Quarterly Report (10-q)

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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


	☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022


	☐	TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______to _______

Commission File Number: 001-35737

NORTHWEST BIOTHERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware	94-3306718
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)

4800 Montgomery Lane, Suite 800, Bethesda, MD 20814

(Address of principal executive offices) (Zip Code)

(240) 497-9024

(Registrant’s telephone number)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
		Emerging growth company	☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	NWBO	OTCQB

As of November 8, 2022, the total number of shares of common stock, par value $0.001 per share, outstanding was 1,052,853,970.

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

FORM 10-Q

TABLE OF CONTENTS


PART I - FINANCIAL INFORMATION		3

Item 1.	Condensed Consolidated Interim Financial Statements (Unaudited)

	Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021	3

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021	4

	Condensed Consolidated Statements of Stockholders’ Deficit for the three and nine months ended September 30, 2022 and 2021	5

	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021	7

	Notes to Condensed Consolidated Financial Statements	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	29

PART II - OTHER INFORMATION		30

Item 1.	Legal Proceedings	30

Item 1A.	Risk Factors	30

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30

Item 3.	Defaults Upon Senior Securities	30

Item 4.	Mine Safety Disclosures	30

Item 5.	Other Information	30

Item 6.	Exhibits	31

SIGNATURES		32

Table of Contents

PART I - FINANCIAL INFORMATION

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)


	September 30,		December 31,
	2022		2021
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	9,425	$	15,169
Prepaid expenses and other current assets		2,339		2,121
Total current assets		11,764		17,290

Non-current assets:
Property, plant and equipment, net		13,126		15,027
Right-of-use asset, net		3,951		4,889
Indefinite-lived intangible asset		1,292		1,292
Goodwill		626		626
Other assets		339		1,036
Total non-current assets		19,334		22,870

TOTAL ASSETS	$	31,098	$	40,160

LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable and accrued expenses	$	8,237	$	6,976
Accounts payable and accrued expenses to related parties and affiliates		5,728		3,971
Convertible notes, net		135		135
Notes payable, net		20,032		7,104
Contingent payable derivative liability		8,012		8,232
Warrant liability		73,650		106,784
Lease liabilities		334		317
Shares payable		—		250
Total current liabilities		116,128		133,769

Non-current liabilities:
Notes payable, net of current portion, net		5,942		25,156
Lease liabilities, net of current portion		4,132		5,226
Total non-current liabilities		10,074		30,382

Total liabilities		126,202		164,151

COMMITMENTS AND CONTINGENCIES (Note 11)

MEZZANINE EQUITY
Series C Convertible Preferred Stock, 10,000,000 shares designated; 885,155 and 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively; aggregate liquidation preference of $13.2 million		13,746		—

Stockholders’ deficit:
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively		—		—
Common stock ($0.001 par value); 1,200,000,000 shares authorized; 1,051.3 million and 948.4 million shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively		1,051		948
Additional paid-in capital		1,152,689		1,066,873
Stock subscription receivable		(79)		(79)
Accumulated deficit		(1,268,824)		(1,192,090)
Accumulated other comprehensive income		6,313		357
Total stockholders’ deficit		(108,850)		(123,991)

TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT	$	31,098	$	40,160

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share amounts)

(Unaudited)


	For the three months ended				For the nine months ended
	September 30,				September 30,
	2022		2021		2022		2021
Revenues:
Research and other	$	206	$	350	$	1,086	$	1,005
Total revenues		206		350		1,086		1,005
Operating costs and expenses:
Research and development		7,694		3,748		26,159		16,122
General and administrative		8,130		6,651		23,930		26,909
Total operating costs and expenses		15,824		10,399		50,089		43,031
Loss from operations		(15,618)		(10,049)		(49,003)		(42,026)
Other (expense) income:
Change in fair value of derivative liabilities		(12,169)		58,473		(15,883)		93,536
Loss from extinguishment of debt		(456)		—		(156)		(144)
Interest expense		(1,512)		(1,604)		(4,847)		(3,858)
Inducement expense		—		(314)		—		(314)
Foreign currency transaction loss		(3,097)		(987)		(6,845)		(1,388)
Total other (loss) income		(17,234)		55,568		(27,731)		87,832
Net (loss) income	$	(32,852)	$	45,519	$	(76,734)	$	45,806

