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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended March 31, 2025

OR

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)

(240497-9024

(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 May 12, 2025, the total number of shares of common stock, par value $0.001 per share, outstanding was 1,437,692,257.

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 March 31, 2025 and December 31, 2024

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024

4

 

Condensed Consolidated Statements of Stockholders’ Deficit for the three months ended March 31, 2025 and 2024

5

 

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024

6

 

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

24

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

 

 

Item 4.

Controls and Procedures

29

PART II - OTHER INFORMATION

30

Item 1.

Legal Proceedings

30

 

 

Item 1A.

Risk Factors

31

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

31

 

 

Item 3.

Defaults Upon Senior Securities

31

 

 

Item 4.

Mine Safety Disclosures

31

 

Item 5.

Other Information

31

 

 

Item 6.

Exhibits

32

SIGNATURES

33

2

Table of Contents

PART I - FINANCIAL INFORMATION

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

    

March 31, 

    

December 31, 

2025

2024

(Unaudited)

ASSETS

 

  

 

Current assets:

 

  

 

  

Cash and cash equivalents

$

2,779

$

2,175

Prepaid expenses and other current assets

 

1,907

 

1,887

Total current assets

 

4,686

 

4,062

Non-current assets:

 

 

Property, plant and equipment, net

 

16,288

 

16,196

Right-of-use asset, net

4,246

4,187

Indefinite-lived intangible asset

1,292

1,292

Goodwill

626

626

Other assets

 

367

 

365

Total non-current assets

 

22,819

 

22,666

TOTAL ASSETS

$

27,505

$

26,728

LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

 

 

Current liabilities:

 

 

Accounts payable and accrued expenses

$

20,749

$

16,969

Accounts payable and accrued expenses to related parties and affiliates

 

6,472

 

4,452

Convertible notes, net

 

1,489

 

1,870

Convertible notes at fair value

22,900

18,324

Notes payable, net

 

19,642

 

14,186

Contingent payable derivative liability

9,481

9,578

Warrant liability

 

1,036

 

2,219

Investor advances

207

207

Share payable

693

143

Lease liabilities

390

326

Total current liabilities

 

83,059

 

68,274

Non-current liabilities:

 

 

Convertible notes at fair value, net of current portion

13,044

15,900

Notes payable, net of current portion, net

 

7,069

 

12,396

Lease liabilities, net of current portion

4,471

4,438

Contingent payment obligation

4,700

4,700

Total non-current liabilities

 

29,284

 

37,434

Total liabilities

 

112,343

 

105,708

COMMITMENTS AND CONTINGENCIES (Note 12)

 

 

Mezzanine equity:

Series C Convertible Preferred Stock, 10,000,000 shares designated; 0.9 million and 1.0 million shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively; aggregate liquidation preference of $13.0 million

14,641

15,507

Stockholders’ deficit:

 

 

Preferred stock ($0.001 par value); 100,000,000 shares authorized as of March 31, 2025 and December 31, 2024, respectively

Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,391.3 million and 1,175.5 million shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

 

1,391

 

1,328

Additional paid-in capital

 

1,360,652

 

1,344,720

Stock subscription receivable

 

(79)

 

(79)

Accumulated deficit

 

(1,462,842)

 

(1,443,499)

Accumulated other comprehensive income

 

1,399

 

3,043

Total stockholders’ deficit

 

(99,479)

 

(94,487)

TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

$

27,505

$

26,728

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

3

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share amounts)

(Unaudited)

For the three months ended

March 31, 

    

2025

    

2024

Revenues:

Research and other

$

375

$

284

Total revenues

375

284

Operating costs and expenses:

Research and development

8,351

7,942

General and administrative

9,335

8,086

Total operating costs and expenses

17,686

16,028

Loss from operations

(17,311)

(15,744)

Other income (expense):

Change in fair value of derivative liabilities

1,280

120

Change in fair value of share payable

(23)

(106)

Change in fair value of convertible notes

3,697

1,775

Loss from extinguishment of debt

(7,282)

(2,171)

Loss from warrant modification

Interest expense

(1,602)

(1,518)

Foreign currency transaction gain (loss)

1,898

(668)

Total other expense

(2,032)

(2,568)

Net loss

(19,343)

(18,312)

Deemed dividend related to warrant modifications

(265)

(568)

Net loss attributable to common stockholders

$

(19,608)

$

(18,880)

Other comprehensive income (loss)

Foreign currency translation adjustment

(1,644)

614

Total comprehensive loss

$

(21,252)

$

(18,266)

Net loss per share applicable to common stockholders

Basic and diluted

$

(0.01)

$

(0.02)

Weighted average shares used in computing basic and diluted loss per share

1,359,496

1,188,149

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

4

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)

    

For the Three Months Ended March 31, 2025

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, 2025

    

973

    

$

15,507

 

1,328,622

$

1,328

$

1,344,720

$

(79)

$

(1,443,499)

$

3,043

$

(94,487)

Series C convertible preferred stock conversion

 

(69)

 

(866)

