Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 12, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Entity File Number | 001-35737 | |
Entity Registrant Name | NORTHWEST BIOTHERAPEUTICS, INC | |
Entity Central Index Key | 0001072379 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 94-3306718 | |
Entity Address, Address Line One | 4800 Montgomery Lane, Suite 800 | |
Entity Address, City or Town | Bethesda | |
Entity Address, Country | MD | |
Entity Address, Postal Zip Code | 20814 | |
City Area Code | 240 | |
Local Phone Number | 497-9024 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | NWBO | |
Security Exchange Name | NONE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 0 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 3,836 | $ 9,983 |
Prepaid expenses and other current assets | 2,473 | 5,528 |
Total current assets | 6,309 | 15,511 |
Non-current assets: | ||
Property, plant and equipment, net | 1,264 | 1,040 |
Construction in progress | 12,748 | 9,074 |
Right-of-use asset, net | 4,929 | 4,489 |
Indefinite-lived intangible asset | 1,292 | 1,292 |
Goodwill | 626 | 626 |
Other assets | 1,053 | 867 |
Total non-current assets | 21,912 | 17,388 |
TOTAL ASSETS | 28,221 | 32,899 |
Current liabilities: | ||
Accounts payable and accrued expenses | 9,271 | 7,380 |
Accounts payable and accrued expenses to related parties and affiliates | 2,989 | 5,363 |
Convertible notes, net | 135 | 3,830 |
Notes payable, net | 7,939 | 2,437 |
Contingent payable derivative liability | 8,322 | 8,275 |
Warrant liability | 282,593 | 354,972 |
Lease liabilities | 305 | 167 |
Investor advances | 767 | |
Total current liabilities | 312,321 | 382,424 |
Non-current liabilities: | ||
Note payable, net of current portion, net | 12,342 | 8,507 |
Lease liabilities, net of current portion | 5,291 | 4,916 |
Total non-current liabilities | 17,633 | 13,423 |
Total liabilities | 329,954 | 395,847 |
COMMITMENTS AND CONTINGENCIES (Note 10) | ||
Stockholders' deficit: | ||
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively | ||
Common stock ($0.001 par value); 1,200,000,000 shares authorized; 891.9 million and 829.6 million shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 892 | 830 |
Additional paid-in capital | 1,022,826 | 1,008,665 |
Stock subscription receivable | (79) | (79) |
Accumulated deficit | (1,325,410) | (1,371,216) |
Accumulated other comprehensive (income) loss | 38 | (1,148) |
Total stockholders' deficit | (301,733) | (362,948) |
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ 28,221 | $ 32,899 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,200,000,000 | 1,200,000,000 |
Common stock, shares issued | 891,900,000 | 829,600,000 |
Common stock, shares outstanding | 891,900,000 | 829,600,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Research and other revenues | $ 350 | $ 216 | $ 1,005 | $ 788 |
Operating costs and expenses: | ||||
Research and development | 3,748 | 17,660 | 16,122 | 24,737 |
General and administrative | 6,651 | 30,433 | 26,909 | 39,297 |
Total operating costs and expenses | 10,399 | 48,093 | 43,031 | 64,034 |
Loss from operations | (10,049) | (47,877) | (42,026) | (63,246) |
Other income (expense): | ||||
Change in fair value of derivative liabilities | 58,473 | (138,969) | 93,536 | (175,170) |
Loss from extinguishment of debt | (2,994) | (144) | (4,260) | |
Interest expense | (1,604) | (5,540) | (3,858) | (7,224) |
Inducement expense | (314) | (314) | ||
Foreign currency transaction gain (loss) | (987) | 1,284 | (1,388) | 378 |
Total other income (loss) | 55,568 | (146,219) | 87,832 | (186,276) |
Net income (loss) | 45,519 | (194,096) | 45,806 | (249,522) |
Other comprehensive income (loss) | ||||
Foreign currency translation adjustment | 836 | (1,240) | 1,186 | (477) |
Total comprehensive income (loss) | $ 46,355 | $ (195,336) | $ 46,992 | $ (249,999) |
Net earnings (loss) per share applicable to common stockholders Basic | $ 0.05 | $ (0.26) | $ 0.05 | $ (0.36) |
Net earnings (loss) per share applicable to common stockholders Diluted | $ (0.01) | $ (0.26) | $ (0.04) | $ (0.36) |
Weighted average shares used in computing basic earnings (loss) per share | 875,963 | 747,749 | 854,276 | 695,423 |
Weighted average shares used in computing diluted earnings (loss) per share | 1,135,762 | 747,749 | 1,099,598 | 695,423 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Subscription Receivable | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Balance at Dec. 31, 2019 | $ 614 | $ 794,900 | $ (10) | $ (841,395) | $ 836 | $ (45,055) |
Balance (in shares) at Dec. 31, 2019 | 614,292 | |||||
Issuance of common stock and warrants for cash in a registered direct offering (net of warrant liability, and cash offering cost) | $ 86 | 8,792 | (16) | 8,862 | ||
Issuance of common stock and warrants for cash in a registered direct offering (net of warrant liability, and cash offering cost) (in shares) | 85,756 | |||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 43 | 13,383 | 13,426 | |||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 42,764 | |||||
Reclassification of warrant liabilities related to warrants exercised for cash | 11,228 | 11,228 | ||||
Warrants exercised for cash | $ 35 | 9,591 | 9,626 | |||
Warrants exercised for cash (in shares) | 34,746 | |||||
Cashless warrants exercise | 222 | |||||
Reclassification of warrant liabilities related to cashless warrants exercise | 133 | 133 | ||||
Beneficial conversion feature related to amended convertible note | 44 | 44 | ||||
Stock-based compensation | $ 2 | 39,305 | 39,307 | |||
Stock-based compensation (in shares) | 1,923 | |||||
Net income (loss) | (249,522) | (249,522) | ||||
Cumulative translation adjustment | (477) | (477) | ||||
Balance at Sep. 30, 2020 | $ 780 | 877,376 | (26) | (1,090,917) | 359 | (212,428) |
Balance (in shares) at Sep. 30, 2020 | 779,703 | |||||
Balance at Jun. 30, 2020 | $ 722 | 811,526 | (31) | (896,821) | 1,599 | (83,005) |
Balance (in shares) at Jun. 30, 2020 | 722,158 | |||||
Issuance of common stock and warrants for cash in a registered direct offering (net of warrant liability, and cash offering cost) | $ 18 | 3,891 | 3,909 | |||
Issuance of common stock and warrants for cash in a registered direct offering (net of warrant liability, and cash offering cost) (in shares) | 17,177 | |||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 20 | 8,758 | 8,778 | |||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 20,146 | |||||
Reclassification of warrant liabilities related to warrants exercised for cash | 8,507 | 8,507 | ||||
Warrants exercised for cash | $ 19 | 5,610 | 5,629 | |||
Warrants exercised for cash (in shares) | 19,050 | |||||
Cashless warrants exercise | 222 | |||||
Reclassification of warrant liabilities related to cashless warrants exercise | 133 | 133 | ||||
Beneficial conversion feature related to amended convertible note | 44 | 44 | ||||
Proceeds from investor to offset subscription receivable | 5 | 5 | ||||
Stock-based compensation | $ 1 | 38,907 | 38,908 | |||
Stock-based compensation (in shares) | 950 | |||||
Net income (loss) | (194,096) | (194,096) | ||||
Cumulative translation adjustment | (1,240) | (1,240) | ||||
Balance at Sep. 30, 2020 | $ 780 | 877,376 | (26) | (1,090,917) | 359 | (212,428) |
Balance (in shares) at Sep. 30, 2020 | 779,703 | |||||
Balance at Dec. 31, 2020 | $ 830 | 1,008,665 | (79) | (1,371,216) | (1,148) | (362,948) |
Balance (in shares) at Dec. 31, 2020 | 829,631 | |||||
Issuance of common stock for cash | 16 | 16 | ||||
Issuance of common stock for cash ( in shares) | 69 | |||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 5 | 7,495 | 7,500 | |||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 5,145 | |||||
Warrants and stock options exercised for cash | $ 50 | 12,058 | 12,108 | |||
Warrants and stock options exercised for cash (in shares) | 50,340 | |||||
Reclassification of warrant liabilities related to warrants exercised for cash | 34,412 | 34,412 | ||||
Cashless warrants and stock options exercise | $ 7 | (7) | ||||
Cashless warrants and stock options exercise (in shares) | 6,627 | |||||
Reclassification of warrant liabilities related to cashless warrants exercise | 1,596 | 1,596 | ||||
Reclassification of warrant liabilities based on authorized shares | (56,114) | (56,114) | ||||
Stock-based compensation | 14,705 | 14,705 | ||||
Stock-based compensation (in shares) | 48 | |||||
Net income (loss) | 45,806 | 45,806 | ||||
Cumulative translation adjustment | 1,186 | 1,186 | ||||
Balance at Sep. 30, 2021 | $ 892 | 1,022,826 | (79) | (1,325,410) | 38 | (301,733) |
Balance (in shares) at Sep. 30, 2021 | 891,860 | |||||
Balance at Jun. 30, 2021 | $ 857 | 1,021,107 | (79) | (1,370,929) | (798) | (349,842) |
Balance (in shares) at Jun. 30, 2021 | 857,230 | |||||
Reclassification of warrant liabilities related to warrants exercised for cash | 23,018 | 23,018 | ||||
