted- Average (in thousands, except for weighted-average data) Average Remaining Stock Options Shares Exercise Contractual Outstanding at January 1, 2018 84 $ 163.20 Granted 4,337 4.22 Forfeited or expired (4 ) 617.75 Outstanding at December 31, 2018 4,417 $ 6.73 9.9 Vested and exercisable at December 31, 2018 63 $ 171.87 6.5 Vested and expected to vest at December 31, 2018 4,243 $ 6.78 9.9 |
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 | (in thousands, except for weighted-average data) Restricted Stock Units Shares Weighted- Unvested at January 1, 2018 190 $ 4.33 Awarded 56 4.22 Vested (95 ) 4.33 Unvested at December 31, 2018 151 $ 4.29 |
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 - | Year Ended 2018 2017 Weighted average expected volatility 93% 79% Weighted average expected term (in years) 7.0 6.6 Weighted average risk-free interest rate 2.7% 2.2% 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 | Year Ended (in thousands) 2018 2017 Research and development $ 232 $ 837 Selling, general and administrative 723 724 Total $ 955 $ 1,561 |
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 - Business Combination_2
Note 3 - Business Combination (Details Textual) - CVie Investments [Member] $ in Millions | Dec. 31, 2018USD ($) | Dec. 21, 2018USD ($)shares |
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares | shares | 16,256,060 | |
Business Combination, Consideration Transferred, Total | $ | $ 67.5 | |
Indemnification Agreement, Shares Placed in Escrow | shares | 984,000 | |
Business Combination, Pro Forma Information, Earnings or Loss of Acquiree since Acquisition Date, Actual | $ | $ 0.5 | |
In Process Research and Development [Member] | ||
Indefinite-lived Intangible Assets Acquired | $ | $ 77.1 | |
Warrants Issued for CVie Acquisition [Member] | ||
Business Combination, Ratio of Warrants Received for Each Share of Common Stock and Certain Warrants | 0.6148 | |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 2,963,167 | |
Warrants and Rights Outstanding, Term | 5 years | |
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | shares | 1 | |
Warrants and Rights Outstanding | $ | $ 12.5 |
Note 3 - Business Combination -
Note 3 - Business Combination - Warrant Valuation Assumptions (Details) - Warrants Issued for CVie Acquisition [Member] | Dec. 21, 2018 |
Measurement Input, Price Volatility [Member] | |
Measurement input | 1.16 |
Measurement Input, Expected Term [Member] | |
Measurement input | 2.5 |
Measurement Input, Risk Free Interest Rate [Member] | |
Measurement input | 0.0262 |
Note 3 - Business Combination_3
Note 3 - Business Combination - Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 21, 2018 | Dec. 31, 2017 |
Goodwill | $ (15,682) | $ (15,682) | ||
CVie Investments [Member] | ||||
Cash and cash equivalents | $ 193 | |||
Restricted cash | 31 | |||
Prepaid expenses and other current assets | 387 | |||
Property and equipment, net | 76 | |||
Intangible assets | 77,090 | |||
Total identifiable assets acquired | 77,777 | |||
Current liabilities | (2,590) | |||
Loan payable, current | (3,453) | |||
Loan payable, non current | (4,491) | |||
Deferred tax liabilities, noncurrent | (15,418) | |||
Other liabilities, noncurrent | (7) | |||
Net identifiable assets acquired | 51,818 | |||
Goodwill | (15,682) | |||
Net assets acquired | $ 67,500 |
Note 3 - Business Combination_4
Note 3 - Business Combination - Pro Forma Information (Details) - CVie Investments [Member] - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Pro forma net loss attributable to common shareholders | $ (38,082) | $ (34,616) |
Pro forma EPS - basic and diluted (in dollars per share) | $ (1.20) | $ (1.19) |
Note 4 - Liquidity Risks and _2
Note 4 - Liquidity Risks and Management's Plans (Details Textual) - USD ($) $ in Thousands | Dec. 21, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 |
Cash and Cash Equivalents, at Carrying Value, Ending Balance | $ 11,187 | $ 1,815 | $ 4,437 | |
Debt Securities, Available-for-sale, Current, Total | 13,959 | |||
Liabilities, Current, Total | 20,633 | 11,760 | 16,278 | |
Loans Payable, Current, Total | 8,000 | $ 7,800 | ||
Proceeds from Issuance of Private Placement | $ 39,000 | $ 32,893 | $ 14,860 | |
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 | 120,000,000 | |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | 5,000,000 | |
Common Stock, Capital Shares Available for Issuance | 72,000,000 | 72,000,000 | ||
Preferred Stock, Capital Shares Available for Issuance | 5,000,000 | 5,000,000 |
Note 5 - Accounting Policies _3
Note 5 - Accounting Policies and Recent Accounting Pronouncements (Details Textual) $ / shares in Units, shares in Thousands | Dec. 27, 2018USD ($)$ / shares | Jul. 02, 2018USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2018USD ($)shares | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Sep. 30, 2019USD ($)shares | Sep. 30, 2018USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 26, 2018$ / shares | Feb. 28, 2018USD ($) | Dec. 01, 2017USD ($) | Nov. 01, 2017USD ($) |
Foreign Currency Transaction Gain (Loss), before Tax, Total | $ 100,000 | $ 0 | $ 400,000 | $ 0 | $ 100,000 | $ 0 | |||||||||||||
Marketable Securities, Realized Gain (Loss), Total | 14,000 | 75,000 | 0 | ||||||||||||||||
Marketable Securities, Unrealized Gain (Loss), Total | (12,000) | 0 | $ 0 | 0 | |||||||||||||||
Asset Impairment Charges, Total | 0 | ||||||||||||||||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000,000 | $ 15,000,000 | $ 15,000,000 | $ 15,000,000 | 15,000,000 | 15,000,000 | |||||||||||||
Preferred Stock Dividends, Income Statement Impact | $ 1,718,000 | $ 2,234,000 | $ 532,000 | $ 3,604,000 | $ 1,718,000 | 6,370,000 | |||||||||||||
Preferred Stock, Discount on Shares | 4,500,000 | 4,500,000 | |||||||||||||||||
Preferred Stock, Shares Remaining to Be Converted | shares | 0 | 0 | |||||||||||||||||
Repayments of Convertible Debt | $ 1,500,000 | ||||||||||||||||||
Gain (Loss) on Extinguishment of Debt, Total | $ (3,345,000) | ||||||||||||||||||
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants | shares | 15,600 | 1,300 | 14,400 | 1,000 | |||||||||||||||
Number of Operating Segments | 1 | ||||||||||||||||||
Conversion of Preferred Stock [Member] | |||||||||||||||||||
