Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2019 | |
Cover [Abstract] | |
Entity Registrant Name | DELCATH SYSTEMS, INC. |
Entity Central Index Key | 0000872912 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 06-1245881 |
Entity Address, Address Line One | 1633 Broadway |
Entity Address, Address Line Two | Suite 22C |
Entity Address, City or Town | New York |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10019 |
City Area Code | 212 |
Local Phone Number | 489-2100 |
Document Type | S-1 |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2019 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||||
Current assets | |||||||
Cash and cash equivalents | $ 15,334 | $ 2,516 | $ 3,999 | ||||
Restricted cash | 181 | 1,062 | 1,325 | ||||
Accounts receivables, net | 12 | 585 | 317 | ||||
Inventories | 736 | 858 | 1,248 | ||||
Prepaid expenses and other current assets | 864 | 898 | 700 | ||||
Total current assets | 17,127 | 5,919 | 7,589 | ||||
Property, plant and equipment, net | 756 | 925 | 1,298 | ||||
Right-of-use assets | 1,012 | ||||||
Total assets | 18,895 | 6,844 | 8,887 | ||||
Current liabilities | |||||||
Accounts payable | 4,871 | 7,715 | 3,846 | ||||
Accrued expenses | 6,537 | 7,964 | 3,408 | ||||
Convertible notes payable, net of debt discount | 2,038 | 0 | |||||
Lease liabilities, current portion | 656 | ||||||
Warrant liability | 20,410 | 33 | 560 | ||||
Total current liabilities | 32,474 | 17,750 | 7,814 | ||||
Deferred revenue | 2,890 | 3,405 | 0 | ||||
Lease liabilities, long-term portion | 356 | ||||||
Convertible notes payable, long-term | 2,000 | ||||||
Other non-current liabilities | 628 | 395 | |||||
Total liabilities | 37,720 | 21,783 | 8,209 | ||||
Commitments and contingencies | |||||||
Stockholders' Equity (Deficit) | |||||||
Preferred stock, value | 0 | 0 | 0 | ||||
Common stock, value | 0 | [1] | 0 | [1],[2] | 0 | [2] | |
Additional paid-in capital | 364,750 | 329,065 | 325,519 | ||||
Accumulated deficit | (383,664) | (344,054) | (324,832) | ||||
Treasury stock, at cost; 0 and 1 share at December 31, 2018 and December 31, 2017, respectively* | [2] | 0 | (51) | ||||
Accumulated other comprehensive income | 89 | 50 | 42 | ||||
Total stockholders' equity (deficit) | (18,825) | (14,939) | 678 | ||||
Total liabilities and stockholders' equity (deficit) | $ 18,895 | $ 6,844 | $ 8,887 | ||||
[1] | reflects a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018 and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. | ||||||
[2] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017, a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 42,082 | 101 | 0 |
Preferred stock, shares outstanding (in shares) | 42,082 | 101 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued (in shares) | 26,112 | 14,715 | 377 |
Common stock, shares outstanding (in shares) | 26,112 | 14,715 | 376 |
Treasury stock, at cost (in shares) | 0 | 1 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - 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 | ||||||
Cost of goods sold | $ (172) | $ (233) | $ (440) | $ (600) | $ (1,009) | $ (701) | |||||
Gross profit | 208 | 591 | 623 | 1,784 | 2,398 | 2,014 | |||||
Operating expenses: | |||||||||||
Selling, general and administrative expenses | 4,002 | 2,279 | 9,204 | 7,286 | 9,819 | 9,684 | |||||
Research and development expenses | 1,778 | 4,106 | 6,789 | 13,886 | 19,650 | 10,495 | |||||
Total operating expenses | 5,780 | 6,385 | 15,993 | 21,172 | 29,469 | 20,179 | |||||
Operating loss | (5,572) | (5,794) | (15,370) | (19,388) | (27,071) | (18,165) | |||||
Change in fair value of the warrant liability, net | 434 | 1,198 | 451 | 18,407 | 19,706 | 15,103 | |||||
Gain on warrant extinguishment | 0 | (1,123) | 0 | 9,613 | |||||||
Loss on debt extinguishment | (1,123) | (1,123) | (1,123) | (29,924) | |||||||
Loss on issuance of financial instrument | (1,714) | (1,721) | (2,826) | (2,826) | 0 | ||||||
Interest expense | (671) | (3,151) | (4,735) | (3,402) | (7,959) | (21,703) | |||||
Other income (expense) | 4 | (10) | 4 | (21) | 51 | (41) | |||||
Net (loss) income | (7,519) | (8,880) | (21,371) | (8,353) | (19,222) | (45,117) | |||||
Other comprehensive (loss) income: | |||||||||||
Foreign currency translation adjustments | 89 | 105 | 39 | 63 | 8 | 83 | |||||
Total other comprehensive (loss) income | $ (7,430) | $ (8,775) | $ (21,332) | $ (8,290) | $ (19,214) | $ (45,034) | |||||
Common share data: | |||||||||||
Basic (loss) income per common share | $ (287) | [1] | $ (175) | [1] | $ (924) | [1] | $ (420) | [1] | $ (504) | $ (2,275,000) | |
Diluted loss per common share | $ (987) | [1] | $ (175) | [1] | $ (1,715) | [1] | $ (448) | [1] | $ (504) | $ (2,275,000) | |
Weighted average number of basic shares outstanding | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | |
Weighted average number of diluted shares outstanding | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | |
Basic and diluted loss per share | [2] | $ (504) | $ (2,275,000) | ||||||||
Weighted average number of basic and diluted shares outstanding | [2] | 38,151 | 21 | ||||||||
Product Revenue [Member] | |||||||||||
Revenue | $ 216 | $ 824 | $ 528 | $ 2,384 | $ 3,378 | $ 2,715 | |||||
Other Revenue [Member] | |||||||||||
Revenue | $ 164 | $ 535 | $ 29 | ||||||||
[1] | reflects a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018 and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. | ||||||||||
[2] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017, a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - Common Stock [Member] | Dec. 24, 2019 | Oct. 22, 2019 | Sep. 17, 2019 | May 02, 2018 | Nov. 06, 2017 |
Reverse stock split | 1:100 | 1:500 | 1:350 | ||
Reverse stock split ratio | 0.01 | 0.002 | 0.0029 | ||
Subsequent Event [Member] | |||||
Reverse stock split | 1:700 | 1:100 | |||
Reverse stock split ratio | 0.0014 | 0.01 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series D Preferred Stock [Member] | Series E Preferred Stock [Member] | Series E-1 Preferred Stock [Member] | Common Stock [Member] | Preferred Stock [Member] | Preferred Stock [Member]Series D Preferred Stock [Member] | Preferred Stock [Member]Series E Preferred Stock [Member] | Preferred Stock [Member]Series E-1 Preferred Stock [Member] | Treasury Stock [Member] | Additional Paid in Capital [Member] | Additional Paid in Capital [Member]Series D Preferred Stock [Member] | Additional Paid in Capital [Member]Series E Preferred Stock [Member] | Additional Paid in Capital [Member]Series E-1 Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Series E Preferred Stock [Member] | Accumulated Deficit [Member]Series E-1 Preferred Stock [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Series D Warrants [Member] | Series D Warrants [Member]Common Stock [Member] | Series D Warrants [Member]Additional Paid in Capital [Member] |
Balance at Dec. 31, 2016 | $ (1,490) | $ (51) | $ 277,790 | $ (279,188) | $ (41) | ||||||||||||||||
Balance (in shares) at Dec. 31, 2016 | 1 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | 50 | 50 | |||||||||||||||||||
Compensation expense for issuance of restricted stock | 79 | 79 | |||||||||||||||||||
Issuance of common stock and rights for payments made in shares on convertible notes payable | 40,121 | 40,121 | |||||||||||||||||||
Issuance of common stock and rights for payments made in shares on convertible notes payable (in shares) | 375 | ||||||||||||||||||||
Fair value of beneficial conversion feature of convertible note | 4,908 | 4,908 | |||||||||||||||||||
Series B preferred stock dividend | (527) | (527) | |||||||||||||||||||
Warrants exercised | 19 | 19 | |||||||||||||||||||
Warrants exercised (in shares) | 1 | ||||||||||||||||||||
Fair value of warrants exercised | 2,552 | 2,552 | |||||||||||||||||||
Net (loss) income | (45,117) | (45,117) | |||||||||||||||||||
Foreign currency translation | 83 | 83 | |||||||||||||||||||
Balance at Dec. 31, 2017 | 678 | $ 0 | $ (51) | 325,519 | (324,832) | 42 | |||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 377 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | 7 | 7 | |||||||||||||||||||
Compensation expense for issuance of restricted stock | 14 | 14 | |||||||||||||||||||
Sale of common stock, net of expenses | 4,251 | 4,251 | |||||||||||||||||||
Sale of common stock, net of expenses (in shares) | 956 | ||||||||||||||||||||
Fair value of warrants issued | (18,306) | (18,306) | |||||||||||||||||||
Net (loss) income | 7,185 | 7,185 | |||||||||||||||||||
Total comprehensive loss | (34) | (34) | |||||||||||||||||||
Balance at Mar. 31, 2018 | (6,205) | $ 0 | $ (51) | 311,485 | (317,647) | 8 | |||||||||||||||
Balance (in shares) at Mar. 31, 2018 | 1,333 | (1) | |||||||||||||||||||
Balance at Dec. 31, 2017 | 678 | $ 0 | $ (51) | 325,519 | (324,832) | 42 | |||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 377 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Net (loss) income | (8,353) | ||||||||||||||||||||
Foreign currency translation | 63 | ||||||||||||||||||||
Balance at Sep. 30, 2018 | (4,865) | $ 0 | $ (51) | 328,266 | (333,185) | 105 | |||||||||||||||
Balance (in shares) at Sep. 30, 2018 | 8,138 | (1) | |||||||||||||||||||
Balance at Dec. 31, 2017 | 678 | $ 0 | $ (51) | 325,519 | (324,832) | 42 | |||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 377 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation income related to cancellation of stock options | (40) | (40) | |||||||||||||||||||
Compensation expense for issuance of restricted stock | 98 | 98 | |||||||||||||||||||
Compensation expense for issuance of restricted stock (in shares) | 236 | ||||||||||||||||||||
Sale of common stock, net of expenses | 10,916 | 10,916 | |||||||||||||||||||
Sale of common stock, net of expenses (in shares) | 7,624 | ||||||||||||||||||||
Fair value of warrants issued | (18,306) | (18,306) | |||||||||||||||||||
Cashless exercise of warrants (in shares) | 49 | ||||||||||||||||||||
Issuance of pre-funded warrants | 520 | 520 | |||||||||||||||||||
Exercise of pre-funded Series D Warrants (in shares) | 5,250 | ||||||||||||||||||||
Fair value of warrants issued with convertible notes | 5,007 | 5,007 | |||||||||||||||||||
Fair value of warrants reclassified from liability to equity | (4,210) | (4,210) | |||||||||||||||||||
Fair value of beneficial conversion feature of convertible note | 44 | 44 | |||||||||||||||||||
Issuance of Preferred Stock | $ 1,004 | $ 1,004 | |||||||||||||||||||
Issuance of Preferred Stock (in shares) | 101 | ||||||||||||||||||||
Exchange of warrants for common stock (in shares) | 1,179 | ||||||||||||||||||||
Fair value of warrants exchanged for common stock | 144 | 144 | |||||||||||||||||||
Retirement of Treasury Stock | $ 51 | (51) | |||||||||||||||||||
Retirement of Treasury Stock (in shares) | 1 | ||||||||||||||||||||
Net (loss) income | (19,222) | (19,222) | |||||||||||||||||||
Foreign currency translation | 8 | 8 | |||||||||||||||||||
Balance at Dec. 31, 2018 | (14,939) | $ 0 | $ 0 | 329,065 | (344,054) | 50 | |||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 14,715 | 101 | |||||||||||||||||||
Balance at Mar. 31, 2018 | (6,205) | $ 0 | $ (51) | 311,485 | (317,647) | 8 | |||||||||||||||
Balance (in shares) at Mar. 31, 2018 | 1,333 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | (47) | (47) | |||||||||||||||||||
Compensation expense for issuance of restricted stock | (95) | (95) | |||||||||||||||||||
Sale of common stock, net of expenses | (41) | (41) | |||||||||||||||||||
Net (loss) income | (6,658) | (6,658) | |||||||||||||||||||
Total comprehensive loss | (44) | (44) | |||||||||||||||||||
Balance at Jun. 30, 2018 | (13,090) | $ 0 | $ (51) | 311,302 | (324,305) | (36) | |||||||||||||||
Balance (in shares) at Jun. 30, 2018 | 1,333 | (1) | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of restricted stock | 116 | 116 | |||||||||||||||||||
Compensation expense for issuance of restricted stock (in shares) | 86 | ||||||||||||||||||||
Sale of common stock, net of expenses | 7,067 | 7,067 | |||||||||||||||||||
Sale of common stock, net of expenses (in shares) | 6,669 | ||||||||||||||||||||
Cashless exercise of warrants (in shares) | 50 | ||||||||||||||||||||
Issuance of pre-funded warrants | 520 | 520 | |||||||||||||||||||
Fair value of warrants issued with convertible notes | 5,007 | 5,007 | |||||||||||||||||||
Fair value of warrants reclassified from liability to equity | (4,210) | (4,210) | |||||||||||||||||||
Fair value of beneficial conversion feature of convertible note | 44 | 44 | |||||||||||||||||||
Net (loss) income | (8,880) | (8,880) | |||||||||||||||||||
Foreign currency translation | 105 | ||||||||||||||||||||
Total comprehensive loss | 141 | 141 | |||||||||||||||||||
Balance at Sep. 30, 2018 | (4,865) | $ 0 | $ (51) | 328,266 | (333,185) | 105 | |||||||||||||||
Balance (in shares) at Sep. 30, 2018 | 8,138 | (1) | |||||||||||||||||||
Balance at Dec. 31, 2018 | (14,939) | $ 0 | $ 0 | 329,065 | (344,054) | 50 | |||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 14,715 | 101 | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | 54 | 54 | |||||||||||||||||||
Compensation expense for issuance of restricted stock | 4 | 4 | |||||||||||||||||||
Compensation expense for issuance of restricted stock (in shares) | 20 | ||||||||||||||||||||
Exercise of Pre-Funded Series D Warrants | $ (41) | ||||||||||||||||||||
Exercise of pre-funded Series D Warrants (in shares) | 5,885 | ||||||||||||||||||||
Issuance of Preferred Stock | $ 150 | $ 150 | |||||||||||||||||||
Issuance of Preferred Stock (in shares) | 15 | ||||||||||||||||||||
Net (loss) income | (7,894) | (7,894) | |||||||||||||||||||
Retirement of Series D Preferred Stock | (1,160) | (1,160) | |||||||||||||||||||
Retirement of Series D Preferred Stock (in Shares) | (116) | ||||||||||||||||||||
Total comprehensive loss | 7 | 7 | |||||||||||||||||||
Balance at Mar. 31, 2019 | (23,778) | $ 0 | 328,113 | (351,948) | 57 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2019 | 20,620 | ||||||||||||||||||||
Balance at Dec. 31, 2018 | $ (14,939) | $ 0 | $ 0 | 329,065 | (344,054) | 50 | |||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 14,715 | 101 | |||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Exchange of warrants for common stock (in shares) | 82,521 | ||||||||||||||||||||
Net (loss) income | $ (21,371) | ||||||||||||||||||||
Foreign currency translation | 39 | ||||||||||||||||||||
Balance at Sep. 30, 2019 | (18,825) | $ 0 | 364,750 | (383,664) | 89 | ||||||||||||||||
Balance (in shares) at Sep. 30, 2019 | 26,112 | 42,082 | |||||||||||||||||||
Balance at Mar. 31, 2019 | (23,778) | $ 0 | 328,113 | (351,948) | 57 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2019 | 20,620 | ||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | 75 | 75 | |||||||||||||||||||
Exercise of Pre-Funded Series D Warrants | $ (1) | $ (39) | |||||||||||||||||||
Exercise of pre-funded Series D Warrants (in shares) | 5,400 | ||||||||||||||||||||
Exchange of warrants for common stock | 14 | 14 | |||||||||||||||||||
Exchange of warrants for common stock (in shares) | 92 | ||||||||||||||||||||
Net (loss) income | (5,959) | (5,959) | |||||||||||||||||||
Total comprehensive loss | (80) | (80) | |||||||||||||||||||
Balance at Jun. 30, 2019 | (29,729) | $ 0 | 328,201 | (357,907) | (23) | ||||||||||||||||
Balance (in shares) at Jun. 30, 2019 | 26,112 | ||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Compensation expense for issuance of stock options | 70 | 70 | |||||||||||||||||||
Fair value of warrants issued | (20,844) | (20,844) | |||||||||||||||||||
Issuance of Preferred Stock | $ 29,575 | $ 9,510 | $ 42,915 | $ 14,408 | $ (13,340) | $ (4,898) | |||||||||||||||
Issuance of Preferred Stock (in shares) | 32,572 | 9,510 | |||||||||||||||||||
Net (loss) income | (7,519) | (7,519) | |||||||||||||||||||
Foreign currency translation | 89 | ||||||||||||||||||||
Total comprehensive loss | 112 | 112 | |||||||||||||||||||
Balance at Sep. 30, 2019 | $ (18,825) | $ 0 | $ 364,750 | $ (383,664) | $ 89 | ||||||||||||||||
Balance (in shares) at Sep. 30, 2019 | 26,112 | 42,082 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) | Dec. 24, 2019$ / shares | Oct. 22, 2019$ / shares | Sep. 17, 2019$ / shares | May 02, 2018 | Nov. 06, 2017 | Sep. 30, 2019$ / shares | Dec. 31, 2018$ / shares | Dec. 31, 2017$ / shares |
Common stock par value per share | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Preferred stock issued, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||
Common Stock [Member] | ||||||||
Reverse stock split ratio | 0.01 | 0.002 | 0.0029 | |||||
Reverse stock split | 1:100 | 1:500 | 1:350 | |||||
Subsequent Event [Member] | ||||||||
Common stock par value per share | $ 0.01 | |||||||
Subsequent Event [Member] | Common Stock [Member] | ||||||||
Common stock par value per share | $ 0.01 | |||||||
Reverse stock split ratio | 0.0014 | 0.01 | ||||||
Reverse stock split | 1:700 | 1:100 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||||
Net loss | $ (21,371) | $ (8,353) | $ (19,222) | $ (45,117) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Stock option compensation expense | 199 | (40) | (40) | 50 |
Restricted stock compensation expense | 4 | 35 | 98 | 79 |
Depreciation expense | 168 | 342 | 444 | 310 |
Loss on disposal of equipment | 0 | 18 | ||
Warrant liability fair value adjustment | (451) | (18,407) | (19,706) | (15,103) |
Gain on warrant extinguishment | 0 | 1,123 | 0 | (9,613) |
Non-cash interest income | (23) | (2) | (1) | (1) |
Interest expense accrued related to convertible notes | 33 | 0 | 402 | 0 |
Debt discount and deferred finance costs amortization | 7,572 | 21,544 | ||
Loss on issuance of financial instrument | 1,721 | 2,826 | 2,826 | 0 |
Loss on debt settlements and extinguishments | 1,123 | 29,924 | ||
Amortization of right of use assets | 1,535 | 0 | ||
Equitization of expenses | 1,474 | 0 | ||
Loss on issuance of financial instrument | 1,715 | 2,826 | ||
Debt discount amortization | 4,467 | 3,381 | ||
Changes in assets and liabilities: | ||||
Prepaid expenses and other assets | 43 | 171 | (218) | 7 |
Accounts receivable | 564 | (60) | (293) | 108 |
Inventories | 85 | 289 | 385 | (543) |
Accounts payable and accrued expenses | (4,289) | 5,662 | 8,163 | 3,180 |
Deferred revenue | (360) | 0 | 3,503 | (32) |
Interest payments on financing lease | (3) | 0 | ||
Payments on operating leases | (1,485) | 0 | ||
Other non-current liabilities | (627) | 139 | 232 | (209) |
Net cash used in operating activities | (18,322) | (12,894) | (14,732) | (15,398) |
Cash flows from investing activities: | ||||
Purchase of property, plant and equipment | (2) | (59) | (76) | (524) |
Net cash (used in) provided by investing activities | (2) | (59) | (76) | (524) |
Cash flows from financing activities: | ||||
Expenses from the release of restricted cash | 0 | (1,212) | ||
Cash paid pursuant to Exchange Agreement | 0 | (804) | ||
Net proceeds from convertible note debt financing | 0 | 5,727 | 5,664 | 0 |
Net proceeds from sale of stock | 10,917 | 15 | ||
Net proceeds from exercise of warrants | 520 | 0 | ||
Repayment of convertible note debt | (4,870) | 0 | ||
Net cash provided by (used in) financing activities | 30,330 | 17,524 | 13,236 | (10,517) |
Net proceeds from the issuance of debt | 3,719 | 0 | ||
Principal payments on financing leases | (49) | 0 | ||
Net proceeds from sale of common stock and warrants | 0 | 11,797 | ||
Foreign currency effects on cash, cash equivalents and restricted cash | (69) | 80 | (174) | 67 |
