Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 11, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | DELCATH SYSTEMS, INC. | |
Entity Central Index Key | 0000872912 | |
Current Fiscal Year End Date | --12-31 | |
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 Line2 | 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 Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 6,472,398 | |
Document Fiscal Year Focus | 2021 | |
Trading Symbol | DCTH | |
Title of 12(b) Security | Common stock, $0.01 par value per share | |
Document Fiscal Period Focus | Q1 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 26,600 | $ 28,575 |
Restricted cash | 50 | 181 |
Accounts receivable, net | 75 | 57 |
Inventories | 1,109 | 855 |
Prepaid expenses and other current assets | 2,369 | 2,670 |
Total current assets | 30,203 | 32,338 |
Property, plant and equipment, net | 1,321 | 1,351 |
Right-of-use assets | 791 | 946 |
Total assets | 32,315 | 34,635 |
Current liabilities | ||
Accounts payable | 1,234 | 1,774 |
Accrued expenses | 5,927 | 5,241 |
Deferred revenue, current | 502 | 525 |
Lease liabilities, current | 433 | 495 |
Convertible notes payable, current | 2,000 | 2,000 |
Total current liabilities | 10,096 | 10,035 |
Deferred revenue, non-current | 1,856 | 2,072 |
Lease liabilities, non-current | 357 | 450 |
Total liabilities | 12,309 | 12,557 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity | ||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 20,480 and 20,631 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | ||
Common stock, $.01 par value; 40,000,000 shares authorized; 6,251,257 and 5,996,101 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 63 | 60 |
Additional paid-in capital | 422,027 | 417,449 |
Accumulated deficit | (402,074) | (395,327) |
Accumulated other comprehensive income | (10) | (104) |
Total stockholders' equity | 20,006 | 22,078 |
Total liabilities and stockholders' equity | $ 32,315 | $ 34,635 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
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) | 20,480 | 20,631 |
Preferred stock, shares outstanding (in shares) | 20,480 | 20,631 |
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) | 6,251,257 | 5,996,101 |
Common stock, shares outstanding (in shares) | 6,251,257 | 5,996,101 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cost of goods sold | $ (112) | $ (78) |
Gross profit | 276 | 216 |
Operating expenses: | ||
Research and development expenses | 3,707 | 2,974 |
Selling, general and administrative expenses | 3,296 | 2,316 |
Total operating expenses | 7,003 | 5,290 |
Operating loss | (6,727) | (5,074) |
Change in fair value of the warrant liability, net | (2,832) | |
Interest expense, net | (41) | (36) |
Other income | 21 | 81 |
Net loss | (6,747) | (7,861) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustments | 94 | 65 |
Total other comprehensive loss | $ (6,653) | $ (7,796) |
Common share data: | ||
Basic loss per common share | $ (1.04) | $ (108.07) |
Diluted loss per common share | $ (1.04) | $ (108.07) |
Weighted average number of basic shares outstanding | 6,496,922 | 72,740 |
Weighted average number of diluted shares outstanding | 6,496,922 | 72,740 |
Product Revenue [Member] | ||
Revenue | $ 261 | $ 176 |
Other Revenue [Member] | ||
Revenue | $ 127 | $ 118 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Preferred Stock [Member] | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income [Member] |
Balance at Dec. 31, 2019 | $ (6,357) | $ 1 | $ 364,785 | $ (371,171) | $ 28 | |
Balance (in shares) at Dec. 31, 2019 | 41,517 | 67,091 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation expense for issuance of stock options | 25 | 25 | ||||
Shares settled for services | 30 | 30 | ||||
Shares settled for services (in shares) | 2,717 | |||||
Conversion of Preferred stock into common stock (in shares) | (70) | 2,915 | ||||
Fractional rounding related to Reverse stock split | $ 50 | |||||
Registration costs | (106) | (106) | ||||
Fair value of warrants issued | 6,199 | 6,199 | ||||
Net loss | (7,861) | (7,861) | ||||
Total comprehensive income (loss) | 65 | 65 | ||||
Balance at Mar. 31, 2020 | (8,005) | $ 1 | 370,933 | (379,032) | 93 | |
Balance (in shares) at Mar. 31, 2020 | 41,447 | 72,773 | ||||
Balance at Dec. 31, 2020 | 22,078 | $ 60 | 417,449 | (395,327) | (104) | |
Balance (in shares) at Dec. 31, 2020 | 20,631 | 5,996,101 | ||||
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) | (150) | 15,000 | ||||
Exercise of warrants into common stock | 2,376 | $ 3 | ||||
Exercise of warrants into common stock (in shares) | 237,520 | 2,373 | ||||
Net loss | (6,747) | (6,747) | ||||
Total comprehensive income (loss) | 94 | 94 | ||||
Balance at Mar. 31, 2021 | $ 20,006 | $ 63 | $ 422,027 | $ (402,074) | $ (10) | |
Balance (in shares) at Mar. 31, 2021 | 20,481 | 6,251,257 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (6,747) | $ (7,861) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock option compensation expense | 2,148 | 25 |
Restricted stock compensation expense | 30 | |
Depreciation expense | 39 | 48 |
Amortization of right of use assets | 11 | |
Warrant liability fair value adjustment | 2,832 | |
Non-cash interest income | (1) | (3) |