 

1,720

 

2

 

864

 

 

 

 

866

Issuance of common stock for cash, net

 

 

 

22,747

 

23

 

5,100

 

 

 

 

5,123

Warrants exercised for cash

 

 

 

76

 

 

17

 

 

 

 

17

Issuance of common stock for conversion of debt and accrued interest

 

 

 

38,013

 

38

 

9,566

 

 

 

 

9,604

Stock-based compensation

 

 

 

75

 

 

385

 

 

 

 

385

Net loss

 

 

 

 

 

 

 

(19,343)

 

 

(19,343)

Warrant modifications

 

 

 

 

 

265

 

 

 

 

265

Deemed dividend related to warrant modifications

 

 

 

 

 

(265)

 

 

 

 

(265)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

(1,644)

 

(1,644)

Balances at March 31, 2025

 

904

$

14,641

 

1,391,253

$

1,391

$

1,360,652

$

(79)

$

(1,462,842)

$

1,399

$

(99,479)

For the Three Months Ended March 31, 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

    

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

308

 

3,624

 

 

 

 

 

Series C convertible preferred stock conversion

(220)

 

(2,532)

5,493

 

5

 

2,527

2,532

Warrants exercised for cash

 

5,831

 

6

 

1,305

 

 

 

1,311

Cashless warrants and stock options exercise

 

1,633

 

2

 

(2)

 

 

 

Issuance of common stock for conversion of debt and accrued interest

6,942

7

3,945

3,952

Stock-based compensation

 

 

 

1,164

 

 

 

1,164

Net loss

 

 

 

 

(18,312)

 

 

(18,312)

Warrants modfication

 

 

 

1,798

 

 

 

1,798

Deemed dividend related to warrants modification

 

 

 

(568)

 

 

 

(568)

Cumulative translation adjustment

 

 

614

 

614

Balances at March 31, 2024

1,297

$

19,810

1,195,358

$

1,195

$

1,301,485

$

(79)

$

(1,378,033)

$

2,150

$

(73,282)

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

5

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

For the three months ended

March 31, 

    

2025

    

2024

Cash Flows from Operating Activities:

 

Net loss

$

(19,343)

$

(18,312)

Reconciliation of net loss to net cash used in operating activities:

Depreciation and amortization

434

428

Amortization of debt discount

334

576

Change in fair value of derivatives

(1,280)

(120)

Change in fair value of share payable

23

106

Change in fair value of convertible notes

(3,697)

(1,775)

Loss from extinguishment of debt

7,282

2,171

Amortization of operating lease right-of-use asset

64

77

Stock-based compensation for services

385

1,164

Subtotal of non-cash charges

3,545

2,627

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

2

(477)

Other non-current assets

2

(8)

Accounts payable and accrued expenses

4,375

4,531

Related party accounts payable and accrued expenses

2,020

(810)

Lease liabilities

(19)

43

Net cash used in operating activities

(9,418)

(12,406)

Cash Flows from Investing Activities:

Purchase of equipment and construction in progress

(93)

(239)

Net cash used in investing activities

(93)

(239)

Cash Flows from Financing Activities:

Proceeds from issuance of Series C convertible preferred stock

3,624

Proceeds from issuance of common shares

5,123

Proceeds from exercise of warrants

17

1,311

Proceeds from issuance of notes payable, net

5,000

Proceeds from issuance of convertible notes payable, net

2,200

7,100

Proceeds from contingent payment obligation

50

Repayment of notes payable

(71)

Repayment of convertible notes payable

(536)

Net cash provided by financing activities

11,733

12,085

Effect of exchange rate changes on cash and cash equivalents

(1,618)

912

Net increase in cash and cash equivalents

604

352

Cash and cash equivalents, beginning of the period

2,175

2,126

Cash and cash equivalents, end of the period

$

2,779

$

2,478

Supplemental disclosure of cash flow information

Interest payments on notes payable

$

(89)

$

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

6

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

For the three months ended

March 31, 

    

2025

    

2024

Supplemental schedule of non-cash activities:

 

  

 

Cashless warrants and stock options exercise

$

$

2

Issuance of common stock for conversion of debt and accrued interest

$

9,604

$

3,952

Series C convertible preferred stock conversion

$

866

$

2,532

Capital expenditures included in accounts payable

$

171

$

500

Deemed dividend related to warrant modifications

$

265

$

568

Debt discount related to warrant modifications

$

$

8

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

7

Table of Contents

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, 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. The Company is also in the process of restarting its DCVax®-Direct program for inoperable tumors.

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 $19.3 million for the three months ended March 31, 2025. The Company used approximately $9.4 million of cash in its operating activities during the three months ended March 31, 2025.

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.

8

Table of Contents

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 March 31, 2025, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three months ended March 31, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025 or for any future interim period. The condensed consolidated balance sheet at December 31, 2024 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2024 and notes thereto included in the Company’s annual report on Form 10-K (the “2024 Annual Report”), which was filed with the SEC on March 31, 2025.

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.