Net increase in cash, cash equivalents and restricted cash | 11,937 | 4,651 | (1,746) | (26,372) |
Cash, cash equivalents and restricted cash: | ||||
Beginning of period | 3,578 | 5,324 | 5,324 | 31,696 |
End of period | 15,515 | 9,975 | 3,578 | 5,324 |
Supplemental non-cash financing activities: | ||||
Conversion of convertible notes | 0 | 40,121 | ||
Fair value of warrants issued | 20,844 | 28,539 | 28,539 | 16,953 |
Cashless exercise of warrants | 0 | 2,537 | ||
Deemed dividend | 0 | 527 | ||
Fair value of warrants exercised for cash | 0 | 19 | ||
Series B and Series C Preferred Shares [Member] | ||||
Cash flows from financing activities: | ||||
Net proceeds from sale of Preferred Stock | 0 | 2,310 | ||
Series A and Series B Preferred Shares [Member] | ||||
Cash flows from financing activities: | ||||
Cash paid to redeem preferred shares | 0 | (2,360) | ||
Series C Preferred Shares [Member] | ||||
Cash flows from financing activities: | ||||
Cash paid to redeem preferred shares | 0 | (590) | ||
Series D Preferred Shares [Member] | ||||
Cash flows from financing activities: | ||||
Net proceeds from sale of Preferred Stock | 150 | 0 | 1,005 | 0 |
Series E Preferred Stock and Warrants [Member] | ||||
Cash flows from financing activities: | ||||
Net proceeds from sale of Series E Preferred Stock and warrants | $ 26,510 | $ 0 | ||
Series C Warrants [Member] | ||||
Cash flows from financing activities: | ||||
Cash paid to extinguish of Series C Warrants | $ 0 | $ (7,876) |
General
General | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
General | (1) GENERAL The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three and nine months ended September 30, 2019 and 2018 should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K Description of Business Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (“Melphalan/HDS”)—is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our system is commercially available under the trade name Delcath Hepatic CHEMOSAT ® Our clinical development program (“CDP”) for Melphalan/HDS is comprised of The FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in mOM, and the ALIGN Trial, a global Phase 3 clinical trial for ICC (the “ALIGN Trial”). Our CDP also includes a registry for CHEMOSAT commercial cases performed in Europe and sponsorship of select investigator-initiated trials (“IITs”). Liquidity and Operating Matters The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q S-X. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements, in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended September 30, 2019 and 2018; however, certain information and footnote disclosures normally included in our Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. Significant Accounting Policies A description of our significant accounting policies has been provided in Note 3 Summary of Significant Accounting Policies to the Consolidated Financial Statements included in the Company’s Annual Report filed for the fiscal year ended December 31, 2018. Derivative Financial Instruments The accounting treatment of derivative financial instruments requires that the Company record financial instruments at their fair value as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash 815-40-35-12 E-1 Recently Adopted Accounting Pronouncements In February 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2018-02, 2018-02 2018-02 2018-02, In February 2016, the FASB issued ASU 2016-02, |
Restricted Cash
Restricted Cash | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Restricted Cash [Abstract] | ||
Restricted Cash | (2) RESTRICTED CASH Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash Cash, cash equivalents, and restricted cash balances were as follows: (in thousands) September 30, December 31, Cash and cash equivalents $ 15,334 $ 2,516 Letters of credit 131 1,012 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 15,515 $ 3,578 | (4) RESTRICTED CASH Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash (in thousands) December 31, December 31, Cash and cash equivalents $ 2,516 $ 3,999 Convertible Notes — 238 Letters of credit 1,012 1,012 Security for credit cards 50 75 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 3,578 $ 5,324 |
Inventories
Inventories | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | ||
Inventories | (3) INVENTORIES Inventories consist of the following: (in thousands) September 30, December 31, Raw materials $ 351 $ 358 Work-in-process 350 500 Finished goods 35 — Total inventories $ 736 $ 858 | (5) INVENTORIES Inventories consist of: (in thousands) December 31, December 31, Raw materials $ 358 $ 298 Work-in-process 500 721 Finished goods — 229 Total Inventory $ 858 $ 1,248 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Prepaid Expenses And Other Current Assets | (4) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consist of the following: (in thousands) September 30, December 31, Clinical trial expenses $ 500 $ — Insurance premiums 54 140 Security deposit 50 51 Income tax and VAT receivable 33 579 Other 1 227 128 Total prepaid expenses and other current assets $ 864 $ 898 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% of prepaid expenses and other current assets at September 30, 2019 and December 31, 2018. | (6) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets include the following: (in thousands) December 31, December 31, Insurance premiums $ 140 $ 421 Financing costs — 70 Security deposit 51 50 Income tax and VAT receivable 579 29 Other 1 128 130 Total prepaid expenses and other current assets $ 898 $ 700 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2018 and 2017. |
Property, Plant, and Equipment
Property, Plant, and Equipment | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Property, Plant, and Equipment | (5) PROPERTY, PLANT, AND EQUIPMENT Property, plant, and equipment consist of the following: (in thousands) September 30, December 31, Estimated Useful Life Buildings and land $ 589 $ 589 30 years - Buildings Enterprise hardware and software 1,739 1,742 3 years Leaseholds 1,687 1,701 Lesser of lease term or estimated useful life Equipment 1,002 1,002 7 years Furniture 197 198 5 years Property, plant and equipment, gross 5,214 5,232 Accumulated depreciation (4,458 ) (4,307 ) Property, plant and equipment, net $ 756 $ 925 Depreciation expense for the three and nine months ended September 30, 2019 was approximately $0.1 million and $0.2 million, respectively as compared to approximately $0.1 million and $0.3 million, respectively, for the same periods in 2018. | (7) PROPERTY, PLANT, AND EQUIPMENT Property, plant, and equipment consists of: (in thousands) December 31, 2018 December 31, 2017 Estimated Useful Life Buildings and land $ 589 $ 579 30 years-Buildings Enterprise hardware and software 1,742 1,744 3 years Leaseholds 1,701 1,705 Lesser of lease term or estimated useful life Equipment 1,002 971 7 years Furniture 198 175 5 years Property, plant and equipment, gross 5,232 5,174 Accumulated depreciation (4,307 ) (3,876 ) Property, plant and equipment, net $ 925 $ 1,298 Depreciation expense for the years ended December 31, 2018 and 2017 was $0.4 million, $0.3 million, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Payables And Accruals [Abstract] | ||
Accrued Expenses | (6) ACCRUED EXPENSES Accrued expenses consist of the following: (in thousands) September 30, December 31, Compensation, excluding taxes $ 3,274 $ 1,785 Clinical trial expenses 2,590 4,530 Interest payable 33 402 Other 1 640 1,247 Total accrued expenses $ 6,537 $ 7,964 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at September 30, 2019 and December 31, 2018. | (8) CURRENT ACCRUED EXPENSES Current accrued expenses include the following: (in thousands) December 31, December 31, Clinical trial expenses $ 4,530 $ 869 Compensation, excluding taxes 1,785 1,124 Professional fees 190 221 Short-term portion of lease restructuring 184 209 Other 1 1,275 985 Total accrued expenses $ 7,964 $ 3,408 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2018 and 2017. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2018 | |
Leases [Abstract] | |
Leases | (7) LEASES The Company recognizes right-of-use non-cancellable The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The following table summarizes the Company’s operating and financing leases as of and for the nine months ended September 30, 2019: (in thousands) U.S. Ireland Total Lease cost Operating lease cost $ 592 $ 160 $ 752 Financing lease cost 32 — 32 Sublease income (215 ) (133 ) (348 ) Total $ 409 $ 27 436 Other information Operating cash flows out from operating leases (634 ) (160 ) (794 ) Operating cash flows in from operating leases 215 133 348 Operating cash flows from financing leases (235 ) — (35 ) Right-of-use 874 — 874 Weighted average remaining lease term 1.4 1.8 Weighted average discount rate—operating leases 8 % 8 % Maturities of the Company’s operating leases, excluding short-term leases, are as follows: (in thousands) U.S. Ireland Total Nine months ended December 31, 2019 $ 129 $ 51 $ 180 Year ended December 31, 2020 498 203 701 Year ended December 31, 2021 79 119 198 Total 706 373 1,079 Less present value discount (40 ) (27 ) (67 ) Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2019 $ 666 $ 346 $ 1,012 |
Outstanding Debt
Outstanding Debt | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Outstanding Debt | (8) OUTSTANDING DEBT On June 6, 2019, the Company entered into an agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender to the Company for cancellation of warrants to purchase 5,605 shares of the Company’s common stock (the “Series D Warrants”) and warrants to purchase 0.1 million shares of the Company’s common stock (the “Pre-Funded Pre-Funded On April 19, 2019, April 26, 2019, May 9, 2019 and May 23, 2019, the Company issued 8% senior secured notes (collectively, the “2019 Notes”) in the aggregate principal amount of $3.3 million, to two institutional investors. The 2019 Notes bore interest at the rate of 8% per annum and were to mature on the six-month In March 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for a senior secured promissory note (the “March 2019 Note”) in the principal amount of $1,560,000. The March 2019 Note bore interest at the rate of 8% per annum, and were to mature on April 1, 2020, and was not convertible. The March 2019 Note was exchanged as part of the recent equity financing discussed further in Note 9 and is no longer outstanding. On June 4, 2018, July 21, 2018, August 29, 2018, and September 21, 2018, the Company issued 8% senior secured convertible notes (collectively, “the 2018 Notes”) in the aggregate principal amount of $9.4 million to several institutional investors. The 2018 Notes bore interest at the rate of 8% per annum and had maturity dates between December 2018 and March 2021. The 2018 Notes were initially convertible and secured pursuant to a Security Agreement which created a first priority security interest in all of the personal property (other than Excluded Collateral as defined in the Security Agreement) of the Company of every kind and description, tangible or intangible, whether currently owned and existing or created or acquired in the future. In March 2019, the Company amended the June 2018, July 2018 and August 2018 Notes to make them non-convertible. The following tables provide a summary of the various notes issued at September 30, 2019 and December 31, 2018: (in millions) Conversion Current Principal Long term convertible notes payable 8.0% July 2019 Notes $ 1,500 8 % $ 2.0 (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % $ 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % $ 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % $ 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % $ 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % $ 1,225 0.1 (0.1 ) — Balance at December 31, 2018 $ 4.5 $ (2.5 ) $ 2.0 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | ||
Stockholders' Equity | (9) STOCKHOLDERS’ EQUITY Preferred Stock Issuances Series E and Series E-1 On July 11, 2019, the Company and certain accredited investors entered into a securities purchase agreement pursuant to which the Company sold to investors an aggregate of 20,000 shares of Series E convertible preferred stock, par value $0.01 per share (the “Series E Preferred Stock”) at a price of $1,000 per share and a warrant (a “2019 Warrant”) to purchase a number of shares of common stock of the Company, equal to the number of shares of common stock issuable upon conversion of the Series E Preferred Stock purchased by the investor (the “July 2019 Private Placement”). The Company received gross proceeds from the July 2019 Private Placement of $20.0 million. On August 19, 2019, the Company and certain accredited investors entered into a securities purchase agreement pursuant to which the Company sold to investors an aggregate of 9,510 shares of Series E-1 E-1 E-1 Each share of Series E Preferred Stock and Series E-1 The Conversion Price and the Exercise Price may, upon each of (i) the third trading day following the date that the Company effects a reverse stock split, (ii) the date that the initial registration statement to be filed pursuant to the Registration Rights Agreement (as further discussed below) is declared effective by the United States Securities and Exchange Commission (“SEC”), and (iii) in the event that all of the registrable securities (as defined in the Registration Rights Agreement) are not then registered on an effective registration statement, the date that all of the shares underlying the Preferred Stock and Warrants may be sold pursuant to Rule 144, be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the Common Stock immediately prior to such dates. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares shall be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such reduction in the Exercise Price is equal to the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s Common Stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections. The Company received net proceeds after expenses of $26.5 million. As discussed further in Note 8, the Company exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related warrants. The Company also exchanged $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related warrants and issued 923 shares of Series E Preferred Stock and related Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019. Of the net proceeds and equitized value received, the Company allocated an estimated fair value of $20.8 million to the 2019 Warrants. As a result of the Series E Preferred Stock and Series E-1 E-1 Series D Preferred Stock On November 5, 2018, the Company’s Board authorized the establishment of a new series of preferred stock designated as Series D Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock. On March 29, 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for the issuance of the March 2019 Notes. Please see the discussion under Note 8 above. Common Stock Issuances During the nine months ended September 30, 2019 the Company issued 11,285 shares of the Company’s common stock pursuant to the exercise of Pre-Funded Warrant Exchange In April 2019, the Company entered into an exchange agreement with an institutional investor with respect to warrants held by such investor (the “February 2018 Warrants”). The February 2018 Warrants were issued to several institutional investors as part of the Company’s February 2018 sale of the Company’s common stock and the issuance of warrants to purchase common shares. Pursuant to the exchange agreement, the Company issued 92 shares of the Company’s common stock (the “Exchange Shares”) in exchange for the February 2018 Warrants. The exchange resulted in a loss of approximately $6,000 which is recognized in the statement of operations. Share-Based Compensation The Company’s 2019 Equity Incentive Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares reserved for issuance under the Plan is 2,142. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair value on the dates of grant. As of September 30, 2019, the Plan had approximately 502 shares available for grant. The following is a summary of stock option activity under the Plan for the nine months ended September 30, 2019: Number of Weighted Average Weighted Aggregate Outstanding at December 31, 2018 — Granted 1,782 196.70 Exercised — Cancelled/Forfeited (142 ) 196.70 Outstanding at September 30, 2019 1,640 $ 196.70 9.4 $ — Exercisable at September 30, 2019 1,095 $ 196.70 9.4 $ — The following weighted average assumptions were used to compute the fair value of stock options granted during the nine months ended September 30, 2019: Nine months ended Dividend yield N/A Expected volatility 147.6 % Weighted average risk-free interest rate 2.6 % Weighted average expected life (in years) 5.5 Weighted average grant date fair value $ 0.259 At September 30, 2019, there was approximately $0.1 million of total unrecognized compensation expense related to non-vested Three months ended Nine months ended (in thousands) 2019 2018 2019 2018 Selling, general and administrative $ 54 $ 116 $ 160 $ 58 Research and development 16 — 43 (63 ) Total $ 70 $ 116 $ 203 $ (5 ) Warrants The following is a summary of warrant activity for the nine months ended September 30, 2019: Warrants Exercise Price per Weighted Average Weighted Outstanding at December 31, 2018 93,835 $ 7.00 - $7,000 $ 150.67 5.75 Issued 1,001,995 42.00 Exercised (11,285 ) 7.00 Exchanged (82,521 ) 170.31 Outstanding at September 30, 2019 1,002,024 $ 7.00 - $42.00 $ 42.00 5.05 | (11) STOCKHOLDERS’ EQUITY Preferred Stock Issuances Series D Preferred Stock On November 5, 2018, the Company’s Board authorized the establishment of a new series of preferred stock designated as Series D Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock which was filed with the State of Delaware on November 5, 2018. On November 6, 2018 and November 30, 2018, the Company entered into a securities purchase agreements with an institutional investor which had purchased 101 shares of Series D Preferred Stock. At issuance, the Series D Preferred Stock would convert to 2,366 common shares. On March 29, 2019, the Company exchanged all of its Series D Preferred Stock (with a stated value of $1,160,000) and received $400,000 in proceeds and issued a senior secured promissory note to an investor with a principal amount of $1,560,000. As a result, the Series D Preferred Stock is no longer outstanding. Stock and Warrant Issuances February 2018 Financing In February 2018, the Company completed the sale of 606 shares of its Common Stock, 109 pre-funded September 2018 Rights Offering In September 2018, the Company completed the sale of 6,669 shares of its Common Stock, with net proceeds after expenses of approximately $7.0 million. The rights offering was made pursuant to a Registration Statement on Form S-1 December 2018 Warrant Exchange In December 2018, the Company entered into exchange agreements with several institutional investors with respect to their November 2017 Warrants and February 2018 Warrants. The Company issued to the investors 1,179 shares of Common Stock (the “Exchange Shares”) in exchange for the Existing Warrants (the “Exchange”). The Exchange was made in reliance upon the exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended. Pre-Funded 5,379 Pre-Funded In October 2018, the Company filed a registration statement on Form S-3 S-3 10-K 10-Q Stock