Other comprehensive (loss) income
Foreign currency translation adjustment		2,773		836		5,956		1,186
Total comprehensive (loss) income	$	(30,079)	$	46,355	$	(70,778)	$	46,992

Net (loss) earnings per share applicable to common stockholders
Basic	$	(0.03)	$	0.05	$	(0.08)	$	0.05
Diluted	$	(0.03)	$	(0.01)	$	(0.08)	$	(0.04)

Weighted average shares used in computing basic (loss) earnings per share		1,040,982		875,963		1,001,703		854,276
Weighted average shares used in computing diluted (loss) earnings per share		1,040,982		1,135,762		1,001,703		1,099,598

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)


	For the Three Months Ended September 30, 2022
													Accumulated
	Series C Covertible						Additional						Other		Total
	Preferred Stock			Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Shares	Par value		Capital		Receivable		Deficit		Income		Deficit
Balances at July 1, 2022	—	$	—	1,034,475	$	1,034	$	1,139,811	$	(79)	$	(1,235,972)	$	3,540	$	(91,666)
Issuance of Series C convertible preferred stock for cash	704		10,904	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock in lieu of debt redemption	126		1,978	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock by common stock warrant exercise	55		329	—		—		—		—		—		—		—
Warrants exercised for cash	—		—	1,926		2		428		—		—		—		430
Reclassification of warrant liabilities related to warrants exercised for cash	—		535	—		—		2,402		—		—		—		2,402
Cashless warrants and stock options exercised	—		—	5,321		5		(5)		—		—		—		—
Reclassification of warrant liabilities related to cashless warrants exercise	—		—	—		—		1,421		—		—		—		1,421
Issuance of common stock for conversion of debt and accrued interest	—		—	6,892		7		5,274		—		—		—		5,281

Stock-based compensation	—		—	2,636		3		3,358		—		—		—		3,361
Fractional shares adjustment	—		—	10		—		—		—		—		—		—
Net loss	—		—	—		—		—		—		(32,852)		—		(32,852)
Cumulative translation adjustment	—		—	—		—		—		—		—		2,773		2,773
Balances at September 30, 2022	885	$	13,746	1,051,260	$	1,051	$	1,152,689	$	(79)	$	(1,268,824)	$	6,313	$	(108,850)


	For the Three Months Ended September 30, 2021
										Accumulated
				Additional						Other		Total
	Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Par value		Capital		Receivable		Deficit		Income (Loss)		Deficit
Balance at July 1, 2021	857,230	$	857	$	1,021,107	$	(79)	$	(1,370,929)	$	(798)	$	(349,842)
Warrants exercised for cash	34,142		34		8,001		—		—		—		8,035
Reclassification of warrant liabilities related to warrants exercised for cash	—		—		23,018		—		—		—		23,018
Cashless warrants and stock options exercise	488		1		(1)		—		—		—		—
Reclassification of warrant liabilities related to cashless warrants exercise	—		—		4		—		—		—		4
Stock-based compensation	—		—		1,263		—		—		—		1,263
Reclassification of warrant liabilities based on authorized shares	—		—		(30,566)		—		—		—		(30,566)
Net income	—		—		—		—		45,519		—		45,519
Cumulative translation adjustment	—		—		—		—		—		836		836
Balance at September 30, 2021	891,860	$	892	$	1,022,826	$	(79)	$	(1,325,410)	$	38	$	(301,733)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

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NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)


