Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.001 per share | |
Trading Symbol | NWBO | |
Security Exchange Name | NONE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,208,177,416 | |
Entity Central Index Key | 0001072379 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 2,478 | $ 2,126 |
Prepaid expenses and other current assets | 2,470 | 1,999 |
Total current assets | 4,948 | 4,125 |
Non-current assets: | ||
Property, plant and equipment, net | 17,268 | 17,278 |
Right-of-use asset, net | 4,070 | 4,183 |
Indefinite-lived intangible asset | 1,292 | 1,292 |
Goodwill | 626 | 626 |
Other assets | 363 | 361 |
Total non-current assets | 23,619 | 23,740 |
TOTAL ASSETS | 28,567 | 27,865 |
Current liabilities: | ||
Accounts payable and accrued expenses | 15,089 | 10,244 |
Accounts payable and accrued expenses to related parties and affiliates | 2,734 | 3,544 |
Convertible notes, net | 5,612 | 3,765 |
Convertible notes at fair value | 16,496 | 12,771 |
Notes payable, net | 12,125 | 3,944 |
Contingent payable derivative liability | 9,099 | 9,188 |
Warrant liability | 913 | 944 |
Investor advances | 7 | 7 |
Share liability | 120 | 483 |
Lease liabilities | 245 | 314 |
Total current liabilities | 62,440 | 45,204 |
Non-current liabilities: | ||
Notes payable, net of current portion, net | 10,215 | 20,312 |
Lease liabilities, net of current portion | 4,384 | 4,454 |
Contingent payment obligation | 5,000 | 4,950 |
Total non-current liabilities | 19,599 | 29,716 |
Total liabilities | 82,039 | 74,920 |
COMMITMENTS AND CONTINGENCIES (Note 12) | ||
Stockholders' deficit: | ||
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively | ||
Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,195.4 million and 1,175.5 million shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 1,195 | 1,175 |
Additional paid-in capital | 1,301,485 | 1,291,316 |
Stock subscription receivable | (79) | (79) |
Accumulated deficit | (1,378,033) | (1,359,721) |
Accumulated other comprehensive income | 2,150 | 1,536 |
Total stockholders' deficit | (73,282) | (65,773) |
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' DEFICIT | 28,567 | 27,865 |
Series C Convertible Preferred Stock | ||
Mezzanine equity: | ||
Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.3 million and 1.2 million shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $18.1 million | $ 19,810 | $ 18,718 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 1,195,400,000 | 1,175,500,000 |
Common stock, shares outstanding | 1,195,400,000 | 1,175,500,000 |
Series C Convertible Preferred Stock | ||
Temporary equity, shares designated | 10,000,000 | 10,000,000 |
Temporary equity, shares issued | 1,300,000 | 1,200,000 |
Temporary equity, shares outstanding | 1,297,000 | 1,209,000 |
Temporary equity, aggregate liquidation preference | $ 18.1 | $ 18.1 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues: | ||
Research and other | $ 284 | $ 880 |
Total revenues | 284 | 880 |
Operating costs and expenses: | ||
Research and development | 7,942 | 6,861 |
General and administrative | 8,086 | 6,983 |
Total operating costs and expenses | 16,028 | 13,844 |
Loss from operations | (15,744) | (12,964) |
Other income (expense): | ||
Change in fair value of derivative liabilities | 120 | 3,880 |
Change in fair value of share liabilities | (106) | (52) |
Change in fair value of convertible notes | 1,775 | |
Loss from extinguishment of debt | (2,171) | (1,408) |
Interest expense | (1,518) | (1,027) |
Foreign currency transaction gain (loss) | (668) | 919 |
Total other (loss) income | (2,568) | 2,312 |
Net loss | (18,312) | (10,652) |
Deemed dividend related to warrant modification | (568) | (395) |
Net loss attributable to common stockholders | (18,880) | (11,047) |
Other comprehensive loss | ||
Foreign currency translation adjustment | 614 | (750) |
Total comprehensive loss | $ (18,266) | $ (11,797) |
Net loss per share applicable to common stockholders, Basic | $ (0.02) | $ (0.01) |
Net loss per share applicable to common stockholders, Diluted | $ (0.02) | $ (0.01) |
Weighted average shares used in computing basic loss per share | 1,188,149 | 1,074,902 |
Weighted average shares used in computing diluted loss per share | 1,188,149 | 1,074,902 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) shares in Thousands, $ in Thousands | Series C Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Subscription Receivable | Accumulated Deficit | Accumulated Other Comprehensive Income | Total |
Balance at the beginning (in shares) at Dec. 31, 2022 | 1,415 | ||||||
Balance at the beginning at Dec. 31, 2022 | $ 23,060 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash | $ 2,385 | ||||||
Issuance of stock for cash (in shares) | 148 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 43 | ||||||
Issuance of stock in lieu of debt redemption | $ 806 | ||||||
Convertible preferred stock conversion | $ (2,617) | $ 5 | $ 2,612 | $ 2,617 | |||
Convertible preferred stock conversion (in shares) | (198) | 4,946 | |||||
Balance at the end (in shares) at Mar. 31, 2023 | 1,416 | ||||||
Balance at the end at Mar. 31, 2023 | $ 23,752 | ||||||
Balance at the beginning at Dec. 31, 2022 | $ 1,068 | 1,164,885 | $ (79) | $ (1,297,122) | $ 3,145 | (128,103) | |
Balance at the beginning (in shares) at Dec. 31, 2022 | 1,068,394 | ||||||
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 | ||||||
Convertible preferred stock conversion | $ (2,617) | $ 5 | 2,612 | 2,617 | |||
Convertible preferred stock conversion (in shares) | (198) | 4,946 | |||||
Warrants exercised for cash | $ 1 | 247 | 248 | ||||
Warrants exercised for cash (in shares) | 767 | ||||||
Cashless warrants and stock options exercise | $ 1 | (1) | |||||
Cashless warrants and stock options exercise (in shares) | 710 | ||||||
Issuance of common stock for conversion of debt and accrued interest | $ 8 | 5,608 | 5,616 | ||||
Issuance of common stock for conversion of debt and accrued interest (in shares) | 8,267 | ||||||
Reclassification of warrant liabilities related to warrants exercised for cash | 76,258 | 76,258 | |||||
Stock-based compensation | $ 118 | 918 | 918 | ||||
Stock-based compensation (in shares) | 8 | ||||||
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 Income (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 | ||||||
Balance at the beginning (in shares) at Dec. 31, 2023 | 1,209 | ||||||
Balance at the beginning at Dec. 31, 2023 | $ 18,718 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash | $ 3,624 | ||||||
Issuance of stock for cash (in shares) | 308 | ||||||
Convertible preferred stock conversion | $ (2,532) | $ 5 | 2,527 | 2,532 | |||
Convertible preferred stock conversion (in shares) | (220) | 5,493 | |||||
Balance at the end (in shares) at Mar. 31, 2024 | 1,297 | ||||||
Balance at the end at Mar. 31, 2024 | $ 19,810 | ||||||
Balance at the beginning at Dec. 31, 2023 | $ 1,175 | 1,291,316 | (79) | (1,359,721) | 1,536 | (65,773) | |
Balance at the beginning (in shares) at Dec. 31, 2023 | 1,175,459 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of stock for cash | $ 3,624 | ||||||
Issuance of stock for cash (in shares) | 308 | ||||||
Convertible preferred stock conversion | $ (2,532) | $ 5 | 2,527 | 2,532 | |||
Convertible preferred stock conversion (in shares) | (220) | 5,493 | |||||
Warrants exercised for cash | $ 6 | 1,305 | $ 1,311 | ||||
Warrants exercised for cash (in shares) | 5,831 | ||||||
Cashless warrants and stock options exercise | $ 2 | (2) | |||||
Cashless warrants and stock options exercise (in shares) | 1,633 | 650 | |||||
Issuance of common stock for conversion of debt and accrued interest | $ 7 | 3,945 | $ 3,952 | ||||
Issuance of common stock for conversion of debt and accrued interest (in shares) | 6,942 | ||||||
Stock-based compensation | 1,164 | 1,164 | |||||
Cumulative translation adjustment | 614 | 614 | |||||
Warrants modfication | 1,798 | 1,798 | |||||
Deemed dividend related to warrants modification | (568) | (568) | |||||
Net Income (Loss) | (18,312) | (18,312) | |||||
Balance at the end at Mar. 31, 2024 | $ 1,195 | $ 1,301,485 | $ (79) | $ (1,378,033) | $ 2,150 | $ (73,282) | |
Balance at the end (in shares) at Mar. 31, 2024 | 1,195,358 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (18,312) | $ (10,652) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation and amortization | 428 | 335 |
Amortization of debt discount | 576 | 552 |
Change in fair value of derivatives | (120) | (3,880) |
Change in fair value of share liability | 106 | 52 |
Change in fair value of convertible notes | (1,775) | |
Loss from extinguishment of debt | 2,171 | 1,408 |
Amortization of operating lease right-of-use asset | 77 | 67 |
Stock-based compensation for services | 1,164 | 933 |
Subtotal of non-cash charges | 2,627 | (533) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (477) | (709) |
Other non-current assets | (8) | (16) |
Accounts payable and accrued expenses | 4,531 | 975 |
Related party accounts payable and accrued expenses | (810) | (341) |
Lease liabilities | 43 | 37 |
Net cash used in operating activities | (12,406) | (11,239) |
Cash Flows from Investing Activities: | ||
Purchase of equipment and construction in progress | (239) | (1,333) |
Net cash used in investing activities | (239) | (1,333) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of Series C convertible preferred stock | 3,624 | 2,385 |
Proceeds from exercise of warrants | 1,311 | 248 |
Proceeds from investor advance | 50 | |
Proceeds from issuance of notes payable, net | 10,000 | |
Proceeds from issuance of convertible notes payable, net | 7,100 | |
Proceeds from contingent payment obligation | 50 | |
Repayment of notes payable | (101) | |
Net cash provided by financing activities | 12,085 | 12,582 |
Effect of exchange rate changes on cash and cash equivalents | 912 | (784) |
Net increase (decrease) in cash and cash equivalents | 352 | (774) |
Cash and cash equivalents, beginning of the period | 2,126 | 6,965 |
Cash and cash equivalents, end of the period | 2,478 | 6,191 |
Supplemental schedule of non-cash investing and financing activities: | ||
Cashless warrants and stock options exercise | 2 | 1 |
Reclassification of warrant liabilities to stockholders' deficit | 76,258 | |
Issuance of common stock for conversion of debt and accrued interest | 3,952 | 5,616 |
Series C convertible preferred stock conversion | 2,532 | 2,617 |