Incentive Plans As a result of the May 2, 2018 reverse stock split, the Company’s Stock Incentive Plan has no active grants and no further shares available to be granted. As previously reported, on February 1, 2019 the Board of Directors of the Company adopted the Company’s 2019 Equity Incentive Plan (the “2019 Plan”), pursuant to which 2,142 shares of Common Stock of the Company are available for grants through February 1, 2029 to the Company’s employees, directors and consultants. On February 1, 2019, options to purchase 1,782 shares of Common Stock, at an exercise price of $196.70 per share, were granted under the 2019 Plan to certain executive officers and employees of the Company. The stock options are vesting over a period of one year commencing from the date of grant in twelve equal monthly increments commencing on the one month anniversary of the grant date. The stock options carry a ten year term and expire on February 1, 2029. For the years ended December 31, 2018 and December 31, 2017, the Company recognized compensation income of $0.04 million and $0.05 million, respectively, related to stock options granted to employees. For the years ended December 31, 2018 and December 31, 2017, the Company recognized compensation expense of approximately $0.1 million and $0.1 million, respectively, related to restricted stock granted to employees and consultants. Warrants The Company issued warrants as part of its offerings in 2013, 2015, 2016 and 2018 as well as part of its issuance of convertible notes in 2016 and 2018 and an exchange agreement in 2017. A summary of warrant activity is as follows: Warrants Exercise Price per Weighted Average Weighted Average Outstanding at January 1, 2017 1 $ $ 197,225,000 - 13,798,400,000 $ 637,218,564 5.59 Warrants issued 21 1,610,000 Warrants exercised (1 ) 2,954,000 Warrants expired (1 ) 591,675,000 Outstanding at December 31, 2017 20 $ $ 857,500 - 13,798,400,000 $ 4,868,205,366 4.88 Warrants issued in Feb 2018 registered direct offering 1,538 6,531 Warrants issued with convertible notes 98,814 126 Exercised (6,536 ) 1,252 Expired (1 ) 13,798,400,000 Outstanding at December 31, 2018 93,835 $ 7.00 - $7,000 $ 150.67 5.75 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (10) FAIR VALUE MEASUREMENTS The table below presents the activity within Level 3 of the fair value hierarchy for the nine months ended September 30, 2019: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at December 31, 2018 $ 33 Total change in the liability included in earnings (456 ) Reclass from liability to equity (11 ) Fair value of warrants issued 20,844 Balance at September 30, 2019 $ 20,410 At September 30, 2019, the Company had a total of 125,000 February 2018 Warrants outstanding. As discussed in Part II—Item 1 “Legal Proceedings” and in Note 12 to the Company’s condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q, September 30, December 31, Expected life (in years) 5.0 1.1 - 5.1 Expected volatility 201.8 % 145.7% - 265.3% Risk-free interest rates 1.6 % 2.5% - 2.6% The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2019, aggregated by the level in the fair value hierarchy within which those measurements fall in accordance with ASC 820. Assets and Liabilities Measured at Fair Value on a Recurring Basis (in thousands) Level 1 Level 2 Level 3 Total September 30, December 31, September 30, December 31, September 30, December 31, September 30, December 31, Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 20,410 $ 33 $ 20,410 $ 33 For the periods ended September 30, 2019 and December 31, 2018, there were no transfers in or out of Level 1, 2 or 3 inputs. |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | (11) NET LOSS PER COMMON SHARE Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to the mark-to-market Three months ended Nine months ended (in thousands, except share data) 2019 2018 2019 2018 Net (loss) income—basic $ (7,519 ) $ (8,880 ) $ (21,371 ) $ (8,353 ) Preferred stock dividends (18,238 ) — (18,238 ) — Adjustment for gain on warrant income — (13 ) — (534 ) Net loss—diluted $ (25,757 ) $ (8,893 ) $ (39,609 ) $ (8,887 ) Weighted average shares outstanding—basic* 26,112 51,229 23,095 19,841 Weighted average shares outstanding—diluted* 26,112 51,229 23,095 19,841 Net loss per share—basic* $ (287.00 ) $ (175.00 ) $ (924.00 ) $ (420.00 ) Net loss per share—diluted* $ (987.00 ) $ (175.00 ) $ (1,715.00 ) $ (448.00 ) * reflects a one-for-five one-for-seven As discussed in Note 9, the Series E Preferred Stock and the Series E-1 The following potentially dilutive securities were excluded from the computation of earnings per share as of September 30, 2019 and 2018 because their effects would be anti-dilutive: September 30, 2019 2018 Stock options 1,643 — Common stock warrants—equity — 6,005 Common stock warrants—liability 1,001,963 1,429 Assumed conversion of Series E and E-1 1,001,963 — Assumed conversion of convertible notes 31,747 8,057 Total 2,037,316 15,491 |
Taxes
Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Taxes | (12) TAXES As discussed in Note 14 Income Taxes The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Additional information regarding the statutes of limitations can be found in Note 14 Income Taxes | (14) INCOME TAXES Income (loss) before income taxes consists of: Year Ended December 31, (in thousands) 2018 2017 Domestic $ (12,961 ) $ (41,313 ) Foreign (6,261 ) (3,804 ) Income (loss) before taxes $ (19,222 ) $ (45,117 ) The provision for income taxes differs from the amount computed by applying the statutory rate as follows: Year Ended December 31, (in thousands) 2018 2017 Income taxes using U.S federal statutory rate $ (4,037 ) $ (15,340 ) Tax Cuts and Jobs Act — 143 Nondeductible interest 2,273 6,912 Loss on extinguishment of debt 236 10,174 Loss of tax benefit of federal net operating loss carryforwards (588 ) 5,067 Loss of tax benefit of state net operating loss carryforwards 1,040 1,373 Loss of tax benefit of federal tax credit carryforwards 495 324 Amortization of gain on IP migration — 767 State income taxes, net of federal benefit (2,355 ) (1,339 ) Foreign rate differential 1,166 1,196 Valuation allowance 6,323 (1,423 ) Derivative charge (4,138 ) (8,403 ) Stock option exercises and cancellations 215 841 Research and development costs (636 ) (295 ) Other 6 3 $ — $ — Significant components of the Company’s deferred tax assets are as follows: Year Ended December 31, (in thousands) 2018 2017 Deferred tax assets: Employee compensation accruals $ — $ 292 Accrued liabilities 519 353 Research tax credits 161 17 Other 60 34 Net operating losses 10,624 5,289 Total deferred tax assets 11,364 5,985 Deferred tax liabilities: Beneficial conversion feature — — Other — 13 Total deferred tax liabilities 13 Valuation allowance 11,364 5,972 Net deferred tax assets $ — $ — As of December 31, 2018 and 2017 the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $230.0 million and $211.3 million respectively. A significant portion of the federal amount is subject to an annual limitation as low as $27,500 as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017 and 2018, as defined by Federal Internal Revenue Code Section 382 and the related income tax regulations. As a result of the limitations caused by the May 2003, November 2016 and multiple 2017 and 2018 ownership changes, approximately $208.1 million of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $21.9 million of net operating loss carryforwards remains available to offset future federal taxable income, of which $1.7 million will expire between 2019 and 2037 and $20.2 million will have an unlimited carryforward period as a result of the Tax Cuts and Jobs Act. In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow the federal Section 382 provisions (with the exception of Connecticut), adjusted for each state’s respective income apportionment percentages. As of December 31, 2018 and 2017, the Company had net operating loss carryforwards for state and city income tax purposes between approximately $27.3 million and $167.3 million and between approximately $27.3 million and $150.3 million, respectively, which expire through 2038. As a result of the 382 limitations, approximately $157.2 million and $141.5 million of New York State and New York City net operating losses are expected to expire unutilized and will be unavailable to offset future taxable income. Approximately $10.1 million and $10.1 million of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2018 and 2017 the Company had a net operating loss carryforward for foreign income tax purposes of $25.2 million and $25.0 million, respectively, which have indefinite carryforward periods. As of December 31, 2018 and 2017, the Company had federal research and development tax credit carryforwards of approximately $5.0 million and $4.3 million respectively, which expire through 2038. As a result of the section 382 limitations, all but $0.2 million of the tax credit carryforwards is expected to expire unutilized. Management has established a 100% valuation allowance against the deferred tax assets as management does not believe it is more likely than not that these assets will be realized. The Company’s valuation allowance decreased by approximately $5.4 million and decreased by $1.1 million in 2018 and 2017, respectively. The change in valuation allowance is as follows: (in thousands) December 31, December 31, Beginning balance $ 5,972 $ 7,094 Charged to costs and expenses 6,323 (1,423 ) Charged to additional paid-in — — Charged to retained earnings (834 ) — Charged to other comprehensive income (97 ) 301 Ending balance $ 11,364 $ 5,972 On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “Act”). The Act, which is also commonly referred to as “U.S. tax reform”, significantly changes U.S. corporate income tax laws by, among other provisions, reducing the maximum U.S. corporate income tax rate from 35% to 21% starting in 2018. During the year ended December 31, 2017, the Company reduced deferred tax assets by a provisional amount of $143,500, offset by a corresponding reduction to its valuation allowance, as a result of the re-measurement The Act also requires a mandatory one-time one-time one-time On December, 22, 2017, Staff Accounting Bulletin 118 was issued due to the complexities involved in accounting for the recently enacted Act. SAB 118 requires the Company to include in its financial statements a reasonable estimate of the impact of the Act on earnings to the extent such estimate has been determined. Accordingly, the U.S. provision for income tax for December 31, 2017 was based on the reasonable estimate guidance provided by SAB 118. The Company finalized the impact from the Act and recorded insignificant adjustments. The Company complies with the provisions of ASC 740-10, 740-10 740-10, 740-10 The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2015; tax years ending December 31, 2015 through December 31, 2018 remain open to examination. The Republic of Ireland is the Company’s only significant foreign jurisdiction. The Company is no longer subject to Ireland tax examination for tax years ending prior to December 31, 2014 (as Ireland has not initiated an audit of 2013 as of December 31, 2018); tax years ending December 31, 2014 through December 31, 2018 remain open to examination. However, the Company’s tax years December 31, 1998 through December 31, 2018 generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards are utilized or expire prior to utilization, and the applicable statutes of limitation have expired in the utilization year. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Delcath recognizes interest accrued related to unrecognized tax benefits and penalties, if incurred, as a component of income tax expense. |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (13) COMMITMENT AND CONTINGENCIES On May 9, 2018, the Company received a Demand Letter from a vendor for an outstanding balance owed at that time of $2.1 million. The Company has worked with the vendor since that time to establish a payment plan for the balance owed. |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Subsequent Events [Abstract] | ||
Subsequent Events | (14) SUBSEQUENT EVENTS Amendments to Registration Rights Agreements On September 30, 2019, the Company and holders of a majority of the Company’s Series E and Series E-1 On October 18, 2019, the Company and holders of a majority of the Company’s Series E and Series E-1 pre-effective On October 29, 2019, the Company and holders of a majority of the Company’s Series E and Series E-1 Waiver and Forbearance Agreement Also on October 29, 2019, the Company entered into a Waiver and Forbearance Agreement (“Waiver”) with Rosalind Master Fund LP and Rosalind Opportunities Fund I LP, holders of its Series E and Series E-1 Reverse Stock Split Pursuant to the Company’s obligations under the July 2019 Private Placement and the August 2019 Private Placement, the Company presented a proposal for a reverse stock split at its Annual Meeting of Stockholders on September 17, 2019. On the same date, a majority of stockholders of the Company approved a proposal to approve and adopt an amendment to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our shares of common stock, $0.01 par value per share, issued and outstanding or reserved for issuance, at a specific ratio within a range from 1-for-50 1-for-1,200, 1-for-100. On October 17, 2019, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock, $0.01 par value per share, at a ratio of 1-for-100 On October 22, 2019, the Company filed with the Secretary of State of the State of Delaware a Certificate of Correction (the “Certificate of Correction”) to the Charter Amendment, rescinding the Charter Amendment, citing an inaccuracy in Article Third of the Charter Amendment, which states an effective time for the Reverse Stock Split of 8:30 a.m. New York City time on October 22, 2019. Such effective time was based upon the Company’s prior receipt, on October 17, 2019, of confirmation by the Financial Industry Regulatory Authority, Inc. (“FINRA”) that it had completed its review of the Reverse Stock Split, including the effective time, whereupon the Company undertook to effect the Reverse Stock Split by filing the Charter Amendment. On the evening of October 21, 2019, subsequent to the Company’s filing of the Charter Amendment and issuance of a press release on October 18, 2019 announcing the confirmation by FINRA, FINRA notified the Company’s counsel that it was rescinding its prior confirmation. The Certificate of Correction further provides that the Company is currently awaiting FINRA confirmation. When such confirmation is obtained, the Company intends to file a Certificate of Amendment effectuating the Reverse Stock Split. Following FINRA’s completion of its review of the Company’s Reverse Stock Split, on December 24, 2019, the Company effected a reverse stock split at which time Delcath’s common stock began trading on the OTCQB on a one-for-seven one-for-seven Preferred Stock conversions From October 1, 2019 through November 14, 2019, the Company issued 5,286 shares of Common Stock to the holders of Series E and Series E-1 | (15) SUBSEQUENT EVENTS Since January 1, 2019, the Company has issued 11,285 shares pursuant to exercises of Pre-Funded As previously reported, in January 2019, the Company terminated Backstop Commitment Purchase Agreements with four institutional investors, by their mutual agreement. The Company and such institutional investors entered into Backstop Commitment Purchase Agreements in connection with a rights offering conducted by the Company that closed in September 2018 in which the Company proposed to raise up to $50 million by distributing, at no charge, to holders of its Common Stock non-transferable On March 29, 2019, the Company exchanged all of its Series D Preferred Stock (with a stated value of $1,160,000) and received $400,000 in proceeds and issued a senior secured promissory note to an investor with a principal amount of $1,560,000. The note is due on April 1, 2020, bears interest at 8% per annum and is nonconvertible. On April 19, 2019, April 26, 2019, May 9, 2019 and May 23, 2019, the Company borrowed an aggregate $3.3 million from two institutional investors and issued promissory notes to the investors. The promissory notes have an aggregate principal amount of $3.3 million, bear interest at the rate of 8% per annum and are due six months from the issuance of each note. The promissory notes are nonconvertible. The notes contain standard events of default and remedies therefor. The Company’s obligations under the promissory notes to the institutional investor are secured by a lien on the Company’s assets. On June 6, 2019, the Company entered into an agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender to the Company for cancellation of 5,605 Series D Warrants and 0.1 million Pre-Funded Pre-Funded Pre-Funded On December 24, 2019, the Company effected a reverse stock split at which time Delcath’s common stock began trading on the OTCQB on a one-for-seven one-for-seven |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | (1) DESCRIPTION OF BUSINESS Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product, “Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System” (“Melphalan/HDS”), is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. Our primary research focus is on ocular melanoma liver metastases (“mOM”) and intrahepatic cholangiocarcinoma (“ICC”) and certain other cancers that are metastatic to the liver. Currently there are few effective treatment options for certain cancers in the liver. Traditional treatment options include surgery, systemic chemotherapy, liver transplant, radiation therapy, interventional radiology techniques, and isolated hepatic perfusion. We believe that Melphalan/HDS and CHEMOSAT represent a potentially important advancement in regional therapy for primary liver cancer and certain other cancers metastatic to the liver and are uniquely positioned to treat the entire liver either as a standalone therapy or as a complement to other therapies. Our clinical development program for Melphalan/HDS is comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the “FOCUS Trial”), a global registration clinical trial that is investigating objective response rate in mOM, and the ALIGN Trial, a global Phase 3 clinical trial for ICC (the “ALIGN Trial”). Our product also includes a registry for CHEMOSAT commercial cases performed in Europe and sponsorship of select Investigator Initiated Trials. While we currently utilize third parties to manufacture some components of our product, we also have our own manufacturing operations for certain components of our product and assemble and package our products in Queensbury, New York. See the discussion in Part 1, Item 1 under the caption “Manufacturing and Quality Assurance” above. We commercialize our product in Europe through alliances with third parties. Liquidity The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements during the year ended December 31, 2018, the Company incurred net losses of $19.2 million and used $14.7 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its Common Stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. At December 31, 2018, management believed that its capital resources were adequate to fund operations through March 2019. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel. See Note 15 of these notes to the Company’s audited consolidated financial statements relating to subsequent events. |