Preferred Stock Dividends, Income Statement Impact | $ 1,700,000 | $ 2,800,000 | |||||||||||||||||
Panacea [Member] | Warrant Issued Related to Secured Convertible Promissory Note [Member] | |||||||||||||||||||
Warrants and Rights Outstanding | $ 400,000 | ||||||||||||||||||
Panacea [Member] | Secured Convertible Promissory Note [Member] | |||||||||||||||||||
Debt Instrument, Face Amount | 1,500,000 | ||||||||||||||||||
Debt Instrument, Convertible, Beneficial Conversion Feature | $ 400,000 | ||||||||||||||||||
Repayments of Convertible Debt | $ 1,500,000 | ||||||||||||||||||
Gain (Loss) on Extinguishment of Debt, Total | $ 400,000 | ||||||||||||||||||
Share Price | $ / shares | $ 5.11 | ||||||||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 4 | $ 4 | |||||||||||||||||
Debt Instrument, Convertible, Number of Equity Instruments | 375,000 | ||||||||||||||||||
Deerfield Loan [Member] | |||||||||||||||||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000,000 | $ 15,000,000 | 15,000,000 | $ 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 | $ 15,000,000 | |||||||||||||||||
Headquarters [Member] | |||||||||||||||||||
Security Deposit | 140,000 | $ 225,000 | 140,000 | $ 225,000 | $ 140,000 | ||||||||||||||
Offices, Taipei, Taiwan [Member] | |||||||||||||||||||
Security Deposit | $ 31,000 | $ 31,000 | |||||||||||||||||
Minimum [Member] | |||||||||||||||||||
Property, Plant and Equipment, Useful Life | 3 years | ||||||||||||||||||
Maximum [Member] | |||||||||||||||||||
Property, Plant and Equipment, Useful Life | 10 years |
Note 5 - Accounting Policies _4
Note 5 - Accounting Policies and Recent Accounting Pronouncements - Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Indefinite intangible asset | $ 77,090 | $ 77,090 | |
Istaroxime Drug Candidate [Member] | |||
Indefinite intangible asset | 22,340 | 22,340 | |
Rostafuroxin Drug Candidate [Member] | |||
Indefinite intangible asset | $ 54,750 | $ 54,750 |
Note 6 - License Revenue with_3
Note 6 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
License [Member] | |||||||||||||
License revenue with affiliate | $ 304 | $ 159 | $ 356 | $ 204 | $ 102 | $ 198 | $ 719 | $ 1,023 | $ 102 |
Note 7 - Fair Value Measureme_3
Note 7 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Cash and cash equivalents | $ 4,437 | $ 5,234 | $ 1,815 |
Total Assets | 4,591 | 25,317 | 2,040 |
Certificates of Deposit [Member] | |||
Certificate of deposit | 154 | 171 | 225 |
US Treasury Securities [Member] | |||
Cash and cash equivalents | 19,912 | ||
Cash and cash equivalents | 19,912 | ||
Fair Value, Inputs, Level 1 [Member] | |||
Cash and cash equivalents | 4,437 | 5,234 | 1,815 |
Total Assets | 4,591 | 25,317 | 2,040 |
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | |||
Certificate of deposit | 154 | 171 | 225 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | |||
Cash and cash equivalents | 19,912 | ||
Cash and cash equivalents | 19,912 | ||
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 | |||
Cash and cash equivalents | |||
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 | |||
Cash and cash equivalents |
Note 8 - Property and Equipme_3
Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Depreciation, Total | $ 178 | $ 121 | $ 160 | $ 192 |
Note 8 - Property and Equipme_4
Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment, gross | $ 7,218 | $ 8,038 | |
Accumulated depreciation and amortization | (6,416) | (7,153) | |
Property and equipment, net | $ 877 | 802 | 885 |
Manufacturing, Laboratory, and Office Equipment [Member] | |||
Property and equipment, gross | 4,359 | 4,965 | |
Furniture and Fixtures [Member] | |||
Property and equipment, gross | 390 | 615 | |
Leasehold Improvements [Member] | |||
Property and equipment, gross | $ 2,469 | $ 2,458 |
Note 9 - Collaboration and De_3
Note 9 - Collaboration and Device Development Payable (Details Textual) | Dec. 21, 2018USD ($)$ / sharesshares | Dec. 07, 2018USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2019USD ($) | Dec. 06, 2018USD ($) |
Collaboration and Device Development Payable, Current | $ 4,400,000 | $ 2,576,000 | $ 4,418,000 | $ 1,873,000 | ||
Gain (Loss) on Extinguishment of Debt, Total | (3,345,000) | |||||
Conversion of Battelle Payables [Member] | ||||||
Gain (Loss) on Extinguishment of Debt, Total | $ (500,000) | |||||
Debt Conversion, Converted Instrument, Amount | 1,500,000 | |||||
Debt Conversion, Original Debt, Amount | 1,000,000 | |||||
Private Placement [Member] | ||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | |||||
Private Placement [Member] | Series F Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 2,003,541 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.68 | |||||
Warrants and Rights Outstanding, Term | 1 year 180 days | |||||
Private Placement [Member] | Series G Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 3,889,229 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4.05 | |||||
Warrants and Rights Outstanding, Term | 5 years | |||||
Payment Restructuring of Battelle Payables [Member] | ||||||
Collaboration and Device Development Payable, Interest Rate | 6.00% | |||||
Collaboration and Device Development Payable, Repaid Payable Threshold to Qualify for Services on Credit | $ 3,000,000 | |||||
Payments for Collaboration and Device Development Payable | 972,281 | |||||
Collaboration and Device Development Agreement, Aggregate Payments | $ 1,250,000 | |||||
Collaboration and Device DevelopmentPayable, Number of Monthly Installments Payments Deferred | 5 | |||||
Collaboration and Device Development Payable, Periodic Payment, Total | $ 250,000 | |||||
Royalty Guarantees, Commitments, Amount | $ 35,000,000 | $ 25,000,000 | ||||
Interest Payable, Current | $ 300,000 | |||||
Payment Restructuring of Battelle Payables [Member] | Series E Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 6.50 | |||||
Warrants and Rights Outstanding, Term | 5 years | |||||
Common Stock Maximum Ownership Percentage For Warrant Exercise | 9.99% | |||||
Payment Restructuring of Battelle Payables [Member] | Series E Warrants [Member] | Common Stock [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 75,000 | |||||
Payment Restructuring of Battelle Payables [Member] | Private Placement [Member] | ||||||
Collaboration and Device Development Payable, Converted Payable Amount into Equity | $ 1,000,000 | |||||