Interest expense accrued related to convertible notes | 39 | 40 |
Changes in assets and liabilities: | ||
(Increase) decrease in prepaid expenses and other assets | 302 | (880) |
Increase in accounts receivable | (18) | (48) |
Increase in inventories | (254) | (136) |
Increase in accounts payable and accrued expenses | 164 | 901 |
Decrease in deferred revenue | (239) | (188) |
Net cash used in operating activities | (4,567) | (5,229) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (9) | (180) |
Net cash used in investing activities | (9) | (180) |
Cash flows from financing activities: | ||
Principal payments on financing leases | (11) | |
Net payments related to registration costs | (106) | |
Net proceeds from the exercise of warrants | 2,376 | |
Net cash provided by/(used in) financing activities | 2,376 | (117) |
Foreign currency effects on cash | 94 | 64 |
Net decrease in total cash | (2,106) | (5,462) |
Total Cash: | ||
Beginning of period | 28,756 | 10,183 |
End of period | 26,650 | 4,721 |
Supplemental Disclosure of Cash Flow Information: | ||
Interest expense | 3 | 4 |
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Reclassification of 2019 warrants from liability to equity | $ 6,199 | |
Board of Directors Chairman | ||
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Issuance of restricted stock for accrued fees due to a former board member | $ 57 |
General
General | 3 Months Ended |
Mar. 31, 2021 | |
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 months ended March 31, 2021 and 2020 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 for the fiscal year ended December 31, 2020 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2021 and may also be found on the Company’s website (www.delcath.com). In these notes to the condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries. Description of Business We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our lead product candidate, the HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO™, is a drug/device combination product. HEPZATO is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our commercial product is a stand-alone medical device having the same device components as the HEPZATO KIT but without the melphalan hydrochloride. The device is approved for sale under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver. Our clinical development program for HEPZATO is primarily comprised of the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (FOCUS Trial), a global registration clinical trial that is investigating objective response rate in metastatic ocular melanoma, or mOM. We are 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 indications which will maximize the value of the HEPZATO platform. Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, a novel strain of coronavirus that causes Coronavirus disease (COVID-19), the Company experienced an impact on certain areas of its business. These effects included a slowing of patient recruitment in the FOCUS trial and a reduction in the pace at which we can monitor data at our clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data caused our announcement for the top-line data from our FOCUS Trial to shift to early 2021 and to be modified to a preliminary analysis. We now plan to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022 for the treatment of mOM. The ability to achieve this goal is contingent on our ability to monitor data at our clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. We have also experienced an increased volatility in EU commercial product revenue and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity, or capital resources cannot be reasonably estimated at this time. 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 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. 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 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 interim condensed 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 . 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 and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. 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 March 31, 2021 and 2020; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K 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 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 for the fiscal year ended December 31, 2020, except for the following: Reclassifications . Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share. Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes. The list of changes is comprehensive; however the changes will not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. Early adoption of ASU 2019-12 is permitted, including adoption in any interim period for public business entities for periods for which financial statements have not yet been issued. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s financial statements or disclosures. |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 3 Months Ended |
Mar. 31, 2021 | |