Capital expenditures included in accounts payable | 500 | 1,013 |
Reclass earned but unissued milestone shares from equity to liability | 2,130 | |
Deemed dividend related to warrant modification | 568 | 395 |
Debt discout related to warrant modificaiton | $ 8 | |
Issuance of Series C convertible preferred stock in lieu of debt redemption | 806 | |
Convertible notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments on notes payable | $ (30) |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2024 | |
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, Northwest Biotherapeutics Limited (formerly known as 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®. On July 24, 2023, the Company’s wholly-owned subsidiary changed its name from Aracaris Ltd to Northwest Biotherapeutics Limited. 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 submitted a Marketing Authorization Application (MAA) for regulatory approval in the U.K. in December 2023. |
Financial Condition, Going Conc
Financial Condition, Going Concern and Management Plans | 3 Months Ended |
Mar. 31, 2024 | |
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 $18.3 million for the three months ended March 31, 2024. The Company used approximately $12.4 million of cash in its operating activities during the three months ended March 31, 2024. 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, 2024 | |
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, 2024, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2024 and 2023, and the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 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, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at March 31, 2024 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, 2023 and notes thereto included in the Company’s annual report on Form 10-K (the “2023 Annual Report”), which was filed with the SEC on March 5, 2024. 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. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2023 Annual Report. Recently Issued Accounting Standards Not Yet Adopted Compensation - Stock Compensation In March 2024, the FASB issued ASU No. 2024-01, Compensation - Stock Compensation (Topic 718) - Scope Application of Profits Interest and Similar Awards, to clarify whether profits interest and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock Compensation. The guidance applies to all business entities that issue profits interest awards as compensation to employees or nonemployees in exchange for goods or services. These amendments are effective for the Company for annual and interim periods in 2025, applied prospectively, with early adoption and retrospective application permitted. As the Company does not issue profit interest awards, the impact of the adoption of the amendments in this update is not expected to be material to the Company’s consolidated financial statements. Improvements to Income Tax Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements. Recently Issued Accounting Standards, 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 adopted ASU 2022-03 effective January 1, 2024. The adoption of this guidance did not have a material impact on its condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
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 embedded conversion features associated with convertible debt, share liability (receivable), and the contingent payable to Cognate BioServices on a recurring basis to determine the fair value of these liabilities. The Company also elects the fair value option (“FVO”) for certain eligible financial instruments, such as convertible notes, in order to simplify the accounting treatment. 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, 2024 and December 31, 2023 (in thousands): Fair value measured at March 31, 2024 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs March 31, 2024 (Level 1) (Level 2) (Level 3) Warrant liability $ 913 $ — $ — $ 913 Contingent payable derivative liability 9,099 — — 9,099 Convertible notes at fair value 16,496 — — 16,496 Share liability 120 — — 120 Total fair value $ 26,628 $ — $ — $ 26,628 Fair value measured at December 31, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2023 (Level 1) (Level 2) (Level 3) Warrant liability $ 944 $ — $ — $ 944 Contingent payable derivative liability 9,188 — — 9,188 Convertible notes at fair value 12,771 — — 12,771 Share liability 483 — — 483 Total fair value $ 23,386 $ — $ — $ 23,386 There were no transfers between Leve 1 3 The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2024. 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). Convertible Warrant Contingent Payable Share Notes Liability Derivative Liability Liability At Fair Value Total Balance - January 1, 2024 $ 944 $ 9,188 $ 483 $ 12,771 $ 23,386 Additional share liability — — 117 — 117 Issuance of convertible notes at fair value — — — 5,500 5,500 Redemption of share liability — — (586) — (586) Change in fair value (31) (89) 106 (1,775) (1,789) Balance - March 31, 2024 $ 913 (1) $ 9,099 $ 120 $ 16,496 $ 26,628 (1) The remaining balance of $0.9 million in warrant liability as of March 31, 2024 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. 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 March 31, 2024 and December 31, 2023 is as follows: As of March 31, 2024 Share Contingent Payable Liability Derivative Liability Strike price $ 0.44 $ 0.52 * Contractual term (years) 0.04 1.0 Volatility (annual) 74 % 73 % Risk-free rate 5.5 % 5.2 % Dividend yield (per share) 0 % 0 % As of December 31, 2023 Share Contingent Payable Liability Derivative Liability Strike price $ 0.64 $ 0.70 * Contractual term (years) 0.1 1.0 Volatility (annual) 71 % 71 % Risk-free rate 5.6 % 5.2 % Dividend yield (per share) 0 % 0 % * The strike price assumes the current stock price as of March 31, 2024 and December 31, 2023. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 and 2023 (in thousands). For the three months ended March 31, 2024 2023 Research and development $ 1,009 $ 296 Research and development - related party Milestones achieved (1) — 520 Future milestones (2) — 100 General and administrative 155 17 Total stock-based compensation expense $ 1,164 $ 933 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 stock compensation (primarily for consultants) cost was approximately $3.6 million as of March 31, 2024 and will be recognized over the next 1.8 years. Stock Options The following table summarizes stock option activity for options granted to key external experts during the three months ended March 31, 2024 (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, 2024 317,076 $ 0.35 6.0 $ 114,097 Granted 500 0.53 4.2 — Cashless exercised (650) 0.35 — — Outstanding as of March 31, 2024 316,926 $ 0.35 5.8 $ 59,173 Options vested (1) 280,514 $ 0.33 5.8 $ 55,534 (1) During the three months ended March 31, 2024, the Company granted 500,000 stock options (the “Options”) with an exercise price at $0.53 per share to a staff employee. The Options vested immediately on the grant date. In addition, the Company will make an additional payment of $0.30 per option exercised by the employee for a maximum amount of $150,000. The Company has fully accrued this additional payment as of March 31, 2024 on its condensed consolidated balance sheets. The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The assumptions used in calculating the fair values of stock options that were granted during the three months ended March 31, 2024 was as follows: For the three months ended March 31, 2024 Exercise price $ 0.53 Expected term (years) 2.1 Expected stock price volatility 73 % Risk-free rate 4.5 % Dividend yield (per share) 0 % Restricted Stock Awards Advent SOW 6 There was no stock based compensation recognized during the three months ended March 31, 2024. As previously reported, the Company previously achieved all of the 10 one-time milestones (i.e., for all six workstreams that are prerequisites for a MAA application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the MAA application) pursuant to the Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company. As of March 31, 2024, 1.5 million shares related to the completed milestone (submission of the application to MHRA for approval) had not been issued and the fair value of the shares of $1.1 million remained accrued in accounts payable and accrued expenses to related parties and affiliates. |
Property, Plant and Equipment
Property, Plant and Equipment | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 6. Property, Plant and Equipment Property, plant and equipment consist of the following at March 31, 2024 and December 31, 2023 (in thousands): March 31, December 31, Estimated 2024 2023 Useful Life Leasehold improvements $ 17,867 $ 17,785 Lesser of lease term or estimated useful life Office furniture and equipment 527 487 3-5 years Computer and manufacturing equipment and software 3,055 2,776 3-5 years Land in the United Kingdom 85 86 NA 21,534 21,134 NA Less: accumulated depreciation (4,266) (3,856) Total property, plant and equipment, net $ 17,268 $ 17,278 Depreciation expense was approximately $0.4 million and $0.3 million for the three months ended March 31, 2024, and 2023, respectively. |
Outstanding Debt
Outstanding Debt | 3 Months Ended |
Mar. 31, 2024 | |
Outstanding Debt | |