Sale of Stock, Number of Shares Issued in Transaction | shares | 301,823 | |||||
Sale of Stock, Price Per Share | $ / shares | $ 3.3132 | |||||
Payment Restructuring of Battelle Payables [Member] | Private Placement [Member] | Series F Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.68 | |||||
Warrants and Rights Outstanding, Term | 1 year 180 days | |||||
Payment Restructuring of Battelle Payables [Member] | Private Placement [Member] | Series F Warrants [Member] | Common Stock [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 51,310 | |||||
Payment Restructuring of Battelle Payables [Member] | Private Placement [Member] | Series G Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4.05 | |||||
Warrants and Rights Outstanding, Term | 5 years | |||||
Payment Restructuring of Battelle Payables [Member] | Private Placement [Member] | Series G Warrants [Member] | Common Stock [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 99,602 |
Note 9 - Collaboration and De_4
Note 9 - Collaboration and Device Development Payable - Significant Input Assumptions of Warrant Valuation (Details) - Series E Warrants [Member] | Dec. 07, 2018 |
Measurement Input, Price Volatility [Member] | |
Measurement input | 1.03 |
Measurement Input, Expected Term [Member] | |
Measurement input | 5 |
Measurement Input, Risk Free Interest Rate [Member] | |
Measurement input | 0.027 |
Note 10 - Accrued Expenses - Ac
Note 10 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Professional fees | $ 2,473 | $ 412 | |
Research and development | 2,361 | 1,778 | |
Salaries, bonus & benefits | 815 | 1,008 | |
Manufacturing operations | 212 | 537 | |
Other | 604 | 399 | |
Total accrued expenses | $ 5,235 | $ 6,465 | $ 4,134 |
Note 11 - Loan Payable (Details
Note 11 - Loan Payable (Details Textual) $ / shares in Units, $ in Millions | Dec. 27, 2018USD ($) | Dec. 21, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($) | Jan. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2018TWD ($) | Dec. 21, 2018TWD ($)shares | Dec. 05, 2018USD ($) | Nov. 19, 2018USD ($) | Nov. 16, 2018USD ($) | Nov. 02, 2018USD ($) | Oct. 19, 2018USD ($) | Sep. 27, 2018USD ($) | Sep. 12, 2018USD ($) | Aug. 29, 2018USD ($) | Aug. 14, 2018USD ($) | Sep. 30, 2017TWD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2016TWD ($) |
Gain (Loss) on Extinguishment of Debt, Total | $ (3,345,000) | |||||||||||||||||||||
Short-term Debt, Total | 7,974,000 | $ 7,782,000 | ||||||||||||||||||||
Debt Payable to Lee's International [Member] | ||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | |||||||||||||||||||||
Debt Instrument, Face Amount | $ 3,500,000 | |||||||||||||||||||||
Short-term Debt, Total | 3,000,000 | |||||||||||||||||||||
Long-term Debt, Current Maturities, Total | $ 3,500,000 | $ 106.2 | ||||||||||||||||||||
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 | |||||||||||||||||||||
CVie Investments [Member] | ||||||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total | $ 2,590,000 | |||||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt | 3,453,000 | |||||||||||||||||||||
CVie Investments [Member] | Debt Payable to Lee's International [Member] | ||||||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt | 3,500,000 | $ 106.2 | ||||||||||||||||||||
Private Placement [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | |||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 1,810,938 | |||||||||||||||||||||
Shares Issued, Price Per Share | $ / shares | $ 3.3132 | |||||||||||||||||||||
Private Placement [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | |||||||||||||||||||||
Private Placement [Member] | Series F Warrants [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 2,003,541 | 2,003,541 | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.68 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term | 1 year 180 days | 1 year 180 days | ||||||||||||||||||||
Private Placement [Member] | Series F Warrants [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 307,859 | 307,859 | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.68 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term | 1 year 180 days | 1 year 180 days | ||||||||||||||||||||
Private Placement [Member] | Series G Warrants [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 3,889,229 | 3,889,229 | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4.05 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term | 5 years | 5 years | ||||||||||||||||||||
Private Placement [Member] | Series G Warrants [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 597,610 | 597,610 | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4.05 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term | 5 years | 5 years | ||||||||||||||||||||
LPH [Member] | ||||||||||||||||||||||
Proceeds from Issuance of Debt | $ 1,000,000 | $ 1,500,000 | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% | 6.00% | ||||||||||||||||||||
Debt Instrument, Face Amount | $ 600,000 | $ 350,000 | $ 500,000 | $ 430,000 | $ 500,000 | $ 500,000 | $ 480,000 | $ 300,000 | ||||||||||||||
Gain (Loss) on Extinguishment of Debt, Total | $ (3,200,000) | |||||||||||||||||||||
Common Stock and Warrants for Debt Settlement, Fair Value | 9,200,000 | |||||||||||||||||||||
Short-term Debt, Total | 6,000,000 | |||||||||||||||||||||
Repayments of Debt | $ 160,000 | |||||||||||||||||||||
Interest Paid, Including Capitalized Interest, Operating and Investing Activities, Total | $ 182,000 | |||||||||||||||||||||
LPH II [Member] | ||||||||||||||||||||||
Debt Instrument Requirement For Minimum Amount Rise | $ 30,000,000 | |||||||||||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | ||||||||||||||||||||||
Line of Credit Facility, Percent of Pledged Deposits Required | 110.00% | 110.00% | 110.00% | 110.00% | ||||||||||||||||||
Line of Credit, Current | $ 4,500,000 | $ 4,500,000 | $ 138 | |||||||||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | Taipei Interbank Offer Rate (TAIBOR) [Member] | ||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.91% | 0.91% | ||||||||||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | CVie Investments [Member] | ||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5,840,000 | $ 180 | $ 2,900,000 | $ 90 | ||||||||||||||||||
