Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-35737 | |
Entity Registrant Name | NORTHWEST BIOTHERAPEUTICS, INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 94-3306718 | |
Entity Address, Address Line One | 4800 Montgomery Lane | |
Entity Address, Address Line Two | Suite 800 | |
Entity Address, City or Town | Bethesda | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20814 | |
City Area Code | 240 | |
Local Phone Number | 497-9024 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | NWBO | |
Security Exchange Name | NONE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,153,846,907 | |
Entity Central Index Key | 0001072379 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 6,097 | $ 6,965 |
Prepaid expenses and other current assets | 1,745 | 2,460 |
Share receivable | 610 | |
Total current assets | 8,452 | 9,425 |
Non-current assets: | ||
Property, plant and equipment, net | 16,751 | 13,418 |
Construction in progress | 2,028 | |
Right-of-use asset, net | 4,014 | 4,189 |
Indefinite-lived intangible asset | 1,292 | 1,292 |
Goodwill | 626 | 626 |
Other assets | 357 | 345 |
Total non-current assets | 23,040 | 21,898 |
TOTAL ASSETS | 31,492 | 31,323 |
Current liabilities: | ||
Accounts payable and accrued expenses | 12,331 | 10,687 |
Accounts payable and accrued expenses to related parties and affiliates | 4,716 | 6,955 |
Convertible notes, net | 3,451 | 135 |
Convertible notes at fair value | 10,250 | |
Notes payable, net | 8,198 | 15,403 |
Contingent payable derivative liability | 8,882 | 8,668 |
Warrant liability | 1,019 | 80,559 |
Investor advances | 7 | 2,566 |
Share liability | 678 | |
Lease liabilities | 369 | 354 |
Total current liabilities | 49,223 | 126,005 |
Non-current liabilities: | ||
Notes payable, net of current portion, net | 11,038 | 5,991 |
Lease liabilities, net of current portion | 4,134 | 4,370 |
Contingent payment obligation | 4,550 | |
Total non-current liabilities | 19,722 | 10,361 |
Total liabilities | 68,945 | 136,366 |
COMMITMENTS AND CONTINGENCIES (Note 12) | ||
Stockholders' deficit: | ||
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively | ||
Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,145.1 million and 1,068.4 million shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 1,145 | 1,068 |
Additional paid-in capital | 1,271,327 | 1,164,885 |
Stock subscription receivable | (79) | (79) |
Accumulated deficit | (1,340,802) | (1,297,122) |
Accumulated other comprehensive income | 3,290 | 3,145 |
Total stockholders' deficit | (65,119) | (128,103) |
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' DEFICIT | 31,492 | 31,323 |
Series C Convertible Preferred Stock | ||
Mezzanine equity: | ||
Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.8 million and 1.4 million shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively; aggregate liquidation preference of $26.0 million and $22.3 million as of September 30, 2023 and December 31, 2022, respectively | $ 27,666 | $ 23,060 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 |
Common stock, shares issued | 1,145,100,000 | 1,068,400,000 |
Common stock, shares outstanding | 1,145,100,000 | 1,068,400,000 |
Series C Convertible Preferred Stock | ||
Temporary equity, shares designated | 10,000,000 | 10,000,000 |
Temporary equity, shares issued | 1,800,000 | 1,400,000 |
Temporary equity, shares outstanding | 1,773,000 | 1,415,000 |
Temporary equity, aggregate liquidation preference | $ 26 | $ 22.3 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Research and other | $ 406 | $ 206 | $ 1,487 | $ 1,086 |
Total revenues | 406 | 206 | 1,487 | 1,086 |
Operating costs and expenses: | ||||
Research and development | 7,201 | 7,694 | 20,276 | 26,159 |
General and administrative | 7,030 | 8,130 | 21,577 | 23,930 |
Total operating costs and expenses | 14,231 | 15,824 | 41,853 | 50,089 |
Loss from operations | (13,825) | (15,618) | (40,366) | (49,003) |
Other income (expense): | ||||
Change in fair value of derivative liabilities | (112) | (12,169) | 3,875 | (15,883) |
Change in fair value of share receivable | 487 | 534 | ||
Loss from extinguishment of debt | (1,768) | (456) | (3,648) | (156) |
Interest expense | (1,670) | (1,512) | (3,999) | (4,847) |
Foreign currency transaction loss | (1,692) | (3,097) | (76) | (6,845) |
Total other loss | (4,755) | (17,234) | (3,314) | (27,731) |
Net loss | (18,580) | (32,852) | (43,680) | (76,734) |
Deemed dividend related to warrant modification | (519) | (1,433) | ||
Net loss attributable to common stockholders | (19,099) | (32,852) | (45,113) | (76,734) |
Other comprehensive income (loss) | ||||
Foreign currency translation adjustment | 1,397 | 2,773 | 145 | 5,956 |
Total comprehensive loss | $ (17,702) | $ (30,079) | $ (44,968) | $ (70,778) |
Net loss per share applicable to common stockholders, Basic | $ (0.02) | $ (0.03) | $ (0.04) | $ (0.08) |
Net loss per share applicable to common stockholders, Diluted | $ (0.02) | $ (0.03) | $ (0.04) | $ (0.08) |
Weighted average shares used in computing basic loss per share | 1,134,359 | 1,040,982 | 1,106,111 | 1,001,703 |
Weighted average shares used in computing diluted loss per share | 1,134,359 | 1,040,982 | 1,106,111 | 1,001,703 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) shares in Thousands, $ in Thousands | Series C Convertible Preferred Stock | Common Stock [Member] | Additional Paid-in Capital [Member] | Subscription Receivable [Member] | Retained Earnings [Member] | Accumulated Other Comprehensive Income (Loss) | Total |
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash (in shares) | 704 | ||||||
Issuance of stock for cash | $ 10,904 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 126 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,978 | ||||||
Issuance of stock by common stock warrant exercise (in shares) | 55 | ||||||
Issuance of stock by common stock warrant exercise | $ 329 | ||||||
Reclassification of warrant liabilities related to warrants exercised for cash | $ 26,800 | ||||||
Balance at the end (in shares) at Sep. 30, 2022 | 885 | ||||||
Balance at the end at Sep. 30, 2022 | $ 13,746 | ||||||
Balance at the beginning at Dec. 31, 2021 | $ 948 | $ 1,066,873 | $ (79) | $ (1,192,090) | $ 357 | (123,991) | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 948,445 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of stock for cash | $ 10,904 | ||||||
Issuance of stock for cash (in shares) | 704 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,978 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 126 | ||||||
Issuance of stock by common stock warrant exercise | $ 329 | ||||||
Issuance of stock by common stock warrant exercise (in shares) | 55 | ||||||
Issuance of common stock for cash | $ 13 | 9,676 | 9,689 | ||||
Issuance of common stock for cash ( in shares) | 13,147 | ||||||
Warrants exercised for cash | $ 41 | 9,945 | 9,986 | ||||
Warrants exercised for cash (in shares) | 40,929 | ||||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 11 | 7,602 | 7,613 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 10,374 | ||||||
Reclassification of warrant liabilities related to warrants exercised for cash | $ 535 | 22,090 | 22,090 | ||||
Cashless warrants and stock options exercise | $ 34 | (34) | |||||
Cashless warrants and stock options exercise (in shares) | 34,224 | ||||||
Stock-based compensation | $ 4 | 9,737 | 9,741 | ||||
Stock-based compensation (in shares) | 4,141 | ||||||
Reclassification of warrant liabilities related to cashless warrants exercise | 26,800 | 26,800 | |||||
Cumulative translation adjustment | 5,956 | 5,956 | |||||
Net loss | (76,734) | (76,734) | |||||
Balance at the end at Sep. 30, 2022 | $ 1,051 | 1,152,689 | (79) | (1,268,824) | 6,313 | (108,850) | |
Balance at the end (in shares) at Sep. 30, 2022 | 1,051,260 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash (in shares) | 704 | ||||||
Issuance of stock for cash | $ 10,904 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 126 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,978 | ||||||
Issuance of stock by common stock warrant exercise (in shares) | 55 | ||||||
Issuance of stock by common stock warrant exercise | $ 329 | ||||||
Balance at the end (in shares) at Sep. 30, 2022 | 885 | ||||||
Balance at the end at Sep. 30, 2022 | $ 13,746 | ||||||
Balance at the beginning at Jun. 30, 2022 | $ 1,034 | 1,139,811 | (79) | (1,235,972) | 3,540 | (91,666) | |
Balance at the beginning (in shares) at Jun. 30, 2022 | 1,034,475 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of stock for cash | $ 10,904 | ||||||
Issuance of stock for cash (in shares) | 704 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,978 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 126 | ||||||
Issuance of stock by common stock warrant exercise | $ 329 | ||||||
Issuance of stock by common stock warrant exercise (in shares) | 55 | ||||||
Warrants exercised for cash | $ 2 | 428 | 430 | ||||
Warrants exercised for cash (in shares) | 1,926 | ||||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 7 | 5,274 | 5,281 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 6,892 | ||||||
Reclassification of warrant liabilities related to warrants exercised for cash | $ 535 | 2,402 | 2,402 | ||||
Cashless warrants and stock options exercise | $ 5 | (5) | |||||
Cashless warrants and stock options exercise (in shares) | 5,321 | ||||||
Stock-based compensation | $ 3 | 3,358 | 3,361 | ||||
Stock-based compensation (in shares) | 2,636 | ||||||
Reclassification of warrant liabilities related to cashless warrants exercise | 1,421 | 1,421 | |||||
Cumulative translation adjustment | 2,773 | 2,773 | |||||
Fractional shares adjustment | 10 | ||||||
Net loss | (32,852) | (32,852) | |||||
Balance at the end at Sep. 30, 2022 | $ 1,051 | 1,152,689 | (79) | (1,268,824) | 6,313 | (108,850) | |
Balance at the end (in shares) at Sep. 30, 2022 | 1,051,260 | ||||||
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 (in shares) | 729 | ||||||
Issuance of stock for cash | $ 9,899 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 56 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,013 | ||||||
Issuance of stock by common stock warrant exercise | $ (6,536) | ||||||
Convertible preferred stock conversion | $ 11 | 6,525 | 6,536 | ||||
Convertible preferred stock conversion (in shares) | (443) | 11,081 | |||||
Stock Based Compensation | $ 230 | ||||||
Balance at the end (in shares) at Sep. 30, 2023 | 1,773 | ||||||
Balance at the end at Sep. 30, 2023 | $ 27,666 | ||||||
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 | $ 9,899 | ||||||
Issuance of stock for cash (in shares) | 729 | ||||||
Issuance of stock in lieu of debt redemption | $ 1,013 | ||||||
Issuance of stock in lieu of debt redemption (in shares) | 56 | ||||||
Issuance of stock by common stock warrant exercise | $ (6,536) | ||||||
Convertible preferred stock conversion | $ 11 | 6,525 | 6,536 | ||||
Convertible preferred stock conversion (in shares) | (443) | 11,081 | |||||
Warrants exercised for cash | $ 12 | 2,789 | $ 2,801 | ||||
Warrants exercised for cash (in shares) | 12,448 | ||||||
Cashless stock options exercise | $ 21 | (21) | |||||
Cashless stock options exercise (in shares) | 20,433 | 2,507 | |||||
Reclassification of warrant liabilities to stockholders' deficit | 76,258 | $ 76,258 | |||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 28 | 17,456 | 17,484 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 27,563 | ||||||
Stock-based compensation | $ 5 | 2,668 | 2,673 | ||||
Stock-based compensation (in shares) | 16 | 5,164 | |||||
Cumulative translation adjustment | 145 | 145 | |||||
Warrants modification | 2,200 | 2,200 | |||||
Deemed dividend related to warrants modification | (1,433) | (1,433) | |||||
Net loss | (43,680) | (43,680) | |||||
Balance at the end at Sep. 30, 2023 | $ 1,145 | 1,271,327 | (79) | (1,340,802) | 3,290 | (65,119) | |
Balance at the end (in shares) at Sep. 30, 2023 | 1,145,083 | ||||||
Balance at the beginning (in shares) at Jun. 30, 2023 | 1,546 | ||||||
Balance at the beginning at Jun. 30, 2023 | $ 25,385 | ||||||
Increase (Decrease) in Temporary Equity Deficit | |||||||
Issuance of stock for cash (in shares) | 405 | ||||||
Issuance of stock for cash | $ 5,143 | ||||||
Issuance of stock by common stock warrant exercise | $ (2,974) | ||||||
Convertible preferred stock conversion | $ 4 | 2,970 | 2,974 | ||||
Convertible preferred stock conversion (in shares) | (186) | 4,651 | |||||
Stock Based Compensation | $ 112 | ||||||
Balance at the end (in shares) at Sep. 30, 2023 | 1,773 | ||||||
Balance at the end at Sep. 30, 2023 | $ 27,666 | ||||||
Balance at the beginning at Jun. 30, 2023 | $ 1,115 | 1,258,259 | (79) | (1,322,222) | 1,893 | (61,034) | |
Balance at the beginning (in shares) at Jun. 30, 2023 | 1,115,183 | ||||||
Increase (Decrease) in Stockholders' Deficit | |||||||
Issuance of stock for cash | $ 5,143 | ||||||
Issuance of stock for cash (in shares) | 405 | ||||||
Issuance of stock by common stock warrant exercise | $ (2,974) | ||||||
Convertible preferred stock conversion | $ 4 | 2,970 | 2,974 | ||||
Convertible preferred stock conversion (in shares) | (186) | 4,651 | |||||
Warrants exercised for cash | 32 | 32 | |||||
Warrants exercised for cash (in shares) | 128 | ||||||
Cashless stock options exercise | $ 11 | (11) | |||||
Cashless stock options exercise (in shares) | 10,554 | ||||||
Issuance of common stock and warrants for conversion of debt and accrued interest | $ 13 | 7,907 | 7,920 | ||||
Issuance of common stock and warrants for conversion of debt and accrued interest (in shares) | 12,403 | ||||||
Stock-based compensation | $ 2 | 1,563 | 1,565 | ||||
Stock-based compensation (in shares) | 8 | 2,164 | |||||
Cumulative translation adjustment | 1,397 | 1,397 | |||||
Warrants modification | 1,126 | 1,126 | |||||
Deemed dividend related to warrants modification | (519) | (519) | |||||
Net loss | (18,580) | (18,580) | |||||
Balance at the end at Sep. 30, 2023 | $ 1,145 | $ 1,271,327 | $ (79) | $ (1,340,802) | $ 3,290 | $ (65,119) | |
Balance at the end (in shares) at Sep. 30, 2023 | 1,145,083 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (43,680) | $ (76,734) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,101 | 934 |
Amortization of debt discount | 2,006 | 2,111 |
Change in fair value of derivatives | (3,875) | 15,883 |
Change in fair value of share receivable | (534) | |
Loss from extinguishment of debt | 3,648 | 156 |
Amortization of operating lease right-of-use asset | 211 | 184 |
Stock-based compensation for services | 2,833 | 9,741 |