Warrants exercised for cash | $ 34 | 8,001 | 8,035 | |||
Warrants exercised for cash (in shares) | 34,142 | |||||
Cashless warrants and stock options exercise | $ 1 | (1) | ||||
Cashless warrants and stock options exercise (in shares) | 488 | |||||
Reclassification of warrant liabilities related to cashless warrants exercise | 4 | 4 | ||||
Reclassification of warrant liabilities based on authorized shares | (30,566) | (30,566) | ||||
Stock-based compensation | 1,263 | 1,263 | ||||
Net income (loss) | 45,519 | 45,519 | ||||
Cumulative translation adjustment | 836 | 836 | ||||
Balance at Sep. 30, 2021 | $ 892 | $ 1,022,826 | $ (79) | $ (1,325,410) | $ 38 | $ (301,733) |
Balance (in shares) at Sep. 30, 2021 | 891,860 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT (Parenthetical) - Direct Offering - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Warrant liability | $ 1.4 | $ 8 |
Payments of Stock Issuance Costs | $ 0.2 | $ 0.6 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows from Operating Activities: | ||
Net income (loss) | $ 45,806 | $ (249,522) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation and amortization | 240 | 33 |
Amortization of debt discount | 1,721 | 1,991 |
Change in fair value of derivatives | (93,536) | 175,170 |
Loss from extinguishment of debt | 144 | 4,260 |
Inducement expense | 314 | |
Amortization of operating lease right-of-use asset | 206 | 249 |
Stock-based compensation for services | 14,632 | 39,307 |
Non-cash interest expense | 4,270 | |
Subtotal of non-cash charges | (76,279) | 225,280 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 3,113 | 146 |
Other non-current assets | (198) | (12) |
Accounts payable and accrued expenses | 2,351 | 986 |
Related party accounts payable and accrued expenses | (1,845) | 1,080 |
Lease liabilities | (1) | 152 |
Net cash used in operating activities | (27,053) | (21,890) |
Cash Flows from Investing Activities: | ||
Purchase of equipment and construction in progress | (4,462) | (3,548) |
Acquisition of Flaskworks, net of cash | (1,560) | |
Net cash used in investing activities | (4,462) | (5,108) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common stock and warrants in a registered direct offering, net | 16 | 16,893 |
Proceeds from exercise of warrants and stock options | 12,108 | 9,626 |
Proceeds from issuance of notes payable, net | 13,574 | 8,557 |
Proceeds from warrants modification | 4 | |
Proceeds from issuance of convertible notes payable, net | 3,190 | |
Proceeds from issuance of convertible notes payable to related party | 315 | |
Investor advances | 767 | |
Repayment of notes payable | (2,003) | (1,556) |
Repayment of notes payable to related parties | (64) | |
Repayment of convertible notes payable | (89) | |
Net cash provided by financing activities | 24,462 | 36,876 |
Effect of exchange rate changes on cash and cash equivalents | 906 | (1,000) |
Net (decrease) increase in cash and cash equivalents | (6,147) | 8,878 |
Cash and cash equivalents, beginning of the period | 9,983 | 372 |
Cash and cash equivalents, end of the period | 3,836 | 9,250 |
Supplemental schedule of non-cash investing and financing activities: | ||
Unpaid consideration related to Flaskworks acquisition | 465 | |
Cashless warrants and stock options exercise | 7 | |
Reclassification of warrant liabilities related to warrants exercised for cash | 34,412 | 11,228 |
Reclassification of warrant liabilities related to cashless warrants exercise | 1,596 | 133 |
Reclassification of warrant liabilities based on authorized shares | 56,114 | |
Issuance of common stock and warrants for conversion of debt and accrued interest | 7,487 | 6,850 |
Offering cost related to warrant liability | 3,749 | |
Capital expenditures included in accounts payable | 327 | 954 |
Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates | 559 | 1,294 |
Issuance of common shares to settle accrued service liability | 73 | |
Issuance of warrants in connection with debt modification | 395 | |
Warrant modification in connection with debt amendment | 91 | |
Beneficial conversion feature related to amended convertible note | 44 | |
Notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments | $ (506) | |
Convertible notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments | (11) | |
Related Party | ||
Supplemental schedule of non-cash investing and financing activities: | ||
Issuance of warrants in conjunction with convertible note payable | 153 | |
Related Party | Notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments | $ (9) |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2021 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks L.L.C., NW Bio GmbH, Aracaris Ltd, Aracaris Capital, Ltd, and Northwest Biotherapeutics B.V. (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company is headquartered in Bethesda, Maryland and has wholly owned subsidiaries in the U.K., in the Netherlands, and in Boston, Massachusetts. The Company relies upon contract manufacturers for production of its DCVax products, research and development services, distribution and logistics, and related services, in compliance with the Company’s specifications and the applicable regulatory requirements. |
Financial Condition, Going Conc
Financial Condition, Going Concern and Management Plans | 9 Months Ended |
Sep. 30, 2021 | |
Financial Condition, Going Concern and Management Plans | |
Financial Condition, Going Concern and Management Plans | 2. Financial Condition, Going Concern and Management Plans The Company has incurred annual net operating losses since its inception. The Company had a net income of $45.8 $47.7 The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all. Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date of this filing. The condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty. As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation. The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2021, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2021 and 2020, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at December 31, 2020 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s annual report on Form 10-K (the “2020 Annual Report”), which was filed with the SEC on March 31, 2021. Use of Estimates In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include recoverability and useful lives (indefinite) of intangible asset, assessment of impairment of goodwill, valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets and whether impairment charges may apply. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the 2020 Annual Report. Recently Adopted Accounting Standards Income Taxes In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. On January 1, 2021, the Company adopted this standard without any material impact on its condensed consolidated financial statements and related disclosures. Debt In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted, but no earlier than fiscal years beginning after December 15, 2020. This update permits the use of either the modified retrospective or fully retrospective method of transition. The Company has adopted the new standard as of January 1, 2021, and the adoption did not have a significant effect on the condensed consolidated financial statements and related disclosures. Recently Issued Accounting Standards Not Yet Adopted Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. This ASU will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The adoption of ASU 2021-04 is not expected to have a material impact on the Company’s financial statements or disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the outstanding warrants and certain embedded conversion feature associated with convertible debt on a recurring basis to determine the fair value of the liability. ASC 820 also establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below: Level 1 - Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date Level 2 - Quoted prices in markets that are not active or inputs which are either directly or indirectly observable Level 3 - Unobservable inputs for the instrument requiring the development of assumptions by the Company The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2021 and December 31, 2020 (in thousands): Fair value measured at September 30, 2021 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs September 30, 2021 (Level 1) (Level 2) (Level 3) Warrant liability $ 282,593 $ — $ — $ 282,593 Contingent payable derivative liability 8,322 — — 8,322 Total fair value $ 290,915 $ — $ — $ 290,915 Fair value measured at December 31, 2020 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2020 (Level 1) (Level 2) (Level 3) Warrant liability $ 354,972 $ — $ — $ 354,972 Embedded conversion option 2,507 — — 2,507 Contingent payable derivative liability 8,275 — — 8,275 Total fair value $ 365,754 $ — $ — $ 365,754 There were no transfers between Level 1, 2 or 3 during the nine-month period ended September 30, 2021. The following table presents changes in Level 3 liabilities measured at fair value for the nine-month period ended September 30, 2021. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands). Warrant Embedded Contingent Payable Liability Conversion Option Derivative Liability Total Balance - January 1, 2021 $ 354,972 $ 2,507 $ 8,275 $ 365,754 Additional warrant liability 516 — — 516 Reclassification of warrant liabilities 20,106 — — 20,106 Debt conversion — (1,925) — (1,925) Change in fair value (93,001) (582) 47 (93,536) Balance - September 30, 2021 $ 282,593 $ (0) $ 8,322 $ 290,915 A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of September 30, 2021 and December 31, 2020 is as follows: As of September 30, 2021 Warrant Contingent Payable Liability Derivative Liability Strike price $ 0.28 $ 1.28 Contractual term (years) 1.0 1.5 Volatility (annual) 79 % 101 % Risk-free rate 0.2 % 0.2 % Dividend yield (per share) 0 % 0 % * As of December 31, 2020 Warrant Embedded Contingent Payable Liability Conversion Option Derivative Liability Strike price $ 0.28 $ 0.59 $ 1.53 Contractual term (years) 1.6 0.9 1.4 Volatility (annual) 116 % 106 % 126 % Risk-free rate 0.2 % 0.1 % 0.1 % Dividend yield (per share) 0 % 0 % 0 % * Contingent based on stock price as of December 31, 2020. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-based Compensation | |
Stock-based Compensation | 5. Stock-based Compensation The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2021 and 2020 (in thousands). The general and administrative expense and research and development expense during the three and nine months ended September 30, 2021 and 2020 relate to the applicable portion vesting during this period of stock option awards made in the past to directors, employees, SAB members and consultants. For the three months ended For the nine months ended September 30, 2021, September 30, 2021, 2021 2020 2021 2020 Research and development $ 982 $ 14,206 $ 7,224 $ 14,191 General and administrative 281 24,702 7,408 25,116 Total stock-based compensation expense $ 1,263 $ 38,908 $ 14,632 $ 39,307 The total unrecognized compensation cost was approximately $3.2 million as of September 30, 2021 and will be recognized over the next 1.5 years. Stock Options The following table summarizes stock option activity for the Company’s option plans during the nine months ended September 30, 2021 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Exercise Contractual Life Total Intrinsic Shares Price (in years) Value Outstanding as of January 1, 2021 308,840 $ 0.33 8.9 $ 372,219 Granted 910 0.92 8.9 Cash exercised (183) 0.25 — — Cashless exercise (4,376) 0.25 — — Forfeited/expired — — — — Outstanding as of September 30, 2021 305,191 $ 0.33 8.2 $ 290,517 Options vested (1) 279,875 $ 0.32 8.2 $ 268,218 (1) Approximately 239.3 million options are not exercisable until at least November 30, 2021. Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, are subject to an agreement under which they cannot exercise any options or warrants except upon at least 61 days’ prior notice. |
Outstanding Debt
Outstanding Debt | 9 Months Ended |
Sep. 30, 2021 | |
Outstanding Debt | |
Outstanding Debt | 6. Outstanding Debt The following two tables summarize outstanding debt as of September 30, 2021 and December 31, 2020, respectively (amount in thousands): Stated Interest Conversion Remaining Carrying Maturity Date Rate Price Face Value Debt Discount Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ 135 135 — 135 Short term notes payable 8% unsecured Various 8 % N/A 4,248 (214) 4,034 9% unsecured Various 9 % N/A 3,297 (95) 3,202 12% unsecured On Demand 12 % N/A 703 — 703 8,248 (309) 7,939 Long term notes payable 1% unsecured Various 1 % N/A 433 — 433 8% unsecured 12/31/2022 8 % N/A 11,005 (686) 10,319 6% secured 3/25/2025 6 % N/A 1,590 — 1,590 13,028 (686) 12,342 Ending balance as of September 30, 2021 $ 21,411 $ (995) $ 20,416 Stated Embedded Interest Conversion Remaining Conversion Carrying Maturity Date Rate Price Face Value Debt Discount Option Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured 4/30/2021 8 % $ 0.85 2,125 (937) 2,507 3,695 2,260 (937) 2,507 3,830 Short term notes payable 8% unsecured Various 8 % N/A 1,785 (51) — 1,734 10% unsecured Various 10 % N/A 263 — — 263 12% unsecured On Demand 12 % N/A 440 — — 440 2,488 (51) — 2,437 Long term notes payable 8% unsecured Various 8 % N/A 7,160 (496) — 6,664 6% secured 3/25/2025 6 % N/A 1,843 — — 1,843 9,003 (496) — 8,507 Ending balance as of December 31, 2020 $ 13,751 $ (1,484) $ 2,507 $ 14,774 On March 1, 2021, the Company entered into a Commercial Loan Agreement (the “Commercial Loan”) with a commercial lender for an aggregate principal amount of $10 million. The Commercial Loan bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first 8 months of the term. The Commercial Loan is amortized in 14 installments starting on November 1, 2021. The Commercial Loan carries an original issue discount of $1 million. In April 2021, the Company received two additional loans under the Coronavirus Aid, Relief and Economic Security (“CARES”) Act’s Paycheck Protection Program (“PPP”). The two PPP loans were received on April 9, 2021 in the amount of $0.4 million total. The current terms of the PPP loan is five years with a maturity date of March 2026 and it contains a favorable fixed annual interest rate of 1.00%. Payments of principal and interest on the PPP Loan are deferred for the first 10 months of the term of the PPP Loan. The Company is using the loan to make payments for payroll, health and disability insurance and rent. Between June and August, 2021, the Company entered into four-month note agreements (the “Notes”) with various individual lenders (the “Holders”) with an aggregate principal amount of $3.3 million for net proceeds of $3.1 million. The Notes contain a conditional piggy-back right to independently purchase shares from the Company, which provides a right for the Holders, contingent on the release of clinical trial data and a next private placement offering (“Next Offering”) after this release, to (a) purchase shares from the Company within seven days following such Next Offering at a 12% discount from the share price of the Next Offering for a variable number of shares equal to an amount up to 50% of the principal amount of the loan (the “Contingent Right”)and (b) exchange some or all of the outstanding loan amount for a variable number of shares, within seven days after the Next Offering at a 12% discount, resulting in a reduced cash amount repayable under the loan agreement (the “Contingent share-settled redemption feature”). The Company accounted for the Contingent Right as a freestanding financial instrument, which was classified as a warrant liability at fair value on the Consolidated Balance Sheet with changes in fair value recognized in the Consolidated Statement of Operations. The Company accounted for Contingent Share-settled Redemption Feature as an embedded derivative liability at fair value which requires to be bifurcated, and with changes in fair value recognized in the Consolidated Statement of Operations. During the nine months ended September 30, 2021, $5.6 million of debt and interest was independently exchanged by the lender into 5.1 million shares of common stock and 0.8 million warrants. The fair value of common stock and warrants for these conversions were approximately $7.5 million, extinguishing approximately $1.9 million in liability from the note conversions. During the nine months ended September 30, 2021, the Company made an aggregate $2.0 million cash payment on the existing outstanding notes. For the three months ended September 30, 2021 and 2020, interest expense related to notes payable totaled approximately $0.9 million and $1.3 million including amortization of debt discounts totaling $0.4 million and $0.9 million, respectively. For the nine months ended September 30, 2021 and 2020, interest expense related to notes payable totaled approximately $3.1 million and $2.9 million including amortization of debt discounts totaling $1.7 million and $2 million, respectively. |
Net Earnings (Loss) per Share A
Net Earnings (Loss) per Share Applicable to Common Stockholders | 9 Months Ended |
Sep. 30, 2021 | |
Net Earnings (Loss) per Share Applicable to Common Stockholders | |
