Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-35737 | |
Entity Registrant Name | NORTHWEST BIOTHERAPEUTICS, INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 94-3306718 | |
Entity Address, Address Line One | 4800 Montgomery Lane | |
Entity Address, Address Line Two | Suite 800 | |
Entity Address, City or Town | Bethesda | |
Entity Address, State or Province | 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 $0.001 per share | |
Trading Symbol | NWBO | |
Security Exchange Name | NONE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,086,771,876 | |
Entity Central Index Key | 0001072379 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 6,191 | $ 6,965 |
Prepaid expenses and other current assets | 3,300 | 2,460 |
Total current assets | 9,491 | 9,425 |
Non-current assets: | ||
Property, plant and equipment, net | 13,570 | 13,418 |
Construction in progress | 3,321 | 2,028 |
Right-of-use asset, net | 4,209 | 4,189 |
Indefinite-lived intangible asset | 1,292 | 1,292 |
Goodwill | 626 | 626 |
Other assets | 362 | 345 |
Total non-current assets | 23,380 | 21,898 |
TOTAL ASSETS | 32,871 | 31,323 |
Current liabilities: | ||
Accounts payable and accrued expenses | 11,892 | 10,687 |
Accounts payable and accrued expenses to related parties and affiliates | 8,744 | 6,955 |
Convertible notes, net | 135 | 135 |
Notes payable, net | 10,471 | 15,403 |
Contingent payable derivative liability | 8,451 | 8,668 |
Warrant liability | 1,445 | 80,559 |
Investor advances | 2,616 | 2,566 |
Share liability | 585 | 678 |
Lease liabilities | 369 | 354 |
Total current liabilities | 44,708 | 126,005 |
Non-current liabilities: | ||
Notes payable, net of current portion, net | 16,019 | 5,991 |
Lease liabilities, net of current portion | 4,370 | 4,370 |
Total non-current liabilities | 20,389 | 10,361 |
Total liabilities | 65,097 | 136,366 |
COMMITMENTS AND CONTINGENCIES | ||
Stockholders' deficit: | ||
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of March 31, 2023 and December 31, 2022, respectively | ||
Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,083.1 million and 1,068.4 million shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 1,083 | 1,068 |
Additional paid-in capital | 1,248,397 | 1,164,885 |
Stock subscription receivable | (79) | (79) |
Accumulated deficit | (1,307,774) | (1,297,122) |
Accumulated other comprehensive income | 2,395 | 3,145 |
Total stockholders' deficit | (55,978) | (128,103) |
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' DEFICIT | 32,871 | 31,323 |
Series C Convertible Preferred Stock | ||
Mezzanine equity: | ||
Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.4 million and 1.4 million shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively; aggregate liquidation preference of $22.1 million | $ 23,752 | $ 23,060 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 1,700,000,000 | 1,700,000,000 |
Common stock, shares issued | 1,083,100,000 | 1,068,400,000 |
Common stock, shares outstanding | 1,083,100,000 | 1,068,400,000 |
Series C Convertible Preferred Stock | ||
Temporary equity, shares designated | 10,000,000 | 10,000,000 |
Temporary equity, shares issued | 1,400,000 | 1,400,000 |
Temporary equity, shares outstanding | 1,416,000 | 1,415,000 |
Temporary equity, aggregate liquidation preference | $ 22.1 | $ 22.1 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues: | ||
Research and other | $ 880 | $ 403 |
Total revenues | 880 | 403 |
Operating costs and expenses: | ||
Research and development | 6,861 | 4,820 |
General and administrative | 6,983 | 7,869 |
Total operating costs and expenses | 13,844 | 12,689 |
Loss from operations | (12,964) | (12,286) |
Other income (expense): | ||
Change in fair value of derivative liabilities | 3,880 | 540 |
Change in fair value of share liabilities | (52) | |
(Loss) gain from extinguishment of debt | (1,408) | 410 |
Interest expense | (1,027) | (1,903) |
Foreign currency transaction gain (loss) | 919 | (975) |
Total other income (loss) | 2,312 | (1,928) |
Net loss | (10,652) | (14,214) |
Deemed dividend related to warrant modifications | 395 | |
Net loss attributable to common stockholders | (11,047) | (14,214) |
Other comprehensive income (loss) | ||
Foreign currency translation adjustment | (750) | 808 |
Total comprehensive loss | $ (11,797) | $ (13,406) |
Net loss earnings per share applicable to common stockholders, Basic | $ (0.01) | $ (0.01) |
Net loss earnings per share applicable to common stockholders, Diluted | $ (0.01) | $ (0.01) |
Weighted average shares used in computing basic loss per share | 1,074,902 | 959,251 |
Weighted average shares used in computing diluted loss per share | 1,074,902 | 959,251 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) shares in Thousands, $ in Thousands | Series C Convertible Preferred Stock | Common Stock [Member] | Additional Paid-in Capital [Member] | Subscription Receivable [Member] | Retained Earnings [Member] | Accumulated Other Comprehensive Income (Loss) | Total |
Increase (Decrease) in Temporary Equity Deficit | |||||||
Reclassification of warrant liabilities related to warrants exercised for cash | $ 4 | $ 4 | |||||
Balance at the beginning at Dec. 31, 2021 | $ 948 | 1,066,873 | $ (79) | $ (1,192,090) | $ 357 | (123,991) | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 948,445 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of common stock for cash | $ 5 | 3,359 | 3,364 | ||||
Issuance of common stock for cash ( in shares) | 4,553 | ||||||
Warrants exercised for cash | $ 15 | 4,170 | 4,185 | ||||
Warrants exercised for cash (in shares) | 15,256 | ||||||
Reclassification of warrant liabilities related to warrants exercised for cash | 7,715 | 7,715 | |||||
Cashless Warrants Exercised | 26 | ||||||
Stock-based compensation | $ (5) | (617) | (617) | ||||
Cumulative translation adjustment | 808 | 808 | |||||
Net loss | (14,214) | (14,214) | |||||
Balance at the end at Mar. 31, 2022 | $ 970 | 1,083,723 | (79) | (1,206,304) | 1,165 | (120,525) | |
Balance at the end (in shares) at Mar. 31, 2022 | 969,697 | ||||||
Balance at the end (in shares) at Dec. 31, 2022 | 1,415 | ||||||
Balance at the end at Dec. 31, 2022 | $ 23,060 | ||||||
Balance at the beginning at Dec. 31, 2021 | $ 948 | 1,066,873 | (79) | (1,192,090) | 357 | (123,991) | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 948,445 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 2 | 985 | 987 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 1,412 | ||||||
Balance at the end at Dec. 31, 2022 | $ 1,068 | 1,164,885 | (79) | (1,297,122) | 3,145 | (128,103) | |
Balance at the end (in shares) at Dec. 31, 2022 | 1,068,394 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash (in shares) | 148 | ||||||
Issuance of stock for cash | $ 2,385 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 43 | ||||||
Issuance of stock in lieu of debt redemption | $ 806 | ||||||
Issuance of stock by common stock warrant exercise (in shares) | (198) | 4,946 | |||||
Issuance of stock by common stock warrant exercise | $ (2,617) | $ 5 | 2,612 | 2,617 | |||
Stock Based Compensation | $ 118 | ||||||
Balance at the end (in shares) at Mar. 31, 2023 | 1,416 | ||||||
Balance at the end at Mar. 31, 2023 | $ 23,752 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of stock for cash | $ 2,385 | ||||||
Issuance of stock for cash (in shares) | 148 | ||||||
Issuance of stock in lieu of debt redemption | $ 806 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 43 | ||||||
Issuance of stock by common stock warrant exercise | $ (2,617) | $ 5 | 2,612 | 2,617 | |||
Issuance of stock by common stock warrant exercise (in shares) | (198) | 4,946 | |||||
Warrants exercised for cash | $ 1 | 247 | $ 248 | ||||
Warrants exercised for cash (in shares) | 767 | ||||||
Cashless stock options exercise | $ 1 | (1) | |||||
Cashless stock options exercise (in shares) | 710 | 1,325 | |||||
Reclassification of warrant liabilities to stockholders' deficit | 76,258 | $ 76,258 | |||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 8 | 5,608 | 5,616 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 8,267 | ||||||
Stock-based compensation | 918 | 918 | |||||
Reclass earned but unissued milestone shares from equity to liability | (2,130) | (2,130) | |||||
Cumulative translation adjustment | (750) | (750) | |||||
Warrants modfication | 395 | 395 | |||||
Deemed dividend related to warrants modification | (395) | (395) | |||||
Net loss | (10,652) | (10,652) | |||||
Balance at the end at Mar. 31, 2023 | $ 1,083 | $ 1,248,397 | $ (79) | $ (1,307,774) | $ 2,395 | $ (55,978) | |
Balance at the end (in shares) at Mar. 31, 2023 | 1,083,084 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Stock Based Compensation( in shares) | 8 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (10,652) | $ (14,214) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation and amortization | 335 | 100 |
Amortization of debt discount | 552 | 809 |
Change in fair value of derivatives | (3,880) | (540) |
Change in fair value of share liability | 52 | |
Loss (gain) from extinguishment of debt | 1,408 | (410) |
Amortization of operating lease right-of-use asset | 67 | 60 |
Stock-based compensation for services | 933 | 617 |
Subtotal of non-cash charges | (533) | 636 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (709) | (199) |
Other non-current assets | (16) | 679 |
Accounts payable and accrued expenses | 975 | 795 |
Related party accounts payable and accrued expenses | (341) | (694) |
Lease liabilities | 37 | 30 |
Net cash used in operating activities | (11,239) | (12,967) |
Cash Flows from Investing Activities: | ||
Purchase of equipment and construction in progress | (1,333) | (58) |
Net cash used in investing activities | (1,333) | (58) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common stock | 3,140 | |
Proceeds from exercise of warrants | 248 | 4,185 |
Proceeds from investor advance | 50 | |
Proceeds from issuance of notes payable, net | 10,000 | 600 |
Repayment of notes payable | (101) | (4,005) |
Net cash provided by financing activities | 12,582 | 3,920 |
Effect of exchange rate changes on cash and cash equivalents | (784) | 899 |
Net decrease in cash and cash equivalents | (774) | (8,206) |
Cash and cash equivalents, beginning of the period | 6,965 | 15,169 |
Cash and cash equivalents, end of the period | 6,191 | 6,963 |
Supplemental schedule of non-cash investing and financing activities: | ||
Cashless warrants and stock options exercise | 1 | |
Reclassification of warrant liabilities related to warrants exercised for cash | 7,715 | |
Reclassification of warrant liabilities to stockholders' deficit | 76,258 | |
Reclassification of warrant liabilities related to cashless warrants exercise | 4 | |