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 | $ 4,500,000 | $ 138 |
Note 12 - Convertible Note Pa_3
Note 12 - Convertible Note Payable (Details Textual) | Dec. 27, 2018USD ($)$ / shares | Jul. 23, 2018USD ($) | Jul. 02, 2018USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 26, 2018$ / shares |
Proceeds from Convertible Debt | $ 1,500,000 | $ 1,500,000 | ||||||
Repayments of Convertible Debt | 1,500,000 | |||||||
Gain (Loss) on Extinguishment of Debt, Total | (3,345,000) | |||||||
Panacea [Member] | Secured Convertible Promissory Note [Member] | ||||||||
Debt Instrument, Face Amount | $ 1,500,000 | |||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 4 | $ 4 | ||||||
Debt Instrument, Convertible, Beneficial Conversion Feature | $ 400,000 | |||||||
Repayments of Convertible Debt | $ 1,500,000 | |||||||
Gain (Loss) on Extinguishment of Debt, Total | $ 400,000 | |||||||
Share Price | $ / shares | $ 5.11 | |||||||
Debt Instrument, Convertible, Number of Equity Instruments | 375,000 | |||||||
Panacea [Member] | Series D Warrants [Member] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 187,500 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 4 | |||||||
Class of Warrant or Right, Vesting Period | 180 days | |||||||
Warrants and Rights Outstanding, Term | 5 years | |||||||
Common Stock Maximum Ownership Percentage For Warrant Exercise | 9.99% | |||||||
Panacea [Member] | Series D Warrants [Member] | Warrant [Member] | ||||||||
Derivative Liability, Total | 400,000 | |||||||
Convertible Notes Payable [Member] | Panacea [Member] | ||||||||
Debt Instrument, Face Amount | $ 1,500,000 | |||||||
Proceeds from Convertible Debt | $ 500,000 | $ 1,000,000 | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 15.00% | |||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 4 | |||||||
Debt Instrument, Convertible, Beneficial Conversion Feature | $ 400,000 |
Note 12 - Convertible Note Pa_4
Note 12 - Convertible Note Payable - Significant Input Assumptions of Warrant Valuation (Details) - Series D Warrants [Member] | Dec. 31, 2018 |
Measurement Input, Price Volatility [Member] | |
Measurement input | 1.03 |
Measurement Input, Expected Term [Member] | |
Measurement input | 5 |
Measurement Input, Risk Free Interest Rate [Member] | |
Measurement input | 0.0275 |
Note 12 - Convertible Note Pa_5
Note 12 - Convertible Note Payable - Convertible Note Interest Expense (Details) - Convertible Notes Payable [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Non-cash amortization of debt discounts | $ 833 |
Cash interest expense | 106 |
Total convertible note interest expense | $ 939 |
Note 13 - Restructured Debt L_3
Note 13 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Nov. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 |
Repayments of Long-term Debt, Total | $ 2,500 | |||
Liability for Contingent Milestone Payment, Noncurrent | 15,000 | 15,000 | $ 15,000 | |
Deerfield Loan [Member] | ||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 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 13 - Restructured Debt L_4
Note 13 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 15,000 | $ 15,000 |
Deerfield Loan [Member] | |||
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 15,000 | $ 15,000 |
Note 14 - Stockholders' Equit_2
Note 14 - Stockholders' Equity (Details Textual) - USD ($) | Dec. 24, 2018 | Dec. 21, 2018 | Apr. 04, 2018 | Nov. 01, 2017 | Oct. 27, 2017 | Oct. 25, 2017 | Feb. 15, 2017 | Feb. 11, 2013 | Oct. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 |
Common Stock, Shares, Issued, Total | 32,133,263 | 3,227,495 | 32,188,929 | |||||||||
Proceeds from Issuance of Private Placement | $ 39,000,000 | $ 32,893,000 | $ 14,860,000 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Proceeds from Issuance of Common Stock | $ 1,036,000 | |||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 9,850,000 | 596,000 | ||||||||||
The 2011 Long-term Incentive Plan [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 4,200,000 | 1,750,000 | 37,500 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,453,000 | 1,623,000 | ||||||||||
The 401(k) Plan [Member] | ||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 807 | |||||||||||
LPH [Member] | Acquisition of Windtree [Member] | ||||||||||||
Business Combination, Consideration Transferred, Total | $ 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% | |||||||||||
Battelle [Member] | Series A Preferred Stock [Member] | ||||||||||||
Preferred Stock, Convertible, Shares, Liquidity Preference Waived | 1,095 | |||||||||||
Private Placement [Member] | ||||||||||||
Common Stock, Shares, Issued, Total | 11,785,540 | |||||||||||
Share Price | $ 3.3132 | |||||||||||
Proceeds from Issuance of Private Placement | $ 39,000,000 | |||||||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | |||||||||||
Shares Issued, Price Per Share | $ 3.3132 | |||||||||||
Private Placement [Member] | Series F Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,003,541 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.68 | |||||||||||
Warrants and Rights Outstanding, Term | 1 year 180 days | |||||||||||
Private Placement [Member] | Series G Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,889,229 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.05 | |||||||||||
Warrants and Rights Outstanding, Term | 5 years | |||||||||||
Private Placement [Member] | December 2018 Warrants [Member] | ||||||||||||
Common Stock Maximum Ownership Percentage For Warrant Exercise | 9.99% | |||||||||||
Private Placement [Member] | Series A Units [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | 7,049 | |||||||||||
Convertible Preferred Stock Units, Price Per Unit | $ 1,495 | |||||||||||
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, Exercise Price of Warrants or Rights | $ 27.40 | |||||||||||
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% | |||||||||||
Private Placement [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | ||||||||||||
Debt Conversion, Original Debt, Amount | $ 6,000,000 | |||||||||||
Private Placement [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | Series F Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 307,859 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.68 | |||||||||||
