Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 08, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | DELCATH SYSTEMS, INC. | |
Entity Central Index Key | 0000872912 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes | |
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 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,597,682 | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Trading Symbol | DCTH | |
Title of 12(b) Security | Common stock, $0.01 par value per share | |
Document Fiscal Period Focus | Q2 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 10,203 | $ 22,802 |
Restricted cash | 4,151 | 4,151 |
Accounts receivable, net | 438 | 44 |
Inventories | 2,040 | 1,412 |
Prepaid expenses and other current assets | 2,370 | 2,743 |
Total current assets | 19,202 | 31,152 |
Property, plant and equipment, net | 1,457 | 1,348 |
Right-of-use assets | 407 | 624 |
Total assets | 21,066 | 33,124 |
Current liabilities | ||
Accounts payable | 2,067 | 638 |
Accrued expenses | 5,417 | 4,109 |
Deferred revenue | 0 | 170 |
Lease liabilities | 294 | 416 |
Loan payable, current | 4,474 | 621 |
Total current liabilities | 12,252 | 5,954 |
Lease liabilities, non-current | 113 | 207 |
Loan payable, non-current | 6,838 | 10,372 |
Convertible notes payable, non-current | 4,709 | 4,639 |
Total liabilities | 23,912 | 21,172 |
Commitments and contingencies | ||
Stockholders' equity (Deficit) | ||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 11,357 shares issued and outstanding at June 30, 2022 and December 31, 2021 | ||
Common stock, $.01 par value; 40,000,000 shares authorized; 7,906,728 shares issued and outstanding at June 30, 2022 and December 31, 2021 | 79 | 79 |
Additional paid-in capital | 435,922 | 432,831 |
Accumulated deficit | (438,836) | (420,976) |
Accumulated other comprehensive (loss) income | (11) | 18 |
Total stockholders' equity (deficit) | (2,846) | 11,952 |
Total liabilities and stockholders' equity | $ 21,066 | $ 33,124 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 11,357 | 11,357 |
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Common stock, shares issued (in shares) | 7,906,728 | 7,906,728 |
Common stock, shares outstanding (in shares) | 7,906,728 | 7,906,728 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Cost of goods sold | $ (180) | $ (202) | $ (214) | $ (314) |
Gross profit | 617 | 334 | 960 | 610 |
Operating expenses: | ||||
Research and development expenses | 5,456 | 3,497 | 9,696 | 7,204 |
Selling, general and administrative expenses | 4,145 | 3,288 | 7,791 | 6,584 |
Total operating expenses | 9,601 | 6,785 | 17,487 | 13,788 |
Operating loss | (8,984) | (6,451) | (16,527) | (13,178) |
Interest expense, net | (665) | (40) | (1,309) | (81) |
Other (loss) income | (8) | 61 | (24) | 82 |
Net loss | (9,657) | (6,430) | (17,860) | (13,177) |
Other comprehensive income: | ||||
Foreign currency translation adjustments | (31) | (61) | (29) | 33 |
Total other comprehensive loss | $ (9,688) | $ (6,491) | $ (17,889) | $ (13,144) |
Common share data: | ||||
Basic loss per common share | $ (1.18) | $ (0.96) | $ (2.18) | $ (2) |
Diluted loss per common share | $ (1.18) | $ (0.96) | $ (2.18) | $ (2) |
Weighted average number of basic shares outstanding | 8,190,483 | 6,681,369 | 8,190,483 | 6,589,655 |
Weighted average number of diluted shares outstanding | 8,190,483 | 6,681,369 | 8,190,483 | 6,589,655 |
Product Revenue [Member] | ||||
Revenue | $ 797 | $ 398 | $ 1,003 | $ 659 |
Other Revenue [Member] | ||||
Revenue | $ 0 | $ 138 | $ 171 | $ 265 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Preferred Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2020 | $ 22,078 | $ 60 | $ 417,449 | $ (395,327) | $ (104) | |
Balance (in shares) at Dec. 31, 2020 | 5,996,101 | 20,631 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 2,148 | 2,148 | ||||
Shares settled for services | 57 | 57 | ||||
Shares settled for services (in shares) | 2,636 | |||||
Conversion of Preferred stock into common stock (in shares) | 15,000 | (150) | ||||
Exercise of warrants into common stock | 2,376 | $ 3 | 2,373 | |||
Exercise of warrants into common stock (in shares) | 237,520 | |||||
Net loss | (6,747) | (6,747) | ||||
Total comprehensive income | 94 | 94 | ||||
Balance at Mar. 31, 2021 | 20,006 | $ 63 | 422,027 | (402,074) | (10) | |
Balance (in shares) at Mar. 31, 2021 | 6,251,257 | 20,481 | ||||
Balance at Dec. 31, 2020 | 22,078 | $ 60 | 417,449 | (395,327) | (104) | |
Balance (in shares) at Dec. 31, 2020 | 5,996,101 | 20,631 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (13,177) | |||||
Balance at Jun. 30, 2021 | 15,159 | $ 74 | 423,660 | (408,504) | (71) | |
Balance (in shares) at Jun. 30, 2021 | 7,349,777 | 11,707 | ||||
Balance at Mar. 31, 2021 | 20,006 | $ 63 | 422,027 | (402,074) | (10) | |
Balance (in shares) at Mar. 31, 2021 | 6,251,257 | 20,481 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 1,626 | 1,626 | ||||
Conversion of preferred stock into common stock | 1 | $ 9 | (8) | |||
Conversion of Preferred stock into common stock (in shares) | 877,379 | (8,774) | ||||
Exercise of warrants into common stock | 17 | $ 2 | 15 | |||
Exercise of warrants into common stock (in shares) | 221,141 | |||||
Net loss | (6,430) | (6,430) | ||||
Total comprehensive income | (61) | (61) | ||||
Balance at Jun. 30, 2021 | 15,159 | $ 74 | 423,660 | (408,504) | (71) | |
Balance (in shares) at Jun. 30, 2021 | 7,349,777 | 11,707 | ||||
Balance at Dec. 31, 2021 | 11,952 | $ 79 | 432,831 | (420,976) | 18 | |
Balance (in shares) at Dec. 31, 2021 | 7,906,728 | 11,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 1,474 | 1,474 | ||||
Net loss | (8,203) | (8,203) | ||||
Total comprehensive income | 2 | 2 | ||||
Balance at Mar. 31, 2022 | 5,225 | $ 79 | 434,305 | (429,179) | 20 | |
Balance (in shares) at Mar. 31, 2022 | 7,906,728 | 11,357 | ||||
Balance at Dec. 31, 2021 | 11,952 | $ 79 | 432,831 | (420,976) | 18 | |
Balance (in shares) at Dec. 31, 2021 | 7,906,728 | 11,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (17,860) | |||||
Balance at Jun. 30, 2022 | (2,846) | $ 79 | 435,922 | (438,836) | (11) | |
Balance (in shares) at Jun. 30, 2022 | 7,906,728 | 11,357 | ||||
Balance at Mar. 31, 2022 | 5,225 | $ 79 | 434,305 | (429,179) | 20 | |
Balance (in shares) at Mar. 31, 2022 | 7,906,728 | 11,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 1,617 | 1,617 | ||||
Net loss | (9,657) | (9,657) | ||||
Total comprehensive income | (31) | (31) | ||||
Balance at Jun. 30, 2022 | $ (2,846) | $ 79 | $ 435,922 | $ (438,836) | $ (11) | |
Balance (in shares) at Jun. 30, 2022 | 7,906,728 | 11,357 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||||
Net loss | $ (9,657) | $ (6,430) | $ (17,860) | $ (13,177) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Stock option compensation expense | 3,091 | 3,774 | ||
Depreciation expense | 31 | 78 | ||
Non-cash lease expense | 234 | 0 | ||
Amortization of debt discount | 380 | |||
Interest expense accrued related to convertible notes | 80 | 79 | ||
Changes in assets and liabilities: | ||||
Decrease in prepaid expenses and other assets | 374 | 485 | ||
Increase in accounts receivable | (394) | (17) | ||
Increase in inventories | (628) | (366) | ||
Increase (decrease) in accounts payable and accrued expenses | 2,667 | (2,036) | ||
Decrease in lease liabilities | (217) | (155) | ||
Decrease in deferred revenue | (170) | (334) | ||
Net cash used in operating activities | (12,412) | (11,669) | ||