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 r estricted cash balances were as follows: March 31, December 31, 2021 2020 Cash and cash equivalents $ 26,600 $ 28,575 Letters of credit — 131 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 26,650 $ 28,756 |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | (3) Inventories Inventories consist of the following: March 31, December 31, 2021 2020 Raw materials $ 486 $ 435 Work-in-process 623 420 Total inventories $ 1,109 $ 855 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2021 | |
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: March 31, December 31, 2021 2020 Clinical trial expenses $ 1,497 $ 1,497 Insurance premiums 498 845 Professional services 125 66 Other 249 262 Total prepaid expenses and other current assets $ 2,369 $ 2,670 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 3 Months Ended |
Mar. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property, Plant, and Equipment | (5) Property, Plant, and Equipment Property, plant, and equipment consist of the following: March 31, December 31, Estimated 2021 2020 Useful Life Buildings and land $ 1,120 $ 1,109 30 years - Buildings Enterprise hardware and software 1,861 1,862 3 years Leaseholds 1,809 1,826 Lesser of lease term or estimated useful life Equipment 1,061 1,063 7 years Furniture 203 204 5 years Property, plant and equipment, gross 6,054 6,064 Accumulated depreciation (4,733 ) (4,713 ) Property, plant and equipment, net $ 1,321 $ 1,351 On July 31, 2020, the Company exercised its option to purchase its 95-97 Park Road office location in Queensbury, NY for $460.3, pursuant to the terms of the lease agreement dated September 17, 2018, as amended on January 29, 2019, and further amended on July 31, 2020. Depreciation expense for the three months ended March 31, 2021 was approximately $38.8 as compared to approximately $47.6 for the same period in 2020. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | (6) Accrued Expenses Accrued expenses consist of the following: March 31, December 31, 2021 2020 Clinical expenses $ 3,511 $ 2,698 Compensation, excluding taxes 1,514 1,598 Professional fees 335 225 Interest on convertible note 274 234 Other 293 486 Total accrued expenses $ 5,927 $ 5,241 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Leases | (7) Leases The Company recognizes right-of-use (“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities under non-cancellable operating and financing leases. 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 three months ended March 31, 2021: US Ireland Total Lease cost Operating lease cost $ 112 $ 57 $ 169 Sublease income — (44 ) (44 ) Total $ 112 $ 13 $ 125 Other information Operating cash flows out from operating leases (112 ) (57 ) (169 ) Operating cash flows in from operating leases - 44 44 Weighted average remaining lease term 1.9 0.3 Weighted average discount rate - operating leases 8 % 8 % Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows: US Ireland Total Year ended December 31, 2021 $ 304 $ 73 $ 377 Year ended December 31, 2022 406 - 406 Year ended December 31, 2023 67 - 67 Total 777 73 850 Less present value discount (59 ) (1 ) (60 ) Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2021 $ 718 $ 72 $ 790 |
Convertible Notes Payable
Convertible Notes Payable | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes Payable | (8) Convertible notes payable Conversion price Current interest rate Principal Current convertible notes payable 8.0% July 2019 Notes (maturity date - July 16, 2021) $ 1,500 8 % $ 2,000 The note payable is convertible into Preferred Stock. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | (9) Stockholders’ Equity Preferred Stock Series E and Series E-1 Preferred Stock During the three months ended March 31, 2021, 150 shares of Preferred Stock were converted into 15,000 shares of the Company’s common stock. As of March 31, 2021, there were an aggregate of 20,481 shares of Series E and Series E-1 Preferred Stock outstanding. Other Common Stock Issuances During the three months ended March 31, 2021, the Company issued 237,520 shares of common stock associated with the exercise of warrants. Issuance of Unregistered Securities In February 2021, the Company issued 2,636 shares of unregistered common stock in lieu of a cash payment of deferred accrued director fees to a former director. Stock Incentive Plans 2020 Omnibus Equity Incentive Plan As of March 31, 2021, there were 675,000 shares of the Company’s common stock reserved under the 2020 Plan, of which 95,000 remained available to be issued. On March 30, 2021, the Company’s Board of Directors approved an amendment of the 2020 Plan to increase the number of shares of the Company’s common stock available for issuance under the 2020 Plan by 1,800,000, subject to stockholder approval of the amendment. The amendment of the 2020 Plan was approved by the stockholders at the Company’s annual meeting of stockholders held on May 6, 2021 and, effective as of such date, the number of shares of the Company’s common stock available for issuance under the 2020 Plan increased by 1,800,000 resulting in a total share reserve of 2,475,000 shares of common stock. Share-Based Compensation The following is a summary of stock option activity under the 2019 Plan and the 2020 Plan for the three months ended March 31, 2021: Number of Option Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 1,078,499 $ 12.68 Granted — — Exercised — — Cancelled/Forfeited — — Outstanding at March 