Warrant modifications associated with convertible notes under fair value option | 287 | |
Subtotal of non-cash charges | 5,677 | 29,009 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 802 | (310) |
Other non-current assets | (13) | 633 |
Accounts payable and accrued expenses | 2,657 | 1,251 |
Related party accounts payable and accrued expenses | (2,239) | 2,127 |
Lease liabilities | 117 | 98 |
Net cash used in operating activities | (36,679) | (43,926) |
Cash Flows from Investing Activities: | ||
Purchase of equipment and construction in progress | (3,019) | (742) |
Net cash used in investing activities | (3,019) | (742) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of Series C convertible preferred stock by common stock warrant exercise, net of debt redemption | 52 | |
Proceeds from issuance of common stock | 9,465 | |
Proceeds from exercise of warrants | 1,598 | 9,986 |
Proceeds from investor advance | 7 | |
Proceeds from issuance of notes payable, net | 10,000 | 5,600 |
Proceeds from issuance of convertible notes payable, net | 12,699 | |
Proceeds from contingent payment obligation | 4,550 | |
Repayment of notes payable | (210) | (5,390) |
Repayment of investor advances | (200) | |
Net cash provided by financing activities | 38,343 | 30,617 |
Effect of exchange rate changes on cash and cash equivalents | 487 | 8,307 |
Net decrease in cash and cash equivalents | (868) | (5,744) |
Cash and cash equivalents, beginning of the period | 6,965 | 15,169 |
Cash and cash equivalents, end of the period | 6,097 | 9,425 |
Supplemental schedule of non-cash investing and financing activities: | ||
Cashless warrants and stock options exercise | 21 | 34 |
Reclassification of warrant liabilities related to warrants exercised for cash | 22,625 | |
Reclassification of warrant liabilities to stockholders' deficit | 76,258 | |
Reclassification of warrant liabilities related to cashless warrants exercise | 26,800 | |
Reclassification of investor advances to convertible notes payable | 1,163 | |
Reclassification of investor advances to stockholders' deficit | 1,203 | |
Issuance of common stock for conversion of debt and accrued interest | 17,484 | 7,054 |
Issuance of Series C convertible preferred stock in lieu of debt redemption | 1,013 | 1,978 |
Exercise common stock warrants by debt redemption | 277 | |
Series C convertible preferred stock conversion | 6,536 | |
Capital expenditures included in accounts payable | 71 | 4 |
Reclassification between shares payable and equity | 250 | |
Deemed dividend related to warrant modification | 1,433 | |
Convertible notes payable | ||
Supplemental disclosure of cash flow information | ||
Interest payments on notes payable | (30) | (912) |
Series C convertible preferred stock | ||
Cash Flows from Financing Activities: | ||
Proceeds from issuance of Series C convertible preferred stock | $ 9,899 | $ 10,904 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks, 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 is working on final preparations for filing an application for regulatory approval of the product. |
Financial Condition, Going Conc
Financial Condition, Going Concern and Management Plans | 9 Months Ended |
Sep. 30, 2023 | |
Financial Condition, Going Concern and Management Plans | |
Financial Condition, Going Concern and Management Plans | 2. Financial Condition, Going Concern and Management Plans The Company has incurred annual net operating losses since its inception. The Company had a net loss of $45.1 million for the nine months ended September 30, 2023. The Company used approximately $36.7 million of cash in its operating activities during the nine months ended September 30, 2023. The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all. Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date of this filing. The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, however, they do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation. The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2023, condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2023 and 2022, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s annual report on Form 10-K (the “2022 Annual Report”), which was filed with the SEC on February 28, 2023. Use of Estimates In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets, and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2022 Annual Report other than those discussed below. Sequencing The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, non-employees or directors are not subject to the sequencing policy. On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximately 141 million warrants, with a value of approximately $76.3 million, to purchase shares of the Company’s common stock were reclassified from liabilities to equity on January 9, 2023. The remaining balance of $1.0 million in warrant liability as of September 30, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). Modification of Equity Classified Warrants A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend. Convertible Notes under Fair Value Option The Company accounts for certain convertible notes issued in August and September 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred. Recently Issued Accounting Standards Not Yet Adopted Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the fair value of liabilities related to certain 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 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 September 30, 2023 and December 31, 2022 (in thousands): Fair value measured at September 30, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs September 30, 2023 (Level 1) (Level 2) (Level 3) Share receivable $ 610 $ — $ — $ 610 Warrant liability $ 1,019 $ — $ — $ 1,019 Contingent payable derivative liability 8,882 — — 8,882 Convertible notes 10,250 10,250 Total fair value $ 20,151 $ — $ — $ 20,151 Fair value measured at December 31, 2022 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2022 (Level 1) (Level 2) (Level 3) Warrant liability $ 80,559 $ — $ — $ 80,559 Embedded redemption option 807 — — 807 Contingent payable derivative liability 8,668 — — 8,668 Share liability 678 678 Total fair value $ 90,712 $ — $ — $ 90,712 There were no transfers between Level 1, 2 or 3 during the nine-month period ended September 30, 2023. The following table presents changes in Level 3 liabilities measured at fair value for the nine-month period ended September 30, 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands). Warrant Embedded Contingent Payable Liability Convertible Liability Redemption Option Derivative Liability (Receivable) Notes Total Balance - January 1, 2023 $ 80,559 $ 807 $ 8,668 $ 678 $ — $ 90,712 Additional share liability — — — 508 — 508 Additional convertible notes at fair value — — — — 10,250 10,250 Redemption of share liability — — — (1,262) — (1,262) Reclassification of warrant liabilities (76,258) — — — — (76,258) Change in fair value (3,282) (807) 214 (534) — (4,409) Balance - September 30, 2023 $ 1,019 (1) $ — $ 8,882 $ (610) $ 10,250 $ 19,541 (1) The remaining balance of $1.0 million in warrant liability as of September 30, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet. (2) The convertible notes issued between August and September 2023 with a principal amount of $10.3 million at September 30, 2023 were accounted for using the FVO election. Under the FVO election, the financial instrument is initially measured at its issue-date estimated fair value and subsequently re-measured at estimated fair value on a recurring basis at each reporting period date. Items for which the FVO has been elected are presented at fair value in the condensed consolidated balance sheets. The change in fair value for the three months ended September 30, 2023 was de-minimis. On January 9, 2023, the Company reclassified the fair value of the warrant liability of $76.3 million into the additional paid-in capital. The change in fair value of the common stock warrant liability of $2.3 million between December 31, 2022 and January 9, 2023 is reflected in “Change in fair value of derivative liabilities” in the accompanying condensed consolidated statements of comprehensive loss for the nine months ended September 30, 2023. A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of September 30, 2023, January 9, 2023 (the reclassification date) and December 31, 2022 is as follows: As of September 30, 2023 As of January 9, 2023 Share Contingent Payable Warrant Receivable Derivative Liability Liability Strike price $ 0.56 $ 0.91 * $ 0.31 Contractual term (years) 0.04 1.13 1.46 Volatility (annual) 73 % 73 % 87 % Risk-free rate 5.6 % 5.5 % 4.3 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of September 30, 2023 and December 31, 2022 The key unobservable inputs for Piggy-back rights that was included in the warrant liability as of September 30, 2023 and December 31, 2022 was the assumption of the estimated remaining life which was based on the estimate of the next qualified financing. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stock-based Compensation | |
Stock-based Compensation | 5. Stock-based Compensation The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 (in thousands). For the three months ended For the nine months ended September 30, September 30, 2023 2022 2023 2022 Research and development $ 1,118 $ 921 $ 1,562 $ 2,072 Research and development - related party Milestones achieved (1) 9 195 578 2,120 Future milestones (2) 24 1,205 115 4,620 General and administrative 471 1,040 578 929 Total stock-based compensation expense $ 1,622 $ 3,361 $ 2,833 $ 9,741 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 nine months ended September 30, 2023, the Company recognized the remaining $0.6 million stock-based compensation related to the achieved milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting key portions of the application for product approval). The Company had previously recognized $2.6 million stock-based compensation related to these two milestones as of December 31, 2022. The $2.1 million expense recognized in 2022 covered 3 one-time milestones: 2 required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases) and a workstream related to Fill/Finish. (2) During the three and nine months ended September 30, 2023, the Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining one-time milestone stock awards for submission the application for product approval to MHRA of $24,000 and $0.1 million, respectively. During the three and nine months ended September 30, 2022, the Company recognized and expensed (but did not issue shares for) the pro-rata portion of 6 one-time milestones (partly stock): 5 workstreams (Comparability, Stability, Potency, Product Profile and Mechanism of Action) and one-time milestone for drafting and submission of key portions of the application for product approval of $1.2 million and $4.6 million, respectively. The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The weighted average assumptions used in calculating the fair values of stock options that were granted during the nine months ended September 30, 2023 and 2022 was as follows: For the nine months ended September 30, 2023 2022 Exercise price $ 0.51 $ 0.65 Expected term (years) 6.4 3.9 Expected stock price volatility 84 % 99 % Risk-free rate 4.5 % 3.3 % Dividend yield (per share) 0 % 0 % The total unrecognized stock compensation (primarily for consultants) cost was approximately $6.2 million as of September 30, 2023 and will be recognized over the next 1.9 years. Stock Options The following table summarizes stock option activity for options granted to key external experts during the nine months ended September 30, 2023 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Contractual Life Total Intrinsic Shares Exercise Price (in years) Value Outstanding as of January 1, 2023 301,263 $ 0.34 7.0 $ 135,225 Granted (1) 20,220 0.51 6.3 — Cashless exercised (2,507) 0.45 — — Expired (300) 0.83 — — Outstanding as of September 30, 2023 318,676 $ 0.34 6.3 $ 180,794 Options vested (2) 281,209 $ 0.33 6.3 $ 163,974 (1) During the nine months ended September 30, 2023, the Company granted 20.2 million stock options (the “2023 Options”) with an exercise price ranging from $ 0.47 to $ 0.57 per share, to key external consultants who provide services to the Company. The 2023 Options contain both service and performance vesting conditions, which will vest over a service period, generally during the term of consulting agreement, or upon achievement of specific milestones. (2) An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, General Consul are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days ’ prior notice. Restricted Stock Awards Advent SOW 6 As previously reported, during April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, for five workstreams that are prerequisites for an application for regulatory approval of DCVax-L, for three required licenses for the Sawston facility and for drafting of key portions of the application for approval. The SOW provides for baseline costs and for one-time milestone incentives for successful completion of each of the workstreams, for the completion and submission of each application for product approval, and for obtaining regulatory approval of each of the three Sawston licenses. The milestone incentives will be a combination of cash and stock and are not paid until they are achieved. As also previously reported, the Company amended the SOW6 on September 26, 2022 (the “Amended SOW6”) to (1) extend the service period through September 30, 2023, and (2) clarify the assessment and application of the milestones, and (3) add a sixth workstream. (The potential cost for all unearned stock awards for milestones not yet achieved was re-measured on the modification date and will be further re-measured until the date the milestone award is achieved and the stock awards are earned.) If all of the 10 one-time milestones are achieved (i.e., for all six workstreams that are prerequisites for an application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the application for product approval), the aggregate stock-based compensation under the Amended SOW 6 will be 13.5 million shares (including the shares already earned and issued for the milestones already achieved) for an aggregate fair value of $10.1 million. As of December 31, 2022, seven milestones were completed, including five workstreams and the regulatory approvals of two licenses required for the Sawston facility. An eighth milestone was partly completed and the stock component of that milestone was earned, but the cash portion