Reclass earned but unissued milestone shares from equity to liability | 2,130 | |
Issuance of common stock for conversion of debt and accrued interest | 5,616 | 987 |
Issuance of Series C convertible preferred stock in lieu of debt redemption | 806 | |
Series C convertible preferred stock conversion | 2,617 | |
Capital expenditures included in accounts payable | 1,013 | 86 |
Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates | 11 | |
Reclassification between shares payable and equity | 250 | |
Deemed dividend related to warrant modification | 395 | |
Convertible notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments on notes payable | (30) | $ (702) |
Series C convertible preferred stock | ||
Cash Flows from Financing Activities: | ||
Proceeds from issuance of Series C convertible preferred stock | $ 2,385 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
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, Aracaris Ltd, Aracaris Capital, Ltd, Northwest Biotherapeutics B.V., and NW Bio GmbH (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 has wholly owned subsidiaries in Boston, the U.K., the Netherlands and Germany. On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®. 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. The Company has completed a Phase 3 clinical trial of its DCVax®-L product for glioblastoma brain cancer, has publicly reported the results in a peer reviewed publication in a medical journal as well as at a medical conference, and is working on prerequisites and preparations for filing an application for regulatory approval of the product. |
Financial Condition, Going Conc
Financial Condition, Going Concern and Management Plans | 3 Months Ended |
Mar. 31, 2023 | |
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 loss of $10.7 million for the three months ended March 31, 2023. The Company used approximately $11.2 million of cash in its operating activities during the three months ended March 31, 2023. 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 for at least one year from the date of this filing. The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, however, they 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
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 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 uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of March 31, 2023, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2023 and 2022, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2023 and 2022, and the condensed consolidated statements of cash flows for the three months ended March 31, 2023 and 2022 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 months ended March 31, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 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, 2022 and notes thereto included in the Company’s annual report on Form 10-K (the “2022 Annual Report”), which was filed with the SEC on February 28, 2023. 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 judgments, including 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. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2022 Annual Report other than those discussed below. Sequencing The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy. On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximately 141 million warrants, with a value of approximately $76.3 million, to purchase shares of the Company’s common stock were reclassified from liabilities to equity on January 9, 2023. The remaining balance of $1.4 million in warrant liability as of March 31, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). Modification of Equity Classified Warrants A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend. Recently Issued Accounting Standards Not Yet Adopted Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
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 fair value of liabilities related to certain outstanding warrants, certain embedded conversion features associated with convertible debt and the contingent payable to Cognate BioServices on a recurring basis to determine the fair value of these liabilities. ASC 820 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 March 31, 2023 and December 31, 2022 (in thousands): Fair value measured at March 31, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs March 31, 2023 (Level 1) (Level 2) (Level 3) Warrant liability $ 1,445 $ — $ — $ 1,445 Contingent payable derivative liability 8,451 — — 8,451 Share liability 585 — — 585 Total fair value $ 10,481 $ — $ — $ 10,481 Fair value measured at December 31, 2022 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2022 (Level 1) (Level 2) (Level 3) Warrant liability $ 80,559 $ — $ — $ 80,559 Embedded redemption option 807 — — 807 Contingent payable derivative liability 8,668 — — 8,668 Share liability 678 — — 678 Total fair value $ 90,712 $ — $ — $ 90,712 There were no transfers between Level 1, 2 or 3 during the three-month period ended March 31, 2023. The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2023. 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 Share Liability Redemption Option Derivative Liability Liability Total Balance - January 1, 2023 $ 80,559 $ 807 $ 8,668 $ 678 $ 90,712 Additional share liability — — — 538 538 Redemption of share liability — — — (683) (683) Reclassification of warrant liabilities (76,258) — — — (76,258) Change in fair value (2,856) (807) (217) 52 (3,828) Balance - March 31, 2023 $ 1,445 (1) $ — $ 8,451 $ 585 $ 10,481 (1) The remaining balance of $1.4 million in warrant liability as of March 31, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet. On January 9, 2023, the Company reclassified the fair value of the warrant liability of $76.3 million into the additional paid-in capital. The change in fair value of the common stock warrant liability of $2.3 million between December 31, 2022 and January 9, 2023 is reflected in “Change in fair value of derivative liabilities” in the accompanying condensed consolidated statements of comprehensive loss for the three months ended March 31, 2023. 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 January 9, 2023 (the reclassification date), March 31, 2023 and December 31, 2022 is as follows: As of January 9, 2023 As of March 31, 2023 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.63 * $ 0.63 * Contractual term (years) 1.5 0.04 1.3 Volatility (annual) 87 % 114 % 73 % Risk-free rate 4.3 % 2.2 % 4.9 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of March 31, 2023 and December 31, 2022. The key unobservable inputs for Piggy-back rights that was included in the warrant liability as of March 31, 2023 and December 31, 2022 was the assumption of the estimated remaining life which was based on the estimate of next qualified financing. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation | |
Stock-Based Compensation | 5. Stock-based Compensation The following table summarizes total stock-based compensation expense for the three months ended March 31, 2023 and 2022 (in thousands). For the three months ended March 31, 2023 2022 Research and development $ 296 $ 510 Research and development - related party — — Milestones achieved (1) 520 — Future milestones (2) 100 — General and administrative 17 107 Total stock-based compensation expense $ 933 $ 617 The related party amounts were for milestone incentives that either were earned or are deemed probable to be achieved in the future and become issuable at that time (as detailed below in Restricted Stock Awards). (1) During the quarter ended March 31, 2023, the Company recognized the remaining $0.5 million stock-based compensation related to the achieved milestone (obtaining a commercial manufacturing license from the MHRA) and accrued for 3.0 million shares that will become issuable for this milestone. The Company has previously recognized $1.6 million stock-based compensation as of December 31, 2022. (2) This is related to a one-time milestone (drafting key portions of the application for product approval) that is anticipated to be achieved and earned in the future. The Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining potential milestone stock awards during the quarter ended March 31, 2023, of $0.1 million. The total unrecognized compensation cost was approximately $0.8 million as of March 31, 2023 and will be recognized over the next 1.3 years. Stock Options The following table summarizes stock option activity for the Company’s option plans during the three months ended March 31, 2023 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Contractual Life Total Intrinsic Shares Exercise Price (in years) Value Outstanding as of January 1, 2023 301,263 $ 0.34 7.0 $ 135,225 Cashless exercised (1,325) 0.33 — — Outstanding as of March 31, 2023 299,938 $ 0.34 6.8 $ 90,543 Options vested (1) 281,009 $ 0.33 6.8 $ 85,618 (1) An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days ’ prior notice. Restricted Stock Awards During April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, for five workstreams that are prerequisites for an application for regulatory approval of DCVax-L, for three required licenses for the Sawston facility , and for drafting of key portions of the application for approval. The SOW provides for baseline costs and for milestone incentives for successful completion of each of the workstreams, for the completion and submission of each application for product approval, and for obtaining regulatory approval of each of the three Sawston licenses. The milestone incentives will be a combination of cash and stock and are not paid until they are achieved. On September 26, 2022, the Company amended the SOW6 (the “Amended SOW6”) to (1) extend the service period through September 30, 2023, and (2) clarify the assessment and application of the milestones, and (3) add a sixth workstream. (The potential cost for all unearned stock awards for milestones not yet achieved was re-measured on the modification date and will be further re-measured until the date the milestone award is achieved and the stock awards are earned.) If all of the 10 one-time milestones are achieved (i.e., for all six workstreams that are prerequisites for an application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the application for product approval), the aggregate stock-based compensation under the Amended SOW 6 will be 13.5 million shares (including the shares already earned and issued for the milestones already achieved) for an aggregate fair value of $10.1 million. As of December 31, 2022, seven milestones were completed, including five of the workstreams, and the regulatory approvals of two licenses required for the Sawston facility. An eighth milestone was partly completed and the stock component of that milestone was earned, but the cash portion of that eighth milestone was not yet earned. During the three months ended March 31, 2023, the eighth milestone workstream for Mechanism of Action and the milestone for obtaining the commercial manufacturing license from the MHRA were completed. For this license milestone, the Company recognized the remaining $0.5 million in expense in the condensed consolidated statements of operations and comprehensive loss and accrued for 3.0 million shares that will become issuable. For the remaining one-time milestone that is anticipated to be achieved and earned in the future, the Company recognized and expensed (but did not issue) the pro-rata portion of the remaining potential milestone stock awards during the three months ended March 31, 2023, of $0.1 million. Other Service Agreement On March 16, 2023, the Company issued 8,000 shares of Series C convertible preferred stock to an unrelated vendor who provided professional services for the Company. The fair value of the Series C convertible preferred stock on the issuance date was approximately $0.1 million, which will be expensed over a four-month service period. During the three months ended March 31, 2023, the Company recognized approximately $15,000 as part of general and administrative expenses. |