31, 2021 1,078,499 $ 12.68 9.5 $ 710 Exercisable at March 31, 2021 175,164 $ 13.05 9.5 $ 131 The following table summarizes information for stock option shares outstanding and exercisable at March 31, 2021 Options Exercisable Range of Exercise Prices Outstanding Number of Options Weighted Average Remaining Option Term (in years) Number of Options $10 - $15 946,000 9.5 157,665 $15 - $20 81,000 9.5 8,500 $20 - $25 51,000 9.5 8,500 $25+ 499 7.8 499 1,078,499 9.5 175,164 The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2021 Three months ended March 31, 2021 2020 Selling, general and administrative $ 1,466 $ 49 Research and development 630 5 Cost of goods sold 52 — Total $ 2,148 $ 55 At March 31, 2021, there was $6,677 of aggregate unrecognized compensation expense related employee and board stock option grants. This will be recognized over the next 33 months. Warrants The following is a summary of warrant activity for the three months ended March 31, 2021: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 4,236,687 $ 9.13 Warrants issued — — Warrants exercised (242,580 ) 10.00 Warrants expired — — Outstanding at March 31, 2021 3,994,107 $ 9.07 3.9 $ 13,372 Exercisable at March 31, 2021 3,994,107 $ 9.07 3.9 $ 13,372 The following table presents information related to stock warrants at March 31, 2021 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $ 0.01 371,000 4.1 371,000 $ 10.00 3,623,107 3.9 3,623,107 3,994,107 3.9 3,994,107 As of March 31, 2021, warrants to purchase 371,000 shares of the Company’s common stock were pre-funded, and the exercise price was $0.01 per share. The remaining warrants were exercisable at $10.00 per share. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (10) Fair Value Measurements As a result of the expiration of certain provisions in the 2019 Warrants, the $6,199 fair value of the 2019 Warrants was reclassified from liability to equity on February 19, 2020. The fair value of the outstanding warrants at February 19, 2020, the date the 2019 Warrants were no longer classified as a liability, was determined by using option pricing models with the following assumptions: February 19, 2020 Expected life (in years) 4.3 Expected volatility 208.2% Risk-free interest rates 1.4% |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2021 | |
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. The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2021 and 2020 because their effects would be anti-dilutive: March 31, 2021 2020 Stock options 1,078,499 1,640 Common stock warrants - equity 3,994,107 1,826,599 Common stock reserved for conversion of preferred shares 2,048,101 1,799,093 Assumed conversion of convertible notes 146,288 63,493 Total 7,266,995 3,690,825 At March 31, 2021, the Company had 371,000 pre-funded warrants outstanding. The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2021 and 2020: Three months ended March 31, 2021 2020 Weighted average shares issued 6,125,922 72,740 Weighted average pre-funded warrants 371,000 - Weighted average shares outstanding 6,496,922 72,740 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (1 2 ) Commitments and Contingencies Litigation, Claims and Assessments Following the May 18, 2020 resignation (effective June 1, 2020) of Jennifer Simpson, the Company’s former President and Chief Executive Officer, and Barbra Keck, the Company’s former Chief Financial Officer (the “Claimants”), it became evident that there was a dispute regarding the Company’s compensation obligations to the Claimants. In a letter dated June 29, 2020, an attorney representing the Claimants made certain claims and threatened litigation against the Company. On or about July 27, 2020, the Claimants filed a statement of claim with the American Arbitration Association against the Company. The Claimants seek payment of certain purported unpaid compensation amounts claimed to be due to them, in an approximate amount of $1,140 in the aggregate, as well as unspecified statutory damages under New York Labor Law, attorneys’ fees and costs, and statutory interest. The Company intends to defend the claims vigorously. The arbitrator had scheduled hearings to take place during the week of May 17, 2021. However, the Claimants and the Company recently agreed to participate in non-binding mediation of their dispute before a neutral mediator, which resulted in the arbitration proceedings being placed in abeyance pending the outcome of the mediation process. At this time, the mediation process between the Claimants and the Company is ongoing. As of March 31, 2021, the Company has accrued for the full purported unpaid compensation amounts. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | (1 3 ) Subsequent Events Stock Warrant Exercises Subsequent to March 31, 2021, warrants to purchase 6,141 shares of the Company’s common stock with an exercise price of $10.00 per share were exercised for proceeds of $61.4. In addition, pre-funded warrants to purchase 215,000 shares of the Company’s common stock with an exercise price of $0.01 per share were exercised for proceeds of $2.2. Other Transactions In April 2021, the Company issued an invoice for $1,178 to medac, the Company’s EU product distribution partner, for the achievement of the milestone requirement pertaining to the positive results related to the FOCUS trial, as outlined in the License, Supply and Marketing Agreement dated December 10, 2018 between the Company and medac. |