of that eighth milestone was not yet earned. On September 26, 2023, the Company further amended the SOW 6 (the “Second Amended SOW 6”) to extend the service period through March 31, 2024. As of the amendment date, the remaining unvested one-time milestone for submission of the application to MHRA for approval of DCVax-L was accounted as a Type I modification (probable to probable under FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). The previously remaining unrecognized compensation expense for total $17,000 is expected to be fully recognized by end of November 2023. During the nine months ended September 30, 2023, milestones related to the workstream for Mechanism of Action, obtaining the commercial manufacturing license from the MHRA and completion of key portions of the application for product approval were completed. For this manufacturing license milestone, the Company recognized the remaining $0.5 million in expense in the condensed consolidated statements of operations and comprehensive loss and issued 3.0 million common shares. For the completion of the drafting of the MHRA application milestone, the Company recognized the remaining $0.1 million in expense in the condensed consolidated statements of operations and comprehensive loss and issued 1.5 million common shares. Employee Compensation In August 2023, the Company issued 0.6 million shares of common stock as a bonus payment to two staff employees. These shares were fully vested on the grant date. However, 0.3 million shares are subject to lock-up restrictions, prohibiting their sale or transfer within six months of the grant date. The Company recognized $0.3 million stock-based compensation which is based on the Company’s closing stock price on the grant date. Other Service Agreement During the nine months ended September 30, 2023, the Company issued 16,000 shares of Series C convertible preferred stock to an unrelated vendor who provided professional services for the Company. The fair value of the Series C convertible preferred stock on the issuance date was approximately $0.1 million, which will be expensed over a four-month service period. During the three and nine months ended September 30, 2023, the Company recognized approximately $0.1 million and $0.2 million, respectively as part of general and administrative expenses. |
Property, Plant and Equipment
Property, Plant and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 6. Property, Plant and Equipment Property, plant and equipment consist of the following at September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, Estimated 2023 2022 Useful Life Leasehold improvements $ 17,088 $ 13,070 Lesser of lease term or estimated useful life Office furniture and equipment 460 300 3-5 years Computer and manufacturing equipment and software 2,487 2,238 3-5 years Land in the United Kingdom 83 82 NA 20,118 15,690 NA Less: accumulated depreciation (3,367) (2,272) Total property, plant and equipment, net $ 16,751 $ 13,418 Construction in progress $ — $ 2,028 The construction works related to expanding the operational portion of its UK facility (Phase 1B) were completed and placed in service as of September 30, 2023. All costs associated with the Phase 1B build out were reclassified from construction in progress to leasehold improvements effective June 2023 and are being amortized over the estimated useful life of the facility. Depreciation expense was approximately $1.1 million and $0.9 million for the nine months ended September 30, 2023, and 2022, respectively. |
Outstanding Debt
Outstanding Debt | 9 Months Ended |
Sep. 30, 2023 | |
Outstanding Debt | |
Outstanding Debt | 7. Outstanding Debt The following two tables summarize outstanding debt as of September 30, 2023 and December 31, 2022, respectively (amount in thousands): Stated Interest Conversion Remaining Carrying Maturity Date Rate Price Face Value Debt Discount Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ 135 8% unsecured Various 8 % $ 0.50-$0.70 * 3,332 (516) 2,816 10% unsecured 7/11/2024 10 % $ 0.50 * 500 — 500 3,967 (516) 3,451 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40-$0.49 * 10,250 — 10,250 Short term notes payable 8% unsecured Various 8 % N/A 7,862 (226) 7,636 12% unsecured On Demand 12 % N/A 562 — 562 8,424 (226) 8,198 Long term notes payable 8% unsecured 1/2/2025 8 % N/A 11,005 (688) 10,317 6% secured 3/25/2025 6 % N/A 721 — 721 11,726 (688) 11,038 Ending balance as of September 30, 2023 $ 34,367 $ (1,430) $ 32,937 *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 and $0.70 per share. Stated Embedded Interest Conversion Remaining Redemption Carrying Maturity Date Rate Price Face Value Debt Discount Option Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 135 — — 135 Short term notes payable 8% unsecured Various 8 % N/A 14,540 (1,300) 807 14,047 9% unsecured Various 9 % N/A 793 — — 793 12% unsecured On Demand 12 % N/A 563 — — 563 15,896 (1,300) 807 15,403 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 5,505 (432) — 5,073 6% secured 3/25/2025 6 % N/A 918 — — 918 6,423 (432) — 5,991 Ending balance as of December 31, 2022 $ 22,454 $ (1,732) $ 807 $ 21,529 Promissory Note On March 2, 2023, the Company entered into a Commercial Loan Agreement (the “Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The Commercial Loan bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first eight months of the term. The Commercial Loan is amortized in 14 installments starting on November 2, 2023. The Commercial Loan carries an original issue discount of $1.0 million. During the nine months ended September 30, 2023, the Company issued approximately 27.6 million shares of common stock with a fair value of $17.5 million to certain lenders in lieu of cash payments of $13.2 million of debt, including $1.0 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 nine months ended September 30, 2023, the Company extinguished Share liabilities of $1.3 million and recognized additional $0.5 million in Share liabilities. The Company recognized an approximately $3.5 million debt extinguishment loss during the nine months ended September 30, 2023 from the debt redemption. During the nine months ended September 30, 2023, the Company issued approximately 56,000 shares of Series C preferred stock with a fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million in debt, including $0.1 million of accrued interest. The Company recognized an approximately $0.1 million debt extinguishment loss. During the nine months ended September 30, 2023, the Company recognized $0.8 million change in fair value of embedded redemption option as this embedded feature had de minimis value based on the remaining life of the note and the next qualified financing. Convertible Notes In April 2023, the Company entered into several ten-month convertible notes (the “April Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $0.9 million for a purchase price of $0.8 million. The April Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $13.75 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. The Company reclassed $0.7 million Investor advances that were received from the Holders in December 2022 to Convertible notes payable on the condensed consolidated balance sheet as of September 30, 2023. As a result, the Company received net cash proceeds of $0.1 million. As consideration for entering into the April Convertible Notes, the Company also agreed to amend the investors’ existing outstanding warrants. The exercise price of certain warrants was amended from $2.00 per share to $0.55 per share, and the maturity date was extended for an additional 9 months. The incremental change in fair value resulting from the amendment was approximately $0.2 million, which was recognized as an additional debt discount to the April Convertible Notes. On June 30, 2023, the Company entered into a one-year convertible note (the “June Convertible Note”) with an individual investor (the “Holder”) with principal amount of $1.0 million. The Company received $1.0 million cash from the June Convertible Note. The June Convertible Note bears interest at 8% per annum and is convertible into Series C preferred shares at $12.50 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. On July 11, 2023, the Company entered into another one-year convertible note (the “July Convertible Note”) with the same investor as the June Convertible Note with principal amount of $0.5 million. The Company received $0.5 million cash from the July Convertible Note. The July Convertible Note bears interest at 10% per annum and has same conversion feature and conversion price as the June Convertible Note. During the three months ended September 30, 2023, the Company entered into several one-year convertible notes (the “Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.4 million for a purchase price of $1.3 million. The Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares between $13.75 and $17.50 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. The Company reclassed $0.5 million Investor advances that were received from the Holders in December 2022 to Convertible notes payable on the condensed consolidated balance sheet as of September 30, 2023. As a result, the Company received net cash proceeds of $0.8 million. As additional consideration for entering into the Convertible Notes, the Company also agreed to amend the Holders’ existing outstanding warrants. The exercise price of certain existing warrants was amended from $2.00 per share to price between $0.55 and $0.70 per share, and the maturity date was extended for an additional 10 months. The incremental change in fair value resulting from the amendment was approximately $0.3 million, which was recognized as an additional debt discount to the Convertible Notes. Convertible Notes at Fair Value Between August and September 2023, the Company entered into several one-year convertible notes (the “August & September Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $10.3 million. The August & September Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between One of the August & September Convertible Notes also contains a conversion feature to allow the holder to convert the outstanding debt in lieu of cash payment to purchase common shares via cash exercise of the holder’s existing warrants. In addition, the Company also agreed to amend the holder’s existing warrants to extend the term of the warrant maturity date for an additional 3 months. The Company elected the FVO to fair value the August & September Convertible Notes under the guidance in ASC 825. The fair value of the August & September Convertible Notes on the issuance date and as of September 30, 2023 was approximately the same. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred. Therefore, the incremental change in fair value resulting from the warrant amendment for $0.3 million was recognized as part of interest expenses on the condensed consolidated statement of operations and comprehensive loss. For the three months ended September 30, 2023 and 2022, interest expense related to outstanding debt totaled approximately $1.7 million and $0.5 million including amortization of debt discounts totaling $0.7 million and $0.6 million, respectively. For the nine months ended September 30, 2023 and 2022, interest expense related to outstanding debt totaled approximately $4.0 million and $4.8 million including amortization of debt discounts totaling $2.0 million and $2.1 million, respectively. |
Net Loss per Share Applicable t
Net Loss per Share Applicable to Common Stockholders | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share Applicable to Common Stockholders | |
Net Loss per Share Applicable to Common Stockholders | 8. Net Loss per Share Applicable to Common Stockholders Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share would be computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Because of the net loss from operations for each period, inclusion of such securities in the computation of loss per share would be anti-dilutive and thus they are excluded. Potentially dilutive weighted average common shares include common stock potentially issuable under the Company’s convertible notes and preferred stock, warrants and vested and unvested stock options. The following securities were not included in the diluted net loss per share calculation because their effect was anti-dilutive as of the periods presented (in thousands): For the nine months ended September 30, 2023 2022 Series C convertible preferred stock 44,328 22,129 Common stock options 318,676 304,596 Common stock warrants 105,444 145,417 Convertible notes and accrued interest 32,049 76 Potentially dilutive securities 500,497 472,218 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