Cash flows from investing activities: | ||||
Purchase of property, plant and equipment | (141) | (88) | ||
Net cash used in investing activities | (141) | (88) | ||
Cash flows from financing activities: | ||||
Net proceeds from the exercise of warrants | 2,393 | |||
Net cash provided by financing activities | 2,393 | |||
Foreign currency effects on cash | (46) | 33 | ||
Net decrease in total cash | (12,599) | (9,331) | ||
Total Cash: | ||||
Beginning of period | 26,953 | 28,756 | ||
End of period | 14,354 | 19,425 | 14,354 | 19,425 |
Cash | 10,203 | 19,274 | 10,203 | 19,274 |
Restricted Cash | 4,151 | 151 | 4,151 | 151 |
Total | $ 14,354 | $ 19,425 | 14,354 | 19,425 |
Supplemental Disclosure of Cash Flow Information: | ||||
Interest expense | $ 842 | 4 | ||
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||||
Issuance of restricted stock for accrued fees due to a former board member | 57 | |||
Conversions of preferred stock into common stock | $ 9 |
General
General | 6 Months Ended |
Jun. 30, 2022 | |
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 six months ended June 30, 2022 and 2021 should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K Description of Business The Company is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company’s lead product candidate, the HEPZATO ® ® The Company’s clinical development program for HEPZATO 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 metastatic ocular melanoma, or mOM. The Company is currently reviewing the incidence, unmet need, available efficacy data and development requirements for a broad set of liver cancers in order to select a portfolio of follow-on In the United States, HEPZATO is considered a combination drug and device product regulated by the Food and Drug Administration (“FDA”). Primary jurisdiction for regulation of HEPZATO has been assigned to the FDA’s Center for Drug Evaluation and Research. The FDA has granted the Company six orphan drug designations (five for melphalan in ocular melanoma, cutaneous melanoma, cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the hepatocellular carcinoma indication). In December 2021, the Company announced that the FOCUS Trial of HEPZATO met its pre-specified pre-NDA pre-clinical re-file On February 28, 2022, CHEMOSAT received Medical Device Regulation certification under the European Medical Devices Regulation [2017/745/EU], which may be considered by jurisdictions when evaluating reimbursement. As of March 1, 2022, the Company has assumed direct responsibility for sales, marketing and distribution of CHEMOSAT in Europe. Risks and Uncertainties Although the Company is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. In addition, at this time, although the Company is not aware of any direct impacts, the increase in COVID cases and associated restrictions, which could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. The rise in COVID cases and the associated absences from work of internal and external resources may also impact the Company’s ability to meet anticipated timelines. Liquidity and Going Concern 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 significant losses and has an accumulated deficit of $438.8 million as of June 30, 2022. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the “Common Stock”) and 566,751 pre-funded “Pre-Funded Pre-Funded Pre-Funded Pre-Funded 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 the Company 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 its 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 the Company 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 interim condensed 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. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. 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. 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 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 June 30, 2022 and 2021; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K Significant Accounting Policies There have been no material changes to our significant accounting policies as set forth in Note 3 Summary of Significant Accounting Policies to the consolidated financial statements included in the Company’s Annual Report on Form 10-K Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, “Accounting 2020-06 2020-06 2020-06 In October 2020, the FASB issued ASU 2020-10 On May 3, 2021, the FASB issued ASU 2021-04, 470-50), 815-40): |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 6 Months Ended |
Jun. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Restricted Cash | (2) Cash, Cash Equivalents and 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): June 30, December 31, Cash and cash equivalents $ 10,203 $ 22,802 Restricted balance for loan agreement 4,000 4,000 Letters of credit 101 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash $ 14,354 $ 26,953 Under the terms of a sub-lease |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | (3) Inventories Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 909 $ 767 Work-in-process 1,050 645 Finished goods 81 — Total inventories $ 2,040 $ 1,412 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2022 | |
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): June 30, December 31, Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 400 890 Professional services 154 15 Other 186 208 Total prepaid expenses and other current assets $ 2,370 $ 2,743 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant, and Equipment | (5) Property, Plant, and Equipment Property, plant, and equipment consist of the following (in thousands): June 30, 2022 December 31, 2021 Estimated Useful Life Buildings and land $ 1,271 $ 1,222 30 years -Buildings Enterprise hardware and software 1,853 1,858 3 years Leaseholds 1,765 1,796 Lesser of lease term or Equipment 1,221 1,094 7 years Furniture 201 203 5 years Property, plant and equipment, gross 6,311 6,173 Accumulated depreciation (4,854 ) (4,825 ) Property, plant and equipment, net $ 1,457 $ 1,348 Depreciation expense for the six months ended June 30, 2022 was approximately $65,000 as compared to approximately $78,000 for the same period in 2021. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | (6) Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, December 31, Clinical expenses $ 1,500 $ 1,517 Compensation, excluding taxes 1,228 893 Short-term financing 79 551 Professional fees 1,977 603 Interest on convertible note 473 393 Other 160 152 Total accrued expenses $ 5,417 $ 4,109 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
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 leases as of and for the six months ended June 30, 2022 (in thousands): U.S. Ireland Total Lease cost Operating lease cost $ 203 $ 31 $ 234 Other information Operating cash flows out from operating leases (203 ) (31 ) (234 ) Weighted average remaining lease term 0.7 4.1 Weighted average discount rate - operating leases 8 % 8 % Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows (in thousands): U.S. Ireland Total Six Months Remaining December 31, 2022 $ 203 $ 20 $ 223 Year ended December 31, 2023 67 42 109 Year ended December 31, 2024 — 42 42 Year ended December 31, 2025 — 42 42 Year ended December 31, 2026 — 23 23 Total 270 169 438 Less present value discount (8 ) (24 ) (32 ) Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2022 $ 262 $ 145 $ 407 |
Loans and Convertible Notes Pay