Segment Information

The Company operates in one operating segment for the purposes of assessing performance, making operating decisions, and allocating Company resources. The Company’s chief operating decision maker (CODM) is its chief executive officer, who considers net loss to evaluate overall expenses associated with conducting research and development activities, which includes evaluating the progress of ongoing clinical trials and the planning and execution of current and future research and development activities. Further, the CODM reviews and utilizes functional expenses (research and development and general and administrative) as reported in the consolidated statements of operations to manage the Company’s operations. The measure of performance, significant expenses, and other items are each reflected in the consolidated statements of operations. The accounting policies of the Company’s single reportable segment are the same as those for the consolidated financial statements. The level of disaggregation and amounts of significant segment expenses that are regularly provided to the CODM are the same as those presented in the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total assets.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2024 Annual Report.

9

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Recently Adopted Accounting Standards

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 adopted this standard as of January 1, 2025. The adoption of this ASU did not have any material impact on the Company’s quarterly condensed consolidated financial statements.

Recently Issued Accounting Standards Not Yet Adopted

Disaggregation of Income Statement Expenses

In November 2024, the FASB issued ASU No. 2024-03 (“ASU 2024-03”), Disaggregation of Income Statement Expenses (DISE) which requires disaggregated disclosure of income statement expenses for public business entities. The standard requires public business entities to disclose disaggregated information about specific natural expense categories underlying certain income statement expense line items that are considered relevant. The FASB also issued ASU No. 2025-01 (“ASU 2025-01”), Clarifying the Effective Date, which clarifies the adoption date of ASU 2024-03 as annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the potential effect of this accounting standard update on its consolidated financial statements and related disclosures.

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.

10

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of March 31, 2025 and December 31, 2024 (in thousands):

Fair value measured at March 31, 2025

    

    

Quoted prices in active

    

Significant other

    

Significant

    

Fair value at

markets

observable inputs

unobservable inputs

March 31, 2025

    

(Level 1)

    

(Level 2)

    

(Level 3)

Warrant liability

$

1,036

$

$

$

1,036

Contingent payable derivative liability

9,481

9,481

Convertible notes at fair value

 

35,944

 

 

 

35,944

Share payable

693

693

Total fair value

$

47,154

$

$

$

47,154

Fair value measured at December 31, 2024

    

    

Quoted prices in active

    

Significant other

    

Significant

Fair value at

markets

observable inputs

unobservable inputs

    

December 31, 2024

    

(Level 1)

    

(Level 2)

    

(Level 3)

Warrant liability

$

2,219

$

$

$

2,219

Contingent payable derivative liability

9,578

9,578

Convertible notes at fair value

34,224

34,224

Share payable

 

143

 

 

 

143

Total fair value

$

46,164

$

$

$

46,164

There were no transfers between Level 1, 2 or 3 during the three-month period ended March 31, 2025.

The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2025. 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, 2025

$

2,219

$

9,578

$

143

$

34,224

$

46,164

Additional share payable

625

625

Issuance of convertible notes at fair value

2,200

2,200

Redemption of share payable

(98)

(98)

Additions from debt extinguishment

5,642

5,642

Debt repayment

(525)

(525)

Debt conversion

(1,900)

(1,900)

Change in fair value

(1,183)

(97)

23

(3,697)

(4,954)

Balance - March 31, 2025

$

1,036

$

9,481

$

693

$

35,944

$

47,154

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities, share payable, and contingent conversion feature (excluding the piggy-back right, which was based on key milestone estimates, see Note 7 for piggy-back rights) that are categorized within Level 3 of the fair value hierarchy as of March 31, 2025 and

11

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

December 31, 2024 is as follows. 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 March 31, 2025

    

    

Share Payable

    

Warrant Liability

Strike price

$

0.24

$

0.25

Contractual term (years)

 

0.03

0.32

Volatility (annual)

 

59

%  

60

%

Risk-free rate

 

1.8

%  

4.3

%

Dividend yield (per share)

 

0

%  

0

%

As of December 31, 2024

    

Share Payable

    

Warrant Liability

 

Strike price

$

0.25

$

0.25

Contractual term (years)

0.08

 

0.58

Volatility (annual)

60

%  

 

66

%

Risk-free rate

4.3

%  

 

4.2

%

Dividend yield (per share)

0

%  

 

0

%

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three months ended March 31, 2025 and 2024 (in thousands).

For the three months ended

March 31, 

    

2025

    

2024

Research and development

$

365

$

1,009

General and administrative

 

20

155

Total stock-based compensation expense

$

385

$

1,164

The total unrecognized stock compensation (primarily for consultants) cost was approximately $1.5 million as of March 31, 2025 and will be recognized over the next 1.8 years.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Stock Options

The following table summarizes stock option activity for options during the three months ended March 31, 2025 (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, 2025

 

316,826

$

0.35

5.0

$

3,932

Granted

250

0.25

5.0

Outstanding as of March 31, 2025

 

317,076

$

0.35

4.8

$

10

Options vested (1)

 

282,984

$

0.33

4.7

$

10

(1)

183 million of the 283 million stock options are subject to agreements (the “Blocker Letter Agreements”) under which they are subject to a restriction that the options may only be exercised if the Company has sufficient authorized shares available for issuance.