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, for the following: ● Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing. ● 6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. ● Drafting 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. 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 September 2023. The Company subsequently extended the term by 12 months to July 2024 with no other changes. SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the 3 licenses required for the Sawston facility, (b) successful completion of each of the 6 workstreams and (c) completion of drafting key portions of an application for product approval. The milestone incentives are a combination of cash and stock, and are not paid until the milestone is achieved and earned. During the nine months ended September 30, 2023, the Company paid an aggregate of $3.5 million in cash, of which $1.0 million was related to two milestones that were completed and fully expensed in 2022, but was unpaid as of December 31, 2022, and the other $2.5 million was payment for two completed one-time milestones (MAA workstream for mechanism of Action and obtaining a commercial manufacturing license from the MHRA on March 2023). The Company issued 4.5 million common shares as a result of completion of the two one-time milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting application) at fair value of $3.2 million, of which $0.6 million was recognized during the nine months ended September 30, 2023 and $2.6 million had already been recognized (but not paid) in 2022. The following table summarizes total research and development costs from Advent for the three and nine months ended September 30, 2023 and 2022, respectively (in thousands). For the three months ended For the nine months ended September 30, September 30, 2023 2022 2023 2022 Advent BioServices Manufacturing cost in London $ 1,554 $ 1,334 $ 4,857 $ 4,161 Manufacturing cost at Sawston facility 2,247 1,404 6,057 4,105 SOW 6 one-time milestones - Shares Expensed and paid (milestone complete) (1) 9 195 578 2,120 Expensed but unpaid, not yet due (milestone not yet complete) (2) 24 1,205 115 4,620 SOW 6 one-time milestones - Cash Expensed and paid (milestone complete) (3) — — 551 1,500 Expensed and due, but unpaid (milestone complete) (4) 18 226 111 500 Expensed but unpaid, not yet due (milestone not yet complete) (5) 13 1,230 130 3,270 Total $ 3,865 $ 5,594 $ 12,399 $ 20,276 (1) The payment for the nine months ended September 30, 2023 covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA, and covers 2 other one-time milestones for 2 other required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases). (2) The expense for the nine months ended September 30, 2023 covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and 1 one-time milestone for drafting key portions of the application for product approval. (3) This covers one-time milestone: a required license for the Sawston facility from the Human Tissue Authority. (4) The expense for the nine months ended September 30, 2023 covers the one-time milestone workstream for Mechanism of Action and also covers a one-time milestone for a required license for the Sawston facility from the MHRA for manufacturing for clinical trials and compassionate use cases. (5) The expense for the nine months ended September 30, 2023 covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and one-time milestone for drafting key portions of the application for product approval. 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 $7.02 per square foot based on exchange rate as of September 30, 2023), 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 2023. 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 £500,000 (approximately $610,000) per year. The term of the Agreement shall end on the same date as the head lease term ends. During the three and nine months ended September 30, 2023, the Company recognized sub-lease income of $36,000 and $108,000, respectively. Related Party Accounts Payable As of September 30, 2023, there was approximately $0.2 million of unpaid board compensation to one of our Directors that was included in the accounts payable to related party on the condensed consolidated balance sheets. As of September 30, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section. September 30, December 31, 2023 2022 Advent BioServices - amount invoiced but unpaid $ 2,451 $ 1,844 Advent BioServices - amount accrued but unpaid 2,027 4,736 Total payable and accrued, but unpaid to Advent BioServices $ 4,478 $ 6,580 |
Preferred Stock
Preferred Stock | 9 Months Ended |
Sep. 30, 2023 | |
Preferred Stock. | |
Preferred Stock | 10. Preferred Stock Series C Convertible Preferred Stock During the nine months ended September 30, 2023, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of 0.7 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 $13.58 per share for proceeds of approximately $9.9 million. During the nine months ended September 30, 2023, the Company issued approximately 56,000 Series C Shares with a fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million in debt, including $0.1 million accrued interest. The Company recognized an approximately $0.1 million debt extinguishment loss. During the nine months ended September 30, 2023, approximately 0.4 million Series C Shares with a book value of $6.5 million were converted into 11.1 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 | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Deficit | |
Stockholders' Deficit | 11. Stockholders’ Deficit Common Stock On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. During the nine months ended September 30, 2023, the Company received $2.8 million from the exercise of outstanding warrants with an exercise price between $0.153 and $0.85, of which $1.2 million was received in December 2022 as investor advances. The Company issued approximately 12.4 million shares of common stock upon these warrant exercises. During the nine months ended September 30, 2023, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 20.4 million shares of common stock upon exercise of 22.9 million warrants at exercise prices between $0.17 and $0.22 per share, and 2.5 million options at exercise prices between $0.25 and $0.55 per share. The Company issued approximately 27.6 million shares of common stock with a fair value of $17.5 million to certain lenders in lieu of cash payments of $13.2 million of debt, including $1.0 million of accrued interest, and settled $1.3 million true-up provision (see Note 7). Stock Purchase Warrants The following is a summary of warrant activity for the three months ended September 30, 2023 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2023 141,048 $ 0.31 1.16 Warrants exercised for cash (12,447) 0.22 — Cashless warrrants exercise (22,907) 0.20 — Warrants expired and cancellation (250) 1.36 — Outstanding as of September 30, 2023 105,444 $ 0.32 1.92 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 September 30, 2023, of the approximately 105 million total outstanding warrants listed above, approximately 100 million warrants were under the Blocker Letter Agreement or suspension agreements. Warrant Modifications Between January 10 and September 30, 2023, the Company amended multiple warrants whereby the maturity dates of certain warrants were extended for an additional approximately 3 months. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions. Post-modification Pre-modification Exercise price $ 0.30 $ 0.31 Expected term (in years) 1.8 1.5 Volatility 73 % 90 % Risk-free interest rate 4.9 % 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 $2.2 million, of which $0.8 million was associated with debt financing and was recognized as an additional debt discount and interest expense (see Note 7), and the remaining $1.4 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 | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 12. Commitments and Contingencies Operating Lease- Lessee Arrangements The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected the practical expedient to account for each separate lease component of a contract and its associated non-lease components as a single lease component, thus causing all fixed payments to be capitalized. The Company also elected the package of practical expedients permitted within the new standard, which among other things, allows the Company to carry forward historical lease classification. The lease renewal options have not been included in the calculation of the lease liabilities and right-of-use (“ROU”) assets as the Company has not yet determined whether to exercise the options. Variable lease payment amounts that cannot be determined at the commencement of the lease such as increases in lease payments based on changes in index rates or usage, are not included in the ROU assets or liabilities. These are expensed as incurred and recorded as variable lease expense. At September 30, 2023, the Company had operating lease liabilities of approximately $4.5 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 $4.0 million for the Sawston lease and U.S. office lease are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases (amount in thousands): For the Nine Months ended September 30, 2023 U.K U.S Total Lease cost Operating lease cost $ 443 $ 190 $ 633 Short-term lease cost 62 — 62 Variable lease cost — 10 10 Sub-lease income (108) — (108) Total $ 397 $ 200 $ 597 Other information Operating cash flows from operating leases $ (467) $ (224) $ (691) Weighted-average remaining lease term – operating leases 8.1 0.7 Weighted-average discount rate – operating leases 12 % 12 % For the Nine Months ended September 30, 2022 U.K U.S Total Lease cost Operating lease cost $ 448 $ 195 $ 643 Short-term lease cost 56 — 56 Variable lease cost — 9 9 Sub-lease income (110) — (110) Total $ 394 $ 204 $ 598 Other information Operating cash flows from operating leases $ (472) $ (217) $ (689) Weighted-average remaining lease term – operating leases 8.6 1.4 Weighted-average discount rate – operating leases 12 % 12 % The Company recorded lease costs as a component of general and administrative expense during the nine months ended September 30, 2023 and 2022, respectively. Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows: Three months ended December 31, 2023 $ 228 Year ended December 31, 2024 815 Year ended December 31, 2025 610 Year ended December 31, 2026 610 Year ended December 31, 2027 610 Thereafter 6,692 Total 9,565 Less present value discount (5,062) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2023 $ 4,503 Maturities of our operating leases under the sublease agreement, are as follows: Three months ended December 31, 2023 $ 36 Year ended December 31, 2024 145 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Thereafter 1,740 Total $ 2,211 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 ($5.5 million). The Company entered into SOW 6 with Advent, which was incorporated into the Ancillary Services Agreement, on April 1, 2022, and amended it on September 26, 2022 and again on September 26, 2023. The milestone incentives involve a combination of cash and stock and are not paid until they are achieved and earned, as described in Note German Tax Matter The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015 and assessed additional tax against the subsidiary. NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €277,000 (approximately $293,000), 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 $244,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (now approximately $542,000) 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 $235,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $143,000) of the penalties. The Company offered to pay this reduced penalty if an extended payment plan was approved. A response was received dated November 14, 2022 indicating that the tax authority would not be able to grant a further deferral of payment of these penalties. In a letter dated December 27, 2022, the Leipzig tax authority sent letters to the former and current managing directors of NW Bio GmbH giving 30 days to respond to a tax liability questionnaire. Based on the responses to the liability questionnaires the tax authorities have currently not directed any further measures against former and current managing directors of NW Bio GmbH with respect to tax liability proceedings. The Company currently has accrued for the current amounts owed for these penalties of €377,000 (approximately $399,000) as well as for all unpaid taxes as of September 30, 2023. Subsequently on October 12, 2023, the Company paid €189,000 (approximately $200,000), which represents 50% of the total penalties. The Company is expecting to make the other half payment by end of November 2023. Based on the Company’s current operating state in Germany and the negotiations, the Company believes, based on its evaluation under ASC 740, that the resolution of these tax matters will not likely result in a net material charge to the Company. Other Contingent Payment Obligation Between May and September 2023, the Company entered into certain non-dilutive funding agreements with multiple investors, pursuant to which the Company received funding of $4.6 million 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 | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events Between October 1, 2023 and November 6, 2023, the Company received $1.9 million in funding from the sale of preferred shares, proceeds from warrant and option exercise, proceeds of debt arrangements. Between October 1, 2023 and November 6, 2023, the Company issued approximately 80,000 shares of Series C preferred stock for proceeds of $1.2 million. Between October 1, 2023 and November 6, 2023, the Company received $0.1 million from the exercise of 0.2 million outstanding warrants and options. The Company also issued 0.6 million shares of common stock from a cashless exercise of 0.8 million options. Between October 1, 2023 and November 6, 2023, approximately 0.2 million Series C Shares with a book value of $3.6 million were converted into 6.1 million common shares in accordance with their terms at a ratio of 1:25. In October 2023, the Company issued approximately 1.9 million net shares of common stock to a lender in lieu of cash payments on $1.6 million of outstanding debt, which is offset by a settlement of $0.7 million shares receivable. On October 4, 2023, the Company entered into a one-year convertible note (the “Convertible Note”) with an investor (the “Holder”) with an aggregate principal amount of $154,000 for a purchase price of $140,000. The Convertible Note bear interest at 8% per annum and is convertible into Series C preferred shares at $17.50 per share at the Holder’s sole option. As additional consideration for entering into the Convertible Note, the Company also extended the holder’s existing warrants maturity date for additional 8.5 months. On October 20, 2023, the Company received $0.5 million cash from issuance a one-year convertible note. The note has same conversion features as the August & September Note (see Note 7). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation. The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2023, condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2023 and 2022, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s annual report on Form 10-K (the “2022 Annual Report”), which was filed with the SEC on February 28, 2023. |
Use of Estimates | Use of Estimates In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets, and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2022 Annual Report other than those discussed below. |
Sequencing | Sequencing The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, non-employees or directors are not subject to the sequencing policy. On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximately 141 million warrants, with a value of approximately $76.3 million, to purchase shares of the Company’s common stock were reclassified from liabilities to equity on January 9, 2023. The remaining balance of $1.0 million in warrant liability as of September 30, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). |
Modification of Equity Classified Warrants | Modification of Equity Classified Warrants A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend. |