Property, Plant and Equipment
Property, Plant and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 6. Property, Plant and Equipment Property, plant and equipment consist of the following at March 31, 2023 and December 31, 2022 (in thousands): March 31, December 31, Estimated 2023 2022 Useful Life Leasehold improvements $ 13,213 $ 13,070 Lesser of lease term or estimated useful life Office furniture and equipment 445 300 3-5 years Computer and manufacturing equipment and software 2,454 2,238 3-5 years Land in the United Kingdom 84 82 NA 16,196 15,690 NA Less: accumulated depreciation (2,626) (2,272) Total property, plant and equipment, net $ 13,570 $ 13,418 Construction in progress $ 3,321 $ 2,028 Depreciation expense was approximately $0.3 million and $0.1 million for the three months ended March 31, 2023, and 2022, respectively. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable | |
Notes Payable | 7. Notes Payable The following two tables summarize outstanding debt as of March 31, 2023 and December 31, 2022, 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 10,610 (859) 9,751 9% unsecured Various 9 % N/A 157 — 157 12% unsecured On Demand 12 % N/A 563 — 563 11,330 (859) 10,471 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 16,510 (1,326) 15,184 6% secured 3/25/2025 6 % N/A 835 — 835 17,345 (1,326) 16,019 Ending balance as of March 31, 2023 $ 28,810 $ (2,185) $ 26,625 Stated Embedded Interest Conversion Remaining Redemption Carrying Maturity Date Rate Price Face Value Debt Discount Option 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 14,540 (1,300) 807 14,047 9% unsecured Various 9 % N/A 793 — — 793 12% unsecured On Demand 12 % N/A 563 — — 563 15,896 (1,300) 807 15,403 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 5,505 (432) — 5,073 6% secured 3/25/2025 6 % N/A 918 — — 918 6,423 (432) — 5,991 Ending balance as of December 31, 2022 $ 22,454 $ (1,732) $ 807 $ 21,529 On March 2, 2023, the Company entered into a Commercial Loan Agreement (the “Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The Commercial Loan bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first eight months of the term. The Commercial Loan is amortized in 14 installments starting on November 2, 2023. The Commercial Loan carries an original issue discount of $1.0 million. During the three months ended March 31, 2023, the Company issued approximately 8.3 million shares of common stock with a fair value of $5.6 million to certain lenders in lieu of cash payments of $4.1 million of debt, including $0.2 million of accrued interest. In addition, pursuant to exchange agreements executed with various holders, the Company is required to potentially issue additional common stock (the “Share liability”) if the stock price is less than the price defined in the exchange agreement as of the true-up date. During the three months ended March 31, 2023, the Company extinguished Share liabilities of $0.7 million and recognized an additional $0.5 million in Share liabilities. The Company recognized an approximately $1.3 million debt extinguishment loss during the three months ended March 31, 2023 from the debt redemption. During the three months ended March 31, 2023, the Company recognized $0.8 million change in fair value of embedded redemption option as this embedded feature had de minimis value based on the remaining life of the note and the next qualified financing. During the three months ended March 31, 2023, the Company issued approximately 43,000 shares of Series C preferred stock with a fair value of $0.8 million to certain lenders in lieu of cash payments of For the three months ended March 31, 2023 and 2022, interest expense related to notes payable totaled approximately $0.5 million and $1.1 million including amortization of debt discounts totaling $0.6 million and $0.8 million, respectively. |
Net Loss per Share Applicable t
Net Loss per Share Applicable to Common Stockholders | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Share Applicable to Common Stockholders | |
Net Loss per Share Applicable to Common Stockholders | 8. Net Loss per Share Applicable to Common Stockholders Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share would be computed similar to basic 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. Because of the net loss from operations for each period, inclusion of such securities in the computation of loss per share would be anti-dilutive and thus they are excluded. Potentially dilutive weighted average common shares include common stock potentially issuable under the Company’s convertible notes and preferred stock, warrants and vested and unvested stock options. The following securities were not included in the diluted net loss per share calculation because their effect was anti-dilutive as of the periods presented (in thousands): For the three months ended March 31, 2023 2022 Series C convertible preferred stock 35,412 — Common stock options 299,938 304,867 Common stock warrants 140,244 208,705 Convertible notes and accrued interest 79 76 Potentially dilutive securities 475,673 513,648 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 9. Related Party Transactions The Company had three operational programs with Advent: (a) an ongoing manufacturing program at the GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston GMP facility, and (c) a one-time program for specialized work, organized into 10 sets of one-time milestones, for the following: ● Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing. ● 6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. ● Drafting of key portions of the application for product approval itself. Each of the three operational programs is covered by a separate contract. The ongoing manufacturing in the London facility is covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility is covered by an Ancillary Services Agreement entered into on November 18, 2019. The specialized work associated with the 10 one-time milestones is covered by an SOW 6 entered into under the Ancillary Services Agreement as of April 1, 2022 and amended on September 26, 2022. The Ancillary Services Agreement establishes a structure under which the Company and Advent negotiate and agree upon the scope and terms for Statements of Work (“SOWs”) for facility development activities and compassionate use program activities. After an SOW is agreed and 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 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 SOWs may involve ongoing activities or specialized one-time projects and related one-time milestone payments. The current term of the Ancillary Services Agreement ends in July 2023. SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the 3 licenses required for the Sawston facility, (b) successful completion of each of the 6 workstreams and (c) completion of drafting key portions of an application for product approval. The milestone incentives are a combination of cash and stock, and are not paid until the milestone is achieved and earned. During the three months ended March 31, 2023, the Company paid an aggregate of $1.0 million in cash, which was related to two milestones that were completed and fully expensed but unpaid as of December 31, 2022, and accrued for 3.0 million shares that will become issuable for completion of the milestone (obtaining a commercial manufacturing license from the MHRA). The fair value of the 3.0 million shares was approximate $2.1 million, of which $0.5 million was recognized during the three months ended March 31, 2023 and $1.6 million had already been recognized in 2022. During the three months ended March 31, 2023, the Company also expensed (but did not pay) an aggregate of $0.5 million related to completed cash milestone payments; the Company also expensed (but did not pay) an aggregate of $0.2 million related to future cash milestone payments that the Company anticipates will be achieved and earned, and $0.1 million related to fair value of future shares milestone payments that the Company anticipates will be achieved and earned over the course of the contract period. The following table summarizes total research and development costs from Advent for the three months ended March 31, 2023 and 2022, respectively (in thousands). For the three months ended March 31, 2023 2022 Advent BioServices Manufacturing cost in London $ 1,643 $ 1,404 Manufacturing cost at Sawston facility 1,712 1,425 SOW 6 one-time milestones - Shares Expensed but unpaid (milestone complete) (1) 520 — Expensed but unpaid, not yet due (milestone not yet complete) (2) 100 — SOW 6 one-time milestones - Cash Expensed and due, but unpaid (milestone complete) (3) 550 — Expensed but unpaid, not yet due (milestone not yet complete) (2) 150 — Total $ 4,675 $ 2,829 (1) This covers the one-time milestone for obtaining a commercial manufacturing license for the Sawston facility. The milestone was achieved and the shares will become issuable following final Board approval. The shares were not issued as of March 31, 2023. (2) This covers the one-time milestone for drafting key portions of the application for product approval. (3) This covers two one-time milestones: Mechanism of Action and obtaining a commercial manufacturing license from the MHRA. Advent BioServices Sublease