Basis of Consolidated Financial
Basis of Consolidated Financial Statement Presentation | 12 Months Ended |
Dec. 31, 2018 | |
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract] | |
Basis of Consolidated Financial Statement Presentation | (2) BASIS OF CONSOLIDATED FINANCIAL STATEMENT PRESENTATION The accounting and financial reporting policies of the Company conform to generally accepted accounting principles in the United States of America (“GAAP”). The preparation of consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company’s consolidated financial statements. The consolidated financial statements include the accounts of all entities controlled by Delcath. All significant inter-company accounts and transactions are eliminated. Reverse Stock Splits All share numbers presented in this footnote reflect a one-for-three one-for-five one-for-seven |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (3) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (“FDIC”), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. Inventories Inventories are valued at the lower of cost or market value using the first-in, first-out work-in-process, Property, Plant and Equipment Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized. Derivative Instrument Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At December 31, 2018 and 2017, the Company did not have any derivative instruments that were designated as hedges. Fair Value Measurements The Company adheres to ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including: up-front Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under ASC 606, Revenue from Contracts with Customers, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard in 2018 were not material to our consolidated financial statements. In assessing our revenue arrangements in accordance with ASC 606, Revenue from Contracts with Customers, we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods. Deferred Revenue License fees and milestones received in exchange for the grant of a license for the commercialization of CHEMOSAT are generally recognized over the development period, as the license is considered distinct from the delivery of product. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, Non-Employees, non-employees. Under 505-50, non-employees non-employee The Company periodically grants stock options for a fixed number of shares of Common Stock to its employees, directors and non-employee Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740, Income Taxes. Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 14 for additional information. Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of Common Stock outstanding during the period. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all stock options, unvested restricted stock and warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. The calculation of net loss and the number of shares used to compute basic and diluted earnings per share for the years ended December 31, 2018 and 2017: December 31, (in thousands, except share data) 2018 2017 Net loss—basic $ (19,222 ) $ (45,117 ) Preferred stock dividends — (527 ) Net loss—diluted $ (19,222 ) $ (45,644 ) Weighted average shares outstanding—basic 38,151 21 Weighted average shares outstanding—diluted 38,151 21 Net loss per share—basic $ (504.00 ) $ (2,275,000 ) Net loss per share—diluted $ (504.00 ) $ (2,275,000 ) In the third quarter of 2017, the Company issued Series B Preferred Shares. A portion of the redemption price of the Series B Preferred Shares was accounted for as a deemed dividend. At December 31, 2018, the Company has 0.1 million pre-funded December 31, Weighted average shares issued 3,913 Weighted average pre-funded 34,238 Weighted average shares outstanding 38,151 For the years ended December 31, 2018 and 2017 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive. Shares excluded from the computation of diluted earnings per share: 2018 2017 Common stock warrants—equity 6,005 21 Common stock warrants—liability 271 — Assumed conversion of convertible notes 3,681 — Total 9,957 21 Segment Information The Company currently operates in one business segment, which is the development and commercialization of Melphalan/HDS and CHEMOSAT. A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States Dollar (“USD”). Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, 2014-09 2014-09 In June 2016, the FASB issued ASU 2016-15, In October 2016, the FASB issues ASU 2016-16 2016-16, 2016-16 In November 2016, the FASB issued ASU 2016-18, 2016-18 SEC Disclosure Update and Simplification In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Recent Accounting Standards to be Adopted In February 2016, the FASB issued ASU No. 2016-02, 2016-02 right-of-use 2016-02 No. 2018-11, In July 2017, the FASB issued ASU 2017-11, re-characterized re-characterization 2017-11 |
Restructuring Expenses
Restructuring Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Expenses | (9) RESTRUCTURING EXPENSES In order to help reduce operating costs and more appropriately align its office space with the size of its workforce, the Company entered into two sub-leases sub-lease (“Sub-lease one-half sub-lease (“Sub-lease one-half non-current The following table provides the year-to-date (in thousands) Lease Liability Reserve balance at December 31, 2017 $ 604 Charges — Payments/Utilizations (208 ) Reserve balance at December 31, 2018 $ 396 |
Convertible Notes Payable
Convertible Notes Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Notes Payable | (10) CONVERTIBLE NOTES PAYABLE (SECURED CONVERTIBLE NOTES AND RELATED COMMON STOCK PURCHASE WARRANTS) On June 4, 2018, July 21, 2018, August 29, 2018, and September 21, 2018, the Company issued 8% senior secured convertible notes (collectively, “the Notes”) to investors with aggregate principal of $9.4 million and maturity dates between December 2018 and March 2021. The Notes are secured pursuant to a Security Agreement which creates a first priority security interest in all of the personal property (other than Excluded Collateral (as defined in the Security Agreement) of the Company of every kind and description, tangible or intangible, whether currently owned and existing or created or acquired in the future. At December 31, 2018, the Notes were convertible at $1,225 per share subject to customary terms. In April 2019, the Company received notices of default from the investors in the Notes. In connection with the issuance of the Notes, the Company also issued 6,005 Series D Warrants with exercise prices ranging from $1,225—$2,800 and 0.1 million Pre-Funded Pre-Funded The Company valued the June 2018 Series D Warrants using the following inputs: June 2018 June 2018 Pre- Contractual life 5.0 5.5 - 6.5 Expected volatility 194.10 % 215.0% - 389.0% Risk-free interest rates 2.78 % 2.13% - 2.30% First Amendment to June 2018 Series D Warrants In July 2018, the Company and the investor from the June 2018 transaction amended the June 2018 Pre-Funded Amendment to June 2018 and July 2018 Notes and Pre-Funded In August 2018, the Company amended its June 2018 Notes and July 2018 Notes such that the conversion price was reduced to $1,225, interest shall accrue until maturity, and the first $2.5 million and 50% of any subsequent financings shall be used to satisfy the Company’s obligations under the Notes. Effective the same date, the Company also amended its Pre-Funded Pre-Funded Pre-Funded The following table provides a summary of the Notes by their maturity dates (absent provisions of default): (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % 1,225 0.1 (0.1 ) — Total Convertible Notes Payable, net $ 4.5 $ (2.5 ) $ 2.0 |
Derivative Financial Instrument
Derivative Financial Instruments | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | (12) DERIVATIVE FINANCIAL INSTRUMENTS Management expects that the Warrants will either be exercised or expire worthless. The fair value of the Warrants at December 31, 2018 was determined by using option pricing models assuming the following: December 31, December 31, Expected life (in years) 1.13 - 5.11 0.82 - 4.88 Expected volatility 145.7% - 265.3% 130.9% - 266.9% Risk-free interest rates 2.5% - 2.6% 1.7% - 2.1% The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2018 and 2017, aggregated by the level in the fair value hierarchy within which those measurements fall. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and Liabilities Measured at Fair Value on a Level 1 Level 2 Level 3 Balance at (in thousands) 2018 2017 2018 2017 2018 2017 2018 2017 Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 33 $ 560 $ 33 $ 560 For the twelve months ended December 31, 2018 and December 31, 2017 there were no transfers in or out of Level 1, 2 or 3 inputs. The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2018: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at January 1, 2017 $ 18,751 Total change in the liability included in earnings (15,103 ) Extinguishment of convertible note warrant (17,489 ) Fair value of warrants issued 16,953 Fair value of warrants exercised (2,552 ) Balance at December 31, 2017 560 Fair value of warrants issued 23,533 Total change in the liability included in earnings (19,706 ) Reclass from liability to equity (4,210 ) Fair value of warrants exchanged (144 ) Balance at December 31, 2018 $ 33 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | (13) COMMITMENTS Operating Leases In February 2010, the Company entered into an agreement to lease (Initial Lease) 8,629 square feet of office space at 810 Seventh Avenue, New York, NY with an option to expand an additional 8,629 square feet. The term of the Initial Lease began in March, 2010. In September 2010, the Company exercised its option right under the Initial Lease and entered into an agreement to lease (Lease Amendment) an additional 8,629 square feet of office space. The term of the Lease Amendment began in January 2011 and will expire in March 2021. In addition, the Lease Amendment extends the term of the Initial Lease to March 2021. The Initial Lease and the Lease Amendment provide for annual rent of $1.0 million in 2015, $1.0 million in 2016, and $1.2 million in 2017-2020. As discussed in Note 9, the Company has sub-leased In August 2011, Delcath Systems Ltd. entered into an agreement of lease for an office and manufacturing facility located in the city of Galway, Ireland. This facility is approximately 19,200 square feet and is intended to be the location of Delcath’s European headquarters. The Lease is for a term of ten years, commencing August, 2011. The Lease provides for fixed annual lease amounts payable in advance in equal quarterly installments. The remaining annual lease amount is $0.2 million. Delcath Systems Ltd. is also required to pay for customary building operating expenses. Delcath Systems Ltd.’s payment obligations and performance of the Lease are guaranteed by Delcath. The Company has sub-leased In September 2018, the Company entered into an amendment (the “1633 Sublease Amendment”) to a sub-lease In January 2019, the Company entered into an amendment (the “Park Road Lease Amendment”) to a lease agreement entered into in October 2018 (the “Park Road Lease”) for approximately 6,000 square feet of space located at 95-97 Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2018 are as follows: (in thousands) Future Lease 2019 885 2020 916 2021 348 $ 2,149 For the years ended December 31, 2018 and 2017 rent expense, net of receipts under the terms of subleases, totaled approximately $0.6 million and $0.6 million, respectively. Litigation As previously reported, on March 26, 2019, the Company commenced an action (the “Action”) in the Commercial Division of the Supreme Court for the State of New York, County of New York, styled as Delcath Systems, Inc., v. Iroquois Capital Investment Group LLC, Iroquois Master Fund Ltd., L1 Capital Global Opportunities Master Fund and First Fire Global Opportunities Fund LLC (Index No. 651749/2019). The Action seeks expedited equitable relief in the form of reformation and a declaratory judgement to remedy a scrivener’s error in the Series D Warrants issued in the Company’s February 2018 public offering such that those warrants do not contain a price and quantity ratchet upon a sale of Company securities at a price lower than the offering price in the February 2018 offering. The defendant, L1 Capital Global Opportunities Master Fund, settled with the Company by exchanging its Series D Warrants for Company Common Stock on a one-for-one 10-K, one-fifth As previously reported, on July 27, 2018, Hudson Bay Master Fund Ltd. filed a summons and complaint against the Company in the New York State Supreme Court, New York County alleging breaches by the Company of Hudson Bay’s rights of participation in future Company offerings granted in the September 2017 Securities Purchase Agreement between the Company and Hudson Bay and in the February 2018 Securities Purchase Agreement among, inter alia, the Company and Hudson Bay. In terms of relief sought, Hudson Bay claimed both monetary damages (which it claims to be in excess of $1 million) and specific performance. The Company denied any liability with respect to the claims set forth in the lawsuit. As previously reported, on January 4, 2019, the Company was notified by its litigation counsel that on December 28, 2018, the Suit was dismissed with prejudice by the filing of a Stipulation for Discontinuance in the New York State Supreme Court, New York County. On May 9, 2018, the Company received a Demand Letter from a vendor for an outstanding balance owed at that time of $2.1 million. The Company has worked with the vendor since that time to establish a payment plan for the balance owed. Letters of Credit Under the terms of the lease agreement for office space at 810 Seventh Avenue, New York, NY, the Company is required to maintain a letter of credit in the amount of $0.9 million which will expire in February 2021 if not renewed by the Company. Under the terms of a sub-lease |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Liquidity | Liquidity The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements during the year ended December 31, 2018, the Company incurred net losses of $19.2 million and used $14.7 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its Common Stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. At December 31, 2018, management believed that its capital resources were adequate to fund operations through March 2019. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel. See Note 15 of these notes to the Company’s audited consolidated financial statements relating to subsequent events. | |
Use of Estimates | Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. | |
Cash Equivalents and Concentrations of Credit Risk | Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (“FDIC”), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. | |
Restricted Cash | Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. | |
Accounts Receivable | Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. | |
Inventories | Inventories Inventories are valued at the lower of cost or market value using the first-in, first-out work-in-process, | |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized. | |
Derivative Financial Instruments | Derivative Financial Instruments The accounting treatment of derivative financial instruments requires that the Company record financial instruments at their fair value as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash 815-40-35-12 E-1 | Derivative Instrument Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At December 31, 2018 and 2017, the Company did not have any derivative instruments that were designated as hedges. |
Fair Value Measurements | Fair Value Measurements The Company adheres to ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. | |
Revenue Recognition | Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including: up-front Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under ASC 606, Revenue from Contracts with Customers, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard in 2018 were not material to our consolidated financial statements. In assessing our revenue arrangements in accordance with ASC 606, Revenue from Contracts with Customers, we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods. | |
Deferred Revenue | Deferred Revenue License fees and milestones received in exchange for the grant of a license for the commercialization of CHEMOSAT are generally recognized over the development period, as the license is considered distinct from the delivery of product. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. | |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. | |
Research and Development | Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. | |
Stock Based Compensation | Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, Non-Employees, non-employees. Under 505-50, non-employees non-employee The Company periodically grants stock options for a fixed number of shares of Common Stock to its employees, directors and non-employee | |
Income Taxes | Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740, Income Taxes. Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 14 for additional information. | |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of Common Stock outstanding during the period. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all stock options, unvested restricted stock and warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. The calculation of net loss and the number of shares used to compute basic and diluted earnings per share for the years ended December 31, 2018 and 2017: December 31, (in thousands, except share data) 2018 2017 Net loss—basic $ (19,222 ) $ (45,117 ) Preferred stock dividends — (527 ) Net loss—diluted $ (19,222 ) $ (45,644 ) Weighted average shares outstanding—basic 38,151 21 Weighted average shares outstanding—diluted 38,151 21 Net loss per share—basic $ (504.00 ) $ (2,275,000 ) Net loss per share—diluted $ (504.00 ) $ (2,275,000 ) In the third quarter of 2017, the Company issued Series B Preferred Shares. A portion of the redemption price of the Series B Preferred Shares was accounted for as a deemed dividend. At December 31, 2018, the Company has 0.1 million pre-funded December 31, Weighted average shares issued 3,913 Weighted average pre-funded 34,238 Weighted average shares outstanding 38,151 For the years ended December 31, 2018 and 2017 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive. Shares excluded from the computation of diluted earnings per share: 2018 2017 Common stock warrants—equity 6,005 21 Common stock warrants—liability 271 — Assumed conversion of convertible notes 3,681 — Total 9,957 21 | |
Segment Information | Segment Information The Company currently operates in one business segment, which is the development and commercialization of Melphalan/HDS and CHEMOSAT. A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. | |