General (Policies)
General (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Risk and Uncertainties | Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, a novel strain of coronavirus that causes Coronavirus disease (COVID-19), the Company experienced an impact on certain areas of its business. These effects included a slowing of patient recruitment in the FOCUS trial and a reduction in the pace at which we can monitor data at our clinical trial sites. The resulting delay in completing enrollment and additional time required to monitor data caused our announcement for the top-line data from our FOCUS Trial to shift to early 2021 and to be modified to a preliminary analysis. We now plan to submit a New Drug Application (NDA) to the FDA in the first quarter of 2022 for the treatment of mOM. The ability to achieve this goal is contingent on our ability to monitor data at our clinical sites and therefore the timeline may shift as access to the clinical sites changes in response to the rapidly evolving situation. We have also experienced an increased volatility in EU commercial product revenue and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity, or capital resources cannot be reasonably estimated at this time. |
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 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. 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 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 interim condensed 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 . |
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 and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. 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 March 31, 2021 and 2020; however, certain information and footnote disclosures normally included in our audited consolidated financial statements included in our Annual Report on Form 10-K 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. |
Reclassifications | Reclassifications . Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes. The list of changes is comprehensive; however the changes will not significantly impact the Company due to the full valuation allowance that is recorded against the Company’s deferred tax assets. Early adoption of ASU 2019-12 is permitted, including adoption in any interim period for public business entities for periods for which financial statements have not yet been issued. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s financial statements or disclosures. |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Cash And Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents, and Restricted Cash | Cash, cash equivalents, and r estricted cash balances were as follows: March 31, December 31, 2021 2020 Cash and cash equivalents $ 26,600 $ 28,575 Letters of credit — 131 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 26,650 $ 28,756 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following: March 31, December 31, 2021 2020 Raw materials $ 486 $ 435 Work-in-process 623 420 Total inventories $ 1,109 $ 855 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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: March 31, December 31, 2021 2020 Clinical trial expenses $ 1,497 $ 1,497 Insurance premiums 498 845 Professional services 125 66 Other 249 262 Total prepaid expenses and other current assets $ 2,369 $ 2,670 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consist of the following: March 31, December 31, Estimated 2021 2020 Useful Life Buildings and land $ 1,120 $ 1,109 30 years - Buildings Enterprise hardware and software 1,861 1,862 3 years Leaseholds 1,809 1,826 Lesser of lease term or estimated useful life Equipment 1,061 1,063 7 years Furniture 203 204 5 years Property, plant and equipment, gross 6,054 6,064 Accumulated depreciation (4,733 ) (4,713 ) Property, plant and equipment, net $ 1,321 $ 1,351 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of the following: March 31, December 31, 2021 2020 Clinical expenses $ 3,511 $ 2,698 Compensation, excluding taxes 1,514 1,598 Professional fees 335 225 Interest on convertible note 274 234 Other 293 486 Total accrued expenses $ 5,927 $ 5,241 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating leases as of and for the three months ended March 31, 2021: US Ireland Total Lease cost Operating lease cost $ 112 $ 57 $ 169 Sublease income — (44 ) (44 ) Total $ 112 $ 13 $ 125 Other information Operating cash flows out from operating leases (112 ) (57 ) (169 ) Operating cash flows in from operating leases - 44 44 Weighted average remaining lease term 1.9 0.3 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: US Ireland Total Year ended December 31, 2021 $ 304 $ 73 $ 377 Year ended December 31, 2022 406 - 406 Year ended December 31, 2023 67 - 67 Total 777 73 850 Less present value discount (59 ) (1 ) (60 ) Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2021 $ 718 $ 72 $ 790 |
Convertible Notes Payable (Tabl