Agreement On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding exterior support space and parking. The lease payments amount under the Agreement are two times the £5.75 rate per square foot (approximately $7.11 per square foot based on exchange rate as of March 31, 2023) payable under the head lease, but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2022. The total lease payments paid by the Company to Huawei for the facility, exterior spaces and parking under the head lease are 500,000 pounds (approximately $618,000) per year. The term of the Agreement shall end on the same date as the head lease term ends. During the three months ended March 31, 2023, the Company recognized sub-lease income of $36,000. Related Party Accounts Payable As of March 31, 2023, there was approximately $0.4 million of unpaid board compensation to one of our Directors that was included in the accounts payable to related party on the condensed consolidated balance sheets. As of March 31, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section. March 31, December 31, 2023 2022 Advent BioServices - amount invoiced but unpaid $ 1,765 $ 1,844 Advent BioServices - amount accrued but unpaid (1) 6,566 4,736 Total payable and accrued, but unpaid to Advent BioServices $ 8,331 $ 6,580 (1) This includes $2.1 million which is not payable in cash but represents the value of 3 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for obtaining a commercial manufacturing license for the Sawston facility. Such shares were not issued as of March 31, 2023, and the total value, previously recognized as stock compensation expense, was reclassified from Additional Paid-in-Capital to Accounts payable and accrued expenses to related parties and affiliates. |
Preferred Stock
Preferred Stock | 3 Months Ended |
Mar. 31, 2023 | |
Preferred Stock. | |
Preferred Stock | 10. Preferred Stock Series C Convertible Preferred Stock During the three months ended March 31, 2023, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of 0.1 million shares of the Company’s Series C convertible preferred stock, par value $0.001 per share (the “Series C Shares”), at a weighted purchase price of $16.11 per share for proceeds of approximately $2.4 million. During the three months ended March 31, 2023, the Company issued approximately 43,000 Series C Shares with a fair value of $0.8 million to certain lenders in lieu of cash payments of $0.7 million in debt, including $0.1 million accrued interest. The Company recognized an approximately $0.1 million debt extinguishment loss. During the three months ended March 31, 2023, approximately 0.2 million Series C Shares with a book value of $2.6 million were converted into 4.9 million common shares at a ratio of 1: 25 The Company determined that the Series C Shares contain contingent redemption provisions allowing redemption by the holder upon certain defined events (“deemed liquidation events”). As the event that may trigger the redemption of the Series C Shares is not solely within the Company’s control, the Series C Shares are classified as mezzanine equity (temporary equity) in the Company’s condensed consolidated balance sheets. |
Stockholders' Deficit
Stockholders' Deficit | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Deficit | |
Stockholders' Deficit | 11. Stockholders’ Deficit Common Stock On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. During the three months ended March 31, 2023, the Company received $0.2 million from the exercise of warrants with an exercise price between $0.22 and $0.85. The Company issued approximately 0.8 million shares of common stock upon these warrant exercises. During the three months ended March 31, 2023, certain options holders elected to exercise some of their options pursuant to cashless exercise formulas. The Company issued approximately 0.7 million shares of common stock upon exercise of 1.3 million options at exercise prices between $0.25 and $0.35. During the three months ended March 31, 2023, the Company issued approximately 8.3 million shares of common stock to certain lenders in lieu of cash payments on $4.1 million of outstanding debt, including $0.2 million interest (see Note 7). Stock Purchase Warrants The following is a summary of warrant activity for the three months ended March 31, 2023 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2023 141,048 $ 0.31 1.46 Warrants exercised for cash (767) 0.32 — Warrants expired and cancellations (38) 0.34 — Outstanding as of March 31, 2023 140,243 $ 0.31 1.42 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 Agreement. At March 31, 2023, of the approximately 140 million total outstanding warrants listed above, approximately 97 million warrants were under the Blocker Letter Agreement or suspension agreements. Warrant Modifications Between January 10 and March 31, 2023, the Company amended multiple warrants whereby the maturity dates of certain warrants were extended for an additional approximately 3 months. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions. Post-modification Pre-modification Exercise price $ 0.27 $ 0.27 Expected term (in years) 2.1 1.9 Volatility 74 % 95 % Risk-free interest rate 4.3 % 4.2 % Dividend yield 0 % 0 % The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $0.4 million and was treated as a deemed dividend and is reflected as “Deemed dividend related to warrant modifications” in the accompanying condensed consolidated statement of operations and comprehensive loss. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 12. Commitments and Contingencies Operating Lease- Lessee Arrangements 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. At March 31, 2023, the Company had operating lease liabilities of approximately $4.7 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. and ROU assets of approximately $4.2 million for the Sawston lease and U.S. 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 three months ended March 31, 2023 U.K U.S Total Lease cost Operating lease cost $ 144 $ 65 $ 209 Short-term lease cost 23 — 23 Variable lease cost — 4 4 Sub-lease income (36) — (36) Total $ 131 $ 69 $ 200 Other information Operating cash flows from operating leases $ (152) $ (73) $ (225) Weighted-average remaining lease term – operating leases 8.4 1.1 Weighted-average discount rate – operating leases 12 % 12 % For the three months ended March 31, 2022 U.K U.S Total Lease cost Operating lease cost $ 87 $ 65 $ 152 Short-term lease cost 13 — 13 Variable lease cost — 10 10 Total (36) — (36) $ 64 $ 75 $ 138 Other information Operating cash flows from operating leases $ (168) $ (71) $ (239) Weighted-average remaining lease term – operating leases 8.9 1.6 Weighted-average discount rate – operating leases 12 % 12 % The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2023 and 2022, respectively. Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows: Nine months ended December 31, 2023 $ 688 Year ended December 31, 2024 823 Year ended December 31, 2025 618 Year ended December 31, 2026 618 Year ended December 31, 2027 618 Thereafter 6,783 Total 10,148 Less present value discount (5,409) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023 $ 4,739 Maturities of our operating leases under the sublease agreement, are as follows: Nine months ended December 31, 2023 $ 109 Year ended December 31, 2024 145 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Thereafter 1,740 Total $ 2,284 Advent BioServices Services Agreement The Company had three operational programs with Advent: (a) an ongoing manufacturing program at the existing GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston facility, and (c) a one-time program for specialized work, organized into 10 sets of one-time milestones, for the following: ● Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing. ● 6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. ● Drafting of key portions of the application for product approval itself. 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 MSA provides for manufacturing of DCVax-L products at an existing facility in London. The MSA is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA 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 reserved exclusively 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. The MSA remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate the MSA on twelve months’ notice, to allow for transition arrangements by both parties. During the notice period services would still be provided. Minimum required payments for this notice period are anticipated to total approximately £4.4 million ($5.5 million). 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 Agreement also provides for Statements of Work (SOWs) with operational milestones and related payments. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company and Advent have entered into a series of modifications which have expanded the scope of work and milestones to be achieved and extended the term to September 2023. The Company entered into SOW 6 with Advent, which was incorporated into the Ancillary Services Agreement on April 1, 2022 and amended it on September 26, 2022. The amended SOW 6 provides for six workstreams that are prerequisites for an application for regulatory approval of DCVax-L, for drafting of key portions of the application, and for obtaining three required licenses for the Sawston facility. The SOW provides for baseline costs and provides for milestone incentives for completion of each of the six workstreams, for obtaining regulatory approval of each of the three Sawston licenses, and for the completion of the key portions of an application for product approval. The milestone incentives involve a combination of cash and stock and are not paid until they are achieved and earned, as described in Note German Tax Matter The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015 and assessed additional tax against the subsidiary. 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. 