Northwest Biotherapeutics 10Q 2024 Q3 Quarterly report

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, 2024


	☐	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, 2024, the total number of shares of common stock, par value $0.001 per share, outstanding was 1,297,445,623.

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, 2024 and December 31, 2023	3

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023	4

	Condensed Consolidated Statements of Stockholders’ Deficit for the three and nine months ended September 30, 2024 and 2023	5

	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	7

	Notes to Condensed Consolidated Financial Statements	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33

Item 4.	Controls and Procedures	34

PART II - OTHER INFORMATION		35

Item 1.	Legal Proceedings	35

Item 1A.	Risk Factors	36

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36

Item 3.	Defaults Upon Senior Securities	36

Item 4.	Mine Safety Disclosures	36

Item 5.	Other Information	36

Item 6.	Exhibits	37

SIGNATURES		38

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,
	2024		2023
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	2,939	$	2,126
Prepaid expenses and other current assets		2,253		1,999
Total current assets		5,192		4,125
Non-current assets:
Property, plant and equipment, net		17,322		17,278
Right-of-use asset, net		4,515		4,183
Indefinite-lived intangible asset		1,292		1,292
Goodwill		626		626
Other assets		374		361
Total non-current assets		24,129		23,740
TOTAL ASSETS	$	29,321	$	27,865

LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable and accrued expenses	$	17,913	$	10,244
Accounts payable and accrued expenses to related parties and affiliates		3,043		3,544
Convertible notes, net		1,825		3,765
Convertible notes at fair value		19,380		12,771
Notes payable, net		7,577		3,944
Contingent payable derivative liability		9,193		9,188
Warrant liability		—		944
Investor advances		207		7
Share payable		170		483
Lease liabilities		256		314
Total current liabilities		59,564		45,204

Non-current liabilities:
Convertible notes at fair value, net of current portion		3,774		—
Notes payable, net of current portion, net		20,695		20,312
Lease liabilities, net of current portion		4,828		4,454
Contingent payment obligation		4,700		4,950
Total non-current liabilities		33,997		29,716
Total liabilities		93,561		74,920

COMMITMENTS AND CONTINGENCIES (Note 12)

Mezzanine equity:
Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.0 million and 1.2 million shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $14.2 million		15,877		18,718
Stockholders’ deficit:
Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively		—		—
Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,286.3 million and 1,175.5 million shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively		1,286		1,175
Additional paid-in capital		1,333,981		1,291,316
Stock subscription receivable		(79)		(79)
Accumulated deficit		(1,415,276)		(1,359,721)
Accumulated other comprehensive (loss) income		(29)		1,536
Total stockholders’ deficit		(80,117)		(65,773)
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT	$	29,321	$	27,865

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 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,
	2024		2023		2024		2023
Revenues:
Research and other	$	357	$	406	$	1,151	$	1,487
Total revenues		357		406		1,151		1,487
Operating costs and expenses:
Research and development		8,130		7,201		24,365		20,276
General and administrative		7,028		7,030		24,795		21,577
Total operating costs and expenses		15,158		14,231		49,160		41,853
Loss from operations		(14,801)		(13,825)		(48,009)		(40,366)
Other income (expense):
Change in fair value of derivative liabilities		(1,590)		(112)		939		3,875
Change in fair value of share payable		70		487		31		534
Change in fair value of convertible notes		3,087		(4,942)		4,621		(4,942)
Loss from extinguishment of debt		(6,820)		(1,768)		(9,905)		(3,648)
Interest expense		(2,080)		(1,670)		(5,279)		(3,999)
Foreign currency transaction gain (loss)		2,760		(1,692)		2,047		(76)
Total other loss		(4,573)		(9,697)		(7,546)		(8,256)
Net loss		(19,374)		(23,522)		(55,555)		(48,622)
Deemed dividend related to warrant modification		(132)		(519)		(1,141)		(1,433)
Net loss attributable to common stockholders	$	(19,506)	$	(24,041)	$	(56,696)	$	(50,055)

Other comprehensive income (loss)
Foreign currency translation adjustment		(2,253)		1,397		(1,565)		145
Total comprehensive loss	$	(21,759)	$	(22,644)	$	(58,261)	$	(49,910)

Net loss per share applicable to common stockholders
Basic	$	(0.02)	$	(0.02)	$	(0.05)	$	(0.05)
Diluted	$	(0.02)	$	(0.02)	$	(0.05)	$	(0.05)

Weighted average shares used in computing basic loss per share		1,258,532		1,134,359		1,220,472		1,106,111
Weighted average shares used in computing diluted loss per share		1,258,532		1,134,359		1,220,472		1,106,111

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, 2024
	Mezzanine equity												Accumulated
	Series C Convertible						Additional						Other		Total
	Preferred Stock			Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Shares	Par value		Capital		Receivable		Deficit		Income (Loss)		Deficit
Balances at July 1, 2024	1,265	$	18,753	1,229,703	$	1,229	$	1,316,031	$	(79)	$	(1,395,902)	$	2,224	$	(76,497)
Issuance of Series C convertible preferred stock for cash	33		267	—		—		—		—		—		—		—
Series C convertible preferred stock conversion	(668)		(4,987)	16,711		17		4,970		—		—		—		4,987
Issuance of common stock for cash, net	—		—	25,363		26		7,088		—		—		—		7,114
Warrants exercised for cash	—		—	106		—		26		—		—		—		26
Cashless warrants exercise	—		—	157		—		—		—		—		—		—
Issuance of common stock for conversion of debt and accrued interest	—		—	14,043		14		4,854		—		—		—		4,868
Issuance of Series C preferred stock for conversion of debt and accrued interest	368		1,844	—		—		—		—		—		—		—
Stock-based compensation	—		—	175		—		685		—		—		—		685
Net loss	—		—	—		—		—		—		(19,374)		—		(19,374)
Warrants modification	—		—	—		—		459		—		—		—		459
Deemed dividend related to warrants modification	—		—	—		—		(132)		—		—		—		(132)
Cumulative translation adjustment	—		—	—		—		—		—		—		(2,253)		(2,253)
Balances at September 30, 2024	998	$	15,877	1,286,258	$	1,286	$	1,333,981	$	(79)	$	(1,415,276)	$	(29)	$	(80,117)


	For the Three Months Ended September 30, 2023
	Mezzanine equity												Accumulated
	Series C Convertible						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, 2023	1,546	$	25,385	1,115,183	$	1,115	$	1,258,259	$	(79)	$	(1,322,222)	$	1,893	$	(61,034)
Issuance of Series C convertible preferred stock for cash	405		5,143	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock in lieu of debt redemption	—		—	—		—		—		—		—		—		—
Series C convertible preferred stock conversion	(186)		(2,974)	4,651		4		2,970		—		—		—		2,974
Warrants exercised for cash	—		—	128		—		32		—		—		—		32
Cashless warrants and stock options exercise	—		—	10,554		11		(11)		—		—		—		—
Issuance of common stock for conversion of debt and accrued interest	—		—	12,403		13		7,907		—		—		—		7,920
Stock-based compensation	8		112	2,164		2		1,563		—		—		—		1,565
Net loss	—		—	—		—		—		—		(23,522)		—		(23,522)
Warrants modification	—		—	—		—		1,126		—		—		—		1,126
Deemed dividend related to warrants modification	—		—	—		—		(519)		—		—		—		(519)
Cumulative translation adjustment	—		—	—		—		—		—		—		1,397		1,397
Balances at September 30, 2023	1,773	$	27,666	1,145,083	$	1,145	$	1,271,327	$	(79)	$	(1,345,744)	$	3,290	$	(70,061)

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, 2024
	Mezzanine equity												Accumulated
	Series C Convertible						Additional						Other		Total
	Preferred Stock			Common Stock			Paid-in		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Shares	Par value		Capital		Receivable		Deficit		Income (Loss)		Deficit
Balances at January 1, 2024	1,209	$	18,718	1,175,459	$	1,175	$	1,291,316	$	(79)	$	(1,359,721)	$	1,536	$	(65,773)
Issuance of Series C convertible preferred stock for cash	758		8,201	—		—		—		—		—		—		—
Series C convertible preferred stock conversion	(1,504)		(13,721)	37,602		38		13,683		—		—		—		13,721
Issuance of common stock for cash, net	—		—	33,488		34		9,977		—		—		—		10,011
Warrants exercised for cash	—		—	6,420		6		1,511		—		—		—		1,517
Cashless warrants and stock options exercise	—		—	3,053		3		(3)		—		—		—		—
Issuance of common stock for conversion of debt and accrued interest	—		—	29,886		30		12,938		—		—		—		12,968
Issuance of Series C preferred stock for conversion of debt and accrued interest	535		2,679	—		—		—		—		—		—		—
Stock-based compensation	—		—	350		—		3,002		—		—		—		3,002
Net loss	—		—	—		—		—		—		(55,555)		—		(55,555)
Warrants modification	—		—	—		—		2,698		—		—		—		2,698
Deemed dividend related to warrants modification	—		—	—		—		(1,141)		—		—		—		(1,141)
Cumulative translation adjustment	—		—	—		—		—		—		—		(1,565)		(1,565)
Balances at September 30, 2024	998	$	15,877	1,286,258	$	1,286	$	1,333,981	$	(79)	$	(1,415,276)	$	(29)	$	(80,117)