Loans and Convertible Notes Payable | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Loans and Convertible Notes Payable | (8) Loans and Convertible Notes Payable June 30, 2022 December 31, 2021 (in thousands) Gross Discount Net Gross Discount Net Loan - Avenue [1] 12,638 (1,326 ) 11,312 12,638 (1,645 ) 10,993 Loan - Avenue [1] (4,998 ) 524 (4,474 ) (714 ) 93 (621 ) Total - Loans Payable, Non-Current $ 7,640 $ (802 ) $ 6,838 $ 11,924 $ (1,552 ) $ 10,372 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (291 ) 2,709 3,000 (361 ) 2,639 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (291 ) $ 4,709 $ 5,000 $ (361 ) $ 4,639 [1] The gross amount includes the 4.25% final payment of $638,000. Remaining maturities of the Company’s loan and convertible note payables are as follows (in thousands): Loans Convertible Total Year ended December 31, 2022 $ 714 $ — $ 714 Year ended December 31, 2023 8,571 — 8,571 Year ended December 31, 2024 3,353 5,000 8,353 Total $ 12,638 $ 5,000 $ 17,638 Term Loan from Avenue Venture Opportunities Fund, L.P. On August 6, 2021, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (the “Lender,” or “Avenue”) for a term loan in an aggregate principal amount of up to $20 million (the “Avenue Loan”). The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at June 30, 2022 was 11.7% and increased to 12.45% for July 2022 and 13.2% effective August 2022 The initial tranche of the Avenue Loan is $15.0 million, including $4.0 million which has been funded into a restricted account and will be released upon achievement of (a)(x) positive FOCUS trial efficacy per the trial’s predefined Statistical Analysis Plan (SAP) (specifically the Overall Response Rate exceeds the pre-specified Up to $3 million of the principal amount of the Avenue Loan outstanding may be converted, at the option of Avenue, into shares of the Company’s common stock at a conversion price of $11.98 per share. In connection with the Avenue Loan, the Company issued to Avenue a warrant (the “Avenue Warrant”) to purchase 127,755 shares of common stock at an exercise price per share equal to $0.01. The Avenue Warrant is exercisable until August 31, 2026. The Company will make monthly interest-only payments during the first fifteen months of the term of the Avenue Loan, which could be increased to up to twenty-four months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal plus interest until the maturity date, when all remaining principal outstanding and accrued interest must be paid. If the Company prepays the Avenue Loan, it will be required to pay (a) a prepayment fee of 3% if the Avenue Loan is prepaid during the interest-only period; and (b) a prepayment fee of 1% if the Avenue Loan is prepaid after the interest-only period. The Company must make an incremental final payment equal to 4.25% of the aggregate funding. The Company paid an aggregate commitment fee of $150,000 at closing. Upon funding a second tranche of the Avenue Loan, the Lender will earn a 1.0% fee on the $5.0 million of incremental committed capital, for a total commitment fee of $0.2 million. The Avenue Loan Agreement requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan Agreement also contains customary events of default, including non-payment The Company determined that the embedded conversion option associated with the Avenue Loan was not required to be bifurcated. The Company determined that the Avenue Warrant met the criteria to be equity-classified. The $0.6 million value of the final payment was treated as original issue discount. The $1.2 million relative fair value of the Avenue Warrant was credited to Additional Paid in Capital while it was debited as debt discount. Of the $563,000 of cash issuance costs, $519,000 was allocated to the Avenue Loan and was recorded as debit discount, while $44,000 was allocated to the Avenue Warrant and was debited to Additional Paid in Capital. Of the $2.3 million of aggregate debt discount, $1.9 million was allocated to the non-convertible non-convertible si x The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, 2021 Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % Convertible Notes Payable The Company has $2.0 million of principal outstanding related to Senior Secured Promissory Notes (the “Rosalind Notes”) which bear interest at 8% per annum. Pursuant to their original terms, the Rosalind Notes were convertible into Series E Preferred Stock at a price of $1,500 per share and were to mature on July 16, 2021 . On August 6, 2021, the Company executed an agreement to amend the Rosalind Notes to (a) reduce the conversion price to $1,198 per share of the Company’s Series E Convertible Preferred Stock; and (b) extend the maturity date to October 30, 2024. In addition, in order to induce Avenue to provide the Avenue Loan described above, the holders of the Rosalind Notes agreed to subordinate (a) all of the Company’s indebtedness and obligations to the holders; and (b) all of the holders’ security interest, to the Avenue Loan and Avenue’s security interest in the Company’s property. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | (9) Stockholders’ Equity (Deficit) Authorized Shares The Company is authorized to issue 40,000,000 shares of common stock, $0.01 par value, and 10,000,000 shares of preferred stock, $0.01 par value. To date, the Company has designated the following preferred stock: Series A (4,200 shares), Series B (2,360 shares), Series C (590 shares), Series D (10,000 shares), Series E (40,000 shares) and Series E-1 Preferred Stock As of June 30, 2022, there were an aggregate of 11,357 shares of Series E and Series E-1 Omnibus Equity Incentive Plan On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. The 2020 Plan provides for the grant of incentive stock options, non-qualified Employee Stock Purchase Plan In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (ESPP). The Company ESPP’s plan provides for a maximum of 260,295 shares of common stock to be purchased by participating employees. Employees who elect to participate in the Company’s ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month Equity Offerings and Placements At-the-Market On August 18, 2020, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, as sales agent or principal, shares of the Company’s common stock, (the “Placement Shares”), having an aggregate offering price of up to $10.0 million (the “ATM Offering”). The Company has no obligation to sell any Placement Shares under the sales agreement. Subject to the terms and conditions of the sales agreement, Cantor Fitzgerald is required to use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, to sell Placement Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from each sale of Placement Shares, reimburse Cantor Fitzgerald’s legal fees and disbursements up to $50,000 and provide Cantor Fitzgerald with customary indemnification and contribution rights. The sales agreement may be terminated by Cantor Fitzgerald or the Company upon notice to the other party as provided in the sales agreement, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the Placement Shares or to enforce contracts for the sale of the Placement Shares. In connection with the ATM Offering, in consideration for a fee equal to 1.05% of the gross sales price per share sold in the ATM Offering, ROTH Capital Advisors, LLC (“Roth”) waived, solely with respect to the ATM Offering, (i) Roth’s right, pursuant to certain engagement letters