Net Earnings (Loss) per Share Applicable to Common Stockholders | 7. Net Earnings (Loss) per Share Applicable to Common Stockholders Basic earnings (loss) per common share is computed by dividing net earnings (loss) by the weighted average number of common shares outstanding during the reporting period. Diluted earnings (loss) per common share is computed similar to basic earnings (loss) per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Diluted weighted average common shares include common stock potentially issuable under the Company’s convertible notes, warrants and vested and unvested stock options. For the three and nine months ended September 30, 2021, net income is adjusted for gain from change in fair value of warrant liabilities. The following table sets forth the computation of earnings (loss) per share (amounts in thousands): For the three months ended For the nine months ended September 30, 2021 September 30, 2021 2021 2020 2021 2020 Net earnings (loss) - basic $ 45,519 $ (194,096) $ 45,806 $ (249,522) Reversal of gain due to change in fair value of warrant liability (58,473) — (93,536) — Net loss - diluted (12,954) (194,096) (47,730) (249,522) Weighted average shares outstanding - basic 875,963 747,749 854,276 695,423 Diluted shares- Options 40,189 — 41,773 — Diluted shares- Warrants 219,535 — 203,474 — Convertible notes and interest 75 — 75 — Weighted average shares outstanding - diluted 1,135,762 747,749 1,099,598 695,423 The following securities were not included in the diluted net earnings (loss) per share calculation because their effect was anti-dilutive as of the periods presented (in thousands): For the nine months ended September 30, 2021 2021 2020 Common stock options 263,418 304,009 Common stock warrants 74,292 341,798 Convertible notes and accrued interest — 16,193 Potentially dilutive securities 337,710 662,000 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions | |
Related Party Transactions | 8. Related Party Transactions Advent BioServices Agreement The Company has a Manufacturing Services Agreement with Advent BioServices (“Advent”) for the manufacture of DCVax-L products at an existing facility in London, as previously reported. The Company also has an Ancillary Services Agreement with Advent, which establishes a structure under which Advent submits Statements of Work (“SOWs”) for activities related to the development of the Sawston facility and the compassionate use activities in the UK, as previously reported. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company extended the initial term by 12 months to July 2021, with no other changes, and recently extended the term for another 12 months to July 2022. Related Party Expenses and Accounts Payable During the three months ended September 30, 2021 and 2020, the Company recognized approximately $1.7 million and $1.4 million, respectively, in research and development costs from Advent. During the nine months ended September 30, 2021 and 2020, the Company recognized approximately $5.1 million and $4.2 million, respectively, in research and development costs from Advent. Additionally, during the nine months ended September 30, 2021 and 2020, the Company capitalized $2.3 million and $1.3 million costs, invoiced by Advent, related to the Sawston buildout. Some of these amounts have been paid and some have not been paid. The following table summarizes outstanding unpaid accounts payable and accrued expenses held by related parties as of September 30, 2021 and December 31, 2020 (amount in thousands). These unpaid amounts include part of the expenses reported in the above section and also certain expenses incurred in prior periods. September 30, 2021 December 31, 2020 Advent BioServices – amount invoiced $ 1,173 $ 3,734 Advent BioServices – amount accrued 1,816 1,629 Accounts payable and accrued expenses to Advent BioServices $ 2,989 $ 5,363 |
Stockholders' Deficit
Stockholders' Deficit | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Deficit | |
Stockholders' Deficit | 9. Stockholders’ Deficit Common Stock Warrants and Stock Options Exercised for Cash During the nine months ended September 30, 2021, the Company received $12.1 million from the exercise of warrants and stock options issued in the past with an exercise price between $0.175 and $0.40. The Company issued approximately 50.3 million shares of common stock upon these warrant and stock option exercises. The Company also received approximate $0.8 million cash proceeds from investors prior to September 30, 2021, for which the corresponding exercise agreement was not finalized and thus, common stock totaling 3.4 million was not issued as of September 30, 2021. Accordingly, such amounts are included in Investor advances in the accompanying condensed consolidated balance sheet as of September 30, 2021. The Company also entered into certain warrant exercise agreement which contains conditional piggy-back right to purchase shares (the “Piggy-back Right”). In exchange for the exercise, Company agrees that if the Company (i) publicly releases top line data from the Phase III trial of its DCVax®-L vaccine (such eventuality, the “Release”) and (ii) consummates the first offering of its common stock following such Release (the “Next Offering”) then Holder shall have the right, at its sole option exercisable within seven (7) days following the Next Offering, to piggy-back on the Next Offering by independently purchasing from Company up to a number of shares equal in value to 50% of the Total Exercise Amount provided that: the price per share paid by Holder shall be equal to the Next Offering price per share less 12%. The Piggy-back Right was given to the holders as an inducement offer (a sweetener) in order for the holders to exercise the warrants. The Company recognized approximately $0.3 million inducement expense during the nine months ended September 30, 2021. Warrants and Stock Options Cashless Exercise During the nine months ended September 30, 2021, certain warrant and stock option holders elected to cashless exercise some of their warrants and stock options, with exercise prices between $0.22 and $0.52. The Company issued approximately 6.6 million shares of common stock upon 8 million warrants and stock options exercises. Stock Purchase Warrants The following is a summary of warrant activity for the nine months ended September 30, 2021 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2021 331,753 $ 0.28 1.61 Warrants granted 774 2.00 Warrants exercised for cash (50,156) 0.24 Cashless warrrants exercised (3,581) 0.24 Warrants expired and cancelled (1,024) 2.95 Outstanding as of September 30, 2021 277,766 $ 0.28 1.00 Warrants and Options Suspension The options and warrants held by Ms. Powers and Mr. Goldman are subject to an ongoing suspension on a rolling basis pursuant to the Blocker Letter. In addition, other executive officers and directors extended their suspensions from September 30, 2021 until October 31, 2021, and from October 31 to at least November 30, 2021. At September 30, 2021, approximately a total of 247.3 million options and 58.4 million warrants were under block or suspension agreements. At October 31, 2021, approximately a total of 239.3 million options and 59.7 million warrants were under block or suspension until at least November 30, 2021. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 10. Commitments and Contingencies Operating Lease The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected the practical expedient to account for each separate lease component of a contract and its associated non-lease components as a single lease component, thus causing all fixed payments to be capitalized. The Company also elected the package of practical expedients permitted within the new standard, which among other things, allows the Company to carry forward historical lease classification. The lease renewal options have not been included in the calculation of the lease liabilities and right-of-use (“ROU”) assets as the Company has not yet determined whether to exercise the options. Variable lease payment amounts that cannot be determined at the commencement of the lease such as increases in lease payments based on changes in index rates or usage, are not included in the ROU assets or liabilities. These are expensed as incurred and recorded as variable lease expense. On March 8, 2021, the Company extended its office lease in the U.S for additional three years and five months under an amended agreement. The extension included a waiver of any rent payment for the initial five-month extension period as well as insignificant change to monthly rent costs for the remainder of the lease. The Company recognized additional $0.7 million ROU assets and lease liabilities for its amended office lease in the U.S. At September 30, 2021, the Company had operating lease liabilities of approximately $5.6 million for both the 20-year lease of the building for the manufacturing facility in Sawston, U.K., and the current office lease in the U.S. ROU assets of approximately $4.9 million for the Sawston lease and US office lease are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases (amount in thousands): For the Nine Months ended September 30, 2021 U.K U.S Total Lease cost Operating lease cost $ 493 $ 212 $ 705 Short-term lease cost 38 — 38 Variable lease cost 48 5 53 Total $ 579 $ 217 $ 796 Other information Operating cash flows