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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 June 30, 2023

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 August 7, 2023, the total number of shares of common stock, par value $0.001 per share, outstanding was 1,121,070,972.

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 June 30, 2023 and December 31, 2022

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2023 and 2022

4

 

Condensed Consolidated Statements of Stockholders’ Deficit for the three and six months ended June 30, 2023 and 2022

5

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022

7

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

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

26

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

 

 

Item 4.

Controls and Procedures

32

PART II - OTHER INFORMATION

33

Item 1.

Legal Proceedings

33

 

 

Item 1A.

Risk Factors

33

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

33

 

 

Item 3.

Defaults Upon Senior Securities

33

 

 

Item 4.

Mine Safety Disclosures

33

 

Item 5.

Other Information

33

 

 

Item 6.

Exhibits

34

SIGNATURES

35

2

PART I - FINANCIAL INFORMATION

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

    

June 30, 

    

December 31, 

2023

2022

(Unaudited)

ASSETS

 

  

 

Current assets:

 

  

 

  

Cash and cash equivalents

$

1,424

$

6,965

Prepaid expenses and other current assets

 

3,218

 

2,460

Total current assets

 

4,642

 

9,425

Non-current assets:

 

 

Property, plant and equipment, net

 

17,286

 

13,418

Construction in progress

2,028

Right-of-use asset, net

4,231

4,189

Indefinite-lived intangible asset

1,292

1,292

Goodwill

626

626

Other assets

 

361

 

345

Total non-current assets

 

23,796

 

21,898

TOTAL ASSETS

$

28,438

$

31,323

LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

 

 

Current liabilities:

 

 

Accounts payable and accrued expenses

$

12,107

$

10,687

Accounts payable and accrued expenses to related parties and affiliates

 

6,551

 

6,955

Convertible notes, net

 

1,858

 

135

Notes payable, net

 

8,403

 

15,403

Contingent payable derivative liability

8,706

8,668

Warrant liability

 

1,083

 

80,559

Investor advances

609

2,566

Share liability

223

678

Lease liabilities

385

354

Total current liabilities

 

39,925

 

126,005

Non-current liabilities:

 

 

Notes payable, net of current portion, net

 

15,743

 

5,991

Lease liabilities, net of current portion

4,369

4,370

Contingent payment obligation

4,050

Total non-current liabilities

 

24,162

 

10,361

Total liabilities

 

64,087

 

136,366

COMMITMENTS AND CONTINGENCIES (Note 12)

 

 

Mezzanine equity:

Series C Convertible Preferred Stock, 10,000,000 shares designated; 1.5 million and 1.4 million shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively; aggregate liquidation preference of $23.7 million

25,385

23,060

Stockholders’ deficit:

 

 

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

Common stock ($0.001 par value); 1,700,000,000 shares authorized; 1,115.2 million and 1,068.4 million shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

 

1,115

 

1,068

Additional paid-in capital

 

1,258,259

 

1,164,885

Stock subscription receivable

 

(79)

 

(79)

Accumulated deficit

 

(1,322,222)

 

(1,297,122)

Accumulated other comprehensive income

 

1,893

 

3,145

Total stockholders’ deficit

 

(61,034)

 

(128,103)

TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

$

28,438

$

31,323

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

3

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 six months ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

Revenues:

Research and other

$

201

$

477

$

1,081

$

880

Total revenues

201

477

1,081

880

Operating costs and expenses:

Research and development

6,214

13,645

13,075

18,465

General and administrative

7,564

7,931

14,547

15,800

Total operating costs and expenses

13,778

21,576

27,622

34,265

Loss from operations

(13,577)

(21,099)

(26,541)

(33,385)

Other income (expense):

Change in fair value of derivative liabilities

107

(4,254)

3,987

(3,714)

Change in fair value of share liabilities

99

47

(Loss) gain from extinguishment of debt

(472)

(110)

(1,880)

300

Interest expense

(1,302)

(1,432)

(2,329)

(3,335)

Foreign currency transaction gain (loss)

697

(2,773)

1,616

(3,748)

Total other income (loss)

(871)

(8,569)

1,441

(10,497)

Net loss

(14,448)

(29,668)

(25,100)

(43,882)

Deemed dividend related to warrant modification

(519)

(914)

Net loss attributable to common stockholders

$

(14,967)

$

(29,668)

$

(26,014)

$

(43,882)

Other comprehensive income (loss)

Foreign currency translation adjustment

(502)

2,375

(1,252)

3,183

Total comprehensive loss

$

(15,469)

$

(27,293)

$

(27,266)

$

(40,699)

Net loss per share applicable to common stockholders

Basic

$

(0.01)

$

(0.01)

$

(0.02)

$

0.21

Diluted

$

(0.01)

$

(0.01)

$

(0.02)

$

(0.06)

Weighted average shares used in computing basic loss per share

1,108,420

1,003,976

1,091,754

981,737

Weighted average shares used in computing diluted loss per share

1,108,420

1,003,976

1,091,754

981,737

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

4

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)

    

For the Three Months Ended June 30, 2023

Mezzanine equity

Accumulated

Series C Convertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders'

Shares

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at April 1, 2023

    

1,416

    