Convertible Notes under Fair Value Option | Convertible Notes under Fair Value Option The Company accounts for certain convertible notes issued in August and September 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred. |
Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements | |
Summary of fair value assets and liabilities measured on recurring basis | The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands): Fair value measured at September 30, 2023 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs September 30, 2023 (Level 1) (Level 2) (Level 3) Share receivable $ 610 $ — $ — $ 610 Warrant liability $ 1,019 $ — $ — $ 1,019 Contingent payable derivative liability 8,882 — — 8,882 Convertible notes 10,250 10,250 Total fair value $ 20,151 $ — $ — $ 20,151 Fair value measured at December 31, 2022 Quoted prices in active Significant other Significant Fair value at markets observable inputs unobservable inputs December 31, 2022 (Level 1) (Level 2) (Level 3) Warrant liability $ 80,559 $ — $ — $ 80,559 Embedded redemption option 807 — — 807 Contingent payable derivative liability 8,668 — — 8,668 Share liability 678 678 Total fair value $ 90,712 $ — $ — $ 90,712 |
Summary 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 nine-month period ended September 30, 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands). Warrant Embedded Contingent Payable Liability Convertible Liability Redemption Option Derivative Liability (Receivable) Notes Total Balance - January 1, 2023 $ 80,559 $ 807 $ 8,668 $ 678 $ — $ 90,712 Additional share liability — — — 508 — 508 Additional convertible notes at fair value — — — — 10,250 10,250 Redemption of share liability — — — (1,262) — (1,262) Reclassification of warrant liabilities (76,258) — — — — (76,258) Change in fair value (3,282) (807) 214 (534) — (4,409) Balance - September 30, 2023 $ 1,019 (1) $ — $ 8,882 $ (610) $ 10,250 $ 19,541 (1) The remaining balance of $1.0 million in warrant liability as of September 30, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet. (2) The convertible notes issued between August and September 2023 with a principal amount of $10.3 million at September 30, 2023 were accounted for using the FVO election. Under the FVO election, the financial instrument is initially measured at its issue-date estimated fair value and subsequently re-measured at estimated fair value on a recurring basis at each reporting period date. Items for which the FVO has been elected are presented at fair value in the condensed consolidated balance sheets. The change in fair value for the three months ended September 30, 2023 was de-minimis. |
Summary of Company's warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy | As of September 30, 2023 As of January 9, 2023 Share Contingent Payable Warrant Receivable Derivative Liability Liability Strike price $ 0.56 $ 0.91 * $ 0.31 Contractual term (years) 0.04 1.13 1.46 Volatility (annual) 73 % 73 % 87 % Risk-free rate 5.6 % 5.5 % 4.3 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of September 30, 2023 and December 31, 2022 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-based Compensation | |
Summary of total stock based compensation expense | The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 (in thousands). For the three months ended For the nine months ended September 30, September 30, 2023 2022 2023 2022 Research and development $ 1,118 $ 921 $ 1,562 $ 2,072 Research and development - related party Milestones achieved (1) 9 195 578 2,120 Future milestones (2) 24 1,205 115 4,620 General and administrative 471 1,040 578 929 Total stock-based compensation expense $ 1,622 $ 3,361 $ 2,833 $ 9,741 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 nine months ended September 30, 2023, the Company recognized the remaining $0.6 million stock-based compensation related to the achieved milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting key portions of the application for product approval). The Company had previously recognized $2.6 million stock-based compensation related to these two milestones as of December 31, 2022. The $2.1 million expense recognized in 2022 covered 3 one-time milestones: 2 required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases) and a workstream related to Fill/Finish. (2) During the three and nine months ended September 30, 2023, the Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining one-time milestone stock awards for submission the application for product approval to MHRA of $24,000 and $0.1 million, respectively. During the three and nine months ended September 30, 2022, the Company recognized and expensed (but did not issue shares for) the pro-rata portion of 6 one-time milestones (partly stock): 5 workstreams (Comparability, Stability, Potency, Product Profile and Mechanism of Action) and one-time milestone for drafting and submission of key portions of the application for product approval of $1.2 million and $4.6 million, respectively. |
Schedule of weighted average assumptions for stock options modification | For the nine months ended September 30, 2023 2022 Exercise price $ 0.51 $ 0.65 Expected term (years) 6.4 3.9 Expected stock price volatility 84 % 99 % Risk-free rate 4.5 % 3.3 % Dividend yield (per share) 0 % 0 % |
Summary of stock option activity | The following table summarizes stock option activity for options granted to key external experts during the nine months ended September 30, 2023 (amount in thousands, except per share number): Weighted Average Weighted Remaining Number of Average Contractual Life Total Intrinsic Shares Exercise Price (in years) Value Outstanding as of January 1, 2023 301,263 $ 0.34 7.0 $ 135,225 Granted (1) 20,220 0.51 6.3 — Cashless exercised (2,507) 0.45 — — Expired (300) 0.83 — — Outstanding as of September 30, 2023 318,676 $ 0.34 6.3 $ 180,794 Options vested (2) 281,209 $ 0.33 6.3 $ 163,974 (1) During the nine months ended September 30, 2023, the Company granted 20.2 million stock options (the “2023 Options”) with an exercise price ranging from $ 0.47 to $ 0.57 per share, to key external consultants who provide services to the Company. The 2023 Options contain both service and performance vesting conditions, which will vest over a service period, generally during the term of consulting agreement, or upon achievement of specific milestones. (2) An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, General Consul are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days ’ prior notice. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment | |
Schedule of property and equipment | Property, plant and equipment consist of the following at September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, Estimated 2023 2022 Useful Life Leasehold improvements $ 17,088 $ 13,070 Lesser of lease term or estimated useful life Office furniture and equipment 460 300 3-5 years Computer and manufacturing equipment and software 2,487 2,238 3-5 years Land in the United Kingdom 83 82 NA 20,118 15,690 NA Less: accumulated depreciation (3,367) (2,272) Total property, plant and equipment, net $ 16,751 $ 13,418 Construction in progress $ — $ 2,028 |
Outstanding Debt (Tables)
Outstanding Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Outstanding Debt | |
Schedule of outstanding debt | The following two tables summarize outstanding debt as of September 30, 2023 and December 31, 2022, respectively (amount in thousands): Stated Interest Conversion Remaining Carrying Maturity Date Rate Price Face Value Debt Discount Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ 135 8% unsecured Various 8 % $ 0.50-$0.70 * 3,332 (516) 2,816 10% unsecured 7/11/2024 10 % $ 0.50 * 500 — 500 3,967 (516) 3,451 Short term convertible notes at fair value 11% unsecured Various 11 % $ 0.40-$0.49 * 10,250 — 10,250 Short term notes payable 8% unsecured Various 8 % N/A 7,862 (226) 7,636 12% unsecured On Demand 12 % N/A 562 — 562 8,424 (226) 8,198 Long term notes payable 8% unsecured 1/2/2025 8 % N/A 11,005 (688) 10,317 6% secured 3/25/2025 6 % N/A 721 — 721 11,726 (688) 11,038 Ending balance as of September 30, 2023 $ 34,367 $ (1,430) $ 32,937 *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 and $0.70 per share. Stated Embedded Interest Conversion Remaining Redemption Carrying Maturity Date Rate Price Face Value Debt Discount Option Value Short term convertible notes payable 6% unsecured Due 6 % $ 3.09 $ 135 $ — $ — $ 135 135 — — 135 Short term notes payable 8% unsecured Various 8 % N/A 14,540 (1,300) 807 14,047 9% unsecured Various 9 % N/A 793 — — 793 12% unsecured On Demand 12 % N/A 563 — — 563 15,896 (1,300) 807 15,403 Long term notes payable 8% unsecured 7/26/2024 8 % N/A 5,505 (432) — 5,073 6% secured 3/25/2025 6 % N/A 918 — — 918 6,423 (432) — 5,991 Ending balance as of December 31, 2022 $ 22,454 $ (1,732) $ 807 $ 21,529 |
Net Loss per Share Applicable_2
Net Loss per Share Applicable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 30, 2023 2022 Series C convertible preferred stock 44,328 22,129 Common stock options 318,676 304,596 Common stock warrants 105,444 145,417 Convertible notes and accrued interest 32,049 76 Potentially dilutive securities 500,497 472,218 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 and nine months ended September 30, 2023 and 2022, respectively (in thousands). For the three months ended For the nine months ended September 30, September 30, 2023 2022 2023 2022 Advent BioServices Manufacturing cost in London $ 1,554 $ 1,334 $ 4,857 $ 4,161 Manufacturing cost at Sawston facility 2,247 1,404 6,057 4,105 SOW 6 one-time milestones - Shares Expensed and paid (milestone complete) (1) 9 195 578 2,120 Expensed but unpaid, not yet due (milestone not yet complete) (2) 24 1,205 115 4,620 SOW 6 one-time milestones - Cash Expensed and paid (milestone complete) (3) — — 551 1,500 Expensed and due, but unpaid (milestone complete) (4) 18 226 111 500 Expensed but unpaid, not yet due (milestone not yet complete) (5) 13 1,230 130 3,270 Total $ 3,865 $ 5,594 $ 12,399 $ 20,276 (1) The payment for the nine months ended September 30, 2023 covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA, and covers 2 other one-time milestones for 2 other required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases). (2) The expense for the nine months ended September 30, 2023 covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and 1 one-time milestone for drafting key portions of the application for product approval. (3) This covers one-time milestone: a required license for the Sawston facility from the Human Tissue Authority. (4) The expense for the nine months ended September 30, 2023 covers the one-time milestone workstream for Mechanism of Action and also covers a one-time milestone for a required license for the Sawston facility from the MHRA for manufacturing for clinical trials and compassionate use cases. (5) The expense for the nine months ended September 30, 2023 covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and one-time milestone for drafting key portions of the application for product approval. |
Summary of outstanding unpaid accounts payable and accrued expenses held by related parties | As of September 30, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section. September 30, December 31, 2023 2022 Advent BioServices - amount invoiced but unpaid $ 2,451 $ 1,844 Advent BioServices - amount accrued but unpaid 2,027 4,736 Total payable and accrued, but unpaid to Advent BioServices $ 4,478 $ 6,580 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Deficit | |
Schedule of warrant activity | The following is a summary of warrant activity for the three months ended September 30, 2023 (dollars in thousands, except per share data): Number of Weighted Average Remaining Warrants Exercise Price Contractual Term Outstanding as of January 1, 2023 141,048 $ 0.31 1.16 Warrants exercised for cash (12,447) 0.22 — Cashless warrrants exercise (22,907) 0.20 — Warrants expired and cancellation (250) 1.36 — Outstanding as of September 30, 2023 105,444 $ 0.32 1.92 |
Schedule of modifications to the warrants following weighted average assumptions | As of September 30, 2023 As of January 9, 2023 Share Contingent Payable Warrant Receivable Derivative Liability Liability Strike price $ 0.56 $ 0.91 * $ 0.31 Contractual term (years) 0.04 1.13 1.46 Volatility (annual) 73 % 73 % 87 % Risk-free rate 5.6 % 5.5 % 4.3 % Dividend yield (per share) 0 % 0 % 0 % As of December 31, 2022 Warrant Share Contingent Payable Liability Liability Derivative Liability Strike price $ 0.31 $ 0.78 * $ 0.78 * Contractual term (years) 1.5 0.1 0.6 Volatility (annual) 86 % 76 % 77 % Risk-free rate 4.3 % 2.0 % 4.8 % Dividend yield (per share) 0 % 0 % 0 % * The strike price assumes the current stock price as of September 30, 2023 and December 31, 2022 |
Warrants | |
Stockholders' Deficit | |
Schedule of modifications to the warrants following weighted average assumptions | Post-modification Pre-modification Exercise price $ 0.30 $ 0.31 Expected term (in years) 1.8 1.5 Volatility 73 % 90 % Risk-free interest rate 4.9 % 4.9 % Dividend yield 0 % 0 % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Schedule of quantitative information about the company's operating leases | The following summarizes quantitative information about the Company’s operating leases (amount in thousands): For the Nine Months ended September 30, 2023 U.K U.S Total Lease cost Operating lease cost $ 443 $ 190 $ 633 Short-term lease cost 62 — 62 Variable lease cost — 10 10 Sub-lease income (108) — (108) Total $ 397 $ 200 $ 597 Other information Operating cash flows from operating leases $ (467) $ (224) $ (691) Weighted-average remaining lease term – operating leases 8.1 0.7 Weighted-average discount rate – operating leases 12 % 12 % For the Nine Months ended September 30, 2022 U.K U.S Total Lease cost Operating lease cost $ 448 $ 195 $ 643 Short-term lease cost 56 — 56 Variable lease cost — 9 9 Sub-lease income (110) — (110) Total $ 394 $ 204 $ 598 Other information Operating cash flows from operating leases $ (472) $ (217) $ (689) Weighted-average remaining lease term – operating leases 8.6 1.4 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: Three months ended December 31, 2023 $ 228 Year ended December 31, 2024 815 Year ended December 31, 2025 610 Year ended December 31, 2026 610 Year ended December 31, 2027 610 Thereafter 6,692 Total 9,565 Less present value discount (5,062) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2023 $ 4,503 Maturities of our operating leases under the sublease agreement, are as follows: Three months ended December 31, 2023 $ 36 Year ended December 31, 2024 145 Year ended December 31, 2025 145 Year ended December 31, 2026 145 Thereafter 1,740 Total $ 2,211 |