from operating leases $ (519) $ (84) $ (603) Weighted-average remaining lease term – operating leases 9.1 1.9 Weighted-average discount rate – operating leases 12 % 12 % The Company recorded lease costs as a component of general and administrative expense during the nine months ended September 30, 2021 and 2020, respectively. Maturities of the operating leases, excluding short-term leases, are as follows: Three months ended December 31, 2021 $ 239 Year ended December 31, 2022 963 Year ended December 31, 2023 972 Year ended December 31, 2024 878 Thereafter 9,401 Total 12,453 Less present value discount (6,857) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2021 $ 5,596 Manufacturing Services Agreements Advent BioServices On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The Advent Agreement provides for manufacturing of DCVax-L products at an existing facility in London. The Agreement is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The Advent Agreement provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity for DCVax production, and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. Either party may terminate the MSA on 12 months’ notice, to allow for transition arrangements by both parties. On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for U.K. Facility Development Activities and Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent develops Statements of Work (“SOWs”) for the U.K. Facility Development Activities and Compassionate Use Program Activities, and delivers those SOWs to the Company for review and approval. After an SOW is approved by the Company, Advent will proceed with or continue the applicable services and will invoice the Company pursuant to the SOW. Since both the U.K. Facility Development and the Compassionate Use Program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus fifteen percent. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company extended the term by 12 months to July 2021, with no other changes, and recently extended it for another 12 months to July 2022. German Tax Matter The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015. The NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. The Company provided documentation and accrued for a proposed settlement offer, that included €346,000 (approximately $406,000 as of December 31, 2020) for the years under audit, with an additional €101,000 (approximately $118,000) for the more recent years to date. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €277,000 (approximately $329,000), for corporate taxes, interest, and reduced penalty for the period under audit, which the Company paid on September 2, 2021. The Company also received and paid the final settlement bill from the local authority for trade taxes for the audit period in the amount of €231,000 (approximately $272,000). The Company estimated €100,528 (approximately $117,000) for the expected taxes and interest owed for more recent periods and has sufficient accruals. On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (approximately $595,000) on reimbursable withholding taxes that had been waived during the settlement process. While the Company has accrued for this new amount, we believe this new bill is not consistent with the settlement that was reached with the federal and city officials earlier this year, and the Company plans to appeal. Based on the negotiations, the Company concluded based on its evaluation under ASC 740, it is in the view of the Company that the resolution of these tax matters will not more likely than not ultimately result in a net material charge to the Company. |
Revision to Prior Period Financ
Revision to Prior Period Financial Statements | 9 Months Ended |
Sep. 30, 2021 | |
Revision to Prior Period Financial Statements | |
Revision to Prior Period Financial Statements | 11. Subsequent Events In total, the Company received $8.2 million from exercises of warrants and issuance of notes between October 1, 2021 and November 12, 2021. During October and November 2021, 34.8 million shares of common stock were issued upon warrant exercises of $6.9 million. Approximately 0.9 million shares of common stock are pending to be issued. During October 2021, the Company entered into multiple four-month note agreements (the “Notes”) with various individual lenders (the “Holders”) with an aggregate principal amount of $1.14 million for net proceeds of $1.1 million. The Notes contain a conditional piggy-back right to independently purchase shares from the Company, which provides a right for the Holders, contingent on the release of clinical trial data and the next private placement offering (“Next Offering”) after this release, to (a) purchase shares from the Company within seven days following such Next Offering at a 12% discount from the share price of the Next Offering for a variable number of shares equal to an amount up to 50% of the principal amount of the loan and (b) exchange some or all of the outstanding loan amount for a variable number of shares, within seven days after the Next Offering at a 12% discount, resulting in a reduced cash amount repayable under the loan agreement. In October 2021, the Company entered into multiple note extension agreements whereby the maturity date of the notes was extended for additional 2-4 months. On October 31, 2021, the Company further extended the suspension of approximately 297.6 million warrants and options held by the Company’s certain officers and board of directors until at least November 30, 2021. Additionally, certain investors also agreed to suspend total 1.4 million warrants until February and April 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation. The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2021, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2021 and 2020, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at December 31, 2020 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s annual report on Form 10-K (the “2020 Annual Report”), which was filed with the SEC on March 31, 2021. |
Use of Estimates | Use of Estimates In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include recoverability and useful lives (indefinite) of intangible asset, assessment of impairment of goodwill, valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets and whether impairment charges may apply. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the 2020 Annual Report. |
Recently Adopted & Issued Accounting Standards | Recently Adopted Accounting Standards Income Taxes In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. On January 1, 2021, the Company adopted this standard without any material impact on its condensed consolidated financial statements and related disclosures. Debt In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted, but no earlier than fiscal years beginning after December 15, 2020. This update permits the use of either the modified retrospective or fully retrospective method of transition. The Company has adopted the new standard as of January 1, 2021, and the adoption did not have a significant effect on the condensed consolidated financial statements and related disclosures. Recently Issued Accounting Standards Not Yet Adopted Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. This ASU will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The adoption of ASU 2021-04 is not expected to have a material impact on the Company’s financial statements or disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of fair value assets and liabilities measured on recurring basis | The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2021 and December 31, 2020 (in thousands): Fair value measured at September 30, 2021 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs September 30, 2021 (Level 1) (Level 2) (Level 3) Warrant liability $ 282,593 $ — $ — $ 282,593 Contingent payable derivative liability 8,322 — — 8,322 Total fair value $ 290,915 $ — $ — $ 290,915 Fair value measured at December 31, 2020 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2020 (Level 1) (Level 2) (Level 3) Warrant liability $ 354,972 $ — $ — $ 354,972 Embedded conversion option 2,507 — — 2,507 Contingent payable derivative liability 8,275 — — 8,275 Total fair value $ 365,754 $ — $ — $ 365,754 |
Schedule of Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation | The following table presents changes in Level 3 liabilities measured at fair value for the nine-month period ended September 30, 2021. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands). Warrant Embedded Contingent Payable Liability Conversion Option Derivative Liability Total Balance - January 1, 2021 $ 354,972 $ 2,507 $ 8,275 $ 365,754 Additional warrant liability 516 — — 516 Reclassification of warrant liabilities 20,106 — — 20,106 Debt conversion — (1,925) — (1,925) Change in fair value (93,001) (582) 47 (93,536) Balance - September 30, 2021 $ 282,593 $ (0) $ 8,322 $ 290,915 |