Outstanding Debt | 7. Outstanding Debt The following two tables summarize outstanding debt as of March 31, 2024 and December 31, 2023, respectively (amount in thousands): Stated Fair Interest Conversion Remaining Value Carrying Maturity Date Rate Price Face Value Debt Discount Adjustment Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured Various 8 % $ 0.20-$0.50 * 5,246 (269) — 4,977 10 % unsecured 7/11/2024 10 % $ 0.50 * 500 — — 500 5,881 (269) — 5,612 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40 - $0.49 * 16,250 — 246 16,496 Short term notes payable 8% unsecured Various 8 % N/A 11,399 (404) — 10,995 12% unsecured On Demand 12 % N/A 562 — — 562 6% secured 3/25/2025 6 % N/A 568 — — 568 12,529 (404) — 12,125 Long term notes payable 8% unsecured Various 8 % N/A 11,005 (790) — 10,215 Ending balance as of March 31, 2024 $ 45,665 $ (1,463) $ 246 $ 44,448 *These convertible notes are convertible into Series C preferred shares at $5.00 - $12.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.20-$0.50 per share. Stated Interest Conversion Remaining Fair Value Carrying Maturity Date Rate Price Face Value Debt Discount Adjustment Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured Various 8 % $ 0.50-$0.70 * 3,486 (356) — 3,130 10% unsecured 7/11/2024 10 % $ 0.50 * 500 — — 500 4,121 (356) — 3,765 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40-$0.49 * 10,750 — 2,021 12,771 Short term notes payable 8% unsecured Various 8 % N/A 3,539 (157) — 3,382 12% unsecured On Demand 12 % N/A 562 — — 562 4,101 (157) — 3,944 Long term notes payable 8% unsecured Various 8 % N/A 21,224 (1,485) — 19,739 6% secured 3/25/2025 6 % N/A 573 — — 573 21,797 (1,485) — 20,312 Ending balance as of December 31, 2023 $ 40,769 $ (1,998) $ 2,021 $ 40,792 *These convertible notes are convertible into Series C preferred shares at $10.00 - $17.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.40 - $0.70 per share. Promissory Note During the three months ended March 31, 2024, the Company issued approximately 6.9 million shares of common stock with a fair value of $4.0 million to certain lenders in lieu of cash payments of $2.7 million of debt, including $0.3 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 (the “True-up Price”), or the lender is required to return common shares to the Company (the “Share receivable”) if the stock price is greater than the True-up Price as of the true-up date. During the three months ended March 31, 2024, the Company extinguished Share liabilities of $0.6 million and recognized additional $0.1 million in Share liabilities. The Company recognized an approximately $0.8 million debt extinguishment loss during the three months ended March 31, 2024 from the debt redemption. Convertible Notes On February 21, 2024, the Company entered into several one-year convertible notes (the “February Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.8 million for a purchase price of $1.6 million. The February Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $12.50 per share at the Holders’ sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. As consideration for entering into the package of February Convertible Notes for $1.8 million as described above, the Company amended the Holders’ existing convertible notes and warrants, whereby the maturity date of certain notes and warrants were extended, the conversion price of certain notes were reduced, and the exercise prices of certain warrants were reduced. These amendments in January and February of 2024 involving 16 tranches warrants and 10 debt instruments were accounted for as both debt modification and debt extinguishment. The Company recognized approximately $1.4 million of debt extinguishment losses during the three months ended March 31, 2024 from these debt amendments. Convertible Notes at Fair Value During the three months ended March 31, 2024, the Company entered into several one-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $5.5 million. The Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between $10.00 and $11.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. In addition, the Holders have an alternative option to convert the Convertible Notes into a non-dilutive financial instrument, which has the same terms at those in the non-dilutive funding agreements as described in Note 12. The Company elected the FVO to fair value the Convertible Notes under the guidance in ASC 825. The convertible notes at fair value are required to be remeasured using level 3 fair value measurements (see Note 4). For the three months ended March 31, 2024 and 2023, interest expense related to outstanding debt totaled approximately $1.5 million and $1.0 million including amortization of debt discounts totaling $0.6 million and $0.6 million, respectively |
Net Loss per Share Applicable t
Net Loss per Share Applicable to Common Stockholders | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 2023 Series C convertible preferred stock 32,420 35,412 Common stock options 316,926 299,938 Common stock warrants 97,040 140,244 Convertible notes and accrued interest 60,929 79 Potentially dilutive securities 507,315 475,673 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions | |
Related Party Transactions | 9. Related Party Transactions The Company had three operational programs with Advent: (a) an ongoing development and 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 that were required for the MAA application, 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 the MAA application, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. ● Drafting and submission 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 and September 26, 2023. The 2023 amendment extended the SOW 6 service period for about 6 months, through March 31, 2024. Subsequently on April 1, 2024, the SOW 6 was further extended through September 30, 2024. 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 Ancillary Services Agreement ended in July 2023. The Company subsequently extended the term by 12 months to July 2024 with no other changes. The following table summarizes total research and development costs from Advent for the three months ended March 31, 2024 and 2023, respectively (in thousands). For the three months ended March 31, 2024 2023 Advent BioServices Manufacturing cost in London $ 1,726 $ 1,643 Manufacturing cost at Sawston facility 2,652 1,712 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 $ 4,378 $ 4,675 (1) This covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA. The milestone was achieved but shares were not yet 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 support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently £5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), 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 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior parking During the three months ended March 31, 2024 and 2023, the Company recognized sub-lease income of $36,000 and $36,000, respectively. Related Party Accounts Payable As of March 31, 2024, 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, 2024 2023 Advent BioServices - amount invoiced but unpaid $ 1,633 $ 1,668 Advent BioServices - amount accrued but unpaid (1) 1,101 1,601 Total payable and accrued, but unpaid to Advent BioServices $ 2,734 $ 3,269 (1) This includes $1.1 million which is not payable in cash but represents the value of 1.5 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for submission of the MAA application to MHRA on December 20, 2023. Such shares were not issued as of March 31, 2024, 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, 2024 | |
Preferred Stock. | |
Preferred Stock | 10. Preferred Stock Series C Convertible Preferred Stock During the three months ended March 31, 2024, 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 0.3 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 $11.77 per share for proceeds of approximately $3.6 million. During the three months ended March 31, 2024, approximately 0.2 million Series C Shares with a book value of $2.5 million were converted into 5.5 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, 2024 | |
Stockholders' Deficit | |
Stockholders' Deficit | 11. Stockholders’ Deficit Common Stock During the three months ended March 31, 2024, the Company received $1.3 million from the exercise of outstanding warrants with a weighted average exercise price of $0.22 per share. The Company issued approximately 5.8 million shares of common stock upon these warrant exercises. During the three months ended March 31, 2024, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 1.6 million shares of common stock upon exercise of 2.4 million warrants at exercise prices between $0.20 and $0.34 per share, and 0.7 million options at exercise prices of $0.35 per share. Stock Purchase Warrants The following is a summary of warrant activity for the three months ended March 31, 2024 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2024 105,241 $ 0.31 1.83 Warrants exercised for cash (5,831) 0.22 — Cashless warrrants exercise (2,369) 0.35 — Outstanding as of March 31, 2024 97,040 $ 0.28 2.05 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, 2024, of the approximately 97 million total outstanding warrants listed above, approximately 92 million warrants were under the Blocker Letter Agreement or suspension agreements. Warrant Modifications During the three months ended March 31, 2024, 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 $ 0.28 $ 0.31 Expected term (in years) 2.1 1.8 Volatility 80 % 81 % Risk-free interest rate 4.7 % 4.9 % 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 $1.8 million, of which $1.2 million was associated with debt amendments and was recognized as an additional debt discount under debt modification and debt extinguishment loss under debt extinguishment (see Note 7), and the remaining $0.6 million 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, 2024 | |