Foreign Currency and Currency Translation | Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States Dollar (“USD”). Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. | |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2018-02, 2018-02 2018-02 2018-02, In February 2016, the FASB issued ASU 2016-02, | Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, 2014-09 2014-09 In June 2016, the FASB issued ASU 2016-15, In October 2016, the FASB issues ASU 2016-16 2016-16, 2016-16 In November 2016, the FASB issued ASU 2016-18, 2016-18 SEC Disclosure Update and Simplification In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Recent Accounting Standards to be Adopted In February 2016, the FASB issued ASU No. 2016-02, 2016-02 right-of-use 2016-02 No. 2018-11, In July 2017, the FASB issued ASU 2017-11, re-characterized re-characterization 2017-11 |
Liquidity and Operating Matters | Liquidity and Operating Matters The accompanying interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. | |
Basis of Presentation | Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q S-X. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements, in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended September 30, 2019 and 2018; however, certain information and footnote disclosures normally included in our Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Restricted Cash [Abstract] | ||
Schedule of Cash, Cash Equivalents, and Restricted Cash | Cash, cash equivalents, and restricted cash balances were as follows: (in thousands) September 30, December 31, Cash and cash equivalents $ 15,334 $ 2,516 Letters of credit 131 1,012 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 15,515 $ 3,578 | (in thousands) December 31, December 31, Cash and cash equivalents $ 2,516 $ 3,999 Convertible Notes — 238 Letters of credit 1,012 1,012 Security for credit cards 50 75 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 3,578 $ 5,324 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | ||
Schedule of inventories | Inventories consist of the following: (in thousands) September 30, December 31, Raw materials $ 351 $ 358 Work-in-process 350 500 Finished goods 35 — Total inventories $ 736 $ 858 | Inventories consist of: (in thousands) December 31, December 31, Raw materials $ 358 $ 298 Work-in-process 500 721 Finished goods — 229 Total Inventory $ 858 $ 1,248 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: (in thousands) September 30, December 31, Clinical trial expenses $ 500 $ — Insurance premiums 54 140 Security deposit 50 51 Income tax and VAT receivable 33 579 Other 1 227 128 Total prepaid expenses and other current assets $ 864 $ 898 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% of prepaid expenses and other current assets at September 30, 2019 and December 31, 2018. | Prepaid expenses and other current assets include the following: (in thousands) December 31, December 31, Insurance premiums $ 140 $ 421 Financing costs — 70 Security deposit 51 50 Income tax and VAT receivable 579 29 Other 1 128 130 Total prepaid expenses and other current assets $ 898 $ 700 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2018 and 2017. |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Components of property, plant and equipment | Property, plant, and equipment consist of the following: (in thousands) September 30, December 31, Estimated Useful Life Buildings and land $ 589 $ 589 30 years - Buildings Enterprise hardware and software 1,739 1,742 3 years Leaseholds 1,687 1,701 Lesser of lease term or estimated useful life Equipment 1,002 1,002 7 years Furniture 197 198 5 years Property, plant and equipment, gross 5,214 5,232 Accumulated depreciation (4,458 ) (4,307 ) Property, plant and equipment, net $ 756 $ 925 | Property, plant, and equipment consists of: (in thousands) December 31, 2018 December 31, 2017 Estimated Useful Life Buildings and land $ 589 $ 579 30 years-Buildings Enterprise hardware and software 1,742 1,744 3 years Leaseholds 1,701 1,705 Lesser of lease term or estimated useful life Equipment 1,002 971 7 years Furniture 198 175 5 years Property, plant and equipment, gross 5,232 5,174 Accumulated depreciation (4,307 ) (3,876 ) Property, plant and equipment, net $ 925 $ 1,298 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Payables And Accruals [Abstract] | ||
Schedule of current accrued expenses | Accrued expenses consist of the following: (in thousands) September 30, December 31, Compensation, excluding taxes $ 3,274 $ 1,785 Clinical trial expenses 2,590 4,530 Interest payable 33 402 Other 1 640 1,247 Total accrued expenses $ 6,537 $ 7,964 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at September 30, 2019 and December 31, 2018. | Current accrued expenses include the following: (in thousands) December 31, December 31, Clinical trial expenses $ 4,530 $ 869 Compensation, excluding taxes 1,785 1,124 Professional fees 190 221 Short-term portion of lease restructuring 184 209 Other 1 1,275 985 Total accrued expenses $ 7,964 $ 3,408 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2018 and 2017. |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating and financing leases as of and for the nine months ended September 30, 2019: (in thousands) U.S. Ireland Total Lease cost Operating lease cost $ 592 $ 160 $ 752 Financing lease cost 32 — 32 Sublease income (215 ) (133 ) (348 ) Total $ 409 $ 27 436 Other information Operating cash flows out from operating leases (634 ) (160 ) (794 ) Operating cash flows in from operating leases 215 133 348 Operating cash flows from financing leases (235 ) — (35 ) Right-of-use 874 — 874 Weighted average remaining lease term 1.4 1.8 Weighted average discount rate—operating leases 8 % 8 % |
Schedule of Maturity of Operating Leases Excluding Short-Term Leases | Maturities of the Company’s operating leases, excluding short-term leases, are as follows: (in thousands) U.S. Ireland Total Nine months ended December 31, 2019 $ 129 $ 51 $ 180 Year ended December 31, 2020 498 203 701 Year ended December 31, 2021 79 119 198 Total 706 373 1,079 Less present value discount (40 ) (27 ) (67 ) Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2019 $ 666 $ 346 $ 1,012 |
Outstanding Debt (Tables)
Outstanding Debt (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Debt Disclosure [Abstract] | ||
Summary of the Notes by Maturity Dates | The following tables provide a summary of the various notes issued at September 30, 2019 and December 31, 2018: (in millions) Conversion Current Principal Long term convertible notes payable 8.0% July 2019 Notes $ 1,500 8 % $ 2.0 (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % $ 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % $ 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % $ 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % $ 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % $ 1,225 0.1 (0.1 ) — Balance at December 31, 2018 $ 4.5 $ (2.5 ) $ 2.0 | The following table provides a summary of the Notes by their maturity dates (absent provisions of default): (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % 1,225 0.1 (0.1 ) — Total Convertible Notes Payable, net $ 4.5 $ (2.5 ) $ 2.0 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | ||
Summary of Stock Option Activity | The following is a summary of stock option activity under the Plan for the nine months ended September 30, 2019: Number of Weighted Average Weighted Aggregate Outstanding at December 31, 2018 — Granted 1,782 196.70 Exercised — Cancelled/Forfeited (142 ) 196.70 Outstanding at September 30, 2019 1,640 $ 196.70 9.4 $ — Exercisable at September 30, 2019 1,095 $ 196.70 9.4 $ — | |
Summary of Weighted Average Assumptions Used to Compute Fair Value | The following weighted average assumptions were used to compute the fair value of stock options granted during the nine months ended September 30, 2019: Nine months ended Dividend yield N/A Expected volatility 147.6 % Weighted average risk-free interest rate 2.6 % Weighted average expected life (in years) 5.5 Weighted average grant date fair value $ 0.259 | |
Summary of Recognized Share-based Compensation Cost | Three months ended Nine months ended (in thousands) 2019 2018 2019 2018 Selling, general and administrative $ 54 $ 116 $ 160 $ 58 Research and development 16 — 43 (63 ) Total $ 70 $ 116 $ 203 $ (5 ) | |
Summary of Warrant Activity | The following is a summary of warrant activity for the nine months ended September 30, 2019: Warrants Exercise Price per Weighted Average Weighted Outstanding at December 31, 2018 93,835 $ 7.00 - $7,000 $ 150.67 5.75 Issued 1,001,995 42.00 Exercised (11,285 ) 7.00 Exchanged (82,521 ) 170.31 Outstanding at September 30, 2019 1,002,024 $ 7.00 - $42.00 $ 42.00 5.05 | The Company issued warrants as part of its offerings in 2013, 2015, 2016 and 2018 as well as part of its issuance of convertible notes in 2016 and 2018 and an exchange agreement in 2017. A summary of warrant activity is as follows: Warrants Exercise Price per Weighted Average Weighted Average Outstanding at January 1, 2017 1 $ $ 197,225,000 - 13,798,400,000 $ 637,218,564 5.59 Warrants issued 21 1,610,000 Warrants exercised (1 ) 2,954,000 Warrants expired (1 ) 591,675,000 Outstanding at December 31, 2017 20 $ $ 857,500 - 13,798,400,000 $ 4,868,205,366 4.88 Warrants issued in Feb 2018 registered direct offering 1,538 6,531 Warrants issued with convertible notes 98,814 126 Exercised (6,536 ) 1,252 Expired (1 ) 13,798,400,000 Outstanding at December 31, 2018 93,835 $ 7.00 - $7,000 $ 150.67 5.75 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Fair value measurements using significant unobservable inputs | The table below presents the activity within Level 3 of the fair value hierarchy for the nine months ended September 30, 2019: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at December 31, 2018 $ 33 Total change in the liability included in earnings (456 ) Reclass from liability to equity (11 ) Fair value of warrants issued 20,844 Balance at September 30, 2019 $ 20,410 | The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2018: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at January 1, 2017 $ 18,751 Total change in the liability included in earnings (15,103 ) Extinguishment of convertible note warrant (17,489 ) Fair value of warrants issued 16,953 Fair value of warrants exercised (2,552 ) Balance at December 31, 2017 560 Fair value of warrants issued 23,533 Total change in the liability included in earnings (19,706 ) Reclass from liability to equity (4,210 ) Fair value of warrants exchanged (144 ) Balance at December 31, 2018 $ 33 |
Schedule of fair value of the outstanding warrants | The fair value of the outstanding warrants at September 30, 2019 and December 31, 2018 was determined by using option pricing models with the following assumptions: September 30, December 31, Expected life (in years) 5.0 1.1 - 5.1 Expected volatility 201.8 % 145.7% - 265.3% Risk-free interest rates 1.6 % 2.5% - 2.6% | The fair value of the Warrants at December 31, 2018 was determined by using option pricing models assuming the following: December 31, December 31, Expected life (in years) 1.13 - 5.11 0.82 - 4.88 Expected volatility 145.7% - 265.3% 130.9% - 266.9% Risk-free interest rates 2.5% - 2.6% 1.7% - 2.1% |
Assets and liabilities measured at fair value on a recurring basis | The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2019, aggregated by the level in the fair value hierarchy within which those measurements fall in accordance with ASC 820. Assets and Liabilities Measured at Fair Value on a Recurring Basis (in thousands) Level 1 Level 2 Level 3 Total September 30, December 31, September 30, December 31, September 30, December 31, September 30, December 31, Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 20,410 $ 33 $ 20,410 $ 33 | The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2018 and 2017, aggregated by the level in the fair value hierarchy within which those measurements fall. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and Liabilities Measured at Fair Value on a Level 1 Level 2 Level 3 Balance at (in thousands) 2018 2017 2018 2017 2018 2017 2018 2017 Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 33 $ 560 $ 33 $ 560 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Calculation of net loss and number of shares used to compute basic and diluted earnings per share | Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to the mark-to-market Three months ended Nine months ended (in thousands, except share data) 2019 2018 2019 2018 Net (loss) income—basic $ (7,519 ) $ (8,880 ) $ (21,371 ) $ (8,353 ) Preferred stock dividends (18,238 ) — (18,238 ) — Adjustment for gain on warrant income — (13 ) — (534 ) Net loss—diluted $ (25,757 ) $ (8,893 ) $ (39,609 ) $ (8,887 ) Weighted average shares outstanding—basic* 26,112 51,229 23,095 19,841 Weighted average shares outstanding—diluted* 26,112 51,229 23,095 19,841 Net loss per share—basic* $ (287.00 ) $ (175.00 ) $ (924.00 ) $ (420.00 ) Net loss per share—diluted* $ (987.00 ) $ (175.00 ) $ (1,715.00 ) $ (448.00 ) * reflects a one-for-five one-for-seven | The calculation of net loss and the number of shares used to compute basic and diluted earnings per share for the years ended December 31, 2018 and 2017: December 31, (in thousands, except share data) 2018 2017 Net loss—basic $ (19,222 ) $ (45,117 ) Preferred stock dividends — (527 ) Net loss—diluted $ (19,222 ) $ (45,644 ) Weighted average shares outstanding—basic 38,151 21 Weighted average shares outstanding—diluted 38,151 21 Net loss per share—basic $ (504.00 ) $ (2,275,000 ) Net loss per share—diluted $ (504.00 ) $ (2,275,000 ) |
Anti-dilutive securities excluded from the computation of earnings per share | The following potentially dilutive securities were excluded from the computation of earnings per share as of September 30, 2019 and 2018 because their effects would be anti-dilutive: September 30, 2019 2018 Stock options 1,643 — Common stock warrants—equity — 6,005 Common stock warrants—liability 1,001,963 1,429 Assumed conversion of Series E and E-1 1,001,963 — Assumed conversion of convertible notes 31,747 8,057 Total 2,037,316 15,491 | Shares excluded from the computation of diluted earnings per share: 2018 2017 Common stock warrants—equity 6,005 21 Common stock warrants—liability 271 — Assumed conversion of convertible notes 3,681 — Total 9,957 21 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Calculation of net loss and number of shares used to compute basic and diluted earnings per share | Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to the mark-to-market Three months ended Nine months ended (in thousands, except share data) 2019 2018 2019 2018 Net (loss) income—basic $ (7,519 ) $ (8,880 ) $ (21,371 ) $ (8,353 ) Preferred stock dividends (18,238 ) — (18,238 ) — Adjustment for gain on warrant income — (13 ) — (534 ) Net loss—diluted $ (25,757 ) $ (8,893 ) $ (39,609 ) $ (8,887 ) Weighted average shares outstanding—basic* 26,112 51,229 23,095 19,841 Weighted average shares outstanding—diluted* 26,112 51,229 23,095 19,841 Net loss per share—basic* $ (287.00 ) $ (175.00 ) $ (924.00 ) $ (420.00 ) Net loss per share—diluted* $ (987.00 ) $ (175.00 ) $ (1,715.00 ) $ (448.00 ) * reflects a one-for-five one-for-seven | The calculation of net loss and the number of shares used to compute basic and diluted earnings per share for the years ended December 31, 2018 and 2017: December 31, (in thousands, except share data) 2018 2017 Net loss—basic $ (19,222 ) $ (45,117 ) Preferred stock dividends — (527 ) Net loss—diluted $ (19,222 ) $ (45,644 ) Weighted average shares outstanding—basic 38,151 21 Weighted average shares outstanding—diluted 38,151 21 Net loss per share—basic $ (504.00 ) $ (2,275,000 ) Net loss per share—diluted $ (504.00 ) $ (2,275,000 ) |
Summary of Reconciliation of Weighted Average Shares Outstanding Calculation | The following table provides a reconciliation of the weighted average shares outstanding calculation at December 31, 2018: December 31, Weighted average shares issued 3,913 Weighted average pre-funded 34,238 Weighted average shares outstanding 38,151 | |
Anti-dilutive securities excluded from the computation of earnings per share | The following potentially dilutive securities were excluded from the computation of earnings per share as of September 30, 2019 and 2018 because their effects would be anti-dilutive: September 30, 2019 2018 Stock options 1,643 — Common stock warrants—equity — 6,005 Common stock warrants—liability 1,001,963 1,429 Assumed conversion of Series E and E-1 1,001,963 — Assumed conversion of convertible notes 31,747 8,057 Total 2,037,316 15,491 | Shares excluded from the computation of diluted earnings per share: 2018 2017 Common stock warrants—equity 6,005 21 Common stock warrants—liability 271 — Assumed conversion of convertible notes 3,681 — Total 9,957 21 |
Restructuring Expenses (Tables)
Restructuring Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring And Related Activities [Abstract] | |
Schedule of restructuring and related costs | The following table provides the year-to-date (in thousands) Lease Liability Reserve balance at December 31, 2017 $ 604 Charges — Payments/Utilizations (208 ) Reserve balance at December 31, 2018 $ 396 |
Convertible Notes Payable (Tabl
Convertible Notes Payable (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Debt Disclosure [Abstract] | ||
Schedule of Inputs Used to Value the Series D Warrants | The Company valued the June 2018 Series D Warrants using the following inputs: June 2018 June 2018 Pre- Contractual life 5.0 5.5 - 6.5 Expected volatility 194.10 % 215.0% - 389.0% Risk-free interest rates 2.78 % 2.13% - 2.30% | |
Summary of the Notes by Maturity Dates | The following tables provide a summary of the various notes issued at September 30, 2019 and December 31, 2018: (in millions) Conversion Current Principal Long term convertible notes payable 8.0% July 2019 Notes $ 1,500 8 % $ 2.0 (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % $ 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % $ 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % $ 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % $ 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % $ 1,225 0.1 (0.1 ) — Balance at December 31, 2018 $ 4.5 $ (2.5 ) $ 2.0 | The following table provides a summary of the Notes by their maturity dates (absent provisions of default): (in millions) Interest Conversion Principal Unamortized Carrying December 4, 2018 8.0 % $ 1,225 $ 1.7 $ — $ 1.7 March 1, 2019 8.0 % 1,225 0.6 (0.5 ) 0.1 March 21, 2019 8.0 % 1,225 0.4 (0.2 ) 0.2 December 4, 2019 8.0 % 1,225 0.9 (0.9 ) — March 1, 2020 8.0 % 1,225 0.8 (0.8 ) — March 21, 2020 8.0 % 1,225 0.1 (0.1 ) — Total Convertible Notes Payable, net $ 4.5 $ (2.5 ) $ 2.0 |
Derivative Financial Instrume_2
Derivative Financial Instruments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | ||
Schedule of fair value of the outstanding warrants | The fair value of the outstanding warrants at September 30, 2019 and December 31, 2018 was determined by using option pricing models with the following assumptions: September 30, December 31, Expected life (in years) 5.0 1.1 - 5.1 Expected volatility 201.8 % 145.7% - 265.3% Risk-free interest rates 1.6 % 2.5% - 2.6% | The fair value of the Warrants at December 31, 2018 was determined by using option pricing models assuming the following: December 31, December 31, Expected life (in years) 1.13 - 5.11 0.82 - 4.88 Expected volatility 145.7% - 265.3% 130.9% - 266.9% Risk-free interest rates 2.5% - 2.6% 1.7% - 2.1% |