Warrants and Rights Outstanding, Term | 1 year 180 days | |||||||||||
Private Placement [Member] | Lee’s Pharmaceutical Holdings Limited [Member] | Series G Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 597,610 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.05 | |||||||||||
Warrants and Rights Outstanding, Term | 5 years | |||||||||||
Private Placement [Member] | Battelle [Member] | ||||||||||||
Debt Conversion, Original Debt, Amount | $ 1,000,000 | |||||||||||
Private Placement [Member] | LPH II [Member] | ||||||||||||
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 | |||||||||||
Warrants and Rights Outstanding, Term | 7 years | |||||||||||
Private Placement, Purchase Price of Common Stock and Warrants | $ 2,600,000 | |||||||||||
Shares Issued, Price Per Share | $ 4.80 | |||||||||||
Stock Issued During Period, Shares, New Issues | 541,667 | |||||||||||
Class of Warrant or Right, Vesting Period | 180 days | |||||||||||
Registration Rights Agreement, Rights Percentage | 25.00% | |||||||||||
Stifel ATM Program [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | 42,357 | |||||||||||
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 | |||||||||||
Proceeds from Issuance of Common Stock, Net | $ 1,000,000 | |||||||||||
The 401(k) Plan [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues | 7,561 | |||||||||||
Defined Contribution Plan, Cost | $ 0 | $ 100,000 |
Note 14 - Stockholders' Equit_3
Note 14 - Stockholders' Equity - Common Shares Reserved for Future Issuance (Details) - $ / shares shares in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | |||
Common Stock, Capital Shares Reserved for Future Issuance | 9,850 | 596 | ||
Investors - Aerosurf [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 2,963 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | ||||
Expiration date | 02/14/24 | |||
Investors - December 2018 Financing - Long-term [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 3,889 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.05 | |||
Expiration date | 12/04/23 | |||
Investors - December 2018 Financing - Short-term [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 2,004 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.68 | |||
Expiration date | 06/24/20 | |||
Battelle - 2018 Payables Restructuring Agreement [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 75 | [1] | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | [1] | $ 6.50 | ||
Expiration date | [1] | 12/07/23 | ||
Panacea Venture Management Company Ltd. [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 188 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4 | |||
Expiration date | 07/02/23 | |||
LPH II Investments Limited [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 135 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5.52 | |||
Expiration date | 04/04/25 | |||
Investors - February 2017 Financing [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 352 | 352 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 27.40 | |||
Expiration date | 02/15/24 | |||
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 | 07/22/22 | |||
Battelle 2014 Collaboration Agreement [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance | [1] | 4 | 4 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | [1] | $ 1,400 | ||
Expiration date | [1] | 10/10/24 | ||
[1] | See, - Note 16 - Collaboration and Device Development Payment Restructuring, Licensing and Research Funding Agreements for further details on the Battelle collaboration agreement. |
Note 15 - Stock Options and S_3
Note 15 - Stock Options and Stock-based Employee Compensation (Details Textual) - USD ($) $ / shares in Units, shares in Thousands | Feb. 01, 2016 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3.39 | $ 17.44 | ||||||||||
APIC, Share-based Payment Arrangement, Increase for Cost Recognition, Total | $ 1,938,000 | $ 1,739,000 | $ 1,530,000 | $ 145,000 | $ 140,000 | $ 418,000 | $ 1,000,000 | $ 955,000 | $ 1,600,000 | |||
Share-based Payment Arrangement, Expense | $ 1,939,000 | $ 145,000 | $ 5,208,000 | $ 703,000 | 955,000 | 1,561,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 600,000 | $ 1,900,000 | ||||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | 13,900,000 | $ 13,900,000 | ||||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 328 days | |||||||||||
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 | $ 3.95 | $ 4.22 | $ 4.33 | |||||||||
Share-based Payment Arrangement, Option [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 0 | $ 0 | ||||||||||
Chief Executive Officer [Member] | Non-plan Stock Options [Member] | ||||||||||||
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 | 6,100 | 6,100 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,453 | 1,453 | 1,623 | |||||||||
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 | |||||||||||
Share-based Payment Arrangement, Expense | $ 400,000 |
Note 15 - Stock Options and S_4
Note 15 - 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, 2018 | Dec. 31, 2017 |
2011 Plan (in shares) | 4,568 | 273 |
The 2011 Long-term Incentive Plan [Member] | ||
2011 Plan (in shares) | 4,558 | 263 |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,453 | 1,623 |
Non-Plan [Member] | ||
2011 Plan (in shares) | 10 | 10 |
Note 15 - Stock Options and S_5
Note 15 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Shares Outstanding, Beginning Balance (in shares) | 4,417 | 84 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ 6.73 | $ 163.20 |
Shares Granted (in shares) | 1,144 | 4,337 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ 4.20 | $ 4.22 |
Shares Forfeited or Expired (in shares) | (5) | (4) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ 467.57 | $ 617.75 |
Shares Outstanding, Ending Balance (in shares) | 5,556 | 4,417 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ 5.80 | $ 6.73 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 9 years 73 days | 9 years 328 days |
Shares Vested and Exercisable (in shares) | 70 | 63 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ 128.45 | $ 171.87 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 6 years 109 days | 6 years 182 days |