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 $251,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (now approximately $558,000) on reimbursable withholding taxes that had been waived during the settlement process. On December 8, 2021, the Company appealed the assessment of additional late fees. Additionally, the Company requested that NW Bio GmbH be deregistered from the trade register, as it no longer had current operations. The deregistration was granted effective December 31, 2021. Between January 2022 and July 2022, the Company received tax bills for the corporate and trade taxes for the 2016-2020 tax years that totaled approximately €222,000 (approximately $241,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $147,000) of the penalties. The Company offered to pay this reduced penalty if an extended payment plan was approved. A response was received dated November 14, 2022 indicating that the tax authority would not be able to grant a further deferral of payment of these penalties. In a letter dated December 27, 2022, the Leipzig tax authority sent letters to the former and current managing directors of NW Bio GmbH giving 30 days to respond to a tax liability questionnaire. Based on the responses to the liability questionnaires the tax authorities have currently not directed any further measures against former and current managing directors of NW Bio GmbH with respect to tax liability proceedings. The Company currently has accrued for the current amounts owed for these penalties of €377,000 (approximately $410,000) as well as for all unpaid taxes as of March 31, 2023. Based on the Company’s current operating state in Germany and the negotiations, the Company believes, based on its evaluation under ASC 740, that the resolution of these tax matters will not likely result in a net material charge to the Company. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events In April 2023, approximately 45,000 Series C Shares with a book value of $0.7 million were converted into 1.1 million common shares in accordance with their terms at a ratio of 1: 25 On April 19, 2023, the Company the Company issued approximately 2.6 million shares of common stock to certain lender in lieu of cash payments on $1.3 million of outstanding debt, including $0.1 million interest. On May 8, 2023, the Company received a $3.0 million prepayment for the purchase of securities for which the terms are in the process of being finalized. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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 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 uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of March 31, 2023, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2023 and 2022, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2023 and 2022, and the condensed consolidated statements of cash flows for the three months ended March 31, 2023 and 2022 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 months ended March 31, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 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, 2022 and notes thereto included in the Company’s annual report on Form 10-K (the “2022 Annual Report”), which was filed with the SEC on February 28, 2023. |
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 judgments, including 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. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2022 Annual Report other than those discussed below. |
Sequencing | Sequencing The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy. On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximately 141 million warrants, with a value of approximately $76.3 million, to purchase shares of the Company’s common stock were reclassified from liabilities to equity on January 9, 2023. The remaining balance of $1.4 million in warrant liability as of March 31, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). |
Modification of Equity Classified Warrants | Modification of Equity Classified Warrants A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend. |
Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 and December 31, 2022 (in thousands): Fair value measured at March 31, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs March 31, 2023 (Level 1) (Level 2) (Level 3) Warrant liability $ 1,445 $ — $ — $ 1,445 Contingent payable derivative liability 8,451 — — 8,451 Share liability 585 — — 585 Total fair value $ 10,481 $ — $ — $ 10,481 Fair value measured at December 31, 2022 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2022 (Level 1) (Level 2) (Level 3) Warrant liability $ 80,559 $ — $ — $ 80,559 Embedded redemption option 807 — — 807 Contingent payable derivative liability 8,668 — — 8,668 Share liability 678 — — 678 Total fair value $ 90,712 $ — $ — $ 90,712 |
Schedule of changes in Level 3 liabilities measured at fair value | The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2023. 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 Share Liability Redemption Option Derivative Liability Liability Total Balance - January 1, 2023 $ 80,559 $ 807 $ 8,668 $ 678 $ 90,712 Additional share liability — — — 538 538 Redemption of share liability — — — (683) (683) Reclassification of warrant liabilities (76,258) — — — (76,258) Change in fair value (2,856) (807) (217) 52 (3,828) Balance - March 31, 2023 $ 1,445 (1) $ — $ 8,451 $ 585 $ 10,481 (1) The remaining balance of $1.4 million in warrant liability as of March 31, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet. |
Schedule of Company's warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy | As of January 9, 2023 As of March 31, 2023 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.63 * $ 0.63 * Contractual term (years) 1.5 0.04 1.3 Volatility (annual) 87 % 114 % 73 % Risk-free rate 4.3 % 2.2 % 4.9 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of March 31, 2023 and December 31, 2022. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation | |
Schedule of stock based compensation | The following table summarizes total stock-based compensation expense for the three months ended March 31, 2023 and 2022 (in thousands). For the three months ended March 31, 2023 2022 Research and development $ 296 $ 510 Research and development - related party — — Milestones achieved (1) 520 — Future milestones (2) 100 — General and administrative 17 107 Total stock-based compensation expense $ 933 $ 617 The related party amounts were for milestone incentives that either were earned or are deemed probable to be achieved in the future and become issuable at that time (as detailed below in Restricted Stock Awards). (1) During the quarter ended March 31, 2023, the Company recognized the remaining $0.5 million stock-based compensation related to the achieved milestone (obtaining a commercial manufacturing license from the MHRA) and accrued for 3.0 million shares that will become issuable for this milestone. The Company has previously recognized $1.6 million stock-based compensation as of December 31, 2022. (2) This is related to a one-time milestone (drafting key portions of the application for product approval) that is anticipated to be achieved and earned in the future. The Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining potential milestone stock awards during the quarter ended March 31, 2023, of $0.1 million. |
Schedule of stock option activity | The following table summarizes stock option activity for the Company’s option plans during the three months ended March 31, 2023 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Contractual Life Total Intrinsic Shares Exercise Price (in years) Value Outstanding as of January 1, 2023 301,263 $ 0.34 7.0 $ 135,225 Cashless exercised (1,325) 0.33 — — Outstanding as of March 31, 2023 299,938 $ 0.34 6.8 $ 90,543 Options vested (1) 281,009 $ 0.33 6.8 $ 85,618 (1) An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days ’ prior notice. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment | |
Schedule of property and equipment | March 31, December 31, Estimated 2023 2022 Useful Life Leasehold improvements $ 13,213 $ 13,070 Lesser of lease term or estimated useful life Office furniture and equipment 445 300 3-5 years Computer and manufacturing equipment and software 2,454 2,238 3-5 years Land in the United Kingdom 84 82 NA 16,196 15,690 NA Less: accumulated depreciation (2,626) (2,272) Total property, plant and equipment, net $ 13,570 $ 13,418 Construction in progress $ 3,321 $ 2,028 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable | |
Schedule of outstanding debt | The following two tables summarize outstanding debt as of March 31, 2023 and December 31, 2022, 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 10,610 (859) 9,751 9% unsecured Various 9 % N/A 157 — 157 12% unsecured On Demand 12 % N/A 563 — 563 11,330 (859) 10,471 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 16,510 (1,326) 15,184 6% secured 3/25/2025 6 % N/A 835 — 835 17,345 (1,326) 16,019 Ending balance as of March 31, 2023 $ 28,810 $ (2,185) $ 26,625 Stated Embedded Interest Conversion Remaining Redemption Carrying Maturity Date Rate Price Face Value Debt Discount Option 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 14,540 (1,300) 807 14,047 9% unsecured Various 9 % N/A 793 — — 793 12% unsecured On Demand 12 % N/A 563 — — 563 15,896 (1,300) 807 15,403 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 5,505 (432) — 5,073 6% secured 3/25/2025 6 % N/A 918 — — 918 6,423 (432) — 5,991 Ending balance as of December 31, 2022 $ 22,454 $ (1,732) $ 807 $ 21,529 |
Net Loss per Share Applicable_2
Net Loss per Share Applicable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Share Applicable to Common Stockholders | |
Schedule of antidilutive securities were not included in the diluted net earnings (loss) per share | For the three months ended March 31, 2023 2022 Series C convertible preferred stock 35,412 — Common stock options 299,938 304,867 Common stock warrants 140,244 208,705 Convertible notes and accrued interest 79 76 Potentially dilutive securities 475,673 513,648 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions | |
Schedule of total research and development costs from related party | The following table summarizes total research and development costs from Advent for the three months ended March 31, 2023 and 2022, respectively (in thousands). For the three months ended March 31, 2023 2022 Advent BioServices Manufacturing cost in London $ 1,643 $ 1,404 Manufacturing cost at Sawston facility 1,712 1,425 SOW 6 one-time milestones - Shares Expensed but unpaid (milestone complete) (1) 520 — Expensed but unpaid, not yet due (milestone not yet complete) (2) 100 — SOW 6 one-time milestones - Cash Expensed and due, but unpaid (milestone complete) (3) 550 — Expensed but unpaid, not yet due (milestone not yet complete) (2) 150 — Total $ 4,675 $ 2,829 |
Schedule of outstanding unpaid accounts payable and accrued expenses held by related parties | As of March 31, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section. March 31, December 31, 2023 2022 Advent BioServices - amount invoiced but unpaid $ 1,765 $ 1,844 Advent BioServices - amount accrued but unpaid (1) 6,566 4,736 Total payable and accrued, but unpaid to Advent BioServices $ 8,331 $ 6,580 (1) This includes $2.1 million which is not payable in cash but represents the value of 3 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for obtaining a commercial manufacturing license for the Sawston facility. Such shares were not issued as of March 31, 2023, and the total value, previously recognized as stock compensation expense, was reclassified from Additional Paid-in-Capital to Accounts payable and accrued expenses to related parties and affiliates. |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Deficit | |
