Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2023March 31, 2024

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 NovemberMay 6, 2023,2024, the total number of shares of common stock, par value $0.001 per share, outstanding was 1,153,846,907.1,208,177,416.

Table of Contents

NORTHWEST BIOTHERAPEUTICS, INC.

FORM 10-Q

TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION

3

Item 1.

Condensed Consolidated Interim Financial Statements (Unaudited)

 

Condensed Consolidated Balance Sheets as of September 30, 2023March 31, 2024 and December 31, 20222023

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30,March 31, 2024 and 2023 and 2022

4

 

Condensed Consolidated Statements of Stockholders’ Deficit for the three and nine months ended September 30,March 31, 2024 and 2023 and 2022

5

 

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30,March 31, 2024 and 2023 and 2022

76

 

Notes to Condensed Consolidated Financial Statements

98

Item 2.

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

2623

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3127

 

 

Item 4.

Controls and Procedures

3228

PART II - OTHER INFORMATION

3329

Item 1.

Legal Proceedings

3329

 

 

Item 1A.

Risk Factors

3329

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3329

 

 

Item 3.

Defaults Upon Senior Securities

3430

 

 

Item 4.

Mine Safety Disclosures

3430

 

Item 5.

Other Information

3430

 

 

Item 6.

Exhibits

3430

SIGNATURES

3531

2

Table of Contents

PART I - FINANCIAL INFORMATION

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

    

September 30, 

    

December 31, 

    

March 31, 

    

December 31, 

2023

2022

2024

2023

(Unaudited)

(Unaudited)

ASSETS

 

  

 

 

  

 

Current assets:

 

  

 

  

 

  

 

  

Cash and cash equivalents

$

6,097

$

6,965

$

2,478

$

2,126

Prepaid expenses and other current assets

 

1,745

 

2,460

 

2,470

 

1,999

Share receivable

610

Total current assets

 

8,452

 

9,425

 

4,948

 

4,125

Non-current assets:

 

 

 

 

Property, plant and equipment, net

 

16,751

 

13,418

 

17,268

 

17,278

Construction in progress

2,028

Right-of-use asset, net

4,014

4,189

4,070

4,183

Indefinite-lived intangible asset

1,292

1,292

1,292

1,292

Goodwill

626

626

626

626

Other assets

 

357

 

345

 

363

 

361

Total non-current assets

 

23,040

 

21,898

 

23,619

 

23,740

TOTAL ASSETS

$

31,492

$

31,323

$

28,567

$

27,865

LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable and accrued expenses

$

12,331

$

10,687

$

15,089

$

10,244

Accounts payable and accrued expenses to related parties and affiliates

 

4,716

 

6,955

 

2,734

 

3,544

Convertible notes, net

 

3,451

 

135

 

5,612

 

3,765

Convertible notes at fair value

10,250

16,496

12,771

Notes payable, net

 

8,198

 

15,403

 

12,125

 

3,944

Contingent payable derivative liability

8,882

8,668

9,099

9,188

Warrant liability

 

1,019

 

80,559

 

913

 

944

Investor advances

7

2,566

7

7

Share liability

678

120

483

Lease liabilities

369

354

245

314

Total current liabilities

 

49,223

 

126,005

 

62,440

 

45,204

Non-current liabilities:

 

 

 

 

Notes payable, net of current portion, net

 

11,038

 

5,991

 

10,215

 

20,312

Lease liabilities, net of current portion

4,134

4,370

4,384

4,454

Contingent payment obligation

4,550

5,000

4,950

Total non-current liabilities

 

19,722

 

10,361

 

19,599

 

29,716

Total liabilities

 

68,945

 

136,366

 

82,039

 

74,920

COMMITMENTS AND CONTINGENCIES (Note 12)

 

 

 

 

Mezzanine equity:

Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.8 million and 1.4 million shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively; aggregate liquidation preference of $26.0 million and $22.3 million as of September 30, 2023 and December 31, 2022, respectively

27,666

23,060

Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.3 million and 1.2 million shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $18.1 million

19,810

18,718

Stockholders’ deficit:

 

 

 

 

Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively

Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,145.1 million and 1,068.4 million shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

1,145

 

1,068

Preferred stock ($0.001 par value); 100,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively

Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,195.4 million and 1,175.5 million shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

 

1,195

 

1,175

Additional paid-in capital

 

1,271,327

 

1,164,885

 

1,301,485

 

1,291,316

Stock subscription receivable

 

(79)

 

(79)

 

(79)

 

(79)

Accumulated deficit

 

(1,340,802)

 

(1,297,122)

 

(1,378,033)

 

(1,359,721)

Accumulated other comprehensive income

 

3,290

 

3,145

 

2,150

 

1,536

Total stockholders’ deficit

 

(65,119)

 

(128,103)

 

(73,282)

 

(65,773)

TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

$

31,492

$

31,323

$

28,567

$

27,865

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

For the nine months ended

For the three months ended

September 30, 

September 30, 

March 31, 

    

2023

    

2022

    

2023

    

2022

    

2024

    

2023

Revenues:

Research and other

$

406

$

206

$

1,487

$

1,086

$

284

$

880

Total revenues

406

206

1,487

1,086

284

880

Operating costs and expenses:

Research and development

7,201

7,694

20,276

26,159

7,942

6,861

General and administrative

7,030

8,130

21,577

23,930

8,086

6,983

Total operating costs and expenses

14,231

15,824

41,853

50,089

16,028

13,844

Loss from operations

(13,825)

(15,618)

(40,366)

(49,003)

(15,744)

(12,964)

Other income (expense):

Change in fair value of derivative liabilities

(112)

(12,169)

3,875

(15,883)

120

3,880

Change in fair value of share receivable

487

534

Change in fair value of share liabilities

(106)

(52)

Change in fair value of convertible notes

1,775

Loss from extinguishment of debt

(1,768)

(456)

(3,648)

(156)

(2,171)

(1,408)

Interest expense

(1,670)

(1,512)

(3,999)

(4,847)

(1,518)

(1,027)

Foreign currency transaction loss

(1,692)

(3,097)

(76)

(6,845)

Total other loss

(4,755)

(17,234)

(3,314)

(27,731)

Foreign currency transaction gain (loss)

(668)

919

Total other (loss) income

(2,568)

2,312

Net loss

(18,580)

(32,852)

(43,680)

(76,734)

(18,312)

(10,652)

Deemed dividend related to warrant modification

(519)

(1,433)

(568)

(395)

Net loss attributable to common stockholders

$

(19,099)

$

(32,852)

$

(45,113)

$

(76,734)

$

(18,880)

$

(11,047)

Other comprehensive income (loss)

Other comprehensive loss

Foreign currency translation adjustment

1,397

2,773

145

5,956

614

(750)

Total comprehensive loss

$

(17,702)

$

(30,079)

$

(44,968)

$

(70,778)

$

(18,266)

$

(11,797)

Net loss per share applicable to common stockholders

Basic

$

(0.02)

$

(0.03)

$

(0.04)

$

(0.08)

$

(0.02)

$

(0.01)

Diluted

$

(0.02)

$

(0.03)

$

(0.04)

$

(0.08)

$

(0.02)

$

(0.01)

Weighted average shares used in computing basic loss per share

1,134,359

1,040,982

1,106,111

1,001,703

1,188,149

1,074,902

Weighted average shares used in computing diluted loss per share

1,134,359

1,040,982

1,106,111

1,001,703

1,188,149

1,074,902

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 September 30, 2023

For the Three Months Ended March 31, 2024

Mezzanine equity

Accumulated

Mezzanine equity

Accumulated

Series C Covertible

Additional

Other

Total

Series C Covertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at July 1, 2023

    

1,546

    

$

25,385

 

1,115,183

$

1,115

$

1,258,259

$

(79)

$

(1,322,222)

$

1,893

$

(61,034)

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

 

405

 

5,143

 

 

 

 

 

 

 

308

3,624

Issuance of Series C convertible preferred stock in lieu of debt redemption

 

 

 

 

 

 

 

 

 

Series C convertible preferred stock conversion

 

(186)

 

(2,974)

 

4,651

 

4

 

2,970

 

 

 

 

2,974

 

(220)

(2,532)

5,493

5

2,527

2,532

Warrants exercised for cash

 

 

 

128

 

 

32

 

 

 

 

32

5,831

6

1,305

1,311

Cashless warrants and stock options exercise

 

 

 

10,554

 

11

 

(11)

 

 

 

 

1,633

2

(2)

Issuance of common stock for conversion of debt and accrued interest

 

 

 

12,403

 

13

 

7,907

 

 

 

 

7,920

6,942

7

3,945

3,952

Stock-based compensation

 

8

 

112

 

2,164

 

2

 

1,563

 

 

 

 

1,565

1,164

1,164

Net loss

 

 

 

 

 

 

 

(18,580)

 

 

(18,580)

 

 

 

(18,312)

 

(18,312)

Warrants modfication

 

 

 

 

 

1,126

 

 

 

 

1,126

 

1,798

1,798

Deemed dividend related to warrants modification

 

 

 

 

 

(519)

 

 

 

 

(519)

 

(568)

(568)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

1,397

 

1,397

 

 

 

 

614

614

Balances at September 30, 2023

 

1,773

$

27,666

 

1,145,083

$

1,145

$

1,271,327

$

(79)

$

(1,340,802)

$

3,290

$

(65,119)

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)

    For the Three Months Ended September 30, 2022

Accumulated

Series C Covertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at July 1, 2022

    

$

1,034,475

$

1,034

$

1,139,811

$

(79)

$

(1,235,972)

$

3,540

$

(91,666)

Issuance of Series C convertible preferred stock for cash

704

 

10,904

 

 

 

 

 

Issuance of Series C convertible preferred stock in lieu of debt redemption

126

 

1,978

 

 

Issuance of Series C convertible preferred stock by common stock warrant exercise

55

 

329

 

 

Warrants exercised for cash

 

1,926

 

2

 

428

 

 

 

430

Reclassification of warrant liabilities related to warrants exercised for cash

535

2,402

2,402

Cashless warrants and stock options exercised

 

5,321

 

5

 

(5)

 

 

 

Reclassification of warrant liabilities related to cashless warrants exercise

 

 

 

1,421

 

 

 

1,421

Issuance of common stock for conversion of debt and accrued interest

 

6,892

 

7

 

5,274

 

 

 

5,281

Stock-based compensation

 

2,636

 

3

 

3,358

 

 

 

3,361

Fractional shares adjustment

10

Net loss

 

 

 

 

(32,852)

 

 

(32,852)

Cumulative translation adjustment

 

 

2,773

 

2,773

Balances at September 30, 2022

885

$

13,746

1,051,260

$

1,051

$

1,152,689

$

(79)

$

(1,268,824)

$

6,313

$

(108,850)

For the Three Months Ended March 31, 2023

Mezzanine equity

Accumulated

Series C Covertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at January 1, 2023

1,415

$

23,060

1,068,394

$

1,068

$

1,164,885

$

(79)

$

(1,297,122)

$

3,145

$

(128,103)

Issuance of Series C convertible preferred stock for cash

 

148

2,385

 

 

 

 

Issuance of Series C convertible preferred stock in lieu of debt redemption

43

806

Series C convertible preferred stock conversion

(198)

(2,617)

4,946

5

2,612

2,617

Warrants exercised for cash

767

1

247

248

Cashless stock options exercise

710

1

(1)