	For the Nine Months Ended September 30, 2023
	Mezzanine equity												Accumulated
	Series C Convertible						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, 2023	1,415	$	23,060	1,068,394	$	1,068	$	1,164,885	$	(79)	$	(1,297,122)	$	3,145	$	(128,103)
Issuance of Series C convertible preferred stock for cash	729		9,899	—		—		—		—		—		—		—
Issuance of Series C convertible preferred stock in lieu of debt redemption	56		1,013	—		—		—		—		—		—		—
Series C convertible preferred stock conversion	(443)		(6,536)	11,081		11		6,525		—		—		—		6,536
Warrants exercised for cash	—		—	12,448		12		2,789		—		—		—		2,801
Cashless warrants and stock options exercise	—		—	20,433		21		(21)		—		—		—		—
Reclassification of warrant liabilities to stockholders’ deficit	—		—	—		—		76,258		—		—		—		76,258
Issuance of common stock for conversion of debt and accrued interest	—		—	27,563		28		17,456		—		—		—		17,484
Stock-based compensation	16		230	5,164		5		2,668		—		—		—		2,673
Net loss	—		—	—		—		—		—		(48,622)		—		(48,622)
Warrants modification	—		—	—		—		2,200		—		—		—		2,200
Deemed dividend related to warrants modification	—		—	—		—		(1,433)		—		—		—		(1,433)
Cumulative translation adjustment	—		—	—		—		—		—		—		145		145
Balances at September 30, 2023	1,773	$	27,666	1,145,083	$	1,145	$	1,271,327	$	(79)	$	(1,345,744)	$	3,290	$	(70,061)

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,
	2024		2023
Cash Flows from Operating Activities:
Net loss	$	(55,555)	$	(48,622)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization		1,307		1,101
Amortization of debt discount		1,618		2,006
Change in fair value of derivatives		(939)		(3,875)
Change in fair value of share payable		(31)		(534)
Change in fair value of convertible notes		(4,621)		4,942
Loss from extinguishment of debt		9,905		3,648
Amortization of operating lease right-of-use asset		236		211
Stock-based compensation for services		3,002		2,833
Warrant modifications associated with convertible notes under fair value option		327		287
Subtotal of non-cash charges		10,804		10,619
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(216)		802
Other non-current assets		(9)		(13)
Accounts payable and accrued expenses		8,535		2,657
Related party accounts payable and accrued expenses		(501)		(2,239)
Lease liabilities		106		117
Net cash used in operating activities		(36,836)		(36,679)
Cash Flows from Investing Activities:
Purchase of equipment and construction in progress		(936)		(3,019)
Net cash used in investing activities		(936)		(3,019)
Cash Flows from Financing Activities:
Proceeds from issuance of Series C convertible preferred stock		8,201		9,899
Proceeds from issuance of common shares		10,011		—
Proceeds from exercise of warrants		1,517		1,598
Proceeds from investor advance		200		7
Proceeds from issuance of notes payable, net		12,000		10,000
Proceeds from issuance of convertible notes payable, net		9,915		12,699
Proceeds from contingent payment obligation		50		4,550
Repayment of notes payable		(251)		(210)
Repayment of convertible notes payable		(800)		—
Repayment of investor advances		—		(200)
Net cash provided by financing activities		40,843		38,343
Effect of exchange rate changes on cash and cash equivalents		(2,258)		487
Net increase (decrease) in cash and cash equivalents		813		(868)

Cash and cash equivalents, beginning of the period		2,126		6,965
Cash and cash equivalents, end of the period	$	2,939	$	6,097

Supplemental disclosure of cash flow information
Interest payments on notes payable	$	(18)	$	(30)

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,
	2024		2023
Supplemental schedule of non-cash activities:
Cashless warrants and stock options exercise	$	3	$	21
Reclassification of warrant liabilities to stockholders’ deficit	$	—	$	76,258
Issuance of common stock for conversion of debt and accrued interest	$	12,968	$	17,484
Issuance of Series C preferred stock for conversion of debt and accrued interest	$	2,679	$	—
Series C convertible preferred stock conversion	$	13,721	$	6,536
Capital expenditures included in accounts payable	$	238	$	71
Issuance of Series C convertible preferred stock in lieu of debt redemption	$	—	$	1,013
Deemed dividend related to warrant modification	$	1,141	$	1,433
Debt discount related to warrant modification	$	8	$	—
Reclassification between contingent payment obligation and convertible notes payable at fair value	$	300	$	—
Reclassification of investor advances to convertible notes payable	$	—	$	1,163
Reclassification of investor advances to stockholders’ deficit	$	—	$	1,203
Right-of-use asset recognized in exchange for lease liability	$	364	$	—

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, Northwest Biotherapeutics Limited, Northwest Biotherapeutics Capital Limited (formerly known as Aracaris Capital Limited), Northwest Biotherapeutics B.V., and NW Bio GmbH (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company has wholly owned subsidiaries in Boston, the U.K., the Netherlands and Germany. On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®.

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

The Company has completed a Phase 3 clinical trial of its DCVax®-L product for glioblastoma brain cancer, has publicly reported the results in a peer reviewed publication in a medical journal as well as at a medical conference, and submitted a Marketing Authorization Application (MAA) for regulatory approval in the U.K. in December 2023. The MAA is in process of their review.

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 $55.6 million for the nine months ended September 30, 2024. The Company used approximately $36.8 million of cash in its operating activities during the nine months ended September 30, 2024.

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

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

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.

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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 uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2024, condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at September 30, 2024 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2023 and notes thereto included in the Company’s annual report on Form 10-K (the “2023 Annual Report”), which was filed with the SEC on March 5, 2024.

Revision of Prior Period Consolidated Financial Statements

As previously disclosed in the 2023 Annual Report, the Company revised its prior period financial statements to reflect an adjustment related to the fair value of convertible notes that was not material, individually or in the aggregate, to the Company’s previously issued consolidated financial statements. The appropriate revisions to the Company’s historical condensed consolidated financial statements and the notes thereto are reflected herein. See Note 14 to the “Consolidated Financial Statements” in the 2023 Annual Report for additional information.

Use of Estimates

In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.

On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets, and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2023 Annual Report.

Recently Issued Accounting Standards Not Yet Adopted

Compensation - Stock Compensation

In March 2024, the FASB issued ASU No. 2024-01, Compensation - Stock Compensation (Topic 718) - Scope Application of Profits Interest and Similar Awards, to clarify whether profits interest and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock Compensation. The guidance applies to all business entities that issue profits interest awards as compensation to employees or nonemployees in exchange for goods or services. These amendments are effective for the Company for annual and interim periods in 2025, applied prospectively, with early adoption and retrospective application permitted. As the Company does not issue profit interest awards, the impact of the adoption of the amendments in this update is not expected to be material to the Company’s consolidated financial statements.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Improvements to Income Tax Disclosures

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.

Recently Issued Accounting Standards, Adopted

Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions

In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820.

For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company adopted ASU 2022-03 effective January 1, 2024. The adoption of this guidance did not have a material impact on its condensed consolidated financial statements.

4. Fair Value Measurements

In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the fair value of liabilities related to certain embedded conversion features associated with convertible debt, share liability (receivable), and the contingent payable to Cognate BioServices on a recurring basis to determine the fair value of these liabilities. The Company also elects the fair value option (“FVO”) for certain eligible financial instruments, such as convertible notes, in order to simplify the accounting treatment.