Schedule of warrant activity | The following is a summary of warrant activity for the three months ended March 31, 2023 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2023 141,048 $ 0.31 1.46 Warrants exercised for cash (767) 0.32 — Warrants expired and cancellations (38) 0.34 — Outstanding as of March 31, 2023 140,243 $ 0.31 1.42 |
Schedule of modifications to the warrants following weighted average assumptions | As of January 9, 2023 As of March 31, 2023 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.63 * $ 0.63 * Contractual term (years) 1.5 0.04 1.3 Volatility (annual) 87 % 114 % 73 % Risk-free rate 4.3 % 2.2 % 4.9 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of March 31, 2023 and December 31, 2022. |
Warrants | |
Stockholders' Deficit | |
Schedule of modifications to the warrants following weighted average assumptions | Post-modification Pre-modification Exercise price $ 0.27 $ 0.27 Expected term (in years) 2.1 1.9 Volatility 74 % 95 % Risk-free interest rate 4.3 % 4.2 % Dividend yield 0 % 0 % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 three months ended March 31, 2023 U.K U.S Total Lease cost Operating lease cost $ 144 $ 65 $ 209 Short-term lease cost 23 — 23 Variable lease cost — 4 4 Sub-lease income (36) — (36) Total $ 131 $ 69 $ 200 Other information Operating cash flows from operating leases $ (152) $ (73) $ (225) Weighted-average remaining lease term – operating leases 8.4 1.1 Weighted-average discount rate – operating leases 12 % 12 % For the three months ended March 31, 2022 U.K U.S Total Lease cost Operating lease cost $ 87 $ 65 $ 152 Short-term lease cost 13 — 13 Variable lease cost — 10 10 Total (36) — (36) $ 64 $ 75 $ 138 Other information Operating cash flows from operating leases $ (168) $ (71) $ (239) Weighted-average remaining lease term – operating leases 8.9 1.6 Weighted-average discount rate – operating leases 12 % 12 % |
Schedule of maturities of our operating leases, excluding short-term leases | Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows: Nine months ended December 31, 2023 $ 688 Year ended December 31, 2024 823 Year ended December 31, 2025 618 Year ended December 31, 2026 618 Year ended December 31, 2027 618 Thereafter 6,783 Total 10,148 Less present value discount (5,409) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023 $ 4,739 Maturities of our operating leases under the sublease agreement, are as follows: Nine months ended December 31, 2023 $ 109 Year ended December 31, 2024 145 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Thereafter 1,740 Total $ 2,284 |
Financial Condition, Going Co_2
Financial Condition, Going Concern and Management Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Financial Condition, Going Concern and Management Plans | ||
Net loss | $ 10,652 | $ 14,214 |
Payments for operating activities | $ 11,200 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Millions | Jan. 09, 2023 | Mar. 31, 2023 | Jan. 08, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 | 1,200,000,000 | 1,700,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Number of warrants to purchase shares of common stock reclassified from liability to equity | 141,000,000 | |||
Reclassification of fair value of the warrant liability to equity | $ 76.3 | |||
Remaining balance in warrant liability | $ 1.4 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Fair Value Measurements | ||
Warrant liability | $ 1,445 | $ 80,559 |
Embedded redemption option | 807 | |
Contingent payable derivative liability | 8,451 | 8,668 |
Share liability | 585 | 678 |
Total fair value | 10,481 | 90,712 |
Fair value, transfer between level 1, 2 or 3 | 0 | |
Level 3 | ||
Fair Value Measurements | ||
Warrant liability | 1,445 | 80,559 |
Embedded redemption option | 807 | |
Contingent payable derivative liability | 8,451 | 8,668 |
Share liability | 585 | 678 |
Total fair value | $ 10,481 | $ 90,712 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Level 3 liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Jan. 09, 2023 | Mar. 31, 2023 | |
Fair Value Measurements | ||
Balance | $ 90,712 | |
Additional share liability | 538 | |
Redemption of share liability | (683) | |
Reclassification of warrant liabilities | (76,258) | |
Change in fair value | (3,828) | |
Balance | 10,481 | |
Warrant liability related to purchase shares in a future raise of capital | 1,400 | |
Reclassification of fair value of the warrant liability into the additional paid-in capital | $ 76,300 | |
Change in fair value of the common stock warrant liability | $ 2,300 | |
Warrant Liability | ||
Fair Value Measurements | ||
Balance | 80,559 | |
Reclassification of warrant liabilities | (76,258) | |
Change in fair value | (2,856) | |
Balance | 1,445 | |
Embedded Redemption Option | ||
Fair Value Measurements | ||
Balance | 807 | |
Change in fair value | (807) | |
Contingent Payable Derivative Liability | ||
Fair Value Measurements | ||
Balance | 8,668 | |
Change in fair value | (217) | |
Balance | 8,451 | |
Share liability | ||
Fair Value Measurements | ||
Balance | 678 | |
Additional share liability | 538 | |
Redemption of share liability | (683) | |
Change in fair value | 52 | |
Balance | $ 585 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted average (in aggregate) significant unobservable inputs (Details) - Level 3 - $ / shares | 3 Months Ended | 12 Months Ended | |
Jan. 09, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Warrant Liability | |||
Fair Value Measurements | |||
Strike price | $ 0.31 | $ 0.31 | |
Contractual term (years) | 1 year 6 months | 1 year 6 months | |
Volatility (annual) | 87% | 86% | |
Risk-free rate | 4.30% | 4.30% | |
Dividend yield (per share) | 0% | 0% | |
Contingent Payable Derivative Liability | |||
Fair Value Measurements | |||
Strike price | $ 0.63 | $ 0.78 | |
Contractual term (years) | 1 year 3 months 18 days | 7 months 6 days | |
Volatility (annual) | 73% | 77% | |
Risk-free rate | 4.90% | 4.80% | |
Dividend yield (per share) | 0% | 0% | |
Share liability | |||
Fair Value Measurements | |||
Strike price | $ 0.63 | $ 0.78 | |
Contractual term (years) | 14 days | 1 month 6 days | |
Volatility (annual) | 114% | 76% | |
Risk-free rate | 2.20% | 2% | |
Dividend yield (per share) | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock-based compensation expense (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) Milestone | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Stock-Based Compensation | |||
Number of milestones completed | 2 | ||
Total stock-based compensation expense | $ 933 | $ 617 | |
Total unrecognized compensation cost | 800 | ||
Stock based compensation recognized and expensed but not yet paid | 500 | ||
Shares related to all milestones | 3,000 | ||
Restricted Stock Awards | |||
Stock-Based Compensation | |||
Stock based compensation | $ 1,600 | ||
Stock based compensation recognized and expensed but not yet paid | $ 100 | ||
Shares related to all milestones | 3,000 | ||
Research and development | |||
Stock-Based Compensation | |||
Total stock-based compensation expense | 296 | 510 | |
Milestone achieved | |||
Stock-Based Compensation | |||
Total stock-based compensation expense | 520 | ||
Future milestone | |||
Stock-Based Compensation | |||
Total stock-based compensation expense | 100 | ||
General and administrative | |||
Stock-Based Compensation | |||
Total stock-based compensation expense | $ 17 | $ 107 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||
Number of Shares, Outstanding | 301,263 | |
Number of Shares, Cashless exercised | (1,325) | |
Number of Shares, Outstanding | 299,938 | 301,263 |
Number of Shares, Options vested | 281,009 | |
Weighted Average Exercise Price, Outstanding | $ 0.34 | |
Weighted Average Exercise Price, Cashless exercised | 0.33 | |
Weighted Average Exercise Price, Outstanding | 0.34 | $ 0.34 |
Weighted Average Exercise Price, Options vested | $ 0.33 | |
Weighted Average Remaining Contractual Life (in years), Outstanding | 6 years 9 months 18 days | 7 years |
Weighted Average Remaining Contractual Life (in years), Options vested | 6 years 9 months 18 days | |
Total Intrinsic Value, Outstanding | $ 135,225 | |
Total Intrinsic Value, Outstanding | 90,543 | $ 135,225 |
Total Intrinsic Value, Options vested | $ 85,618 |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Awards (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Mar. 16, 2023 USD ($) shares | Sep. 26, 2022 Milestone item shares | Apr. 30, 2022 item | Mar. 31, 2023 USD ($) Milestone shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) item Milestone | |
Stock-Based Compensation | ||||||
Proceeds from issuance of common stock to investors | $ 3,364 | |||||
Total intrinsic value of all outstanding options | $ 90,543 | $ 135,225 | ||||
Amended Statement of Work 6 | ||||||
Stock-Based Compensation | ||||||
Number of milestones | Milestone | 10 | |||||
Other Service Agreement | ||||||
Stock-Based Compensation | ||||||
Proceeds from issuance of common stock to investors | 15 | |||||
Service period | 4 months | |||||
Restricted Stock Awards | ||||||
Stock-Based Compensation | ||||||
Number of milestones | Milestone | 7 | |||||
Number of workstreams | Milestone | 5 | |||||
Number of required licenses for the Sawston facility | item | 2 | |||||
Amount recognized and expensed related to stock component | $ 100 | |||||
Share based compensation arrangement by share based payment award number of shares available for grant | shares | 13,500,000 | |||||
Total intrinsic value of all outstanding options | $ 10,100 | |||||
Restricted Stock Awards | Statement of Work 6 | ||||||
Stock-Based Compensation | ||||||
Number of workstreams | item | 6 | |||||
Restricted Stock Awards | Amended Statement of Work 6 | ||||||
Stock-Based Compensation | ||||||
Number of required licenses for the Sawston facility | item | 3 | |||||
Remaining cash component milestones that are anticipated to be achieved and earned in the future | Milestone | 3 | |||||
Amount recognized and expensed related to cash component | $ 500 | $ 3,000 | ||||
Share based compensation arrangement by share based payment award number of shares available for grant | shares | 6,000,000 | |||||
Restricted Stock Awards | Other Service Agreement | ||||||
Stock-Based Compensation | ||||||