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, 2024, the Company had operating lease liabilities of approximately $4.6 million for both the 20-year lease of the building for the manufacturing facility in Sawston, U.K., and the current office lease in the U.S. and ROU assets of approximately $4.1 million for the Sawston lease and U.S. office lease are included in the condensed consolidated balance sheet. Operating Lease - Lessor Arrangements 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 support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently L5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), 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 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are L550,000 (approximately $694,000) per year. The term of the Agreement shall end on the same date as the head lease term ends. The following summarizes quantitative information about the Company’s operating leases (amount in thousands): For the three months ended March 31, 2024 U.K U.S Total Lease cost Operating lease cost $ 156 $ 65 $ 221 Short-term lease cost 13 — 13 Variable lease cost — 6 6 Sub-lease income (36) — (36) Total $ 133 $ 71 $ 205 Other information Operating cash flows from operating leases $ (166) $ (75) $ (241) Weighted-average remaining lease term – operating leases 7.7 0.4 Weighted-average discount rate – operating leases 12 % 12 % 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 % The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2024 and 2023, respectively. Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows: Nine months ended December 31, 2024 $ 621 Year ended December 31, 2025 656 Year ended December 31, 2026 656 Year ended December 31, 2027 656 Year ended December 31, 2028 656 Thereafter 6,542 Total 9,787 Less present value discount (5,158) Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2024 $ 4,629 Maturities of our operating leases under the sublease agreement, are as follows: Nine months ended December 31, 2024 $ 108 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Year ended December 31, 2027 145 Year ended December 31, 2028 145 Thereafter 1,450 Total $ 2,138 Advent BioServices Services Agreement 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 £4.5 million ($5.7 million). German Tax Matter The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015. The NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. 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 $299,000), 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 $249,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (now approximately $554,000) 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 $240,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $146,000) 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. On October 12, 2023 and January 16, 2024, the Company made €189,000 and €189,000 payments, respectively, regarding to the late payment penalty. As of March 31, 2024, the Company accrued for trade tax liability of €155,000 (approximately $168,000) and corporation tax of €99,000 (approximately $107,000). 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. Other Contingent Payment Obligation During the three months ended March 31, 2024, the Company entered into a non-dilutive funding agreement with an individual investor, pursuant to which the Company received funding of $50,000 related to a gain contingency. These agreements are accounted for under ASC 470 and are recognized as contingent payment obligations on the Company’s condensed consolidated balance sheet. The Company’s payment obligations only apply when such are received by the Company. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events Between April 1, 2024 and May 8, 2024, the Company received $11.4 million in funding from the sale of preferred shares, proceeds from warrant exercise, and proceeds of debt arrangements. Between April 1, 2024 and May 8, 2024, the Company issued approximately 0.1 million shares of Series C preferred stock for proceeds of $1.4 million. Between April 1, 2024 and May 8, 2024, the Company received $9,000 from the exercise of 43,000 outstanding warrants. Between April 1, 2024 and May 8, 2024, approximately 0.3 million Series C Shares with a book value of $3.5 million were converted into 8.5 million common shares in accordance with their terms at a ratio of 1: 25 Between April 1, 2024 and May 8, 2024, the Company issued approximately 2.8 million shares of common stock to certain lenders in lieu of cash payments of $1.3 million of debt, including $0.1 million of accrued interest. The Company also issued 0.2 million shares of common stock to extinguish $0.1 million outstanding share liability. On April 4, 2024, the Company issued approximately 0.1 million shares of Series C Shares to certain lenders for debt conversion of $0.5 million, including $0.1 million of accrued interest. On April 26, 2024, the Company entered into a Commercial Loan Agreement (the “April Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The April 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 April Commercial Loan is amortized in 14 installments starting on December 26, 2024. The April Commercial Loan carries an original issue discount of $1.0 million. On April 29, 2024, the Company issued approximately 1.3 million shares of common stock upon cashless exercise of 2.1 million warrants at exercise prices of $0.20 per share. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2024 and 2023, and the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 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, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at March 31, 2024 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, 2023 and notes thereto included in the Company’s annual report on Form 10-K (the “2023 Annual Report”), which was filed with the SEC on March 5, 2024. |
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 2023 Annual Report. |
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. |
Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted Compensation - Stock Compensation In March 2024, the FASB issued ASU No. 2024-01, Compensation - Stock Compensation (Topic 718) - Scope Application of Profits Interest and Similar Awards, to clarify whether profits interest and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock Compensation. The guidance applies to all business entities that issue profits interest awards as compensation to employees or nonemployees in exchange for goods or services. These amendments are effective for the Company for annual and interim periods in 2025, applied prospectively, with early adoption and retrospective application permitted. As the Company does not issue profit interest awards, the impact of the adoption of the amendments in this update is not expected to be material to the Company’s consolidated financial statements. Improvements to Income Tax Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements. Recently Issued Accounting Standards, 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 adopted ASU 2022-03 effective January 1, 2024. The adoption of this guidance did not have a material impact on its condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 1 Months Ended | 3 Months Ended |
Jan. 31, 2024 | Mar. 31, 2024 | |
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, 2024 and December 31, 2023 (in thousands): Fair value measured at March 31, 2024 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs March 31, 2024 (Level 1) (Level 2) (Level 3) Warrant liability $ 913 $ — $ — $ 913 Contingent payable derivative liability 9,099 — — 9,099 Convertible notes at fair value 16,496 — — 16,496 Share liability 120 — — 120 Total fair value $ 26,628 $ — $ — $ 26,628 Fair value measured at December 31, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2023 (Level 1) (Level 2) (Level 3) Warrant liability $ 944 $ — $ — $ 944 Contingent payable derivative liability 9,188 — — 9,188 Convertible notes at fair value 12,771 — — 12,771 Share liability 483 — — 483 Total fair value $ 23,386 $ — $ — $ 23,386 | |
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, 2024. 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). Convertible Warrant Contingent Payable Share Notes Liability Derivative Liability Liability At Fair Value Total Balance - January 1, 2024 $ 944 $ 9,188 $ 483 $ 12,771 $ 23,386 Additional share liability — — 117 — 117 Issuance of convertible notes at fair value — — — 5,500 5,500 Redemption of share liability — — (586) — (586) Change in fair value (31) (89) 106 (1,775) (1,789) Balance - March 31, 2024 $ 913 (1) $ 9,099 $ 120 $ 16,496 $ 26,628 (1) The remaining balance of $0.9 million in warrant liability as of March 31, 2024 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. | |
Summary of Company's warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy | As of March 31, 2024 Share Contingent Payable Liability Derivative Liability Strike price $ 0.44 $ 0.52 * Contractual term (years) 0.04 1.0 Volatility (annual) 74 % 73 % Risk-free rate 5.5 % 5.2 % Dividend yield (per share) 0 % 0 % As of December 31, 2023 Share Contingent Payable Liability Derivative Liability Strike price $ 0.64 $ 0.70 * Contractual term (years) 0.1 1.0 Volatility (annual) 71 % 71 % Risk-free rate 5.6 % 5.2 % Dividend yield (per share) 0 % 0 % * The strike price assumes the current stock price as of March 31, 2024 and December 31, 2023. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stock-based Compensation | |
Summary of total stock based compensation expense | The following table summarizes total stock-based compensation expense for the three months ended March 31, 2024 and 2023 (in thousands). For the three months ended March 31, 2024 2023 Research and development $ 1,009 $ 296 Research and development - related party Milestones achieved (1) — 520 Future milestones (2) — 100 General and administrative 155 17 Total stock-based compensation expense $ 1,164 $ 933 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 stock compensation (primarily for consultants) cost was approximately $3.6 million as of March 31, 2024 and will be recognized over the next 1.8 years. |
Summary of stock option activity | The following table summarizes stock option activity for options granted to key external experts during the three months ended March 31, 2024 (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, 2024 317,076 $ 0.35 6.0 $ 114,097 Granted 500 0.53 4.2 — Cashless exercised (650) 0.35 — — Outstanding as of March 31, 2024 316,926 $ 0.35 5.8 $ 59,173 Options vested (1) 280,514 $ 0.33 5.8 $ 55,534 (1) |
Schedule of weighted average assumptions for stock options modification | For the three months ended March 31, 2024 Exercise price $ 0.53 Expected term (years) 2.1 Expected stock price volatility 73 % Risk-free rate 4.5 % Dividend yield (per share) 0 % |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment | |
Schedule of property and equipment | Property, plant and equipment consist of the following at March 31, 2024 and December 31, 2023 (in thousands): March 31, December 31, Estimated 2024 2023 Useful Life Leasehold improvements $ 17,867 $ 17,785 Lesser of lease term or estimated useful life Office furniture and equipment 527 487 3-5 years Computer and manufacturing equipment and software 3,055 2,776 3-5 years Land in the United Kingdom 85 86 NA 21,534 21,134 NA Less: accumulated depreciation (4,266) (3,856) Total property, plant and equipment, net $ 17,268 $ 17,278 |
Outstanding Debt (Tables)
Outstanding Debt (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Outstanding Debt | |