$

23,752

 

1,083,084

$

1,083

$

1,248,397

$

(79)

$

(1,307,774)

$

2,395

$

(55,978)

Issuance of Series C convertible preferred stock for cash

 

176

 

2,371

 

 

 

 

 

 

 

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

 

13

 

207

 

 

 

 

 

 

 

Series C convertible preferred stock conversion

 

(59)

 

(945)

 

1,484

 

2

 

943

 

 

 

 

945

Warrants exercised for cash

 

 

 

11,553

 

11

 

2,510

 

 

 

 

2,521

Cashless warrants and stock options exercise

 

 

 

9,169

 

9

 

(9)

 

 

 

 

Issuance of common stock for conversion of debt and accrued interest

 

 

 

6,893

 

7

 

3,941

 

 

 

 

3,948

Stock-based compensation

 

 

 

3,000

 

3

 

187

 

 

 

 

190

Reclass issued milestone shares from liability to equity

 

 

 

 

 

2,130

 

 

 

 

2,130

Net loss

 

 

 

 

 

 

 

(14,448)

 

 

(14,448)

Warrants modification

 

 

 

 

 

679

 

 

 

 

679

Deemed dividend related to warrants modification

 

 

 

 

 

(519)

 

 

 

 

(519)

Cumulative translation adjustment

 

 

 

 

 

 

 

 

(502)

 

(502)

Balances at June 30, 2023

 

1,546

$

25,385

 

1,115,183

$

1,115

$

1,258,259

$

(79)

$

(1,322,222)

$

1,893

$

(61,034)

    

For the Three Months Ended June 30, 2022

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders'

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at April 1, 2022

 

969,697

$

970

$

1,083,723

$

(79)

$

(1,206,304)

$

1,165

$

(120,525)

Issuance of common stock for cash

 

8,584

 

8

 

6,317

 

 

 

 

6,325

Warrants exercised for cash

 

23,747

 

24

 

5,347

 

 

 

 

5,371

Reclassification of warrant liabilities related to warrants exercised for cash

 

 

 

11,973

 

 

 

 

11,973

Cashless warrants and stock options exercise

 

28,877

 

29

 

(29)

 

 

 

 

Reclassification of warrant liabilities related to cashless warrants exercise

 

 

 

25,375

 

 

 

 

25,375

Issuance of common stock conversion of debt and accrued interest

 

2,070

 

2

 

1,343

 

 

 

 

1,345

Stock-based compensation

 

1,500

 

1

 

5,762

 

 

 

 

5,763

Net loss

 

 

 

 

 

(29,668)

 

 

(29,668)

Cumulative translation adjustment

 

 

 

 

 

 

2,375

 

2,375

Balances at June 30, 2022

 

1,034,475

$

1,034

$

1,139,811

$

(79)

$

(1,235,972)

$

3,540

$

(91,666)

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

5

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

(Unaudited)

For the Six Months Ended June 30, 2023

Mezzanine equity

Accumulated

Series C Convertible

Additional

Other

Total

Preferred Stock

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balances at January 1, 2023

 

1,415

$

23,060

1,068,394

$

1,068

 

$

1,164,885

 

$

(79)

$

(1,297,122)

 

$

3,145

$

(128,103)

Issuance of Series C convertible preferred stock for cash

324

4,756

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

 

56

1,013

Series C convertible preferred stock conversion

 

(257)

(3,562)

6,430

7

3,555

3,562

Warrants exercised for cash

12,320

12

2,757

2,769

Cashless warrants and stock options exercise

9,879

10

(10)

Reclassification of warrant liabilities to stockholders’ deficit

76,258

76,258

Issuance of common stock for conversion of debt and accrued interest

15,160

15

9,549

9,564

Stock-based compensation

8

118

3,000

3

1,105

1,108

Net loss

 

 

 

(25,100)

 

(25,100)

Warrants modification

 

1,074

1,074

Deemed dividend related to warrants modification

 

(914)

(914)

Cumulative translation adjustment

 

 

 

 

(1,252)

(1,252)

Balances at June 30, 2023

 

1,546

$

25,385

1,115,183

$

1,115

$

1,258,259

$

(79)

$

(1,322,222)

$

1,893

$

(61,034)

For the Six Months Ended June 30, 2022

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Subscription

Accumulated

Comprehensive

Stockholders’

    

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 common stock for cash

 

13,137

13

9,676

 

 

 

 

9,689

Warrants exercised for cash

39,003

39

9,517

9,556

Reclassification of warrant liabilities related to warrants exercised for cash

19,688

19,688

Cashless warrants and stock options exercise

28,903

29

(29)

Reclassification of warrant liabilities related to cashless warrants exercise

25,379

25,379

Issuance of common stock conversion of debt and accrued interest

3,482

4

2,328

2,332

Stock-based compensation

 

1,505

1

6,379

 

 

 

 

6,380

Net loss

(43,882)

(43,882)

Cumulative translation adjustment

 

 

 

 

3,183

 

3,183

Balances at June 30, 2022

 

1,034,475

$

1,034

$

1,139,811

$

(79)

$

(1,235,972)

$

3,540

$

(91,666)

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

6

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

For the six months ended

June 30,