Convertible Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Various Notes Issued | Conversion price Current interest rate Principal Current convertible notes payable 8.0% July 2019 Notes (maturity date - July 16, 2021) $ 1,500 8 % $ 2,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Summary of Stock Option Activity | The following is a summary of stock option activity under the 2019 Plan and the 2020 Plan for the three months ended March 31, 2021: Number of Option Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 1,078,499 $ 12.68 Granted — — Exercised — — Cancelled/Forfeited — — Outstanding at March 31, 2021 1,078,499 $ 12.68 9.5 $ 710 Exercisable at March 31, 2021 175,164 $ 13.05 9.5 $ 131 |
Summary of Stock Option Shares Outstanding and Exercisable | The following table summarizes information for stock option shares outstanding and exercisable at March 31, 2021 Options Exercisable Range of Exercise Prices Outstanding Number of Options Weighted Average Remaining Option Term (in years) Number of Options $10 - $15 946,000 9.5 157,665 $15 - $20 81,000 9.5 8,500 $20 - $25 51,000 9.5 8,500 $25+ 499 7.8 499 1,078,499 9.5 175,164 |
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 months ended March 31, 2021 Three months ended March 31, 2021 2020 Selling, general and administrative $ 1,466 $ 49 Research and development 630 5 Cost of goods sold 52 — Total $ 2,148 $ 55 |
Summary of Warrant Activity | The following is a summary of warrant activity for the three months ended March 31, 2021: Warrants Weighted Average Exercise Price Weighted Average Remaining Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2021 4,236,687 $ 9.13 Warrants issued — — Warrants exercised (242,580 ) 10.00 Warrants expired — — Outstanding at March 31, 2021 3,994,107 $ 9.07 3.9 $ 13,372 Exercisable at March 31, 2021 3,994,107 $ 9.07 3.9 $ 13,372 |
Schedule of Information Related to Stock Warrants Outstanding and Exercisable | The following table presents information related to stock warrants at March 31, 2021 Warrants Exercisable Range of Exercise Prices Outstanding Number of Warrants Weighted Average Remaining Warrant Term (in years) Number of Warrants $ 0.01 371,000 4.1 371,000 $ 10.00 3,623,107 3.9 3,623,107 3,994,107 3.9 3,994,107 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of the outstanding warrants | The fair value of the outstanding warrants at February 19, 2020, the date the 2019 Warrants were no longer classified as a liability, was determined by using option pricing models with the following assumptions: February 19, 2020 Expected life (in years) 4.3 Expected volatility 208.2% Risk-free interest rates 1.4% |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, 2021 and 2020 because their effects would be anti-dilutive: March 31, 2021 2020 Stock options 1,078,499 1,640 Common stock warrants - equity 3,994,107 1,826,599 Common stock reserved for conversion of preferred shares 2,048,101 1,799,093 Assumed conversion of convertible notes 146,288 63,493 Total 7,266,995 3,690,825 |
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 months ended March 31, 2021 and 2020: Three months ended March 31, 2021 2020 Weighted average shares issued 6,125,922 72,740 Weighted average pre-funded warrants 371,000 - Weighted average shares outstanding 6,496,922 72,740 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Cash And Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 26,600 | $ 28,575 | ||
Letters of credit | 131 | |||
Security for credit cards | 50 | 50 | ||
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 26,650 | $ 28,756 | $ 4,721 | $ 10,183 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 486 | $ 435 |
Work-in-process | 623 | 420 |
Total inventories | $ 1,109 | $ 855 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Clinical trial expenses | $ 1,497 | $ 1,497 |
Insurance premiums | 498 | 845 |
Professional services | 125 | 66 |
Other | 249 | 262 |
Total prepaid expenses and other current assets | $ 2,369 | $ 2,670 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 6,054 | $ 6,064 |
Accumulated depreciation | (4,733) | (4,713) |
Property, plant and equipment, net | 1,321 | 1,351 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,120 | 1,109 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,861 | 1,862 |
Property, plant and equipment, estimated useful life | 3 years | |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,809 | 1,826 |
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 | $ 1,061 | 1,063 |
Property, plant and equipment, estimated useful life | 7 years | |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 203 | $ 204 |
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 ($) | Jul. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 |
Property Plant And Equipment [Abstract] | |||
Exercised option to purchase | $ 460,300 | ||
Depreciation expense | $ 38,800 | $ 47,600 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Clinical expenses | $ 3,511 | $ 2,698 |
Compensation, excluding taxes | 1,514 | 1,598 |
Professional fees | 335 | 225 |
Interest on convertible note | 274 | 234 |
Other | 293 | 486 |
Total accrued expenses | $ 5,927 | $ 5,241 |
Leases - Additional Information
Leases - Additional Information (Details) | Mar. 31, 2021 |
Leases [Abstract] | |
Lease term | 12 months |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Lease cost | |
Operating lease cost | $ 169 |