ASC 820 establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below:

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

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

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

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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, 2024 and December 31, 2023 (in thousands):


	Fair value measured at September 30, 2024
			Quoted prices in active		Significant other		Significant
	Fair value at		markets		observable inputs		unobservable inputs
	September 30, 2024		(Level 1)		(Level 2)		(Level 3)
Contingent payable derivative liability	$	9,193		—		—		9,193
Convertible notes at fair value		23,154		—		—		23,154
Share payable		170		—		—		170
Total fair value	$	32,517	$	—	$	—	$	32,517


	Fair value measured at December 31, 2023
			Quoted prices in active		Significant other		Significant
	Fair value at		markets		observable inputs		unobservable inputs
	December 31, 2023		(Level 1)		(Level 2)		(Level 3)
Warrant liability	$	944	$	—	$	—	$	944
Contingent payable derivative liability		9,188		—		—		9,188
Convertible notes at fair value		12,771		—		—		12,771
Share payable		483		—		—		483
Total fair value	$	23,386	$	—	$	—	$	23,386

There were no transfers between Level 1, 2 or 3 during the three-month period ended September 30, 2024.

The following table presents changes in Level 3 liabilities measured at fair value for the nine-month period ended September 30, 2024. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands).


								Convertible
	Warrant			Contingent Payable		Share		Notes
	Liability			Derivative Liability		Payable		At Fair Value		Total
Balance - January 1, 2024	$	944		$	9,188	$	483	$	12,771	$	23,386
Additional share payable		—			—		543		—		543
Issuance of convertible notes at fair value		—			—		—		8,615		8,615
Redemption of share payable		—			—		(825)		—		(825)
Additions from debt extinguishment		—			—		—		7,189		7,189
Debt repayment		—			—		—		(800)		(800)
Change in fair value		(944)			5		(31)		(4,621)		(5,591)
Balance - September 30, 2024	$	—	⁽¹⁾	$	9,193	$	170	$	23,154	$	32,517

(1)	The warrant liability related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”), which expired as of June 11, 2024.

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s share payable and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of September 30, 2024 and December 31, 2023 is as follows. The contingent conversion option of the contingent payable expired during the nine months ended

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

September 30, 2024. The liability relates to the remaining redemption feature which, like the convertible notes at fair value, includes discount factors that are unobservable inputs and proprietary in nature.


	As of September 30, 2024
	Share Payable
Strike price	$	0.29
Contractual term (years)		0.03
Volatility (annual)		63	%
Risk-free rate		3.3	%
Dividend yield (per share)		0	%


	As of December 31, 2023
	Share			Contingent Payable
	Payable			Derivative Liability
Strike price	$	0.64		$	0.70	*
Contractual term (years)		0.1			1.0
Volatility (annual)		71	%		71	%
Risk-free rate		5.6	%		5.2	%
Dividend yield (per share)		0	%		0	%

*	The strike price assumes the current stock price as of December 31, 2023.

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023 (in thousands).


	For the three months ended				For the nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	609	$	1,118	$	2,660	$	1,562
Research and development - related party
Milestones achieved ⁽¹⁾		—		9		—		578
Future milestones ⁽²⁾		—		24		—		115
General and administrative ⁽³⁾		80		471		320		578
Total stock-based compensation expense	$	689	$	1,622	$	2,980	$	2,833

(1)	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).

(2)	The general and administrative expense during the three and nine months ended September 30, 2024 and 2023 is related to the applicable vesting portion of stock options awards and restricted shares to employees and consultants.

The total unrecognized stock compensation (primarily for consultants) cost was approximately $2.2 million as of September 30, 2024 and will be recognized over the next 1.5 years.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Stock Options

The following table summarizes stock option activity for options during the nine months ended September 30, 2024 (amount in thousands, except per share number):


				Weighted Average
		Weighted		Remaining
	Number of	Average		Contractual Life	Total Intrinsic
	Shares	Exercise Price		(in years)	Value
Outstanding as of January 1, 2024	317,076	$	0.35	6.0	$	114,097
Granted	500		0.53	3.7		—
Cashless exercised	(650)		0.35	—		—
Outstanding as of September 30, 2024	316,926	$	0.35	5.3	$	9,558
Options vested ⁽¹⁾	282,679	$	0.33	5.2	$	8,718

⁽¹⁾

153 million of the 283 million stock options are subject to agreements (the “Blocker Letter Agreements”) under which they cannot be exercised except upon at least 61 days’ prior notice, and are also subject to a restriction that the options may only be exercised if the Company has sufficient authorized shares available for issuance.

During the nine months ended September 30, 2024, the Company granted 500,000 stock options (the “Options”) with an exercise price at $0.53 per share to a staff employee. The Options vested immediately on the grant date. In addition, the Company will make an additional payment of $0.30 per option exercised by the employee for a maximum amount of $150,000. The Company has fully accrued this additional payment as of September 30, 2024 on its condensed consolidated balance sheets.

The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The assumptions used in calculating the fair values of stock options that were granted during the nine months ended September 30, 2024 was as follows:


	For the nine months ended
	September 30,
	2024
Exercise price	$	0.53
Expected term (years)		2.1
Expected stock price volatility		73	%
Risk-free rate		4.5	%
Dividend yield (per share)		0	%

Restricted Stock Awards

Advent SOW 6

There was no stock based compensation related to Statement of Work #6 (“SOW 6”) recognized during the three and nine months ended September 30, 2024. As previously reported, Advent previously achieved all of the 10 one-time milestones (i.e., for all six workstreams that were prerequisites for a MAA application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the MAA application) pursuant to SOW 6.

As of September 30, 2024, 1.5 million shares related to the milestone for completion and submission of the MAA had not been issued and the fair value of the shares of $1.1 million remained accrued in accounts payable and accrued expenses to related parties and affiliates.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

6. Property, Plant and Equipment

Property, plant and equipment consist of the following at September 30, 2024 and December 31, 2023 (in thousands):


	September 30,		December 31,		Estimated
	2024		2023		Useful Life
Leasehold improvements	$	18,721	$	17,785	Lesser of lease term or estimated useful life
Office furniture and equipment		555		487	3-5 years
Computer and manufacturing equipment and software		3,242		2,776	3-5 years
Land in the United Kingdom		91		86	NA
		22,609		21,134	NA
Less: accumulated depreciation		(5,287)		(3,856)
Total property, plant and equipment, net	$	17,322	$	17,278

Depreciation and amortization expense was approximately $1.3 million and $1.1 million for the nine months ended September 30, 2024, and 2023, respectively.

7. Outstanding Debt

The following two tables summarize outstanding debt as of September 30, 2024 and December 31, 2023, respectively (amount in thousands, except per share amounts):


		Stated										Fair
		Interest			Conversion					Remaining		Value		Carrying
	Maturity Date	Rate			Price			Face Value		Debt Discount		Adjustment		Value
Short term convertible notes payable
6% unsecured	Due		6	%	$	3.09		$	135	$	—	$	—	$	135
8% unsecured	Various		8	%	$	0.50	*		1,760		(70)		—		1,690
									1,895		(70)		—		1,825
Short term convertible notes at fair value
8% unsecured	Various		8	%	$	0.30			1,000		—		128		1,128
10% unsecured	Various		10	%	$	0.35			500		—		72		572
11% unsecured	Various		11	%	$	0.30 - $0.46			15,560		—		2,120		17,680
									17,060		—		2,320		19,380
Short term notes payable
0% unsecured	On Demand		0	%		N/A			2,140		(56)		—		2,084
6% secured	3/25/2025		6	%		N/A			339		—		—		339
8% unsecured	Various		8	%		N/A			4,717		(125)		—		4,592
12% unsecured	On Demand		12	%		N/A			562		—		—		562
									7,758		(181)		—		7,577
Long term convertible notes at fair value
11% unsecured	Various		11	%	$	0.30 - $0.38			3,115		—		659		3,774

Long term notes payable
8% unsecured	Various		8	%		N/A			22,010		(1,315)		—		20,695


Ending balance as of September 30, 2024								$	51,838	$	(1,566)	$	2,979	$	53,251

*These convertible notes are convertible into Series C preferred shares at conversion prices of $12.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at conversion prices of $0.50 per share.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS


		Stated
		Interest			Conversion					Remaining		Fair Value		Carrying
	Maturity Date	Rate			Price			Face Value		Debt Discount		Adjustment		Value
Short term convertible notes payable
6% unsecured	Due		6	%	$	3.09		$	135	$	—	$	—	$	135
8% unsecured	Various		8	%	$	0.50-$0.70	*		3,486		(356)		—		3,130
10% unsecured	7/11/2024		10	%	$	0.5	*		500		—		—		500
									4,121		(356)		—		3,765
Short term convertible notes at fair value
11% unsecured	Various		11	%	$	0.40-$0.49	*		10,750		—		2,021		12,771

Short term notes payable
8% unsecured	Various		8	%		N/A			3,539		(157)		—		3,382
12% unsecured	On Demand		12	%		N/A			562		—		—		562
									4,101		(157)		—		3,944
Long term notes payable
8% unsecured	Various		8	%		N/A			21,224		(1,485)		—		19,739
6% secured	3/25/2025		6	%		N/A			573		—		—		573
									21,797		(1,485)		—		20,312

Ending balance as of December 31, 2023								$	40,769	$	(1,998)	$	2,021	$	40,792

*These convertible notes are convertible into Series C preferred shares at conversion prices ranging from $10.00 - $17.50 per share. The conversion price in common share equivalent is at conversion prices ranging from $0.40 - $0.70 per share.