Schedule of Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques | A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of September 30, 2021 and December 31, 2020 is as follows: As of September 30, 2021 Warrant Contingent Payable Liability Derivative Liability Strike price $ 0.28 $ 1.28 Contractual term (years) 1.0 1.5 Volatility (annual) 79 % 101 % Risk-free rate 0.2 % 0.2 % Dividend yield (per share) 0 % 0 % * As of December 31, 2020 Warrant Embedded Contingent Payable Liability Conversion Option Derivative Liability Strike price $ 0.28 $ 0.59 $ 1.53 Contractual term (years) 1.6 0.9 1.4 Volatility (annual) 116 % 106 % 126 % Risk-free rate 0.2 % 0.1 % 0.1 % Dividend yield (per share) 0 % 0 % 0 % * Contingent based on stock price as of December 31, 2020. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stock-based Compensation | |
Schedule of stock based compensation | The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2021 and 2020 (in thousands). The general and administrative expense and research and development expense during the three and nine months ended September 30, 2021 and 2020 relate to the applicable portion vesting during this period of stock option awards made in the past to directors, employees, SAB members and consultants. For the three months ended For the nine months ended September 30, 2021, September 30, 2021, 2021 2020 2021 2020 Research and development $ 982 $ 14,206 $ 7,224 $ 14,191 General and administrative 281 24,702 7,408 25,116 Total stock-based compensation expense $ 1,263 $ 38,908 $ 14,632 $ 39,307 |
Schedule of stock option activity | The following table summarizes stock option activity for the Company’s option plans during the nine months ended September 30, 2021 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Exercise Contractual Life Total Intrinsic Shares Price (in years) Value Outstanding as of January 1, 2021 308,840 $ 0.33 8.9 $ 372,219 Granted 910 0.92 8.9 Cash exercised (183) 0.25 — — Cashless exercise (4,376) 0.25 — — Forfeited/expired — — — — Outstanding as of September 30, 2021 305,191 $ 0.33 8.2 $ 290,517 Options vested (1) 279,875 $ 0.32 8.2 $ 268,218 (1) Approximately 239.3 million options are not exercisable until at least November 30, 2021. |
Outstanding Debt (Tables)
Outstanding Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Outstanding Debt | |
Schedule of outstanding debt | The following two tables summarize outstanding debt as of September 30, 2021 and December 31, 2020, respectively (amount in thousands): Stated Interest Conversion Remaining Carrying Maturity Date Rate Price Face Value Debt Discount Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ 135 135 — 135 Short term notes payable 8% unsecured Various 8 % N/A 4,248 (214) 4,034 9% unsecured Various 9 % N/A 3,297 (95) 3,202 12% unsecured On Demand 12 % N/A 703 — 703 8,248 (309) 7,939 Long term notes payable 1% unsecured Various 1 % N/A 433 — 433 8% unsecured 12/31/2022 8 % N/A 11,005 (686) 10,319 6% secured 3/25/2025 6 % N/A 1,590 — 1,590 13,028 (686) 12,342 Ending balance as of September 30, 2021 $ 21,411 $ (995) $ 20,416 Stated Embedded Interest Conversion Remaining Conversion Carrying Maturity Date Rate Price Face Value Debt Discount Option Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured 4/30/2021 8 % $ 0.85 2,125 (937) 2,507 3,695 2,260 (937) 2,507 3,830 Short term notes payable 8% unsecured Various 8 % N/A 1,785 (51) — 1,734 10% unsecured Various 10 % N/A 263 — — 263 12% unsecured On Demand 12 % N/A 440 — — 440 2,488 (51) — 2,437 Long term notes payable 8% unsecured Various 8 % N/A 7,160 (496) — 6,664 6% secured 3/25/2025 6 % N/A 1,843 — — 1,843 9,003 (496) — 8,507 Ending balance as of December 31, 2020 $ 13,751 $ (1,484) $ 2,507 $ 14,774 |
Net Earnings (Loss) per Share_2
Net Earnings (Loss) per Share Applicable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Net Earnings (Loss) per Share Applicable to Common Stockholders | |
Schedule of computation of earnings (loss) per share | The following table sets forth the computation of earnings (loss) per share (amounts in thousands): For the three months ended For the nine months ended September 30, 2021 September 30, 2021 2021 2020 2021 2020 Net earnings (loss) - basic $ 45,519 $ (194,096) $ 45,806 $ (249,522) Reversal of gain due to change in fair value of warrant liability (58,473) — (93,536) — Net loss - diluted (12,954) (194,096) (47,730) (249,522) Weighted average shares outstanding - basic 875,963 747,749 854,276 695,423 Diluted shares- Options 40,189 — 41,773 — Diluted shares- Warrants 219,535 — 203,474 — Convertible notes and interest 75 — 75 — Weighted average shares outstanding - diluted 1,135,762 747,749 1,099,598 695,423 |
Schedule of antidilutive securities excluded from computation of earnings per share | The following securities were not included in the diluted net earnings (loss) per share calculation because their effect was anti-dilutive as of the periods presented (in thousands): For the nine months ended September 30, 2021 2021 2020 Common stock options 263,418 304,009 Common stock warrants 74,292 341,798 Convertible notes and accrued interest — 16,193 Potentially dilutive securities 337,710 662,000 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions | |
Schedule of outstanding unpaid accounts payable held by related parties | The following table summarizes outstanding unpaid accounts payable and accrued expenses held by related parties as of September 30, 2021 and December 31, 2020 (amount in thousands). These unpaid amounts include part of the expenses reported in the above section and also certain expenses incurred in prior periods. September 30, 2021 December 31, 2020 Advent BioServices – amount invoiced $ 1,173 $ 3,734 Advent BioServices – amount accrued 1,816 1,629 Accounts payable and accrued expenses to Advent BioServices $ 2,989 $ 5,363 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Deficit | |
Schedule of warrant activity | The following is a summary of warrant activity for the nine months ended September 30, 2021 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2021 331,753 $ 0.28 1.61 Warrants granted 774 2.00 Warrants exercised for cash (50,156) 0.24 Cashless warrrants exercised (3,581) 0.24 Warrants expired and cancelled (1,024) 2.95 Outstanding as of September 30, 2021 277,766 $ 0.28 1.00 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies. | |
Schedule of quantitative information about the company's operating leases | The following summarizes quantitative information about the Company’s operating leases (amount in thousands): For the Nine Months ended September 30, 2021 U.K U.S Total Lease cost Operating lease cost $ 493 $ 212 $ 705 Short-term lease cost 38 — 38 Variable lease cost 48 5 53 Total $ 579 $ 217 $ 796 Other information Operating cash flows from operating leases $ (519) $ (84) $ (603) Weighted-average remaining lease term – operating leases 9.1 1.9 Weighted-average discount rate – operating leases 12 % 12 % |
Schedule of maturities of our operating leases, excluding short-term leases | Maturities of the operating leases, excluding short-term leases, are as follows: Three months ended December 31, 2021 $ 239 Year ended December 31, 2022 963 Year ended December 31, 2023 972 Year ended December 31, 2024 878 Thereafter 9,401 Total 12,453 Less present value discount (6,857) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2021 $ 5,596 |
Financial Condition, Going Co_2
Financial Condition, Going Concern and Management Plans (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Financial Condition, Going Concern and Management Plans | ||||
Net income (loss) | $ 45,519 | $ (194,096) | $ 45,806 | $ (249,522) |
Payments for Operating Activities | $ 27,100 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | $ 282,593 | $ 354,972 |
Embedded conversion option | 2,507 | |
Contingent payable derivative liability | 8,322 | 8,275 |
Total fair value | 290,915 | 365,754 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 0 | 0 |
Embedded conversion option | 0 | |
Contingent payable derivative liability | 0 | 0 |
Total fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 0 | 0 |
Embedded conversion option | 0 | |
Contingent payable derivative liability | 0 | 0 |
Total fair value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 282,593 | 354,972 |
Embedded conversion option | 2,507 | |
Contingent payable derivative liability | 8,322 | 8,275 |
Total fair value | $ 290,915 | $ 365,754 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Level 3 liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance | $ 365,754 |
Additional warrant liability | 516 |
Reclassification of warrant liabilities | 20,106 |
Debt conversion | (1,925) |
Change in fair value | (93,536) |
Balance | 290,915 |
Warrant Liability [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance | 354,972 |