	For the Nine Months Ended September 30, 2022
													Accumulated
	Series C Covertible						Additional						Other		Total
	Preferred Stock			Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Shares	Par value		Capital		Receivable		Deficit		Income		Deficit
Balances at January 1, 2022	—	$	—	948,445	$	948	$	1,066,873	$	(79)	$	(1,192,090)	$	357	$	(123,991)
Issuance of Series C convertible preferred stock for cash	704		10,904	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock in lieu of debt redemption	126		1,978	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock by common stock warrant exercise	55		329	—		—		—		—		—		—		—
Issuance of common stock for cash	—		—	13,147		13		9,676		—		—		—		9,689
Warrants exercised for cash	—		—	40,929		41		9,945		—		—		—		9,986
Reclassification of warrant liabilities related to warrants exercised for cash	—		535	—		—		22,090		—		—		—		22,090
Cashless warrants and stock options exercise	—		—	34,224		34		(34)		—		—		—		—
Reclassification of warrant liabilities related to cashless warrants exercise	—		—	—		—		26,800		—		—		—		26,800
Issuance of common stock for conversion of debt and accrued interest	—		—	10,374		11		7,602		—		—		—		7,613
Stock-based compensation	—		—	4,141		4		9,737		—		—		—		9,741
Net loss	—		—	—		—		—		—		(76,734)		—		(76,734)
Cumulative translation adjustment	—		—	—		—		—		—		—		5,956		5,956
Balances at September 30, 2022	885	$	13,746	1,051,260	$	1,051	$	1,152,689	$	(79)	$	(1,268,824)	$	6,313	$	(108,850)


	For the Nine Months Ended September 30, 2021
										Accumulated
				Additional						Other		Total
	Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Par value		Capital		Receivable		Deficit		Income (Loss)		Deficit
Balance at January 1, 2021	829,631	$	830	$	1,008,665	$	(79)	$	(1,371,216)	$	(1,148)	$	(362,948)
Issuance of common stock for cash	69		—		16		—		—		—		16
Issuance of common stock and warrants for conversion of debt and accrued interest	5,145		5		7,495		—		—		—		7,500
Warrants and stock options exercised for cash	50,340		50		12,058		—		—		—		12,108
Reclassification of warrant liabilities related to warrants exercised for cash	—		—		34,412		—		—		—		34,412
Cashless warrants and stock options exercise	6,627		7		(7)		—		—		—		—
Reclassification of warrant liabilities related to cashless warrants exercise	—		—		1,596		—		—		—		1,596
Stock-based compensation	48		—		14,705		—		—		—		14,705
Reclassification of warrant liabilities based on authorized shares	—		—		(56,114)		—		—		—		(56,114)
Net income	—		—		—		—		45,806		—		45,806
Cumulative translation adjustment	—		—		—		—		—		1,186		1,186
Balance at September 30, 2021	891,860	$	892	$	1,022,826	$	(79)	$	(1,325,410)	$	38	$	(301,733)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)


	For the nine months ended
	September 30,
	2022		2021
Cash Flows from Operating Activities:
Net (loss) income	$	(76,734)	$	45,806
Reconciliation of net (loss) income to net cash used in operating activities:
Depreciation and amortization		934		240
Amortization of debt discount		2,111		1,721
Change in fair value of derivatives		15,883		(93,536)
Loss from extinguishment of debt		156		144
Inducement expense		—		314
Amortization of operating lease right-of-use asset		184		206
Stock-based compensation		9,741		14,632
Subtotal of non-cash charges		29,009		(76,279)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(310)		3,113
Other non-current assets		633		(198)
Accounts payable and accrued expenses		1,251		2,351
Related party accounts payable and accrued expenses		2,127		(1,845)
Lease liabilities		98		(1)
Net cash used in operating activities		(43,926)		(27,053)
Cash Flows from Investing Activities:
Purchase of equipment and construction in progress		(742)		(4,462)
Net cash used in investing activities		(742)		(4,462)
Cash Flows from Financing Activities:
Proceeds from issuance of Series C convertible preferred stock		10,904		—
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, net		9,465		16
Proceeds from exercise of warrants and stock options		9,986		12,108
Proceeds from issuance of notes payable, net		5,600		13,574
Investor advances		—		767
Repayment of notes payable		(5,390)		(2,003)
Net cash provided by financing activities		30,617		24,462
Effect of exchange rate changes on cash and cash equivalents		8,307		906
Net decrease in cash and cash equivalents		(5,744)		(6,147)