Schedule of outstanding debt | The following two tables summarize outstanding debt as of March 31, 2024 and December 31, 2023, respectively (amount in thousands): Stated Fair Interest Conversion Remaining Value Carrying Maturity Date Rate Price Face Value Debt Discount Adjustment Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured Various 8 % $ 0.20-$0.50 * 5,246 (269) — 4,977 10 % unsecured 7/11/2024 10 % $ 0.50 * 500 — — 500 5,881 (269) — 5,612 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40 - $0.49 * 16,250 — 246 16,496 Short term notes payable 8% unsecured Various 8 % N/A 11,399 (404) — 10,995 12% unsecured On Demand 12 % N/A 562 — — 562 6% secured 3/25/2025 6 % N/A 568 — — 568 12,529 (404) — 12,125 Long term notes payable 8% unsecured Various 8 % N/A 11,005 (790) — 10,215 Ending balance as of March 31, 2024 $ 45,665 $ (1,463) $ 246 $ 44,448 *These convertible notes are convertible into Series C preferred shares at $5.00 - $12.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.20-$0.50 per share. Stated Interest Conversion Remaining Fair Value Carrying Maturity Date Rate Price Face Value Debt Discount Adjustment Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 8% unsecured Various 8 % $ 0.50-$0.70 * 3,486 (356) — 3,130 10% unsecured 7/11/2024 10 % $ 0.50 * 500 — — 500 4,121 (356) — 3,765 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40-$0.49 * 10,750 — 2,021 12,771 Short term notes payable 8% unsecured Various 8 % N/A 3,539 (157) — 3,382 12% unsecured On Demand 12 % N/A 562 — — 562 4,101 (157) — 3,944 Long term notes payable 8% unsecured Various 8 % N/A 21,224 (1,485) — 19,739 6% secured 3/25/2025 6 % N/A 573 — — 573 21,797 (1,485) — 20,312 Ending balance as of December 31, 2023 $ 40,769 $ (1,998) $ 2,021 $ 40,792 *These convertible notes are convertible into Series C preferred shares at $10.00 - $17.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.40 - $0.70 per share. |
Net Loss per Share Applicable_2
Net Loss per Share Applicable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share Applicable to Common Stockholders | |
Schedule of antidilutive securities were not included in the diluted net earnings (loss) per share | 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, 2024 2023 Series C convertible preferred stock 32,420 35,412 Common stock options 316,926 299,938 Common stock warrants 97,040 140,244 Convertible notes and accrued interest 60,929 79 Potentially dilutive securities 507,315 475,673 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions | |
Summary 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, 2024 and 2023, respectively (in thousands). For the three months ended March 31, 2024 2023 Advent BioServices Manufacturing cost in London $ 1,726 $ 1,643 Manufacturing cost at Sawston facility 2,652 1,712 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 $ 4,378 $ 4,675 (1) This covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA. The milestone was achieved but shares were not yet 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. |
Summary of outstanding unpaid accounts payable and accrued expenses held by related parties | As of March 31, 2024, 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, 2024 2023 Advent BioServices - amount invoiced but unpaid $ 1,633 $ 1,668 Advent BioServices - amount accrued but unpaid (1) 1,101 1,601 Total payable and accrued, but unpaid to Advent BioServices $ 2,734 $ 3,269 (1) This includes $1.1 million which is not payable in cash but represents the value of 1.5 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for submission of the MAA application to MHRA on December 20, 2023. Such shares were not issued as of March 31, 2024, 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) | 1 Months Ended | 3 Months Ended |
Jan. 31, 2024 | Mar. 31, 2024 | |
Stockholders' Deficit | ||
Schedule of warrant activity | The following is a summary of warrant activity for the three months ended March 31, 2024 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2024 105,241 $ 0.31 1.83 Warrants exercised for cash (5,831) 0.22 — Cashless warrrants exercise (2,369) 0.35 — Outstanding as of March 31, 2024 97,040 $ 0.28 2.05 | |
Schedule of modifications to the warrants following weighted average assumptions | As of March 31, 2024 Share Contingent Payable Liability Derivative Liability Strike price $ 0.44 $ 0.52 * Contractual term (years) 0.04 1.0 Volatility (annual) 74 % 73 % Risk-free rate 5.5 % 5.2 % Dividend yield (per share) 0 % 0 % As of December 31, 2023 Share Contingent Payable Liability Derivative Liability Strike price $ 0.64 $ 0.70 * Contractual term (years) 0.1 1.0 Volatility (annual) 71 % 71 % Risk-free rate 5.6 % 5.2 % Dividend yield (per share) 0 % 0 % * The strike price assumes the current stock price as of March 31, 2024 and December 31, 2023. | |
Warrants | ||
Stockholders' Deficit | ||
Schedule of modifications to the warrants following weighted average assumptions | Post-modification Pre-modification Exercise price $ 0.28 $ 0.31 Expected term (in years) 2.1 1.8 Volatility 80 % 81 % Risk-free interest rate 4.7 % 4.9 % Dividend yield 0 % 0 % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 U.K U.S Total Lease cost Operating lease cost $ 156 $ 65 $ 221 Short-term lease cost 13 — 13 Variable lease cost — 6 6 Sub-lease income (36) — (36) Total $ 133 $ 71 $ 205 Other information Operating cash flows from operating leases $ (166) $ (75) $ (241) Weighted-average remaining lease term – operating leases 7.7 0.4 Weighted-average discount rate – operating leases 12 % 12 % 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 % |
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, 2024 $ 621 Year ended December 31, 2025 656 Year ended December 31, 2026 656 Year ended December 31, 2027 656 Year ended December 31, 2028 656 Thereafter 6,542 Total 9,787 Less present value discount (5,158) Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2024 $ 4,629 Maturities of our operating leases under the sublease agreement, are as follows: Nine months ended December 31, 2024 $ 108 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Year ended December 31, 2027 145 Year ended December 31, 2028 145 Thereafter 1,450 Total $ 2,138 |
Financial Condition, Going Co_2
Financial Condition, Going Concern and Management Plans (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Financial Condition, Going Concern and Management Plans | |
Net loss | $ (18.3) |
Payments for operating activities | $ 12.4 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
Summary of Significant Accounting Policies | ||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Remaining balance in warrant liability | $ 0.9 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Fair Value Measurements | ||
Warrant liability | $ 913 | $ 944 |
Contingent payable derivative liability | 9,099 | 9,188 |
Convertible notes at fair value | 16,496 | 12,771 |
Share liability | 120 | 483 |
Total fair value | 26,628 | 23,386 |
Assets transfer from Level 1 to 2 | 0 | |
Assets transfer from Level 2 to 1 | 0 | |
Liabilities transfer from Level 1 to 2 | 0 | |
Liabilities transfer from Level 2 to 1 | 0 | |
Assets transfer from in/ out from Level 1 to 3 | 0 | |
Liabilities transfer from in/out level 1 to 3 | 0 | |
Level 3 | ||
Fair Value Measurements | ||
Warrant liability | 913 | 944 |
Contingent payable derivative liability | 9,099 | 9,188 |
Convertible notes at fair value | 16,496 | 12,771 |
Share liability | 120 | 483 |
Total fair value | $ 26,628 | $ 23,386 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Level 3 liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value Measurements | |
Balance | $ 23,386 |
Additional share liability | 117 |
Issuance of convertible notes at fair value | 5,500 |
Redemption of share liability | (586) |
Change in fair value | (1,789) |
Balance | 26,628 |
Warrant liability related to purchase shares in a future raise of capital | 900 |
Warrant Liability | |
Fair Value Measurements | |
Balance | 944 |
Change in fair value | (31) |
Balance | 913 |
Contingent Payable Derivative Liability | |
Fair Value Measurements | |
Balance | 9,188 |
Change in fair value | (89) |
Balance | 9,099 |
Share Payable | |
Fair Value Measurements | |
Balance | 483 |
Additional share liability | 117 |
Redemption of share liability | (586) |
Change in fair value | 106 |
Balance | 120 |
Convertible Notes | |
Fair Value Measurements | |
Balance | 12,771 |
Issuance of convertible notes at fair value | 5,500 |
Change in fair value | (1,775) |
Balance | $ 16,496 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted average (in aggregate) significant unobservable inputs (Details) - Level 3 - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share Payable | ||
Fair Value Measurements | ||
Strike price | $ 0.44 | $ 0.64 |
Contractual term (years) | 14 days | 1 month 6 days |
Volatility (annual) | 74% | 71% |
Risk-free rate | 5.50% | 5.60% |
Dividend yield (per share) | 0% | 0% |
Contingent Payable Derivative Liability | ||
Fair Value Measurements | ||
Strike price | $ 0.52 | $ 0.70 |
Contractual term (years) | 1 year | 1 year |
Volatility (annual) | 73% | 71% |
Risk-free rate | 5.20% | 5.20% |
Dividend yield (per share) | 0% | 0% |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of stock-based compensation expense (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2022 | |
Stock-based Compensation | |||
Total stock-based compensation expense | $ 1,164 | $ 933 | |
Unrecognized compensation cost recognized period (in years) | 1 year 9 months 18 days | ||
Total unrecognized stock compensation cost | $ 3,600 | ||
Milestone achieved | |||
Stock-based Compensation | |||
Total stock-based compensation expense | $ 500 | ||
Restricted stock | |||
Stock-based Compensation | |||
Total stock-based compensation expense | 0 | ||
Number of shares issuable for the accrued milestone | 3 | ||
Stock based compensation | $ 1,600 | ||
Stock based compensation recognized and expensed but not yet paid | $ 100 | ||
Research and development | |||
Stock-based Compensation | |||
Total stock-based compensation expense | 1,009 | 296 | |
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 | $ 155 | $ 17 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock option granted (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares | |
Stock-based Compensation | |
Exercise price | $ 0.53 |
Expected term (years) | 2 years 1 month 6 days |
Expected stock price volatility | 73% |
Risk-free rate | 4.50% |