Number of shares issued during the period | shares | 8,000 | |||||
Proceeds from issuance of common stock to investors | $ 100 | |||||
Restricted Stock Awards | Advent BioServices | Statement of Work 6 | ||||||
Stock-Based Compensation | ||||||
Number of workstreams | item | 5 | |||||
Number of required licenses for the Sawston facility | item | 3 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) shares | |
Stock-Based Compensation | |
Total unrecognized compensation cost | $ | $ 0.8 |
Unrecognized compensation cost recognized period (in years) | 1 year 3 months 18 days |
Notice for exercising any option or warrant (in days) | 61 days |
Share-based Payment Arrangement, Option [Member] | |
Stock-Based Compensation | |
Number of Shares, Vested | shares | 153 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment | ||
Construction in progress | $ 3,321 | $ 2,028 |
Property, plant and equipment, net | 13,570 | 13,418 |
Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 16,196 | 15,690 |
Less: accumulated depreciation | (2,626) | (2,272) |
Construction in progress | 3,321 | 2,028 |
Leasehold improvements | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 13,213 | 13,070 |
Leasehold improvements useful life | Lesser of lease term or estimated useful life | |
Office furniture and equipment | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Office furniture and equipment | Minimum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 3 years | |
Office furniture and equipment | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 445 | 300 |
Computer and manufacturing equipment and software | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Computer and manufacturing equipment and software | Minimum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 3 years | |
Computer and manufacturing equipment and software | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 2,454 | 2,238 |
Land | U.K | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 84 | $ 82 |
Property, Plant and Equipment -
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment | ||
Depreciation | $ 0.3 | $ 0.1 |
Notes Payable - Outstanding deb
Notes Payable - Outstanding debt (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Notes Payable | ||
Face Value | $ 28,810 | $ 22,454 |
Remaining Debt Discount | (2,185) | (1,732) |
Embedded Redemption Option | 807 | |
Carrying Value | 26,625 | 21,529 |
Short term convertible notes payable | ||
Notes Payable | ||
Face Value | 135 | 135 |
Carrying Value | $ 135 | $ 135 |
Short term convertible notes payable | 6% unsecured | ||
Notes Payable | ||
Maturity Date | Due | Due |
Stated Interest Rate | 6% | 6% |
Conversion Price | $ 3.09 | |
Face Value | $ 135 | $ 135 |
Carrying Value | 135 | 135 |
Short term notes payable | ||
Notes Payable | ||
Face Value | 11,330 | 15,896 |
Remaining Debt Discount | (859) | (1,300) |
Embedded Redemption Option | 807 | |
Carrying Value | $ 10,471 | $ 15,403 |
Short term notes payable | 8% unsecured | ||
Notes Payable | ||
Maturity Date | Various | Various |
Stated Interest Rate | 8% | 8% |
Face Value | $ 10,610 | $ 14,540 |
Remaining Debt Discount | (859) | (1,300) |
Embedded Redemption Option | 807 | |
Carrying Value | $ 9,751 | $ 14,047 |
Short term notes payable | 9% unsecured | ||
Notes Payable | ||
Maturity Date | Various | Various |
Stated Interest Rate | 9% | 9% |
Face Value | $ 157 | $ 793 |
Carrying Value | $ 157 | $ 793 |
Short term notes payable | 12% unsecured | ||
Notes Payable | ||
Maturity Date | On Demand | On Demand |
Stated Interest Rate | 12% | 12% |
Face Value | $ 563 | $ 563 |
Carrying Value | 563 | 563 |
Long term notes payable | ||
Notes Payable | ||
Face Value | 17,345 | 6,423 |
Remaining Debt Discount | (1,326) | (432) |
Carrying Value | $ 16,019 | $ 5,991 |
Long term notes payable | 8% unsecured | ||
Notes Payable | ||
Maturity Date | 7/26/2024 | 7/26/2024 |
Stated Interest Rate | 8% | 8% |
Face Value | $ 16,510 | $ 5,505 |
Remaining Debt Discount | (1,326) | (432) |
Carrying Value | $ 15,184 | $ 5,073 |
Long term notes payable | 6% secured | ||
Notes Payable | ||
Maturity Date | 3/25/2025 | 3/25/2025 |
Stated Interest Rate | 6% | 6% |
Face Value | $ 835 | $ 918 |
Carrying Value | $ 835 | $ 918 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) $ in Thousands | 3 Months Ended | |||
Mar. 02, 2023 USD ($) installment | Mar. 31, 2023 USD ($) shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Notes Payable | ||||
Fair value of debt converted | $ 2,100 | |||
Aggregate principal amount | 28,810 | $ 22,454 | ||
Share liabilities extinguished | 700 | |||
Additional share liability recognized | 500 | |||
Gain (loss) from debt extinguishment | 1,300 | |||
Change in fair value of embedded redemption option | 800 | |||
Notes | ||||
Notes Payable | ||||
Cash payments | $ 4,100 | |||
Number of shares issued to lenders in lieu of cash payments | shares | 8,300,000 | |||
Conversion of share settled debt into common stock | $ 5,600 | |||
Accrued interest expense on debt | 200 | |||
Interest expense including amortization of debt discount | 500 | $ 1,100 | ||
Amortization of debt discount | 600 | $ 800 | ||
Notes | Series C convertible preferred stock | ||||
Notes Payable | ||||
Aggregate principal amount | 700 | |||
Accrued interest expense on debt | 100 | |||
Gain (loss) from debt extinguishment | $ 100 | |||
Notes | Senior Convertible Notes [Member] | ||||
Notes Payable | ||||
Number of shares issued to lenders in lieu of cash payments | shares | 43,000 | |||
Conversion of share settled debt into common stock | $ 800 | |||
Commercial Loan | ||||
Notes Payable | ||||
Aggregate principal amount | $ 11,000 | |||
Debt instrument, interest rate | 8% | |||
Term of debt instrument | 22 months | |||
Term when no principal repayments was made | 8 months | |||
Number of installments for amortization | installment | 14 | |||
Original issue discount | $ 1,000 |
Net Loss per Share Applicable_3
Net Loss per Share Applicable to Common Stockholders (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 475,673 | 513,648 |
Series C convertible preferred stock | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 35,412 | |
Common stock options | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 299,938 | 304,867 |
Common stock warrants | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 140,244 | 208,705 |
Convertible notes and accrued interest | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 79 | 76 |
Net Loss per Share Applicable_4
Net Loss per Share Applicable to Common Stockholders - Additional Information (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Notes Payable | |||
Aggregate principal amount | $ 28,810 | $ 22,454 | |
Face Value | 28,810 | $ 22,454 | |
Extinguishment of debt including accrued interest | 700 | ||
Gain from debt extinguishment | $ 1,300 | ||
Notes [Member] | |||
Notes Payable | |||
Number of shares issued to lenders in lieu of cash payments | 8.3 | ||
Conversion of share settled debt into common stock | $ 5,600 | ||
Interest expense including amortization of debt discount | 500 | $ 1,100 | |
Amortization of debt discount | 600 | $ 800 | |
Notes [Member] | Series C Convertible Preferred Stock | |||
Notes Payable | |||
Aggregate principal amount | 700 | ||
Face Value | 700 | ||
Gain from debt extinguishment | $ 100 |
Related Party Transactions (Det
Related Party Transactions (Details) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 USD ($) Milestone item Program | Dec. 31, 2022 USD ($) | |
Related Party Transactions | ||
Percentage of margin | 15% | |
Number of milestones completed | 2 | |
Amount recognized and expensed related to Current cash component | $ 1 | |
Number of shares issuable for the accrued milestone | 3 | |
Fair value of debt converted | 2.1 | |
Stock-based compensation related to the achieved milestone | 0.5 | $ 1.6 |
Stock based compensation recognized and expensed but not yet paid | 0.5 | |
Amount related to future cash milestone payments anticipated to achieve and earn | 0.2 | |
Fair value of future shares milestone payments anticipate to achieve and earn | $ 0.1 | |
Advent Bio services agreement | ||
Related Party Transactions | ||
Number of operational programs | Program | 3 | |
Number of sets of one-time milestones | Milestone | 10 | |
Number of required licenses for the Sawston facility | item | 3 |
Related Party Transactions - Re
Related Party Transactions - Research and development Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Related Party Transactions | ||
Total | $ 4,675 | $ 2,829 |
Expensed and paid (milestone complete) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Shares | 520 | |
Expensed and paid (partial milestone earned) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Cash | 550 | |
Expensed and due, but unpaid (milestone complete) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Shares | 100 | |
Related party costs, SOW 6 one-time milestones - Cash | 150 | |
Advent BioServices | Manufacturing cost in London | ||
Related Party Transactions | ||
Related party costs, Manufacturing costs | 1,643 | 1,404 |
Advent BioServices | Manufacturing cost at Sawston facility | ||
Related Party Transactions | ||
Related party costs, Manufacturing costs | $ 1,712 | $ 1,425 |
Related Party Transactions - Ad
Related Party Transactions - Advent BioServices Sublease Agreement (Details) | 3 Months Ended | ||
Mar. 31, 2023 GBP (£) ft² item | Mar. 31, 2023 USD ($) ft² item | Mar. 31, 2022 USD ($) | |
Related Party Transactions | |||
Lease payments | $ 225,000 | $ 239,000 | |
Sub-lease income | $ 36,000 | $ 36,000 | |
Advent BioServices | |||
Related Party Transactions | |||
Area of sublease (in sqft) | item | 14,459 | 14,459 | |
Total area of lease (in sqft) | ft² | 88,000 | 88,000 | |
Number of times calculated for lease payment under sub-lease | item | 2 | 2 | |
Rate per square foot under sub-lease | £ 5.75 | $ 7.11 | |
Cap rate per square foot under sub-lease | 10 | ||
Sub-lease payments receivable | 145,000 | ||
Lease payments | £ | £ 500,000 | ||
Approximate lease payments | $ 618,000 |
Related Party Transactions - _2
Related Party Transactions - Related Party Accounts Payable (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Related Party Transactions | ||
Fair value of debt converted | $ 2,100 | |
Number of shares issuable for the accrued milestone | 3,000 | |
Accounts payable to related party | ||
Related Party Transactions | ||
Unpaid board compensation | 400 | |
Advent BioServices - amount invoiced | ||
Related Party Transactions | ||
Accounts payable and accrued expenses | 1,765 | $ 1,844 |
Advent BioServices - amount invoiced but unpaid | ||
Related Party Transactions | ||
Accounts payable and accrued expenses | 6,566 | 4,736 |