Additional warrant liability | 516 |
Reclassification of warrant liabilities | 20,106 |
Debt conversion | 0 |
Change in fair value | (93,001) |
Balance | 282,593 |
Embedded Conversion Option [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance | 2,507 |
Additional warrant liability | 0 |
Reclassification of warrant liabilities | 0 |
Debt conversion | (1,925) |
Change in fair value | (582) |
Balance | 0 |
Contingent Payable Derivative Liability [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance | 8,275 |
Additional warrant liability | 0 |
Reclassification of warrant liabilities | 0 |
Debt conversion | 0 |
Change in fair value | 47 |
Balance | $ 8,322 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted average (in aggregate) significant unobservable inputs (Details) - Fair Value, Inputs, Level 3 [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Strike price | $ 0.28 | $ 0.28 |
Contractual term (years) | 1 year | 1 year 7 months 6 days |
Volatility (annual) | 79.00% | 116.00% |
Risk-free rate | 0.20% | 0.20% |
Dividend yield (per share) | 0.00% | 0.00% |
Embedded Conversion Option [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Strike price | $ 0.59 | |
Contractual term (years) | 10 months 24 days | |
Volatility (annual) | 106.00% | |
Risk-free rate | 0.10% | |
Dividend yield (per share) | 0.00% | |
Contingent Payable Derivative Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Strike price | $ 1.28 | $ 1.53 |
Contractual term (years) | 1 year 6 months | 1 year 4 months 24 days |
Volatility (annual) | 101.00% | 126.00% |
Risk-free rate | 0.20% | 0.10% |
Dividend yield (per share) | 0.00% | 0.00% |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Total stock-based compensation expense | $ 1,263 | $ 38,908 | $ 14,632 | $ 39,307 |
Research and development | ||||
Total stock-based compensation expense | 982 | 14,206 | 7,224 | 14,191 |
General and administrative | ||||
Total stock-based compensation expense | $ 281 | $ 24,702 | $ 7,408 | $ 25,116 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock-based Compensation | ||
Number of Shares, Outstanding | 308,840 | |
Number of Shares, Granted | 910 | |
Number of Shares, Cash exercised | (183) | |
Number of Shares, Cashless exercise | (4,376) | |
Number of Shares, Outstanding | 305,191 | 308,840 |
Number of Shares, Options vested | 279,875 | |
Weighted Average Exercise Price, Outstanding | $ 0.33 | |
Weighted Average Exercise Price, Granted | 0.92 | |
Weighted Average Exercise Price, Cash exercise | 0.25 | |
Weighted Average Exercise Price, Cashless exercise | 0.25 | |
Weighted Average Exercise Price, Outstanding | 0.33 | $ 0.33 |
Weighted Average Exercise Price, Options vested | $ 0.32 | |
Weighted Average Remaining Contractual Life (in years), Outstanding | 8 years 2 months 12 days | 8 years 10 months 24 days |
Weighted Average Remaining Contractual Life (in years), Granted | 8 years 10 months 24 days | |
Weighted Average Remaining Contractual Life (in years), Options vested | 8 years 2 months 12 days | |
Total Intrinsic Value, Outstanding | $ 372,219 | |
Total Intrinsic Value, Outstanding | 290,517 | $ 372,219 |
Total Intrinsic Value, Options vested | $ 268,218 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ | $ 3.2 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 6 months |
Notice for exercising any option or warrant (in days) | 61 days |
Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Vested | shares | 239.3 |
Outstanding Debt - Outstanding
Outstanding Debt - Outstanding debt (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument, Face Value | $ 21,411 | $ 13,751 |
Debt Instrument, Remaining Debt Discount | (995) | (1,484) |
Debt Instrument, Embedded Conversion Option | 2,507 | |
Debt Instrument, Carrying Value | 20,416 | 14,774 |
Short term convertible notes payable [Member] | ||
Debt Instrument, Face Value | 135 | 2,260 |
Debt Instrument, Remaining Debt Discount | (937) | |
Debt Instrument, Embedded Conversion Option | 2,507 | |
Debt Instrument, Carrying Value | $ 135 | $ 3,830 |
Short term convertible notes payable [Member] | 6% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | Due | Due |
Debt Instrument, Stated Interest Rate | 6.00% | 6.00% |
Debt Instrument, Conversion Price | $ 3.09 | $ 3.09 |
Debt Instrument, Face Value | $ 135 | $ 135 |
Debt Instrument, Carrying Value | 135 | $ 135 |
Short term convertible notes payable [Member] | 8% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | 4/30/2021 | |
Debt Instrument, Stated Interest Rate | 8.00% | |
Debt Instrument, Conversion Price | $ 0.85 | |
Debt Instrument, Face Value | $ 2,125 | |
Debt Instrument, Remaining Debt Discount | (937) | |
Debt Instrument, Embedded Conversion Option | 2,507 | |
Debt Instrument, Carrying Value | 3,695 | |
Short Term Notes Payable [Member] | ||
Debt Instrument, Face Value | 8,248 | 2,488 |
Debt Instrument, Remaining Debt Discount | (309) | (51) |
Debt Instrument, Carrying Value | $ 7,939 | $ 2,437 |
Short Term Notes Payable [Member] | 8% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | Various | Various |
Debt Instrument, Stated Interest Rate | 8.00% | 8.00% |
Debt Instrument, Face Value | $ 4,248 | $ 1,785 |
Debt Instrument, Remaining Debt Discount | (214) | (51) |
Debt Instrument, Carrying Value | $ 4,034 | $ 1,734 |
Short Term Notes Payable [Member] | 9% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | Various | |
Debt Instrument, Stated Interest Rate | 9.00% | |
Debt Instrument, Face Value | $ 3,297 | |
Debt Instrument, Remaining Debt Discount | (95) | |
Debt Instrument, Carrying Value | $ 3,202 | |
Short Term Notes Payable [Member] | 10% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | Various | |
Debt Instrument, Stated Interest Rate | 10.00% | |
Debt Instrument, Face Value | $ 263 | |
Debt Instrument, Carrying Value | $ 263 | |
Short Term Notes Payable [Member] | 12% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | On Demand | On Demand |
Debt Instrument, Stated Interest Rate | 12.00% | 12.00% |
Debt Instrument, Face Value | $ 703 | $ 440 |
Debt Instrument, Carrying Value | 703 | 440 |
Long Term Notes Payable [Member] | ||
Debt Instrument, Face Value | 13,028 | 9,003 |
Debt Instrument, Remaining Debt Discount | (686) | (496) |
Debt Instrument, Carrying Value | $ 12,342 | $ 8,507 |
Long Term Notes Payable [Member] | 1% unsecured | ||
Debt Instrument, Maturity Date, Description | Various | |
Debt Instrument, Stated Interest Rate | 1.00% | |
Debt Instrument, Face Value | $ 433 | |
Debt Instrument, Carrying Value | $ 433 | |
Long Term Notes Payable [Member] | 8% unsecured [Member] | ||
Debt Instrument, Maturity Date, Description | 12/31/2022 | Various |
Debt Instrument, Stated Interest Rate | 8.00% | 8.00% |
Debt Instrument, Face Value | $ 11,005 | $ 7,160 |
Debt Instrument, Remaining Debt Discount | (686) | (496) |
Debt Instrument, Carrying Value | $ 10,319 | $ 6,664 |
Long Term Notes Payable [Member] | 6% secured [Member] | ||
Debt Instrument, Maturity Date, Description | 3/25/2025 | 3/25/2025 |
Debt Instrument, Stated Interest Rate | 6.00% | 6.00% |
Debt Instrument, Face Value | $ 1,590 | $ 1,843 |
Debt Instrument, Carrying Value | $ 1,590 | $ 1,843 |
Outstanding Debt - Additional I
Outstanding Debt - Additional Information (Details) $ in Thousands, shares in Millions | Apr. 09, 2021USD ($) | Mar. 01, 2021USD ($)installment | Oct. 31, 2021USD ($) | Apr. 30, 2021loan | Sep. 30, 2021USD ($) | Aug. 31, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)shares | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) |
Debt Instrument, Face Amount | $ 21,411 | $ 21,411 | $ 13,751 | |||||||
Original issue discount | $ 1,000 | |||||||||
Debt amount converted | $ 5,600 | |||||||||
Shares issued upon conversion | shares | 5.1 | |||||||||
Extinguishment of Debt, Amount | $ 1,900 | |||||||||
Cash payments | 2,000 | |||||||||
Convertible Debt, Fair Value Disclosures | 7,500 | $ 7,500 | ||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | shares | 0.8 | |||||||||
Notes [Member] | ||||||||||
Debt Instrument, Face Amount | $ 10,000 | $ 3,300 | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | |||||||||
Debt instrument term | 22 months | |||||||||
Discount rate (as a percent) | 12.00% | |||||||||
Number of installments for amortization | installment | 14 | |||||||||
Amortization of Debt Issuance Costs and Discounts | 400 | $ 900 | $ 1,700 | $ 2,000 | ||||||
Proceeds from Issuance of Debt | $ 3,100 | |||||||||
Interest and Debt Expense | $ 900 | $ 1,300 | $ 3,100 | $ 2,900 | ||||||
Paycheck Protection Program [Member] | ||||||||||
Debt instrument term | 5 years | |||||||||
Debt Instrument, Deferred Term | 10 months | |||||||||
Number of Additional Loans | loan | 2 | |||||||||
Proceeds from Issuance of Debt | $ 400 | |||||||||
Four-month note agreements | ||||||||||
Debt Instrument, Face Amount | $ 1,140 | |||||||||
Discount rate (as a percent) | 12.00% | 12.00% | ||||||||