Dividend yield (per share) | 0% |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Awards (Details) $ in Thousands, shares in Millions | 3 Months Ended | ||||
Dec. 20, 2023 USD ($) shares | Sep. 26, 2022 Milestone item | Mar. 31, 2024 USD ($) shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Stock-based Compensation | |||||
Additional Paid-in-Capital to Accounts Payable and accrued expenses | $ 2,130 | ||||
Stock-based compensation | $ 1,164 | 933 | |||
Total intrinsic value of all outstanding options | 59,173 | $ 114,097 | |||
Amended Statement of Work 6 | |||||
Stock-based Compensation | |||||
Number of milestones | Milestone | 10 | ||||
General and administrative | |||||
Stock-based Compensation | |||||
Stock-based compensation | 155 | $ 17 | |||
Restricted Stock Awards | Advent BioServices | Completion of MHRA application milestone | |||||
Stock-based Compensation | |||||
Number of shares not issued | shares | 1.5 | ||||
Additional Paid-in-Capital to Accounts Payable and accrued expenses | $ 1,100 | ||||
Restricted Stock [Member] | |||||
Stock-based Compensation | |||||
Stock-based compensation | $ 0 | ||||
Restricted Stock [Member] | Amended Statement of Work 6 | |||||
Stock-based Compensation | |||||
Number of workstreams | item | 6 | ||||
Number of required licenses for the Sawston facility | item | 3 | ||||
Restricted Stock [Member] | Advent BioServices | Completion of MHRA application milestone | |||||
Stock-based Compensation | |||||
Number of shares not issued | shares | 1.5 | ||||
Additional Paid-in-Capital to Accounts Payable and accrued expenses | $ 1,100 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | |
Stock-based Compensation | |
Total unrecognized stock compensation cost | $ | $ 3.6 |
Unrecognized compensation cost recognized period (in years) | 1 year 9 months 18 days |
Notice for exercising any option or warrant (in days) | 61 days |
Employee Stock Option | |
Stock-based Compensation | |
Number of Shares, Vested | shares | 153 |
Stock-based Compensation - St_2
Stock-based Compensation - Stock option activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Stock-based Compensation | ||
Number of Shares, Outstanding | 317,076,000 | |
Number of Shares, Granted | 500,000 | |
Number of Shares, Cashless exercised | (650,000) | |
Number of Shares, Outstanding | 316,926,000 | 317,076,000 |
Number of Shares, Options vested | 280,514,000 | |
Weighted Average Exercise Price, Outstanding | $ 0.35 | |
Weighted Average Exercise Price, Granted | 0.53 | |
Stock based compensation per share option exercised | $ 0.30 | |
Share based compensation maximum amount | $ 150,000 | |
Weighted Average Exercise Price, Cashless exercised | $ 0.35 | |
Weighted Average Exercise Price, Outstanding | 0.35 | $ 0.35 |
Weighted Average Exercise Price, Options vested | $ 0.33 | |
Weighted Average Remaining Contractual Life (in years), Granted | 4 years 2 months 12 days | |
Weighted Average Remaining Contractual Life (in years), Outstanding | 5 years 9 months 18 days | 6 years |
Weighted Average Remaining Contractual Life (in years), Options vested | 5 years 9 months 18 days | |
Total Intrinsic Value, Outstanding | $ 114,097,000 | |
Total Intrinsic Value, Outstanding | 59,173,000 | $ 114,097,000 |
Total Intrinsic Value, Options vested | $ 55,534,000 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Property, Plant and Equipment | ||
Property, plant and equipment, net | $ 17,268 | $ 17,278 |
Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 21,534 | 21,134 |
Less: accumulated depreciation | (4,266) | (3,856) |
Leasehold improvements | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 17,867 | 17,785 |
Leasehold improvements useful life | Lesser of lease term or estimated useful life | |
Office furniture and equipment | Minimum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 3 years | |
Office furniture and equipment | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Office furniture and equipment | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 527 | 487 |
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 | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Computer and manufacturing equipment and software | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 3,055 | 2,776 |
Land in the United Kingdom | U.K | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 85 | $ 86 |
Property, Plant and Equipment -
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment | ||
Depreciation | $ 0.4 | $ 0.3 |
Outstanding Debt (Details)
Outstanding Debt (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Outstanding Debt | ||
Face Value | $ 45,665 | $ 40,769 |
Fair Value Adjustment | 246 | 2,021 |
Remaining Debt Discount | (1,463) | (1,998) |
Carrying Value | 44,448 | 40,792 |
Short term convertible notes payable | ||
Outstanding Debt | ||
Face Value | 5,881 | 4,121 |
Remaining Debt Discount | (269) | (356) |
Carrying Value | $ 5,612 | $ 3,765 |
Short term convertible notes payable | 6% unsecured | ||
Outstanding Debt | ||
Maturity Date | Due | Due |
Stated Interest Rate | 6% | 6% |
Conversion price | $ 3.09 | |
Face Value | $ 135 | $ 135 |
Carrying Value | $ 135 | $ 135 |
Short term convertible notes payable | 6% unsecured | 6% secured | ||
Outstanding Debt | ||
Conversion price | $ 3.09 | |
Short term convertible notes payable | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | Various |
Stated Interest Rate | 8% | 8% |
Face Value | $ 5,246 | $ 3,486 |
Remaining Debt Discount | (269) | (356) |
Carrying Value | $ 4,977 | $ 3,130 |
Short term convertible notes payable | 8% unsecured due 1/31/2024 | ||
Outstanding Debt | ||
Conversion price | $ 0.50 | $ 0.70 |
Short term convertible notes payable | 8% unsecured due 6/30/2024 | ||
Outstanding Debt | ||
Conversion price | $ 0.20 | $ 0.40 |
Short term convertible notes payable | 10% unsecured | ||
Outstanding Debt | ||
Maturity Date | 7/11/2024 | 7/11/2024 |
Stated Interest Rate | 10% | 10% |
Conversion price | $ 0.50 | $ 0.50 |
Face Value | $ 500 | $ 500 |
Carrying Value | $ 500 | $ 500 |
Short term convertible notes payable | Minimum | 8% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.20 | $ 0.50 |
Short term convertible notes payable | Maximum | 8% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.50 | $ 0.70 |
Short term convertible note at fair value | 11% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | Various |
Stated Interest Rate | 11% | 11% |
Conversion price | $ 0.49 | |
Face Value | $ 16,250 | $ 10,750 |
Fair Value Adjustment | 246 | 2,021 |
Carrying Value | $ 16,496 | $ 12,771 |
Short term convertible note at fair value | Minimum | 11% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.40 | $ 0.40 |
Short term convertible note at fair value | Maximum | 11% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.49 | |
Short term notes payable | ||
Outstanding Debt | ||
Face Value | $ 12,529 | $ 4,101 |
Remaining Debt Discount | (404) | (157) |
Carrying Value | $ 12,125 | $ 3,944 |
Short term notes payable | 6% unsecured | ||
Outstanding Debt | ||
Maturity Date | 3/25/2025 | |
Stated Interest Rate | 6% | |
Face Value | $ 568 | |
Carrying Value | $ 568 | |
Short term notes payable | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | Various |
Stated Interest Rate | 8% | 8% |
Face Value | $ 11,399 | $ 3,539 |
Remaining Debt Discount | (404) | (157) |
Carrying Value | $ 10,995 | $ 3,382 |
Short term notes payable | 12% unsecured | ||
Outstanding Debt | ||
Maturity Date | On Demand | On Demand |
Stated Interest Rate | 12% | 12% |
Face Value | $ 562 | $ 562 |
Carrying Value | $ 562 | 562 |
Long term notes payable | ||
Outstanding Debt | ||
Face Value | 21,797 | |
Remaining Debt Discount | (1,485) | |
Carrying Value | $ 20,312 | |
Long term notes payable | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | Various |
Stated Interest Rate | 8% | 8% |
Face Value | $ 11,005 | $ 21,224 |
Remaining Debt Discount | (790) | (1,485) |
Carrying Value | $ 10,215 | $ 19,739 |
Long term notes payable | 6% secured | ||
Outstanding Debt | ||
Maturity Date | 3/25/2025 | |
Stated Interest Rate | 6% | |
Face Value | $ 573 | |
Carrying Value | $ 573 |
Outstanding Debt - Additional I
Outstanding Debt - Additional Information (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Apr. 04, 2024 shares | Feb. 21, 2024 USD ($) item instrument tranche $ / shares | Mar. 31, 2024 USD ($) item $ / shares shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) $ / shares | |
Notes Payable | |||||
Conversion of share settled debt into common stock | $ 2,532 | $ 2,617 | |||
Extinguishment of debt upon conversion | 600 | ||||
Additional share liability recognized | 100 | ||||
Gain (loss) from debt extinguishment | 800 | ||||
Interest expense including amortization of debt discount | 1,500 | 1,000 | |||
Amortization of debt discount | 600 | $ 600 | |||
Principal amount | $ 45,665 | $ 40,769 | |||
Series C convertible preferred stock | |||||
Notes Payable | |||||
Number of shares issued to lenders in lieu of cash payments | shares | 100 | (220) | (198) | ||
Conversion of share settled debt into common stock | $ (2,532) | $ (2,617) | |||
Short term convertible notes payable | |||||
Notes Payable | |||||
Principal amount | 5,881 | 4,121 | |||
10% unsecured | Short term convertible notes payable | |||||
Notes Payable | |||||
Principal amount | $ 500 | $ 500 | |||
Interest rate (in percent) | 10% | 10% | |||
Conversion price | $ / shares | $ 0.50 | $ 0.50 | |||
6% unsecured | Short term convertible notes payable | |||||
Notes Payable | |||||
Principal amount | $ 135 | $ 135 | |||
Interest rate (in percent) | 6% | 6% | |||
Conversion price | $ / shares | $ 3.09 | ||||
8% unsecured | Short term convertible notes payable | |||||
Notes Payable | |||||
Principal amount | $ 5,246 | $ 3,486 | |||
Interest rate (in percent) | 8% | 8% | |||
Period of which preferred stock can convert into common shares | 30 days | 30 days | |||
8% unsecured due 1/31/2024 | Short term convertible notes payable | |||||
Notes Payable | |||||
Conversion price | $ / shares | $ 0.50 | $ 0.70 | |||
8% unsecured due 6/30/2024 | Short term convertible notes payable | |||||
Notes Payable | |||||
Conversion price | $ / shares | 0.20 | 0.40 | |||
Minimum | 8% unsecured | Short term convertible notes payable | |||||
Notes Payable | |||||
Conversion price | $ / shares | 0.20 | 0.50 | |||