Sublease income | (44) |
Total | 125 |
Other information | |
Operating cash flows out from operating leases | (169) |
Operating cash flows in from operating leases | 44 |
U.S. [Member] | |
Lease cost | |
Operating lease cost | 112 |
Total | 112 |
Other information | |
Operating cash flows out from operating leases | $ (112) |
Weighted average remaining lease term | 1 year 10 months 25 days |
Weighted average discount rate - operating leases | 8.00% |
Ireland [Member] | |
Lease cost | |
Operating lease cost | $ 57 |
Sublease income | (44) |
Total | 13 |
Other information | |
Operating cash flows out from operating leases | (57) |
Operating cash flows in from operating leases | $ 44 |
Weighted average remaining lease term | 3 months 19 days |
Weighted average discount rate - operating leases | 8.00% |
Leases - Schedule of Remaining
Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2021 | $ 377 |
Year ended December 31, 2022 | 406 |
Year ended December 31, 2023 | 67 |
Total | 850 |
Less present value discount | (60) |
Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2021 | 790 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2021 | 304 |
Year ended December 31, 2022 | 406 |
Year ended December 31, 2023 | 67 |
Total | 777 |
Less present value discount | (59) |
Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2021 | 718 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2021 | 73 |
Total | 73 |
Less present value discount | (1) |
Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2021 | $ 72 |
Convertible Notes Payable - Sum
Convertible Notes Payable - Summary of Various Notes Issued (Details) - Convertible Notes Payable [Member] - 8.0% July 2019 Notes [Member] | Mar. 31, 2021USD ($)$ / shares |
Debt Instrument [Line Items] | |
Conversion price | $ / shares | $ 1,500 |
Current interest rate | 8.00% |
Principal | $ | $ 2,000 |
Convertible Notes Payable - S_2
Convertible Notes Payable - Summary of Various Notes Issued (Details) (Parenthetical) | 3 Months Ended |
Mar. 31, 2021 | |
Equity Method Investments And Cost Method Investments [Abstract] | |
Maturity date | Jul. 16, 2021 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Stockholders Equity Note [Line Items] | ||
Conversion of stock shares issued | 15,000 | |
Preferred stock, shares outstanding (in shares) | 20,480 | 20,631 |
Series E Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Conversion of stock preferred shares converted | 150 | |
Preferred stock, shares outstanding (in shares) | 20,481 | |
Series E1 Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Conversion of stock preferred shares converted | 150 | |
Preferred stock, shares outstanding (in shares) | 20,481 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Issuances - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2021shares | |
Stockholders Equity Note [Abstract] | |
Common stock associated with the exercise of warrants | 237,520 |
Stockholders' Equity - Issuance
Stockholders' Equity - Issuance of Unregistered Securities - Additional Information (Details) | 1 Months Ended |
Feb. 28, 2021shares | |
Stockholders Equity Note [Abstract] | |
Issue of unregistered common stock for advisory services | 2,636 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - 2020 Omnibus Equity Incentive Plan [Member] | Mar. 31, 2021shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of common shares reserved for issuance | 675,000 |
Number of common shares remained available to be issued | 95,000 |
Number of increased common shares for future issuance | 1,800,000 |
Maximum [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of common shares reserved for issuance | 2,475,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Stockholders Equity Note [Abstract] | |
Number of Shares, Outstanding | shares | 1,078,499 |
Number of Shares, Outstanding | shares | 1,078,499 |
Number of Shares, Exercisable | shares | 175,164 |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 12.68 |
Weighted Average Exercise Price, Outstanding | $ / shares | 12.68 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 13.05 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 6 months |
Weighted Average Remaining Contractual Term (Years), Exercisable | 9 years 6 months |
Aggregate Intrinsic Value, Outstanding | $ | $ 710 |
Aggregate Intrinsic Value, Exercisable | $ | $ 131 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Shares Outstanding and Exercisable (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 1,078,499 | 1,078,499 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 6 months | |
Number of Shares, Exercisable | 175,164 | |
$10 - $15 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 946,000 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 6 months | |
Number of Shares, Exercisable | 157,665 | |
$15 - $20 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 81,000 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 6 months | |
Number of Shares, Exercisable | 8,500 | |
$20 - $25 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 51,000 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 6 months | |
Number of Shares, Exercisable | 8,500 | |
+ $25 [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding Number of Options | 499 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 7 years 9 months 18 days | |