dated August 14, 2019 and January 13, 2020 between Roth and the Company, to act as placement agent or underwriter with respect to offerings of the Company’s securities and to receive a minimum of 35% of the fees paid to the agents or underwriters for such offerings and (ii) the lock-up 90-day There were no shares sold during the six months ended June 30, 2022. Private Placement On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the “Common Stock”) and 566,751 pre-funded “Pre-Funded Pre-Funded Pre-Funded Pre-Funded Stock Options The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Six months ended June 30, 2022 2021 Expected terms (years) 5.23 - 6.46 5.86 Expected volatility 174.81% -180.33% 178.33 Risk-free interest rate 1.75% -2.93% 0.9% Expected dividends 0.00% 0.00% The weighted average estimated fair value of the stock options granted during the six months ended June 30, 2022 and 2021 was approximately and $9.87 per share, respectively. The following is a summary of stock option activity for the six months ended June 30, 2022: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2022 1,732,460 $ 11.69 Granted 650,083 7.05 Expired (29,116 ) 10.73 Cancelled/Forfeited (42,034 ) 10.35 Outstanding at June 30, 2022 2,311,393 $ 10.42 8.7 $ — Exercisable at June, 2022 952,670 $ 11.48 8.4 $ — The following table summarizes information for stock option shares outstanding and exercisable at June 3 Options Exercisable Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $6.24 - $53.85 2,310,894 8.7 952,171 $53.85+ 499 6.6 499 2,311,393 8.4 952,670 The following is a summary of share-based compensation expense in the statement of operations for the three and six months ended June 30, 2022 and 2021 (in thousands): Three months ended J u , Six months ended June 30, 2022 2021 2022 2021 Selling, general and administrative $ 918 $ 1,124 $ 1,958 $ 2,590 Research and development 503 463 1,025 1,093 Cost of goods sold 52 39 108 91 Total $ 1,473 $ 1,626 $ 3,091 $ 3,774 At June 30, 2022, there was $8.0 million of aggregate unrecognized compensation expense related employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 2 years. Warrants The following is a summary of warrant activity for the six months ended June 30, 2022: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Outstanding at January 1, 2022 3,894,498 $ 9.27 Warrants issued — — Warrants exercised — — Warrants expired — — Outstanding at June 30, 2022 3,894,498 $ 9.27 2.7 Exercisable at June 30, 2022 3,894,498 $ 9.27 2.7 The following table presents information related to stock warrants at June 30, 2022 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $0.01 283,755 3.4 283,755 $10.00 3,610,743 2.7 3,610,743 3,894,498 2.7 3,894,498 |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | (10) 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. The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2022 and 2021 because their effects would be anti-dilutive: June 30, 2022 2021 Common stock warrants - equity 3,894,498 3,773,266 Assumed conversion of Series E and Series E-1 1,135,721 1,170,700 Assumed conversion of convertible notes 488,031 154,222 Stock options 2,315,643 1,091,888 Total 7,829,643 6,190,076 At June 30, 2022, the Company had 283,755 pre-funded Six months ended June 30, Three months ended June 30, 2022 2021 2022 2021 Weighted average shares issued 7,906,728 6,319,622 7,906,728 6,511,194 Weighted average pre-funded 283,755 270,033 283,755 170,175 Weighted average shares outstanding 8,190,483 6,589,655 8,190,483 6,681,369 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (11) Income Taxes As discussed in Note 14 Income Taxes of the Company’s Annual Report, the Company has a valuation allowance against the full amount of its net deferred tax assets. The Company currently provides a valuation allowance against deferred tax assets when it is more likely than not that some portion or all of its deferred tax assets will not be realized. The Company has not recognized any unrecognized tax benefits in its balance sheet. 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 of the Company’s Annual Report. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (12) Commitments and Contingencies Litigation, Claims and Assessments medac Matter In April 2021, the Company issued an invoice for €1 million (which currently converts to approximately $1.0 million) to medac GmbH, a privately held, multi-national pharmaceutical company based in Germany (“medac”), the Company’s EU product distribution partner, for a milestone payment due under the License, Supply and Marketing Agreement (the “License Agreement”) dated December 10, 2018, between the Company and medac. Pursuant to the License Agreement, a milestone is due upon achieving positive efficacy in the FOCUS Trial as defined by the FOCUS Trial protocol. Per the trial protocol and associated Statistical Analysis Plan, positive efficacy is based on whether the Objective Response Rate (ORR) exceeds a pre-specified pre-specified pre-specified pre-specified On October 12, 2021, the Company notified medac in writing that it was terminating the License Agreement due to medac’s nonpayment of the milestone payment due under the License Agreement, with the effective date of termination of the License Agreement being April 12, 2022. medac disputed having an obligation to make a milestone payment under the Agreement and demanded withdrawal of the termination notice. The Company declined to withdraw the termination notice and, on December 16, 2021, the Company initiated an arbitration proceeding pursuant to the dispute resolution provisions of the License Agreement. On December 30, 2021, the Company received a letter from medac stating that, due to its failure to withdraw the termination notice, medac was terminating the License Agreement with immediate effect. In the letter, medac reserved its rights in full, including a purported claim for damages for wrongful termination. In a separate letter, medac agreed to an orderly transition through February 28, 2022 in order to minimize the impact of any termination on patients and physicians. The Company agreed to purchase inventory held at medac in March 2022 for approximately $0.2 million. The arbitration proceeding is moving forward with the parties agreeing to stay the arbitration for a finite period to pursue settlement discussions. |
General (Policies)
General (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Risk and Uncertainties | Risks and Uncertainties Although the Company is not aware of any direct impacts of the war between the Ukraine and the Russian Federation on its supply chain, the war could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. In addition, at this time, although the Company is not aware of any direct impacts, the increase in COVID cases and associated restrictions, which could adversely impact the Company’s ability to obtain components and/or significantly increase the cost of obtaining such components for the Company’s products from its third-party suppliers in a timely manner or at all. The rise in COVID cases and the associated absences from work of internal and external resources may also impact the Company’s ability to meet anticipated timelines. |