Restricted Stock Awards

Advent SOW 6

There was no stock based compensation related to Statement of Work #6 (“SOW 6”) recognized during the three months ended March 31, 2025 and 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 March 31, 2025, 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.

6. Property, Plant and Equipment

Property, plant and equipment consist of the following at March 31, 2025 and December 31, 2024 (in thousands):

    

March 31,

    

December 31,

    

Estimated

2025

2024

Useful Life

Leasehold improvements

$

18,397

$

17,973

 

Lesser of lease term or estimated useful life

Office furniture and equipment

 

569

 

531

 

3-5 years

Computer and manufacturing equipment and software

 

3,316

 

3,160

 

3-5 years

Land in the United Kingdom

 

88

 

85

 

NA

 

22,370

 

21,749

 

NA

Less: accumulated depreciation

 

(6,082)

 

(5,553)

 

  

Total property, plant and equipment, net

$

16,288

$

16,196

 

  

Depreciation and amortization expense was approximately $0.4 million and $0.4 million for the three months ended March 31, 2025, and 2024, respectively.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

7. Outstanding Debt

The following two tables summarize outstanding debt as of March 31, 2025 and December 31, 2024, 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

%  

$

0.20

1,355

(1)

 

 

1,354

1,490

(1)

1,489

Short term convertible notes at fair value

0% unsecured

1/19/2026

0

%  

Variable

3,100

307

3,407

8% unsecured

Various

8

%  

$

0.27

1,000

157

1,157

11% unsecured

Various

11

%  

$

0.21 - $0.32

15,225

3,111

18,336

19,325

3,575

22,900

Short term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

 

  

0% unsecured

On Demand

0

%  

N/A

2,140

2,140

6% secured

 

3/25/2025

 

6

%  

 

N/A

 

182

 

 

 

182

8% unsecured

 

Various

 

8

%  

 

N/A

 

17,555

 

(798)

 

 

16,757

12% unsecured

 

On Demand

 

12

%  

 

N/A

 

563

 

 

 

563

 

20,440

 

(798)

 

 

 

19,642

Long term convertible notes at fair value

11% unsecured

Various

11

%  

$

0.20 - $0.38

10,765

2,279

13,044

10,765

2,279

13,044

Long term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

 

8% unsecured

 

Various

 

8

%  

 

N/A

 

7,710

 

(641)

 

 

7,069

 

Ending balance as of March 31, 2025

$

59,730

$

(1,440)

$

5,854

$

64,144

(1)This note was paid in full on April 25, 2025.

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NORTHWEST BIOTHERAPEUTICS, INC.

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

2/21/2025

8

%  

$

0.50

*

1,760

(25)

1,735

1,895

(25)

1,870

Short term convertible notes at fair value

8% unsecured

2/15/2025

8

%  

$

0.27

1,000

95

1,095

10% unsecured

1/11/2025

10

%  

$

0.35

500

46

546

11% unsecured

Various

11

%  

$

0.26-$0.46

15,250

1,433

16,683

16,750

1,574

18,324

Short term notes payable

 

  

 

  

 

  

 

 

  

 

 

  

0% unsecured

On Demand

0

%  

N/A

2,140

2,140

6% secured

3/25/2025

6

%  

N/A

247

247

8% unsecured

 

Various

 

8

%  

 

N/A

 

11,660

 

(424)

 

 

11,236

12% unsecured

 

On Demand

 

12

%  

 

N/A

 

563

 

 

 

563

 

14,610

 

(424)

 

 

14,186

Long term convertible notes at fair value

0% unsecured

1/19/2026

0

%  

Variable

5,000

918

5,918

11% unsecured

Various

11

%  

$

0.29-$0.38

8,565

1,417

9,982

13,565

2,335

15,900

Long term notes payable

8% unsecured

 

Various

 

8

%  

 

N/A

 

13,210

 

(814)

 

 

12,396

Ending balance as of December 31, 2024

$

60,030

$

(1,263)

$

3,909

$

62,676

* These convertible notes are convertible into Series C preferred shares at $12.50 per share. Each Series C preferred share is convertible into common shares after a 30-day restriction period. The conversion price in common share equivalent is $0.50 per share.

Notes Payable

On March 7, 2025, the Company entered into a Commercial Loan Agreement (the “March Commercial Loan”) with a commercial lender for an aggregate principal amount of $5.5 million. The March 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 March Commercial Loan is amortized in 14 installments starting on May 7, 2026. The March Commercial Loan carries an original issue discount of $0.5 million.

During the three months ended March 31, 2025, the Company issued approximately 27.9 million shares of common stock with a fair value of 7.3 million to certain lenders in lieu of cash payments of $6.2 million of debt, including $1.1 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 three months ended March 31, 2025, the Company settled $0.1 million of Share payables and accrued $0.6 million of Share payables. The Company recognized an approximately $1.6 million debt extinguishment loss during the three months ended March 31, 2025 from the debt redemption.