Notes Payable

On April 26, 2024, the Company entered into a Commercial Loan Agreement (the “April Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The April Commercial Loan bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first eight months of the term. The April Commercial Loan is amortized in 14 installments starting on December 26, 2024. The April Commercial Loan carries an original issue discount of $1.0 million.

On September 27, 2024, the Company entered into a promissory note agreement (the “Note”) with an individual investor (the “Holder”) for principal amount of $2.0 million. The Note bears zero interest, and is payable upon demand. The Holder should provide 5 days’ advance written notice to the Company (the “Maturity Date”) for the redemption. In addition, the Company agreed to pay the Holder a service fee of $140,000 at the Maturity Date. The $140,000 service fee was recognized as an additional debt discount to the Note and was amortized to interest expense in 5 days.

During the nine months ended September 30, 2024, the Company issued approximately 29.9 million shares of common stock with a fair value of $13.0 million to certain lenders in lieu of cash payments of $9.7 million of debt, including $0.7 million of accrued interest. In addition, the Company has extinguished certain debt pursuant to exchange agreements executed with various holders pursuant to which the Company issues common stock at a price based on a limited pricing period (the “Share payable”). During the nine months ended September 30, 2024, the Company settled $0.8 million of Share payables and accrued $0.5 million of Share payables. The Company recognized an approximately $3.0 million debt extinguishment loss during the nine months ended September 30, 2024 from the debt redemption.

Convertible Notes

On February 21, 2024, the Company entered into several one-year convertible notes (the “February Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.8 million for a purchase price of $1.6 million. The February Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $12.50 per share at the Holders’ sole option. The Series C preferred shares are convertible into common stock. Each Series C preferred share is convertible into 25 shares of common stock.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

As consideration for entering into the package of February Convertible Notes for $1.8 million as described above, the Company amended the Holders’ existing convertible notes and warrants, whereby the maturity date of certain notes and warrants was extended, the conversion price of certain notes was reduced, and the exercise prices of certain warrants were reduced. These amendments in January and February of 2024 involving 16 tranches of warrants and 10 debt instruments were accounted for as both debt modification and debt extinguishment. The Company recognized approximately $1.4 million of debt extinguishment losses during the nine months ended September 30, 2024 from these debt amendments.

During the nine months ended September 30, 2024, the Company modified the terms of existing $1.5 million convertible notes (the “Notes”) by (i) extending the maturity dates; (ii) reducing the conversion price, and (iii) granting the Notes holders the right to convert the Notes into a non-dilutive financial instrument. The modifications were accounted for as a debt extinguishment as the conversion feature of the amended notes were substantially different from the original terms. As a result, the Company recognized approximately $0.1 million of debt extinguishment loss during the nine months ended September 30, 2024 from this debt amendment.

During the nine months ended September 30, 2024, the Company converted $2.7 million convertible notes including $0.2 million accrued interest into 0.5 million Series C preferred shares.

Convertible Notes at Fair Value

During the nine months ended September 30, 2024, the Company entered into several one-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $5.5 million. The Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between $10.00 and $11.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. In addition, the Holders have an alternative option to convert the Convertible Notes into a non-dilutive financial instrument, which has the same terms at those in the non-dilutive funding agreements as described in Note 12.

During the nine months ended September 30, 2024, the Company entered into several two-year convertible notes (the “Long-term Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $3.1 million. Of the total $3.1 million, $0.3 million was exchanged from a previously executed non-dilutive financial instrument. The Company received net cash proceeds of $2.8 million. The Long-term Convertible Notes bear interest at 11% per annum and are convertible into common shares between $0.30 and $0.38 per share at the Holder’s sole option. In addition, the Holders have an alternative option to convert the Long-term Convertible Notes into a non-dilutive financial instrument, which has the same terms at those in the non-dilutive funding agreements as described in Note 12.

As consideration for entering the Long-term Convertible Notes, the Company also agreed to amend certain holder’s existing warrants to extend the term of the warrant maturity date for an additional 5 months. 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.

The Company elected the FVO to fair value the convertible notes described above under the guidance in ASC 825. The convertible notes at fair value are required to be remeasured using level 3 fair value measurements (see Note 4).

During the nine months ended September 30, 2024, the Company modified certain convertible notes that were originally issued in 2023 by (i) extending the maturity dates; (ii) reducing the conversion price, and (iii) granting the notes holders the right to further extend the maturity date of the notes from a period of time not to exceed 24 months. The modifications were accounted for as a debt extinguishment as the conversion feature of the amended notes were substantially different from the original terms. As a result, the Company recognized approximately $5.5 million of debt extinguishment loss during the nine months ended September 30, 2024 from these debt amendments.

For the three months ended September 30, 2024 and 2023, interest expense related to outstanding debt totaled approximately $2.1 million and $1.7 million including amortization of debt discounts totaling $0.6 million and $0.7 million, respectively.

For the nine months ended September 30, 2024 and 2023, interest expense related to outstanding debt totaled approximately $5.3 million and $4.0 million including amortization of debt discounts totaling $1.6 million and $2.0 million, respectively.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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,
	2024	2023
Series C convertible preferred stock	24,955	44,328
Common stock options	316,926	318,676
Common stock warrants	94,270	105,444
Convertible notes and accrued interest	69,726	32,049
Potentially dilutive securities	505,877	500,497

9. Related Party Transactions

The Company has 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) periodic specialized programs such as the program related to the MAA pre-requisites, drafting and submission. The Company has also executed a new SOW #8 covering the work required to establish the DCVax-Direct program in the U.K. and manufacture DCVax-Direct products for global use (see Note 13).

Each of the 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. Each periodic specialized program is covered by an SOW that sets forth the role and activities to be undertaken by Advent for that program, and provides for milestone payments upon completion of key elements of the program.

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, as well as for the periodic specialized programs. 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 Ancillary Services Agreement was to end in July 2023, but the Company extended the term by 12 months to July 2024, and it was further extended for an additional one year until July 2025.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The following table summarizes total research and development costs from Advent for the three and nine months ended September 30, 2024 and 2023, respectively (in thousands).


	For the three months ended				For the nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Advent BioServices
Manufacturing cost in London		2,430	$	1,554		6,008	$	4,857
Manufacturing cost at Sawston facility		2,606		2,247		7,758		6,057
SOW 6 one-time milestones - Shares
Expensed and paid (milestone complete) ⁽¹⁾		—		9		—		578
Expensed but unpaid, not yet due (milestone not yet complete) ⁽²⁾		—		24		—		115
SOW 6 one-time milestones - Cash
Expensed and paid (milestone complete) ⁽³⁾		—		—		—		551
Expensed and due, but unpaid (milestone complete) ⁽⁴⁾		—		18		—		111
Expensed but unpaid, not yet due (milestone not yet complete) ⁽²⁾		—		13		—		130
Total	$	5,036	$	3,865	$	13,766	$	12,399

(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)	The expense for the nine months ended September 30, 2023 covers 2 one-time milestones: Mechanism of Action and milestone for obtaining a commercial manufacturing license from the MHRA.

(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.

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 $7.70 per square foot based on exchange rate as of September 30, 2024), but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are £550,000 (approximately $736,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

During the three months ended September 30, 2024 and 2023, the Company recognized sub-lease income of $36,000 and $36,000, respectively.

During the nine months ended September 30, 2024 and 2023, the Company recognized sub-lease income of $109,000 and $108,000, respectively.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Related Party Accounts Payable

As of September 30, 2024 and December 31, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section.


	September 30,		December 31,
	2024		2023
Advent BioServices - amount invoiced but unpaid	$	1,942	$	1,668
Advent BioServices - amount accrued but unpaid ⁽¹⁾		1,101		1,601
Total payable and accrued, but unpaid to Advent BioServices	$	3,043	$	3,269

(1) This includes $1.1 million which is not payable in cash but represents the value of 1.5 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for submission of the MAA application to MHRA on December 20, 2023. Such shares were not issued as of September 30, 2024, and the total value, previously recognized as stock compensation expense, was reclassified from Additional Paid-in-Capital to Accounts payable and accrued expenses to related parties and affiliates.