Liquidity and Going Concern | Liquidity and Going Concern 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 significant losses and has an accumulated deficit of $438.8 million as of June 30, 2022. These losses, among other factors, raise substantial doubt about the Company’s ability to continue as a going concern. On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the “Common Stock”) and 566,751 pre-funded “Pre-Funded Pre-Funded Pre-Funded Pre-Funded 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 the Company 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 its 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 the Company 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 interim condensed 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. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. 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. |
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 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 June 30, 2022 and 2021; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, “Accounting 2020-06 2020-06 2020-06 In October 2020, the FASB issued ASU 2020-10 On May 3, 2021, the FASB issued ASU 2021-04, 470-50), 815-40): |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents, and Restricted Cash | Cash, cash equivalents, and restricted cash balances were as follows (in thousands): June 30, December 31, Cash and cash equivalents $ 10,203 $ 22,802 Restricted balance for loan agreement 4,000 4,000 Letters of credit 101 101 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash $ 14,354 $ 26,953 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 909 $ 767 Work-in-process 1,050 645 Finished goods 81 — Total inventories $ 2,040 $ 1,412 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): June 30, December 31, Clinical trial expenses $ 1,630 $ 1,630 Insurance premiums 400 890 Professional services 154 15 Other 186 208 Total prepaid expenses and other current assets $ 2,370 $ 2,743 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consist of the following (in thousands): June 30, 2022 December 31, 2021 Estimated Useful Life Buildings and land $ 1,271 $ 1,222 30 years -Buildings Enterprise hardware and software 1,853 1,858 3 years Leaseholds 1,765 1,796 Lesser of lease term or Equipment 1,221 1,094 7 years Furniture 201 203 5 years Property, plant and equipment, gross 6,311 6,173 Accumulated depreciation (4,854 ) (4,825 ) Property, plant and equipment, net $ 1,457 $ 1,348 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): June 30, December 31, Clinical expenses $ 1,500 $ 1,517 Compensation, excluding taxes 1,228 893 Short-term financing 79 551 Professional fees 1,977 603 Interest on convertible note 473 393 Other 160 152 Total accrued expenses $ 5,417 $ 4,109 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating leases as of and for the six months ended June 30, 2022 (in thousands): U.S. Ireland Total Lease cost Operating lease cost $ 203 $ 31 $ 234 Other information Operating cash flows out from operating leases (203 ) (31 ) (234 ) Weighted average remaining lease term 0.7 4.1 Weighted average discount rate - operating leases 8 % 8 % |
Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases | Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows (in thousands): U.S. Ireland Total Six Months Remaining December 31, 2022 $ 203 $ 20 $ 223 Year ended December 31, 2023 67 42 109 Year ended December 31, 2024 — 42 42 Year ended December 31, 2025 — 42 42 Year ended December 31, 2026 — 23 23 Total 270 169 438 Less present value discount (8 ) (24 ) (32 ) Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2022 $ 262 $ 145 $ 407 |
Loans and Convertible Notes P_2
Loans and Convertible Notes Payable (Tables) | 6 Months Ended | |
Aug. 06, 2021 | Jun. 30, 2022 | |
Debt Disclosure [Abstract] | ||
Summary of Loans and Convertible Notes Payable | June 30, 2022 December 31, 2021 (in thousands) Gross Discount Net Gross Discount Net Loan - Avenue [1] 12,638 (1,326 ) 11,312 12,638 (1,645 ) 10,993 Loan - Avenue [1] (4,998 ) 524 (4,474 ) (714 ) 93 (621 ) Total - Loans Payable, Non-Current $ 7,640 $ (802 ) $ 6,838 $ 11,924 $ (1,552 ) $ 10,372 Convertible Note Payable - Rosalind 2,000 — 2,000 2,000 — 2,000 Convertible Portion of Loan Payable - Avenue 3,000 (291 ) 2,709 3,000 (361 ) 2,639 Total - Convertible Notes Payable - Non-Current $ 5,000 $ (291 ) $ 4,709 $ 5,000 $ (361 ) $ 4,639 [1] The gross amount includes the 4.25% final payment of $638,000. | |
Summary of Remaining Maturities of Company's Loan and Convertible Note Payables | Remaining maturities of the Company’s loan and convertible note payables are as follows (in thousands): Loans Convertible Total Year ended December 31, 2022 $ 714 $ — $ 714 Year ended December 31, 2023 8,571 — 8,571 Year ended December 31, 2024 3,353 5,000 8,353 Total $ 12,638 $ 5,000 $ 17,638 | |
Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method | The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, 2021 Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % | The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Six months ended June 30, 2022 2021 Expected terms (years) 5.23 - 6.46 5.86 Expected volatility 174.81% -180.33% 178.33 Risk-free interest rate 1.75% -2.93% 0.9% Expected dividends 0.00% 0.00% |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 6 Months Ended | |
Aug. 06, 2021 | Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | ||
Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method | The Avenue Warrant was valued at issuance at $1.3 million using the Black-Scholes option pricing method using the following assumptions: August 6, 2021 Contractual term (years) 5.07 Expected volatility 187.0 % Risk-free interest rate 0.77 % Expected dividends 0.00 % | The Company values stock options using the Black-Scholes option pricing model and used the following assumptions during the reporting periods: Six months ended June 30, 2022 2021 Expected terms (years) 5.23 - 6.46 5.86 Expected volatility 174.81% -180.33% 178.33 Risk-free interest rate 1.75% -2.93% 0.9% Expected dividends 0.00% 0.00% |
Summary of Stock Option Activity | The following is a summary of stock option activity for the six months ended June 30, 2022: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2022 1,732,460 $ 11.69 Granted 650,083 7.05 Expired (29,116 ) 10.73 Cancelled/Forfeited (42,034 ) 10.35 Outstanding at June 30, 2022 2,311,393 $ 10.42 8.7 $ — Exercisable at June, 2022 952,670 $ 11.48 8.4 $ — | |
Summary of Stock Option Shares Outstanding and Exercisable | The following table summarizes information for stock option shares outstanding and exercisable at June 3 Options Exercisable Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $6.24 - $53.85 2,310,894 8.7 952,171 $53.85+ 499 6.6 499 2,311,393 8.4 952,670 | |
Summary of Recognized Share-based Compensation Cost | The following is a summary of share-based compensation expense in the statement of operations for the three and six months ended June 30, 2022 and 2021 (in thousands): Three months ended J u , Six months ended June 30, 2022 2021 2022 2021 Selling, general and administrative $ 918 $ 1,124 $ 1,958 $ 2,590 Research and development 503 463 1,025 1,093 Cost of goods sold 52 39 108 91 Total $ 1,473 $ 1,626 $ 3,091 $ 3,774 | |
Summary of Warrant Activity | The following is a summary of warrant activity for the six months ended June 30, 2022: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Outstanding at January 1, 2022 3,894,498 $ 9.27 Warrants issued — — Warrants exercised — — Warrants expired — — Outstanding at June 30, 2022 3,894,498 $ 9.27 2.7 Exercisable at June 30, 2022 3,894,498 $ 9.27 2.7 | |