Convertible Notes

During the three months ended March 31, 2025, the Company modified an existing $1.7 million convertible note by extending the maturity dates and reducing the conversion price (the “Amended Convertible Note”). The modification was accounted for as a debt extinguishment as the conversion feature of the amended note was substantially different from the original terms. As a result, the Company recognized approximately $6,000 of debt extinguishment gain during the three months ended March 31, 2025 from this debt amendment.

In addition, the Company converted $0.4 million of the Amended Convertible Note including $31,000 accrued interest into 2.1 million shares of common stock at a conversion price of $0.20 per share.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Convertible Notes at Fair Value

During the three months ended March 31, 2025, 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 $2.2 million. The Long-term Convertible Notes bear interest at 11% per annum and are convertible into common shares between $0.20 and $0.245 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.

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 three months ended March 31, 2025, the Company modified certain existing convertible notes 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 $5.6 million of debt extinguishment loss during the three months ended March 31, 2025 from these debt amendments.

During the three months ended March 31, 2025, the Company converted $1.9 million of certain convertible notes that were originally issued in December 2024 into 8.0 million shares of common stock at a weighted average conversion price of $0.24 per share.

For the three months ended March 31, 2025 and 2024, interest expense related to outstanding debt totaled approximately $1.6 million and $1.5 million including amortization of debt discounts totaling $0.3 million and $0.6 million, respectively.

8. Net Loss per Share Applicable to Common Stockholders

Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share would be computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Because of the net loss from operations for each period, inclusion of such securities in the computation of loss per share would be anti-dilutive and thus they are excluded. Potentially dilutive weighted average common shares include common stock potentially issuable under the Company’s convertible notes and preferred stock, warrants and vested and unvested stock options.

The following securities were not included in the diluted net loss per share calculation because their effect was anti-dilutive as of the periods presented (in thousands):

For the three months ended

March 31, 

    

2025

    

2024

Series C convertible preferred stock

22,599

32,420

Common stock options

317,076

316,926

Common stock warrants - equity classified

60,422

97,040

Common stock warrants - liability classified

32,497

Convertible notes and accrued interest

137,267

 

60,929

Potentially dilutive securities

569,861

507,315

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).

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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 year until July 2025.

SOW 8

On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that is 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 cash milestone payments 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 as work was 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 the following 5 one-time milestones with corresponding milestone payments (which are only payable after the milestone has been achieved):

(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.

As of March 31, 2025, this milestone had been completed and paid.

(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 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.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.6 million as of March 31, 2025 related to this milestone.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

(c) Process Development: Existing and New Product Composition.

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.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.8 million as of March 31, 2025 related to this milestone.

(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.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company recognized an incremental accrued liability of $0.3 million during the three months ended March 31, 2025. The Company had an accrued liability of $0.5 million as of March 31, 2025 related to this milestone.

(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.

As of March 31, 2025, this milestone had not been completed. The Company recognized an incremental accrued liability of $0.2 million related to a future cash milestone payment that the Company anticipates will be achieved and earned over the course of the contract period during the three months ended March 31, 2025. The Company had an accrued liability of $0.3 million as of March 31, 2025 related to this milestone.

The following table summarizes total research and development costs from Advent for the three months ended March 31, 2025 and 2024, respectively (in thousands).

For the three months ended

March 31,

    

2025

    

2024

Advent BioServices

  

  

Manufacturing cost in London

1,937

$

1,726

Manufacturing cost at Sawston facility

 

3,377

 

2,652

SOW 8 one-time milestones - Cash

 

 

Expensed and due, but unpaid (milestone complete) (1)

 

285

 

Expensed but unpaid, not yet due (milestone not yet complete) (2)

 

200

 

Total

$

5,799

$

4,378

(1)This covers one-time milestone: Technology transfer: clean room implementation.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

(2)This convers one-time milestone: Draft new IMPD (Investigational Medicinal Product Dossier) and new IND (CMC section).

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 $7.44 per square foot based on exchange rate as of March 31, 2025), 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 March 31, 2025 and 2024, the Company recognized sub-lease income of $36,000 and $36,000, respectively.

Related Party Accounts Payable

As of March 31, 2025 and December 31, 2024, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section.