10. Preferred Stock

Series C Convertible Preferred Stock

During the nine months ended September 30, 2024, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of 0.8 million shares of the Company’s Series C convertible preferred stock, par value $0.001 per share (the “Series C Shares”), at a weighted average purchase price of $10.82 per share for proceeds of approximately $8.2 million.

During the nine months ended September 30, 2024, the Company converted $2.7 million convertible notes including $0.2 million accrued interest into 0.5 million Series C preferred shares.

During the nine months ended September 30, 2024, approximately 1.5 million Series C Shares with a book value of $13.7 million were converted into 37.6 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.

11. Stockholders’ Deficit

Common Stock

On June 4, 2024, the Company entered into a Stock Purchase Agreement with SIO Capital Management LLC (SIO), for SIO’s purchase of 8,125,000 shares of the Company’s common stock at $0.40 per share based on certain terms initially negotiated on May 31, 2024 (the “June Offering”). The transaction was closed on June 5, 2024. The June Offering generated gross proceeds of approximately $3.3 million and net proceeds to the Company of approximately $2.9 million. In connection therewith, the placement agent was granted a warrant to purchase up to an aggregate of 0.2 million shares of Common Stock (the “Placement Agent Warrant”) at an exercise price of $0.40 per share, which Placement Agent Warrant is exercisable at any time on or after August 4, 2024 and will expire on June 4, 2026.

During the nine months ended September 30, 2024, the Company received $1.5 million from the exercise of outstanding warrants with a weighted average exercise price of $0.24 per share. The Company issued approximately 6.4 million shares of common stock upon these warrant exercises.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

During the nine months ended September 30, 2024, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 3.1 million shares of common stock upon exercise of 4.8 million warrants at exercise prices between $0.20 and $0.34 per share, and 0.7 million options at exercise prices of $0.35 per share.

Stock Purchase Warrants

The following is a summary of warrant activity for the nine months ended September 30, 2024 (dollars in thousands, except per share data):


	Number of	Weighted Average		Remaining
	Warrants	Exercise Price		Contractual Term
Outstanding as of January 1, 2024	105,241	$	0.31	1.83
Warrants granted ⁽¹⁾	244		0.40
Warrants exercised for cash	(6,421)		0.24
Cashless warrants exercise	(4,794)		0.27
Outstanding as of September 30, 2024 ⁽²⁾	94,270	$	0.28	2.08

(1)	Warrants granted to the placement agent.

(2)	At September 30, 2024, of the approximately 94 million total outstanding warrants listed above, approximately 90 million warrants were under Blocker Letter Agreements or suspension agreements.

Warrant Modifications

During the nine months ended September 30, 2024, the Company amended certain warrants whereby the maturity dates were extended for an additional approximately 3 months. The value of these modifications was calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.


	Post-modification			Pre-modification
Exercise price	$	0.29		$	0.30
Expected term (in years)		2.4			2.1
Volatility		75	%		75	%
Risk-free interest rate		4.7	%		4.9	%
Dividend yield		0	%		0	%

The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $2.7 million, of which $1.6 million was associated with debt amendments and was recognized as an additional debt discount under debt modification, debt extinguishment loss and interest expense under debt extinguishment (see Note 7), and the remaining $1.1 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.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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.

On August 22, 2024, the Company extended its office lease in the U.S for additional 2 years under an amended agreement. The Company recognized additional $0.4 million ROU assets and lease liabilities for its amended office lease in the U.S.

At September 30, 2024, the Company had operating lease liabilities of approximately $5.1 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 $4.5 million for the Sawston lease and U.S. office lease are included in the condensed consolidated balance sheet.

Operating Lease - Lessor Arrangements

On December 31, 2021, the Company entered into a Sub - lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently £5.75 or approximately $7.70 per square foot based on exchange rate as of September 30, 2024), but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are £550,000 (approximately $736,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The following summarizes quantitative information about the Company’s operating leases (amount in thousands):


	For the nine months ended
	September 30, 2024
	U.K			U.S			Total
Lease cost
Operating lease cost	$	470		$	191		$	661
Short-term lease cost		39			—			39
Variable lease cost		—			24			24
Sub-lease income		(109)			—			(109)
Total	$	400		$	215		$	615

Other information
Right of use assets exchanged for new operating lease liabilities	$	—		$	364		$	364
Operating cash flows from operating leases	$	(499)		$	(205)		$	(704)
Weighted-average remaining lease term – operating leases		7.2			1.5
Weighted-average discount rate – operating leases		12	%		12	%


	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	%

The Company recorded lease costs as a component of general and administrative expense during the nine months ended September 30, 2024 and 2023, respectively.

Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows:


Three months ended December 31, 2024	$	174
Year ended December 31, 2025		929
Year ended December 31, 2026		886
Year ended December 31, 2027		696
Year ended December 31, 2028		696
Thereafter		6,940
Total		10,321
Less present value discount		(5,237)
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2024	$	5,084

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Maturities of our operating leases under the sublease agreement, are as follows:


Three months ended December 31, 2024	$	36
Year ended December 31, 2025		145
Year ended December 31, 2026		145
Year ended December 31, 2027		145
Year ended December 31, 2028		145
Thereafter		1,450
Total	$	2,066

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 £4.6 million ($6.2 million).

German Tax Matter

The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015. The NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €277,000 (approximately $329,000), for corporate taxes, interest, and reduced penalty for the period under audit, which the Company paid on September 2, 2021. The Company also received and paid the final settlement bill from the local authority for trade taxes for the audit period in the amount of €231,000 (approximately $272,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (approximately $554,000) on reimbursable withholding taxes that had been waived during the settlement process. On December 8, 2021, the Company appealed the assessment of additional late fees. Additionally, the Company requested that NW Bio GmbH be deregistered from the trade register, as it no longer had current operations. The deregistration was granted effective December 31, 2021. Between January 2022 and July 2022, the Company received tax bills for the corporate and trade taxes for the 2016-2020 tax years that totaled approximately €222,000 (approximately $238,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $145,000) of the penalties. The Company offered to pay this reduced penalty if an extended payment plan was approved. A response was received dated November 14, 2022 indicating that the tax authority would not be able to grant a further deferral of payment of these penalties. In a letter dated December 27, 2022, the Leipzig tax authority sent letters to the former and current managing directors of NW Bio GmbH giving 30 days to respond to a tax liability questionnaire. Based on the responses to the liability questionnaires the tax authorities have currently not directed any further measures against former and current managing directors of NW Bio GmbH with respect to tax liability proceedings. On October 12, 2023 and January 16, 2024, the Company made €189,000 (approximately $201,000) and €189,000 (approximately $207,000) payments, respectively, regarding to the late payment penalty. As of September 30, 2024, the Company accrued for trade tax liability of €155,000 (approximately $173,000) and corporation tax of €99,000 (approximately $110,000). Based on the Company’s current operating state in Germany and the negotiations, the Company believes, based on its evaluation under ASC 740, that the resolution of these tax matters will not likely result in a net material charge to the Company.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Other Contingent Payment Obligation

During the nine months ended September 30, 2024, the Company entered into a non-dilutive funding agreement with an individual investor, pursuant to which the Company received funding of $50,000 related to a gain contingency. In addition, the Company exchanged $0.3 million from a previously executed non - dilutive financial instrument to a new convertible note (see Note 7). 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.

13. Subsequent Events

Between October 1, 2024 and November 8, 2024, the Company received $8.4 million in funding from the sale of common shares, proceeds from warrant exercise, and proceeds of debt arrangements.

Between October 1, 2024 and November 8, 2024, the Company issued approximately 3.8 million shares of common stock for proceeds of $1.0 million.

On October 18, 2024, the Company entered into a Commercial Loan Agreement (the “October Commercial Loan”) with a commercial lender for an aggregate principal amount of $2.2 million. The October 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 October Commercial Loan is amortized in 14 installments starting on June 18, 2025. The October Commercial Loan carries an original issue discount of $0.2 million.

Between October 1, 2024 and November 8, 2024, the Company entered into several 2-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $5.5 million. The Convertible Notes bear interest at 11% per annum and are convertible into common shares between $0.285 and $0.30 per share at the Holder’s sole option. In addition, the Holders have an alternative option to convert the Convertible Notes into a non-dilutive financial instrument, which has the same terms at those in the non-dilutive funding agreements as described in Note 12.