Financial Condition, Going Co_2
Financial Condition, Going Concern and Management Plans (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Financial Condition, Going Concern and Management Plans | |
Net loss | $ (45.1) |
Payments for operating activities | $ 36.7 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Millions | Jan. 09, 2023 | Sep. 30, 2023 | Jan. 08, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 | 1,200,000,000 | 1,700,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Number of warrants to purchase shares of common stock reclassified from liability to equity | 141,000,000 | |||
Reclassification of fair value of the warrant liability to equity | $ 76.3 | |||
Remaining balance in warrant liability | $ 1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value Measurements | ||
Share receivable | $ 610 | |
Warrant liability | 1,019 | $ 80,559 |
Embedded redemption option | 807 | |
Contingent payable derivative liability | 8,882 | 8,668 |
Convertible notes | 10,250 | |
Share liability | 678 | |
Total fair value | 20,151 | 90,712 |
Fair value, transfer between level 1, 2 or 3 | 0 | |
Level 3 | ||
Fair Value Measurements | ||
Share receivable | 610 | |
Warrant liability | 1,019 | 80,559 |
Embedded redemption option | 807 | |
Contingent payable derivative liability | 8,882 | 8,668 |
Convertible notes | 10,250 | |
Share liability | 678 | |
Total fair value | $ 20,151 | $ 90,712 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Level 3 liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Jan. 09, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value Measurements | |||
Balance | $ 90,712 | ||
Additional share liability | 508 | ||
Redemption of share liability | (1,262) | ||
Reclassification of warrant liabilities | (76,258) | ||
Change in fair value | (4,409) | ||
Balance | 19,541 | ||
Warrant liability related to purchase shares in a future raise of capital | 1,000 | ||
Reclassification of fair value of the warrant liability into the additional paid-in capital | $ 76,300 | ||
Change in fair value of the common stock warrant liability | $ 2,300 | ||
Principal amount | 34,367 | $ 22,454 | |
August & September Convertible Notes | |||
Fair Value Measurements | |||
Principal amount | 10,300 | ||
Warrant Liability | |||
Fair Value Measurements | |||
Balance | 80,559 | ||
Reclassification of warrant liabilities | (76,258) | ||
Change in fair value | (3,282) | ||
Balance | 1,019 | ||
Embedded Redemption Option | |||
Fair Value Measurements | |||
Balance | 807 | ||
Change in fair value | (807) | ||
Contingent Payable Derivative Liability | |||
Fair Value Measurements | |||
Balance | 8,668 | ||
Change in fair value | 214 | ||
Balance | 8,882 | ||
Share liability | |||
Fair Value Measurements | |||
Balance | 678 | ||
Additional share liability | 508 | ||
Redemption of share liability | (1,262) | ||
Change in fair value | (534) | ||
Balance | (610) | ||
Convertible Notes | |||
Fair Value Measurements | |||
Additional share liability | 10,250 | ||
Balance | $ 10,250 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted average (in aggregate) significant unobservable inputs (Details) - Level 3 - $ / shares | 9 Months Ended | 12 Months Ended | |
Jan. 09, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Warrant Liability | |||
Fair Value Measurements | |||
Strike price | $ 0.31 | $ 0.31 | |
Contractual term (years) | 1 year 5 months 15 days | 1 year 6 months | |
Volatility (annual) | 87% | 86% | |
Risk-free rate | 4.30% | 4.30% | |
Dividend yield (per share) | 0% | 0% | |
Contingent Payable Derivative Liability | |||
Fair Value Measurements | |||
Strike price | $ 0.91 | $ 0.78 | |
Contractual term (years) | 1 year 1 month 17 days | 7 months 6 days | |
Volatility (annual) | 73% | 77% | |
Risk-free rate | 5.50% | 4.80% | |
Dividend yield (per share) | 0% | 0% | |
Share liability | |||
Fair Value Measurements | |||
Strike price | $ 0.56 | $ 0.78 | |
Contractual term (years) | 14 days | 1 month 6 days | |
Volatility (annual) | 73% | 76% | |
Risk-free rate | 5.60% | 2% | |
Dividend yield (per share) | 0% | 0% |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of stock-based compensation expense (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) item Milestone | Sep. 30, 2023 USD ($) Milestone | Sep. 30, 2022 USD ($) item Milestone | Dec. 31, 2022 USD ($) item Milestone | |
Stock-based Compensation | |||||
Number of milestones completed | Milestone | 2 | ||||
Total stock-based compensation expense | $ 1,622,000 | $ 3,361,000 | $ 2,833,000 | $ 9,741,000 | |
Total unrecognized stock compensation cost | 6,200,000 | 6,200,000 | |||
Stock based compensation | $ 2,600,000 | ||||
Milestone achieved | |||||
Stock-based Compensation | |||||
Total stock-based compensation expense | 600,000 | ||||
Research and development | |||||
Stock-based Compensation | |||||
Total stock-based compensation expense | 1,118,000 | 921,000 | 1,562,000 | 2,072,000 | |
Milestone achieved | |||||
Stock-based Compensation | |||||
Number of milestones | Milestone | 3 | ||||
Number of required licenses for the Sawston facility | item | 2 | ||||
Total stock-based compensation expense | 9,000 | $ 195,000 | 578,000 | $ 2,120,000 | $ 2,100,000 |
Future milestone | |||||
Stock-based Compensation | |||||
Number of milestones | Milestone | 6 | 6 | |||
Number of workstreams | item | 5 | 5 | |||
Total stock-based compensation expense | 24,000 | $ 1,205,000 | 115,000 | $ 4,620,000 | |
General and administrative | |||||
Stock-based Compensation | |||||
Total stock-based compensation expense | $ 471,000 | $ 1,040,000 | $ 578,000 | $ 929,000 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock option granted (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based Compensation | ||
Exercise price | $ 0.51 | $ 0.65 |
Expected term (years) | 6 years 4 months 24 days | 3 years 10 months 24 days |
Expected stock price volatility | 84% | 99% |
Risk-free rate | 4.50% | 3.30% |
Dividend yield (per share) | 0% | 0% |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Awards (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 26, 2022 USD ($) Milestone item shares | Aug. 31, 2023 USD ($) employee shares | Apr. 30, 2022 item | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 USD ($) item Milestone | Sep. 26, 2023 USD ($) | |
Stock-based Compensation | |||||||||
Proceeds from issuance of common stock to investors | $ 9,689 | ||||||||
Stock-based compensation | $ 1,622 | $ 3,361 | $ 2,833 | $ 9,741 | |||||
Total intrinsic value of all outstanding options | 180,794 | $ 180,794 | $ 135,225 | ||||||
Employees | |||||||||
Stock-based Compensation | |||||||||
Number of shares issued during the period | shares | 600,000 | ||||||||
Number of employees to whom the shares issued | employee | 2 | ||||||||
Number of shares subject to lock-up restrictions, prohibiting their sale or transfer | shares | 300,000 | ||||||||
Period for lock-up restrictions, prohibiting their sale or transfer | 6 months | ||||||||
Stock-based compensation | $ 300 | ||||||||
Common Stock | |||||||||
Stock-based Compensation | |||||||||
Number of shares issued during the period | shares | 13,147,000 | ||||||||
Proceeds from issuance of common stock to investors | $ 13 | ||||||||
Amended Statement of Work 6 | |||||||||
Stock-based Compensation | |||||||||
Number of milestones | Milestone | 10 | ||||||||
Other Service Agreement | |||||||||
Stock-based Compensation | |||||||||
Service period | 4 months | ||||||||
General and administrative | |||||||||
Stock-based Compensation | |||||||||
Stock-based compensation | 471 | $ 1,040 | $ 578 | $ 929 | |||||
General and administrative | Other Service Agreement | |||||||||
Stock-based Compensation | |||||||||
Stock-based compensation | $ 100 | 200 | |||||||
Restricted Stock Awards | |||||||||
Stock-based Compensation | |||||||||
Number of milestones | Milestone | 7 | ||||||||
Number of workstreams | Milestone | 5 | ||||||||
Number of required licenses for the Sawston facility | item | 2 | ||||||||
Total intrinsic value of all outstanding options | $ 10,100 | ||||||||
Restricted Stock Awards | Amended Statement of Work 6 | |||||||||
Stock-based Compensation | |||||||||
Number of workstreams | item | 6 | ||||||||
Number of required licenses for the Sawston facility | item | 3 | ||||||||
Amount recognized and expensed related to cash component | 500 | ||||||||
Share based compensation arrangement by share based payment award number of shares available for grant | shares | 13,500,000 | ||||||||
Restricted Stock Awards | Amended Statement of Work 6 | Common Stock | |||||||||
Stock-based Compensation | |||||||||
Stock issued | $ 3,000 | ||||||||
Restricted Stock Awards | Other Service Agreement | |||||||||
Stock-based Compensation | |||||||||
Number of shares issued during the period | shares | 16,000 | ||||||||
Proceeds from issuance of common stock to investors | $ 100 | ||||||||
Restricted Stock Awards | Second Amended SOW 6 | |||||||||
Stock-based Compensation | |||||||||
Remaining unrecognized compensation expense | $ 17,000 | ||||||||
Restricted Stock Awards | Manufacturing license milestone | |||||||||
Stock-based Compensation | |||||||||
Amount recognized and expensed related to cash component | 100 | ||||||||
Restricted Stock Awards | Completion of MHRA application milestone | |||||||||
Stock-based Compensation | |||||||||
Stock issued | $ 1,500 | ||||||||
Restricted Stock Awards | Advent BioServices | Statement of Work 6 | |||||||||
Stock-based Compensation | |||||||||
Number of workstreams | item | 5 | ||||||||
Number of required licenses for the Sawston facility | item | 3 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | |
Stock-based Compensation | |
Total unrecognized stock compensation cost | $ | $ 6.2 |
Unrecognized compensation cost recognized period (in years) | 1 year 10 months 24 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) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Stock-based Compensation | ||
Number of Shares, Outstanding | shares | 301,263 | |
Number of Shares, Granted | shares | 20,220 | |
Number of Shares, Cashless exercised | shares | (2,507) | |
Number of Shares, Expired | shares | 300 | |
Number of Shares, Outstanding | shares | 318,676 | 301,263 |
Number of Shares, Options vested | shares | 281,209 | |
Weighted Average Exercise Price, Outstanding | $ 0.34 | |
Weighted Average Exercise Price, Granted | 0.51 | |
Weighted Average Exercise Price, Cashless exercised | 0.45 | |
Weighted Average Exercise Price, Expired | 0.83 | |
Weighted Average Exercise Price, Outstanding | 0.34 | $ 0.34 |
Weighted Average Exercise Price, Options vested | $ 0.33 | |
Weighted Average Remaining Contractual Life (in years), Granted | 6 years 3 months 18 days | |
Weighted Average Remaining Contractual Life (in years), Outstanding | 6 years 3 months 18 days | 7 years |
Weighted Average Remaining Contractual Life (in years), Options vested | 6 years 3 months 18 days | |
Total Intrinsic Value, Outstanding | $ | $ 135,225 | |
Total Intrinsic Value, Outstanding | $ | 180,794 | $ 135,225 |
Total Intrinsic Value, Options vested | $ | $ 163,974 | |
Minimum | ||
Stock-based Compensation | ||
Weighted Average Exercise Price, Granted | $ 0.47 | |
Maximum | ||
Stock-based Compensation | ||
Weighted Average Exercise Price, Granted | $ 0.57 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment | ||
Construction in progress | $ 2,028 | |
Property, plant and equipment, net | $ 16,751 | 13,418 |
Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 20,118 | 15,690 |
Less: accumulated depreciation | (3,367) | (2,272) |
Construction in progress | 2,028 | |
Leasehold improvements | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 17,088 | 13,070 |
Leasehold improvements useful life | Lesser of lease term or estimated useful life | |
Office furniture and equipment | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Office furniture and equipment | Minimum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 3 years | |
Office furniture and equipment | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 460 | 300 |
Computer and manufacturing equipment and software | Maximum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 5 years | |
Computer and manufacturing equipment and software | Minimum | ||
Property, Plant and Equipment | ||
Property, plant and equipment, useful life | 3 years | |
Computer and manufacturing equipment and software | Domestic | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 2,487 | 2,238 |
Land | U.K | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 83 | $ 82 |
Property, Plant and Equipment -
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment | ||
Depreciation | $ 1.1 | $ 0.9 |
Outstanding Debt (Details)
Outstanding Debt (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Outstanding Debt | ||
Face Value | $ 34,367 | $ 22,454 |
Remaining Debt Discount | (1,430) | (1,732) |
Embedded Redemption Option | 807 | |
Carrying Value | 32,937 | 21,529 |
Short term convertible notes payable | ||
Outstanding Debt | ||
Face Value | 3,967 | 135 |
Remaining Debt Discount | (516) | |
Carrying Value | $ 3,451 | $ 135 |
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 | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | |
Stated Interest Rate | 8% | |
Face Value | $ 3,332 | |
Remaining Debt Discount | (516) | |
Carrying Value | $ 2,816 | |
Short term convertible notes payable | 8% unsecured due 1/31/2024 | ||
Outstanding Debt | ||
Conversion price | $ 0.70 | |
Short term convertible notes payable | 8% unsecured due 6/30/2024 | ||
Outstanding Debt | ||
Conversion price | $ 0.40 | |
Short term convertible notes payable | 10% unsecured | ||
Outstanding Debt | ||
Maturity Date | 7/11/2024 | |
Stated Interest Rate | 10% | |
Conversion price | $ 0.50 | |
Face Value | $ 500 | |
Carrying Value | $ 500 | |
Short term convertible notes payable | Minimum | 8% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.50 | |
Short term convertible notes payable | Maximum | 8% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 0.70 | |
Short term convertible note at fair value | 11% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | |
Stated Interest Rate | 11% | |
Face Value | $ 10,250 | |
Carrying Value | $ 10,250 | |
Short term convertible note at fair value | Minimum | 11% unsecured | ||
Outstanding Debt | ||
Conversion price | $ 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 | $ 8,424 | 15,896 |
Remaining Debt Discount | (226) | (1,300) |
Embedded Redemption Option | 807 | |