Assets and liabilities measured at fair value on a recurring basis | The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2019, aggregated by the level in the fair value hierarchy within which those measurements fall in accordance with ASC 820. Assets and Liabilities Measured at Fair Value on a Recurring Basis (in thousands) Level 1 Level 2 Level 3 Total September 30, December 31, September 30, December 31, September 30, December 31, September 30, December 31, Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 20,410 $ 33 $ 20,410 $ 33 | The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2018 and 2017, aggregated by the level in the fair value hierarchy within which those measurements fall. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and Liabilities Measured at Fair Value on a Level 1 Level 2 Level 3 Balance at (in thousands) 2018 2017 2018 2017 2018 2017 2018 2017 Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 33 $ 560 $ 33 $ 560 |
Fair value measurements using significant unobservable inputs | The table below presents the activity within Level 3 of the fair value hierarchy for the nine months ended September 30, 2019: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at December 31, 2018 $ 33 Total change in the liability included in earnings (456 ) Reclass from liability to equity (11 ) Fair value of warrants issued 20,844 Balance at September 30, 2019 $ 20,410 | The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2018: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at January 1, 2017 $ 18,751 Total change in the liability included in earnings (15,103 ) Extinguishment of convertible note warrant (17,489 ) Fair value of warrants issued 16,953 Fair value of warrants exercised (2,552 ) Balance at December 31, 2017 560 Fair value of warrants issued 23,533 Total change in the liability included in earnings (19,706 ) Reclass from liability to equity (4,210 ) Fair value of warrants exchanged (144 ) Balance at December 31, 2018 $ 33 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments, net of receipts due under terms of subleases under all operating leases | Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2018 are as follows: (in thousands) Future Lease 2019 885 2020 916 2021 348 $ 2,149 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income (Loss) Before Income Taxes | Income (loss) before income taxes consists of: Year Ended December 31, (in thousands) 2018 2017 Domestic $ (12,961 ) $ (41,313 ) Foreign (6,261 ) (3,804 ) Income (loss) before taxes $ (19,222 ) $ (45,117 ) |
Income tax reconciliation | The provision for income taxes differs from the amount computed by applying the statutory rate as follows: Year Ended December 31, (in thousands) 2018 2017 Income taxes using U.S federal statutory rate $ (4,037 ) $ (15,340 ) Tax Cuts and Jobs Act — 143 Nondeductible interest 2,273 6,912 Loss on extinguishment of debt 236 10,174 Loss of tax benefit of federal net operating loss carryforwards (588 ) 5,067 Loss of tax benefit of state net operating loss carryforwards 1,040 1,373 Loss of tax benefit of federal tax credit carryforwards 495 324 Amortization of gain on IP migration — 767 State income taxes, net of federal benefit (2,355 ) (1,339 ) Foreign rate differential 1,166 1,196 Valuation allowance 6,323 (1,423 ) Derivative charge (4,138 ) (8,403 ) Stock option exercises and cancellations 215 841 Research and development costs (636 ) (295 ) Other 6 3 $ — $ — |
Significant components of deferred tax assets | Significant components of the Company’s deferred tax assets are as follows: Year Ended December 31, (in thousands) 2018 2017 Deferred tax assets: Employee compensation accruals $ — $ 292 Accrued liabilities 519 353 Research tax credits 161 17 Other 60 34 Net operating losses 10,624 5,289 Total deferred tax assets 11,364 5,985 Deferred tax liabilities: Beneficial conversion feature — — Other — 13 Total deferred tax liabilities 13 Valuation allowance 11,364 5,972 Net deferred tax assets $ — $ — |
Summary of Change in Valuation Allowance | The change in valuation allowance is as follows: (in thousands) December 31, December 31, Beginning balance $ 5,972 $ 7,094 Charged to costs and expenses 6,323 (1,423 ) Charged to additional paid-in — — Charged to retained earnings (834 ) — Charged to other comprehensive income (97 ) 301 Ending balance $ 11,364 $ 5,972 |
Restricted Cash - Schedule of C
Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Restricted Cash [Abstract] | |||||
Cash and cash equivalents | $ 15,334 | $ 2,516 | $ 3,999 | ||
Letters of credit | 131 | 1,012 | 1,012 | ||
Security for credit cards | 50 | 50 | 75 | ||
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 15,515 | $ 3,578 | $ 9,975 | $ 5,324 | $ 31,696 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 351 | $ 358 | $ 298 |
Work-in-process | 350 | 500 | 721 |
Finished goods | 35 | 229 | |
Total inventories | $ 736 | $ 858 | $ 1,248 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid Expense And Other Assets Current [Abstract] | |||
Clinical trial expenses | $ 500 | ||
Financing costs | $ 70 | ||
Insurance premiums | 54 | $ 140 | 421 |
Security deposit | 50 | 51 | 50 |
Income tax and VAT receivable | 33 | 579 | 29 |
Other | 227 | 128 | 130 |
Total prepaid expenses and other current assets | $ 864 | $ 898 | $ 700 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Additional Information (Details) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid Expense And Other Assets Current [Abstract] | |||
Maximum percentage of prepaid expenses and other current assets (in hundredths) | 5.00% | 5.00% | 5.00% |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 5,214 | $ 5,232 | $ 5,174 |
Accumulated depreciation | (4,458) | (4,307) | (3,876) |
Property, plant and equipment, net | 756 | 925 | 1,298 |
Buildings and Land [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | 589 | 589 | 579 |
Enterprise Hardware and Software [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 1,739 | $ 1,742 | 1,744 |
Property, plant and equipment, estimated useful life | 3 years | 3 years | |
Leaseholds [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 1,687 | $ 1,701 | 1,705 |
Property, plant and equipment, estimated useful life | Lesser of lease term or estimated useful life | Lesser of lease term or estimated useful life | |
Equipment [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 1,002 | $ 1,002 | 971 |
Property, plant and equipment, estimated useful life | 7 years | 7 years | |
Furniture [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 197 | $ 198 | $ 175 |
Property, plant and equipment, estimated useful life | 5 years | 5 years | |
Buildings [Member] | |||
Property Plant And Equipment [Line Items] | |||
Property, plant and equipment, estimated useful life | 30 years | 30 years |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Additional Information (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 | |
Property Plant And Equipment [Abstract] | ||||||
Depreciation expense | $ 100 | $ 100 | $ 168 | $ 342 | $ 444 | $ 310 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | |||
Compensation, excluding taxes | $ 3,274 | $ 1,785 | $ 1,124 |
Clinical trial expenses | 2,590 | 4,530 | 869 |
Interest payable | 33 | 402 | |
Other | 640 | 1,247 | 985 |
Total accrued expenses | $ 6,537 | $ 7,964 | $ 3,408 |
Accrued Expenses - Schedule o_2
Accrued Expenses - Schedule of Accrued Expenses (Parenthetical) (Details) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | |||
Maximum percentage of current liabilities accrued (in hundredths) | 5.00% | 5.00% | 5.00% |
Leases - Additional Information
Leases - Additional Information (Details) | Sep. 30, 2019 |
Leases [Abstract] | |
Lease term | 12 months |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Lease cost | |
Operating lease cost | $ 752 |
Financing lease cost | 32 |
Sublease income | (348) |
Total | 436 |
Other information | |
Operating cash flows out from operating leases | (794) |
Operating cash flows in from operating leases | 348 |
Operating cash flows from financing leases | (35) |
Right-of-use assets exchanged for new operating lease liabilities | 874 |
U.S. [Member] | |
Lease cost | |
Operating lease cost | 592 |
Financing lease cost | 32 |
Sublease income | (215) |
Total | 409 |
Other information | |
Operating cash flows out from operating leases | (634) |
Operating cash flows in from operating leases | 215 |
Operating cash flows from financing leases | (35) |
Right-of-use assets exchanged for new operating lease liabilities | $ 874 |
Weighted average remaining lease term | 1 year 4 months 24 days |
Weighted average discount rate - operating leases | 8.00% |
Ireland [Member] | |
Lease cost | |
Operating lease cost | $ 160 |
Sublease income | (133) |
Total | 27 |
Other information | |
Operating cash flows out from operating leases | (160) |
Operating cash flows in from operating leases | $ 133 |
Weighted average remaining lease term | 1 year 9 months 18 days |
Weighted average discount rate - operating leases | 8.00% |
Leases - Schedule of Maturity o
Leases - Schedule of Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Lessee Lease Description [Line Items] | |
Three months ended December 31, 2019 | $ 180 |
Year ended December 31, 2020 | 701 |
Year ended December 31, 2021 | 198 |
Total | 1,079 |
Less present value discount | (67) |
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2019 | 1,012 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Three months ended December 31, 2019 | 129 |
Year ended December 31, 2020 | 498 |
Year ended December 31, 2021 | 79 |
Total | 706 |
Less present value discount | (40) |
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2019 | 666 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Three months ended December 31, 2019 | 51 |
Year ended December 31, 2020 | 203 |
Year ended December 31, 2021 | 119 |
Total | 373 |
Less present value discount | (27) |
Operating lease liabilities included in the condensed consolidated balance sheets at September 30, 2019 | $ 346 |
Outstanding Debt - Additional I
Outstanding Debt - Additional Information (Details) - USD ($) | Mar. 29, 2019 | May 23, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Jun. 06, 2019 | Apr. 30, 2019 | Sep. 21, 2018 |
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 4,500,000 | ||||||
Series D Preferred Shares [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate | 8.00% | ||||||
Preferred stock, stated value | $ 1,160,000 | ||||||
Proceeds from exchange of senior secured promissory note | 400,000 | ||||||
Issuance of senior secured promissory note in exchange of preferred stock | $ 1,560,000 | ||||||
Maturity date | Apr. 1, 2020 | ||||||
Senior Secured Promissory Notes [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 2,000,000 | ||||||
Interest rate | 8.00% | ||||||
Senior Secured Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 3,300,000 | ||||||
Interest rate | 8.00% | ||||||
Maturity period | 6 months | ||||||
Senior Secured Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 9,400,000 | ||||||
Interest rate | 8.00% | ||||||
Debt instrument maturity start date | Dec. 31, 2018 | Dec. 31, 2018 | |||||
Debt instrument maturity end date | Mar. 31, 2021 | Mar. 31, 2021 | |||||
8.0% 2018 Notes [Member] | Short Term Notes Payable [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, notice of default description | Company received notices of default from the investors in the 2018 Notes which resulted in a 25%, or $1.1 million, increase in principal and an increase in the interest rates from 8% to 18%. | ||||||
Debt instrument, default amount percentage | 25.00% | ||||||
Debt instrument, default amount | $ 1,100,000 | ||||||
Increase in interest rate on notes in event of default | 18.00% | ||||||
Series D Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of common shares issuable on cancellation of warrants | 5,605 | ||||||
Pre-Funded Series D Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of common shares issuable on cancellation of warrants | 100,000 |
Outstanding Debt - Summary of V
Outstanding Debt - Summary of Various Notes Issued (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Principal | $ 4.5 | |
Unamortized discount | (2.5) | |
Carrying value | $ 2 | |
December 4, 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2018 | Dec. 4, 2018 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 1.7 | |
Carrying value | $ 1.7 | |
March 1, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2019 | Mar. 1, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.6 | |
Unamortized discount | (0.5) | |
Carrying value | $ 0.1 | |
March 21, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2019 | Mar. 21, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.4 | |
Unamortized discount | (0.2) | |
Carrying value | $ 0.2 | |
December 4, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2019 | Dec. 4, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.9 | |
Unamortized discount | $ (0.9) | |
March 1, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2020 | Mar. 1, 2020 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.8 | |
Unamortized discount | $ (0.8) | |
March 21, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2020 | Mar. 21, 2020 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.1 | |
Unamortized discount | $ (0.1) | |
Long Term Convertible Notes Payable [Member] | 8.0% July 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 8.00% | |
Conversion price | $ 1,500 | |
Principal | $ 2 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - USD ($) | Aug. 19, 2019 | Jul. 11, 2019 | Mar. 29, 2019 | Mar. 29, 2019 | Nov. 06, 2018 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Nov. 05, 2018 |
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Fair value of warrants issued | $ 20,844,000 | $ 28,539,000 | $ 28,539,000 | $ 16,953,000 | |||||||
Preferred stock, aggregate stated value | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
2019 Warrants [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Fair value of warrants issued | $ 20,800,000 | ||||||||||
Series E Convertible Preferred Stock [Member] | July 2019 Private Placement [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Proceeds from private placement, gross | $ 20,000,000 | ||||||||||
Series E Convertible Preferred Stock [Member] | July 2019 Private Placement [Member] | Securities Purchase Agreement [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, shares issued | 20,000 | ||||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||||
Shares issued, price per share | $ 1,000 | ||||||||||
Series E-1 Convertible Preferred Stock [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Conversion of stock, description | The Conversion Price and the Exercise Price may, upon each of (i) the third trading day following the date that the Company effects a reverse stock split, (ii) the date that the initial registration statement to be filed pursuant to the Registration Rights Agreement (as further discussed below) is declared effective by the United States Securities and Exchange Commission (“SEC”), and (iii) in the event that all of the registrable securities (as defined in the Registration Rights Agreement) are not then registered on an effective registration statement, the date that all of the shares underlying the Preferred Stock and Warrants may be sold pursuant to Rule 144, be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the Common Stock immediately prior to such dates. | ||||||||||
Series E-1 Convertible Preferred Stock [Member] | August 2019 Private Placement [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Proceeds from private placement, gross | $ 9,500,000 | ||||||||||
Series E-1 Convertible Preferred Stock [Member] | August 2019 Private Placement [Member] | Securities Purchase Agreement [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, shares issued | 9,510 | ||||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||||
Shares issued, price per share | $ 1,000 | ||||||||||
Preferred Stock [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Debt instrument, conversion price | $ 25.36 | $ 25.36 | |||||||||
Exercise price of warrants | $ 25.36 | $ 25.36 | |||||||||
Warrant exercisable term | 5 years | ||||||||||
Net proceeds from issuance of preferred stock | $ 26,500,000 | ||||||||||
Beneficial conversion feature | 18,300,000 | ||||||||||
Series E Preferred Stock and Related Warrants [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Debt and warrants exchanged for preferred stock | $ 11,800,000 | ||||||||||
Number of preferred stock and warrants issued upon conversion | 11,500 | ||||||||||
Value of accounts payable exchanged | $ 100,000 | ||||||||||
Number of shares issued upon exchange of accounts payable | 149 | ||||||||||
Number of shares issued upon exchange of investor waiver rights | 923 | ||||||||||
Series D Preferred Shares [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||||
Preferred stock, aggregate stated value | $ 1,160,000 | $ 1,160,000 | |||||||||
Proceeds from exchange of senior secured promissory note | 400,000 | ||||||||||
Issuance of senior secured promissory note in exchange of preferred stock | 1,560,000 | 1,560,000 | |||||||||
Series D Preferred Shares [Member] | Common Stock [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Number of preferred stock and warrants issued upon conversion | 2,366 | ||||||||||
Series D Preferred Shares [Member] | Securities Purchase Agreement [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, shares issued | 101 | ||||||||||
Subsequent Event [Member] | Series D Preferred Shares [Member] | |||||||||||
Stockholders Equity Note [Line Items] | |||||||||||
Preferred stock, aggregate stated value | 1,160,000 | 1,160,000 | |||||||||
Proceeds from exchange of senior secured promissory note | 400,000 | ||||||||||
Issuance of senior secured promissory note in exchange of preferred stock | 1,560,000 | 1,560,000 | |||||||||
Preferred stock, value outstanding | $ 0 | $ 0 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Issuances - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2019shares | |
Pre-Funded Series D Warrants [Member] | |
Stockholders Equity Note [Line Items] | |
Exercise of pre-funded Series D Warrants (in shares) | 11,285 |
Stockholders' Equity - Warrant
Stockholders' Equity - Warrant Exchange - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Apr. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders Equity Note [Line Items] | |||||||
Loss in exchange of common stock for warrants | $ 1,714,000 | $ 1,721,000 | $ 2,826,000 | $ 2,826,000 | $ 0 | ||
Exchange Agreement [Member] | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of common stock and rights for payments made in shares on convertible notes payable (in shares) | 92 | 1,179 | |||||
Loss in exchange of common stock for warrants | $ 6,000 |
Stockholders' Equity - Share-Ba
Stockholders' Equity - Share-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | May 02, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares available for grant | 0 | ||||
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 100,000 | $ 100,000 | |||
Cost expected to be recognized over weighted average period | 3 months 18 days | ||||
Share-based compensation (Income) expense | $ 70,000 | $ 116,000 | $ 203,000 | $ (5,000) | |
2019 Equity Incentive Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares available for grant | 502 | 502 | |||
2019 Equity Incentive Plan [Member] | Maximum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of shares reserved for issuance | 1,500,000 | 1,500,000 | |||