Schedule of Information Related to Stock Warrants Outstanding and Exercisable | The following table presents information related to stock warrants at June 30, 2022 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $0.01 283,755 3.4 283,755 $10.00 3,610,743 2.7 3,610,743 3,894,498 2.7 3,894,498 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Anti-dilutive securities excluded from the computation of earnings per share | The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2022 and 2021 because their effects would be anti-dilutive: June 30, 2022 2021 Common stock warrants - equity 3,894,498 3,773,266 Assumed conversion of Series E and Series E-1 1,135,721 1,170,700 Assumed conversion of convertible notes 488,031 154,222 Stock options 2,315,643 1,091,888 Total 7,829,643 6,190,076 |
Summary of reconciliation of weighted average shares outstanding calculation | The following table provides a reconciliation of the weighted average shares outstanding calculation for the three and six months ended June 30, 2022 and 2021: Six months ended June 30, Three months ended June 30, 2022 2021 2022 2021 Weighted average shares issued 7,906,728 6,319,622 7,906,728 6,511,194 Weighted average pre-funded 283,755 270,033 283,755 170,175 Weighted average shares outstanding 8,190,483 6,589,655 8,190,483 6,681,369 |
General - Additional Informatio
General - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 20, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
OrganizationConsolidationBasisOfPresentationBusinessDescriptionAndAccountingPolicies [Line Items] | |||
Retained Earnings Accumulated Deficit | $ (438,836) | $ (420,976) | |
Private Placement [Member] | Subsequent Event [Member] | |||
OrganizationConsolidationBasisOfPresentationBusinessDescriptionAndAccountingPolicies [Line Items] | |||
Sale Of stock price per share | $ 3.98 | ||
Proceeds from issuance of private placement | $ 5,000 | ||
Private Placement [Member] | Subsequent Event [Member] | Common Stock [Member] | |||
OrganizationConsolidationBasisOfPresentationBusinessDescriptionAndAccountingPolicies [Line Items] | |||
Stock issued during period shares | 690,954 | ||
Private Placement [Member] | PreFundedWarrants [Member] | Subsequent Event [Member] | |||
OrganizationConsolidationBasisOfPresentationBusinessDescriptionAndAccountingPolicies [Line Items] | |||
Class of warrants and rights issued during the period | 566,751 | ||
Class of warrants and rights issued, price per warrant | $ 3.97 | ||
Exercise price of warrant | $ 0.01 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 10,203 | $ 22,802 | ||
Restricted balance for loan agreement | 4,000 | 4,000 | ||
Letters of credit | 101 | 101 | ||
Security for credit cards | 50 | 50 | ||
Total cash, cash equivalents and restricted cash | $ 14,354 | $ 26,953 | $ 19,425 | $ 28,756 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 909 | $ 767 |
Work-in-process | 1,050 | 645 |
Finished goods | 81 | 0 |
Total inventories | $ 2,040 | $ 1,412 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Clinical trial expenses | $ 1,630 | $ 1,630 |
Insurance premiums | 400 | 890 |
Professional services | 154 | 15 |
Other | 186 | 208 |
Total prepaid expenses and other current assets | $ 2,370 | $ 2,743 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 6,311 | $ 6,173 |
Accumulated depreciation | (4,854) | (4,825) |
Property, plant, and equipment, net | 1,457 | 1,348 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,271 | 1,222 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,853 | 1,858 |
Property, plant and equipment, estimated useful life | 3 years | |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,765 | 1,796 |
Property, plant and equipment, estimated useful life | Lesser of lease term or estimated useful life | |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,221 | 1,094 |
Property, plant and equipment, estimated useful life | 7 years | |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 201 | $ 203 |
Property, plant and equipment, estimated useful life | 5 years | |
Buildings [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, estimated useful life | 30 years |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 65 | $ 78 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Clinical expenses | $ 1,500 | $ 1,517 |
Compensation, excluding taxes | 1,228 | 893 |
Short-term financing | 79 | 551 |
Professional fees | 1,977 | 603 |
Interest on convertible note | 473 | 393 |
Other | 160 | 152 |
Total accrued expenses | $ 5,417 | $ 4,109 |
Leases - Additional Information
Leases - Additional Information (Details) | Jun. 30, 2022 |
Lease term | 12 months |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Lease Cost | |
Operating lease cost | $ 234 |
Other information | |
Operating cash flows out from operating leases | (234) |
U.S. [Member] | |
Lease Cost | |
Operating lease cost | 203 |
Other information | |
Operating cash flows out from operating leases | $ (203) |
Weighted average remaining lease term | 8 months 12 days |
Weighted average discount rate - operating leases | 8% |
Ireland [Member] | |
Lease Cost | |
Operating lease cost | $ 31 |
Other information | |
Operating cash flows out from operating leases | $ (31) |
Weighted average remaining lease term | 4 years 1 month 6 days |
Weighted average discount rate - operating leases | 8% |
Leases - Schedule of Remaining
Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2022 | $ 223 |
Year ended December 31, 2023 | 109 |
Year ended December 31, 2024 | 42 |
Year ended December 31, 2025 | 42 |
Year ended December 31, 2026 | 23 |
Total | 438 |
Less present value discount | (32) |
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2022 | 407 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2022 | 203 |
Year ended December 31, 2023 | 67 |
Total | 270 |
Less present value discount | (8) |
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2022 | 262 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2022 | 20 |
Year ended December 31, 2023 | 42 |
Year ended December 31, 2024 | 42 |
Year ended December 31, 2025 | 42 |
Year ended December 31, 2026 | 23 |
Total | 169 |
Less present value discount | (24) |
Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2022 | $ 145 |
Loans and Convertible Notes P_3
Loans and Convertible Notes Payable - Additional Information (Details) - USD ($) | 6 Months Ended | ||||
Aug. 06, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Aug. 31, 2022 | Jul. 31, 2022 | |
Debt Instrument [Line Items] | |||||
Avenue warrant value | $ 1,300,000 | ||||
Debt instrument, commitment fee | $ 150,000 | ||||
Interest expense incurred | $ 800,000 | ||||
Secured Convertible Notes Payable [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal face amount | $ 2,000,000 | ||||
Series E Preferred Stock [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, conversion price | $ 1,500 | ||||
Series E Preferred Stock [Member] | Secured Convertible Notes Payable [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument maturity date | Oct. 30, 2024 | ||||
Debt instrument, conversion price | $ 1,198 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument maturity date | Aug. 01, 2024 | ||||
Debt instrument, interest rate | 7.70% | ||||
Debt instrument, interest rate | 10.95% | 11.70% | |||