Vested and expected to vest (in shares) | 5,245 | 4,243 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ 5.79 | $ 6.78 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 9 years 73 days | 9 years 328 days |
Note 15 - Stock Options and S_6
Note 15 - Stock Options and Stock-based Employee Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Unvested, Beginning Balance (in shares) | 151 | 190 | |
Unvested, Beginning Balance (in dollars per share) | $ 4.29 | $ 4.33 | |
Awarded (in shares) | 249 | 56 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3.95 | $ 4.22 | $ 4.33 |
Vested (in shares) | (95) | (95) | |
Vested (in dollars per share) | $ 3.95 | $ 4.33 | |
Unvested, Ending Balance (in shares) | 161 | 151 | 190 |
Unvested, Ending Balance (in dollars per share) | $ 4.04 | $ 4.29 | $ 4.33 |
Note 15 - Stock Options and S_7
Note 15 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Payment Arrangement, Expense | $ 1,939 | $ 145 | $ 5,208 | $ 703 | $ 955 | $ 1,561 |
Research and Development Expense [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 574 | $ 29 | $ 1,613 | $ 169 | 232 | 837 |
Selling, General and Administrative Expenses [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 723 | $ 724 |
Note 15 - Stock Options and S_8
Note 15 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted average expected volatility | 95.00% | 93.00% | 79.00% |
Weighted average expected term (Year) | 6 years 219 days | 7 years | 6 years 219 days |
Weighted average risk-free interest rate | 2.60% | 2.70% | 2.20% |
Expected dividends |
Note 16 - Collaboration, Lice_2
Note 16 - Collaboration, Licensing and Research Funding Agreements (Details Textual) € in Millions | Nov. 01, 2017USD ($) | Oct. 27, 2017USD ($) | Aug. 31, 2017USD ($) | Jun. 30, 2017USD ($) | Oct. 31, 2014USD ($) | Oct. 31, 2017USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2012USD ($) |
Proceeds from Short-term Debt, Total | $ 4,280,000 | $ 6,160,000 | $ 3,900,000 | ||||||||||
LPH [Member] | Acquisition of Windtree [Member] | |||||||||||||
Business Combination, Consideration Transferred, Total | $ 10,000,000 | $ 10,000,000 | |||||||||||
Maximum [Member] | Lee's [Member] | Lee's Loan to Support Operations [Member] | |||||||||||||
Proceeds from Short-term Debt, Total | $ 3,900,000 | ||||||||||||
License Agreement With Lee’s [Member] | |||||||||||||
Proceeds from License Fees Received | $ 1,000,000 | 1,000,000 | |||||||||||
License Agreement, Contingent Receivable, Maximum | $ 35,800,000 | $ 37,500,000 | |||||||||||
Fair Value of Royalties and Milestones Foregone | 300,000 | ||||||||||||
Revenue, Remaining Performance Obligation, Amount | 1,300,000 | ||||||||||||
Philip Morris USA Inc. - License Agreement [Member] | |||||||||||||
Payments for Royalties | 300,000 | ||||||||||||
Deferred Royalty Expense | 300,000 | ||||||||||||
Philip Morris Products S.A. - License Agreement [Member] | |||||||||||||
Payments for Royalties | $ 487,500 | ||||||||||||
Deferred Royalty Expense | 400,000 | $ 187,500 | |||||||||||
Johnson and Johnson - License Agreement [Member] | |||||||||||||
Potential License Fee Payable | 2,500,000 | ||||||||||||
Payment of License Cost Subject to Regulatory Approval | $ 1,000,000 | $ 500,000 | |||||||||||
Percent of Cash Upfront and Milestone Fees Payable to Esteve | 10.00% | ||||||||||||
Maximum Aggregate Cash Upfront and Milestone Fees Payable to Esteve | $ 20,000,000 | ||||||||||||
Universita Degli Studi Do Miano-Biocca [Member] | |||||||||||||
Payment of License Cost for New Compounds Modulating | 100,000 | € 0.1 | |||||||||||
Payment of License Cost Upon Obtaining Marketing Authorization | 1,700,000 | € 1.5 | |||||||||||
Payment of License Cost, Aggregation Fund | 200,000 | ||||||||||||
Battelle Applies [Member] | |||||||||||||
Maximum Royalty Paid on Completion of Activities Under the Agreement | $ 25,000,000 | $ 35,000,000 |
Note 17 - Related Party Trans_2
Note 17 - Related Party Transactions (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2018 | Jul. 31, 2018 | Apr. 30, 2018 | Oct. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Affiliate of Lee’s [Member] | Share Purchase Agreement [Member] | ||||||
Related Party Transaction, Amounts of Transaction | $ 10 | |||||
Affiliate of Lee’s [Member] | Private Placement in a related Party Transaction [Member] | ||||||
Related Party Transaction, Amounts of Transaction | $ 2.6 | |||||
Affiliate of Lee’s [Member] | Converting Existing Loans Payable [Member] | ||||||
Related Party Transaction, Amounts of Transaction | $ 6 | |||||
Lee’s Pharmaceutical Holdings Limited [Member] | Bank Credit Facility is Guaranteed [Member] | ||||||
Related Party Transaction, Amounts of Transaction | $ 4.5 | |||||
Affiliate of Panacea [Member] | Secured Convertible Promissory Note [Member] | ||||||
Related Party Transaction, Amounts of Transaction | $ 1.5 | |||||
Rui Jin (HK) Consulting Management Company Limited, an affiliate of Panacea [Member] | ||||||
Related Party Transaction, Shares Issued | 114,415 | |||||
Lee’s Pharmaceutical Holdings Limited [Member] | Windtree Therapeutics [Member] | ||||||
Ownership Percentage | 40.00% | 40.00% | 73.00% | |||
Lee’s Pharmaceutical Holdings Limited [Member] | CVie Investment [Member] | ||||||
Ownership Percentage | 49.00% | 49.00% | ||||
KPCB [Member] | Windtree Therapeutics [Member] | ||||||
Ownership Percentage | 14.00% | 14.00% | ||||
KPCB [Member] | CVie [Member] | ||||||
Ownership Percentage | 27.00% | 27.00% |
Note 18 - Commitments (Details
Note 18 - Commitments (Details Textual) | Dec. 21, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2019USD ($) | Nov. 30, 2018USD ($) | Feb. 28, 2018USD ($)ft² | Apr. 30, 2016ft² |
Operating Leases, Rent Expense, Net, Total | $ 800,000 | $ 700,000 | |||||
Eligible Transaction, Minimum Gross Proceeds from Financing | $ 30,000,000 | ||||||
Strategic and Retention Bonus, Maximum Bonus, Requirement, Eligible Transaction, Minimum Gross Proceeds | $ 45,000,000 | ||||||
Minimum Bonus Amount, Percentage of Maximum Bonus Amount | 20.00% | ||||||
Private Placement Financing, Value | $ 39,000,000 | ||||||
Eligible Participants, Total Bonus | $ 1,400,000 | ||||||
Eligible Participants, Bonus Installment | 700,000 | ||||||
Forecast [Member] | |||||||
Eligible Participants, Bonus Installment | $ 700,000 | ||||||
Headquarters [Member] | |||||||
Area of Real Estate Property | ft² | 21,189 | 30,506 | |||||