Advent BioServices | ||
Related Party Transactions | ||
Accounts payable and accrued expenses | 8,331 | $ 6,580 |
Advent BioServices | Accounts payable to related party | ||
Related Party Transactions | ||
Fair value of debt converted | 2,100 | |
Number of shares issuable for the accrued milestone | $ 3,000 |
Preferred Stock (Details)
Preferred Stock (Details) | 3 Months Ended | ||
Mar. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | |
Preferred Stock | |||
Extinguishment of debt including accrued interest | $ 700,000 | ||
Proceeds from exercise of warrants | 248,000 | $ 4,185,000 | |
Aggregate principal amount | 28,810,000 | $ 22,454,000 | |
Gain (loss) from debt extinguishment | $ 1,300,000 | ||
Notes | |||
Preferred Stock | |||
Number of shares issued to lenders in lieu of cash payments | shares | 8,300,000 | ||
Conversion of share settled debt into common stock | $ 5,600,000 | ||
Accrued interest expense on debt | $ 200,000 | ||
Notes | Senior Convertible Notes [Member] | |||
Preferred Stock | |||
Number of shares issued to lenders in lieu of cash payments | shares | 43,000 | ||
Conversion of share settled debt into common stock | $ 800,000 | ||
Minimum | |||
Preferred Stock | |||
Warrants exercise price | $ / shares | $ 0.22 | ||
Maximum | |||
Preferred Stock | |||
Warrants exercise price | $ / shares | 0.85 | ||
Series C Subscription Agreements | Series C Investors | |||
Preferred Stock | |||
Temporary equity, par value | $ / shares | $ 0.001 | ||
Series C Convertible Preferred Stock | |||
Preferred Stock | |||
Issuance of stock for cash (in shares) | shares | 148,000 | ||
Temporary equity, shares designated | shares | 10,000,000 | 10,000,000 | |
Proceeds from issuance of Series C convertible preferred stock | $ 2,385,000 | ||
Series C Convertible Preferred Stock | Notes | |||
Preferred Stock | |||
Aggregate principal amount | 700,000 | ||
Accrued interest expense on debt | 100,000 | ||
Gain (loss) from debt extinguishment | $ 100,000 | ||
Series C Convertible Preferred Stock | Common Stock | |||
Preferred Stock | |||
Number of shares converted | shares | 200,000 | ||
Value of shares converted | $ 2,600,000 | ||
Number of shares issued on conversion | shares | 4,900,000 | ||
Conversion ratio from preferred stock to common stock | 0.04 | ||
Series C Convertible Preferred Stock | Series C Subscription Agreements | Series C Investors | |||
Preferred Stock | |||
Issuance of stock for cash (in shares) | shares | 100,000 | ||
Purchase price | $ / shares | $ 16.11 | ||
Gross proceeds from issuance of shares | $ 2,400,000 | ||
Price per share | $ / shares | $ 16.11 |
Stockholders' Deficit - Stock P
Stockholders' Deficit - Stock Purchase Warrants (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Deficit | ||
Number of Warrants, Outstanding | 141,048 | |
Number of Warrants, Warrants exercised for cash | (767) | |
Number of Warrants, Warrants expired and cancellations | (38) | |
Number of Warrants, Outstanding | 140,243 | 141,048 |
Weighted Average Exercise Price - Outstanding | $ 0.31 | |
Weighted Average Exercise Price - Warrants exercised for cash | 0.32 | |
Weighted Average Exercise Price, Warrants expired and cancellations | 0.34 | |
Weighted Average Exercise Price - Outstanding | $ 0.31 | $ 0.31 |
Remaining Contractual Term | 1 year 5 months 1 day | 1 year 5 months 15 days |
Stockholders' Deficit - Warrant
Stockholders' Deficit - Warrant Modifications (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) $ / shares | |
Stock-Based Compensation | |
Deemed dividend related to warrant modifications | $ | $ 395 |
Post Modification | |
Stock-Based Compensation | |
Exercise price | $ / shares | $ 0.27 |
Expected term (in years) | 2 years 1 month 6 days |
Volatility | 74% |
Risk-free interest rate | 4.30% |
Dividend yield | 0% |
Pre Modification | |
Stock-Based Compensation | |
Exercise price | $ / shares | $ 0.27 |
Expected term (in years) | 1 year 10 months 24 days |
Volatility | 95% |
Risk-free interest rate | 4.20% |
Dividend yield | 0% |
Deemed dividend related to warrant modifications | $ | $ 400 |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2023 | Mar. 31, 2022 | Jan. 09, 2023 | Jan. 08, 2023 | Dec. 31, 2022 | |
Stockholders' Deficit | |||||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 | 1,200,000,000 | 1,700,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Aggregate proceeds from exercise of warrants | $ 248 | $ 4,185 | |||
Stock issued on exercise of warrants | 800,000 | ||||
Number of shares issued for repayments of debt | 8,300,000 | ||||
Amount of debt redeemed from issuance of shares | $ 4,100 | ||||
Amount of interest on debt redeemed from issuance of shares | $ 200 | ||||
Number of warrants outstanding | 140,243 | 141,048 | |||
Class of warrant or right, extended in suspension | 97,000,000 | ||||
Warrants issued as consideration for warrants suspension | |||||
Stockholders' Deficit | |||||
Number of warrants outstanding | 140,000,000 | ||||
Cashless Warrants Exercise | |||||
Stockholders' Deficit | |||||
Number of Warrants, cashless warrants exercise | 1,300,000 | ||||
Common Stock | |||||
Stockholders' Deficit | |||||
Stock issued on exercise of warrants | 700,000 | ||||
Minimum | |||||
Stockholders' Deficit | |||||
Warrants exercise price | $ 0.22 | ||||
Minimum | Common Stock | Cashless Warrants Exercise | |||||
Stockholders' Deficit | |||||
Warrants exercise price | 0.25 | ||||
Maximum | |||||
Stockholders' Deficit | |||||
Warrants exercise price | 0.85 | ||||
Maximum | Common Stock | Cashless Warrants Exercise | |||||
Stockholders' Deficit | |||||
Warrants exercise price | $ 0.35 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Lease cost | ||
Operating lease cost | $ 209,000 | $ 152,000 |
Short-term lease cost | 23,000 | 13,000 |
Variable lease cost | 4,000 | 10,000 |
Sub-lease income | (36,000) | (36,000) |
Total | 200,000 | 138,000 |
Other information | ||
Operating cash flows from operating leases | (225,000) | (239,000) |
U.K | ||
Lease cost | ||
Operating lease cost | 144,000 | 87,000 |
Short-term lease cost | 23,000 | 13,000 |
Sub-lease income | (36,000) | (36,000) |
Total | 131,000 | 64,000 |
Other information | ||
Operating cash flows from operating leases | $ (152,000) | $ (168,000) |
Weighted-average remaining lease term - operating leases | 8 years 4 months 24 days | 8 years 10 months 24 days |
Weighted-average discount rate - operating leases | 12% | 12% |
U.S | ||
Lease cost | ||
Operating lease cost | $ 65,000 | $ 65,000 |
Variable lease cost | 4,000 | 10,000 |
Total | 69,000 | 75,000 |
Other information | ||
Operating cash flows from operating leases | $ (73,000) | $ (71,000) |
Weighted-average remaining lease term - operating leases | 1 year 1 month 6 days | 1 year 7 months 6 days |
Weighted-average discount rate - operating leases | 12% | 12% |
Commitments and Contingencies -
Commitments and Contingencies - Maturities of our operating leases (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Commitments and Contingencies | |
Nine months ended December 31, 2023 | $ 688 |
Year ended December 31, 2024 | 823 |
Year ended December 31, 2025 | 618 |
Year ended December 31, 2026 | 618 |
Year ended December 31, 2027 | 618 |
Thereafter | 6,783 |
Total | 10,148 |
Less present value discount | (5,409) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023 | 4,739 |
Sublease agreement | |
Commitments and Contingencies | |
Nine months ended December 31, 2023 | 109 |
Year ended December 31, 2024 | 145 |
Year ended December 31, 2025 | 145 |
Year ended December 31, 2026 | 145 |
Thereafter | 1,740 |
Total | $ 2,284 |
Commitments and Contingencies_3
Commitments and Contingencies - Additional Information (Details) £ in Millions | 3 Months Ended | 6 Months Ended | |||||||||||
Sep. 26, 2022 item | Jul. 27, 2022 USD ($) | Jul. 27, 2022 EUR (€) | Nov. 04, 2021 USD ($) | Nov. 04, 2021 EUR (€) | May 14, 2018 USD ($) | May 14, 2018 GBP (£) | Mar. 31, 2023 USD ($) | Mar. 31, 2023 EUR (€) | Jun. 30, 2022 USD ($) | Jun. 30, 2022 EUR (€) | Mar. 31, 2023 EUR (€) | Dec. 31, 2022 USD ($) | |
Commitments and Contingencies | |||||||||||||
Operating lease liabilities | $ 4,739,000 | ||||||||||||
Lease, practical expedient, lessor single lease component [true false] | true | true | |||||||||||
Operating lease, term of contract | 20 years | 20 years | |||||||||||
ROU asset | $ 4,209,000 | $ 4,189,000 | |||||||||||
Original term of the agreement | 8 months | 8 months | |||||||||||
Litigation settlement waiver of penalty | $ 147,000 | € 135,000 | |||||||||||
Loss contingency accrual | $ 410,000 | € 377,000 | |||||||||||
Advent Bioscience accrued | |||||||||||||
Commitments and Contingencies | |||||||||||||
Number of workstreams | item | 6 | ||||||||||||
Advent Bio services agreement | |||||||||||||
Commitments and Contingencies | |||||||||||||
Term of agreement | 12 months | 12 months | |||||||||||
Advent Bio services agreement | Minimum | |||||||||||||
Commitments and Contingencies | |||||||||||||
Minimum required payments for this notice period | $ 5,500,000 | £ 4.4 | |||||||||||
German tax authority | |||||||||||||
Commitments and Contingencies | |||||||||||||
Settlement expense | 329,000 | € 277,000 | |||||||||||
Received tax bills | $ 241,000 | € 222,000 | |||||||||||
State and local jurisdiction | |||||||||||||
Commitments and Contingencies | |||||||||||||
Settlement expense | $ 251,000 | € 231,000 | |||||||||||
Additional late fees | $ 558,000 | € 513,000 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | 1 Months Ended | 3 Months Ended | ||||
May 08, 2023 USD ($) | Apr. 19, 2023 USD ($) shares | Apr. 30, 2023 USD ($) shares | Mar. 31, 2023 USD ($) shares | Mar. 31, 2022 shares | May 05, 2023 | |
Common Stock | ||||||
Subsequent Events | ||||||
Number of shares issued during the period | 4,553,000 | |||||
Series C convertible preferred stock | Common Stock | ||||||
Subsequent Events | ||||||
Number of shares converted | 200,000 | |||||
Value of shares converted | $ | $ 2.6 | |||||
Number of shares issued on conversion | 4,900,000 | |||||
Conversion ratio from preferred stock to common stock | 0.04 | |||||
Subsequent event | ||||||
Subsequent Events | ||||||
Proceeds from prepayments of purchase of securities | $ | $ 3 | |||||
Subsequent event | Common Stock | ||||||
Subsequent Events | ||||||
Number of shares issued during the period | 2,600,000 | |||||
Cash payments | $ | $ 1.3 | |||||
Interest | $ | $ 0.1 | |||||
Subsequent event | Series C convertible preferred stock | Common Stock | ||||||
Subsequent Events | ||||||
Number of shares converted | 45,000 | |||||
Value of shares converted | $ | $ 0.7 | |||||
Number of shares issued on conversion | 1,100,000 | |||||
Conversion ratio from preferred stock to common stock | 0.04 |