Debt instrument, interest rate term | The Avenue Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.70% plus the prime rate as reported in The Wall Street Journal and (b) 10.95%. The interest rate at June 30, 2022 was 11.7% and increased to 12.45% for July 2022 and 13.2% effective August 2022. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. | ||||
Initial tranche of loan | $ 15,000,000 | ||||
Loan amount funded into restricted account | 4,000,000 | ||||
Gross proceeds from ATM Offering | 20,000,000 | ||||
Second tranche of loan | $ 5,000,000 | ||||
Frequency of periodic payment | monthly | ||||
Periodic interest payments, term | 15 months | ||||
Debt instrument, incremental final payment | 4.25% | ||||
Debt instrument, commitment fee, percentage | 1% | ||||
Debt instrument, commitment fee upon funding of second tranche of loan | $ 200,000 | ||||
Original issue discount | 600,000 | ||||
Cash issuance costs | 563,000 | ||||
Debit discount | 519,000 | ||||
Fair value of warrants reclassified from liability to equity | 44,000 | ||||
Aggregate debt discount | $ 2,300,000 | ||||
Amortization of debt discount | $ 500,000 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, Interest rate, Effective percentage | 13.20% | 12.45% | |||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Warrant [Member] | |||||
Debt Instrument [Line Items] | |||||
Warrants Issued To Purchase Of Common Stock | 127,755 | ||||
Warrant exercise price | $ 0.01 | ||||
Warrants, maturity date | Aug. 31, 2026 | ||||
Fair value of the Avenue Warrant | $ 1,200,000 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Maximum [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal face amount | $ 20,000,000 | ||||
Periodic interest payments, term | 24 months | ||||
Prepayment fee, percentage | 3% | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Prepayment fee, percentage | 1% | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Non Convertible Debt [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate debt discount | $ 1,900,000 | ||||
Amortization of debt discount | 400,000 | ||||
Term Loan from Avenue Venture Opportunities Fund L.P [Member] | Convertible Debt [Member] | |||||
Debt Instrument [Line Items] | |||||
Aggregate debt discount | $ 418,000 | ||||
Amortization of debt discount | $ 70,000 | ||||
Eight Point Zero Percentage July Two Thousand And Nineteen Notes [Member] | Convertible Notes Payable [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, interest rate | 8% | ||||
Interest expense incurred | $ 80,000 | $ 80,000 |
Loans and Convertible Notes P_4
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Gross | $ 5,000 | $ 5,000 | |
Discount | (291) | (361) | |
Net | 4,709 | 4,639 | |
Less Current Portion, Net | (4,474) | (621) | |
Total - Loans Payable, Non-Current, Gross | 7,640 | 11,924 | |
Total - Loans Payable, Non-Current, Discount | (802) | (1,552) | |
Total - Loans Payable, Non-Current, Net | 6,838 | 10,372 | |
Loan Avenue [Member] | |||
Gross | [1] | 12,638 | 12,638 |
Discount | [1] | (1,326) | (1,645) |
Net | [1] | 11,312 | 10,993 |
Less Current Portion, Gross | [1] | (4,998) | (714) |
Less Current Portion, Discount | [1] | 524 | 93 |
Less Current Portion, Net | [1] | (4,474) | (621) |
Convertible Note Payable Rosalind [Member] | |||
Gross | 2,000 | 2,000 | |
Net | 2,000 | 2,000 | |
Convertible Loan Payable Avenue [Member] | |||
Gross | 3,000 | 3,000 | |
Discount | (291) | (361) | |
Net | $ 2,709 | $ 2,639 | |
[1]The gross amount includes the 4.25% final payment of $638,000. |
Loans and Convertible Notes P_5
Loans and Convertible Notes Payable - Summary of Loans and Convertible Notes Payable (Details) (Parenthetical) | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Equity Method Investments And Cost Method Investments [Abstract] | |
Percentage of final payment included in gross amount | 4.25% |
Final payment | $ 638,000 |
Loans and Convertible Notes P_6
Loans and Convertible Notes Payable - Summary of Remaining Maturities of Company's Loan and Convertible Note Payables (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Instrument [Line Items] | |
Loans | $ 12,638 |
Convertible Notes | 5,000 |
Total | 17,638 |
Year ended December 31, 2022 | |
Debt Instrument [Line Items] | |
Loans | 714 |
Total | 714 |
Year ended December 31, 2023 | |
Debt Instrument [Line Items] | |
Loans | 8,571 |
Total | 8,571 |
Year ended December 31, 2024 | |
Debt Instrument [Line Items] | |
Loans | 3,353 |
Convertible Notes | 5,000 |
Total | $ 8,353 |
Loans and Convertible Notes P_7
Loans and Convertible Notes Payable - Summary of Avenue Warrant Valued Using the Black-Scholes Option Pricing Method (Details) | 6 Months Ended | ||
Aug. 06, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Contractual term (years) | 5 years 25 days | 5 days 20 hours | |
Expected volatility | 187% | 178.33% | |
Risk-free interest rate | 0.77% | 0.90% | |
Expected dividends | 0% | 0% | 0% |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Preferred Stock Issuances - Additional Information (Details) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Preferred stock, shares outstanding (in shares) | 11,357 | 11,357 |
Series A Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 4,200 | |
Series B Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 2,360 | |
Series C Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 590 | |
Series D Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 10,000 | |
Series E Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 40,000 | |
Series E1 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares authorized (in shares) | 12,960 | |
Series E-1 Convertible Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Preferred stock, shares outstanding (in shares) | 11,357 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Equity Incentive Plan - Additional Information (Details) - shares | Jun. 30, 2022 | Dec. 31, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of common shares reserved for issuance | 2,475,000 | |
Number of common shares remained available to be issued | 737,417 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Summary of Employee Stock Purchase Plan (Details) - May 2022 Employee Stock Purchase Plan (ESPP) [Member] | 1 Months Ended |
Aug. 31, 2021 shares | |
Stockholders Equity Note [Line Items] | |
Share-based compensation arrangement by share-based payment award number of shares authorized | 260,295 |
Share-based compensation arrangement by share-based payment award purchase price of common stock, percent | 85% |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) - At-the-Market Offering - Additional Information (Details) - USD ($) | 6 Months Ended | ||
Jul. 20, 2022 | Aug. 18, 2020 | Jun. 30, 2022 | |
Stockholders Equity Note [Line Items] | |||
Number of Shares Sold | 0 | ||
Subsequent Event [Member] | Private Placement [Member] | |||
Stockholders Equity Note [Line Items] | |||
Proceeds from issuance of private placement | $ 5,000,000 | ||
Subsequent Event [Member] | Private Placement [Member] | Pre-Funded Warrants [Member] | |||
Stockholders Equity Note [Line Items] | |||
Warrants issued to purchase of common stock | 566,751 | ||
Warrants issued to purchase of common stock, Price per warrant | $ 3.97 | ||
Warrant exercise price | $ 0.01 | ||
Subsequent Event [Member] | Private Placement [Member] | Common Stock [Member] | |||
Stockholders Equity Note [Line Items] | |||
Shares issued in public offering | 690,954 | ||
Shares issued, price per share | $ 3.98 | ||
Cantor Fitzgerald & Co [Member] | |||
Stockholders Equity Note [Line Items] | |||