    

March 31, 

    

December 31, 

2025

2024

Advent BioServices - amount invoiced but unpaid

$

3,227

$

1,692

Advent BioServices - amount accrued but unpaid (1)

3,245

2,760

Total payable and accrued, but unpaid to Advent BioServices

$

6,472

$

4,452

(1) This includes $1.1 million which is not payable in cash but represents the value of 1.5 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for submission of the MAA application to MHRA on December 20, 2023. Such shares were not issued as of March 31, 2025, 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 three months ended March 31, 2025, approximately 0.1 million Series C Shares with a book value of $0.9 million were converted into 1.7 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

During the three months ended March 31, 2025, the Company received $5.1 million from the issuance of 22.7 million shares of common stock.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Stock Purchase Warrants

The following is a summary of warrant activity for the three months ended March 31, 2025 (dollars in thousands, except per share data):

    

Number of

    

Weighted Average

    

Remaining

Warrants

Exercise Price

Contractual Term

Outstanding as of January 1, 2025

 

94,199

$

0.28

 

2.20

Warrants exercised for cash

 

(76)

 

0.23

 

Warrants expired and cancellation

 

(1,204)

 

0.34

 

Outstanding as of March 31, 2025 (1)

 

92,919

$

0.28

 

1.99

(1)At March 31, 2025, of the approximately 93 million total outstanding warrants listed above, approximately 90 million warrants were under Blocker Letter Agreements or suspension agreements.

Warrant Modifications

During the three months ended March 31, 2025, the Company amended certain warrants whereby the maturity dates were extended for an additional approximately 3-6 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

$

0.28

$

0.28

Expected term (in years)

 

3.2

 

2.9

Volatility

 

71

%  

 

71

%

Risk-free interest rate

 

3.9

%  

 

3.9

%

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 $0.3 million which 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.

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.

The Company’s current office lease in the U.K. will expire in July 2025. In January 2025, the Company entered into a new office lease agreement for the U.K. (the “2025 U.K. Office Lease”). The commencement date for the 2025 U.K. Office Lease is expected to be between May 2025 and November 2025, when the buildout of the office is completed and the Company gains the access to the leased property. The 2025 U.K. Office Lease will expire 5 years after the commencement date. As of March 31, 2025, the Company has not taken possession of the premises.

On August 22, 2024, the Company extended its office lease in the U.S for an 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.

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

At March 31, 2025, the Company had operating lease liabilities of approximately $4.9 million for both the 20-year lease of the building for the manufacturing facility in Sawston, U.K., and the current office lease in the U.S. and ROU assets of approximately $4.2 million for the Sawston lease and U.S. office lease are included in the condensed consolidated balance sheet.

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 $7.44 per square foot based on exchange rate as of March 31, 2025), 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 2025. 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 $711,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

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

For the three months ended

March 31, 2025

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

154

$

53

$

207

Short-term lease cost

 

13

 

 

13

Variable lease cost

 

 

 

Sub-lease income

 

(36)

 

 

(36)

Total

$

131

$

53

$

184

Other information

 

 

 

Operating cash flows from operating leases

$

(164)

$

(23)

$

(187)

Weighted-average remaining lease term – operating leases

 

7.2

 

1.1

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

For the three months ended

March 31, 2024

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

156

$

65

$

221

Short-term lease cost

 

13

 

 

13

Variable lease cost

 

 

6

 

6

Sub-lease income

(36)

(36)

Total

$

133

$

71

$

204

Other information

 

 

 

Operating cash flows from operating leases

$

(166)

$

(75)

$

(241)

Weighted-average remaining lease term – operating leases

 

7.7

 

0.4

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2025 and 2024, respectively.

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

Nine months ended December 31, 2025

$

714

Year ended December 31, 2026

    

863

Year ended December 31, 2027

673

Year ended December 31, 2028

673

Year ended December 31, 2029

673

Thereafter

6,033

Total

9,629

Less present value discount

(4,768)

Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2025

$

4,861

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

Nine months ended December 31, 2025

    

$

108

Year ended December 31, 2026

 

145

Year ended December 31, 2027

 

145

Year ended December 31, 2028

 

145

Year ended December 31, 2029

 

145

Thereafter

 

1,305

Total

$

1,993

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 ($6.1 million).

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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 March 31, 2025, the Company accrued for trade tax liability of €155,000 (approximately $168,000) and corporation tax of €99,000 (approximately $107,000). Based on the Company’s current operating state in Germany and the negotiations, the Company believes, based on its evaluation under ASC 740, that the resolution of these tax matters will not likely result in a net material charge to the Company.

Other Contingent Payment Obligation

As of March 31, 2025, the Company had contingent payment obligation of $4.7 million, which are related to a gain contingency from non-dilutive funding agreements with various investors. 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 April 1, 2025 and May 9, 2025, the Company received $5.5 million in funding from the sale of common shares, proceeds from warrant exercise, and proceeds of debt arrangements.

Between April 1, 2025 and May 9, 2025, the Company issued approximately 24.4 million shares of common stock for proceeds of $5.2 million.

Between April 1, 2025 and May 9, 2025, the Company entered into several 2-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $0.3 million. The Convertible Notes bear interest at 11% per annum and are convertible into common shares at $0.19 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 April 1, 2025 and May 9, 2025, the Company issued approximately 8.3 million shares of common stock to certain lenders in lieu of cash payments of $2.7 million of debt, including $0.2 million interest. The Company also issued 3.7 million shares of common stock to extinguish $0.9 million outstanding share liability.

Between April 1, 2025 and May 9, 2025, $2 million of convertible note was converted into 9.5 million shares of common stock pursuant to the conversion option.

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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, 2024 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 three months of 2025, the Company continued its progress on multiple fronts, including the following.