Security Deposit | 140,000 | $ 225,000 | $ 140,000 | ||||
Operating Leases, Future Minimum Payments Due, Total | $ 2,100,000 |
Note 20 - Income Taxes (Details
Note 20 - Income Taxes (Details Textual) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Operating Loss Carryforwards, Total | $ 606.6 | $ 590 |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards, Total | 584.8 | 567.7 |
State and Local Jurisdiction [Member] | Pennsylvania [Member] | ||
Operating Loss Carryforwards, Total | 570.2 | |
Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | $ 16.7 | $ 16.8 |
Note 20 - Income Taxes - Income
Note 20 - Income Taxes - Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income tax benefit, statutory rates | $ (4,312) | $ (6,272) |
State taxes on income, net of federal benefit | (535) | (398) |
Impact of tax reform | 5 | 71,151 |
Research and development tax credit | (351) | (797) |
Foreign rate differential | 24 | |
Employee related | 2,875 | 953 |
Interest related | 186 | (147) |
Income tax expense / (benefit), statutory rates | (2,108) | 64,490 |
Valuation allowance | 2,108 | (64,490) |
Income tax benefit, net |
Note 20 - Income Taxes - Deferr
Note 20 - Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Net operating loss carryforwards (federal and state) | $ 176,759 | $ 168,263 |
Research and development tax credit | 16,718 | 16,813 |
Compensation expense on stock | 1,121 | 1,191 |
Charitable contribution carryforward | 5 | |
Other accrued | 1,016 | 2,547 |
Deferred revenue | 57 | 317 |
Depreciation | 309 | 297 |
Total long-term deferred tax assets | 195,980 | 189,433 |
IPR&D | (15,476) | |
Total long-term deferred tax liabilities | (15,476) | |
Valuation allowance | (195,980) | (189,433) |
Deferred tax liabilities, net | $ (15,476) |
Note 21 - Selected Quarterly _3
Note 21 - Selected Quarterly Financial Data (Unaudited) - Schedule of Quarterly Financial Data (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Grant revenue | $ 70 | $ 695 | $ 17 | $ 1,147 | $ 219 | $ 765 | $ 1,383 | ||||||||
Total revenues | 304 | 229 | 1,051 | 204 | 102 | 17 | 1,147 | 219 | $ 198 | $ 1,484 | 1,788 | 1,485 | |||
Research and development | 3,792 | 2,368 | 2,197 | 2,879 | 3,118 | 2,418 | 3,062 | 5,483 | 6,413 | 10,547 | 8,194 | 10,562 | 17,376 | ||
Selling, general and administrative | 3,395 | 2,787 | 1,500 | 1,208 | 1,926 | 1,182 | 1,749 | 1,804 | 1,922 | 9,990 | 4,634 | 7,421 | 6,657 | ||
Total expenses | 7,187 | 5,155 | 3,697 | 4,087 | 5,044 | 3,600 | 4,811 | 7,287 | 8,335 | 20,537 | 12,828 | 17,983 | 24,033 | ||
Operating loss | (7,187) | (4,851) | (3,468) | (3,036) | (4,840) | (3,498) | (4,794) | (6,140) | (8,116) | (20,339) | (11,344) | (16,195) | (22,548) | ||
Other income / (expense), net | (4,191) | (459) | (16) | 328 | 5,971 | (649) | (612) | (608) | (4,338) | 4,102 | |||||
Net (loss) / income | (7,126) | $ (6,437) | $ (6,537) | (9,042) | (3,927) | (3,052) | (4,512) | 2,473 | (5,443) | (6,752) | (8,724) | (20,100) | (11,491) | (20,533) | (18,446) |
AEROSURF warrant dividend | (12,505) | (12,505) | |||||||||||||
Deemed dividend on preferred stock | (1,718) | (2,234) | (532) | (3,604) | (1,718) | (6,370) | |||||||||
Net (loss) / income attributable to common shareholders | $ (23,265) | $ (3,927) | $ (3,052) | $ (4,512) | $ 2,473 | $ (7,677) | $ (7,284) | $ (12,328) | $ (34,756) | $ (24,816) | |||||
Net (loss) / income per common share - basic (in dollars per share) | $ (3.24) | $ (1.04) | $ (0.81) | $ (1.40) | $ 1.03 | $ (10.53) | $ (14.37) | $ (27.40) | $ (7.74) | $ (24.14) | |||||
Net (loss) / income per common share - diluted (in dollars per share) | $ (3.24) | $ (1.04) | $ (0.81) | $ (1.40) | $ 0.97 | $ (10.53) | $ (14.37) | $ (27.40) | $ (7.74) | $ (24.14) | |||||
Weighted average number of common shares outstanding - basic (in shares) | 7,191 | 3,769 | 3,751 | 3,227 | 2,405 | 729 | 507 | 450 | 4,493 | 1,028 | |||||
Weighted average number of common shares outstanding - diluted (in shares) | 7,191 | 3,769 | 3,751 | 3,227 | 2,540 | 729 | 507 | 450 | 4,493 | 1,028 | |||||
License [Member] | |||||||||||||||
License revenue with affiliate | $ 304 | $ 159 | $ 356 | $ 204 | $ 102 | $ 198 | $ 719 | $ 1,023 | $ 102 |
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 | Dec. 31, 2017 |
Cash and Cash Equivalents, at Carrying Value, Ending Balance | $ 4,437 | $ 11,187 | $ 1,815 | |
Liabilities, Current, Total | 16,278 | 20,633 | $ 11,760 | |
Loans Payable, Current, Total | $ 7,800 | $ 8,000 | ||
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 | 120,000,000 | |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | 5,000,000 | |
Common Stock, Capital Shares Available for Issuance | 72,000,000 | 72,000,000 | ||
Preferred Stock, Capital Shares Available for Issuance | 5,000,000 | 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 Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 | Dec. 01, 2017 | Nov. 01, 2017 | |
Foreign Currency Transaction Gain (Loss), before Tax, Total | $ 100,000 | $ 0 | $ 400,000 | $ 0 | $ 100,000 | $ 0 | |||
Marketable Securities, Realized Gain (Loss), Total | 14,000 | 75,000 | 0 | ||||||
Marketable Securities, Unrealized Gain (Loss), Total | (12,000) | 0 | $ 0 | 0 | |||||
Liability for Contingent Milestone Payment, Noncurrent | 15,000,000 | $ 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 | 15,600 | 1,300 | 14,400 | 1,000 | |||||
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 | $ 4,134,000 | |||||
Other Liabilities, Noncurrent, Total | 106,000 | 106,000 | 175,000 | 100,000 | |||||
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 | $ 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 | $ 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 | Dec. 31, 2017 |
Indefinite intangible asset | $ 77,090 | $ 77,090 | |
Istaroxime Drug Candidate [Member] | |||
Indefinite intangible asset | 22,340 | 22,340 | |
Rostafuroxin Drug Candidate [Member] | |||
Indefinite intangible asset | $ 54,750 | $ 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 | 12 Months Ended | ||||||||||
Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
License [Member] | |||||||||||||
License revenue with affiliate | $ 304 | $ 159 | $ 356 | $ 204 | $ 102 | $ 198 | $ 719 | $ 1,023 | $ 102 |
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 | Dec. 31, 2017 |