Carrying Value | $ 8,198 | $ 15,403 |
Short term notes payable | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | Various |
Stated Interest Rate | 8% | 8% |
Face Value | $ 7,862 | $ 14,540 |
Remaining Debt Discount | (226) | (1,300) |
Embedded Redemption Option | 807 | |
Carrying Value | $ 7,636 | $ 14,047 |
Short term notes payable | 9% unsecured | ||
Outstanding Debt | ||
Maturity Date | Various | |
Stated Interest Rate | 9% | |
Face Value | $ 793 | |
Carrying Value | $ 793 | |
Short term notes payable | 12% unsecured | ||
Outstanding Debt | ||
Maturity Date | On Demand | On Demand |
Stated Interest Rate | 12% | 12% |
Face Value | $ 562 | $ 563 |
Carrying Value | 562 | 563 |
Long term notes payable | ||
Outstanding Debt | ||
Face Value | 11,726 | 6,423 |
Remaining Debt Discount | (688) | (432) |
Carrying Value | $ 11,038 | $ 5,991 |
Long term notes payable | 8% unsecured | ||
Outstanding Debt | ||
Maturity Date | 1/2/2025 | 7/26/2024 |
Stated Interest Rate | 8% | 8% |
Face Value | $ 11,005 | $ 5,505 |
Remaining Debt Discount | (688) | (432) |
Carrying Value | $ 10,317 | $ 5,073 |
Long term notes payable | 6% secured | ||
Outstanding Debt | ||
Maturity Date | 3/25/2025 | 3/25/2025 |
Stated Interest Rate | 6% | 6% |
Face Value | $ 721 | $ 918 |
Carrying Value | $ 721 | $ 918 |
Outstanding Debt - Additional I
Outstanding Debt - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Sep. 30, 2023 USD ($) item $ / shares | Jul. 11, 2023 USD ($) | Jun. 11, 2023 | Mar. 02, 2023 USD ($) installment | Apr. 30, 2023 USD ($) item $ / shares | Sep. 30, 2023 USD ($) item $ / shares shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) item $ / shares shares | Sep. 30, 2022 USD ($) | Jul. 31, 2023 USD ($) | Jun. 30, 2023 $ / shares | Dec. 31, 2022 USD ($) | |
Notes Payable | ||||||||||||
Debt discount | $ 1,430 | $ 1,430 | $ 1,430 | $ 1,732 | ||||||||
Conversion of share settled debt into common stock | 2,974 | 6,536 | ||||||||||
Share liabilities extinguished | 1,300 | |||||||||||
Additional share liability recognized | 500 | |||||||||||
Gain (loss) from debt extinguishment | 3,500 | |||||||||||
Change in fair value of embedded redemption option | 800 | 800 | 800 | |||||||||
Interest expense including amortization of debt discount | 1,700 | $ 500 | 4,000 | $ 4,800 | ||||||||
Amortization of debt discount | $ 600 | 2,000 | $ 2,100 | |||||||||
Principal amount | 34,367 | 34,367 | 34,367 | 22,454 | ||||||||
Amount reclassed from investor advances to convertible notes payable | 3,451 | 3,451 | 3,451 | 135 | ||||||||
Gain contingency | 4,600 | $ 4,600 | 4,600 | |||||||||
Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Cash payments | $ 900 | |||||||||||
Number of shares issued to lenders in lieu of cash payments | shares | (186,000) | (443,000) | ||||||||||
Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Debt discount | 516 | $ 516 | $ 516 | |||||||||
Principal amount | 3,967 | 3,967 | 3,967 | $ 135 | ||||||||
10% unsecured [Member] | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Principal amount | $ 500 | $ 500 | $ 500 | |||||||||
Interest rate (in percent) | 10% | 10% | 10% | |||||||||
Conversion price | $ / shares | $ 0.50 | $ 0.50 | $ 0.50 | |||||||||
8% unsecured [Member] | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Debt discount | $ 516 | $ 516 | $ 516 | |||||||||
Principal amount | $ 3,332 | $ 3,332 | $ 3,332 | |||||||||
Interest rate (in percent) | 8% | 8% | 8% | |||||||||
Period of which preferred stock can convert into common shares | 30 days | |||||||||||
8% unsecured due 1/31/2024 | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | $ 0.70 | $ 0.70 | $ 0.70 | |||||||||
8% unsecured due 6/30/2024 | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | 0.40 | 0.40 | 0.40 | |||||||||
Minimum | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | 0.153 | 0.153 | 0.153 | |||||||||
Minimum | 8% unsecured [Member] | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | 0.50 | 0.50 | 0.50 | |||||||||
Minimum | 8% unsecured [Member] | Short term convertible notes payable | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | 10 | 10 | 10 | |||||||||
Maximum | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | 0.85 | 0.85 | 0.85 | |||||||||
Maximum | 8% unsecured [Member] | Short term convertible notes payable | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | 0.70 | 0.70 | 0.70 | |||||||||
Maximum | 8% unsecured [Member] | Short term convertible notes payable | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | $ 17.50 | $ 17.50 | $ 17.50 | |||||||||
Notes | ||||||||||||
Notes Payable | ||||||||||||
Cash payments | $ 10,000 | $ 13,200 | ||||||||||
Number of shares issued to lenders in lieu of cash payments | shares | 27,600,000 | |||||||||||
Conversion of share settled debt into common stock | 500 | $ 17,500 | ||||||||||
Accrued interest expense on debt | $ 1,000 | |||||||||||
Amortization of debt discount | $ 700 | |||||||||||
Notes | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Number of shares issued to lenders in lieu of cash payments | shares | 56,000 | |||||||||||
Conversion of share settled debt into common stock | $ 1,000 | |||||||||||
Accrued interest expense on debt | 100 | |||||||||||
Gain (loss) from debt extinguishment | 100 | |||||||||||
Principal amount | $ 900 | $ 900 | $ 900 | |||||||||
Notes | Senior convertible notes | ||||||||||||
Notes Payable | ||||||||||||
Number of shares issued to lenders in lieu of cash payments | shares | 56,000 | |||||||||||
Conversion of share settled debt into common stock | $ 1,000 | |||||||||||
Interest rate (in percent) | 11% | 11% | 11% | |||||||||
Commercial Loan | ||||||||||||
Notes Payable | ||||||||||||
Term of debt instrument | 22 months | |||||||||||
Principal amount | $ 11,000 | |||||||||||
Interest rate (in percent) | 8% | |||||||||||
Term when no principal repayments was made | 8 months | |||||||||||
Number of installments for amortization | installment | 14 | |||||||||||
Original issue discount | $ 1,000 | |||||||||||
April convertible Notes | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | $ 0.55 | $ 0.55 | $ 0.55 | $ 2 | ||||||||
Additional term (in months) | 9 months | |||||||||||
Debt discount | $ 200 | $ 200 | $ 200 | |||||||||
Term of debt instrument | 10 months | |||||||||||
Principal amount | $ 900 | |||||||||||
Purchase price | $ 800 | |||||||||||
Interest rate (in percent) | 8% | |||||||||||
Amount reclassed from investor advances to convertible notes payable | $ 700 | |||||||||||
Cash proceeds | 100 | |||||||||||
April convertible Notes | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | $ 13.75 | |||||||||||
Period of which preferred stock can convert into common shares | 30 days | |||||||||||
Number of common stock shares issued upon conversion | item | 25 | |||||||||||
June Convertible Note | ||||||||||||
Notes Payable | ||||||||||||
Term of debt instrument | 1 year | |||||||||||
Principal amount | $ 1,000 | 1,000 | 1,000 | |||||||||
Purchase price | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||
Interest rate (in percent) | 8% | 8% | 8% | |||||||||
June Convertible Note | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | $ 12.50 | $ 12.50 | $ 12.50 | |||||||||
Period of which preferred stock can convert into common shares | 30 days | |||||||||||
Number of common stock shares issued upon conversion | item | 25 | |||||||||||
July Convertible Note | ||||||||||||
Notes Payable | ||||||||||||
Term of debt instrument | 1 year | |||||||||||
Principal amount | $ 500 | |||||||||||
August & September convertible notes | ||||||||||||
Notes Payable | ||||||||||||
Term of debt instrument | 1 year | |||||||||||
Principal amount | $ 10,300 | $ 10,300 | $ 10,300 | |||||||||
Period of which preferred stock can convert into common shares | 30 days | |||||||||||
Number of common stock shares issued upon conversion | item | 25 | |||||||||||
Interest Expense, Debt | $ 300 | |||||||||||
August & September convertible notes | Maximum | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
Conversion price | $ / shares | $ 12.25 | $ 12.25 | $ 12.25 | |||||||||
One year convertible notes | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | $ 2 | $ 2 | $ 2 | |||||||||
Additional term (in months) | 10 months | |||||||||||
Debt discount | $ 300 | $ 300 | $ 300 | |||||||||
Term of debt instrument | 1 year | |||||||||||
Principal amount | $ 1,400 | |||||||||||
Purchase price | $ 1,300 | $ 1,300 | $ 1,300 | |||||||||
Interest rate (in percent) | 8% | 8% | 8% | |||||||||
Amount reclassed from investor advances to convertible notes payable | $ 500 | $ 500 | $ 500 | |||||||||
Cash proceeds | $ 800 | |||||||||||
One year convertible notes | Series C convertible preferred stock | ||||||||||||
Notes Payable | ||||||||||||
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 | Minimum | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | $ 0.55 | $ 0.55 | $ 0.55 | |||||||||
Conversion price | $ / shares | 13.75 | 13.75 | 13.75 | |||||||||
One year convertible notes | Maximum | ||||||||||||
Notes Payable | ||||||||||||
Exercise price | $ / shares | 0.70 | 0.70 | 0.70 | |||||||||
Conversion price | $ / shares | $ 17.50 | $ 17.50 | $ 17.50 |
Net Loss per Share Applicable_3
Net Loss per Share Applicable to Common Stockholders (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 500,497 | 472,218 |
Series C convertible preferred stock | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 44,328 | 22,129 |
Common stock options | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 318,676 | 304,596 |
Common stock warrants | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 105,444 | 145,417 |
Convertible notes and accrued interest | ||
Net Loss per Share Applicable to Common Stockholders | ||
Potentially dilutive securities | 32,049 | 76 |
Related Party Transactions (Det
Related Party Transactions (Details) $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) Program Milestone item shares | Dec. 31, 2022 USD ($) | |
Related Party Transactions | ||
Percentage of margin | 15% | |
Additional term of agreement | 12 months | |
Amount paid in cash for milestones | $ 3.5 | |
Number of milestones completed | Milestone | 2 | |
Amount of payment for milestone completed and fully expensed but unpaid | $ 1 | |
Partial payment for milestone completed | $ 2.5 | |
Shares issued for completion of milestone | shares | 4.5 | |
Fair value on milestone payable | $ 3.2 | |
Stock-based compensation related to the achieved milestone | $ 0.6 | $ 2.6 |
Advent Bio services agreement | ||
Related Party Transactions | ||
Number of operational programs | Program | 3 | |
Number of sets of one-time milestones | Milestone | 10 | |
Number of required licenses for the Sawston facility | item | 3 |
Related Party Transactions - Re
Related Party Transactions - Research and development Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transactions | ||||
Total operating costs and expenses | $ 14,231 | $ 15,824 | $ 41,853 | $ 50,089 |
Advent BioServices | ||||
Related Party Transactions | ||||
Total operating costs and expenses | $ 3,865 | $ 5,594 | $ 12,399 | $ 20,276 |
Operating Cost and Expense, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember |
Advent BioServices | Manufacturing cost in London | ||||
Related Party Transactions | ||||
Related party costs, Manufacturing costs | $ 1,554 | $ 1,334 | $ 4,857 | $ 4,161 |
Advent BioServices | Manufacturing cost at Sawston facility | ||||
Related Party Transactions | ||||
Related party costs, Manufacturing costs | 2,247 | 1,404 | 6,057 | 4,105 |
Advent BioServices | Expensed and paid (milestone complete) | ||||
Related Party Transactions | ||||
Related party costs, SOW 6 one-time milestones - Shares | 9 | 195 | 578 | 2,120 |
Related party costs, SOW 6 one-time milestones - Cash | 551 | 1,500 | ||
Advent BioServices | Expensed and due, but unpaid (milestone complete) | ||||
Related Party Transactions | ||||
Related party costs, SOW 6 one-time milestones - Cash | 18 | 226 | 111 | 500 |
Advent BioServices | Expensed but unpaid, not yet due (milestone not yet complete) | ||||
Related Party Transactions | ||||
Related party costs, SOW 6 one-time milestones - Shares | 24 | 1,205 | 115 | 4,620 |
Related party costs, SOW 6 one-time milestones - Cash | $ 13 | $ 1,230 | $ 130 | $ 3,270 |
Related Party Transactions - Ad
Related Party Transactions - Advent BioServices Sublease Agreement (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) ft² item | Sep. 30, 2023 GBP (£) ft² item | Sep. 30, 2023 USD ($) ft² item | Sep. 30, 2022 USD ($) | |
Related Party Transactions | ||||
Total area of lease (in sqft) | ft² | 88,000 | 88,000 | 88,000 | |
Lease payments | $ 691,000 | $ 689,000 | ||
Sub-lease income | $ 36,000 | $ 108,000 | $ 110,000 | |
Advent BioServices | ||||
Related Party Transactions | ||||
Area of sublease (in sqft) | item | 14,459 | 14,459 | 14,459 | |
Total area of lease (in sqft) | ft² | 88,000 | 88,000 | 88,000 | |
Number of times calculated for lease payment under sub-lease | item | 2 | 2 | ||
Rate per square foot under sub-lease | £ 5.75 | $ 7.02 | ||
Cap rate per square foot under sub-lease | 10 | |||
Sub-lease payments receivable | 145,000 | |||
Lease payments | £ | £ 500,000 | |||
Approximate lease payments | $ 610,000 |
Related Party Transactions - _2
Related Party Transactions - Related Party Accounts Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounts payable to related party | ||
Related Party Transactions | ||
Unpaid board compensation | $ 200 | |
Advent BioServices - amount invoiced | ||
Related Party Transactions | ||
Invoiced but unpaid | 2,451 | $ 1,844 |
Advent BioServices - amount invoiced but unpaid | ||
Related Party Transactions | ||
Accrued and unpaid | 2,027 | 4,736 |
Advent BioServices | ||
Related Party Transactions | ||
Accounts payable and accrued expenses | $ 4,478 | $ 6,580 |
Accounts Payable, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember |
Preferred Stock (Details)
Preferred Stock (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jul. 11, 2023 USD ($) | Nov. 06, 2023 shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 shares | Dec. 31, 2022 USD ($) | |
Preferred Stock | |||||||
Conversion of share settled debt into common stock | $ 2,974,000 | $ 6,536,000 | |||||
Principal amount | $ 34,367,000 | 34,367,000 | $ 22,454,000 | ||||
Gain (loss) from debt extinguishment | $ 3,500,000 | ||||||
Notes | |||||||
Preferred Stock | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 27,600,000 | ||||||
Conversion of share settled debt into common stock | $ 500,000 | $ 17,500,000 | |||||
Accrued interest expense on debt | $ 1,000,000 | ||||||