Percentage of commission on aggregate gross proceeds | 3% | ||
Roth Capital Partners L L C | |||
Stockholders Equity Note [Line Items] | |||
Percentage of fee on gross sale price per share | 1.05% | ||
Percentage of underwriting fee to be received on company offerings | 35% | ||
Common stock offering period | 90 days | ||
Maximum [Member] | Cantor Fitzgerald & Co [Member] | |||
Stockholders Equity Note [Line Items] | |||
At-the-market offering, aggregate offering price | $ 10,000,000 | ||
Legal fees and disbursements | $ 50,000 |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) - Stock Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average estimated fair value of the stock options granted | $ 6.31 | $ 9.87 |
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 8 | |
Cost expected to be recognized over weighted average period | 2 years |
Stockholders' Equity (Deficit_7
Stockholders' Equity (Deficit) - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details) | 6 Months Ended | ||
Aug. 06, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 187% | 178.33% | |
Expected terms (years) | 5 years 25 days | 5 days 20 hours | |
Risk-free interest rate | 0.77% | 0.90% | |
Expected dividends | 0% | 0% | 0% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 174.81% | ||
Expected terms (years) | 5 years 2 months 23 days | ||
Risk-free interest rate | 1.75% | ||
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 180.33% | ||
Expected terms (years) | 6 years 5 months 15 days | ||
Risk-free interest rate | 2.93% |
Stockholders' Equity (Deficit_8
Stockholders' Equity (Deficit) - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | |
Stockholders' Equity Note [Abstract] | ||
Number of Shares, Outstanding | shares | 1,732,460 | |
Number of Shares, Granted | shares | 650,083 | |
Number of Shares, Expired | shares | (29,116) | |
Number of Shares, Cancelled/Forfeited | shares | (42,034) | |
Number of Shares, Outstanding | shares | 2,311,393 | 2,311,393 |
Number of Shares, Exercisable | shares | 952,670 | 952,670 |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 11.69 | |
Weighted Average Exercise Price, Granted | $ / shares | 7.05 | |
Weighted Average Exercise Price, Expired | $ / shares | 10.73 | |
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares | 10.35 | |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 10.42 | 10.42 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 11.48 | $ 11.48 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 8 years 8 months 12 days | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 8 years 4 months 24 days | 8 years 4 months 24 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 0 | $ 0 |
Aggregate Intrinsic Value, Exercisable | $ | $ 0 | $ 0 |
Stockholders' Equity (Deficit_9
Stockholders' Equity (Deficit) - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Outstanding Number of Options | 2,311,393 | 2,311,393 | 1,732,460 |
Weighted Average Remaining Contractual Term (Years), Exercisable | 8 years 4 months 24 days | 8 years 4 months 24 days | |
Number of Shares, Exercisable | 952,670 | 952,670 | |
6.24 - $53.85 [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Outstanding Number of Options | 2,310,894 | 2,310,894 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 8 years 8 months 12 days | ||
Number of Shares, Exercisable | 952,171 | 952,171 | |
53.85+ [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Outstanding Number of Options | 499 | 499 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 6 years 7 months 6 days | ||
Number of Shares, Exercisable | 499 | 499 |
Stockholders' Equity (Defici_10
Stockholders' Equity (Deficit) - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | $ 1,473 | $ 1,626 | $ 3,091 | $ 3,774 |
Selling general and administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | 918 | 1,124 | 1,958 | 2,590 |
Research and development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | 503 | 463 | 1,025 | 1,093 |
Cost of goods sold [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation (Income) expense | $ 52 | $ 39 | $ 108 | $ 91 |
Stockholders' Equity (Defici_11
Stockholders' Equity (Deficit) - Summary of Warrant Activity (Details) | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Warrants outstanding [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 3,894,498 |
Warrants issued (in shares) | shares | 0 |
Warrants exercised (in shares) | shares | 0 |
Warrants expired (in shares) | shares | 0 |
Outstanding, end of period (in shares) | shares | 3,894,498 |
Exercisable, end of period (in shares) | shares | 3,894,498 |
Warrants, Exercise Price per Share [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 9.27 |
Warrants issued (in dollars per share) | $ / shares | 0 |
Warrants exercised (in dollars per share) | $ / shares | 0 |
Warrants expired (in dollars per share) | $ / shares | 0 |
Outstanding, ending of period (in dollars per share) | $ / shares | 9.27 |
Exercisable, (in dollars per share) | $ / shares | $ 9.27 |
Weighted average remaining life | 2 years 8 months 12 days |
Weighted average remaining life, Exercisable | 2 years 8 months 12 days |
Stockholders' Equity (Defici_12
Stockholders' Equity (Deficit) - Summary of Warrants Outstanding and Exercisable (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,894,498 | 3,894,498 |
Weighted average remaining life | 2 years 8 months 12 days | |
Warrants Exercisable, Number Exercisable | 3,894,498 | |
$0.01 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 283,755 | |
Weighted average remaining life | 3 years 4 months 24 days | |
Warrants Exercisable, Number Exercisable | 283,755 | |
$10.00 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,610,743 | |
Weighted average remaining life | 2 years 8 months 12 days | |
Warrants Exercisable, Number Exercisable | 3,610,743 |
Net Loss per Common Share - Ant
Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 7,829,643 | 6,190,076 |
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) | 3,894,498 | 3,773,266 |
Assumed conversion of Series E and Series 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) | 1,135,721 | 1,170,700 |
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) | 488,031 | 154,222 |
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) | 2,315,643 | 1,091,888 |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2022 shares | |
Earnings Per Share [Abstract] | |
Pre-funded penny warrants outstanding | 283,755 |
Net Loss per Common Share - Sum
Net Loss per Common Share - Summary of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Weighted average shares issued | 7,906,728 | 6,511,194 | 7,906,728 | 6,319,622 |
Weighted average pre-funded warrants | 283,755 | 170,175 | 283,755 | 270,033 |
Weighted average number of basic shares outstanding | 8,190,483 | 6,681,369 | 8,190,483 | 6,589,655 |
Weighted average number of diluted shares outstanding | 8,190,483 | 6,681,369 | 8,190,483 | 6,589,655 |
Commitments and contingencies -
Commitments and contingencies - Additional Information (Details) € in Millions | Jun. 30, 2022 USD ($) | Apr. 01, 2020 | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Apr. 01, 2021 USD ($) | Apr. 01, 2021 EUR (€) |
Loss Contingencies [Line Items] | ||||||
Percentage of enrolled patients | 87% | |||||
Inventory | $ 2,040,000 | $ 1,412,000 | ||||
Medac [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Due from related parties | $ 1,000 | € 1 | ||||
Agreement date | Dec. 10, 2018 | |||||
Inventory | $ 200,000 |