Number of Shares, Exercisable | 499 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 2,148 | $ 55 |
Selling, General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 1,466 | 49 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 630 | $ 5 |
Cost of Goods Sold [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 52 |
Stockholders' Equity - Share-Ba
Stockholders' Equity - Share-Based Compensation - Additional Information (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Stockholders Equity Note [Abstract] | |
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 6,677 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Warrant Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Warrants outstanding [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 4,236,687 |
Warrants exercised (in shares) | shares | (242,580) |
Outstanding, end of period (in shares) | shares | 3,994,107 |
Exercisable, end of period (in shares) | shares | 3,994,107 |
Warrants, Exercise Price per Share [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 9.13 |
Outstanding, ending of period (in dollars per share) | $ / shares | 9.07 |
Warrants exercised (in dollars per share) | $ / shares | 10 |
Exercisable, (in dollars per share) | $ / shares | $ 9.07 |
Weighted average remaining life | 3 years 10 months 24 days |
Weighted average remaining life, Exercisable | 3 years 10 months 24 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 13,372 |
Aggregate Intrinsic Value, Exercisable | $ | $ 13,372 |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Warrants Outstanding and Exercisable (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,994,107 | 4,236,687 |
Weighted average remaining life | 3 years 10 months 24 days | |
Warrants Exercisable, Number Exercisable | 3,994,107 | |
$0.01 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 371,000 | |
Weighted average remaining life | 4 years 1 month 6 days | |
Warrants Exercisable, Number Exercisable | 371,000 | |
$10.00 [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,623,107 | |
Weighted average remaining life | 3 years 10 months 24 days | |
Warrants Exercisable, Number Exercisable | 3,623,107 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants - Additional Information (Details) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 3,994,107 | 4,236,687 |
Warrant exercise price | $ 10 | |
Prefunded Warrant [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Warrants Outstanding, Number Outstanding | 371,000 | |
Warrant exercise price | $ 0.01 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Thousands | Feb. 19, 2020USD ($) |
Fair Value Disclosures [Abstract] | |
Fair value of warrants reclassified from liability to equity | $ 6,199 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) | Feb. 19, 2020 |
Contractual Term [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrant expiration period | 4 years 3 months 18 days |
Expected Volatility [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 2.082 |
Risk-free Interest Rates [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Warrants measurement input | 0.014 |
Net Loss per Common Share - Ant
Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 7,266,995 | 3,690,825 |
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) | 1,078,499 | 1,640 |
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) | 3,994,107 | 1,826,599 |
Common Stock Reserved For Conversion of Preferred Shares [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,048,101 | 1,799,093 |
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) | 146,288 | 63,493 |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2021shares | |
Earnings Per Share [Abstract] | |
Pre-funded penny warrants outstanding | 371,000 |
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 | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Earnings Per Share [Abstract] | ||
Weighted average shares issued | 6,125,922 | 72,740 |
Weighted average pre-funded warrants | 371,000 | |
Weighted average shares outstanding | 6,496,922 | 72,740 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - Pending Litigation [Member] - USD ($) $ in Thousands | Jul. 27, 2020 | Mar. 31, 2021 |
Loss Contingencies [Line Items] | ||
Unpaid compensation amounts claimed | $ 1,140 | |
Accrued unpaid compensation amounts | $ 1,140 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | Apr. 01, 2021 | Mar. 31, 2021 |
Subsequent Event [Line Items] | ||
Warrant exercise price | $ 10 | |
Proceeds from warrant exercises | $ 2,376,000 | |
Prefunded Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrant exercise price | $ 0.01 | |
Subsequent Event [Member] | Medac [Member] | ||
Subsequent Event [Line Items] | ||
Due from related parties | $ 1,178,000 | |
Agreement date | Dec. 10, 2018 | |
Subsequent Event [Member] | Prefunded Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued to purchase of common stock | 215,000 | |
Warrant exercise price | $ 0.01 | |
Proceeds from warrant exercises | $ 2,200 | |
Stock Warrant Exercises [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued to purchase of common stock | 6,141 | |
Warrant exercise price | $ 10 | |
Proceeds from warrant exercises | $ 61,400 |