Cash and cash equivalents | $ 4,437 | $ 5,234 | $ 1,815 |
Total Assets | 4,591 | 25,317 | 2,040 |
Certificates of Deposit [Member] | |||
Certificate of deposit | 154 | 171 | 225 |
US Treasury Securities [Member] | |||
Cash and cash equivalents | 19,912 | ||
Cash and cash equivalents | 19,912 | ||
Fair Value, Inputs, Level 1 [Member] | |||
Cash and cash equivalents | 4,437 | 5,234 | 1,815 |
Total Assets | 4,591 | 25,317 | 2,040 |
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | |||
Certificate of deposit | 154 | 171 | 225 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | |||
Cash and cash equivalents | 19,912 | ||
Cash and cash equivalents | 19,912 | ||
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 | |||
Cash and cash equivalents | |||
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 | |||
Cash and cash equivalents |
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, 2017USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2018TWD ($) | Dec. 21, 2018TWD ($) | Nov. 19, 2018USD ($) | Nov. 16, 2018USD ($) | Nov. 02, 2018USD ($) | Oct. 19, 2018USD ($) | Sep. 27, 2018USD ($) | Sep. 12, 2018USD ($) | Aug. 29, 2018USD ($) | Aug. 14, 2018USD ($) | Sep. 30, 2017TWD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2016TWD ($) |
Repayments of Short-term Debt, Total | $ 820,000 | $ 160,000 | |||||||||||||||||||||||
Short-term Debt, Total | 7,782,000 | $ 7,974,000 | |||||||||||||||||||||||
CVie Investments [Member] | |||||||||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Total | $ 2,590,000 | ||||||||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Long-term Debt | 3,453,000 | ||||||||||||||||||||||||
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 | $ 106.2 | |||||||||||||||||||||||
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% | 6.00% | |||||||||||||||||||||||
Debt Instrument, Face Amount | $ 600,000 | $ 350,000 | $ 500,000 | $ 430,000 | $ 500,000 | $ 500,000 | $ 480,000 | $ 300,000 | |||||||||||||||||
Short-term Debt, Total | 6,000,000 | ||||||||||||||||||||||||
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% | 110.00% | 110.00% | 110.00% | |||||||||||||||||||||
Line of Credit, Current | $ 4,500,000 | $ 4,500,000 | $ 138 | ||||||||||||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | Taipei Interbank Offer Rate (TAIBOR) [Member] | |||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.91% | 0.91% | |||||||||||||||||||||||
O-Bank Co., Ltd. [Member] | Revolving Credit Facility [Member] | CVie Investments [Member] | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5,840,000 | $ 180 | $ 2,900,000 | $ 90 | |||||||||||||||||||||
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 | $ 4,500,000 | $ 138 |
Note 8 - Restructured Debt Li_3
Note 8 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Nov. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 |
Repayments of Long-term Debt, Total | $ 2,500 | |||
Liability for Contingent Milestone Payment, Noncurrent | 15,000 | 15,000 | $ 15,000 | |
Deerfield Loan [Member] | ||||
Liability for Contingent Milestone Payment, Noncurrent | $ 15,000 | $ 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 | Dec. 31, 2017 |
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 15,000 | $ 15,000 |
Deerfield Loan [Member] | |||
Restructured debt liability - contingent milestone payments | $ 15,000 | $ 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period | 3 years | |
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 shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Shares Outstanding, Beginning Balance (in shares) | 4,417 | 84 |
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) | $ 6.73 | $ 163.20 |
Shares Granted (in shares) | 1,144 | 4,337 |
Weighted Average Exercise Price, Granted (in dollars per share) | $ 4.20 | $ 4.22 |
Shares Forfeited or Expired (in shares) | (5) | (4) |
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) | $ 467.57 | $ 617.75 |
Shares Outstanding, Ending Balance (in shares) | 5,556 | 4,417 |
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) | $ 5.80 | $ 6.73 |
Weighted Average Remaining Contractual Life, Outstanding (Year) | 9 years 73 days | 9 years 328 days |
Shares Vested and Exercisable (in shares) | 70 | 63 |
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) | $ 128.45 | $ 171.87 |
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year) | 6 years 109 days | 6 years 182 days |
Vested and expected to vest (in shares) | 5,245 | 4,243 |
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) | $ 5.79 | $ 6.78 |
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year) | 9 years 73 days | 9 years 328 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 shares in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Unvested, Beginning Balance (in shares) | 151 | 190 | |
Unvested, Beginning Balance (in dollars per share) | $ 4.29 | $ 4.33 | |
Awarded (in shares) | 249 | 56 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3.95 | $ 4.22 | $ 4.33 |
Vested (in shares) | (95) | (95) | |
Vested (in dollars per share) | $ 3.95 | $ 4.33 | |
Cancelled (in shares) | (144) | ||
Cancelled (in dollars per share) | $ 4.33 | ||
Unvested, Ending Balance (in shares) | 161 | 151 | 190 |
Unvested, Ending Balance (in dollars per share) | $ 4.04 | $ 4.29 | $ 4.33 |
Note 9 - Stock Options and St_6
Note 9 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted average expected volatility | 95.00% | 93.00% | 79.00% |
Weighted average expected term (Year) | 6 years 219 days | 7 years | 6 years 219 days |
Weighted average risk-free interest rate | 2.60% | 2.70% | 2.20% |
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 | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Payment Arrangement, Expense | $ 1,939 | $ 145 | $ 5,208 | $ 703 | $ 955 | $ 1,561 |
Research and Development Expense [Member] | ||||||
Share-based Payment Arrangement, Expense | 574 | 29 | 1,613 | 169 | $ 232 | $ 837 |
General and Administrative Expense [Member] | ||||||
Share-based Payment Arrangement, Expense | $ 1,365 | $ 116 | $ 3,595 | $ 534 |
Note 10 - Leases (Details Textu
Note 10 - Leases (Details Textual) | Sep. 30, 2019 |
Operating Lease, Weighted Average Remaining Lease Term | 2 years 146 days |
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% |