Minimum | 8% unsecured | Short term convertible notes payable | Series C convertible preferred stock | |||||
Notes Payable | |||||
Conversion price | $ / shares | 5 | 10 | |||
Maximum | Series C convertible preferred stock | |||||
Notes Payable | |||||
Conversion price | $ / shares | 11.50 | ||||
Maximum | 8% unsecured | Short term convertible notes payable | |||||
Notes Payable | |||||
Conversion price | $ / shares | 0.50 | 0.70 | |||
Maximum | 8% unsecured | Short term convertible notes payable | Series C convertible preferred stock | |||||
Notes Payable | |||||
Conversion price | $ / shares | $ 12.50 | $ 17.50 | |||
Notes | |||||
Notes Payable | |||||
Cash payments | $ 2,700 | ||||
Number of shares issued to lenders in lieu of cash payments | shares | 6,900 | ||||
Conversion of share settled debt into common stock | $ 4,000 | ||||
Accrued interest expense on debt | $ 300 | ||||
February Convertible Notes | |||||
Notes Payable | |||||
Term of debt instrument | 1 year | ||||
Principal amount | $ 1,800 | ||||
Purchase price | $ 1,600 | ||||
Interest rate (in percent) | 8% | ||||
February Convertible Notes | Series C convertible preferred stock | |||||
Notes Payable | |||||
Conversion price | $ / shares | $ 12.50 | ||||
Period of which preferred stock can convert into common shares | 30 days | ||||
Number of common stock shares issued upon conversion | item | 25 | ||||
One year convertible notes | |||||
Notes Payable | |||||
Term of debt instrument | 1 year | ||||
Principal amount | $ 5,500 | ||||
Period of which preferred stock can convert into common shares | 30 days | ||||
Number of common stock shares issued upon conversion | item | 25 | ||||
One year convertible notes | Series C convertible preferred stock | |||||
Notes Payable | |||||
Interest rate (in percent) | 11% | ||||
One year convertible notes | Minimum | Series C convertible preferred stock | |||||
Notes Payable | |||||
Conversion price | $ / shares | $ 10 | ||||
Amended | Notes | |||||
Notes Payable | |||||
Gain (loss) from debt extinguishment | $ 1,400 | ||||
Number of tranches warrants | tranche | 16 | ||||
Number of debt instruments | instrument | 10 |
Net Loss per Share Applicable_3
Net Loss per Share Applicable to Common Stockholders (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Earnings (Loss) per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 507,315 | 475,673 |
Series C convertible preferred stock | ||
Net Earnings (Loss) per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 32,420 | 35,412 |
Common stock options | ||
Net Earnings (Loss) per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 316,926 | 299,938 |
Common stock warrants | ||
Net Earnings (Loss) per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 97,040 | 140,244 |
Convertible notes and accrued interest | ||
Net Earnings (Loss) per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 60,929 | 79 |
Related Party Transactions (Det
Related Party Transactions (Details) | 3 Months Ended |
Mar. 31, 2024 item Program Milestone | |
Related Party Transactions | |
Percentage of margin | 15% |
Additional term of agreement | 12 months |
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 | 3 |
Number of workstreams | 6 |
Related Party Transactions - Re
Related Party Transactions - Research and development Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Related Party Transactions | ||
Total operating costs and expenses | $ 16,028 | $ 13,844 |
Advent BioServices | ||
Related Party Transactions | ||
Total operating costs and expenses | $ 4,378 | $ 4,675 |
Operating Cost and Expense, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember |
Advent BioServices | Manufacturing cost in London | ||
Related Party Transactions | ||
Related party costs, Manufacturing costs | $ 1,726 | $ 1,643 |
Advent BioServices | Manufacturing cost at Sawston facility | ||
Related Party Transactions | ||
Related party costs, Manufacturing costs | $ 2,652 | 1,712 |
Advent BioServices | Expensed and unpaid (milestone complete) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Shares | 520 | |
Advent BioServices | Expensed and due, but unpaid (milestone complete) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Cash | 550 | |
Advent BioServices | Expensed but unpaid, not yet due (milestone not yet complete) | ||
Related Party Transactions | ||
Related party costs, SOW 6 one-time milestones - Shares | 100 | |
Related party costs, SOW 6 one-time milestones - Cash | $ 150 |
Related Party Transactions - Ad
Related Party Transactions - Advent BioServices Sublease Agreement (Details) $ / shares in Units, € in Thousands | 3 Months Ended | ||||
Mar. 31, 2024 EUR (€) item | Mar. 31, 2024 USD ($) ft² item | Mar. 31, 2024 GBP (£) item | Mar. 31, 2023 USD ($) | Apr. 29, 2024 $ / shares | |
Related Party Transactions | |||||
Total area of lease (in sqft) | ft² | 88,000 | ||||
Lease payments | $ 241,000 | $ 225,000 | |||
Sub-lease income | $ 36,000 | $ 36,000 | |||
Exercise price | $ / shares | $ 0.20 | ||||
Advent BioServices | |||||
Related Party Transactions | |||||
Area of sublease (in sqft) | ft² | 14,459 | ||||
Total area of lease (in sqft) | ft² | 88,000 | ||||
Number of times calculated for lease payment under sub-lease | item | 2 | 2 | 2 | ||
Rate per square foot under sub-lease | $ 7.26 | £ 5.75 | |||
Cap rate per square foot under sub-lease | 10,000 | ||||
Sub-lease payments receivable | 145,000,000 | ||||
Advent BioServices | Exterior spaces | |||||
Related Party Transactions | |||||
Lease payments | £ | £ 550,000 | ||||
Approximate Operating Lease Payments | 694,000,000 | ||||
Advent BioServices | Parking | |||||
Related Party Transactions | |||||
Lease payments | € | € 550,000 | ||||
Approximate Operating Lease Payments | $ 694,000 |
Related Party Transactions - _2
Related Party Transactions - Related Party Accounts Payable (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | |||
Dec. 20, 2023 | Mar. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Related Party Transactions | ||||
Reclass earned but unissued milestone shares from equity to liability | $ 2,130 | |||
Advent BioServices - amount invoiced but unpaid | ||||
Related Party Transactions | ||||
Invoiced but unpaid | $ 1,633 | $ 1,668 | ||
Advent BioServices - amount accrued but unpaid | ||||
Related Party Transactions | ||||
Accrued and unpaid | 1,101 | 1,601 | ||
Advent BioServices | ||||
Related Party Transactions | ||||
Accounts payable and accrued expenses | $ 2,734 | $ 3,269 | ||
Accounts Payable, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember | ||
Advent BioServices Agreement | Restricted Stock Awards | Completion of MHRA application milestone | ||||
Related Party Transactions | ||||
Number of shares not issued | 1.5 | |||
Reclass earned but unissued milestone shares from equity to liability | $ 1,100 |
Preferred Stock (Details)
Preferred Stock (Details) | 3 Months Ended | ||||
Apr. 04, 2024 shares | Mar. 31, 2024 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) shares | Apr. 29, 2024 $ / shares | Dec. 31, 2023 USD ($) shares | |
Preferred Stock | |||||
Warrants exercise price | $ / shares | $ 0.20 | ||||
Proceeds from exercise of warrants | $ 1,311,000 | $ 248,000 | |||
Proceeds from Issuance of Redeemable Convertible Preferred Stock | 3,624,000 | 2,385,000 | |||
Extinguishment of Debt, Amount | 600,000 | ||||
Conversion of share settled debt into common stock | 2,532,000 | $ 2,617,000 | |||
Principal amount | 45,665,000 | $ 40,769,000 | |||
Gain (loss) from debt extinguishment | $ 800,000 | ||||
Minimum | |||||
Preferred Stock | |||||
Warrants exercise price | $ / shares | $ 0.22 | ||||
Notes | |||||
Preferred Stock | |||||
Number of shares issued to lenders in lieu of cash payments | shares | 6,900,000 | ||||
Conversion of share settled debt into common stock | $ 4,000,000 | ||||
Accrued interest expense on debt | $ 300,000 | ||||
Common Stock | |||||
Preferred Stock | |||||
Number of shares issued to lenders in lieu of cash payments | shares | 5,493,000 | 4,946,000 | |||
Conversion of share settled debt into common stock | $ 5,000 | $ 5,000 | |||
Series C Convertible Preferred Stock | |||||
Preferred Stock | |||||
Issuance of stock for cash (in shares) | shares | 308,000 | 148,000 | |||
Temporary equity, shares designated | shares | 10,000,000 | 10,000,000 | |||
Number of shares issued to lenders in lieu of cash payments | shares | 100,000 | (220,000) | (198,000) | ||
Conversion of share settled debt into common stock | $ (2,532,000) | $ (2,617,000) | |||
Series C Convertible Preferred Stock | Common Stock | |||||
Preferred Stock | |||||
Number of shares converted | shares | 200,000 | ||||
Value of shares converted | $ 2,500,000 | ||||
Number of shares issued on conversion | shares | 5,500,000 | ||||
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 | 300,000 | ||||
Temporary equity, par value | $ / shares | $ 0.001 | ||||
Purchase price | $ / shares | $ 11.77 | ||||
Gross proceeds from issuance of shares | $ 3,600,000 |
Stockholders' Deficit - Stock P
Stockholders' Deficit - Stock Purchase Warrants (Details) - $ / shares shares in Thousands | 3 Months Ended | 12 Months Ended | |
Apr. 29, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | |
Stockholders' Deficit | |||
Number of Warrants, Outstanding | 105,241 | ||
Number of Warrants, Warrants exercised for cash | (5,831) | ||
Number of Warrants, Cashless warrants exercise | (2,100) | (2,369) | |
Number of Warrants, Outstanding | 97,040 | 105,241 | |
Weighted Average Exercise Price - Outstanding | $ 0.31 | ||
Weighted Average Exercise Price - Warrants exercised for cash | 0.22 | ||
Weighted Average Exercise Price, Cashless warrants exercise | 0.35 | ||
Weighted Average Exercise Price - Outstanding | $ 0.28 | $ 0.31 | |
Remaining Contractual Term | 2 years 18 days | 1 year 9 months 29 days |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Apr. 29, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Stockholders' Deficit | ||||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||
Proceeds from exercise of outstanding warrants | $ 1,300 | |||
Warrants exercise price | $ 0.20 | |||
Stock issued on exercise of warrants | 5,800,000 | |||
Conversion of share settled debt into common stock | $ 2,532 | $ 2,617 | ||
Number of options exercised in cashless | 700,000 | |||
Number of warrants, cashless warrants exercise | 2,100,000 | 2,369,000 | ||