Between October 1, 2024 and November 8, 2024, the Company issued approximately 6.2 million shares of common stock to certain lenders in lieu of cash payments of $1.6 million of debt. The Company also issued 0.6 million shares of common stock to extinguish $0.2 million outstanding share liability.

On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that will be incorporated into the Ancillary Services Agreement that was originally entered into dated November 8, 2019 and was extended on July 8, 2024. SOW 8 covers the work required to establish the DCVax-Direct program in the U.K and manufacture DCVax-Direct products for global use. Under SOW 8, the compensation consists solely of one-time milestones for each stage of the work and Advent will only receive the compensation when the applicable work is successfully completed. (When the Company previously contracted with a different company for restart of DCVax-Direct manufacturing, the contract required payment for work performed, regardless of whether the work was successful or not, as is typical for such contract services. The other company did not succeed in producing any DCVax-Direct products meeting the specifications.)

SOW 8 includes 5 one-time milestones with corresponding milestone payments:

(a) Basic Technology Transfer, New SOPs & Regulatory Documents.

Review of documents, specifications and data from prior DCVax-Direct program conducted by Cognate BioServices. Development of a new set of SOPs for DCVax-Direct production in Sawston and new regulatory documents for the UK. Initial implementation in Sawston; many engineering runs. Data generation for comparability analyses of both the process and the product. Milestone payment of £0.55 million (approximately $0.7 million) upon completion.

(b) Process Development: TFF System vs. Other Systems.

Evaluation of the TFF system used in the prior DCVax-Direct manufacturing. Evaluation of the remaining TFF equipment from the prior program, parts needed to re-establish functional TFF systems, potential sourcing and timelines. Evaluation of remaining disposables from the prior program, requirements for new molds to enable new production of disposables (which are used for each manufacturing run with the TFF system), production arrangements for new disposables, development of new sealing method for disposables, potential sourcing and timelines for disposables. Identification and evaluation of commercially available systems to

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

potentially substitute for TFF system. Engineering runs. Data generation for comparability analyses of TFF system vs. others. Milestone payment of £0.45 million (approximately $0.6 million) upon completion.

Worldwide search for sourcing of BCG (1 of 2 essential reagents/ingredients required for DCVax-Direct besides the DCs), due to a severe worldwide shortage. Evaluation of the BCG mechanism of action (MoA) in DCVax-Direct, search for other agents that could have similar MoA or effects, with similar safety profile too. Sourcing of other agents, testing and selection of other agents for a new DCVax-Direct product composition. Many engineering runs. Data generation for comparability analyses of new reagents vs BCG and new composition of DCVax-Direct vs prior composition. Milestone payment of £0.60 million (approximately $0.8 million) upon completion.

(d) Technology Transfer: Clean Room Implementation.

After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, process performance qualifications. For technology transfer into the clean rooms, each operator must pass 3 consecutive and successful aseptic process simulations in the clean room and 3 consecutive and successful PQQ runs at scale in the clean room; microbial analysis (sterility, endotoxin, mycoplasma all need to pass); growth promotion tests; validation of all equipment used after being placed in the clean room; validation of all cell analysis assays used via flow cytometry and validation of the fill and finish protocols. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.

(e) New IMPD and New IND.

Draft a new IMPD (Investigational Medicinal Product Dossier) for the revised DCVax-Direct product composition and production process, containing all changes to the manufacturing system, reagents and product composition, processes, sources and/or Mechanism of Action vs those used in the prior DCVax-Direct program. Also draft a new IND (CMC section), for the first clinical trial with the new manufacturing process and new product composition. Obtain the first approval or clearance of the new IND by a regulator. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not rely upon on these forward-looking statements.

Overview

We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.

Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.

During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.

MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.

Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.

Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.

Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.

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Collaborations: Complementary or Synergistic Technologies. The Company has also been pursuing ongoing efforts to identify and develop collaborations with other companies who have technologies that the Company believes may be complementary to the Company’s DCVax technologies (for example for combination treatment regimens) or may be synergistic with the Company’s technologies (for example, to enhance DCVax products). The Company completed negotiations and entered into a contract with a company that has a complementary immunotherapy agent, and the two companies have been engaged for a number of months in joint development of trial designs and selection of candidate cancers for a combination treatment clinical trial. The companies are particularly focusing on trial designs in which the primary endpoint will be tumor response (shrinkage), with potential timeframes in months, rather than time-to-event survival outcomes, with timeframes in years. The Company anticipates potentially being ready to submit an IND for such a combination trial to regulators during Q1 of next year.

The Company has also completed negotiations and entered into a contract with a company that has an immune booster agent that may have the potential to further increase the potency of DCVax products. The contract provides for material supply and in vitro testing of the booster agent with DCVax products. If the in vitro testing is successful, the parties plan to enter into a license of the booster agent to NWBio. The parties jointly designed the program of experiments, and the experiments were carried out and completed by the Flaskworks team. The parties are now evaluating the results and developing plans for further experiments.

Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January. For the same reasons as described above in connection with the planned combination treatment trial, the Company plans to focus DCVax-Direct clinical trial designs on tumor response endpoints with potential timeframes of months rather than survival endpoints with timepoints of years. The preparations to date involve technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, engineering runs and comparability testing. In addition, new development work has been carried out to develop a second version of DCVax-Direct because there is a worldwide shortage of one key ingredient of the original DCVax-Direct (an immune booster ingredient). The Company and Advent have been working together to evaluate other potential immune booster agents -- both their properties in the manufacturing process and their effects immunologically -- to identify an alternative booster agent that can be suitable and is available for production of new batches of DCVax-Direct. Advent is continuing to conduct final engineering runs for validation of the new SOPs, processes and formulation. The Company has entered into SOW 8 with Advent covering the work involved in restarting the DCVax-Direct program. SOW 8 is structured so that Advent only receives compensation for the work in the form of milestone payments and only after the applicable work has been successfully completed (see Note 13).

Ongoing and Expanded Phase 2 Clinical Trials Under the Roswell & Pittsburgh Portfolios. As previously reported, the Company entered into exclusive licenses from Roswell Park Cancer Center and the University of Pittsburgh, covering a large portfolio dendritic cell technologies developed over the course of more than 27 years of work by a leading team of dendritic cell experts, as well as 5 new patent families. The in-licensed technologies in the combined portfolios are currently in three Phase 2 clinical trials that are fully funded by grants and fully being carried out by the investigators. These Phase 2 trials are ongoing and one of them has been approved for a significant expansion in scope by the grant funding agency. That trial is testing an in-licensed dendritic cell treatment in melanoma that is refractory (unresponsive) to checkpoint inhibitor drugs. That dendritic cell treatment aims at a set of targets on abnormal blood vessels that are associated with tumors. As such, that dendritic cell treatment is anticipated to be tumor-agnostic and potentially applicable to most types of solid tumors. The expansion of the trial scope that has been approved is to add refractory lung, breast and bladder cancers to the trial in addition to refractory melanoma.

Intellectual Property. The Company’s intellectual property (IP) portfolio continued to grow during Q3 2024, complementing the Company’s growing pipeline. Patents from 3 different patent families developed by the Company were granted or allowed in several countries, particularly Europe. Patents from 2 different patent families which are part of the Roswell and Pittsburgh in-licenses were granted in the U.S. and elsewhere. New divisional applications were also filed to extend the scope of patents from 2 different patent families, in Europe and elsewhere. In regard to the Flaskworks technologies and IP, 5 new patents were allowed in the U.S. and elsewhere, from 4 different patent families, during Q3 2024. In addition, 4 new patents were issued in the U.S. during Q3 2024, which had been allowed during Q2 2024, and a 5^th patent elsewhere was also issued. The Company believes that the ongoing expansion of its IP portfolio is an important and valuable part of building a leading franchise in dendritic cell technologies.

Litigation. In the Company’s lawsuit against certain market makers, the Company is awaiting the Magistrate’s Report and Recommendation on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: i.e., loss causation. The Magistrate and the Court already previously determined that all but this one of the required elements were sufficiently alleged in the Company’s Complaint, and the Court invited the Company to file expanded allegations about the loss causation element. The Company submitted expanded claims earlier this year, the parties’ filings were finished in June, and the parties are now waiting to receive the Magistrate’s recommendation.

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Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues and expenses.

On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses and stock-based compensation. We based our estimates on historical experience and on various other assumptions that we believe 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.

Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2023. Our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Results of Operations

Operating costs:

Our operating costs and expenses consist primarily of research and development (R&D) expenses. R&D expenses include clinical trial expenses, and increased costs after completion of a Phase III trial, especially for the extensive preparations, and teams of expert consultants, required for an application for product approval.

