(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (IRS Employer Identification No.) |
Title of each class | Trading | Name of each exchange | ||||||||||||
symbol(s) | on which registered | |||||||||||||
The |
Exhibit No. | Description | |||||||
99.1 | ||||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
DELCATH SYSTEMS, INC. | |||||||||||
Date: November 13, 2023 | By: | /s/ Gerard Michel | |||||||||
Name: Gerard Michel | |||||||||||
Title: Chief Executive Officer |
September 30, 2023 | December 31, 2022 | ||||||||||
Assets | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | 40,462 | $ | 7,671 | |||||||
Restricted cash | 50 | 4,151 | |||||||||
Accounts receivable, net | 205 | 366 | |||||||||
Inventory | 2,667 | 1,998 | |||||||||
Prepaid expenses and other current assets | 2,712 | 1,969 | |||||||||
Total current assets | 46,096 | 16,155 | |||||||||
Property, plant and equipment, net | 1,374 | 1,422 | |||||||||
Right-of-use assets | 107 | 285 | |||||||||
Total assets | $ | 47,577 | $ | 17,862 | |||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | 753 | $ | 2,018 | |||||||
Accrued expenses | 5,230 | 4,685 | |||||||||
Lease liabilities, current | 35 | 186 | |||||||||
Loan payable, current | 5,080 | 7,846 | |||||||||
Convertible notes payable, current | 2,876 | — | |||||||||
Total current liabilities | 13,974 | 14,735 | |||||||||
Warrant liability | 5,773 | — | |||||||||
Other liabilities, non-current | 1,111 | 1,144 | |||||||||
Loan payable, non-current | — | 3,070 | |||||||||
Convertible notes payable, non-current | 2,000 | 4,772 | |||||||||
Total liabilities | 22,858 | 23,721 | |||||||||
Commitments and contingencies | |||||||||||
Stockholders’ equity (deficit) | |||||||||||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 37,787 and 11,357 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | — | — | |||||||||
Common stock, $.01 par value; 80,000,000 shares authorized; 19,688,991 shares and 10,046,571 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 197 | 100 | |||||||||
Additional paid-in capital | 518,607 | 451,608 | |||||||||
Accumulated deficit | (494,026) | (457,484) | |||||||||
Accumulated other comprehensive loss | (59) | (83) | |||||||||
Total stockholders’ equity (deficit) | 24,719 | (5,859) | |||||||||
Total liabilities and stockholders’ equity | $ | 47,577 | $ | 17,862 |
Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Product revenue | $ | 434 | $ | 906 | $ | 1,526 | $ | 1,909 | |||||||||||||||
Other revenue | — | — | — | 171 | |||||||||||||||||||
Total revenues | 434 | 906 | 1,526 | 2,080 | |||||||||||||||||||
Cost of goods sold | (133) | (235) | (464) | (449) | |||||||||||||||||||
Gross profit | 301 | 671 | 1,062 | 1,631 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development expenses | 4,662 | 4,065 | 12,793 | 14,152 | |||||||||||||||||||
Selling, general and administrative expenses | 6,195 | 4,779 | 15,147 | 13,477 | |||||||||||||||||||
Total operating expenses | 10,857 | 8,844 | 27,940 | 27,629 | |||||||||||||||||||
Operating loss | (10,556) | (8,173) | (26,878) | (25,998) | |||||||||||||||||||
Change in fair value of warrant liability | (9,384) | — | (8,224) | — | |||||||||||||||||||
Interest expense, net | (395) | (730) | (1,454) | (2,040) | |||||||||||||||||||
Other income (expense) | (5) | 26 | 14 | 2 | |||||||||||||||||||
Net loss | (20,340) | (8,877) | (36,542) | (28,036) | |||||||||||||||||||
Other comprehensive income: | |||||||||||||||||||||||
Foreign currency translation adjustments | 5 | (46) | 24 | (82) | |||||||||||||||||||
Total other comprehensive loss | $ | (20,335) | $ | (8,923) | $ | (36,518) | $ | (28,118) | |||||||||||||||
Common share data: | |||||||||||||||||||||||
Basic and diluted loss per common share | $ | (1.14) | $ | (0.96) | $ | (2.61) | $ | (3.29) | |||||||||||||||
Weighted average number of basic and diluted shares outstanding | 17,863,078 | 9,215,786 | 13,985,248 | 8,536,006 |
Cover |
Nov. 13, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Document Period End Date | Nov. 13, 2023 |
Entity Registrant Name | DELCATH SYSTEMS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity File Number | 001-16133 |
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 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, $.01 par value |
Trading Symbol | DCTH |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Amendment Flag | false |
Entity Central Index Key | 0000872912 |
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