Cash and cash equivalents, beginning of the period		15,169		9,983
Cash and cash equivalents, end of the period	$	9,425	$	3,836

Supplemental disclosure of cash flow information
Interest payments on notes payable	$	(912)	$	(506)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)


	For the nine months ended
	September 30,
	2022		2021
Supplemental schedule of non-cash investing and financing activities:
Cashless warrants and stock options exercise	$	34	$	7
Reclassification of warrant liabilities related to warrants exercised for cash	$	22,625	$	34,412
Reclassification of warrant liabilities related to cashless warrants exercise	$	26,800	$	1,596
Reclassification of warrant liabilities based on authorized shares	$	—	$	56,114
Issuance of common stock and warrants for conversion of debt and accrued interest	$	7,054	$	7,487
Issuance of Series C convertible preferred stock in lieu of debt redemption	$	1,978	$	—
Exercise common stock warrants by debt redemption	$	277	$	—
Reclassification between shares payable and equity	$	250	$	—
Capital expenditures included in accounts payable	$	4	$	327
Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates	$	—	$	559
Issuance of common shares to settle accrued service liability	$	—	$	73

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

1. Organization and Description of Business

Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks L.L.C., NW Bio GmbH, Aracaris Ltd, Aracaris Capital, Ltd, and Northwest Biotherapeutics B.V. (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company is headquartered in Bethesda, Maryland and has wholly owned subsidiaries in the U.K., in the Netherlands, and in Boston, Massachusetts.

The Company relies upon contract manufacturers for production of its DCVax products, research and development services, distribution and logistics, and related services, in compliance with the Company’s specifications and the applicable regulatory requirements.

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 $76.7 million for the nine months ended September 30, 2022. The Company used approximately $43.9 million of cash in its operating activities during the nine months ended September 30, 2022.

The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all.

Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date of this filing. The condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.

3. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2022, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2022 and 2021, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021 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, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or for any future interim period. The condensed consolidated balance sheet at December 31, 2021 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, 2021 and notes thereto included in the Company’s annual report on Form 10-K (the “2021 Annual Report”), which was filed with the SEC on March 1, 2022.

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 to those previously disclosed in the 2021 Annual Report.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Recently Adopted Accounting Standards

Modifications or Exchanges of Freestanding Equity-Classified Written Call Options

In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. This ASU will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. On January 1, 2022, the Company adopted this standard without any material impact on the Company’s condensed consolidated financial statements or disclosures.

Recent 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 condensed consolidated financial statements.

4. Fair Value Measurements

In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the outstanding warrants and certain embedded conversion feature associated with convertible debt on a recurring basis to determine the fair value of the liability. ASC 820 also establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below:

Level 1 - Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date

Level 2 - Quoted prices in markets that are not active or inputs which are either directly or indirectly observable

Level 3 - Unobservable inputs for the instrument requiring the development of assumptions by the Company

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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, 2022 and December 31, 2021 (in thousands):


	Fair value measured at September 30, 2022
			Quoted prices in active		Significant other		Significant
	Fair value at		markets		observable inputs		unobservable inputs
	September 30, 2022		(Level 1)		(Level 2)		(Level 3)
Warrant liability	$	73,650	$	—	$	—	$	73,650
Embedded redemption option		922		—		—		922
Contingent payable derivative liability		8,012		—		—		8,012
Total fair value	$	82,584	$	—	$	—	$	82,584


	Fair value measured at December 31, 2021
			Quoted prices in active		Significant other		Significant
	Fair value at		markets		observable inputs		unobservable inputs
	December 31, 2021		(Level 1)		(Level 2)		(Level 3)
Warrant liability	$	106,784	$	—	$	—	$	106,784
Embedded redemption option		988		—		—		988
Contingent payable derivative liability </

Boards:

Quotes:

NWBO