Notes | Senior convertible notes | |||||||
Preferred Stock | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 56,000 | ||||||
Conversion of share settled debt into common stock | $ 1,000,000 | ||||||
Common Stock | |||||||
Preferred Stock | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 4,651,000 | 11,081,000 | |||||
Conversion of share settled debt into common stock | $ 4,000 | $ 11,000 | |||||
Common Stock | Notes | |||||||
Preferred Stock | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 27,600,000 | ||||||
Conversion of share settled debt into common stock | $ 17,500,000 | ||||||
Accrued interest expense on debt | $ 1,000,000 | ||||||
Series C Subscription Agreements | Series C Investors | |||||||
Preferred Stock | |||||||
Temporary equity, par value | $ / shares | $ 0.001 | $ 0.001 | |||||
Series C Convertible Preferred Stock | |||||||
Preferred Stock | |||||||
Issuance of stock for cash (in shares) | shares | 405,000 | 704,000 | 729,000 | 704,000 | |||
Number of shares issued to lenders in lieu of cash payments | shares | (186,000) | (443,000) | |||||
Series C Convertible Preferred Stock | Notes | |||||||
Preferred Stock | |||||||
Number of shares issued to lenders in lieu of cash payments | shares | 56,000 | ||||||
Conversion of share settled debt into common stock | $ 1,000,000 | ||||||
Principal amount | $ 900,000 | 900,000 | |||||
Accrued interest expense on debt | 100,000 | ||||||
Gain (loss) from debt extinguishment | $ 100,000 | ||||||
Series C Convertible Preferred Stock | Common Stock | |||||||
Preferred Stock | |||||||
Number of shares converted | shares | 200,000 | 400,000 | |||||
Value of shares converted | $ 6,500,000 | ||||||
Number of shares issued on conversion | shares | 11,100,000 | 11,100,000 | |||||
Conversion ratio from preferred stock to common stock | 0.04 | 0.04 | |||||
Series C Convertible Preferred Stock | Series C Subscription Agreements | Series C Investors | |||||||
Preferred Stock | |||||||
Issuance of stock for cash (in shares) | shares | 700,000 | ||||||
Purchase price | $ / shares | $ 13.58 | $ 13.58 | |||||
Gross proceeds from issuance of shares | $ 9,900,000 | ||||||
Price per share | $ / shares | $ 13.58 | $ 13.58 |
Stockholders' Deficit - Stock P
Stockholders' Deficit - Stock Purchase Warrants (Details) - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stockholders' Deficit | ||
Number of Warrants, Outstanding | 141,048 | |
Number of Warrants, Warrants exercised for cash | (12,447) | |
Number of Warrants, Cashless warrants exercise | (22,907) | |
Number of Warrants, Warrants expired and cancellations | (250) | |
Number of Warrants, Outstanding | 105,444 | 141,048 |
Weighted Average Exercise Price - Outstanding | $ 0.31 | |
Weighted Average Exercise Price - Warrants exercised for cash | 0.22 | |
Weighted Average Exercise Price, Cashless warrants exercise | 0.20 | |
Weighted Average Exercise Price, Warrants expired and cancellations | 1.36 | |
Weighted Average Exercise Price - Outstanding | $ 0.32 | $ 0.31 |
Remaining Contractual Term | 1 year 11 months 1 day | 1 year 1 month 28 days |
Stockholders' Deficit - Warrant
Stockholders' Deficit - Warrant Modifications (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based Compensation | ||
Exercise price | $ 0.51 | $ 0.65 |
Expected term (years) | 6 years 4 months 24 days | 3 years 10 months 24 days |
Volatility | 84% | 99% |
Risk-free rate | 4.50% | 3.30% |
Dividend yield | 0% | 0% |
Post Modification | Warrants | ||
Stock-based Compensation | ||
Exercise price | $ 0.30 | |
Expected term (years) | 1 year 9 months 18 days | |
Volatility | 73% | |
Risk-free rate | 4.90% | |
Dividend yield | 0% | |
Pre Modification | Warrants | ||
Stock-based Compensation | ||
Exercise price | $ 0.31 | |
Expected term (years) | 1 year 6 months | |
Volatility | 90% | |
Risk-free rate | 4.90% | |
Dividend yield | 0% |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jul. 11, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Jan. 09, 2023 | Jan. 08, 2023 | |
Stockholders' Deficit | ||||||
Common stock, shares authorized | 1,700,000,000 | 1,700,000,000 | 1,700,000,000 | 1,700,000,000 | 1,200,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||
Proceeds from exercise of outstanding warrants | $ 2,800 | |||||
Proceeds from investor advances for exercise of warrants | $ 1,200 | |||||
Stock issued on exercise of warrants | 12,400,000 | |||||
Conversion of share settled debt into common stock | $ 2,974 | $ 6,536 | ||||
Number of options exercised in cashless | 2,500,000 | |||||
Number of warrants, cashless warrants exercise | 22,907,000 | |||||
Settled true-up provision | $ 1,300 | |||||
Number of warrants outstanding | 105,444,000 | 105,444,000 | 141,048,000 | |||
Class of warrant or right, extended in suspension | 100,000,000 | |||||
Modification cost associated with debt financing | $ 800 | |||||
Deemed dividend related to warrant modification | $ 519 | 1,433 | ||||
Pre Modification | ||||||
Stockholders' Deficit | ||||||
Incremental stock-based compensation for stock options modification | 2,200 | |||||
Notes | ||||||
Stockholders' Deficit | ||||||
Cash payments | $ 10,000 | 13,200 | ||||
Conversion of share settled debt into common stock | $ 500 | 17,500 | ||||
Accrued interest expense on debt | $ 1,000 | |||||
Number of shares issued to lenders in lieu of cash payments | 27,600,000 | |||||
Warrants issued as consideration for warrants suspension | ||||||
Stockholders' Deficit | ||||||
Number of warrants outstanding | 105,000,000 | 105,000,000 | ||||
Cashless Warrants Exercise | ||||||
Stockholders' Deficit | ||||||
Number of warrants, cashless warrants exercise | 22,900,000 | |||||
Common Stock | ||||||
Stockholders' Deficit | ||||||
Shares of common stock issued on exercise of warrants and options | 20,400,000 | |||||
Conversion of share settled debt into common stock | $ 4 | $ 11 | ||||
Number of shares issued to lenders in lieu of cash payments | 4,651,000 | 11,081,000 | ||||
Common Stock | Notes | ||||||
Stockholders' Deficit | ||||||
Cash payments | $ 13,200 | |||||
Conversion of share settled debt into common stock | 17,500 | |||||
Accrued interest expense on debt | $ 1,000 | |||||
Number of shares issued to lenders in lieu of cash payments | 27,600,000 | |||||
Settled true-up provision | $ 1,300 | |||||
Minimum | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | $ 0.153 | $ 0.153 | ||||
Minimum | Equity Option | Cashless Warrants Exercise | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | 0.25 | 0.25 | ||||
Minimum | Common Stock | Equity Option | Cashless Warrants Exercise | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | 0.17 | 0.17 | ||||
Maximum | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | 0.85 | 0.85 | ||||
Maximum | Common Stock | Cashless Warrants Exercise | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | 0.55 | 0.55 | ||||
Maximum | Common Stock | Equity Option | Cashless Warrants Exercise | ||||||
Stockholders' Deficit | ||||||
Warrants exercise price | $ 0.22 | $ 0.22 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease cost | |||
Operating lease cost | $ 633,000 | $ 643,000 | |
Short-term lease cost | 62,000 | 56,000 | |
Variable lease cost | 10,000 | 9,000 | |
Sub-lease income | $ (36,000) | (108,000) | (110,000) |
Total | 597,000 | 598,000 | |
Other information | |||
Operating cash flows from operating leases | (691,000) | (689,000) | |
U.K | |||
Lease cost | |||
Operating lease cost | 443,000 | 448,000 | |
Short-term lease cost | 62,000 | 56,000 | |
Sub-lease income | (108,000) | (110,000) | |
Total | 397,000 | 394,000 | |
Other information | |||
Operating cash flows from operating leases | $ (467,000) | $ (472,000) | |
Weighted-average remaining lease term - operating leases | 8 years 1 month 6 days | 8 years 1 month 6 days | 8 years 7 months 6 days |
Weighted-average discount rate - operating leases | 12% | 12% | 12% |
U.S | |||
Lease cost | |||
Operating lease cost | $ 190,000 | $ 195,000 | |
Variable lease cost | 10,000 | 9,000 | |
Total | 200,000 | 204,000 | |
Other information | |||
Operating cash flows from operating leases | $ (224,000) | $ (217,000) | |
Weighted-average remaining lease term - operating leases | 8 months 12 days | 8 months 12 days | 1 year 4 months 24 days |
Weighted-average discount rate - operating leases | 12% | 12% | 12% |
Commitments and Contingencies -
Commitments and Contingencies - Maturities of our operating leases (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Commitments and Contingencies | |
Three months ended December 31, 2023 | $ 228 |
Year ended December 31, 2024 | 815 |
Year ended December 31, 2025 | 610 |
Year ended December 31, 2026 | 610 |
Year ended December 31, 2027 | 610 |
Thereafter | 6,692 |
Total | 9,565 |
Less present value discount | (5,062) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2023 | 4,503 |
Sublease agreement | |
Commitments and Contingencies | |
Three months ended December 31, 2023 | 36 |
Year ended December 31, 2024 | 145 |
Year ended December 31, 2025 | 145 |
Year ended December 31, 2026 | 145 |
Thereafter | 1,740 |
Total | $ 2,211 |
Commitments and Contingencies_3
Commitments and Contingencies - Additional Information (Details) £ in Millions | 6 Months Ended | 9 Months Ended | ||||||||||||
Oct. 12, 2023 USD ($) | Oct. 12, 2023 EUR (€) | Jul. 27, 2022 USD ($) | Jul. 27, 2022 EUR (€) | Nov. 04, 2021 USD ($) | Nov. 04, 2021 EUR (€) | May 14, 2018 USD ($) | May 14, 2018 GBP (£) | Jun. 30, 2022 USD ($) | Jun. 30, 2022 EUR (€) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 EUR (€) | Sep. 30, 2023 EUR (€) | Dec. 31, 2022 USD ($) | |
Commitments and Contingencies | ||||||||||||||
Operating lease liabilities | $ 4,503,000 | |||||||||||||
Lease, practical expedient, lessor single lease component [true false] | true | true | ||||||||||||
Operating lease, term of contract | 20 years | 20 years | ||||||||||||
ROU asset | $ 4,014,000 | $ 4,189,000 | ||||||||||||
Litigation settlement waiver of penalty | $ 143,000 | € 135,000 | ||||||||||||
Loss contingency accrual | 399,000 | € 377,000 | ||||||||||||
Gain contingency | 4,600,000 | |||||||||||||
Subsequent event | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Loss contingency accrual payment | $ 200,000 | € 189,000 | ||||||||||||
Loss contingency accrual payment (in percent) | 50% | 50% | ||||||||||||
Advent Bio services agreement | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Term of agreement | 12 months | 12 months | ||||||||||||
Advent Bio services agreement | Minimum | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Minimum required payments for this notice period | $ 5,500,000 | £ 4.5 | ||||||||||||
German tax authority | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Settlement expense | 293,000 | € 277,000 | ||||||||||||
Received tax bills | $ 235,000 | € 222,000 | ||||||||||||
State and local jurisdiction | ||||||||||||||
Commitments and Contingencies | ||||||||||||||
Settlement expense | $ 244,000 | € 231,000 | ||||||||||||
Additional late fees | $ 542,000 | € 513,000 |
Subsequent Events (Details)
Subsequent Events (Details) | 1 Months Ended | 9 Months Ended | ||||||||
Nov. 06, 2023 USD ($) shares | Oct. 20, 2023 USD ($) | Oct. 04, 2023 USD ($) $ / shares | Jun. 11, 2023 | Nov. 06, 2023 USD ($) shares | Oct. 31, 2023 USD ($) shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 shares | Jul. 11, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Subsequent Events | ||||||||||
Principal amount | $ 34,367,000 | $ 22,454,000 | ||||||||
Amount of funding received from contingent obligation | $ 4,550,000 | |||||||||
Number of options exercised in cashless | shares | 2,500,000 | |||||||||
July Convertible Note | ||||||||||
Subsequent Events | ||||||||||
Term of debt (in years) | 1 year | |||||||||
Principal amount | $ 500,000 | |||||||||
Common Stock | ||||||||||
Subsequent Events | ||||||||||
Number of shares issued during the period | shares | 13,147,000 | |||||||||
Series C convertible preferred stock | Common Stock | ||||||||||
Subsequent Events | ||||||||||
Number of shares converted | shares | 200,000 | 400,000 | ||||||||
Value of shares converted | $ 6,500,000 | |||||||||
Number of shares issued on conversion | shares | 11,100,000 | |||||||||
Conversion ratio from preferred stock to common stock | 0.04 | |||||||||
Subsequent event | ||||||||||
Subsequent Events | ||||||||||
Amount of funding from the sale of shares and proceeds of debt arrangements and contingent liability obligations | $ 1,900,000 | |||||||||
Proceeds received from exercise of outstanding warrants and options | $ 100,000 | $ 100,000 | ||||||||
Number of outstanding warrants and options exercised | shares | 200,000 | 200,000 | ||||||||
Amount of settlement of share receivable | $ 700,000 | |||||||||
Number of options exercised in cashless | shares | 800,000 | |||||||||
Subsequent event | July Convertible Note | ||||||||||
Subsequent Events | ||||||||||
Term of debt (in years) | 1 year | |||||||||
Principal amount | $ 154,000,000 | |||||||||
Interest rate (in percent) | 8% | |||||||||
Subsequent event | Convertible Note | ||||||||||
Subsequent Events | ||||||||||
Term of debt (in years) | 1 year | |||||||||
Purchase price | $ 140,000 | |||||||||
Additional maturity period of warrants (in months) | 8 months 15 days | |||||||||
Amount received from issuance | $ 500,000 | |||||||||
Subsequent event | Common Stock | ||||||||||
Subsequent Events | ||||||||||
Number of common stock issued | shares | 600,000 | |||||||||
Subsequent event | Common Stock | Lieu | ||||||||||
Subsequent Events | ||||||||||
Number of shares issued during the period | shares | 1,900,000 | |||||||||
Cash payments | $ 1,600,000 | |||||||||
Subsequent event | Series C convertible preferred stock | ||||||||||
Subsequent Events | ||||||||||
Preferred stock, shares issued | shares | 80,000 | 80,000 | ||||||||
Proceeds for preferred stock | $ 1,200,000 | |||||||||
Value of shares converted | $ 3,600,000 | |||||||||
Number of shares issued on conversion | shares | 6,100,000 | 6,100,000 | ||||||||
Subsequent event | Series C convertible preferred stock | July Convertible Note | ||||||||||
Subsequent Events | ||||||||||
Conversion price | $ / shares | $ 17.50 | |||||||||
Subsequent event | Series C convertible preferred stock | Common Stock | ||||||||||
Subsequent Events | ||||||||||
Conversion ratio from preferred stock to common stock | 25 | 25 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (18,580) | $ (32,852) | $ (43,680) | $ (76,734) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
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 |