In addition to clinical trial and post-trial costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, manufacturing process development, quality control process development, and related matters. Additional substantial costs relate to the development and expansion of manufacturing capacity.

Our operating costs also include the costs of preparations for the launch of new or expanded clinical trial programs, such as our anticipated trials of combination treatment regimens. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other.

Our operating costs also include legal and accounting costs in operating the Company.

The foregoing operating costs include the costs for Flaskworks’ ongoing operations and intellectual property filings, and the operations of our subsidiaries in the U.K., the Netherlands and Germany.

Research and development:

R&D expenses include costs for substantial external scientific personnel, technical and regulatory advisers, and others, costs of laboratory supplies used in our internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial operation and management when we are actively engaged in clinical trials.

Because we are a pre-revenue company, we do not allocate R&D costs on a project basis. We adopted this policy, in part, due to the unreasonable cost burden associated with accounting at such a level of detail and our limited number of financial and personnel resources.

General and administrative:

General and administrative expenses include personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal services, property and equipment and amortization of stock options and warrants.

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Three Months Ended September 30, 2024 and 2023

We recognized a net loss of $19.4 million and $23.5 million for the three months ended September 30, 2024 and 2023, respectively.

Research and Development Expense

For the three months ended September 30, 2024 and 2023, research and development expenses were $8.1 million and $7.2 million, respectively. The increase in 2024 was mainly related to an increase of $1.2 million cost incurred from Advent with extensive ongoing work related to the MAA and review process, which was offset by a decrease of $0.5 million related to stock-based compensation.

General and Administrative Expense

For the three months ended September 30, 2024 and 2023, general and administrative expenses were $7.0 million and $7.0 million, respectively.

Change in Fair Value of Derivatives

We recognized a non-cash loss of $1.6 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively. The loss was primarily due to the change of valuation inputs. The healthcare market yield curve rate that was used in the pricing model was significantly decreased as of September 30, 2024 compared to the value as of June 30, 2024. The rate was about the same level as of September 30, 2023 compared to the value as of June 30, 2023.

Change in Fair Value of Convertible Notes

We recognized a non-cash gain of $3.1 million and a non-cash loss of $4.9 million change in fair value of the convertible notes during the three months ended September 30, 2024 and 2023. The non-cash gain was resulted from the decrease of the Company’s stock price and the non-cash loss was resulted from the increase of the Company’s stock price.

Debt Extinguishment

We recognized approximately $6.8 million and $1.8 million debt extinguishment loss during the three months ended September 30, 2024 and 2023 from debt redemptions and debt amendments, respectively. The increase during the three months ended September 30, 2024 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.

Interest Expense

During the three months ended September 30, 2024 and 2023, we recognized interest expense of $2.1 million and $1.7 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.

Foreign currency transaction gain (loss)

During the three months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.8 million and a loss of $1.7 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.

Nine months ended September 30, 2024 and 2023

We recognized a net loss of $55.6 million and $48.6 million for the nine months ended September 30, 2024 and 2023, respectively.

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Research and Development Expense

For the nine months ended September 30, 2024 and 2023, research and development expenses were $24.4 million and $20.3 million, respectively. The increase in 2024 was mainly related to an increase of $2.6 million to unrelated external service providers primarily related to the MAA, the review process and inspections, of which $1.1 million was related to stock-based compensation, which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023. Additionally, research and development expenses from Advent was increased by $1.4 million with extensive ongoing work related to the MAA and review process for the nine months ended in September 30, 2024 compared to the same period of last year.

General and Administrative Expense

For the nine months ended September 30, 2024 and 2023, general and administrative expenses were $24.8 million and $21.6 million, respectively. The increase in 2024 was primarily related to an increase of $3.2 million in legal expenses.

Change in Fair Value of Derivatives

We recognized non-cash gain of $0.9 million and $3.9 million for the nine months ended September 30, 2024 and 2023, respectively. The higher gain in 2023 was mainly due to the non-cash revaluation gain recognized as of January 9, 2023, when we reclassed all warrants from liability classified to equity classified. The stock price on January 9, 2023 and December 31, 2022 was $0.71 and $0.78 per share, respectively.

Change in Fair Value of Convertible Notes

We recognized a non-cash gain of $4.6 million and non-cash loss of $4.9 million in change in fair value of the convertible notes during the nine months ended September 30, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of September 30, 2024 compared to December 31, 2023. The loss was primarily due to the increase in the stock price as of September 30, 2023 compared to the stock price on the issuance date during August and September 2023.

Debt Extinguishment

We recognized approximately $9.9 million and $3.6 million debt extinguishment loss during the nine months ended September 30, 2024 and 2023 from the debt redemption and debt amendments, respectively. The increase during the nine months ended September 30, 2024 compared to last year was mainly due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.

Interest Expense

During the nine months ended September 30, 2024 and 2023, we recorded interest expense of $5.3 million and $4.0 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.

Foreign currency transaction gain (loss)

During the nine months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.0 million and loss of $0.1 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.

Liquidity and Capital Resources

We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of revenues and must cover our operating expenses through debt and equity financings to allow us to continue as a going concern. Our ability to continue as a going concern depends on the ability to obtain adequate capital to fund operating losses until we generate adequate cash flows from operations to fund our operating costs and obligations. If we are unable to obtain adequate capital, we could be forced to cease operations.

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We depend upon our ability, and will continue to attempt, to secure equity and/or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Our management determined that there was substantial doubt about our ability to continue as a going concern for at least one year after the annual consolidated financial statements were issued, and management’s concerns about our ability to continue as a going concern within the year following this report persist.

Cash Flow

Operating Activities

During the nine months ended September 30, 2024 and 2023, net cash outflows from operations were approximately $36.8 million and $36.7 million, respectively. The slight increase in cash used in operating activities was primarily attributable to an increase payment in legal costs.

Investing Activities

We spent approximately $0.9 million and $3.0 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the nine months ended September 30, 2024 and 2023, respectively.

Financing Activities

We received approximately $8.2 million of cash from issuance of 0.8 million shares of Series C convertible preferred stock during the nine months ended September 30, 2024. We received approximately $9.9 million cash from issuance of 0.7 million shares of Series C convertible preferred stock during the nine months ended September 30, 2023.

We received approximately $10.0 million net proceeds from issuance of 33.5 million shares of common stock during the nine months ended September 30, 2024.

We received approximately $9.9 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2024. We received approximately $12.7 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2023.

We received approximately $10.0 million and $10.0 million of cash from the issuance of a loan from a commercial lender during the nine months ended September 30, 2024 and 2023, respectively. We also received $2.0 million of cash from the issuance of a demand note to an individual investor during the nine months ended September 30, 2024.

We received approximately $1.5 million and $1.6 million of cash from the exercise of warrants during the nine months ended September 30, 2024 and 2023, respectively.

We received $50,000 from issuance of non-dilutive funding agreements during the nine months ended September 30, 2024. We received $4.6 million from issuance of non-dilutive funding agreements during the nine months ended September 30, 2023.

We made aggregate debt payments of $1.1 million and $0.2 million during the nine months ended September 30, 2024 and 2023.

Other factors affecting our ongoing funding requirements include the number of staff we employ, the number of sites, number of patients and amount of activity in our clinical trial programs, the costs of further product and process development work relating to our DCVax products, the costs of preparations for Phase II trials, the costs of expansion of manufacturing, and unanticipated developments. The extent of resources available to us will determine which programs can move forward and at what pace.

Off-Balance Sheet Arrangements

Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Market risk represents the risk of loss that may result from the change in value of financial instruments due to fluctuations in its market price. Market risk is inherent in all financial instruments. Market risk may be exacerbated in times of trading illiquidity when market participants refrain from transacting in normal quantities and/or at normal bid-offer spreads. Our exposure to market risk is directly related to derivatives, debt and equity linked instruments related to our financing activities.

Our assets and liabilities are overwhelmingly denominated in U.S. dollars. We do not use foreign currency contracts or other derivative instruments to manage changes in currency rates. We do not now, nor do we plan to, use derivative financial instruments for speculative or trading purposes. However, these circumstances might change.

The primary quantifiable market risk associated with our financial instruments is sensitivity to changes in interest rates. Interest rate risk represents the potential loss from adverse changes in market interest rates. We use an interest rate sensitivity simulation to assess our interest rate risk exposure. For purposes of presenting the possible earnings effect of a hypothetical, adverse change in interest rates over the 12-month period from our reporting date, we assume that all interest rate sensitive financial instruments will be impacted by a hypothetical, immediate 100 basis point increase in interest rates as of the beginning of the period. The sensitivity is based upon the hypothetical assumption that all relevant types of interest rates that affect our results would increase instantaneously, simultaneously and to the same degree. We do not believe that our cash and equivalents have significant risk of default or illiquidity.