MAA Application. The Company and its teams of consultants continued to be actively engaged in the MAA process. 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.

Manufacturing Scale-Up in the Sawston, UK Facility. The Company and Advent proceeded with detailed planning for buildout and equipping of the simplified C lab in the Sawston, UK facility, including contractor and vendor arrangements. Advent devised arrangements to obtain essential equipment for the C lab quickly, and avoid the delivery lead times of 10-12 months. The simplified C lab will enable a substantial scale-up of production capacity in Sawston. As previously reported, the simplified Grade C lab will be adjacent to an existing Grade B lab, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. This will enable the simplified Grade C lab to be completed for a fraction of the cost and less than half the time for regular Grade C labs.

Manufacturing in the US. The Company continued its discussions with GMP facilities in several states to obtain capacity and availability for potential manufacturing in the US. The Company anticipates reaching an agreement during this summer. The manufacturing is initially contemplated to include DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh, and then DCVax products.

DCVax-Direct Program. The Company believes it is on track to submit the initial INDs during Q2 of this year, as previously projected, for clinical trials of the Company’s new DCVax-Direct product. The trials are designed to be compact and streamlined, by using Simon two-stage designs to start small (e.g., with just 12-20 patients) and then expand if encouraging results are seen, and by focusing on tumor response endpoints. These trials are the culmination of two years of technology transfer and process development work to establish manufacturing for DCVax-Direct products in Sawston, and to develop a new version of DCVax-Direct to replace an ingredient for which there is a persistent worldwide shortage. During Q1, the final stages of the process were being carried out, including engineering runs and validations.

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Enhanced DCVax-Direct Products and Upcoming Presentation. The Company continued its internal testing of certain immune booster agents that it has in-licensed, to identify the most useful booster agent(s) and combination(s) of agents for enhanced DCVax-Direct products. The Company currently anticipates making a presentation about this at a scientific conference in June. The Company is also in discussions with clinicians about which version(s) of enhanced DCVax-Direct products should be selected and for which cancers for the initial clinical trials.

Clinical Trials With Roswell and Pittsburgh Technologies. The Company has continued working with Dr. Kalinski and leading clinicians to develop arrangements for compact Simon 2-stage clinical trials of two dendritic cell treatments from the Roswell and Pittsburgh portfolios: DCs loaded with abnormal tumor blood vessel antigens (TBVA), and intra-tumoral injection of unloaded DCs (prepared differently than the Company’s DCVax-Direct products). The US manufacturing arrangements described above will need to be completed to supply the products for these trials.

Technology Targeting In Vivo DCs. While the clinical trials of the Roswell/Pittsburgh DC technologies are waiting for the US manufacturing agreement to be reached and implemented, the Company has identified another technology in the Roswell/Pittsburgh portfolios that could proceed with clinical testing in the meantime. This technology is designed to mobilize the “endogenous” (resident) DCs inside the patient’s body through cytokine conditioning regimens. The treatment agents are biologics, not cells themselves. As a comparison: for DCVax-L, the DC precursor cells are matured and activated ex vivo in the manufacturing facility, and are also “educated” ex vivo by exposure to tumor material in the manufacturing facility. For DCVax-Direct, the maturation and activation take place ex vivo, but the “education” takes place in vivo when the DCs are injected into the tumor and are exposed to the tumor material there. With the cytokine conditioning regimens, all of the steps take place in vivo in the patient’s body. The Company believes this technology can complement the Company’s cell therapies (for example, where patients have exhausted their DCVax doses).

Compassionate Use Programs. The Company continues to receive an ongoing stream of patient requests for compassionate use of DCVax therapies for a variety of cancers. The Company has previously treated compassionate use cases involving a variety of solid tumor cancers with its DCVax therapies. The Company believes that those compassionate use cases have been helpful for the patients involved, and have also generated useful real world data. The Company is expanding its compassionate use programs.

Litigation Progress. The Company continued to vigorously pursue its lawsuit against certain market makers. The Company received a favorable Report and Recommendation from the Magistrate on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: loss causation. The Company also received a favorable decision from the court related to the Defendants’ Motion to Dismiss the Company’s Complaint. The case will now proceed into the long-awaited discovery stage. The Company believes the litigation activities are making important progress, and the Company plans to continue pursuing the cases vigorously. See Part II Item 1, Legal Proceedings, below.

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, 2024. 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, 2024.

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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.

Three Months Ended March 31, 2025 and 2024

We recognized a net loss of $19.3 million and $18.3 million for the three months ended March 31, 2025 and 2024, respectively.

Research and Development Expense

For the three months ended March 31, 2025 and 2024, research and development expenses were $8.4 million and $7.9 million, respectively. The increase in 2025 was primarily related to an increased cost related to MAA application at the MHRA and the resumption of DCVax-Direct production, and offset by a decrease in stock-based compensation.

General and Administrative Expense

For the three months ended March 31, 2025 and 2024, general and administrative expenses were $9.3 million and $8.1 million, respectively. The increase was mainly related to legal costs.