Percentage of aggregate principal amount for next offering | 50.00% | 50.00% | ||||||||
Proceeds from Issuance of Debt | $ 1,100 |
Net Earnings (Loss) per Share_3
Net Earnings (Loss) per Share Applicable to Common Stockholders - Computation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Net earnings (loss) - basic | $ 45,519 | $ (194,096) | $ 45,806 | $ (249,522) |
Reversal of gain due to change in fair value of warrant liability | (58,473) | (93,536) | ||
Net loss - diluted | $ (12,954) | $ (194,096) | $ (47,730) | $ (249,522) |
Weighted average shares outstanding - basic | 875,963 | 747,749 | 854,276 | 695,423 |
Convertible notes and accrued interest | 75,000 | 75,000 | ||
Weighted average shares outstanding - diluted | 1,135,762 | 747,749 | 1,099,598 | 695,423 |
Warrants | ||||
Diluted shares | 219,535 | 203,474 | ||
Options | ||||
Diluted shares | 40,189 | 41,773 |
Net Earnings (Loss) per Share_4
Net Earnings (Loss) per Share Applicable to Common Stockholders (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 337,710 | 662,000 |
Common Stock Options Member | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 263,418 | 304,009 |
Common Stock Warrants Member | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 74,292 | 341,798 |
Convertible Notes Member | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 16,193 |
Related Party Transactions - Su
Related Party Transactions - Summary of outstanding unpaid accounts payable held by related parties (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Advent Bioscience Accrued | ||
Accounts Payable, Related Parties | $ 1,816 | $ 1,629 |
Advent Bio services [Member] | ||
Accounts Payable, Related Parties | 2,989 | 5,363 |
Advent Bio Services Invoiced [Member] | ||
Accounts Payable, Related Parties | $ 1,173 | $ 3,734 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Related Party Transaction [Line Items] | |||||
Research and development cost | $ 1.7 | $ 1.4 | $ 5.1 | $ 4.2 | |
Capitalized Cost | $ 2.3 | $ 1.3 | |||
Extended term of the Ancillary Services agreement | 12 months | ||||
Ancillary Services Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Term (in months) | 8 months |
Stockholders' Deficit (Details)
Stockholders' Deficit (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stockholders' Deficit | ||
Number of Warrants, Outstanding | 331,753 | |
Number of Warrants, Warrants granted | 774 | |
Number of Warrants, Warrants exercised for cash | (50,156) | |
Number of Warrants, Cashless warrants exercised | (3,581) | |
Number of Warrants, Warrants expired and cancelled | (1,024) | |
Number of Warrants, Outstanding | 277,766 | 331,753 |
Weighted Average Exercise Price - Outstanding | $ 0.28 | |
Weighted Average Exercise Price - Warrants granted | 2 | |
Weighted Average Exercise Price - Warrants exercised for cash | 0.24 | |
Weighted Average Exercise Price, Cashless warrants exercised | $ 0.24 | |
Weighted Average Exercise Price, Warrants expired and cancelled | 2.95% | |
Weighted Average Exercise Price - Outstanding | $ 0.28 | $ 0.28 |
Remaining Contractual Term | 1 year | 1 year 7 months 9 days |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Oct. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Shareholders Deficit [Line Items] | ||||
Aggregate proceeds from exercise of warrants | $ 12,108 | $ 9,626 | ||
Stock issued on exercise of warrants | 50,300,000 | |||
Inducement expense | $ 314 | $ 314 | ||
Number Of Warrants, Warrants Cashless Exercise | 3,581 | |||
Cashless Warrants Exercise | ||||
Shareholders Deficit [Line Items] | ||||
Stock issued on exercise of warrants | 6,600,000 | |||
Number Of Warrants, Warrants Cashless Exercise | 8,000,000 | |||
Options | ||||
Shareholders Deficit [Line Items] | ||||
Class of warrant or right, extended in suspension | 239,300,000 | 247,300,000 | ||
Warrants | ||||
Shareholders Deficit [Line Items] | ||||
Class of warrant or right, extended in suspension | 59,700,000 | 58,400,000 | ||
Common Stock | ||||
Shareholders Deficit [Line Items] | ||||
Aggregate proceeds from exercise of warrants | $ 800 | |||
Common stock not issued | 3,400,000 | |||
Minimum | ||||
Shareholders Deficit [Line Items] | ||||
Warrants exercise price | $ 0.175 | $ 0.175 | ||
Minimum | Cashless Warrants Exercise | ||||
Shareholders Deficit [Line Items] | ||||
Warrants exercise price | 0.22 | 0.22 | ||
Maximum | ||||
Shareholders Deficit [Line Items] | ||||
Warrants exercise price | 0.40 | 0.40 | ||
Maximum | Cashless Warrants Exercise | ||||
Shareholders Deficit [Line Items] | ||||
Warrants exercise price | $ 0.52 | $ 0.52 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Lease cost | |
Operating lease cost | $ 705 |
Short-term lease cost | 38 |
Variable lease cost | 53 |
Total | 796 |
Other information | |
Operating cash flows from operating leases | $ (603) |
Weighted-average discount rate - operating leases | 12.00% |
Minimum | |
Other information | |
Weighted-average remaining lease term - operating leases | 1 year 10 months 24 days |
Maximum | |
Other information | |
Weighted-average remaining lease term - operating leases | 9 years 1 month 6 days |
UNITED KINGDOM | |
Lease cost | |
Operating lease cost | $ 493 |
Short-term lease cost | 38 |
Variable lease cost | 48 |
Total | 579 |
Other information | |
Operating cash flows from operating leases | (519) |
UNITED STATES | |
Lease cost | |
Operating lease cost | 212 |
Variable lease cost | 5 |
Total | 217 |
Other information | |
Operating cash flows from operating leases | $ (84) |
Commitments and Contingencies -
Commitments and Contingencies - maturities of our operating leases (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments and Contingencies. | |
Three months ended December 31, 2021 | $ 239 |
Year ended December 31, 2022 | 963 |
Year ended December 31, 2023 | 972 |
Year ended December 31, 2024 | 878 |
Thereafter | 9,401 |
Total | 12,453 |
Less present value discount | (6,857) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2021 | $ 5,596 |
Commitments and Contingencies_3
Commitments and Contingencies - Additional Information (Details) | Nov. 14, 2021USD ($) | Nov. 04, 2021EUR (€) | Aug. 04, 2021USD ($) | Aug. 04, 2021EUR (€) | Mar. 08, 2021 | Sep. 30, 2021USD ($) | Sep. 30, 2021EUR (€) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Sep. 30, 2021EUR (€) |
Additional Lease Term | 3 years 5 months | |||||||||
Lease, Practical Expedient, Lessor Single Lease Component [true false] | true | true | ||||||||
Operating Lease, Liability | $ 5,596,000 | |||||||||
Lessee, Operating Lease, Term of Contract | 20 years | 20 years | ||||||||
Operating Lease, Right-of-Use Asset | $ 4,929,000 | $ 4,489,000 | ||||||||
Original term of the agreement | 8 months | 8 months | ||||||||
Extended term of the Ancillary Services agreement | 12 months | 12 months | ||||||||
Operating Lease, Liability, Current | $ 305,000 | 167,000 | ||||||||
Amount estimated plus any accrued interest | 117,000 | |||||||||
German Tax Authority | ||||||||||
Litigation Settlement, Expense | $ 329,000 | € 277,000 | ||||||||
Settlement of tax plus penalties | $ 406,000 | € 346,000 | ||||||||
Settlement of withholding tax fully refundable | 118,000 | € 101,000 | ||||||||
State and Local Jurisdiction [Member] | ||||||||||
Litigation Settlement, Expense | 272,000 | € 231,000 | ||||||||
Amount estimated plus any accrued interest | € | € 100,528 | |||||||||
Additional late fees | $ 595,000 | € 513,000 | ||||||||
UNITED STATES | ||||||||||
Operating Lease, Liability, Current | $ 700,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands, shares in Millions | Nov. 12, 2021 | Oct. 01, 2021 | Nov. 30, 2021 | Oct. 31, 2021 | Apr. 30, 2022 | Aug. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Subsequent Event [Line Items] | ||||||||
Warrants exercised (in shares) | 34.8 | 34.8 | ||||||
Warrants exercised | $ 8,200 | $ 8,200 | $ 6,900 | $ 6,900 | ||||
Number of Pending Common Stock to be Issued | 0.9 | 0.9 | ||||||
Aggregate principal amount | $ 21,411 | $ 13,751 | ||||||
Minimum | ||||||||
Subsequent Event [Line Items] | ||||||||
Maturity Date, Extension Period of Notes | 2 months | |||||||
Maximum | ||||||||
Subsequent Event [Line Items] | ||||||||
Maturity Date, Extension Period of Notes | 4 months | |||||||
Four-month note agreements | ||||||||
Subsequent Event [Line Items] | ||||||||
Aggregate principal amount | $ 1,140 | |||||||
Net proceeds | $ 1,100 | |||||||
Debt Instrument, Discount Rate | 12.00% | 12.00% | ||||||
Debt Instrument, Percentage of Aggregate Principal Amount for Next Offering | 50.00% | 50.00% | ||||||
Subsequent Event | Certain officers and board of directors | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of Warrant or Right, Extended in Suspension | 297.6 | |||||||
Subsequent Event | Certain investors | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of Warrant or Right, Extended in Suspension | 1.4 |