The sensitivity analyses of the interest rate sensitive financial instruments are hypothetical and should be used with caution. Changes in fair value based on a 1% or 2% variation in an estimate generally cannot be extrapolated because the relationship of the change in the estimate to the change in fair value may not be linear. Also, the effect of a variation in a particular estimate on the fair value of financial instruments is calculated independent of changes in any other estimate; in practice, changes in one factor may result in changes in another factor, which might magnify or counteract the sensitivities. In addition, the sensitivity analyses do not consider any action that we may take to mitigate the impact of any adverse changes in the key estimates.

Based on our analysis, as of September 30, 2024, the effect of a 100+/- basis point change in interest rates on the value of our financial instruments and the resultant effect on our net loss are considered immaterial.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of September 30, 2024, of the design and operation of our disclosure controls and procedures, as such terms are defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Based on this evaluation, management concluded that, as of such date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Remediation of a Past Material Weakness in Internal Control over Financial Reporting

The Company recognizes the importance of internal controls to ensure accurate financial reporting. Consequently, we designed and implemented remediation measures to address the material weakness previously identified during the quarter ended December 31, 2023, which was due solely to the material weakness over the valuation of debt and derivative liabilities which primarily involved applying an incorrect valuation method using the market price actually paid for certain convertible notes rather than using a Monte Carlo valuation formula. In light of the material weakness, we enhanced our valuation of debt and derivative liability processes. Based on the actions taken, as well as the evaluation of the design of the new controls, management concluded that the material weakness was remediated as of March 31, 2024 and were operating effectively as of September 30, 2024.

Changes in Internal Control over Financial Reporting

No change in internal control over financial reporting occurred during the most recent quarter with respect to our operations, which materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

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Part II - Other Information

Item 1. Legal Proceedings

On December 1, 2022, we filed a Complaint in the United States District Court for the Southern District of New York against certain market makers. The Complaint alleges that the defendants engaged in manipulation of the Company’s stock, in violation of the Securities Exchange Act of 1934 and common law fraud, over a period of years. On March 20, 2023, the defendants filed a Motion to Dismiss the Complaint. On April 10, 2023 we filed an Amended Complaint against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., and Virtu Americas LLC (Northwest Biotherapeutics Inc. v. Canaccord, et al., No. 1:22-cv-10185-GHW-GWG).

Following defendant’s filing of a new Motion to Dismiss (MTD) and various filings on both sides, an oral argument on defendants’ latest Motion to Dismiss was held on November 14, 2023. The Magistrate Judge issued an 85-page Recommendation and Results Opinion (R&R) for review by the Senior Judge. The Magistrate Judge found that the Company had adequately plead all of the elements of its claim of market manipulation, with the exception of producing enough details for calculating actual damages, known as loss causation. On that basis, he granted defendant’s motion to dismiss without prejudice, subject to the Company’s right to replead on just the question of loss causation, finding that such a filing would “not be futile”.

On February 14, 2024, the Senior Judge issued an opinion accepting all the recommendations and findings of the R&R, and gave the Company 30 days to file this limited repleading amendment on loss causation and damages no later than March 15, 2024. On March 15, 2024, the Company filed their more detailed repleading on loss causation and damages. At the end of March, defendants asked for the right to object to the Judge’s findings against them on December 29, 2023 and February 14, 2024. This motion was denied. The defendants then asked for leave to file a new MTD. That motion was granted with a 30-day filing requirement for defendants and a 30-day response time for the Company.

On May 1, 2024, the defendants’ filed a new MTD the Company’s amended repleading complaint, containing the new section on loss causation and damages. On May 31, 2024, the Company responded to the defendants’ new MTD, supporting the Magistrate Judge’s and Senior Judge’s previous opinions, and rejecting the defendants’ objections to the Company’s loss causation repleading and damage formulae.

On June 14, 2024, the defendants filed their last response to the Company’s comments on May 31, 2024, concerning the defendant’s latest MTD. They also asked the Court to schedule an oral argument on the issues raised by these last two filings. There have been no further developments in the case since June. The parties are awaiting the Magistrate’s report and recommendation on loss causation. The Company plans to continue vigorously pursuing this case.

As previously reported, three stockholders filed in the Delaware Court of Chancery three similar derivative lawsuits against the Company and certain of its directors and officers, including J. Cofer Black, Marnix L. Bosch, Alton L. Boynton, Leslie J. Goldman, Jerry Jasinowski, Navid Malik, and Linda F. Powers (the “Individual Defendants”), alleging the Individual Defendants (i) breached their fiduciary duties, and (ii) were unjustly enriched by director and officer compensation awarded in 2020 to the Individual Defendants—notwithstanding the fact that approximately 90% of shareholders voted to approve the Company’s executive compensation (the same compensation that these three stockholders are seeking to challenge) twice (both through its Say on Pay vote at the Company’s Annual Meeting in 2021, and again in a binding vote at the Company’s Annual Meeting in 2022) and approximately 90% of shareholders also voted to approve the director awards at the 2022 Annual Meeting. On March 31, 2022, the Delaware Court of Chancery consolidated these actions into a single action under the caption In re Northwest Biotherapeutics, Inc. Stockholder Litigation (the “Derivative Action”). The descriptions and summary of the lawsuit herein are qualified in their entirety by reference to the proceedings in the Derivative Action, and are described in greater detail by the Company’s June 3, 2024 Definitive Proxy (the “2024 Proxy”).

On December 30, 2022, following the shareholder approvals at the December 2022 Annual Meeting, the Plaintiff filed an Amended Complaint asserting that the shareholder votes should be deemed ineffective. On February 22, 2023, the Individual Defendants and the Company filed a Motion to Dismiss the Amended Complaint. On November 17, 2023, the court issued an oral decision denying the Motion to Dismiss. On December 20, 2023, the Company filed an answer to the Consolidated Amended Complaint. On December 28, 2023, the Individual Defendants, represented by separate counsel, filed their response to the Consolidated Amended Complaint.

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On June 3, 2024, the Company filed the 2024 Proxy which, among other things, asked shareholders to ratify the 2020 option awards that are the subject of the Derivative Action at the Company’s 2024 annual meeting of shareholders (the “2024 Annual Meeting”). On June 20, 2024, the court stayed proceedings in the Derivative Action in light of the potential ratifying effects of the 2024 Annual Meeting. At the Company’s 2024 Annual Meeting, held on June 29, 2024, shareholders holding 88.13% of the shares voted in favor of Proposal 3 (ratification of the 2020 option awards granted to the Company’s four senior executives) and stockholders holding 88.05% of the shares voted in favor of Proposal 4 (ratification of the 2020 option awards granted to the Company’s non-employee directors). On June 30, 2024, the Individual Defendants filed an amended answer to the Consolidated Amended Complaint and have asserted that the claims in the Derivative Action are barred, in whole or in part, by ratification because the Company’s disinterested stockholders ratified the challenged option awards at the 2024 Annual Meeting. The parties are currently seeking guidance from the court regarding the proceedings. On October 31, 2024, the Court gave approval for the parties to file summary judgment motions regarding the effectiveness of stockholder ratification. The Court also permitted discovery regarding ratification.

Item 1A. Risk Factors

Applicable risk factors are set forth in the Company’s report on Form 10-K for the fiscal year ended December 31, 2023.

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

None.

Item 3. Defaults Upon Senior Securities

Not Applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

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Item 6. Exhibits


21.1		Subsidiaries of the Registrant

21.2		Certificate of Incorporation on Change of Name

31.1		Certification of President (Principal Executive Officer and Principal Financial and Accounting Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1		Certification of President, Chief Executive Officer and Principal Financial and Accounting Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document.

101.SCH		Inline XBRL Schema Document.

101.CAL		Inline XBRL Calculation Linkbase Document.

101.DEF		Inline XBRL Definition Linkbase Document.

101.LAB		Inline XBRL Label Linkbase Document.

101.PRE		Inline XBRL Presentation Linkbase Document.

104		The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL (included as Exhibit 101).

* Filed herewith

** Furnished herewith

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	NORTHWEST BIOTHERAPEUTICS, INC

Dated: November 12, 2024	By:	/s/ Linda F. Powers
		Name:	Linda F. Powers


		Title:	President and Chief Executive Officer

			Principal Executive Officer
			Principal Financial and Accounting Officer

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Northwest Biotherapeutics (NWBO) 10-Q2024 Q3 Quarterly report

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