2019 Equity Incentive Plan [Member] | Minimum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options, exercise price of common stock granted as percentage of fair value on the date of grant | 100.00% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Stockholders Equity Note [Abstract] | |
Number of Shares, Granted | shares | 1,782 |
Number of Shares, Cancelled/Forfeited | shares | (142) |
Number of Shares, Outstanding | shares | 1,640 |
Number of Shares, Exercisable | shares | 1,095 |
Weighted Average Exercise Price, Granted | $ / shares | $ 196.70 |
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares | 196.70 |
Weighted Average Exercise Price, Outstanding | $ / shares | 196.70 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 196.70 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 4 months 24 days |
Weighted Average Remaining Contractual Term (Years), Exercisable | 9 years 4 months 24 days |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Weighted Average Assumptions Used to Compute Fair Value (Details) - Stock Options [Member] | 9 Months Ended |
Sep. 30, 2019$ / shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Expected volatility | 147.60% |
Weighted average risk-free interest rate | 2.60% |
Weighted average expected life (in years) | 5 years 6 months |
Weighted average grant date fair value | $ 0.259 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | $ 70,000 | $ 116,000 | $ 203,000 | $ (5,000) |
Selling, General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | 54,000 | $ 116,000 | 160,000 | 58,000 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | $ 16,000 | $ 43,000 | $ (63,000) |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) [Roll Forward] | |||
Beginning balance | $ 33 | $ 560 | $ 18,751 |
Total change in the liability included in earnings | (456) | (19,706) | (15,103) |
Reclass from liability to equity | (11) | (4,210) | |
Fair value of warrants issued | 20,844 | 23,533 | 16,953 |
Ending balance | $ 20,410 | $ 33 | $ 560 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Class Of Warrant Or Right [Line Items] | ||||
Number of warrants outstanding (in shares) | 1,002,024 | 93,835 | 20 | 1 |
Febuary 2018 Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrants outstanding (in shares) | 125,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 5 years | ||
Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 2.018 | ||
Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.016 | ||
Minimum [Member] | Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 1 year 1 month 6 days | 9 months 25 days | |
Minimum [Member] | Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 1.457 | 1.309 | |
Minimum [Member] | Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.025 | 0.017 | |
Maximum [Member] | Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 5 years 1 month 6 days | 4 years 10 months 17 days | |
Maximum [Member] | Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 2.653 | 2.669 | |
Maximum [Member] | Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.026 | 0.021 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Derivative Instruments Liabilities [Member] - Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Liabilities [Abstract] | |||
Total Liabilities | $ 20,410 | $ 33 | $ 560 |
Level 3 [Member] | |||
Liabilities [Abstract] | |||
Total Liabilities | $ 20,410 | $ 33 | $ 560 |
Net Loss per Common Share - Cal
Net Loss per Common Share - Calculation of Net Loss and Number of Shares Used to Compute Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
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, 2017 | |||||
Earnings Per Share [Abstract] | ||||||||||||||
Net (loss) income - basic | $ (7,519) | $ (5,959) | $ (7,894) | $ (8,880) | $ (6,658) | $ 7,185 | $ (21,371) | $ (8,353) | $ (19,222) | $ (45,117) | ||||
Preferred stock dividends | (18,238) | (18,238) | (527) | |||||||||||
Adjustment for gain on warrant income | (13) | (534) | ||||||||||||
Net loss - diluted | $ (25,757) | $ (8,893) | $ (39,609) | $ (8,887) | $ (19,222) | $ (45,644) | ||||||||
Weighted average shares outstanding - basic | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | ||||
Weighted average shares outstanding - diluted | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | ||||
Net loss per share - basic | $ (287) | [1] | $ (175) | [1] | $ (924) | [1] | $ (420) | [1] | $ (504) | $ (2,275,000) | ||||
Net loss per share - diluted | $ (987) | [1] | $ (175) | [1] | $ (1,715) | [1] | $ (448) | [1] | $ (504) | $ (2,275,000) | ||||
[1] | reflects a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018 and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Net Loss per Common Share - Ant
Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,037,316 | 15,491 | 9,957 | 21 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,643 | |||
Common Stock Warrants - Equity [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,005 | 6,005 | 21 | |
Common Stock Warrants - Liability [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,001,963 | 1,429 | 271 | |
Assumed Conversion of Series E and E-1 Preferred Stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,001,963 | |||
Assumed Conversion of Convertible Notes [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 31,747 | 8,057 | 3,681 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) $ in Millions | May 09, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Outstanding balance to vendor | $ 2.1 |
Description of Business - Addit
Description of Business - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
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, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||||||||||
Net loss | $ 7,519 | $ 5,959 | $ 7,894 | $ 8,880 | $ 6,658 | $ (7,185) | $ 21,371 | $ 8,353 | $ 19,222 | $ 45,117 |
Net cash used in operating activities | $ 18,322 | $ 12,894 | $ 14,732 | $ 15,398 |
Basis of Consolidated Financi_2
Basis of Consolidated Financial Statement Presentation - Additional Information (Details) - Common Stock [Member] | Dec. 24, 2019 | Oct. 22, 2019 | Sep. 17, 2019 | May 02, 2018 | Nov. 06, 2017 |
Stockholders Equity Note [Line Items] | |||||
Reverse stock split ratio | 0.01 | 0.002 | 0.0029 | ||
Reverse stock split | 1:100 | 1:500 | 1:350 | ||
Subsequent Event [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Reverse stock split ratio | 0.0014 | 0.01 | |||
Reverse stock split | 1:700 | 1:100 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | 12 Months Ended | |
Dec. 31, 2018DerivativeSegmentshares | Dec. 31, 2017Derivative | |
Summary Of Significant Accounting Policies [Line Items] | ||
Maximum period of investments with original maturities from date of acquisition to be cash equivalents | 3 months | |
Pre-funded penny warrants outstanding | shares | 0.1 | |
Number of business segments | Segment | 1 | |
Designated as Hedges [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Number of derivative instruments | Derivative | 0 | 0 |
Minimum [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, plant and equipment, estimated useful life | 3 years | |
Maximum [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, plant and equipment, estimated useful life | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Calculation of Net Loss and Number of Shares Used to Compute Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
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, 2017 | |||||
Accounting Policies [Abstract] | ||||||||||||||
Net (loss) income | $ (7,519) | $ (5,959) | $ (7,894) | $ (8,880) | $ (6,658) | $ 7,185 | $ (21,371) | $ (8,353) | $ (19,222) | $ (45,117) | ||||
Preferred stock dividends | (18,238) | (18,238) | (527) | |||||||||||
Net loss - diluted | $ (25,757) | $ (8,893) | $ (39,609) | $ (8,887) | $ (19,222) | $ (45,644) | ||||||||
Weighted average number of basic shares outstanding | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | ||||
Weighted average number of diluted shares outstanding | 26,112 | [1] | 51,229 | [1] | 23,095 | [1] | 19,841 | [1] | 38,151 | 21 | ||||
Basic (loss) income per common share | $ (287) | [1] | $ (175) | [1] | $ (924) | [1] | $ (420) | [1] | $ (504) | $ (2,275,000) | ||||
Diluted loss per common share | $ (987) | [1] | $ (175) | [1] | $ (1,715) | [1] | $ (448) | [1] | $ (504) | $ (2,275,000) | ||||
[1] | reflects a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018 and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | ||
Accounting Policies [Abstract] | |||
Weighted average shares issued | 3,913 | ||
Weighted average pre-funded warrants | 34,238 | ||
Weighted average shares outstanding | [1] | 38,151 | 21 |
[1] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017, a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Shares Excluded from the Computation of Diluted Earnings per Share (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,037,316 | 15,491 | 9,957 | 21 |
Common Stock Warrants - Equity [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,005 | 6,005 | 21 | |
Common Stock Warrants - Liability [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,001,963 | 1,429 | 271 | |
Assumed Conversion of Convertible Notes [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 31,747 | 8,057 | 3,681 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Restricted Cash [Abstract] | |||||
Cash and cash equivalents | $ 15,334 | $ 2,516 | $ 3,999 | ||
Convertible Notes | 238 | ||||
Letters of credit | 131 | 1,012 | 1,012 | ||
Security for credit cards | 50 | 50 | 75 | ||
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 15,515 | $ 3,578 | $ 9,975 | $ 5,324 | $ 31,696 |
Current Accrued Expenses - Sche
Current Accrued Expenses - Schedule of Current Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Clinical trial expenses | $ 2,590 | $ 4,530 | $ 869 |
Compensation, excluding taxes | 3,274 | 1,785 | 1,124 |
Professional fees | 190 | 221 | |
Short-term portion of lease restructuring | 184 | 209 | |
Other | 640 | 1,247 | 985 |
Total accrued expenses | $ 6,537 | 7,964 | $ 3,408 |
Scenario, Previously Reported [Member] | |||
Other | $ 1,275 |
Restructuring Expenses - Additi
Restructuring Expenses - Additional Information (Details) $ in Thousands | Aug. 18, 2014USD ($) | May 22, 2014USD ($) | Dec. 31, 2018USD ($)Lease | Dec. 31, 2017USD ($) |
Property Subject to Operating Lease [Member] | ||||
Restructuring Cost And Reserve [Line Items] | ||||
Number of sub leases | Lease | 2 | |||
Restructuring reserve balance | $ 396 | $ 604 | ||
Sub-lease 1 [Member] | Facility Closing [Member] | ||||
Restructuring Cost And Reserve [Line Items] | ||||
Restructuring reserve charges | $ 900 | |||
Sub Lease 2 [Member] | Facility Closing [Member] | ||||
Restructuring Cost And Reserve [Line Items] | ||||
Restructuring reserve charges | $ 700 | |||
Other non-current liabilities [Member] | Property Subject to Operating Lease [Member] | ||||
Restructuring Cost And Reserve [Line Items] | ||||
Restructuring reserve balance | 200 | |||
Accrued Expenses [Member] | Property Subject to Operating Lease [Member] | ||||
Restructuring Cost And Reserve [Line Items] | ||||
Restructuring reserve balance | $ 200 |
Restructuring Expenses - Schedu
Restructuring Expenses - Schedule of Restructuring and Related Costs (Details) - Lease Liability [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring reserve balance | $ 604 |
Payments/Utilizations | (208) |
Restructuring reserve balance | $ 396 |
Convertible Notes Payable - Add
Convertible Notes Payable - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Aug. 31, 2018 | Jul. 31, 2018 | Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 21, 2018 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | ||||||||||
Debt instrument, principal face amount | $ 4,500,000 | |||||||||
Debt discount on senior notes | 2,500,000 | |||||||||
Loss on issuance of financial instrument | $ 1,714,000 | $ 1,721,000 | $ 2,826,000 | 2,826,000 | $ 0 | |||||
Fair value of warrants being reclassified from liability to equity | 11,000 | 4,210,000 | ||||||||
Loss on debt extinguishment | $ 0 | $ 1,123,000 | 0 | $ (9,613,000) | ||||||
Notes payable maturity amount | $ 2,000,000 | |||||||||
Minimum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants | $ 7 | $ 7 | $ 7 | $ 857,500 | $ 197,225,000 | |||||
Maximum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants | $ 42 | $ 42 | 7,000 | $ 13,798,400,000 | $ 13,798,400,000 | |||||
June 2018 Series D Warrants [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of common shares issuable on cancellation of warrants | 6,005 | |||||||||
Warrants expiration period | 5 years | |||||||||
Warrants value | $ 5,100,000 | |||||||||
Debt discount on senior notes | 2,300,000 | |||||||||
Loss on issuance of financial instrument | $ 2,800,000 | |||||||||
June 2018 Series D Warrants [Member] | Minimum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants | $ 1,225 | |||||||||
June 2018 Series D Warrants [Member] | Maximum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants | $ 2,800 | |||||||||
June 2018 Pre-Funded Series D Warrants [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of common shares issuable on cancellation of warrants | 31,724 | 100,000 | ||||||||
Exercise price of warrants | $ 7 | |||||||||
Warrants expiration period | 5 years | |||||||||
Warrants exercisable period | Jul. 20, 2018 | |||||||||
Fair value of warrants being reclassified from liability to equity | $ 4,200,000 | |||||||||
June 2018 Pre-Funded Series D Warrants [Member] | Securities Purchase Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of common shares issuable on cancellation of warrants | 18,506 | |||||||||
June Two Thousand Eighteen and July Two Thousand Eighteen Notes [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument, conversion price | $ 1,225 | |||||||||
Percentage of subsequent financings used to repayment of notes payable | 50.00% | |||||||||
Minimum percentage of change in cash flows | 10.00% | |||||||||
Loss on debt extinguishment | $ 1,100,000 | |||||||||
July Two Thousand Eighteen Pre Funded Series D Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of common shares issuable on cancellation of warrants | 22,640 | |||||||||
July Two Thousand Eighteen Pre Funded Series D Warrants | Second Securities Purchase Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of common shares issuable on cancellation of warrants | 13,207 | |||||||||
Senior Secured Convertible Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 8.00% | |||||||||
Debt instrument, principal face amount | $ 9,400,000 | |||||||||
Debt instrument, conversion price | $ 1,225 | |||||||||
Debt instrument maturity start date | Dec. 31, 2018 | Dec. 31, 2018 | ||||||||
Debt instrument maturity end date | Mar. 31, 2021 | Mar. 31, 2021 | ||||||||
August 2018 Convertible Note [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Notes payable maturity amount | $ 2,500 |
Convertible Notes Payable - Sch
Convertible Notes Payable - Schedule of Inputs Used to Value the Series D Warrants (Details) | Sep. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 |
June 2018 Series D Warrants [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years | |||
June 2018 Pre-Funded Series D Warrants [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years | |||
Contractual Term [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years | |||
Contractual Term [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 1 year 1 month 6 days | 9 months 25 days | ||
Contractual Term [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years 1 month 6 days | 4 years 10 months 17 days | ||
Contractual Term [Member] | June 2018 Series D Warrants [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years | |||
Contractual Term [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 5 years 6 months | |||
Contractual Term [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Contractual life | 6 years 6 months | |||
Expected Volatility [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 2.018 | |||
Expected Volatility [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 1.457 | 1.309 | ||
Expected Volatility [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 2.653 | 2.669 | ||
Expected Volatility [Member] | June 2018 Series D Warrants [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 1.9410 | |||
Expected Volatility [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 2.150 | |||
Expected Volatility [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 3.890 | |||
Risk-free Interest Rates [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.016 | |||
Risk-free Interest Rates [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.025 | 0.017 | ||
Risk-free Interest Rates [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.026 | 0.021 | ||
Risk-free Interest Rates [Member] | June 2018 Series D Warrants [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.0278 | |||
Risk-free Interest Rates [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.0213 | |||
Risk-free Interest Rates [Member] | June 2018 Pre-Funded Series D Warrants [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Warrants measurement input | 0.0230 |
Convertible Notes Payable - Sum
Convertible Notes Payable - Summary of Notes by Maturity Dates (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Principal | $ 4.5 | |
Unamortized discount | (2.5) | |
Carrying value | $ 2 | |
December 4, 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2018 | Dec. 4, 2018 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 1.7 | |
Carrying value | $ 1.7 | |
March 1, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2019 | Mar. 1, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.6 | |
Unamortized discount | (0.5) | |
Carrying value | $ 0.1 | |
March 21, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2019 | Mar. 21, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.4 | |
Unamortized discount | (0.2) | |
Carrying value | $ 0.2 | |
December 4, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2019 | Dec. 4, 2019 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.9 | |
Unamortized discount | $ (0.9) | |
March 1, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2020 | Mar. 1, 2020 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.8 | |
Unamortized discount | $ (0.8) | |
March 21, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2020 | Mar. 21, 2020 |
Interest rate | 8.00% | |
Conversion price | $ 1,225 | |
Principal | $ 0.1 | |
Unamortized discount | $ (0.1) |
Stockholders' Equity - February
Stockholders' Equity - February 2018 Financing - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | |||||
Sep. 30, 2018shares | Feb. 28, 2018USD ($)$ / sharesshares | Sep. 30, 2019shares | Dec. 31, 2018$ / sharesshares | Dec. 31, 2017shares | Dec. 31, 2016shares | |
Stockholders Equity Note [Line Items] | ||||||
Sale of common stock, net of expenses (in shares) | 6,669 | 606 | ||||
Number of pre-funded warrants | 109 | |||||
Net proceeds from issuance of private placement | $ | $ 4.3 | |||||
Number of warrants outstanding (in shares) | 1,002,024 | 93,835 | 20 | 1 | ||
Contractual Term [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 5 years | |||||
Volatility [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 2.018 | |||||
Risk Free Rate [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.016 | |||||
February 2018 Warrants [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants issued to purchase Common Stock | 429 | |||||
Value of warrants issued | $ | $ 18.3 | |||||
Warrants exercisable per share price (in dollars per share) | $ / shares | $ 7,000 | |||||