Reclassification of warrant liabilities to stockholders' deficit

76,258

76,258

Issuance of common stock for conversion of debt and accrued interest

8,267

8

5,608

5,616

Stock-based compensation

 

8

118

 

 

918

 

 

918

Reclass earned but unissued milestone shares from equity to liability

(2,130)

(2,130)

Net loss

(10,652)

(10,652)

Warrants modfication

395

395

Deemed dividend related to warrants modification

(395)

(395)

Cumulative translation adjustment

 

 

 

 

 

(750)

(750)

Balances at March 31, 2023

 

1,416

$

23,752

1,083,084

$

1,083

$

1,248,397

$

(79)

$

(1,307,774)

$

2,395

$

(55,978)

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 STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)

For the Nine Months Ended September 30, 2023

Mezzanine equity

Accumulated

Series C Covertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at January 1, 2023

 

1,415

$

23,060

1,068,394

$

1,068

 

$

1,164,885

 

$

(79)

$

(1,297,122)

 

$

3,145

$

(128,103)

Issuance of Series C convertible preferred stock for cash

729

9,899

Issuance of Series C convertible preferred stock in lieu of debt redemption

 

56

1,013

Series C convertible preferred stock conversion

 

(443)

(6,536)

11,081

11

6,525

6,536

Warrants exercised for cash

12,448

12

2,789

2,801

Cashless warrants and stock options exercise

20,433

21

(21)

Reclassification of warrant liabilities to stockholders’ deficit

76,258

76,258

Issuance of common stock for conversion of debt and accrued interest

27,563

28

17,456

17,484

Stock-based compensation

16

230

5,164

5

2,668

2,673

Net loss

 

 

 

(43,680)

 

(43,680)

Warrants modfication

 

2,200

2,200

Deemed dividend related to warrants modification

 

(1,433)

(1,433)

Cumulative translation adjustment

 

 

 

 

145

145

Balances at September 30, 2023

 

1,773

$

27,666

1,145,083

$

1,145

$

1,271,327

$

(79)

$

(1,340,802)

$

3,290

$

(65,119)

For the Nine Months Ended September 30, 2022

Accumulated

Series C Covertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at January 1, 2022

$

948,445

$

948

$

1,066,873

$

(79)

$

(1,192,090)

$

357

$

(123,991)

Issuance of Series C convertible preferred stock for cash

 

704

10,904

 

 

 

 

Issuance of Series C convertible preferred stock in lieu of debt redemption

126

1,978

Issuance of Series C convertible preferred stock by common stock warrant exercise

55

329

Issuance of common stock for cash

13,147

13

9,676

9,689

Warrants exercised for cash

40,929

41

9,945

9,986

Reclassification of warrant liabilities related to warrants exercised for cash

535

22,090

22,090

Cashless warrants and stock options exercise

34,224

34

(34)

Reclassification of warrant liabilities related to cashless warrants exercise

26,800

26,800

Issuance of common stock for conversion of debt and accrued interest

10,374

11

7,602

7,613

Stock-based compensation

 

���

4,141

 

4

 

9,737

 

 

9,741

Net loss

(76,734)

(76,734)

Cumulative translation adjustment

 

 

 

 

 

5,956

5,956

Balances at September 30, 2022

 

885

$

13,746

1,051,260

$

1,051

$

1,152,689

$

(79)

$

(1,268,824)

$

6,313

$

(108,850)

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 nine months ended

For the three months ended

September 30, 

March 31, 

    

2023

    

2022

    

2024

    

2023

Cash Flows from Operating Activities:

 

 

Net loss

$

(43,680)

$

(76,734)

$

(18,312)

$

(10,652)

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

Depreciation and amortization

1,101

934

428

335

Amortization of debt discount

2,006

2,111

576

552

Change in fair value of derivatives

(3,875)

15,883

(120)

(3,880)

Change in fair value of share receivable

(534)

Change in fair value of share liability

106

52

Change in fair value of convertible notes

(1,775)

Loss from extinguishment of debt

3,648

156

2,171

1,408

Amortization of operating lease right-of-use asset

211

184

77

67

Stock-based compensation for services

2,833

9,741

1,164

933

Warrant modifications associated with convertible notes under fair value option

287

Subtotal of non-cash charges

5,677

29,009

2,627

(533)

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

802

(310)

(477)

(709)

Other non-current assets

(13)

633

(8)

(16)

Accounts payable and accrued expenses

2,657

1,251

4,531

975

Related party accounts payable and accrued expenses

(2,239)

2,127

(810)

(341)

Lease liabilities

117

98

43

37

Net cash used in operating activities

(36,679)

(43,926)

(12,406)

(11,239)

Cash Flows from Investing Activities:

Purchase of equipment and construction in progress

(3,019)

(742)

(239)

(1,333)

Net cash used in investing activities

(3,019)

(742)

(239)

(1,333)

Cash Flows from Financing Activities:

Proceeds from issuance of Series C convertible preferred stock

9,899

10,904

3,624

2,385

Proceeds from issuance of Series C convertible preferred stock by common stock warrant exercise, net of debt redemption

52

Proceeds from issuance of common stock

9,465

Proceeds from exercise of warrants

1,598

9,986

1,311

248

Proceeds from investor advance

7

50

Proceeds from issuance of notes payable, net

10,000

5,600

10,000

Proceeds from issuance of convertible notes payable, net

12,699

7,100

Proceeds from contingent payment obligation

4,550

50

Repayment of notes payable

(210)

(5,390)

(101)

Repayment of investor advances

(200)

Net cash provided by financing activities

38,343

30,617

12,085

12,582

Effect of exchange rate changes on cash and cash equivalents

487

8,307

912

(784)

Net decrease in cash and cash equivalents

(868)

(5,744)

Net increase (decrease) in cash and cash equivalents

352

(774)

Cash and cash equivalents, beginning of the period

6,965

15,169

2,126

6,965

Cash and cash equivalents, end of the period

$

6,097

$

9,425

$

2,478

$

6,191

Supplemental disclosure of cash flow information

Interest payments on notes payable

$

(30)

$

(912)

$

$

(30)

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

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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

For the nine months ended

For the three months ended

September 30, 

March 31, 

    

2023

    

2022

    

2024

    

2023

Supplemental schedule of non-cash investing and financing activities:

 

  

 

 

  

 

Cashless warrants and stock options exercise

$

21

$

34

$

2

$

1

Reclassification of warrant liabilities related to warrants exercised for cash

$

$

22,625

Reclassification of warrant liabilities to stockholders’ deficit

$

76,258

$

$

$

76,258

Reclassification of warrant liabilities related to cashless warrants exercise

$

$

26,800

Reclassisifcation of investor advances to convertible notes payable

$

1,163

$

Reclassisifcation of investor advances to stockholders’ deficit

$

1,203

$

Issuance of common stock for conversion of debt and accrued interest

$

17,484

$

7,054

$

3,952

$

5,616

Issuance of Series C convertible preferred stock in lieu of debt redemption

$

1,013

$

1,978

Exercise common stock warrants by debt redemption

$

$

277

Series C convertible preferred stock conversion

$

6,536

$

$

2,532

$

2,617

Capital expenditures included in accounts payable

$

71

$

4

$

500

$

1,013

Reclassification between shares payable and equity

$

$

250

Reclass earned but unissued milestone shares from equity to liability

$

$

2,130

Deemed dividend related to warrant modification

$

1,433

$

$

568

$

395

Debt discout related to warrant modificaiton

$

8

$

Issuance of Series C convertible preferred stock in lieu of debt redemption

$

$

806

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

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1. Organization and Description of Business

Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks, Northwest Biotherapeutics Limited (formerly known as Aracaris Ltd), Aracaris Capital, Ltd, Northwest Biotherapeutics B.V., and NW Bio GmbH (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company has wholly owned subsidiaries in Boston, the U.K., the Netherlands and Germany. On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®. On July 24, 2023, the Company’s wholly-owned subsidiary changed its name from Aracaris Ltd to Northwest Biotherapeutics Limited.

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

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

2. Financial Condition, Going Concern and Management Plans

The Company has incurred annual net operating losses since its inception. The Company had a net loss of $45.1$18.3 million for the ninethree months ended September 30, 2023.March 31, 2024. The Company used approximately $36.7$12.4 million of cash in its operating activities during the ninethree months ended September 30, 2023.March 31, 2024.

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

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

3. Summary of Significant Accounting Policies

Basis of Presentation

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

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2023,March 31, 2024, condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30,March 31, 2024 and 2023, and 2022, condensed consolidated statement of stockholders’ deficit for the three and nine months ended SeptemberMarch 31, 2024 and 2023, and the

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

30, 2023 and 2022, and the condensed consolidated statements of cash flows for the ninethree months ended September 30,March 31, 2024 and 2023 and 2022 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023March 31, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 20232024 or for any future interim period. The condensed consolidated balance sheet at DecemberMarch 31, 20222024 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, 20222023 and notes thereto included in the Company’s annual report on Form 10-K (the “2022“2023 Annual Report”), which was filed with the SEC on February 28, 2023.March 5, 2024.

Use of Estimates

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

On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets, and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses.estimates.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 20222023 Annual Report other than those discussed below.Report.

Sequencing

The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, non-employees or directors are not subject to the sequencing policy.

On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximately 141 million warrants, with a value of approximately $76.3 million, to purchase shares of the Company’s common stock were reclassified from liabilities to equity on January 9, 2023. The remaining balance of $1.0 million in warrant liability as of September 30, 2023 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”).

Modification of Equity Classified Warrants

A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.

Convertible Notes under Fair Value Option

The Company accounts for certain convertible notes issued in August and September 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred.

Recently Issued Accounting Standards Not Yet Adopted

Compensation - Stock Compensation

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

Improvements to Income Tax Disclosures

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

Recently Issued Accounting Standards, Adopted

Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions

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

For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.

The Company is still evaluating the impactadopted ASU 2022-03 effective January 1, 2024. The adoption of this pronouncementguidance did not have a material impact on theits condensed consolidated financial statements.

4. Fair Value Measurements

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

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

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

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

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

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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

The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2023March 31, 2024 and December 31, 20222023 (in thousands):

Fair value measured at September 30, 2023

Fair value measured at March 31, 2024

    

    

Quoted prices in active

    

Significant other

    

Significant

    

    

Quoted prices in active

    

Significant other

    

Significant

    

Fair value at

markets

observable inputs

unobservable inputs

    

Fair value at

markets

observable inputs

unobservable inputs

September 30, 2023

    

(Level 1)

    

(Level 2)

    

(Level 3)

March 31, 2024

    

(Level 1)

    

(Level 2)

    

(Level 3)

Share receivable

$

610

$

$

$

610

Warrant liability

$

1,019

$

$

$

1,019

$

913

$

$

$

913

Contingent payable derivative liability

8,882

8,882

9,099

9,099

Convertible notes

 

10,250

 

 

 

10,250

Convertible notes at fair value

 

16,496

 

 

 

16,496

Share liability

120

120

Total fair value

$

20,151

$

$

$

20,151

$

26,628

$

$

$

26,628

Fair value measured at December 31, 2022

Fair value measured at December 31, 2023

    

    

Quoted prices in active

    

Significant other

    

Significant

    

    

Quoted prices in active

    

Significant other

    

Significant

Fair value at

markets

observable inputs

unobservable inputs

Fair value at

markets

observable inputs

unobservable inputs

    

December 31, 2022

    

(Level 1)

    

(Level 2)

    

(Level 3)

    

December 31, 2023

    

(Level 1)

    

(Level 2)

    

(Level 3)

Warrant liability

$

80,559

$

$

$

80,559

$

944

$

$

$

944

Embedded redemption option

 

807

 

 

 

807

Contingent payable derivative liability

8,668

8,668

9,188

9,188

Convertible notes at fair value

12,771

12,771

Share liability

 

678

 

 

 

678

 

483

 

 

 

483

Total fair value

$

90,712

$

$

$

90,712

$

23,386

$

$

$

23,386

There were no transfersbetween Level Level 1, 2 or 3 during the nine-monththree-month period ended September 30, 2023.March 31, 2024.