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Change in Fair Value of Derivatives

We recognized a non-cash gain of $1.3 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively. The gain was primarily due to the decrease of our closing stock price as of March 31, 2025 and 2024 compared to December 31, 2024 and 2023. The higher gain in 2025 was mainly due to the non-cash revaluation gain recognized as of March 31, 2025 for certain warrants that were reclassified in liability in December 2024.

Change in Fair Value of Convertible Notes

We recognized a non-cash gain of $3.7 million and $1.8 million change in fair value of the convertible notes during the three months ended March 31, 2025 and 2024. The non-cash gain was resulted from the decrease of the Company’s stock price.

Debt Extinguishment

We recognized approximately $7.3 million and $2.2 million debt extinguishment loss during the three months ended March 31, 2025 and 2024 from debt redemptions and debt amendments, respectively. The increase during the three months ended March 31, 2025 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 March 31, 2025 and 2024, we recognized interest expense of $1.6 million and $1.5 million, respectively. The increase in interest expense in 2025 was mainly related to an increase of outstanding debt balance.

Foreign currency transaction gain (loss)

During the three months ended March 31, 2025 and 2024, we recognized foreign currency transaction gain of $1.9 million and a loss of $0.7 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.

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.

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 three months ended March 31, 2025 and 2024, net cash outflows from operations were approximately $9.4 million and $12.4 million, respectively. The decrease in cash used in operating activities was primarily attributable to lower payments for clinical trial related expenditures, insurance costs and certain consulting expenditures.

Investing Activities

We spent approximately $0.1 million and $0.2 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the three months ended March 31, 2025 and 2024, respectively.

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Financing Activities

We received approximately $5.1 million cash from issuance of 22.7 million shares of common stock during the three months ended March 31, 2025.

We received approximately $3.6 million cash from issuance of 0.3 million shares of Series C convertible preferred stock during the three months ended March 31, 2024.

We received approximately $2.2 million and $7.1 million of cash from issuance of convertible notes to individual lenders during the three months ended March 31, 2025 and 2024, respectively.

We received approximately $5.0 million of cash from the issuance of a loan from a commercial lender during the three months ended March 31, 2025.

We received approximately $17,000 and $1.3 million of cash from the exercise of warrants during the three months ended March 31, 2025 and 2024, respectively.

We received $50,000 from issuance of non-dilutive funding agreements during the three months ended March 31, 2024.

We made aggregate debt payments of $0.6 million during the three months ended March 31, 2025.

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.

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.

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Based on our analysis, as of March 31, 2025, 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.

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 March 31, 2025, 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.

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. The Court never answered the defendants’ request for an oral argument. On January 31, 2025, the Magistrate Judge issued his second R&R dismissing in part the defendants latest MTD on the basis of plaintiff’s having met the requirements of dismissal based on short-term damages but did not approve it based on the pleadings to date based on longer-term damages.

On February 14, 2025, both Plaintiffs and Defendants filed their respective comments on this latest R&R from the Magistrate Judge and on February 28, 2025, each party filed comments on the other parties February 14, 2025 filings. On March 5, 2025, defendants once again filed a motion seeking an oral argument on the most recent issues raised in the Magistrate Judge’s R&R, and on March 6, 2025, Senior Judge Woods denied the motion in writing without prejudice.

On March 26, 2025, Senior Judge Woods issued his opinion adopting Magistrate Stein’s R&R. On April 4, 2025 the Court granted an extension to the defendants to respond to plaintiffs Second Amended Complaint by April 25, 2025.

This was followed on April 23, 2025 by an Initial Case Management Conference Order for June 5, 2025, requiring the submission of a Joint Proposed Case Management Plan no later than one week prior to the scheduled Conference. Plaintiffs and defendants are currently negotiating that Plan with a major focus on the imminent discovery schedule.

The Company plans to continue its vigorous pursuit of 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, 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

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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.

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.

On December 2, 2024, the Individual Defendants filed their motion for summary judgment and brief in support thereof, arguing that the court should enter judgment in favor of the Individual Defendants on the basis of the stockholders’ June 29, 2024 ratification vote. On January 21, 2025, the Plaintiff—who held approximately 0.00089% of the Company’s outstanding shares of stock as of the ratification record date—served discovery requests. On February 14, 2025, the Court issued a letter opinion ruling that allowing Plaintiff to proceed with “full-blown, plenary discovery” would “defeat[] the purpose” of ratification, because that approach “fails to recognize that the [ratification] vote fundamentally altered the factual landscape of the case.” The Court concluded that “the most efficient framework for addressing the effect of the [ratification] vote” is for the Plaintiff to “serve requests for production of documents that seek to obtain the same types of materials regarding the vote that they could have obtained using [8 Del. C. § 220],” then “file an amended and supplemental complaint that pleads [his] bases for challenging the effectiveness of the vote.” As a result of its decision, the Court denied the Individual Defendants’ motion without prejudice.

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, 2024.

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 March 31, 2025, 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: May 15, 2025

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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