Number of warrants outstanding (in shares) | 273 | |||||
February 2018 Warrants [Member] | Exercise Price [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | $ / shares | 7,000 | |||||
February 2018 Warrants [Member] | Contractual Term [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 6 years | |||||
February 2018 Warrants [Member] | Volatility [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 1.2268 | |||||
February 2018 Warrants [Member] | Risk Free Rate [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.01 |
Stockholders' Equity - Septembe
Stockholders' Equity - September 2018 Rights Offering - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | |
Sep. 30, 2018 | Feb. 28, 2018 | |
Stockholders Equity Note [Abstract] | ||
Sale of common stock, net of expenses (in shares) | 6,669 | 606 |
Net proceeds from issuance of common stock | $ 7 |
Stockholders' Equity - December
Stockholders' Equity - December 2018 Warrant Exchange - Additional Information (Details) - shares | 1 Months Ended | |
Apr. 30, 2019 | Dec. 31, 2018 | |
Exchange Agreement [Member] | ||
Stockholders Equity Note [Line Items] | ||
Shares of common stock issued to investors | 92 | 1,179 |
Stockholders' Equity - Pre-Fund
Stockholders' Equity - Pre-Funded Series D Warrant Exercises - Additional Information (Details) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 21, 2018 | |
Stockholders Equity Note [Line Items] | ||||
Warrants exercised | 11,285 | 6,536 | 1 | |
Pre-Funded Series D Warrants [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Warrants exercised | 5,379 | |||
Pre-Funded Series D Warrants [Member] | Maximum [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Maximum offering and selling of stock and securities that entity make to raise capital | $ 100 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 01, 2019 | May 02, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of Shares, Granted | 1,782 | |||||
Shares available for grant | 0 | |||||
Stock option compensation income | $ 199 | $ (40) | $ (40) | $ 50 | ||
Restricted stock compensation expense | $ 4 | $ 35 | 98 | 79 | ||
Stock Options [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted average grant date fair value | $ 0.259 | |||||
Stock option compensation income | (40) | (50) | ||||
Restricted Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Restricted stock compensation expense | $ 100 | $ 100 | ||||
Common Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of Shares, Granted | 0 | |||||
2019 Equity Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares available for grant | 502 | |||||
2019 Equity Incentive Plan [Member] | Subsequent Event [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares available for grant | 2,142 | |||||
Stock option expiration term | 10 years | |||||
Stock option expiration date | Feb. 1, 2029 | |||||
2019 Equity Incentive Plan [Member] | Subsequent Event [Member] | One Month Anniversary of Grant Date [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock option vesting period | 1 year | |||||
2019 Equity Incentive Plan [Member] | Common Stock [Member] | Subsequent Event [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of Shares, Granted | 1,782 | |||||
Weighted average grant date fair value | $ 196.70 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Warrant Activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Warrants outstanding [Roll Forward] | ||||
Outstanding, beginning of period (in shares) | 93,835 | 20 | 1 | |
Warrants issued (in shares) | 1,001,995 | 21 | ||
Warrants exercised (in shares) | (11,285) | (6,536) | (1) | |
Exchanged (in shares) | (82,521) | |||
Warrants expired (in shares) | (1) | (1) | ||
Outstanding, end of period (in shares) | 1,002,024 | 93,835 | 20 | 1 |
Warrants, Weighted Average Exercise Price [Roll Forward] | ||||
Outstanding, beginning of period (in dollars per share) | $ 150.67 | $ 4,868,205,366 | $ 637,218,564 | |
Warrants issued (in dollars per share) | 42 | 1,610,000 | ||
Exchanged (in dollars per share) | 170.31 | |||
Warrants exercised (in dollars per share) | 7 | 1,252 | 2,954,000 | |
Warrants expired (in dollars per share) | 13,798,400,000 | 591,675,000 | ||
Outstanding, end of period (in dollars per share) | $ 42 | $ 150.67 | $ 4,868,205,366 | $ 637,218,564 |
Weighted average remaining life | 5 years 18 days | 5 years 9 months | 4 years 10 months 17 days | 5 years 7 months 2 days |
Minimum [Member] | ||||
Warrants, Exercise Price per Share [Roll Forward] | ||||
Outstanding, (in dollars per share) | $ 7 | $ 7 | $ 857,500 | $ 197,225,000 |
Maximum [Member] | ||||
Warrants, Exercise Price per Share [Roll Forward] | ||||
Outstanding, (in dollars per share) | $ 42 | $ 7,000 | $ 13,798,400,000 | $ 13,798,400,000 |
February 2018 Warrants [Member] | ||||
Warrants outstanding [Roll Forward] | ||||
Outstanding, beginning of period (in shares) | 273 | |||
Warrants issued (in shares) | 1,538 | |||
Outstanding, end of period (in shares) | 273 | |||
Warrants, Exercise Price per Share [Roll Forward] | ||||
Outstanding, (in dollars per share) | $ 7,000 | |||
Warrants, Weighted Average Exercise Price [Roll Forward] | ||||
Warrants issued (in dollars per share) | $ 6,531 | |||
Convertible Notes [Member] | ||||
Warrants outstanding [Roll Forward] | ||||
Warrants issued (in shares) | 98,814 | |||
Warrants, Weighted Average Exercise Price [Roll Forward] | ||||
Warrants issued (in dollars per share) | $ 126 |
Derivative Financial Instrume_3
Derivative Financial Instruments - Schedule of Fair Value of Warrants (Details) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 5 years | ||
Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 2.018 | ||
Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.016 | ||
Minimum [Member] | Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 1 year 1 month 6 days | 9 months 25 days | |
Minimum [Member] | Contractual Term [Member] | Scenario, Previously Reported [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 1 year 1 month 17 days | ||
Minimum [Member] | Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 1.457 | 1.309 | |
Minimum [Member] | Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.025 | 0.017 | |
Maximum [Member] | Contractual Term [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 5 years 1 month 6 days | 4 years 10 months 17 days | |
Maximum [Member] | Contractual Term [Member] | Scenario, Previously Reported [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants expiration period | 5 years 1 month 9 days | ||
Maximum [Member] | Expected Volatility [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 2.653 | 2.669 | |
Maximum [Member] | Risk-free Interest Rates [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants measurement input | 0.026 | 0.021 |
Derivative Financial Instrume_4
Derivative Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Derivative Instruments Liabilities [Member] - Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Liabilities [Abstract] | |||
Total Liabilities | $ 20,410 | $ 33 | $ 560 |
Level 3 [Member] | |||
Liabilities [Abstract] | |||
Total Liabilities | $ 20,410 | $ 33 | $ 560 |
Derivative Financial Instrume_5
Derivative Financial Instruments - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) [Roll Forward] | |||
Beginning balance | $ 33 | $ 560 | $ 18,751 |
Total change in the liability included in earnings | (456) | (19,706) | (15,103) |
Extinguishment of convertible note warrant | (17,489) | ||
Fair value of warrants issued | 20,844 | 23,533 | 16,953 |
Fair value of warrants exercised | (2,552) | ||
Reclass from liability to equity | (11) | (4,210) | |
Fair vaue of warrants exchanged | (144) | ||
Ending balance | $ 20,410 | $ 33 | $ 560 |
Commitments - Additional Inform
Commitments - Additional Information (Details) | Apr. 18, 2019USD ($) | Jul. 27, 2018USD ($) | Jan. 31, 2019USD ($)ft² | Sep. 30, 2018USD ($)ft² | Dec. 31, 2018USD ($)ft² | Dec. 31, 2017USD ($) | May 09, 2018USD ($) |
Operating Leased Assets [Line Items] | |||||||
Rent expense, net of receipts under the terms of subleases | $ 600,000 | $ 600,000 | |||||
Outstanding balance to vendor | $ 2,100,000 | ||||||
Minimum [Member] | Securities Purchase Agreement [Member] | Hudson Bay [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Claims for monetary damages | $ 1,000,000 | ||||||
Subsequent Event [Member] | Settlement Agreement [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Litigation settlement agreement date | April 18, 2019 | ||||||
Litigation settlement, agreed to pay amount to defendants | $ 400,000 | ||||||
Subsequent Event [Member] | Settlement Agreement [Member] | Maximum [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Settlement fees | $ 50,000 | ||||||
Office Space at 810 Seventh Avenue, New York, NY [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Square footage of office space (in square feet) | ft² | 8,629 | ||||||
Expansion option, additional square footage of office space (in square feet) | ft² | 8,629 | ||||||
Letter of credit [Abstract] | |||||||
Minimum letter of credit amount required to be maintained under lease agreement | $ 900,000 | ||||||
Expiration date of letter of credit | Feb. 28, 2021 | ||||||
Office Space in New York, NY, Lease Amendment [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Additional square footage of office space leased under exercise of option right (in square feet) | ft² | 8,629 | ||||||
Lease expiration date | Mar. 31, 2021 | ||||||
Office Space in New York, NY, Initial Lease and Lease Amendment [Member] | Year 4 [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Annual base rent | $ 1,000,000 | ||||||
Office Space in New York, NY, Initial Lease and Lease Amendment [Member] | Year 5 [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Annual base rent | 1,000,000 | ||||||
Office Space in New York, NY, Initial Lease and Lease Amendment [Member] | Years Thereafter [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Annual base rent | $ 1,200,000 | ||||||
Delcath's European Headquarters Lease Agreement [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Square footage of office space (in square feet) | ft² | 19,200 | ||||||
Annual base rent | $ 200,000 | ||||||
Operating lease term | 10 years | ||||||
Office Space At 1633 Broadway, New York, NY [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Square footage of office space (in square feet) | ft² | 6,877 | ||||||
Annual base rent | $ 500,000 | ||||||
Letter of credit [Abstract] | |||||||
Minimum letter of credit amount required to be maintained under lease agreement | $ 100,000 | ||||||
Expiration date of letter of credit | Feb. 28, 2021 | ||||||
Park Road Lease Agreement [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Lease expiration date | Nov. 30, 2020 | ||||||
Operating lease term | 2 years | ||||||
Park Road Lease Agreement [Member] | Subsequent Event [Member] | |||||||
Operating Leased Assets [Line Items] | |||||||
Square footage of office space (in square feet) | ft² | 6,000 | ||||||
Annual base rent | $ 50,000 |
Commitments - Schedule Future M
Commitments - Schedule Future Minimum Lease Payments, Net of Receipts Due Under Terms of Subleases Under All Operating Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Future minimum lease payments under all operating leases [Abstract] | |
2019 | $ 885 |
2020 | 916 |
2021 | 348 |
Total future minimum payments due | $ 2,149 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments [Abstract] | ||
Domestic | $ (12,961) | $ (41,313) |
Foreign | (6,261) | (3,804) |
Income (loss) before taxes | $ (19,222) | $ (45,117) |
Income Taxes - Income tax recon
Income Taxes - Income tax reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Provision for income taxes [Abstract] | ||
Income taxes using U.S federal statutory rate | $ (4,037) | $ (15,340) |
Tax Cuts and Jobs Act | 143 | |
Nondeductible interest | 2,273 | 6,912 |
Loss on extinguishment of debt | 236 | 10,174 |
Loss of tax benefit of federal net operating loss carryforwards | (588) | 5,067 |
Loss of tax benefit of state net operating loss carryforwards | 1,040 | 1,373 |
Loss of tax benefit of federal tax credit carryforwards | 495 | 324 |
Amortization of gain on IP migration | 767 | |
State income taxes, net of federal benefit | (2,355) | (1,339) |
Foreign rate differential | 1,166 | 1,196 |
Valuation allowance | 6,323 | (1,423) |
Derivative charge | (4,138) | (8,403) |
Stock option exercises and cancellations | 215 | 841 |
Research and development costs | (636) | (295) |
Other | $ 6 | $ 3 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | |||
Employee compensation accruals | $ 292 | ||
Accrued liabilities | $ 519 | 353 | |
Research tax credits | 161 | 17 | |
Other | 60 | 34 | |
Net operating losses | 10,624 | 5,289 | |
Total deferred tax assets | 11,364 | 5,985 | |
Deferred tax liabilities: | |||
Other | 13 | ||
Total deferred tax liabilities | 0 | 13 | |
Valuation allowance | 11,364 | 5,972 | $ 7,094 |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||
Percentage of valuation allowance against deferred tax assets | 100.00% | |
Decrease in deferred tax assets valuation allowance | $ 5,400,000 | $ 1,100,000 |
U.S. corporate income tax rate | 21.00% | 34.00% |
Provisional income tax due to reduction in deferred tax assets | $ 143,500 | |
New York State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | $ 157,200,000 | |
New York City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | $ 141,500,000 | |
Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 1998 | |
Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2018 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 230,000,000 | 211,300,000 |
Operating loss carryforwards, annual limitation | 27,500 | |
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | 208,100,000 | |
Operating loss carryforwards available for offset future taxable income | 21,900,000 | |
Operating loss carryforwards for unlimited period | 20,200,000 | |
Federal [Member] | Expire Between 2019 and 2037 [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards available for offset future taxable income | $ 1,700,000 | |
Federal [Member] | Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration dates | 2019 | |
Federal [Member] | Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration dates | 2037 | |
Federal [Member] | Research and Development Tax Credit Carryforwards [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 5,000,000 | 4,300,000 |
Tax credit carryforwards, expiration dates | 2038 | |
Tax credit carryforwards expected to expire unutilized | $ 200,000 | |
State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 10,100,000 | 10,100,000 |
Operating loss carryforwards, expiration dates | 2038 | |
Foreign [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 25,200,000 | 25,000,000 |
Federal and State [Member] | Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2015 | |
Federal and State [Member] | Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax period | Dec. 31, 2018 | |
Minimum [Member] | State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 27,300,000 | $ 27,300,000 |
Maximum [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
U.S. corporate income tax rate | 35.00% | |
Maximum [Member] | State and City [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 167,300,000 | $ 150,300,000 |
Income Taxes - Summary of Chang
Income Taxes - Summary of Change in Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Beginning balance | $ 5,972 | $ 7,094 |
Charged to costs and expenses | 6,323 | (1,423) |
Charged to retained earnings | (834) | |
Charged to other comprehensive income | (97) | 301 |
Ending balance | $ 11,364 | $ 5,972 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | Dec. 24, 2019$ / shares | Oct. 22, 2019$ / shares | Sep. 17, 2019$ / shares | Mar. 29, 2019USD ($) | Mar. 29, 2019USD ($) | May 02, 2018 | Nov. 06, 2017 | Nov. 14, 2019shares | May 23, 2019USD ($) | Dec. 31, 2017$ / sharesshares | Sep. 30, 2019$ / shares | Jun. 06, 2019USD ($)shares | Jan. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / shares |
Subsequent Event [Line Items] | ||||||||||||||
Debt instrument, principal face amount | $ 4,500,000 | |||||||||||||
Common stock par value per share | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||
Pre-Funded Series D Warrants [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Number of common shares issuable on cancellation of warrants | shares | 100,000 | |||||||||||||
Series D Warrants [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Number of common shares issuable on cancellation of warrants | shares | 5,605 | |||||||||||||
Series D Preferred Shares [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Preferred stock, stated value | $ 1,160,000 | $ 1,160,000 | ||||||||||||
Issuance of senior secured promissory note in exchange of preferred stock | $ 1,560,000 | $ 1,560,000 | ||||||||||||
Interest rate on promissory note | 8.00% | 8.00% | ||||||||||||
Maturity date | Apr. 1, 2020 | |||||||||||||
Subsequent Event [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Common stock subscription price per share | $ / shares | $ 1,225 | |||||||||||||
Interest rate on promissory note | 8.00% | 8.00% | ||||||||||||
Aggregate borrowed amount | $ 3,300,000 | |||||||||||||
Debt instrument, principal face amount | $ 3,300,000 | $ 2,000,000 | ||||||||||||
Maturity period | 6 months | |||||||||||||
Common stock par value per share | $ / shares | $ 0.01 | |||||||||||||
Subsequent Event [Member] | Pre-Funded Series D Warrants [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Number of common shares issuable on cancellation of warrants | shares | 11,285 | |||||||||||||
Number of warrants available for cancellation | shares | 100,000 | |||||||||||||
Subsequent Event [Member] | Series D Warrants [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Number of warrants available for cancellation | shares | 5,605 | |||||||||||||
Subsequent Event [Member] | Series D Preferred Shares [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Preferred stock, stated value | $ 1,160,000 | $ 1,160,000 | ||||||||||||
Proceeds from exchanage of preferred stock | 400,000 | |||||||||||||
Issuance of senior secured promissory note in exchange of preferred stock | $ 1,560,000 | $ 1,560,000 | ||||||||||||
Interest rate on promissory note | 8.00% | 8.00% | ||||||||||||
Maturity date | Apr. 1, 2020 | |||||||||||||
Subsequent Event [Member] | Maximum [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Common stock subscription price | $ 50,000,000 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Reverse stock split ratio | 0.01 | 0.002 | 0.0029 | |||||||||||
Issuance of common stock and rights for payments made in shares on convertible notes payable (in shares) | shares | 375 | |||||||||||||
Common Stock [Member] | Maximum [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Reverse stock split ratio | 0.0008 | |||||||||||||
Common Stock [Member] | Minimum [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Reverse stock split ratio | 0.02 | |||||||||||||
Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Common stock par value per share | $ / shares | $ 0.01 | |||||||||||||
Reverse stock split ratio | 0.0014 | 0.01 | ||||||||||||
Common Stock [Member] | Subsequent Event [Member] | Series E and E1 Preferred Stock [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of common stock and rights for payments made in shares on convertible notes payable (in shares) | shares | 3,700,000 |