The following table presents changes in Level 3 liabilities measured at fair value for the nine-monththree-month period ended September 30, 2023.March 31, 2024. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands).

Warrant

Embedded

Contingent Payable

Liability

Convertible

Convertible

    

Liability

    

Redemption Option

    

Derivative Liability

    

(Receivable)

    

Notes

    

Total

Warrant

Contingent Payable

Share

Notes

Balance - January 1, 2023

$

80,559

$

807

$

8,668

$

678

$

$

90,712

    

Liability

    

Derivative Liability

    

Liability

    

At Fair Value

    

Total

Balance - January 1, 2024

$

944

$

9,188

$

483

$

12,771

$

23,386

Additional share liability

508

508

117

117

Additional convertible notes at fair value

10,250

10,250

Issuance of convertible notes at fair value

5,500

5,500

Redemption of share liability

(1,262)

(1,262)

(586)

(586)

Reclassification of warrant liabilities

(76,258)

(76,258)

Change in fair value

(3,282)

(807)

214

(534)

(4,409)

(31)

(89)

106

(1,775)

(1,789)

Balance - September 30, 2023

$

1,019

(1)

$

$

8,882

$

(610)

$

10,250

$

19,541

Balance - March 31, 2024

$

913

(1)

$

9,099

$

120

$

16,496

$

26,628

(1)The remaining balance of $1.0$0.9 million in warrant liability as of September 30, 2023March 31, 2024 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of March 31, 2024 and December 31, 2023 is as follows:

    

As of March 31, 2024

    

Share

Contingent Payable

Liability

Derivative Liability

Strike price

$

0.44

$

0.52

*

Contractual term (years)

 

0.04

 

1.0

 

Volatility (annual)

 

74

%  

 

73

%  

Risk-free rate

 

5.5

%  

 

5.2

%  

Dividend yield (per share)

 

0

%  

 

0

%  

As of December 31, 2023

    

Share

    

Contingent Payable

 

    

Liability

Derivative Liability

 

Strike price

$

0.64

$

0.70

*

Contractual term (years)

0.1

 

1.0

Volatility (annual)

71

%  

 

71

%

Risk-free rate

5.6

%  

 

5.2

%

Dividend yield (per share)

0

%  

 

0

%

*The strike price assumes the current stock price as of March 31, 2024 and December 31, 2023.

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three months ended March 31, 2024 and 2023 (in thousands).

For the three months ended

March 31, 

    

2024

    

2023

Research and development

$

1,009

$

296

Research and development - related party

Milestones achieved (1)

520

Future milestones (2)

100

General and administrative

 

155

17

Total stock-based compensation expense

$

1,164

$

933

The related party amounts were for milestone incentives that either were earned or are deemed probable to be achieved in the future and become issuable at that time (as detailed below in Restricted Stock Awards).

(1)During the quarter ended March 31, 2023, the Company recognized the remaining $0.5 million stock-based compensation related to the achieved milestone (obtaining a commercial manufacturing license from the MHRA) and accrued for 3.0 million shares that will become issuable for this milestone. The Company has previously recognized $1.6 million stock - based compensation as of December 31, 2022.
(2)The convertible notes issued between AugustThis is related to a one-time milestone (drafting key portions of the application for product approval) that is anticipated to be achieved and September 2023 with a principal amount of $10.3 million at September 30, 2023 were accounted for using the FVO election. Under the FVO election, the financial instrument is initially measured at its issue-date estimated fair value and subsequently re-measured at estimated fair value on a recurring basis at each reporting period date. Items for which the FVO has been elected are presented at fair valueearned in the condensed consolidated balance sheets.future. The change in fair value forCompany recognized and expensed (but did not issue shares for) the three monthspro-rata portion of the remaining potential milestone stock awards during the quarter ended September 30,March 31, 2023, was de-minimis.of $0.1 million.

The total unrecognized stock compensation (primarily for consultants) cost was approximately $3.6 million as of March 31, 2024 and will be recognized over the next 1.8 years.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

On January 9, 2023,Stock Options

The following table summarizes stock option activity for options granted to key external experts during the three months ended March 31, 2024 (amount in thousands, except per share number):

Weighted Average

Weighted

Remaining

Number of

Average 

Contractual Life

Total Intrinsic

    

Shares

    

Exercise Price

    

(in years)

    

Value

Outstanding as of January 1, 2024

 

317,076

$

0.35

6.0

$

114,097

Granted

500

0.53

4.2

Cashless exercised

(650)

0.35

Outstanding as of March 31, 2024

 

316,926

$

0.35

5.8

$

59,173

Options vested (1)

 

280,514

$

0.33

5.8

$

55,534

(1)An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, General Counsel are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days’ prior notice.

During the three months ended March 31, 2024, the Company reclassifiedgranted 500,000 stock options (the “Options”) with an exercise price at $0.53 per share to a staff employee. The Options vested immediately on the grant date. In addition, the Company will make an additional payment of $0.30 per option exercised by the employee for a maximum amount of $150,000. The Company has fully accrued this additional payment as of  March 31, 2024 on its condensed consolidated balance sheets.

The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The assumptions used in calculating the fair values of stock options that were granted during the three months ended March 31, 2024 was as follows:

For the three months ended

March 31,

    

2024

    

Exercise price

$

0.53

Expected term (years)

 

2.1

Expected stock price volatility

 

73

%  

Risk-free rate

 

4.5

%  

Dividend yield (per share)

 

0

%  

Restricted Stock Awards

Advent SOW 6

There was no stock based compensation recognized during the three months ended March 31, 2024.  As previously reported, the Company previously achieved all of the 10 one-time milestones (i.e., for all six workstreams that are prerequisites for a MAA application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the MAA application) pursuant to the Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company.

As of March 31, 2024, 1.5 million shares related to the completed milestone (submission of the application to MHRA for approval) had not been  issued and the fair value of the warrant liabilityshares of $76.3$1.1 million into the additional paid-in capital. The changeremained accrued in fair value of the common stock warrant liability of $2.3 million between December 31, 2022accounts payable and January 9, 2023 is reflected in “Change in fair value of derivative liabilities” in the accompanying condensed consolidated statements of comprehensive loss for the nine months ended September 30, 2023.

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilitiesaccrued expenses to related parties and embedded conversion feature that are categorized within Level 3 of the fair value hierarchy as of September 30, 2023, January 9, 2023 (the reclassification date) and December 31, 2022 is as follows:

    

As of September 30, 2023

    

As of January 9, 2023

    

Share

Contingent Payable

Warrant

Receivable

Derivative Liability

Liability

Strike price

$

0.56

$

0.91

*

$

0.31

Contractual term (years)

 

0.04

 

1.13

 

1.46

Volatility (annual)

 

73

%  

 

73

%  

87

%

Risk-free rate

 

5.6

%  

 

5.5

%  

4.3

%

Dividend yield (per share)

 

0

%  

 

0

%  

0

%

As of December 31, 2022

 

    

Warrant

    

Share

    

Contingent Payable

 

    

Liability

    

Liability

Derivative Liability

 

Strike price

$

0.31

$

0.78

*

$

0.78

*

Contractual term (years)

 

1.5

0.1

 

0.6

Volatility (annual)

 

86

%  

76

%  

 

77

%

Risk-free rate

 

4.3

%  

2.0

%  

 

4.8

%

Dividend yield (per share)

 

0

%  

0

%  

 

0

%

*The strike price assumes the current stock price as of September 30, 2023 and December 31, 2022

The key unobservable inputs for Piggy-back rights that was included in the warrant liability as of September 30, 2023 and December 31, 2022 was the assumption of the estimated remaining life which was based on the estimate of the next qualified financing.

affiliates.

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 (in thousands).

For the three months ended

For the nine months ended

September 30, 

September 30, 

    

2023

    

2022

    

2023

    

2022

Research and development

$

1,118

$

921

$

1,562

$

2,072

Research and development - related party

Milestones achieved (1)

9

195

578

2,120

Future milestones (2)

24

1,205

115

4,620

General and administrative

 

471

 

1,040

 

578

 

929

Total stock-based compensation expense

$

1,622

$

3,361

$

2,833

$

9,741

The related party amounts were for milestone incentives that either were earned or are deemed probable to be achieved in the future and become issuable at that time (as detailed below in Restricted Stock Awards).

(1)During the nine months ended September 30, 2023, the Company recognized the remaining $0.6 million stock-based compensation related to the achieved milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting key

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

portions of the application for product approval). The Company had previously recognized  $2.6

6. Property, Plant and Equipment

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

    

March 31,

    

December 31,

    

Estimated

2024

2023

Useful Life

Leasehold improvements

$

17,867

$

17,785

 

Lesser of lease term or estimated useful life

Office furniture and equipment

 

527

 

487

 

3-5 years

Computer and manufacturing equipment and software

 

3,055

 

2,776

 

3-5 years

Land in the United Kingdom

 

85

 

86

 

NA

 

21,534

 

21,134

 

NA

Less: accumulated depreciation

 

(4,266)

 

(3,856)

 

  

Total property, plant and equipment, net

$

17,268

$

17,278

 

  

Depreciation expense was approximately $0.4 million and $0.3 million stock-based compensation related to these two milestones as of December 31, 2022.

The $2.1 million expense recognized in 2022 covered 3 one-time milestones: 2 required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases) and a workstream related to Fill/Finish.

(2)During the three and nine months ended September 30, 2023, the Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining one-time milestone stock awards for submission the application for product approval to MHRA of $24,000 and $0.1 million, respectively.

During the three and nine months ended September 30, 2022, the Company recognizedMarch 31, 2024, and expensed (but did not issue shares for) the pro-rata portion of 6 one-time milestones (partly stock): 5 workstreams (Comparability, Stability, Potency, Product Profile and Mechanism of Action) and one-time milestone for drafting and submission of key portions of the application for product approval of $1.2 million and $4.6 million,2023, respectively.

The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The weighted average assumptions used in calculating the fair values of stock options that were granted during the nine months ended September 30, 2023 and 2022 was as follows:

For the nine months ended

 

September 30,

 

    

2023

    

2022

 

Exercise price

$

0.51

$

0.65

Expected term (years)

 

6.4

 

3.9

Expected stock price volatility

 

84

%  

 

99

%

Risk-free rate

 

4.5

%  

 

3.3

%

Dividend yield (per share)

 

0

%  

 

0

%

The total unrecognized stock compensation (primarily for consultants) cost was approximately $6.2 million as of September 30, 2023 and will be recognized over the next 1.9 years.

Stock Options

The following table summarizes stock option activity for options granted to key external experts during the nine months ended September 30, 2023 (amount in thousands, except per share number):

Weighted Average

Weighted

Remaining

Number of

Average 

Contractual Life

Total Intrinsic

    

Shares

    

Exercise Price

    

(in years)

    

Value

Outstanding as of January 1, 2023

 

301,263

$

0.34

7.0

$

135,225

Granted(1)

20,220

0.51

6.3

Cashless exercised

(2,507)

0.45

Expired

(300)

0.83

Outstanding as of September 30, 2023

 

318,676

$

0.34

6.3

$

180,794

Options vested (2)

 

281,209

$

0.33

6.3

$

163,974

(1)During the nine months ended September 30, 2023, the Company granted 20.2 million stock options (the “2023 Options”) with an exercise price ranging from $0.47 to $0.57 per share, to key external consultants who provide services to the Company. The 2023 Options contain both service and performance vesting conditions, which will vest over a service period, generally during the term of consulting agreement, or upon achievement of specific milestones.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

(2)An aggregate 153 million stock options held by Ms. Linda Powers, the Company’s Chief Executive Officer, and Mr. Leslie Goldman, the Company’s Senior Vice President, General Consul are subject to an agreement (the “Blocker Letter Agreement”) under which they cannot exercise any options or warrants except upon at least 61 days’ prior notice.

Restricted Stock Awards

Advent SOW 6

As previously reported, during April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, for five workstreams that are prerequisites for an application for regulatory approval of DCVax-L, for three required licenses for the Sawston facility and for drafting of key portions of the application for approval. The SOW provides for baseline costs and for one-time milestone incentives for successful completion of each of the workstreams, for the completion and submission of each application for product approval, and for obtaining regulatory approval of each of the three Sawston licenses. The milestone incentives will be a combination of cash and stock and are not paid until they are achieved. As also previously reported, the Company amended the SOW6 on September 26, 2022 (the “Amended SOW6”) to (1) extend the service period through September 30, 2023, and (2) clarify the assessment and application of the milestones, and (3) add a sixth workstream. (The potential cost for all unearned stock awards for milestones not yet achieved was re-measured on the modification date and will be further re-measured until the date the milestone award is achieved and the stock awards are earned.) If all of the 10 one-time milestones are achieved (i.e., for all six workstreams that are prerequisites for an application for product approval, for obtaining all three licenses required for the Sawston facility, and for the completion of key portions of the application for product approval), the aggregate stock-based compensation under the Amended SOW 6 will be 13.5 million shares (including the shares already earned and issued for the milestones already achieved) for an aggregate fair value of $10.1 million.

As of December 31, 2022, seven milestones were completed, including five workstreams and the regulatory approvals of two licenses required for the Sawston facility. An eighth milestone was partly completed and the stock component of that milestone was earned, but the cash portion of that eighth milestone was not yet earned.

On September 26, 2023, the Company further amended the SOW 6 (the “Second Amended SOW 6”) to extend the service period through March 31, 2024. As of the amendment date, the remaining unvested one-time milestone for submission of the application to MHRA for approval of DCVax-L was accounted as a Type I modification (probable to probable under FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). The previously remaining unrecognized compensation expense for total $17,000 is expected to be fully recognized by end of November 2023.

During the nine months ended September 30, 2023, milestones related to the workstream for Mechanism of Action, obtaining the commercial manufacturing license from the MHRA and completion of key portions of the application for product approval were completed. For this manufacturing license milestone, the Company recognized the remaining $0.5 million in expense in the condensed consolidated statements of operations and comprehensive loss and issued 3.0 million common shares. For the completion of the drafting of the MHRA application milestone, the Company recognized the remaining $0.1 million in expense in the condensed consolidated statements of operations and comprehensive loss and issued 1.5 million common shares.

Employee Compensation

In August 2023, the Company issued 0.6 million shares of common stock as a bonus payment to two staff employees. These shares were fully vested on the grant date. However, 0.3 million shares are subject to lock-up restrictions, prohibiting their sale or transfer within six months of the grant date. The Company recognized $0.3 million stock-based compensation which is based on the Company’s closing stock price on the grant date.

Other Service Agreement

During the nine months ended September 30, 2023, the Company issued 16,000 shares of Series C convertible preferred stock to an unrelated vendor who provided professional services for the Company. The fair value of the Series C convertible preferred stock on the issuance date was approximately $0.1 million, which will be expensed over a four-month service period. During the three and nine

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

months ended September 30, 2023, the Company recognized approximately $0.1  million and $0.2 million, respectively as part of general and administrative expenses.

6. Property, Plant and Equipment

Property, plant and equipment consist of the following at September 30, 2023 and December 31, 2022 (in thousands):

    

September 30,

    

December 31,

    

Estimated

2023

2022

Useful Life

Leasehold improvements

$

17,088

$

13,070

 

Lesser of lease term or estimated useful life

Office furniture and equipment

 

460

 

300

 

3-5 years

Computer and manufacturing equipment and software

 

2,487

 

2,238

 

3-5 years

Land in the United Kingdom

 

83

 

82

 

NA

 

20,118

 

15,690

 

NA

Less: accumulated depreciation

 

(3,367)

 

(2,272)

 

  

Total property, plant and equipment, net

$

16,751

$

13,418

 

  

Construction in progress

$

$

2,028

 

  

The construction works related to expanding the operational portion of its UK facility (Phase 1B) were completed and placed in service as of September 30, 2023. All costs associated with the Phase 1B build out were reclassified from construction in progress to leasehold improvements effective June 2023 and are being amortized over the estimated useful life of the facility.

Depreciation expense was approximately $1.1 million and $0.9 million for the nine months ended September 30, 2023, and 2022, respectively.

7. Outstanding Debt

The following two tables summarize outstanding debt as of September 30, 2023March 31, 2024 and December 31, 2022,2023, respectively (amount in thousands):

    

    

Stated

    

    

    

    

    

    

Stated

    

    

    

    

Fair

    

Interest

Conversion

Remaining

Carrying

Interest

Conversion

Remaining

Value

Carrying

Maturity Date

Rate

Price

Face Value

Debt Discount

Value

Maturity Date

Rate

Price

Face Value

Debt Discount

Adjustment

Value

Short term convertible notes payable

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

6% unsecured

 

Due

 

6

%  

$

3.09

$

135

$

$

135

 

Due

 

6

%  

$

3.09

$

135

$

$

$

135

8% unsecured

Various

8

%  

$

0.50-$0.70

*

3,332

(516)

2,816

 

Various

8

%  

$

0.20-$0.50

*

5,246

(269)

 

 

4,977

10% unsecured

7/11/2024

10

%  

$

0.50

*

500

500

10 % unsecured

7/11/2024

10

%  

$

0.50

*

500

500

3,967

(516)

3,451

5,881

(269)

5,612

Short term convertible notes at fair value

11% unsecured

Various

11

%  

$

0.40-$0.49

*

10,250

10,250

Various

11

%  

$

0.40 - $0.49

*

16,250

246

16,496

Short term notes payable

 

  

 

  

 

  

 

 

  

 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

8% unsecured

 

Various

 

8

%  

 

N/A

 

7,862

 

(226)

 

7,636

 

Various

 

8

%  

 

N/A

 

11,399

 

(404)

 

 

10,995

12% unsecured

 

On Demand

 

12

%  

 

N/A

 

562

 

 

562

 

On Demand

 

12

%  

 

N/A

 

562

 

 

 

562

6% secured

 

3/25/2025

 

6

%  

 

N/A

 

568

 

 

 

568

 

8,424

 

(226)

 

 

8,198

 

12,529

 

(404)

 

 

 

12,125

Long term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

 

8% unsecured

 

1/2/2025

 

8

%  

 

N/A

 

11,005

 

(688)

 

10,317

 

Various

 

8

%  

 

N/A

 

11,005

 

(790)

 

 

10,215

6% secured

 

3/25/2025

6

%  

N/A

721

 

 

 

721

11,726

(688)

11,038

 

Ending balance as of September 30, 2023

$

34,367

$

(1,430)

$

32,937

Ending balance as of March 31, 2024

$

45,665

$

(1,463)

$

246

$

44,448

*These convertible notes are convertible into Series C preferred shares at $10.00$5.00 - $17.50$12.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.40 and $0.70$0.20-$0.50 per share.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Stated

Embedded

 

    

    

Stated

    

    

    

    

    

Interest

Conversion

Remaining

Redemption

Carrying

Interest

Conversion

Remaining

Fair Value

Carrying

    

Maturity Date

    

Rate

    

Price

    

Face Value

    

Debt Discount

    

Option

    

Value

Maturity Date

Rate

Price

Face Value

Debt Discount

Adjustment

Value

Short term convertible notes payable

 

  

 

  

 

  

 

  

 

  

 

  

 

  

6% unsecured

 

Due

 

6

%  

$

3.09

$

135

$

$

$

135

 

Due

 

6

%  

$

3.09

$

135

$

$

$

135

8% unsecured

Various

8

%  

$

0.50-$0.70

*

3,486

(356)

3,130

10% unsecured

7/11/2024

10

%  

$

0.50

*

500

500

4,121

(356)

3,765

Short term convertible notes at fair value

11% unsecured

Various

11

%  

$

0.40-$0.49

*

10,750

2,021

12,771

 

135

 

 

135

Short term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

  

 

  

 

  

 

  

 

 

  

 

 

  

8% unsecured

Various

8

N/A

14,540

(1,300)

807

14,047

 

Various

 

8

%  

 

N/A

 

3,539

 

(157)

 

 

3,382

9% unsecured

Various

9

N/A

793

793

12% unsecured

On Demand

12

N/A

563

563

 

On Demand

 

12

%  

 

N/A

 

562

 

 

 

562

 

15,896

 

(1,300)

 

807

15,403

 

4,101

 

(157)

 

 

3,944

Long term notes payable

8% unsecured

7/26/2024

8

N/A

5,505

(432)

5,073

 

Various

 

8

%  

 

N/A

 

21,224

 

(1,485)

 

 

19,739

6% secured

3/25/2025

6

N/A

918

918

 

3/25/2025

6

%  

N/A

573

 

 

 

573

6,423

(432)

5,991

21,797

(1,485)

20,312

Ending balance as of December 31, 2022

$

22,454

$

(1,732)

$

807

$

21,529

Ending balance as of December 31, 2023

$

40,769

$

(1,998)

$

2,021

$

40,792

*These convertible notes are convertible into Series C preferred shares at $10.00 - $17.50 per share. Each Series C preferred share is convertible into common shares with 30 days’ restriction period. The conversion price in common share equivalent is at $0.40 - $0.70 per share.

Promissory Note

On March 2, 2023, the Company entered into a Commercial Loan Agreement (the “Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The Commercial Loan bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first eight months of the term. The Commercial Loan is amortized in 14 installments starting on November 2, 2023. The Commercial Loan carries an original issue discount of $1.0 million.

During the ninethree months ended September 30, 2023,March 31, 2024, the Company issued approximately 27.66.9 million shares of common stock with a fair value of $17.5$4.0 million to certain lenders in lieu of cash payments of $13.2$2.7 million of debt, including $1.0$0.3 million of accrued interest. In addition, pursuant to exchange agreements executed with various holders, the Company is required to potentially issue additional common stock (the “Share liability”) if the stock price is less than the price, defined in the exchange agreement as of the true-up date (the “True-up Price”), or the lender is required to return common shares to the Company (the “Share receivable”) if the stock price is greater than the True-up Price as of the true-up date. During the ninethree months ended September 30, 2023,March 31, 2024, the Company extinguished Share liabilities of $1.3$0.6 million and recognized additional $0.5$0.1 million in Share liabilities. The Company recognized an approximately $3.5$0.8 million debt extinguishment loss during the ninethree months ended September 30, 2023March 31, 2024 from the debt redemption.

During the nine months ended September 30, 2023, the Company issued approximately 56,000 shares of Series C preferred stock with a fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million in debt, including $0.1 million of accrued interest. The Company recognized an approximately $0.1 million debt extinguishment loss.

During the nine months ended September 30, 2023, the Company recognized $0.8 million change in fair value of embedded redemption option as this embedded feature had de minimis value based on the remaining life of the note and the next qualified financing.

Convertible Notes

In April 2023,On February 21, 2024, the Company entered into several ten-monthone-year convertible notes (the “April“February Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $0.9$1.8 million for a purchase price of $0.8$1.6 million. The AprilFebruary Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $13.75$12.50 per share at the Holders’ sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. The Company reclassed $0.7 million Investor advances that were received from the Holders in December 2022 to Convertible notes payable on the condensed consolidated balance sheet as of September 30, 2023. As a result, the Company received net cash proceeds of $0.1 million.

As consideration for entering into the Aprilpackage of February Convertible Notes for $1.8 million as described above, the Company also agreed to amendamended the investors’Holders’ existing outstanding warrants. The exerciseconvertible notes and warrants, whereby the maturity date of certain notes and warrants were extended,  the conversion price of certain warrants was amended from $2.00 per share to $0.55 per share,notes were reduced, and the maturity date was extendedexercise prices of certain warrants were reduced. These amendments in January and February of 2024 involving 16 tranches warrants and 10 debt instruments were accounted for as both debt modification and debt extinguishment. The Company recognized  approximately $1.4 million of debt extinguishment losses during the three months ended March 31, 2024 from these debt amendments.

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for an additional 9 months. The incremental change in fair value resulting from the amendment was approximately $0.2 million, which was recognized as an additional debt discount to the April Convertible Notes.Notes at Fair Value

On June 30, 2023, the Company entered into a one-year convertible note (the “June Convertible Note”) with an individual investor (the “Holder”) with principal amount of $1.0 million. The Company received $1.0 million cash from the June Convertible Note. The June Convertible Note bears interest at 8% per annum and is convertible into Series C preferred shares at $12.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock.

On July 11, 2023, the Company entered into another one-year convertible note (the “July Convertible Note”) with the same investor as the June Convertible Note with principal amount of $0.5 million. The Company received $0.5 million cash from the July Convertible Note. The July Convertible Note bears interest at 10% per annum and has same conversion feature and conversion price as the June Convertible Note.

During the three months ended September 30, 2023,March 31, 2024, the Company entered into several one-year convertible notes (the “Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.4 million for a purchase price of $1.3 million. The Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares between $13.75 and $17.50 per share at the Holders’ sole option.  The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. The Company reclassed $0.5 million Investor advances that were received from the Holders in December 2022 to Convertible notes payable on the condensed consolidated balance sheet as of September 30, 2023. As a result, the Company received net cash proceeds of $0.8 million. As additional consideration for entering into the Convertible Notes, the Company also agreed to amend the Holders’ existing outstanding warrants. The exercise price of certain existing warrants was amended from $2.00 per share to price between $0.55 and $0.70 per share, and the maturity date was extended for an additional 10 months. The incremental change in fair value resulting from the amendment was approximately $0.3 million, which was recognized as an additional debt discount to the Convertible Notes.

Convertible Notes at Fair Value

Between August and September 2023, the Company entered into several one-year convertible notes (the “August & September Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $10.3$5.5 million. The August & September Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between $10.00$10.00 and $12.25$11.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. In addition, the Holders have an alternative option to convert the August & September 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.

One of the August & September Convertible Notes also contains a conversion feature to allow the holder to convert the outstanding debt in lieu of cash payment to purchase common shares via cash exercise of the holder’s existing warrants. In addition, the Company also agreed to amend the holder’s existing warrants to extend the term of the warrant maturity date for an additional 3 months.

The Company elected the FVO to fair value the August & September Convertible Notes under the guidance in ASC 825. The convertible notes at fair value of the August & September Convertible Notes on the issuance date and as of September 30, 2023 was approximately the same. As a result of electing the FVO, issuance costs relatedare required to the convertible notes are expensed as incurred. Therefore, the incremental change inbe remeasured using level 3 fair value resulting from the warrant amendment for $0.3 million was recognized as part of interest expenses on the condensed consolidated statement of operations and comprehensive loss.measurements (see Note 4).

For the three months ended September 30,March 31, 2024 and 2023, and 2022, interest expense related to outstanding debt totaled approximately $1.7$1.5 million and $0.5$1.0 million including amortization of debt discounts totaling $0.7$0.6 million and $0.6 million, respectively.

For the nine months ended September 30, 2023 and 2022, interest expense related to outstanding debt totaled approximately $4.0 million and $4.8 million including amortization of debt discounts totaling $2.0 million and $2.1 million, respectively.respectively.

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8. Net Loss per Share Applicable to Common Stockholders

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

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

For the nine months ended

For the three months ended

September 30, 

March 31, 

    

2023

    

2022

    

2024

    

2023

Series C convertible preferred stock

44,328

22,129

32,420

35,412

Common stock options

318,676

304,596

316,926

299,938

Common stock warrants

105,444

145,417

97,040

140,244

Convertible notes and accrued interest

32,049

 

76

60,929

 

79

Potentially dilutive securities

500,497

472,218

507,315

475,673

9. Related Party Transactions

The Company had three operational programs with Advent: (a) an ongoing development and manufacturing program at the GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston GMP facility, and (c) a one-time program for specialized work, organized into 10 sets of one-time milestones that were required for the MAA application, for the following:

Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing.
6 workstreams relating to product matters required for anthe MAA application, for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish.
Drafting and submission of key portions of the application for product approval itself.

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Each of the three operational programs is covered by a separate contract. The ongoing manufacturing in the London facility is covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility is covered by an Ancillary Services Agreement entered into on November 18, 2019. The specialized work associated with the 10 one-time milestones is covered by an SOW 6 entered into under the Ancillary Services Agreement as of April 1, 2022 and amended on September 26, 2022 and September 26, 2023. The 2023 amendment extended the SOW 6 service period for about 6 months, through March 31, 2024. Subsequently on April 1, 2024, the SOW 6 was further extended through September 30, 2024.

The Ancillary Services Agreement establishes a structure under which the Company and Advent negotiate and agree upon the scope and terms for Statements of Work (“SOWs”) for facility development activities and compassionate use program activities. After an SOW is agreed and approved by the Company, Advent will proceed with, or continue, the applicable services and will invoice the Company pursuant to the SOW. Since both the facility development and the compassionate use program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus fifteen percent. The SOWs may involve ongoing activities or specialized one-time projects and related one-time milestone payments. The current Ancillary Services Agreement ended in SeptemberJuly 2023. The Company subsequently extended the term by 12 months to July 2024 with no other changes.

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SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the 3 licenses required for the Sawston facility, (b) successful completion of each of the 6 workstreams and (c) completion of drafting key portions of an application for product approval. The milestone incentives are a combination of cash and stock, and are not paid until the milestone is achieved and earned.

During the nine months ended September 30, 2023, the Company paid an aggregate of $3.5 million in cash, of which $1.0 million was related to two milestones that were completed and fully expensed in 2022, but was unpaid as of December 31, 2022, and the other $2.5 million was payment for two completed one-time milestones (MAA workstream for mechanism of Action and obtaining a commercial manufacturing license from the MHRA on March 2023). The Company issued 4.5 million common shares as a result of completion of the two one-time milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting application) at fair value of $3.2 million, of which $0.6 million was recognized during the nine months ended September 30, 2023 and $2.6 million had already been recognized (but not paid) in 2022.

The following table summarizes total research and development costs from Advent for the three and nine months ended September 30,March 31, 2024 and 2023, and 2022, respectively (in thousands).

For the three months ended

For the nine months ended

For the three months ended

September 30,

September 30,

March 31,

2023

2022

2023

2022

2024

2023

Advent BioServices

    

  

    

  

    

  

    

  

    

  

    

  

Manufacturing cost in London

$

1,554

$

1,334

$

4,857

$

4,161

$

1,726

$

1,643

Manufacturing cost at Sawston facility

 

2,247

 

1,404

 

6,057

 

4,105

 

2,652

 

1,712

SOW 6 one-time milestones - Shares

 

 

 

 

 

 

Expensed and paid (milestone complete) (1)

 

9

 

195

 

578

 

2,120

Expensed but unpaid (milestone complete) (1)

 

 

520

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

 

24

 

1,205

 

115

 

4,620

 

 

100

SOW 6 one-time milestones - Cash

 

 

  

 

  

 

  

 

Expensed and paid (milestone complete) (3)

 

 

 

551

 

1,500

Expensed and due, but unpaid (milestone complete) (4)

 

18

 

226

 

111

 

500

Expensed but unpaid, not yet due (milestone not yet complete) (5)

13

1,230

130

3,270

Expensed and due, but unpaid (milestone complete) (3)

 

 

550

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

150

Total

$

3,865

$

5,594

$

12,399

$

20,276

$

4,378

$

4,675

(1)The payment for the nine months ended September 30, 2023This covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA, and covers 2 other one-time milestones for 2 other required licenses for the Sawston facility (licenses from the Human Tissue Authority and from the MHRA for manufacturing for clinical trials and compassionate use cases).MHRA. The milestone was achieved but shares were not yet issued as of March 31, 2023.
(2)The expense for the nine months ended September 30, 2023This covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and 1 one-time milestone for drafting key portions of the application for product approval.
(3)This covers two one-time milestone: a required license for the Sawston facility from the Human Tissue Authority.
(4)The expense for the nine months ended September 30, 2023 covers the one-time milestone workstream formilestones: Mechanism of Action and also coversobtaining a one-time milestone for a requiredcommercial manufacturing license for the Sawston facility from the MHRA for manufacturing for clinical trials and compassionate use cases.
(5)The expense for the nine months ended September 30, 2023 covers the one-time milestone for drafting key portions of the application for product approval, and also covers 6 one-time milestones: 5 workstreams (Comparability, Stability, Potency, Product Profile and Fill/Finish) and one-time milestone for drafting key portions of the application for product approval.MHRA.

Advent BioServices Sublease Agreement

On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately 14,459 square feet of

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently  £5.75 or approximately $7.02$7.26 per square foot based on exchange rate as of September 30, 2023)March 31, 2024), but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2023.2024. 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 £500,000£550,000 (approximately $610,000)$694,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

During the three and nine months ended September 30,March 31, 2024 and 2023, the Company recognized sub-lease income of $36,000 and $108,000,$36,000, respectively.

Related Party Accounts Payable

As of September 30, 2023, there was approximately $0.2 million of unpaid board compensation to one of our Directors that was included in the accounts payable to related party on the condensed consolidated balance sheets.

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

    

September 30, 

    

December 31, 

    

March 31, 

    

December 31, 

2023

2022

2024

2023

Advent BioServices - amount invoiced but unpaid

$

2,451

$

1,844

$

1,633

$

1,668

Advent BioServices - amount accrued but unpaid(1)

2,027

4,736

1,101

1,601

Total payable and accrued, but unpaid to Advent BioServices

$

4,478

$

6,580

$

2,734

$

3,269

(1) This includes $1.1 million which is not payable in cash but represents the value of 1.5 million shares that will become issuable to Advent, following final Board approval, for achievement of the one-time milestone for submission of the MAA application to MHRA on December 20, 2023. Such shares were not issued as of March 31, 2024, and the total value, previously recognized as stock compensation expense, was reclassified from Additional Paid-in-Capital to Accounts payable and accrued expenses to related parties and affiliates.

10. Preferred Stock

Series C Convertible Preferred Stock

During the ninethree months ended September 30, 2023,March 31, 2024, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of 0.70.3 million shares of the Company’s Series C convertible preferred stock, par value $0.001 per share (the “Series C Shares”), at a weighted purchase price of $13.58$11.77 per share for proceeds of approximately $9.9$3.6 million.

During the ninethree months ended September 30, 2023, the Company issuedMarch 31, 2024, approximately 56,000 Series C Shares with a fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million in debt, including $0.1 million accrued interest. The Company recognized an approximately $0.1 million debt extinguishment loss.

During the nine months ended September 30, 2023, approximately 0.40.2 million Series C Shares with a book value of $6.5$2.5 million were converted into 11.15.5 million common shares at a ratio of 1:25.

The Company determined that the Series C Shares contain contingent redemption provisions allowing redemption by the holder upon certain defined events (“deemed liquidation events”). As the event that may trigger the redemption of the Series C Shares is not solely within the Company’s control, the Series C Shares are classified as mezzanine equity (temporary equity) in the Company’s condensed consolidated balance sheets.

11. Stockholders’ Deficit

Common Stock

On January 9, 2023,During the three months ended March 31, 2024, the Company filedreceived $1.3 million from the exercise of outstanding warrants with a Certificateweighted average exercise price of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized$0.22 per share. The Company issued approximately 5.8 million shares of common stock from 1.2  billionupon these warrant exercises.

During the three months ended March 31, 2024, certain options and warrants holders elected to 1.7 billion, par value $0.001exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 1.6 million shares of common stock upon exercise of 2.4 million warrants at exercise prices between $0.20 and $0.34 per share, and 0.7 million options at exercise prices of $0.35 per share.

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During the nine months ended September 30, 2023, the Company received $2.8 million from the exercise of outstanding warrants with an exercise price between $0.153 and $0.85, of which $1.2 million was received in December 2022 as investor advances. The Company issued approximately 12.4 million shares of common stock upon these warrant exercises.

During the nine months ended September 30, 2023, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 20.4 million shares of common stock upon exercise of 22.9 million warrants at exercise prices between $0.17 and $0.22 per share, and 2.5 million options at exercise prices between $0.25 and $0.55 per share.

The Company issued approximately 27.6 million shares of common stock with a fair value of $17.5 million to certain lenders in lieu of cash payments of $13.2 million of debt, including $1.0 million of accrued interest, and settled $1.3 million true-up provision (see Note 7).

Stock Purchase Warrants

The following is a summary of warrant activity for the three months ended September 30, 2023March 31, 2024 (dollars in thousands, except per share data):

    

Number of

    

Weighted Average

    

Remaining

    

Number of

    

Weighted Average

    

Remaining

Warrants

Exercise Price

Contractual Term

Warrants

Exercise Price

Contractual Term

Outstanding as of January 1, 2023

 

141,048

$

0.31

 

1.16

Outstanding as of January 1, 2024

 

105,241

$

0.31

 

1.83

Warrants exercised for cash

 

(12,447)

 

0.22

 

 

(5,831)

 

0.22

 

Cashless warrrants exercise

(22,907)

0.20

(2,369)

0.35

Warrants expired and cancellation

 

(250)

 

1.36

 

Outstanding as of September 30, 2023

 

105,444

$

0.32

 

1.92

Outstanding as of March 31, 2024

 

97,040

$

0.28

 

2.05

The options and warrants held by Ms. Powers and Mr. Goldman are subject to an ongoing suspension on a rolling basis pursuant to the Blocker Letter Agreement.

At September 30, 2023,March 31, 2024, of the approximately 10597 million total outstanding warrants listed above, approximately 10092 million warrants were under the Blocker Letter Agreement or suspension agreements.

Warrant Modifications

Between January 10 and September 30, 2023,During the three months ended March 31, 2024, the Company amended multiple warrants whereby the maturity dates of certain warrants were extended for an additional approximately 3 months. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.

    

Post-modification

    

Pre-modification

 

    

Post-modification

    

Pre-modification

 

Exercise price

$

0.30

$

0.31

$

0.28

$

0.31

Expected term (in years)

 

1.8

 

1.5

 

2.1

 

1.8

Volatility

 

73

%  

 

90

%

 

80

%  

 

81

%

Risk-free interest rate

 

4.9

%  

 

4.9

%

 

4.7

%  

 

4.9

%

Dividend yield

 

0

%  

 

0

%

 

0

%  

 

0

%

The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $2.2$1.8 million, of which $0.8$1.2 million was associated with debt financingamendments and was recognized as an additional debt discount under debt modification and interest expensedebt extinguishment loss under debt extinguishment (see Note 7), and the remaining $1.4$0.6 million was treated as a deemed dividend and is reflected as “Deemed dividend related to warrant modifications” in the accompanying condensed consolidated statement of operations and comprehensive loss.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

12. Commitments and Contingencies

Operating Lease- Lessee Arrangements

The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected the practical expedient to account for each separate lease component of a contract and its associated non-lease components as a single lease component, thus causing all fixed payments to be capitalized. The Company also elected the package of practical expedients permitted within the new standard, which among other things, allows the Company to carry forward historical lease classification. The lease renewal options have not been included in the calculation of the lease liabilities and right-of-use (“ROU”) assets as the Company has not yet determined whether to exercise the options. Variable lease payment amounts that cannot be determined at the commencement of the lease such as increases in lease payments based on changes in index rates or usage, are not included in the ROU assets or liabilities. These are expensed as incurred and recorded as variable lease expense.

At September 30, 2023,March 31, 2024, the Company had operating lease liabilities of approximately $4.5$4.6 million for both the 20-year lease of the building for the manufacturing facility in Sawston, U.K., and the current office lease in the U.S. and ROU assets of approximately $4.0$4.1 million for the Sawston lease and U.S. office lease are included in the condensed consolidated balance sheet.

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

For the Nine Months ended

September 30, 2023

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

443

$

190

$

633

Short-term lease cost

 

62

 

 

62

Variable lease cost

 

 

10

 

10

Sub-lease income

 

(108)

 

 

(108)

Total

$

397

$

200

$

597

Other information

 

 

 

Operating cash flows from operating leases

$

(467)

$

(224)

$

(691)

Weighted-average remaining lease term – operating leases

 

8.1

 

0.7

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

For the Nine Months ended

September 30, 2022

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

448

$

195

$

643

Short-term lease cost

 

56

 

 

56

Variable lease cost

 

 

9

 

9

Sub-lease income

(110)

(110)

Total

$

394

$

204

$

598

Other information

 

 

 

Operating cash flows from operating leases

$

(472)

$

(217)

$

(689)

Weighted-average remaining lease term – operating leases

 

8.6

 

1.4

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

The Company recorded lease costs as a component of general and administrative expense during the nine months ended September 30, 2023 and 2022, respectively.

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Operating Lease - Lessor Arrangements

On December 31, 2021, the Company entered into a Sub - lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement are two times the amount payable by the Company under the head lease (which is currently L5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces and parking under the head lease are L550,000 (approximately $694,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

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

For the three months ended

March 31, 2024

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

156

$

65

$

221

Short-term lease cost

 

13

 

 

13

Variable lease cost

 

 

6

 

6

Sub-lease income

 

(36)

 

 

(36)

Total

$

133

$

71

$

205

Other information

 

 

 

Operating cash flows from operating leases

$

(166)

$

(75)

$

(241)

Weighted-average remaining lease term – operating leases

 

7.7

 

0.4

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

For the three months ended

March 31, 2023

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

144

$

65

$

209

Short-term lease cost

 

23

 

 

23

Variable lease cost

 

 

4

 

4

Sub-lease income

(36)

(36)

Total

$

131

$

69

$

200

Other information

 

 

 

Operating cash flows from operating leases

$

(152)

$

(73)

$

(225)

Weighted-average remaining lease term – operating leases

 

8.4

 

1.1

 

Weighted-average discount rate – operating leases

 

12

%  

 

12

%  

 

The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2024 and 2023, respectively.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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

Three months ended December 31, 2023

$

228

Year ended December 31, 2024

    

815

Nine months ended December 31, 2024

$

621

Year ended December 31, 2025

610

    

656

Year ended December 31, 2026

610

656

Year ended December 31, 2027

610

656

Year ended December 31, 2028

656

Thereafter

6,692

6,542

Total

9,565

9,787

Less present value discount

(5,062)

(5,158)

Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2023

$

4,503

Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2024

$

4,629

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

Three months ended December 31, 2023

    

$

36

Year ended December 31, 2024

 

145

Nine months ended December 31, 2024

    

$

108

Year ended December 31, 2025

 

145

 

145

Year ended December 31, 2026

 

145

 

145

Year ended December 31, 2027

 

145

Year ended December 31, 2028

 

145

Thereafter

 

1,740

 

1,450

Total

$

2,211

$

2,138

Advent BioServices Services Agreement

On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The MSA provides for manufacturing of DCVax-L products at an existing facility in London. The MSA is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity reserved exclusively for DCVax production and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. The MSA remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate the MSA on twelve months’ notice, to allow for transition arrangements by both parties. During the notice period services would still be provided. Minimum required payments for this notice period are anticipated to total approximately £4.5 million ($5.55.7 million).

The Company entered into SOW 6 with Advent, which was incorporated into the Ancillary Services Agreement, on April 1, 2022, and amended it on September 26, 2022 and again on September 26, 2023. The milestone incentives involve a combination of cash and stock and are not paid until they are achieved and earned, as described in Note9.

German Tax Matter

The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015 and assessed additional tax against the subsidiary.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 $293,000)$299,000), for corporate taxes, interest, and reduced penalty for the period under audit, which the Company paid on September 2, 2021. The Company also received and paid the final settlement bill from the local authority for trade taxes for the audit period in the amount of €231,000 (approximately $244,000)$249,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (now approximately $542,000)$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,

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

the Company requested that NW Bio GmbH be deregistered from the trade register, as it no longer had current operations. The deregistration was granted effective December 31, 2021. Between January 2022 and July 2022, the Company received tax bills for the corporate and trade taxes for the 2016-2020 tax years that totaled approximately €222,000 (approximately $235,000)$240,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $143,000)$146,000) of the penalties. The Company offered to pay this reduced penalty if an

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

extended payment plan was approved. A response was received dated November 14, 2022 indicating that the tax authority would not be able to grant a further deferral of payment of these penalties. In a letter dated December 27, 2022, the Leipzig tax authority sent letters to the former and current managing directors of NW Bio GmbH giving 30 days to respond to a tax liability questionnaire. Based on the responses to the liability questionnaires the tax authorities have currently not directed any further measures against former and current managing directors of NW Bio GmbH with respect to tax liability proceedings. The Company currently has accrued for the current amounts owed for these penalties of €377,000 (approximately $399,000) as well as for all unpaid taxes as of September 30, 2023. Subsequently onOn October 12, 2023 and January 16, 2024, the Company paidmade €189,000 and €189,000 payments, respectively, regarding to the late payment penalty. As of March 31, 2024, the Company accrued for trade tax liability of €155,000 (approximately $200,000), which represents 50%$168,000) and corporation tax of the total penalties. The Company is expecting to make the other half payment by end of November 2023.€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

Between May and September 2023,During the three months ended March 31, 2024, the Company entered into certaina non-dilutive funding agreementsagreement with multiple investors,an individual investor, pursuant to which the Company received funding of $4.6 million$50,000 related to a gain contingency. These agreements are accounted for under ASC 470 and are recognized as contingent payment obligations on the Company’s condensed consolidated balance sheet. The Company’s payment obligations only apply when such are received by the Company.

13. Subsequent Events

Between OctoberApril 1, 20232024 and November 6, 2023,May 8, 2024, the Company received $1.9$11.4 million in funding from the sale of preferred shares, proceeds from warrant exercise, and option exercise, proceeds of debt arrangements.

Between OctoberApril 1, 20232024 and November 6, 2023,May 8, 2024, the Company issued approximately 80,0000.1 million shares of Series C preferred stock for proceeds of $1.2$1.4 million.

Between OctoberApril 1, 20232024 and November 6, 2023,May 8, 2024, the Company received $0.1 million$9,000 from the exercise of 0.2 million43,000 outstanding warrants and options. The Company also issued 0.6 million shares of common stock from a cashless exercise of 0.8 million options.warrants.

Between OctoberApril 1, 20232024 and November 6, 2023,May 8, 2024, approximately 0.20.3 million Series C Shares with a book value of $3.6$3.5 million were converted into 6.18.5 million common shares in accordance with their terms at a ratio of 1:25.25.

In October 2023,Between April 1, 2024 and May 8, 2024, the Company issued approximately 1.92.8 million net shares of common stock to a lendercertain lenders in lieu of cash payments on $1.6of $1.3 million of outstanding debt, which is offset by a settlementincluding $0.1 million of $0.7accrued interest. The Company also issued 0.2 million shares receivable.of common stock to extinguish $0.1 million outstanding share liability.

On OctoberApril 4, 2023,2024, the Company issued approximately 0.1 million shares of Series C Shares to certain lenders for debt conversion of $0.5 million, including $0.1 million of accrued interest.

On April 26, 2024, the Company entered into a one-year convertible noteCommercial Loan Agreement (the “Convertible Note”“April Commercial Loan”) with an investor (the “Holder”) witha commercial lender for an aggregate principal amount of $154,000 for a purchase price of $140,000.$11.0 million. The Convertible Note bearApril Commercial Loan bears interest at 8% per annum andwith a 22 - month term. There are no principal repayments during the first eight months of the term. The April Commercial Loan is convertible into Series C preferred shares at $17.50 per share at the Holder’s sole option.  As additional consideration for entering into the Convertible Note,amortized in 14 installments starting on December 26, 2024. The April Commercial Loan carries an original issue discount of $1.0 million.

On April 29, 2024, the Company also extended the holder’s existingissued approximately 1.3 million shares of common stock upon cashless exercise of 2.1 million warrants maturity date for additional 8.5 months.

On October 20, 2023, the Company received $0.5 million cash from issuance a one-year convertible note. The note has same conversion features as the August & September Note (see Note 7).at exercise prices of $0.20 per share.

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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, 20222023 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 place undue reliance 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 glioblastomaGlioblastoma multiforme brain cancer (GBM).

The trial, published the results were presented at a scientific conference in May 2022, and were reported in athe JAMA Oncology peer reviewed publication in JAMA Oncology,journal, and on December 20, 2023 we submitted a top scientific and medical journal.

In June 2023, the Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action of its DCVax technology at an Industry Theater presentation during the ASCO (American Society of Clinical Oncology) conference. The Company is pursuing further analyses by independent experts and plans to present further information at an appropriate future conference.

The Company is nowMarketing Authorization Application (MAA) for commercial approval in the final stages of preparing an application to the U.K. regulatory authority for approval of DCVax-L. The Company is working with teams of specialized consultants on preparation of the application package as well as related activities.

In parallel with preparing the application for approval of DCVax-L, the Company is working with the contract research organization (CRO) and with specialized consultants on preparing the Trial Master File and trial sites to be inspection-ready for regulators.

The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive.

The Company is pursuing preparations for the pediatric clinical trials that are required to be conducted in connection with an application for approval of a new medicine for adult patients.

The non-proprietary name for the Company’s DCVax-L product, murcidencel, was finalized and published in rINN List 90 in October 2023. The name was originally assigned by the WHO on May 6, 2022, and then had to go through a series of additional steps and notice periods to become final.

The Company and Advent are working together to prepare for potential commercial operations. The buildout of Phase 1B of the Sawston facility, which had been under way since last year, has been completed. On July 24, 2023, the Company changed the name of its UK subsidiary from Aracaris Limited to Northwest Biotherapeutics Limited.

The Company’s wholly owned subsidiary, Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including to optimize yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.

Supply chain issues and equipment backlogs continue to be factors affecting operations both for Advent and for Flaskworks. This includes months-long backlogs for certain equipment and materials. However, the work is progressing in spite of the backlogs.

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The Company is in active discussions in regard to certain combination treatment regimens and is planning for certain strategic trials with such combination treatments.

In the future, weWe plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers beyond brain cancer,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 it 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. We

The Company’s programs and operations continue to be impacted by supply chain issues and backlogs which, surprisingly, have still not substantially resolved. These involve service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The Company is hopeful that the various backlog circumstances will improve over the course of 2024.

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

MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.

As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete.

Preparations for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.

Pediatric Glioma Clinical Trials. The Company continued its discussions with physicians about the two planned trials of DCVax - L for pediatric gliomas. The arrangements for the trials have not yet been finalized.

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Flaskworks. The Flaskworks team and Advent BioServices continued to work with the specialized contractor on the development of the GMP-grade units of the Flaskworks system. Two key areas of focus in the work have been the ability to clean the machines to GMP requirements and additional safety features for protection of the operators in the GMP setting. Enabling all parts of the machines to be cleanable to the level of sterility required for GMP operations has required changing certain materials to achieve acceptable surface properties, constructing housings around certain portions of the machines or otherwise eliminating nooks and crannies while not interfering with the movements of the machines, and other such development aspects. The Company believes the work is on track for the GMP adaptation work to be finished in the near future, and the first GMP units to be delivered to the Company soon after that.

Sawston Facility. The Company has commenced the design and build works for the construction of the first Grade C cleanroom at the Sawston facility and the contractor is onsite. The Company expects the Grade C cleanrooms to be important for scale - up, as they will accommodate the “closed” Flaskworks system, and be able to manufacture a number of patients’ products in the lab at the same time. In contrast, with the existing “open” process in the Grade B cleanrooms, products must be manufactured for one patient at a time and the whole lab must be cleaned and sterilized between each patient’s process. Since construction work in the facility can directly and/or indirectly impact the existing cleanrooms in the facility (e.g., by generating a lot of dust and particles) and prevent the existing Grade B cleanrooms  from being able to operate in accordance with GMP sterility standards, the Company has been working with Advent BioServices and contractors to arrange for the construction work to take place as much as possible during periodic scheduled shutdowns of the existing clean rooms for deep cleaning and special maintenance which are pursuingrequired for GMP compliance.

Intellectual Property and Collaborations. As previously reported, the prosecution of existingCompany filed new patent applications relating to the Flaskworks system, which the Company believes will be an important factor for facilitating scale - up and addingcommercialization of DCVax - L products. In addition, multiple new patents were granted and 1 new patent was allowed from patent applications previously filed. The Company continued working with certain intellectual property that we consider complementaryit has in - licensed as previously reported, on preparations for expansion of the Company’s pipeline with certain new clinical programs when bandwidth and resources permit. The Company also continued discussions and negotiations during the first quarter of 2024 relating to our existing intellectual property.collaborations which the Company believes will help it build a broad franchise in dendritic cell-based immunotherapies.

Litigation. Significant amounts of Company bandwidth and resources were spent on litigations during the first quarter of 2024 (and to date in the second quarter of 2024). The cases are described in Part II - Item 1, Legal Proceedings, below.

Annual Shareholder Meeting. The Company plans to conduct its Annual Shareholder Meeting before the end of June 2024.

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, particularly given the significant social and economic disruptions and uncertainties associated with the lingering effects from the coronavirus pandemic (“COVID-19”) and the COVID-19 control responses.estimates.

Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2022.2023. Our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022 other than those included below.

Sequencing

The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate if it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary agreements are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, non-employees or directors are not subject to the sequencing policy.

On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximate 141 million warrants to purchase shares of the Company’s common stock were classified as liabilities through January 8, 2023.

Modification of Equity Classified Warrants

A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.

Convertible Notes under Fair Value Option

The Company accounts for certain convertible notes issued in August and September 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for

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under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred.

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.

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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 September 30,March 31, 2024 and 2023 and 2022

We recognized a net loss of $19.1$18.3 million and $32.9$10.7 million for the three months ended September 30,March 31, 2024 and 2023, and 2022, respectively.

Research and Development Expense

For the three months ended September 30,March 31, 2024 and 2023, and 2022, research and development expenses were $7.2$7.9 million and $7.7$6.9 million, respectively. The decreaseincrease in 20232024 was mainly related to an increase of $0.7 million in stock-based compensation which was mainly related to additional awards that were granted to various key external consultants in the following factors:

We incurred $0.1 million and $2.9 million R&D expense related to one-time milestone activities under the SOW 6 with Advent BioServices for the three months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the only unvested

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milestone was to submit an application to a regulatory which is expected to take place during November 2023. Most expenses related to the completed milestones were recognized in prior periods and in 2022.
The stock-based compensation in research and development related to stock options and Flaskworks performance-based awards that were increased by $0.2 million during the three months ended September 30, 2023 compared to the same period in 2022, which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023.
An increased level of research and development activities in 2023 compared to 2022, which resulted in other R&D expenses increased by approximate $2.1 million.

General and Administrative Expense

For the three months ended September 30,March 31, 2024 and 2023, and 2022, general and administrative expenses were $7.0$8.1 million and $8.10$7.0 million, respectively. The decreaseincrease in 20232024 was mainly related to a decreasean increase of $0.5$0.9 million in stock-based compensation, which was related to less amortization related to previously granted awards,legal expenses.

Change in Fair Value of Derivatives

We recognized a non-cash lossgain of $0.1 million and a non-cash lossgain of $12.2$3.9 million for the three months ended September 30,March 31, 2024 and 2023, and 2022, respectively. The lossgain was primarily due to an increasethe decrease of stock price as of September 30,March 31, 2024 and 2023 compared to June 30,December 31, 2023 and 2022.

Change in Fair Value of Convertible Notes

We recognized a non-cash gain of $1.8 million change in fair value of the convertible notes during the three months ended March 31, 2024. The gain was primarily due to the decrease of stock price as of September 30, 2022March 31, 2024 compared to June 30, 2022.December 31, 2023.

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Debt Extinguishment

DuringWe recognized an approximately $0.8 million debt extinguishment loss during the three months ended September 30, 2023, weMarch 31, 2024 from the debt redemption, and $1.4 million from the amendments of certain convertible notes and existing warrants (see Note 7).

We recognized a $1.8an approximately $1.4 million debt extinguishment loss from the redemption of $5.8 million outstanding debt. Duringduring the three months ended September 30, 2022, we recognized a $0.5 million debt extinguishment lossMarch 31, 2023 from the redemption of $4.8 million outstanding debt.debt redemption.

Interest Expense

During the three months ended March 31, 2024 and September 30, 2023, and 2022, we recorded interest expense of $1.7$1.5 million and $1.5$1.0 million, respectively. The decreaseincrease in interest expense in 20232024 was mainly related to a decreasean increase of outstanding debt as a result of the redemption of approximate $18.1 million debt in 2022.balance.

Foreign currency transaction loss

During the three months ended and September 30,March 31, 2024 and 2023, and 2022, we recognized foreign currency transaction loss of $1.7$0.7 million and lossgain of $3.1$0.9 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to the British pound sterling.

Nine months Ended September 30, 2023 and 2022

We recognized a net loss of $43.7 million and $76.7 million for the nine months ended September 30, 2023 and 2022, respectively.

Research and Development Expense

For the nine months ended September 30, 2023 and 2022, research and development expenses were $20.3 million and $26.2 million, respectively. The decrease in 2023 was mainly related to the followings:

We incurred $1.5 million and $12.0 million R&D expense related to one-time milestone activities under the SOW 6 with Advent BioServices for the nine months ended September 30, 2023 and 2022, respectively. Advent had completed 7 out of the total 10 one-time milestones as of December 31, 2022, and the majority of the one-time R&D expense was recognized in 2022. Therefore, we only expensed $1.5 million for the nine months ended September 30, 2023 related to the remaining 3 milestones. During the nine months ended September 30, 2022, we expensed $5.3 million (but only paid $1.5 million) for one-time cash milestones and $6.7 million (but only issued 2.5 million shares of common stock at fair value of $2.1 million) for one-time stock-based milestones that we believe are probable to be achieved and hence to become payable during the contract period.

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The stock-based compensation in research and development related to stock options and Flaskworks performance-based awards that were reduced by $0.5 million during the nine months ended September 30, 2023 compared to the same period in 2022, which was related to less amortization related to previously granted awards.
An increased level of research and development activities in 2023 compared to 2022, which resulted in other R&D expenses increasing by approximately $5.1 million.

General and Administrative Expense

For the nine months ended September 30, 2023 and 2022, general and administrative expenses were $21.6 million and $23.9 million, respectively. The decrease in 2023 was mainly related to a decrease of $1.7 million in consulting, legal and stock-based compensation, and $0.7 million reduction in our D&O insurance.

Change in Fair Value of Derivatives

We recognized a non-cash gain of $3.9 million and a non-cash loss of $15.9 million for the nine months ended September 30, 2023 and 2022, respectively. The gain was mainly due to majority of revaluation expense was recognized as of January 9, 2023, when we reclassed all warrants from liability classified to equity classified. The stock price on January 9, 2023 and December 31, 2022 was $0.71 and $0.78 per share, respectively. The decrease of stock price resulted a gain in change in fair value.

The 2022 loss was primarily due to the extension of certain warrants and an increase of stock price as of September 30, 2022 compared to December 31, 2021.

Debt Extinguishment

During the nine months ended September 30, 2023, we issued approximately 27.6 million shares of common stock with a fair value of $17.5 million to certain lenders in lieu of cash payments of $13.2 million of debt, including $1.0 million of accrued interest. We also extinguished Share liabilities of $1.3 million and recognized additional $0.5 million in Share liabilities. We recognized an approximately $3.5 million debt extinguishment loss during the nine months ended September 30, 2023 from the debt redemption.

During the nine months ended September 30, 2023, we issued approximately 56,000 shares of Series C preferred stock with a fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million in debt, including $0.1 million of accrued interest. We recognized an approximately $0.1 million debt extinguishment loss.

During the nine months ended September 30, 2022, we recognized debt extinguishment loss of $0.2 million. We incurred $0.4 million gain from the forgiveness of two PPP loans and offset by a loss of $0.6 million from redemption of certain loans during the nine months ended September 30, 2022.

Interest Expense

During the nine months ended and September 30, 2023 and 2022, we recorded interest expense of $4.0 million and $4.8 million, respectively. The decrease in interest expense in 2023 was mainly related to a decrease of outstanding debt as a result of the redemption of approximate $18.1 million debt in 2022.

Foreign currency transaction loss

During the nine months ended and September 30, 2023 and 2022, we recognized foreign currency transaction loss of $0.1 million and $6.8 million, respectively. The loss was due to the strengtheningweakening of the U.S. dollar relative to the British pound sterling.

Liquidity and Capital Resources

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

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

Cash Flow

Operating Activities

During the ninethree months ended September 30,March 31, 2024 and 2023, and 2022, net cash outflows from operations were approximately $36.7$12.4 million and $43.9$11.2 million, respectively. The decreaseincrease in cash used in operating activities was primarily attributable to a reductionan increase in payments to external service providers as well as a reduction in interest payments to certain note holders.clinical trial related expenditures.

Investing Activities

We spent approximately $3.0$0.2 million and $0.7$1.3 million in cash for the purchase of additional equipment and our build outbuild-out in Sawston, UK during the ninethree months ended September 30,March 31, 2024 and 2023, and 2022, respectively.

Financing Activities

We received approximately $9.9$3.6 million of cash from issuance of 0.70.3 million shares of Series C convertible preferred stock during the ninethree months ended September 30, 2023.March 31, 2024.  We received approximately $11.0$2.4 million cash from issuance of 0.70.1 million shares of Series C convertible preferred stock during the ninethree months ended September 30, 2022.March 31, 2023.

We received approximately $10.0 million and $5.0 million of cash from issuance the issuance of a loan to a commercial lender during the nine months ended September 30, 2023 and 2022, respectively. During the nine months ended September 30, 2022, we also received $0.6 million of cash from issuance of notes to multiple individual investors.

We received approximately $1.6 million and $10.0 million of cash from the exercise of warrants during the nine months ended September 30, 2023 and 2022, respectively.

We received approximately $9.5 million of cash from issuance of 13.1 million shares of common stock during the nine months ended September 30, 2022.

We received approximately $12.7$7.1 million of cash from issuance of convertible notes to individual lenders during the ninethree months ended September 30, 2023.March 31, 2024.

We received $4.6approximately $10.0 million of cash from the issuance of a loan from a commercial lender during the three months ended March 31, 2023.

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We received approximately $1.3 million and $0.2 million of cash from the exercise of warrants during the three months ended March 31, 2024 and 2023, respectively.

We received $50,000 from issuance of non-dilutive funding agreements during the ninethree months ended September 30, 2023.March 31, 2024.

We made aggregate debt payments of $0.2 million and $5.4$0.1 million during the ninethree months ended September 30, 2023 and 2022, respectively.

We made repayment of $0.2 million of investor advances during the nine months ended September 30,March 31, 2023.

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

Off-Balance Sheet Arrangements

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

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

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participants refrain from transacting in normal quantities and/or at normal bid-offer spreads. Our exposure to market risk is directly related to derivatives, debt and equity linked instruments related to our financing activities.

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

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

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

Based on our analysis, as of September 30, 2023,March 31, 2024, the effect of a 100+/- basis point change in interest rates on the value of our financial instruments and the resultant effect on our net loss are considered immaterial.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of September 30, 2023,March 31, 2024, of the design and operation of our disclosure controls and procedures, as such terms are defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Based on this evaluation, management concluded that, as of such date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Remediation of a Material Weakness in Internal Control over Financial Reporting

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

Changes in Internal Control over Financial Reporting

No change in internal control over financial reporting occurred during the most recent quarter with respect to our operations, which materially affected, or is reasonablereasonably 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(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 their new MTD. The Company is currently drafting its response, and plans to continue to pursue this case vigorously.

As previously reported, three stockholders filed in the Delaware Court of Chancery three similar derivative lawsuits against the Company and certain of its directors and officers, including J. Cofer Black, Marnix L. Bosch, Alton L. Boynton, Leslie J. Goldman, Jerry Jasinowski, Navid Malik, and Linda F. Powers (the “Individual Defendants”), alleging the Individual Defendants (i) breached their fiduciary duties, and (ii) were unjustly enriched by director and officer compensation awarded in 2020 to the Individual Defendants—notwithstanding the fact that approximately 90% of shareholders voted to approve of the Company’s executive compensation (the same compensation that these three stockholders are seeking to challenge) twice (both through its Say on Pay vote at the Company’s Annual Meeting in 2021, and again in a binding vote at the Company’s Annual Meeting in 2022) and approximately 90% of shareholders also voted to approve the director awards were subject to shareholder approval.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”).

On December 30, 2022, shareholders again approvedfollowing the same 2020 executive compensation with approximately 90%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, Gibson Dunn filed an answer to the Consolidated Amended Complaint on behalf of the votes, and also approvedCompany. On December 28, 2023, the directors compensation with approximately 90%Individual Defendants, represented by separate counsel, filed their response to the Consolidated Amended Complaint. The parties are currently in the midst of the votes.

The Company believes this case is baseless and is vigorously contesting it. The Company is expecting a decision in November 2023.discovery.

Item 1A. Risk Factors

Applicable risk factors are set forth in the Company’s report on Form 10-K for 2022.the fiscal year ended December 31, 2023.

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

In April 2023, the Company entered into several ten-month convertible notes (the “April Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $0.9 million for a purchase price of $0.8 million. The April Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $13.75 per share at the Holders’ sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock.None.

On June 30, 2023, the Company entered into a one-year convertible note (the “June Convertible Note”) with an individual investor (the “Holder”) with principal amount of $1.0 million. The Company received $1.0 million cash from the June Convertible Note. The June Convertible Note bears interest at 8% per annum and is convertible into Series C preferred shares at $12.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock.

On July 11, 2023, the Company entered into another one-year convertible note (the “July Convertible Note”) with the same investor as the June Convertible Note with principal amount of $0.5 million. The Company received $0.5 million cash from the July Convertible Note. The July Convertible Note bears interest at 10% per annum and has same conversion feature and conversion price as the June Convertible Note.

During the three months ended September 30, 2023, the Company entered into several one-year convertible notes (the “Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.4 million for a purchase price of $1.3 million. The Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares between $13.75 and $17.50 per share at the Holders’ sole option.  The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock.

Between August and September 2023, the Company entered into several one-year convertible notes (the “August & September Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $10.3 million. The August

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& September Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between $10.00 and $12.50 per share at the Holder’s sole option.  The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. In addition, the Holders have an alternative option to convert the August & September 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.

Item 3. Defaults Upon Senior Securities

Not Applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

21.1

Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 filed with the Registrant’s Quarterly Report on Form 10-Q on August 9, 2023).

21.2

Certificate of Incorporation on Change of Name (incorporated by reference to Exhibit 21.2 filed with the Registrant’s Quarterly Report on Form 10-Q on August 9, 2023).

31.1

    

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

32.1

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

101.INS

Inline XBRL Instance Document.

 

101.SCH

Inline XBRL Schema Document.

 

101.CAL

Inline XBRL Calculation Linkbase Document.

 

101.DEF

Inline XBRL Definition Linkbase Document.

 

101.LAB

Inline XBRL Label Linkbase Document.

 

101.PRE

Inline XBRL Presentation Linkbase Document.

104

The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023,March 31, 2024, formatted in Inline XBRL (included as Exhibit 101).

*    Filed herewith

**  Furnished herewith

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SIGNATURES

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

NORTHWEST BIOTHERAPEUTICS, INC

Dated: November 9, 2023May 10, 2024

By:

/s/ Linda F. Powers

Name:

Linda F. Powers

Title:

President and Chief Executive Officer

Principal Executive Officer

Principal Financial and Accounting Officer

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