Settled true-up provision | $ 600 | |||
Number of warrants outstanding | 97,040,000 | 105,241,000 | ||
Class of warrant or right, extended in suspension | 92,000,000 | |||
Modification cost associated with debt financing | $ 1,200 | |||
Deemed dividend related to warrant modification | 568 | 395 | ||
Pre Modification | ||||
Stockholders' Deficit | ||||
Incremental stock-based compensation for stock options modification | 1,800 | |||
Notes | ||||
Stockholders' Deficit | ||||
Cash payments | 2,700 | |||
Conversion of share settled debt into common stock | 4,000 | |||
Accrued interest expense on debt | $ 300 | |||
Number of shares issued to lenders in lieu of cash payments | 6,900,000 | |||
Warrants issued as consideration for warrants suspension | ||||
Stockholders' Deficit | ||||
Number of warrants outstanding | 97,000,000 | |||
Cashless Warrants Exercise | ||||
Stockholders' Deficit | ||||
Number of warrants, cashless warrants exercise | 2,400,000 | |||
Equity Option | Cashless Warrants Exercise | ||||
Stockholders' Deficit | ||||
Warrants exercise price | $ 0.35 | |||
Common Stock | ||||
Stockholders' Deficit | ||||
Shares of common stock issued on exercise of warrants and options | 1,600,000 | |||
Conversion of share settled debt into common stock | $ 5 | $ 5 | ||
Number of shares issued to lenders in lieu of cash payments | 5,493,000 | 4,946,000 | ||
Minimum | ||||
Stockholders' Deficit | ||||
Warrants exercise price | $ 0.22 | |||
Minimum | Common Stock | Equity Option | Cashless Warrants Exercise | ||||
Stockholders' Deficit | ||||
Warrants exercise price | 0.20 | |||
Maximum | Common Stock | Equity Option | Cashless Warrants Exercise | ||||
Stockholders' Deficit | ||||
Warrants exercise price | $ 0.34 |
Stockholders' Deficit - Warrant
Stockholders' Deficit - Warrant Modifications (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares | |
Stock-based Compensation | |
Exercise price | $ 0.53 |
Expected term (years) | 2 years 1 month 6 days |
Volatility | 73% |
Risk-free rate | 4.50% |
Dividend yield | 0% |
Post Modification | Warrants | |
Stock-based Compensation | |
Exercise price | $ 0.28 |
Expected term (years) | 2 years 1 month 6 days |
Volatility | 80% |
Risk-free rate | 4.70% |
Dividend yield | 0% |
Pre Modification | Warrants | |
Stock-based Compensation | |
Exercise price | $ 0.31 |
Expected term (years) | 1 year 9 months 18 days |
Volatility | 81% |
Risk-free rate | 4.90% |
Dividend yield | 0% |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Lease cost | ||
Operating lease cost | $ 221,000 | $ 209,000 |
Short-term lease cost | 13,000 | 23,000 |
Variable lease cost | 6,000 | 4,000 |
Sub-lease income | (36,000) | (36,000) |
Total | 205,000 | 200,000 |
Other information | ||
Operating cash flows from operating leases | (241,000) | (225,000) |
U.K | ||
Lease cost | ||
Operating lease cost | 156,000 | 144,000 |
Short-term lease cost | 13,000 | 23,000 |
Sub-lease income | (36,000) | (36,000) |
Total | 133,000 | 131,000 |
Other information | ||
Operating cash flows from operating leases | $ (166,000) | $ (152,000) |
Weighted-average remaining lease term - operating leases | 7 years 8 months 12 days | 8 years 4 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 | 6,000 | 4,000 |
Total | 71,000 | 69,000 |
Other information | ||
Operating cash flows from operating leases | $ (75,000) | $ (73,000) |
Weighted-average remaining lease term - operating leases | 4 months 24 days | 1 year 1 month 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, 2024 USD ($) |
Commitments and Contingencies | |
Three months ended December 31, 2023 | $ 621 |
Year ended December 31, 2024 | 656 |
Year ended December 31, 2025 | 656 |
Year ended December 31, 2026 | 656 |
Year ended December 31, 2027 | 656 |
Thereafter | 6,542 |
Total | 9,787 |
Less present value discount | (5,158) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2023 | 4,629 |
Sublease agreement | |
Commitments and Contingencies | |
Three months ended December 31, 2023 | 108 |
Year ended December 31, 2024 | 145 |
Year ended December 31, 2025 | 145 |
Year ended December 31, 2026 | 145 |
Year ended December 31, 2028 | 145 |
Thereafter | 1,450 |
Total | $ 2,138 |
Commitments and Contingencies_3
Commitments and Contingencies - Additional Information (Details) € in Thousands, $ in Thousands, £ in Millions | 3 Months Ended | 7 Months Ended | ||||||||||||
Jan. 16, 2024 EUR (€) | Oct. 12, 2023 EUR (€) | Jul. 27, 2022 USD ($) | Jul. 27, 2022 EUR (€) | Nov. 04, 2021 USD ($) | Nov. 04, 2021 EUR (€) | May 14, 2018 USD ($) | May 14, 2018 GBP (£) | Mar. 31, 2024 USD ($) item | Mar. 31, 2024 EUR (€) item | Jul. 31, 2022 USD ($) | Jul. 31, 2022 EUR (€) | Mar. 31, 2024 EUR (€) | Dec. 31, 2023 USD ($) | |
Commitments and Contingencies | ||||||||||||||
Operating lease liabilities | $ 4,629 | |||||||||||||
Lease, practical expedient, lessor single lease component [true false] | true | true | ||||||||||||
Operating lease, term of contract | 20 years | 20 years | ||||||||||||
ROU asset | $ 4,070 | $ 4,183 | ||||||||||||
Office space taken under lease agreement | The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently L5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), 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 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are L550,000 (approximately $694,000) per year | The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently L5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), 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 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are L550,000 (approximately $694,000) per year | ||||||||||||
Litigation settlement waiver of penalty | $ 146,000 | € 135,000 | ||||||||||||
Accrued trade tax liability | $ 168,000 | € 155,000 | ||||||||||||
Accrued corporate tax liability | 107,000 | € 99,000 | ||||||||||||
Loss contingency accrual payment | € | € 189,000 | € 189,000 | ||||||||||||
Gain contingency | $ 50,000 | |||||||||||||
Advent Bio services agreement | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Term of agreement | 12 months | 12 months | ||||||||||||
Number of workstreams | item | 6 | 6 | ||||||||||||
Advent Bio services agreement | Minimum | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Minimum required payments for this notice period | $ 5,700 | £ 4.5 | ||||||||||||
German tax authority | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Settlement expense | $ 299,000 | € 277,000 | ||||||||||||
Received tax bills | $ 240,000 | € 222,000 | ||||||||||||
State and local jurisdiction | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Settlement expense | $ 249,000 | € 231,000 | ||||||||||||
Additional late fees | $ 554,000 | € 513,000 |
Subsequent Events (Details)
Subsequent Events (Details) | 1 Months Ended | 3 Months Ended | |||||
Apr. 29, 2024 $ / shares shares | Apr. 26, 2024 USD ($) installment | Apr. 04, 2024 USD ($) shares | May 08, 2024 USD ($) shares | Mar. 31, 2024 USD ($) shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) | |
Subsequent Events | |||||||
Principal amount | $ 45,665,000 | $ 40,769,000 | |||||
Amount of funding received from contingent obligation | $ 50,000 | ||||||
Number of options exercised in cashless | shares | 700,000 | ||||||
Warrants exercised (in shares) | shares | 1,300,000 | ||||||
Aggregate proceeds from exercise of warrants | $ 1,311,000 | $ 248,000 | |||||
Outstanding shares liability | 44,448,000 | 40,792,000 | |||||
Warrants exercise price | $ / shares | $ 0.20 | ||||||
Face Value | $ 45,665,000 | $ 40,769,000 | |||||
Number of warrants, cashless warrants exercise | shares | 2,100,000 | 2,369,000 | |||||
Cashless Warrants Exercise [Member] | |||||||
Subsequent Events | |||||||
Number of warrants, cashless warrants exercise | shares | 2,400,000 | ||||||
Common Stock | |||||||
Subsequent Events | |||||||
Shares of common stock issued on exercise of warrants and options | shares | 1,600,000 | ||||||
Number of shares issued to lenders in lieu of cash payments | shares | 5,493,000 | 4,946,000 | |||||
Series C convertible preferred stock | |||||||
Subsequent Events | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 100,000 | (220,000) | (198,000) | ||||
Series C convertible preferred stock | Common Stock | |||||||
Subsequent Events | |||||||
Value of shares converted | $ 2,500,000 | ||||||
Number of shares issued on conversion | shares | 5,500,000 | ||||||
Conversion ratio from preferred stock to common stock | 0.04 | ||||||
Shares converted | shares | 200,000 | ||||||
Subsequent event | |||||||
Subsequent Events | |||||||
Amount of funding from the sale of shares and proceeds of debt arrangements and contingent liability obligations | $ 11,400,000 | ||||||
Accrued interest | $ 100,000 | ||||||
Warrants exercised (in shares) | shares | 43,000 | ||||||
Aggregate proceeds from exercise of warrants | $ 9,000 | ||||||
Debt amount converted | $ 500,000 | ||||||
Subsequent event | Commercial Loan | |||||||
Subsequent Events | |||||||
Term of debt (in years) | 22 months | ||||||
Principal amount | $ 11,000,000 | ||||||
Interest rate (in percent) | 8% | ||||||
Face Value | $ 11,000,000 | ||||||
Term when no principal repayments was made | 8 months | ||||||
Number of installments for amortization | installment | 14 | ||||||
Original issue discount | $ 1,000,000 | ||||||
Subsequent event | Common Stock | |||||||
Subsequent Events | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 2,800,000 | ||||||
Subsequent event | Common Stock | Lieu | |||||||
Subsequent Events | |||||||
Number of shares issued during the period | shares | 200,000 | ||||||
Cash payments | $ 1,300,000 | ||||||
Interest | 100,000 | ||||||
Outstanding shares liability | $ 100,000 | ||||||
Subsequent event | Series C convertible preferred stock | |||||||
Subsequent Events | |||||||
Preferred stock, shares issued | shares | 100,000 | ||||||
Proceeds for preferred stock | $ 1,400,000 | ||||||
Value of shares converted | $ 3,500,000 | ||||||
Number of shares issued on conversion | shares | 8,500,000 | ||||||
Shares converted | shares | 300,000 | ||||||
Subsequent event | Series C convertible preferred stock | Common Stock | |||||||
Subsequent Events | |||||||
Conversion ratio from preferred stock to common stock | 0.04 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (18,312) | $ (10,652) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |