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, 2020March 31, 2021

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 January 10,May 14, 2021, the total number of shares of common stock, par value $0.001 per share, outstanding was 822,716,397.851,564,728.

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)

3

 

Condensed Consolidated Balance Sheets as of September 30, 2020March 31, 2021 and December 31, 20192020

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30,March 31, 2021 and 2020 and 2019

4

 

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)Deficit for the three and nine months ended September 30,March 31, 2021 and 2020 and 2019

5

 

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30,March 31, 2021 and 2020 and 2019

76

 

Notes to Condensed Consolidated Financial Statements

98

Item 2.

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

3319

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

4023

 

 

Item 4.

Controls and Procedures

4123

PART II - OTHER INFORMATION

4124

Item 1.

Legal Proceedings

4124

 

 

Item 1A.

Risk Factors

4124

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

4224

 

 

Item 3.

Defaults Upon Senior Securities

4224

 

 

Item 4.

Mine Safety Disclosures

4224

 

Item 5.

Other Information

4224

 

 

Item 6.

Exhibits

4225

SIGNATURES

4326

2

Table of Contents

PART I - FINANCIAL INFORMATION

NORTHWEST BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

    

September 30, 

    

December 31, 

    

March 31, 

    

December 31, 

2020

2019

2021

2020

(As Revised) (Note 13)

(Unaudited)

ASSETS

 

  

 

 

  

 

Current assets:

 

  

 

  

 

  

 

  

Cash and cash equivalents

$

9,250

$

372

$

7,468

$

9,983

Prepaid expenses and other current assets

 

2,933

 

2,828

 

5,749

 

5,528

Total current assets

 

12,183

 

3,200

 

13,217

 

15,511

Non-current assets:

 

 

  

 

 

  

Property, plant and equipment, net

 

819

 

281

 

1,234

 

1,040

Construction in progress

7,135

1,685

9,881

9,074

Right-of-use asset, net

4,327

4,679

5,140

4,489

Indefinite-lived intangible asset

1,292

0

1,292

1,292

Goodwill

654

0

626

626

Other assets

 

803

 

798

 

1,070

 

867

Total non-current assets

 

15,030

 

7,443

 

19,243

 

17,388

TOTAL ASSETS

$

27,213

$

10,643

$

32,460

$

32,899

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

  

 

 

  

Current liabilities:

 

 

  

 

 

  

Accounts payable and accrued expenses

$

9,171

$

6,348

$

7,471

$

7,380

Accounts payable and accrued expenses to related parties and affiliates

 

4,924

 

3,844

 

2,973

 

5,363

Convertible notes, net

 

5,144

 

568

 

135

 

3,830

Convertible notes to related party, net

 

1,470

 

0

Notes payable, net

 

3,552

 

5,501

 

2,239

 

2,437

Notes payable to related party

 

0

 

66

Contingent payable derivative liability

7,384

7,261

8,554

8,275

Warrant liability

 

194,391

 

20,213

 

341,867

 

354,972

Lease liabilities

240

395

170

167

Total current liabilities

 

226,276

 

44,196

 

363,409

 

382,424

Non-current liabilities:

 

  

 

  

 

  

 

  

Note payable, net of current portion, net

 

8,708

 

6,588

Notes payable, net of current portion, net

 

16,691

 

8,507

Lease liabilities, net of current portion

4,657

4,914

5,560

4,916

Total non-current liabilities

 

13,365

 

11,502

 

22,251

 

13,423

Total liabilities

 

239,641

 

55,698

 

385,660

 

395,847

COMMITMENTS AND CONTINGENCIES (Note 11)

 

  

 

  

COMMITMENTS AND CONTINGENCIES (Note 10)

 

  

 

  

Stockholders’ deficit:

 

  

 

  

 

  

 

  

Preferred stock ($0.001 par value); 100,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively

0

0

Common stock ($0.001 par value); 1,200,000,000 shares authorized; 779.7 million and 614.3 million shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

 

780

 

614

Preferred stock ($0.001 par value); 100,000,000 shares authorized as of March 31, 2021 and December 31, 2020, respectively

Common stock ($0.001 par value); 1,200,000,000 shares authorized; 842.4 million and 829.6 million shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

 

842

 

830

Additional paid-in capital

 

877,376

 

794,900

 

1,021,900

 

1,008,665

Stock subscription receivable

 

(26)

 

(10)

 

(79)

 

(79)

Accumulated deficit

 

(1,090,917)

 

(841,395)

 

(1,375,339)

 

(1,371,216)

Accumulated other comprehensive income

 

359

 

836

Accumulated other comprehensive loss

 

(524)

 

(1,148)

Total stockholders’ deficit

 

(212,428)

 

(45,055)

 

(353,200)

 

(362,948)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

$

27,213

$

10,643

$

32,460

$

32,899

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, 

    

2020

    

2019

    

2020

    

2019

    

2021

    

2020

(As Revised) (Note 13)

(As Revised) (Note 13)

(As revised)

Revenues:

 

  

 

  

 

  

 

  

 

  

 

  

Research and other

$

216

$

593

$

788

$

1,513

$

239

$

570

Total revenues

 

216

 

593

 

788

 

1,513

 

239

 

570

Operating costs and expenses:

 

 

 

 

 

 

Research and development

 

17,660

 

3,538

 

24,737

 

10,092

 

6,923

 

3,857

General and administrative

 

29,321

 

2,838

 

36,822

 

9,413

 

12,886

 

4,546

Legal expenses

 

1,112

 

802

 

2,475

 

3,255

Total operating costs and expenses

 

48,093

 

7,178

 

64,034

 

22,760

 

19,809

 

8,403

Loss from operations

 

(47,877)

 

(6,585)

 

(63,246)

 

(21,247)

 

(19,570)

 

(7,833)

Other income (expense):

 

  

 

  

 

  

 

  

 

  

 

  

Change in fair value of derivative liabilities

 

(138,969)

 

2,460

 

(175,170)

 

(2,360)

 

17,563

 

12,927

Loss from extinguishment of debt

 

(2,994)

 

(504)

 

(4,260)

 

(508)

 

(8)

 

(715)

Interest expense

 

(5,540)

 

(724)

 

(7,224)

 

(2,267)

 

(1,447)

 

(625)

Foreign currency transaction gain (loss)

 

1,284

 

(1,018)

 

378

 

(975)

Total other income (expense)

 

(146,219)

 

214

 

(186,276)

 

(6,110)

Net loss

$

(194,096)

$

(6,371)

$

(249,522)

$

(27,357)

Other comprehensive income (loss)

Foreign currency transaction loss

 

(661)

 

(1,128)

Total other income

 

15,447

 

10,459

Net (loss) income

$

(4,123)

$

2,626

Other comprehensive income

Foreign currency translation adjustment

 

(1,240)

 

892

 

(477)

 

1,023

624

1,041

Total comprehensive loss

$

(195,336)

$

(5,479)

$

(249,999)

$

(26,334)

Total comprehensive (loss) income

$

(3,499)

$

3,667

Net loss per share applicable to common stockholders - basic and diluted

$

(0.26)

$

(0.01)

$

(0.36)

$

(0.05)

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

747,749

577,130

695,423

552,335

Net earnings (loss) per share applicable to common stockholders

Basic

$

(0.00)

$

0.00

Diluted

$

(0.00)

$

0.00

Weighted average shares used in computing basic earnings (loss) per share

834,605

640,390

Weighted average shares used in computing diluted earnings (loss) per share

834,605

648,858

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’ EQUITY (DEFICIT)DEFICIT

(in thousands)

(Unaudited)

For the Three Months Ended September 30, 2020

Additional

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Equity (Deficit)

Balance at July 1, 2020

 

722,158

$

722

 

$

811,526

 

$

(31)

$

(896,821)

 

$

1,599

$

(83,005)

Issuance of common stock and warrants for cash in a registered direct offering (net of $1.4 million warrant liability, and $0.2 million cash offering cost)

17,177

18

3,891

0

0

0

3,909

Issuance of common stock and warrants for conversion of debt and accrued interest

 

20,146

20

 

8,758

 

0

0

 

0

8,778

Warrants exercised for cash

 

19,050

19

5,610

5,629

Reclassification of warrant liabilities related to warrants exercised for cash

 

8,507

8,507

Cashless warrants exercise

222

Reclassification of warrant liabilities related to cashless warrants exercise

133

133

Beneficial conversion feature related to amended convertible note

44

44

Proceeds from investor to offset subscription receivable

5

5

Stock-based compensation

 

950

1

 

38,907

 

0

0

 

0

38,908

Net loss

 

0

0

 

0

 

0

(194,096)

 

0

(194,096)

Cumulative translation adjustment

 

0

0

 

0

 

0

0

 

(1,240)

(1,240)

Balance at September 30, 2020

 

779,703

$

780

$

877,376

$

(26)

$

(1,090,917)

$

359

$

(212,428)

For the Three Months Ended September 30, 2019

(As Revised) (Note 13)

Additional

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balance at July 1, 2019

562,462

$

562

$

785,648

$

(10)

$

(841,569)

$

1,131

$

(54,238)

Issuance of common stock and warrants for cash in a registered direct offering (net of $1.0 million warrant liability and $0.2 million cash offering cost)

10,450

11

1,199

1,210

Warrants exercised for cash

 

 

 

 

 

 

 

Issuance of common stock and warrants for conversion of debt and accrued interest

 

8,736

 

9

 

2,034

 

 

 

 

2,043

Stock-based compensation

 

1,140

 

1

 

568

 

 

 

 

569

Net loss

 

 

 

 

 

(6,371)

 

 

(6,371)

Cumulative translation adjustment

 

 

 

 

 

 

892

 

892

Balance at September 30, 2019

 

582,788

$

583

$

789,449

$

(10)

$

(847,940)

$

2,023

$

(55,895)

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’ EQUITY (DEFICIT)

(in thousands)

(Unaudited)For the Three Months Ended March 31, 2021

For the Nine Months Ended September 30, 2020

Additional

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Equity (Deficit)

Balance at January 1, 2020

614,292

$

614

$

794,900

$

(10)

$

(841,395)

$

836

$

(45,055)

Issuance of common stock and warrants for cash in a registered direct offering (net of $8.0 million warrant liability and $0.6 million cash offering cost)

85,756

86

8,792

(16)

8,862

Issuance of common stock and warrants for conversion of debt and accrued interest

 

42,764

 

43

 

13,383

 

0

 

0

 

0

 

13,426

Warrants exercised for cash

 

34,746

 

35

 

9,591

 

0

 

0

 

0

 

9,626

Reclassification of warrant liabilities related to warrants exercised for cash

 

0

 

0

 

11,228

 

0

 

0

 

0

 

11,228

Cashless warrants exercise

222

0

0

0

0

Reclassification of warrant liabilities related to cashless warrants exercise

0

133

0

133

Beneficial conversion feature related to amended convertible note

0

44

0

44

Stock-based compensation

 

1,923

 

2

 

39,305

 

0

 

0

 

0

 

39,307

Net loss

 

0

 

0

 

0

 

0

 

(249,522)

 

0

 

(249,522)

Cumulative translation adjustment

 

0

 

0

 

0

 

0

 

0

 

(477)

 

(477)

Balance at September 30, 2020

 

779,703

$

780

$

877,376

$

(26)

$

(1,090,917)

$

359

$

(212,428)

For the Nine Months Ended September 30, 2019

(As Revised) (Note 13)

Additional  

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balance at January 1, 2019

523,232

$

523

$

775,741

$

(10)

$

(825,385)

$

1,000

$

(48,131)

Issuance of common stock and warrants for cash in a registered direct offering (net of $1.0 million warrant liability and $0.2 million cash offering cost)

10,450

11

1,199

1,210

Warrants exercised for cash

 

9,532

 

9

 

2,210

 

 

 

 

2,219

Reclassification of warrant liabilities related to warrants exercised for cash

 

 

 

1,759

 

 

 

 

1,759

Issuance of common stock and warrants for conversion of debt and accrued interest

 

26,234

 

27

 

6,993

 

 

 

 

7,020

Stock-based compensation

 

1,340

 

1

 

1,559

 

 

 

 

1,560

Cumulative effect of adopting new accounting standard

4,802

4,802

Issuance of common shares in connection with a settlement agreement

12,000

12

(12)

Net loss

 

 

 

 

 

(27,357)

 

 

(27,357)

Cumulative translation adjustment

 

 

 

 

 

 

1,023

 

1,023

Balance at September 30, 2019

 

582,788

$

583

$

789,449

$

(10)

$

(847,940)

$

2,023

$

(55,895)

Additional

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income (Loss)

    

Deficit

Balance at January 1, 2021

 

829,631

$

830

 

$

1,008,665

 

$

(79)

$

(1,371,216)

 

$

(1,148)

$

(362,948)

Issuance of common stock for cash

69

16

16

Issuance of common stock and warrants for conversion of debt and accrued interest

 

4,533

4

 

6,615

 

 

6,619

Warrants and stock options exercised for cash

 

2,872

3

742

745

Reclassification of warrant liabilities related to warrants exercised for cash

 

2,935

2,935

Cashless warrants and stock options exercise

5,205

5

(5)

Reclassification of warrant liabilities related to cashless warrants exercise

146

146

Stock-based compensation

48

9,891

9,891

Reclassification of warrant liabilities related to sequencing policy

(7,105)

(7,105)

Net loss

 

 

 

(4,123)

 

(4,123)

Cumulative translation adjustment

 

 

 

 

624

624

Balance at March 31, 2021

 

842,358

$

842

$

1,021,900

$

(79)

$

(1,375,339)

$

(524)

$

(353,200)

For the Three Months Ended March 31, 2020

Additional

Accumulated

Total

Common Stock

Paid-in

Subscription

Accumulated

Other Comprehensive

Stockholders’

    

Shares

    

Par value

    

Capital

    

Receivable

    

Deficit

    

Income

    

Deficit

Balance at January 1, 2020

614,292

$

614

$

794,900

$

(10)

$

(841,395)

$

836

$

(45,055)

Issuance of common stock and warrants for cash in a registered direct offering (net of $3.6 million warrant liability and $0.4 million cash offering cost)

 

34,466

 

34

 

2,011

 

 

 

 

2,045

Issuance of common stock and warrants for conversion of debt and accrued interest

 

12,417

 

13

 

2,386

 

 

 

 

2,399

Stock-based compensation

 

973

 

1

 

363

 

 

 

 

364

Net income (as revised)

 

 

 

 

 

2,626

 

 

2,626

Cumulative translation adjustment

 

 

 

 

 

 

1,041

 

1,041

Balance at March 31, 2020

 

662,148

$

662

$

799,660

$

(10)

$

(838,769)

$

1,877

$

(36,580)

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

65

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, 

    

2020

    

2019

    

2021

    

2020

(As Revised) (Note 13)

(As revised)

Cash Flows from Operating Activities:

 

  

 

 

  

 

Net loss

$

(249,522)

$

(27,357)

Net (loss) income

$

(4,123)

$

2,626

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

 

 

 

 

Depreciation and amortization

 

33

 

16

 

68

 

14

Amortization of debt discount

 

1,991

 

1,020

 

1,126

 

343

Change in fair value of derivatives

 

175,170

 

2,360

 

(17,563)

 

(12,927)

Loss from extinguishment of debt

 

4,260

 

508

 

8

 

715

Amortization of operating lease right-of-use asset

249

435

93

80

Stock-based compensation related to warrants modification

 

0

 

3

Stock-based compensation for services

 

39,307

 

1,560

 

9,818

 

364

Non-cash interest expense

4,270

0

Subtotal of non-cash charges

 

225,280

 

5,902

 

(6,450)

 

(11,411)

Changes in operating assets and liabilities:

 

  

 

  

 

  

 

  

Prepaid expenses and other current assets

 

146

 

(1,059)

 

(286)

 

(78)

Other non-current assets

 

(12)

 

(23)

 

(198)

 

Accounts payable and accrued expenses

 

986

 

62

 

876

 

1,208

Related party accounts payable and accrued expenses

 

1,080

 

(3,412)

 

(3,128)

 

81

Lease liabilities

152

6

61

35

Net cash used in operating activities

 

(21,890)

 

(25,881)

 

(13,248)

 

(7,539)

Cash Flows from Investing Activities:

 

  

 

  

 

  

 

  

Purchase of equipment and construction in progress

 

(3,548)

 

(246)

 

(264)

 

(62)

Acquisition of Flaskworks, net of cash

(1,560)

0

Net cash used in investing activities

 

(5,108)

 

(246)

 

(264)

 

(62)

Cash Flows from Financing Activities:

 

  

 

  

 

  

 

  

Proceeds from issuance of common stock and warrants in a registered direct offering, net

 

16,893

 

2,241

 

16

 

5,671

Proceeds from exercise of warrants

 

9,626

 

2,219

Proceeds from warrants modification

4

7

Proceeds from exercise of warrants and stock options

 

745

 

Proceeds from issuance of notes payable, net

 

8,557

 

6,500

 

10,000

 

Proceeds from issuance of convertible notes payable, net

 

3,190

 

0

 

 

1,000

Proceeds from issuance of convertible notes payable to related party

 

315

 

0

 

 

240

Repayment of notes payable

 

(1,556)

 

(420)

Proceeds from investor advance

 

 

178

Repayment of notes payable to related parties

 

(64)

 

(329)

 

 

(64)

Repayment of convertible notes payable

 

(89)

 

0

Repayment of convertible notes payable to related parties

0

(5,400)

Net cash provided by financing activities

 

36,876

 

4,818

 

10,761

 

7,025

Effect of exchange rate changes on cash and cash equivalents

 

(1,000)

 

1,055

 

236

 

968

Net increase (decrease) in cash and cash equivalents

 

8,878

 

(20,254)

Net (decrease) increase in cash and cash equivalents

 

(2,515)

 

392

Cash and cash equivalents, beginning of the period

 

372

 

22,224

Cash and cash equivalents, end of the period

$

9,250

$

1,970

Cash and cash equivalents, beginning of the year

 

9,983

 

372

Cash and cash equivalents, end of the year

$

7,468

$

764

Supplemental disclosure of cash flow information

 

  

 

  

 

  

 

  

Interest payments on notes payable

$

0

$

(43)

Interest payments on notes payable to related party

$

(9)

$

(177)

$

$

(9)

Interest payments on convertible notes payable

$

(11)

$

0

Interest payments on convertible notes payable to related party

$

0

$

(795)

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, 

    

2020

    

2019

    

2021

    

2020

(As Revised) (Note 13)

(As revised)

Supplemental schedule of non-cash investing and financing activities:

 

  

 

 

  

 

Unpaid consideration related to Flaskworks acquisition

$

465

$

0

Cashless warrants and stock options exercise

$

5

$

Reclassification of warrant liabilities related to warrants exercised for cash

$

11,228

$

1,759

$

2,935

$

Reclassification of warrant liabilities related to cashless warrants exercise

$

133

$

0

$

146

$

Reclassification of warrant liabilities related to sequencing policy

$

7,105

$

Issuance of common stock and warrants for conversion of debt and accrued interest

$

6,850

$

5,533

$

6,742

$

1,789

Offering cost related to warrant liability

$

3,749

$

1,031

$

$

2,606

Capital expenditures included in accounts payable

$

753

$

405

Issuance of warrants in conjunction with convertible note payable

$

153

$

0

$

$

79

Issuance of warrants in connection with debt modification

$

395

$

0

$

$

315

Warrant modification in connection with debt amendment

$

91

$

0

Beneficial conversion feature related to amended convertible note

$

44

$

0

Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates

$

1,294

$

710

Capital expenditures included in accounts payable

$

954

$

0

Conversion of outstanding accounts payables to note payable and contingent payable

$

0

$

8,560

Issuance of common shares in connection with a settlement agreement

$

0

$

12

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

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

On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system to close and automate the manufacturing of cell therapy products such as DCVax®.

2. Financial Condition, Going Concern and Management Plans

The Company has incurred annual net operating losses since its inception. ManagementThe Company had a net loss of $4.1 million for the three months ended March 31, 2021. The Company used approximately $13.2 million of cash in its operating activities for the three months ended March 31, 2021.Management believes that the Company has access to capital resources through the sale of equity and debt financing arrangements. However, the Company has not secured any commitments for new financing for this specific purpose at this time.

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 R&D and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues.  Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations.  If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all.

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

The COVID-19 situation, and related restrictions and lockdowns,As also previously reported, coronavirus-related difficulties have adversely affected the Company’s programs.  With the incidence of COVID-19 now rising significantly in both the US and Europe, and expected to continue at a high level through the restimpacted most aspects of the falldatabase lock and the winter, the adverse effects on the Company’s programs may increase and may continue at an increased level throughout this period. The Company has been continuing to make progress in its programs despite these difficulties, so that it can reach data lock, unblind and report the resultsprocess of the its Phase 3 clinical trial of DCVax-L for Glioblastoma brain cancer, and the Company plans to continue these efforts. Examples of effects of the COVID-19 situation include the following: the process for completion of the final data collection from trial sites foranalyzing the Phase 3III trial was materially slowed byresults, especially with the limited availability or capacitysuccessive waves of COVID cases in many areas. The independent service firms responsible for collectinghave had limited capacity, and confirming the data, by the inability to perform in-person monitoring and other visits to trial sites, by very limited availability of investigators and staffrestrictions on operations. Key experts at trial sites (many of whomcertain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned for COVID, and the limited site personnel have had to treating COVID-19 patients), and substantially longer timeframes for Institutional Review Board or Ethicswork under restrictions. Committee meetingsprocesses and regulatory processes have been similarly focused on COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses, continue to have had only limited operations. Even logistical matters other than COVID-19. The Company hassuch as the shipping of materials have been unablesubjected to undertake compassionate use cases during part of March and very limited since then, due to lockdowns, travelsubstantial restrictions and hospitals focusing on COVID-19 patients. In addition, manufacturing of DCVax products is impeded by personnel being under lockdown. The buildout of the Sawston facility was delayed in starting due to the construction sector shutdown and restrictions, and was substantially sloweddelays.

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down due to the contractors having to operate under social distancing arrangements. The Company incurred substantially increased costs to have the contractors operate on two shifts daily rather than the normal one shift in order to try to stay in line with planned timelines to the extent feasible.  The Company relies upon a large number of independent service firms to carry out most aspects of its programs, particularly the Phase 3 trial of DCVax-L for Glioblastoma and its completion and analyses.  These service firms have been substantially impacted by COVID-19 restrictions and limitations, too, with personnel working remotely and having limited availability.

3. Summary of Significant Accounting Policies

Basis of Presentation

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

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of September 30, 2020,March 31, 2021, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statement of stockholders’ equity (deficit)deficit for the three and nine months ended September 30,March 31, 2021 and 2020, and 2019, and the condensed consolidated statements of cash flows for the ninethree months ended September 30,March 31, 2021 and 2020 and 2019 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, 2020March 31, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 20202021 or for any future interim period. The condensed consolidated balance sheet at September 30,December 31, 2020 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, 20192020 and notes thereto included in the Company’s annual report on Form 10-K (the “2020 Annual Report”), which was filed with the SEC on March 16, 2020 and Form 10-K/A filed on June 24, 2020.31, 2021.

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 assumptions. These estimates and assumptions include recoverability and useful lives (indefinite) of intangible asset, assessment of impairment of goodwill, 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.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the 20192020 Annual Report other than the additions below.

Goodwill and Intangible Assets

Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. The Company’s intangible asset with an indefinite life are related to in-process research and development ("IPR&D") programs acquired

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

in the Flaskworks Acquisition, as the Company expects future research and development on these programs to provide the Company with substantial benefit for a period that extends beyond the foreseeable horizon. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite lived and would then be amortized based on their respective estimated useful lives at that point in time.

The Company reviews goodwill and indefinite-lived intangible assets at least annually for possible impairment. Goodwill and indefinite-lived intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values. Goodwill will be tested annually for impairment on October 1.

Stock-Based Compensation

The Company measures stock-based compensation to employees, consultants, and Board members at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. For awards that have a performance condition, compensation cost is measured based on the fair value of the award on the grant date, the date performance targets are established, and is expensed over the requisite service period for each separately vesting tranche when achievement of the performance condition becomes probable. The Company assess the probability of the performance conditions being met on a continuous basis. Forfeitures are recognized when they occur.

The Company estimates the fair value of stock option grants that do not contain market-based vesting conditions using the Black-Scholes option pricing model. The assumptions used in estimating the fair value of these awards, such as expected term, expected dividend yield, volatility and risk-free interest rate, represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company is also required to make estimates as to the probability of achieving the specific performance conditions. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s consolidated results of operations.Report.

RecentRecently Adopted Accounting Standards Not Yet Adopted

Income Taxes

In December 2019, the FASBFinancial Accounting Standards Board (“FASB”) issued ASUAccounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. TheOn January 1, 2021, the Company is currently evaluating the impact ofadopted this standard without any material impact on its condensed consolidated financial statements and related disclosures.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Debt

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. This update permits the use of either the modified retrospective or fully retrospective method of

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

transition. The Company is currently evaluatinghas adopted the new standard as of January 1, 2021 and determined the impact this ASU will have onof the itsadoption to the condensed consolidated financial statements and related disclosures.disclosures is immaterial as of March 31, 2021.

4. Fair Value Measurements

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

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

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

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

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, 2020March 31, 2021 and December 31, 20192020 (in thousands):

Fair value measured at September 30, 2020

Fair value measured at March 31, 2021

    

    

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, 2020

(Level 1)

(Level 2)

(Level 3)

March 31, 2021

(Level 1)

(Level 2)

(Level 3)

Warrant liability

$

194,391

$

0

$

0

$

194,391

$

341,867

$

0

$

0

$

341,867

Embedded conversion option

2,857

0

0

2,857

Contingent payable derivative liability

 

7,384

 

0

 

0

 

7,384

 

8,554

 

0

 

0

 

8,554

Total fair value

$

204,632

$

0

$

0

$

204,632

$

350,421

$

0

$

0

$

350,421

Fair value measured at December 31, 2019

Fair value measured at December 31, 2020

    

    

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, 2019

(Level 1)

(Level 2)

(Level 3)

December 31, 2020

(Level 1)

(Level 2)

(Level 3)

Warrant liability

$

20,213

$

0

$

0

$

20,213

$

354,972

$

0

$

0

$

354,972

Embedded conversion option

 

2,507

 

0

 

0

 

2,507

Contingent payable derivative liability

 

7,261

 

0

 

0

 

7,261

 

8,275

 

0

 

0

 

8,275

Total fair value

$

27,474

$

0

$

0

$

27,474

$

365,754

$

0

$

0

$

365,754

There were no transfers between Level 1, 2 or 3 during the nine-monththree-month period ended September 30, 2020.March 31, 2021.

The following table presents changes in Level 3 liabilities measured at fair value for the nine-monththree-month period ended September 30, 2020.March 31, 2021. 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

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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).

Contingent

Embedded

Payable

Warrant

Conversion

Derivative

    

Liability

    

Option

    

Liability

    

Total

Balance - January 1, 2021

$

354,972

$

2,507

$

8,275

$

365,754

Additional warrant liability

131

0

0

131

Reclassification of warrant liabilities

4,024

0

0

4,024

Debt conversion

0

(1,925)

0

(1,925)

Change in fair value

(17,260)

(582)

279

(17,563)

Balance - March 31, 2021

$

341,867

$

0

$

8,554

$

350,421

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, 2021 and December 31, 2020 is as follows:

As of March 31, 2021

 

    

Warrant

    

Contingent Payable

 

Liability

Derivative Liability

 

Strike price

$

0.25

$

1.49

Contractual term (years)

 

1.2

 

1.4

Volatility (annual)

 

95

%  

 

119

%

Risk-free rate

 

0.1

%  

 

0.1

%

Dividend yield (per share)

 

0

%  

 

0

%

*Contingent based on stock price as of March 31, 2021

As of December 31, 2020

Warrant

Embedded

Contingent Payable

    

Liability

    

Conversion Option

Derivative Liability

    

Strike price

$

0.28

$

0.59

$

1.53

*

Contractual term (years)

 

1.6

 

0.9

1.4

 

Volatility (annual)

 

116

%  

106

%

126

%  

Risk-free rate

 

0.2

%  

0.1

%

0.1

%  

Dividend yield (per share)

 

0

%  

0

%

0

%  

*Contingent based on stock price as of December 31, 2020

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three months ended March 31, 2021 and 2020 (in thousands). The general and administrative expense during the three months ended March 31, 2021 and 2020

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

relate to the applicable portion vesting during this period of stock option awards made in the past to directors and employees.

For the three months ended

March 31, 2021

2021

    

2020

Research and development

$

3,689

$

(23)

General and administrative

 

6,129

 

387

Total stock-based compensation expense

$

9,818

$

364

The total unrecognized compensation cost was approximately $7.4 million as of March 31, 2021, and will be recognized over the next 1.6 years.

Stock Options

The following table summarizes stock option activity for the Company’s option plans during the three months ended March 31, 2021 (amount in thousands, except per share number):

    

    

    

Weighted

    

Average

Weighted

Remaining

Number of

Average Exercise

Contractual Life

Total Intrinsic

Shares

Price

(in years)

Value

Outstanding as of January 1, 2021

 

308,840

$

0.33

8.9

$

372,219

Cash exercised

 

(183)

 

0.25

 

Cashless exercise

(3,695)

0.25

Forfeited/expired

 

 

 

Outstanding as of March 31, 2021

 

304,962

$

0.33

8.7

$

354,723

Options vested (1)

 

254,385

$

0.30

8.7

$

276,262

(1)Approximately 244 million options are not exercisable until May 31, 2021.

Ms. Linda Powers, the Company's Chief Executive Officer, and Mr. Leslie Goldman, the Company's Senior Vice President, are subject to an agreement under which they cannot exercise any options or warrants except upon at least 61 days' prior notice.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

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).

Contingent

Embedded

Payable

Warrant

Conversion

Derivative

    

Liability

    

Option

    

Liability

    

Total

Balance - January 1, 2020

$

20,213

$

0

$

7,261

$

27,474

Additional warrant liability

15,744

0

0

15,744

Reclassification of warrant liabilities related to warrants exercised for cash and cashless exercise

(11,361)

0

0

(11,361)

Extinguishement of embedded conversion option due to debt conversion

0

(3,838)

0

(3,838)

Additional embedded conversion option

0

1,443

0

1,443

Change in fair value

169,795

5,252

123

175,170

Balance - September 30, 2020

$

194,391

$

2,857

$

7,384

$

204,632

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 September 30, 2020 and December 31, 2019 is as follows:

As of September 30, 2020

Warrant

Embedded

Contingent Payable

    

Liability

    

Conversion Option

Derivative Liability

    

Strike price

$

0.25

$

0.25

$

0.77

*

Contractual term (years)

 

1.8

 

1.1

1.5

 

Volatility (annual)

 

92

%  

92

%

95

%  

Risk-free rate

 

0.1

%  

0.1

%

0.1

%  

Dividend yield (per share)

 

0

%  

0

%

0

%  

As of December 31 2019

 

    

Warrant

    

Contingent Payable

 

Liability

Derivative Liability

 

Strike price

$

0.21

$

0.21

*

Contractual term (years)

 

1.4

 

1.0

Volatility (annual)

 

74

%  

 

62

%

Risk-free rate

 

2

%  

 

2

%

Dividend yield (per share)

 

0

%  

 

0

%

*contingent payable derivative liability based on stock price as of September 30, 2020 and December 31, 2019

5. Flaskworks Acquisition

On August 28, 2020, the Company completed the acquisition of Flaskworks (the “Acquisition”), whereby Flaskworks became a wholly-owned subsidiary of the Company.

The Unit Purchase Agreement was executed and closed on August 28, 2020. The Company acquired 100% of the ownership units of Flaskworks. Flaskworks was previously owned by its technical founders and Corning Inc. The technical team from Flaskworks has joined the Company as part of the Acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs. The Company’s buildout of the Sawston, UK facility has been designed to proceed in phases, as modules, both for efficiency

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in the timing of capital costs and to allow flexibility in operations and usage. The Company anticipates that implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.

The total purchase price was approximately $4.3 million, of which $1.7 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting (see Note 6), and $0.7 million is to be paid in either cash or stock, or a combination thereof, within 120 days after the closing. On December 16, 2020, $0.1 million was paid in cash upon the seller’s election.

Based on the Company's preliminary valuation, the total estimated consideration of $2.2 million has been allocated to assets acquired and liabilities assumed as of the acquisition date as follows (amount in thousands):

Cash

    

$

146

Current assets

 

135

Fixed assets, net

 

188

Indefinite-lived intangible asset

 

1,292

Security deposits

 

8

Total assets acquired

 

1,769

Accounts payable

 

(12)

Accrued expenses

 

(240)

Total liabilities assumed

 

(252)

Net identifiable assets acquired

 

1,517

Goodwill

 

654

Total estimated consideration (1)

$

2,171

Less unpaid consideration as of September 30, 2020

$

(465)

Less cash acquired

 

(146)

Total consideraion paid, net of cash acquired

$

1,560

(1)The purchase price allocation excludes $2.01 million stock consideration, which was recorded as stock-based compensation for accounting purposes, although the treatment for tax purposes is anticipated to be different (see Note 6), and $0.2 million payable for services not related to the Acquisition in either cash or stock within 120 days after the closing.

The Acquisition was accounted for under the acquisition method of accounting in accordance with US GAAP. As such, results of operations for Flaskworks are included in the accompanying condensed consolidated statements of operations since the Acquisition date, and the assets acquired and liabilities assumed were recorded at their fair value as of the Acquisition date.

Accordingly, goodwill has been measured as the excess of the total consideration over the amounts assigned to the identifiable assets acquired and liabilities assumed. Based on the Company's preliminary valuation, the Company recorded goodwill of approximately $0.7 million, which was primarily related to the acquisition of the assembled workforce and other indefinite-lived intangible asset of approximate $1.3 million in connection with the Acquisition. The $0.7 million of goodwill is expected to be deductible for tax purposes.

The acquired Licensed IP Agreement was identified as an intangible asset and valued separate and apart from goodwill. Specifically, the Company used the Relief-from-Royalty Method, a form of the Income Approach, to estimate the fair value of the Licensed IP Agreement based on projected sales and cash flow. In application of the Relief-from-Royalty Method, we estimate the value of the Licensed IP Agreement by capitalizing the royalties saved because the Company owns the specific technology and the owner of the technology realizes a benefit from owning the intangible asset rather than paying a rent or royalty for the use of the asset.

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The royalty rate used for this Licensed IP Agreement was based on the rate and terms indicated in the license agreement that was corroborated with the Company’s external research of third-party royalty rates for technology and patents in the pharma, healthcare, and medical industries. The estimation of fair value was determined based on the projected sales assuming commercialization of Flaskworks’ products and the respective royalty rate, tax affected and discounted to the present using a discount rate based on Flaskworks’ weighted average cost of capital.

The preliminary purchase price allocation is adjusted, as necessary, up to one year after the acquisition closing date if management obtains more information regarding asset valuations and liabilities assumed.

6. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2020 and 2019 (in thousands):

For the three months ended

For the nine months ended

September 30, 

September 30, 

    

2020

    

2019

2020

    

2019

Research and development

$

14,206

$

221

$

14,191

$

394

General and administrative (1)

 

24,702

 

351

 

25,116

 

1,169

Total stock-based compensation expense

$

38,908

$

572

$

39,307

$

1,563

(1)The general and administrative expense during the three and nine months ended September 30, 2020 and 2019 is related to the applicable vesting portion of stock options awards made in the past and new options granted during three months ended September 30, 2020 to directors and employees.

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, 2020 was as follows:

For the nine months ended

September 30, 2020

Exercise price

$

0.25

Expected term (years)

5.3

Expected stock price volatility

98

%

Risk-free rate of interest

0

%

The total unrecognized compensation cost was approximately $26.8 million as of September 30, 2020, and will be recognized over the next 2 years.

Stock Options

Equity Compensation Plan

On May 29, 2020, the Board of Directors of the Company approved a new equity compensation plan (the “Plan”). The Company’s prior plan was adopted in 2007, was updated in amended and restated plans that were approved by shareholders in 2012 and 2013, and expired in 2017 (the “Prior Plan”).

The Plan is substantially similar to the Prior Plan. The Plan has a 10-year life, and allows for awards to employees, directors and consultants of the Company, as did the Prior Plan. The Plan allows for any type of equity security to be awarded, as did the Prior Plan. The awards and their terms (including vesting) will be determined by the Board and applicable Committees, as was the case under the Prior Plan. The Plan establishes a pool of potential equity compensation equal to twenty percent of the outstanding securities of the Company, which is on an evergreen basis as under the Prior Plan.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

6. Outstanding Debt

The following table summarizes stock option activity for the Company’s option plans during the nine months ended September 30,two tables summarize outstanding debt as of March 31, 2021 and December 31, 2020, respectively (amount in thousands, except per share number)thousands):

    

    

    

Weighted

    

Average

Weighted

Remaining

Number of

Average Exercise

Contractual Life

Total Intrinsic

Shares

Price

(in years)

Value

Outstanding as of January 1, 2020

 

104,659

$

0.24

8.4

$

Granted (Approved 2018-2020) (1)

 

203,600

 

0.25

(3)

10.0

 

Forfeited/expired

 

(4,250)

 

0.22

 

Outstanding as of September 30, 2020

 

304,009

$

0.24

9.2

$

160,717

Options vested (2)

 

206,232

$

0.24

8.9

$

109,819

(1)The options granted during the nine months ended September 30, 2020 included options already approved at various times during the 3 years 2018 – 2020 but not issued until Q3 2020, and also included options that will vest for performance and milestones going forward over the next 2 years.  The options included awards to key external consultants and vendors in addition to internal parties.
(2)Approximate 121 million vested options as of September 30, 2020 are not exercisable until January 15, 2021.
(3)The weighted average exercise price of the Q3 2020 options was initially $0.25. However, subsequently, the exercise price was amended to a weighted average exercise price of $0.36.

Stock Options Modification

On April 30, 2020, the Company's CEO, Linda Powers agreed to not exercise approximately 39.2 million existing options held by her for 6 months, until November 1, 2020 and correspondingly extended the contractual term for 6 months. The Company recognized approximately $78,000 of incremental stock-based compensation for this modification during the nine months ended September 30, 2020, based on the following weighted average assumptions:

    

Post Modification

    

Pre Modification

 

Exercise price

$

0.23

$

0.23

Expected term (years)

 

4.3

 

4.0

Expected stock price volatility

 

97

%

 

97

%

Risk-free rate of interest

 

0

%  

 

0

%

Stated

Interest

Conversion

Remaining

Carrying

    

Maturity Date

    

Rate

    

Price

    

Face Value

    

Debt Discount

    

Value

Short term convertible notes payable

6% unsecured

 

Due

 

6

%  

$

3.09

$

135

$

$

135

 

135

 

 

135

Short term notes payable

8% unsecured

 

Various

 

8

%  

 

N/A

 

1,615

 

(79)

 

1,536

10% unsecured

 

On Demand

 

10

%  

 

N/A

 

263

 

263

12% unsecured

 

On Demand

 

12

%  

 

N/A

 

440

 

 

440

 

2,318

 

(79)

 

2,239

Long term notes payable

8% unsecured

Various

8

%  

N/A

16,117

(1,284)

14,833

6% secured

 

3/25/2025

 

6

%  

 

N/A

 

1,858

 

 

1,858

 

17,975

 

(1,284)

 

16,691

Ending balance as of March 31, 2021

$

20,428

$

(1,363)

$

19,065

For another officer, on August 5, 2020,

Stated

Embedded

 

Interest

Conversion

Remaining

Conversion

Carrying

    

Maturity Date

    

Rate

    

Price

    

Face Value

    

Debt Discount

    

Option

    

Value

Short term convertible notes payable

6% unsecured

 

Due

 

6

%  

$

3.09

$

135

$

$

$

135

8% unsecured

 

4/30/2021

 

8

%  

$

0.85

 

2,125

 

(937)

 

2,507

3,695

 

2,260

 

(937)

 

2,507

3,830

Short term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

  

8% unsecured

Various

8

N/A

1,785

(51)

1,734

10% unsecured

Various

10

N/A

263

263

12% unsecured

On Demand

12

N/A

440

440

 

2,488

 

(51)

 

2,437

Long term notes payable

8% unsecured

Various

8

N/A

7,160

(496)

6,664

6% secured

3/25/2025

6

N/A

1,843

1,843

9,003

(496)

8,507

Ending balance as of December 31, 2020

$

13,751

$

(1,484)

$

2,507

$

14,774

On March 1, 2021, the Company cancelled 1.75 million options which were originally issued in December 2019, and issued 3 million optionsentered into a Commercial Loan Agreement (the “Replacement Options”“Note”) with a commercial lender for an exercise priceaggregate principal amount of $0.22$10 million. The Note bears interest at 8% per annum with a 22-month term. There are no principal repayments during the first 8 months of the term. The note is amortized in 14 installments starting on November 1, 2021. The Note carries an original issue discount of $1 million.

During the three months ended March 31, 2021, $4.8 million of debt and vestinginterest was converted into 4.5 million shares of 1/3 immediatelycommon stock and the remaining 2/3 vesting ratably over the following 24 months from the grant date.0.8 million warrants. The incremental stock-based compensationfair value of common stock and warrants for this modification was approximately $0.3 million based on the following weighted average assumptions, which will be amortized over the new vesting terms.

    

Post Modification

    

Pre Modification

 

Exercise price

$

0.22

$

0.22

Expected term (years)

 

5.3

 

4.7

Expected stock price volatility

 

96

%  

 

97

%

Risk-free rate of interest

 

0

%  

 

0

%

these conversions were

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Flaskworks Acquisition

On August 28, 2020, the Company entered into a Unit Purchase Agreement (the “Agreement”) to acquire Flaskworks. Included in the consideration pursuant to the Agreement was Stock Consideration in the amount of approximately $2$6.7 million. This Stock Consideration is issued in the form of Rights to receive such value in shares issued pursuant to and subject to the vesting criteria set forth in a Rights Issuance Agreement entered into in connection with the closing of Flaskworks Acquisition. Because the Rights were subject to future employment and performance conditions, the Stock Consideration was not included in consideration payable for the Flaskworks Acquisition but rather was recorded as contingent consideration payable to employees for accounting purposes. The Company anticipates thatalso extinguished approximately $1.9 embedded derivative liability from the treatment of this Stock Consideration for tax purposes may be different than for accounting purposes, and will reflect the fact that this Stock Consideration was payment for acquisition of the ownership interests of certain shareholders of Flaskworks.note conversion.

DuringFor the three and nine months ended September 30,March 31, 2021 and 2020, the Company recognizedinterest expense related to notes payable totaled approximately $1.4 million and $0.6 million including amortization of debt discounts totaling $1.1 million and $0.3 million, stock-based compensation related to the Flaskworks Acquisition. Approximate $0.2 million was recognized in general and administrative and $0.1 million was recognized in research and development.respectively.

7. Property, Equipment & Construction in Progress

Property and equipment consist of the following at September 30, 2020 and December 31, 2019 (in thousands):

    

September 30, 

    

December 31, 

    

Estimated

2020

2019

Useful Life

(As Revised) (Note 13)

Leasehold improvements

$

81

$

186

 

Lesser of lease term or estimated useful life

Office furniture and equipment

 

63

 

59

 

3-5 years

Computer equipment and software

 

1,295

 

611

 

3-5 years

Land in the United Kingdom

87

90

NA

 

1,526

 

946

Less: accumulated depreciation

 

(707)

 

(665)

 

  

Total property, plant and equipment, net

$

819

$

281

 

  

Construction in progress

$

7,135

$

1,685

 

  

Depreciation expenses were approximately $17,000 and $8,000 for the three months ended September 30, 2020 and 2019, respectively, and were approximately $33,000 and $16,000 for the nine months ended September 30, 2020 and 2019, respectively.

Construction in Progress

In connection with the Company’s manufacturing facility in U.K, the Company has incurred and is incurring costs with certain vendors to design and build out the initial stage of the facility. Additionally, the Company purchased certain manufacturing equipment that will be installed in connection with the buildout. These costs were all capitalized and recorded as part of construction in progress as of September 30, 2020.  Upon completion of the buildout, all costs associated with the buildout will be recorded as manufacturing equipment or leasehold improvement, and amortized over the estimated useful life of the facility.

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8. Outstanding Debt

The following two tables summarize outstanding debt as of September 30, 2020 and December 31, 2019, respectively (amount in thousands):

Stated

Embedded

 

Interest

Conversion

Remaining

Conversion

Carrying

  

Maturity Date

  

Rate

  

Price

  

Face Value

  

Debt Discount

  

Option

  

Value

Short term convertible notes payable

6% unsecured (1)

 

Due

 

6

%  

$

3.09

$

135

$

0

$

$

135

10% unsecured (2)

 

Various

 

10

% ��

$

0.27

 

1,575

 

(54)

 

1,521

10% unsecured (3)

11/24/2020

10

%  

$

0.34

1,390

(41)

1,349

8% unsecured (4)

 

11/1/2020

 

8

%  

$

0.25

 

550

 

(113)

 

1,702

2,139

 

3,650

 

(208)

 

1,702

5,144

Short term convertible notes payable - related parties

 

  

 

  

 

  

 

  

 

  

 

  

  

10% unsecured - Related Parties (5)

 

On Demand

 

10

 

N/A

 

315

 

0

 

1,155

1,470

 

315

 

0

 

1,155

1,470

Short term notes payable

 

  

 

  

 

  

 

  

 

  

 

  

  

8% unsecured (6)

Various

8

N/A

2,994

(145)

2,849

10% unsecured (7)

Various

10

N/A

263

0

263

12% unsecured (8)

On Demand

12

N/A

440

0

440

 

3,697

 

(145)

 

3,552

Long term notes payable

1% unsecured(10)

5/14/2022

1

N/A

401

0

401

8% unsecured (12)

Various

8

N/A

7,160

(591)

6,569

6% secured (13)

3/25/2025

6

N/A

1,738

0

1,738

9,299

(591)

8,708

Ending balance as of September 30, 2020

$

16,961

$

(944)

$

2,857

$

18,874

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Stated

Interest

Conversion

Remaining

Carrying

    

Maturity Date

    

Rate

    

Price

    

Face Value

    

Debt Discount

    

Value

Short term convertible notes payable

6% unsecured (1)

 

Due

 

6

%  

$

3.09

$

135

$

0

$

135

10% unsecured (2)

 

4/18/2020

 

10

%  

$

0.22

 

500

 

(67)

 

433

 

635

 

(67)

 

568

Short term notes payable

8% unsecured (6)

 

Various

 

8

%  

 

N/A

 

555

 

(43)

 

512

10% unsecured (7)

 

Various

 

10

%  

 

N/A

 

3,551

 

(73)

3,478

12% unsecured (8)

 

On Demand

 

12

%  

 

N/A

 

440

 

0

 

440

0% unsecured (9)

8/1/2020

0

%

N/A

1,156

(85)

1,071

 

5,702

 

(201)

 

5,501

Short term notes payable - related parties

10% unsecured - Related Parties (11)

 

On Demand

 

10

%  

 

N/A

 

66

 

0

 

66

 

66

 

0

 

66

Long term notes payable

8% unsecured (5)

 

Various

 

8

%  

 

N/A

 

7,008

 

(420)

 

6,588

 

7,008

 

(420)

 

6,588

Ending balance as of December 31, 2019

$

13,411

$

(688)

$

12,723

(1)This $135,000 note as of September 30, 2020 and December 31, 2019 consists of two separate 6% notes in the amounts of $110,000 and $25,000. In regard to the $110,000 note, the Company has made ongoing attempts to locate the creditor to repay or convert this note, but has been unable to locate the creditor to date. In regard to the $25,000 note, the holder has elected to convert these notes into equity, the Company has delivered the applicable conversion documents to the holder, and the Company is waiting for the holder to execute and return the documents.
(2)In February 2020, the Company entered into multiple one-year convertible notes (the “February Notes”) with multiple holders (the “Holders”) for an aggregate principal amount of $1.0 million. The Notes are convertible into common shares of the Company at $0.21 per share and bear interest at the rate of 10% per annum. Upon issuance of the February Notes, the Holders also received a 2-year warrant to purchase a total of 1.4 million common shares of the Company at an exercise price of $0.35 per share. The fair value of the warrants was approximately $79,000 on the grant date.

In April 2020, the Company entered into a six-month convertible note (the “April Note”) with an individual investor (the “Holder”) with an aggregate principal amount of $0.8 million for cash proceeds of $0.7 million. The Company also incurred approximately $69,000 placement agent costs, including both a cash fee and the fair value of common stock warrants issued to the placement agent, which was recognized as additional debt discount.

The April Note bears interest at the rate of 10% per annum and is convertible into common shares of the Company at $0.17 per share plus a warrant to purchase a number of exercise shares equal to 50% of the number of common shares issued upon conversion (the “Conversion Warrants”). The Conversion Warrants will be exercisable until April 9, 2022 beginning on November 1, 2020, with an exercise price of $0.20 per share. The conversion option within the April Note is required to be bifurcated at fair value, which was approximately $0.4 million on the issuance date, resulting in additional debt discount to the April Note.

As consideration for entering into the April Note, the Company also agreed to amend the Holder’s existing outstanding warrants to purchase 5.1 million common shares of the Company. The exercise price of the warrants was amended from $0.25 per share to $0.20 per share. The incremental change in fair value resulting from the amendment was approximately $51,000, which was recognized as additional debt discount to the April Note.

On August 3, 2020, the Company converted approximately $0.8 million of outstanding principal and $26,000 of accrued interest of the April Note into approximately 5.1 million shares of common stock and 2.5 million warrants with fair value of approximately $2.4 million. The Company also extinguished $1.5 million embedded derivative

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

liability and $0.2 million unamortized debt discount upon the conversion. The Company recorded approximately $0.3 million debt extinguishment loss.

In April 2020, the Company entered into a Note Amendment Agreement (the “Amendment”) with an individual holder of a short-term convertible note, primarily to agree on the following changes:

-Reclassed $75,000 accrued interest as of amendment date to the outstanding principal amount;

-Extended the maturity date of a convertible note with approximately $0.6 million of principal outstanding, as of the amendment date, to October 18, 2020;

-Reduced the conversion price from $0.22 to $0.181

-Issued a new 2-year warrant for up to 2.3 million shares of the Company’s common stock at an exercise price of $0.25 per share valued at $115,000 on the amendment date;

The amendment was recognized as a debt extinguishment, resulting in a loss on debt extinguishment of approximately $70,000.

(3)On August 5, 2020, the Company amended a $1.5 million note payable. The note became convertible at a conversion price of $0.34. The amendment was accounted as debt extinguishment, which was also part of debt conversion as described in the Note 8 (7) below.
(4)In May 2020, the Company entered into a six-month convertible note (the “May Note”) with an individual investor (the “Holder”) with an aggregate principal amount of $0.6 million. The May Note contains OID in the amount of $50,000.

The May Note bears interest at the rate of 8% per annum and is convertible into common shares of the Company at $0.25 plus a warrant to purchase a number of exercise shares equal to 40% of the number of common shares issued upon conversion (the “Conversion Warrants”). The Conversion Warrants will be exercisable until November 28, 2022 beginning on November 1, 2020 with exercise price of $0.25 per share. The conversion option within the May Note is required bifurcated at fair value, which was approximately $0.5 million on the issuance date, resulting in additional debt discount to the May Note.

In August 2020, the Company entered into another convertible note (the "August Note") with the same investor as the May Note (the "Holder") with an aggregate principal amount of $1.1 million. The August Note contains OID in the amount of $110,000.

The August Note bears interest at the rate of 8% per annum and is convertible into common shares of the Company at $0.345 plus a warrant to purchase a number of exercise shares equal to 35% of the number of common shares issued upon conversion (the "Conversion Warrants"). The Conversion Warrants will be exercisable until February 4, 2023 beginning on December 15, 2020 with exercise price of $0.34 per share. The conversion option within the August Note is required to be bifurcated at fair value, which was approximately $0.6 million on the issuance date, resulting in additional debt discount to the August Note.

On September 29, 2020, the Company converted entire $1.1 million of August Note into approximately 3.3 million shares of the Company's common stock and 1.1 million warrants with fair value of approximate $3.3 million. The Company also extinguished $2.3 million embedded derivative liability and $0.5 million unamortized debt discount upon the conversion. The company recorded approximately $0.4 million debt extinguishment loss.

(5)Between February and May 2020, the Company entered into multiple demand loan agreements with Leslie Goldman, the Company’s Senior Vice President, General Counsel, for an aggregate principal amount of $0.3 million (the “Goldman Notes”). The Goldman Notes bear interest rate at 10% per annum, and are repayable upon 15 days' notice from Mr. Goldman.

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NOTES TO CONDENSED CONSOLIDATED STATEMENTS

The Goldman Notes are convertible into common shares of the Company at conversion prices ranging from $0.23 to $0.25 per share. Additionally, the Company agreed to issue warrants to Mr. Goldman to purchase 0.6 million shares of the Company’s common stock (the “Initial Warrants”) in conjunction with the Goldman Notes. The Initial Warrants have a five - year term and are exercisable at prices ranging from $0.23 and $0.25 per share. The fair value of the Initial Warrants was approximately $66,000, which was recognized as debt discount to the Goldman Notes at the issuance date. The conversion option within the Goldman Notes are required to be bifurcated at fair value, which was approximately $36,000 on the issuance date, resulting in additional debt discount to the Goldman Notes.

Upon conversion, Mr. Goldman will also receive a five-year term warrant to purchase a number of the Company’s common shares equal to 50% of the number of common shares issued upon conversion of the Goldman Notes (the “Conversion Warrants”). The Conversion Warrants will be exercisable at $0.25 per share.

(6)During the nine months ended September 30, 2020, the Company converted approximately $4.6 million of outstanding principal and $0.6 million of accrued interest into approximately 28.3 million shares of the Company’s common stock with a fair value of $7 million. The Company recognized approximately $1.8 million in debt extinguishment loss from this conversion.
(7)In May 2020, the Company converted approximately $0.3 million of outstanding principal and accrued interest into approximately 1.3 million shares of the Company’s common stock with a fair value of $0.5 million. The Company recognized approximately $0.2 million in debt extinguishment loss from this conversion.

In August 2020, the Company extinguished approximately $1.5 million of outstanding principal and accrued interest into approximately 4.8 million shares of the Company's common stock and 1.7 million warrants. The Company also modified certain existing warrants and issued additional 6.5 million warrants consideration for certain suspension. The Company also agreed to amend the remaining outstanding $1.5 million outstanding debt, see Note 8 (3). The Company recognized approximately $1.6 million in debt extinguishment loss from this transaction.

During the nine months ended September 30, 2020, the Company entered into multiple Note Extension Agreements with multiple holders, primarily resulting in the following changes:

-

Extended the maturity dates of promissory notes with outstanding principal balances aggregating approximately $3.3 million for an additional 6 to 12 months from the original maturity date;

-

Issued new 2-year warrants to purchase up to 10.3 million shares of the Company’s common stock at an exercise prices ranging from $0.20 and $0.23 per share valued at approximately $0.5 million on the amendment date;

The Note Extension Agreements for approximately $2.3 million of outstanding principal of promissory notes was recognized as a debt modification, while the amendments for approximately $1.0 million of outstanding principal of promissory notes was recognized as a debt extinguishment, resulting in a loss on extinguishment of debt of approximately $0.1 million.

(8)The $440,000 balance of outstanding principal as of September 30, 2020 and December 31, 2019 consists of 2 separate 12% demand notes in the amounts of $300,000 and $140,000.
(9)On May 28, 2019, the Company issued a deferred note to a third-party vendor pursuant to a settlement agreement resolving past matters and providing for the restart of DCVax®-Direct Production.

During the nine months ended September 30, 2020, the Company made full repayment of $1.2 million to the note holder.

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(10)PPP Loan

The Company received a loan under the Coronavirus Aid, Relief and Economic Security (“CARES”) Act’s Paycheck Protection Program (“PPP”). The PPP loan was received on May 20, 2020 in the amount of $0.4 million. The current terms of the PPP loan is two years with a maturity date of May 20, 2022 and it contains a favorable fixed annual interest rate of 1.00%. Payments of principal and interest on the PPP Loan are deferred for the first six months of the term of the PPP Loan until November 20, 2020. The Company used the loan to make payments for payroll, health and disability insurance and rent.

The Company submitted a PPP loan forgiveness application to the Lender on October 26, 2020, with the amount which may be forgiven equal to the sum of qualifying expenses, including payroll costs, covered rent obligations, and covered utility payments incurred by the Company during the twenty-four week period beginning on May 20, 2020, calculated in accordance with the terms of the CARES Act. The forgiveness application was approved on December 7, 2020.

(11)On September 26, 2018, Advent BioServices (“Advent”), a related party of the Company, provided a short-term loan in the amount of $65,000. The loan bore interest at 10% per annum, and is payable upon demand, with 7 days’ prior written notice to the Company. During the nine months ended September 30, 2020, the Company made full repayment to Advent, including all outstanding interest.
(12)During the nine months ended September 30, 2020, the Company entered into two note purchase agreements (the “Notes”) with same investor for an aggregate principal amount of approximate $7.2 million. The Notes bear interest at 8% per annum with 21-month term. There are 0 repayments during the first 7 months of the term. The Notes are amortized in 14 installments starting in month 8. The Notes carry an original issue discount of $650,000 and $10,000 legal costs that were reimbursable to the investor.
(13)Cambridge Loan

On March 26, 2020, the Company entered into a Loan Agreement (the “Loan Agreement”) with Cambridge & Peterborough Combined Authority (the “Lender”) for a loan of £1.35 million (approximately $1.7 million) (the “Loan”) for the current phase of buildout of the Sawston facility. The Company received funds on April 6, 2020. The Lender provides funding for selected economic development projects in the Cambridge region through a competitive selection process.

Under the Loan Agreement, there will be no repayments during the first year of the Loan term, although interest will accrue. Following the first anniversary, repayment of the Loan principal and interest will take place over 4 years, for a total term of 5 years. The interest rate on the Loan is 6.25% per annum.

In conjunction with the Loan, the Company agreed to enter into a Security Agreement with the Lender under which the Company is to grant a security interest in the Company’s 17-acre property in Sawston, U.K. to secure the Loan. No other tangible or intangible assets of the Company or its subsidiaries are subject to any security interest. Such security interest on the 17-acre property will be released upon completion of repayment.

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The following table summarizes total interest expenses related to outstanding notes for the three and nine months ended September 30, 2020 and 2019, respectively (in thousands):

For the three months ended

For the nine months ended

September 30, 

September 30, 

    

2020

    

2019

    

2020

    

2019

Interest expenses related to outstanding notes:

 

  

 

  

  

 

  

Contractual interest

$

344

$

330

$

936

$

881

Amortization of debt discount

 

918

 

357

 

1,869

 

1,020

Total interest expenses related to outstanding notes

 

1,262

 

687

 

2,805

 

1,901

Interest expenses related to outstanding notes to related parties:

 

 

 

 

Contractual interest

 

8

 

36

 

19

 

364

Amortization of debt discount

 

 

 

122

 

Total interest expenses related to outstanding notes to related parties

 

8

 

36

 

141

 

364

Interest expenses related to forbearance of debt to related parties

4,270

4,270

Other interest expenses

 

 

1

 

8

 

2

Total interest expense

$

5,540

$

724

$

7,224

$

2,267

9. Net Loss per Share Applicable to Common Stockholders

Basic lossearnings (loss) per common share is computed by dividing net lossearnings (loss) by the weighted average number of common shares outstanding during the reporting period. Diluted lossearnings (loss) per common share is computed similar to basic lossearnings (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. Diluted weighted average common shares include common stock potentially issuable under the Company's convertible notes, warrants and vested and unvested stock options.

The following table sets forth the computation of earnings ( loss) per share (amounts in thousands):

For the three months ended

March 31, 

    

2021

    

2020

(As revised)

Net earnings (loss) - basic

 

$

(4,123)

 

$

2,626

Interest on convertible notes

 

 

173

Net earnings (loss) - diluted

 

(4,123)

 

2,799

Weighted average shares outstanding - basic

834,605

640,390

Convertible notes and accrued interest

 

 

8,468

Weighted average shares outstanding - diluted

 

834,605

 

648,858

For the three months ended March 31, 2021 and 2020, approximately 0.6 million and 0.5 million securities were not included, in the diluted net loss per share calculationrespectively, because their effect was anti-dilutive as of the periods presented (in thousands):anti-dilutive.

For the nine months ended

September 30, 

    

2020

    

2019

Common stock options

 

304,009

 

101,659

Common stock warrants

 

341,798

 

340,769

Contingently issuable warrants

 

 

11,739

Convertible notes and accrued interest

 

16,193

 

2,559

Potentially dilutive securities

 

662,000

 

456,726

10.8. Related Party Transactions

Advent BioServices AgreementsAgreement

The Company has a Manufacturing Services Agreement with Advent BioServices for manufacture of DCVax-L products at an existing facility in London, as previously reported. The Company also has an Ancillary Services Agreement with Advent, which establishes a structure under which Advent will submitsubmits Statements of Work (“SOWs”) for activities related to the development of the Sawston facility and the compassionate use activities in the UK, as previously reported. The Ancillary Services Agreement had an original term of 8 months, which ended in July 2020. The Company extended the term by 12 months, and did not make any other changes.

Related Party Expenses and Accounts Payable

During the three months ended March 31, 2021 and 2020, the Company recognized approximately $1.7 million and $1.4 million, respectively, in research and development costs from a related party.  Additionally, during the three months ended March 31, 2021 and 2020, the Company capitalized $0.7 million and $0.4 million costs related to Sawston buildout. Some of these amounts have been paid and some have not been paid.

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Related Party Expenses and Accounts Payable

The following table summarizes expenses incurred to related parties (i.e., amounts invoiced) during the three and nine months ended September 30, 2020 and 2019 (amount in thousands) (some of which remain unpaid as noted in the second table below):

For the three months ended

For the nine months ended

September 30, 

September 30, 

    

2020

    

2019

    

2020

    

2019

(As Revised) (Note 13)

(As Revised) (Note 13)

Advent BioServices

 

$

1,435

 

$

1,347

$

4,186

 

$

4,319

During the three and nine months ended September 30, 2020, the Company capitalized $0.5 million and $1.3 million costs related to Sawston buildout in addition to the costs disclosed in the above table.

During the three and nine months ended September 30, 2019, the Company capitalized $0.2 million and $0.7 million costs related to Sawston buildout in addition to the costs disclosed in the above table.

The following table summarizes outstanding unpaid accounts payable and the accrued amount under the SOWs relating to the Sawston Facility and the compassionate use programs held by related parties as of September 30, 2020March 31, 2021 and outstanding unpaid accounts payable as of December 31, 20192020 (amount in thousands). These unpaid amounts include part of the expenses reported in the table above and also certain expenses incurred in prior periods.

    

September 30, 2020

    

December 31, 2019

(As Revised) (Note 13)

    

March 31, 2021

    

December 31, 2020

Advent BioServices – amount invoiced

$

1,739

$

834

$

339

$

3,734

Advent BioServices – amount accrued

3,167

3,002

2,634

1,629

Accounts payable and accrued expenses to Advent BioServices

$

4,906

3,836

$

2,973

$

5,363

Loans from Related Parties to the Company

9. Stockholders’ Deficit

Loan from Advent BioServicesCommon Stock

Advent BioServices provided a short-term loan to the Company in the amount of $65,000 on September 26, 2018. The loan bears interest at 10% per annum,Warrants and is payable upon demand, with 7 days’ prior written notice to the Company.

During the nine months ended September 30, 2020, the Company made full repayment of $73,000 to Advent, including all outstanding interest.

Loan from Leslie GoldmanStock Options Exercised for Cash

During the ninethree months ended September 30, 2020, the Company's Senior Vice President, General Counsel, Leslie Goldman, loanedMarch 31, 2021, the Company $315,000 pursuant to various convertible notes (the “Notes”). The Notes bear interest rate at 10% per annum and fifty percent warrant coverage, and are repayable upon 15 days' noticereceived $0.7 million from the holder.exercise of warrants and stock options issued in the past with an exercise price between $0.175 and $0.34. The Notes are convertible, in whole or in part, into stock together with warrants. The Notes are still outstanding as of September 30, 2020 (see Note 8(5) for further details).

Warrants issued to Linda Powers

As previously reported in a Form 4 filing, on July 2, 2020, the Company issued approximately 15.22.9 million shares of common stock upon these warrant and stock option exercises.

Warrants and Stock Options Cashless Exercise

During the three months ended March 31, 2021, certain warrant and stock option holders elected to cashless exercise their warrants and stock options, with exercise prices between $0.22 and $0.52. The Company issued approximately 5.2 million shares of common stock upon 5.8 million warrants (the "Forbearance Warrants") toand stock options exercises.

Stock Purchase Warrants

The following is a summary of warrant activity for the three months ended March 31, 2021 (dollars in thousands, except per share data):

    

Number of

    

Weighted Average

    

Remaining

Warrants

Exercise Price

Contractual Term

Outstanding as of January 1, 2021

 

331,753

$

0.28

 

1.61

Warrants granted

 

774

 

2.00

 

  

Warrants exercised for cash

 

(2,688)

 

0.26

 

  

Cashless warrants exercise

(2,552)

0.23

Warrants expired and cancellation

 

(885)

 

3.37

 

  

Outstanding as of March 31, 2021

 

326,402

$

0.28

 

1.38

Warrants and Options Suspension

On January 15, 2021, the Company extended the suspension of approximately 256 million warrants and options held by certain officers and directors of the Company until February 28, 2021.

On February 28, 2021, the Company further extended the suspension of approximately 262 million warrants and options held by certain officers and directors of the Company until April 30, 2021.

On March 25, 2021, the options and warrants held by Ms. Powers in consideration for Ms. Powers' forbearance and extension of loans of $5.4 million from Ms. PowersMr. Goldman were subjected to an ongoing suspension on a rolling basis pursuant to the Company. TheseBlocker Letter. In addition, other executive officers and directors extended their suspensions from April 30, 2021 until May 31, 2021, accounting for approximately another 81 million in underlying warrants were approved by the Board in November 2018 when the loansand options.

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were long overdue, as previously reported, and the warrants were re-approved in January 2020, but were not issued until July 2, 2020.

The Forbearance Warrants have an exercise price of $0.21 per share with 5-year contractual term. The fair value of the Forbearance Warrants was approximately $4.3 million on the grant date, which was recognized as an additional interest expense.

The following table summarizes total interest expenses related to outstanding notes to related parties for the three months and nine months ended September 30, 2020 and 2019, respectively (in thousands):

For the three months ended

For the nine months ended

September 30, 

September 30, 

    

2020

    

2019

    

2020

    

2019

Interest expenses related to outstanding notes to related parties:

 

  

 

  

 

  

 

  

Contractual interest

$

8

$

36

$

19

$

364

Amortization of debt discount

 

 

 

122

 

Interest expenses related to forbearance of debt to related parties

4,270

4,270

Total interest expense

$

4,278

$

36

$

4,411

$

364

11. Stockholders’ Deficit

Common Stock

Registered Direct Offering

Between January and February 2020, the Company issued an aggregate of 34.5 million shares of its common stock in a registered direct offering (the “Offering”). The net proceeds from the Offering were approximately $5.7 million, after deducting offering costs of $0.4 million paid by the Company.

In connection with the Offering, the Company also issued approximately 8.5 million 2-year term warrants with an exercise price of $0.25 per share to the investors and approximately 0.8 million 2-year term warrants with an exercise price between $0.17 and $0.21 per share to placement agent in this direct offering. The fair value of these new issued warrants was approximately $1.0 million. Additionally, the Company agreed to extend by twelve months the maturity date of certain existing warrants already held by some of those investors. The Company recorded an incremental change of approximately $2.5 million on the fair value of warrants due to the modifications, which was recorded as part of offering cost during the nine months ended September 30, 2020.

During April 2020, the Company issued an aggregate of 19.9 million shares of its common stock and 11.3 million new issued warrants in a registered direct offering (the "April Financing"). The common stock was offered at a price of $0.153 per share. The warrants are exercisable at $0.20 per share. The net proceeds from the April Financing were approximately $3.0 million, after deducting offering costs of $68,000 paid by the Company.

During May 2020, the Company issued an aggregate 14.2 million shares of its common stock and 5.6 million new issued warrants in a registered direct offering (the "May Financing"). The common stock was offered at a price between $0.17 and $0.225 per share. The warrants have an exercise price between $0.22 and $0.23 per share and an exercise period between 1.5-2.5 years. The Company received approximately $2.9 million from the May Financing.

All of the warrants issued in the May Financings are not exercisable until November 1, 2020. In addition, as part of these agreements, the investors who have existing outstanding warrants that have not already been suspended until November 1 are suspending approximately 14.6 million existing warrants until November 1, 2020.

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On August 5, 2020, the Company entered into financings totaling approximately $8 million (the "August Financing"). The financings were comprised of:

Approximately $7 million from an offering at $0.32 per share of newly registered common stock of approximately 21.8 million shares with 20-35% warrants exercisable at $0.34 per share for approximately 5.3 million shares, with an exercise period of 18 to 30 months, and
$1 million from a convertible note (the "August Note") which is convertible at $0.345 per share. The August Note carries no warrants unless it is converted. If, and only to the extent, the note is converted it will carry 35% warrants exercisable at $0.34 per share.
All of the new warrants issued in the August Financing were suspended until December 15, 2020.
In addition, as part of these agreements, the investors who have existing outstanding warrants that had not yet been suspended, suspended approximately 75.5 million additional existing warrant exercise shares until December 15, 2020. In consideration for the suspension of the 75.5 million existing warrant shares as part of the August Financing, the Company issued approximately 12.5 million warrants with an exercise price of $0.34 per share and an exercise period ranging from approximately 13.5 to 25.5 months following the termination of the suspensions. These suspension consideration warrants were also suspended until the same December date.
Only the common stock sold directly or underlying the warrants and convertible note are being registered in this transaction.

Debt Conversion

During the nine months ended September 30, 2020, the Company converted approximately $9 million outstanding debt and interest into 42.8 million shares of common stock and 5.3 million warrants.

Stock Purchase Warrants

The following is a summary of warrant activity for the nine months ended September 30, 2020 (dollars in thousands, except per share data):

    

Number of

    

Weighted Average

    

Remaining

Warrants

Exercise Price

Contractual Term

Outstanding as of January 1, 2020

359,473

$

0.27

1.42

Warrants granted

 

80,809

 

0.24

 

  

Warrants exercised for cash

 

(34,746)

 

0.28

 

  

Cashless warrants exercise

(381)

0.26

Warrants expired and cancellation

 

(63,357)

 

0.31

 

  

Outstanding as of September 30, 2020

 

341,798

$

0.25

 

1.80

Warrant Adjustments

Between April and August 2020, the Company undertook negotiations related to certain warrant adjustments, including suspending certain outstanding warrants, making them unexercisable for a defined period, and suspending extensions of the warrants during that period.

As previously reported, on May 10, 2020, for a number of unrelated warrant holders, the Company agreed to issue 17.5% new warrants and extend the investors' current warrant terms by six months, in consideration of the investor's suspension of the current and newly issued warrants until November 1, 2020. The unrelated investors suspended warrants for the purchase of approximately 81 million shares of the Company’s common stock. The Company agreed to issue new warrants

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to purchase 14.2 million shares of the Company’s common stock to these investors under the suspension agreements, and these additional warrants were also suspended until November 1, 2020.

On August 5, 2020, the investors who had existing outstanding warrants, that had not yet been suspended, suspended approximately 75.5 million additional existing warrant exercise shares until December 15, 2020. In consideration for the suspension of the 75.5 million existing warrant shares as part of the August Financing, the Company issued approximately 12.5 million warrants with an exercise price of $0.34 per share and an exercise period ranging from approximately 13.5 to 25.5 months following the termination of the suspensions. These suspension consideration warrants were also suspended until December 15, 2020.

As also previously reported, on April 30, 2020, the Company entered into an agreement with its CEO, Linda Powers, in regard to approximately 90 million warrants and options held by Ms. Powers. She agreed to suspend approximately 60 million existing warrants and options held or due to her until November 1, 2020, making them unexercisable during this period. In consideration, the Company extended the exercise period of a separate 29 million existing warrants held by Ms. Powers (not part of the 60 million warrants and options), and Ms. Powers also agreed to suspend those 29 million warrants until November 1, 2020. The extension of the 29 million warrants provides an exercise period of 2-1/2 years after the suspension period.

See Note 14 below under Subsequent Events for more information about further warrant suspensions.

Warrants Exercised for Cash

During the nine months ended September 30, 2020, the Company received aggregate proceeds of approximately $9.6 million from the exercise of warrants with an exercise price between $0.20 and $0.40. The Company issued approximately 34.7 million shares of common stock upon exercise of these warrants.

12.10. Commitments and Contingencies

Operating Lease

The Company adopted ASC Topic 842 - Leases as of January 1, 2019, using the transition method wherein entities were allowed to initially apply the new leases standard at adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

The Company has operating leases for corporate offices in the U.S., U.K., Germany and the Netherlands, 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 ishas not reasonably certainyet determined whether to exercise the options. Variable lease payment amounts that cannot be determined at the commencement of the lease such as increases in lease payments based on changes in index rates or usage, are not included in the ROU assets or liabilities. These are expensed as incurred and recorded as variable lease expense.

On March 8, 2021, the Company extended its office lease in the U.S for additional 3 years and 5 months under an amended agreement. The Company recognized additional $0.7 million ROU assets and lease liabilities for its amended office lease in the U.S.

At September 30, 2020,March 31, 2021, the Company had operating lease liabilities of approximately $4.9$5.7 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. ROU assets of approximately $4.3$5.1 million for the Sawston lease and US office lease wereare included in the condensed consolidated balance sheet.

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

For the three months ended

March 31, 

    

2021

    

2020

    

Lease cost

Operating lease cost

$

246

$

234

Short-term lease cost

12

12

Variable lease cost

53

49

Total

$

311

$

295

Other information

Operating cash flows from operating leases

$

(255)

$

(244)

Weighted-average remaining lease term - operating leases

2.4-8.9

0.9-10.0

Weighted-average discount rate - operating leases

12.0

%

12.0

%

The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2021 and 2020, respectively.

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

For the Nine Months ended

September 30, 2020

    

U.K

    

U.S

    

Total

Lease cost

Operating lease cost

$

453

$

247

$

700

Short-term lease cost

33

33

Variable lease cost

45

16

61

Total

$

531

$

263

$

794

Other information

Operating cash flows from operating leases

$

(496)

$

(249)

$

(745)

Weighted-average remaining lease term - operating leases

9.4

0.4

Weighted-average discount rate - operating leases

12

%

12

%

For the Nine Months ended

September 30, 2019

    

U.K

    

U.S

    

Total

Lease cost

 

  

 

  

 

  

Operating lease cost

$

454

���

$

165

$

619

Short-term lease cost

 

38

 

81

 

119

Variable lease cost

 

 

11

 

11

Total

$

492

$

257

$

749

Other information

 

  

 

  

 

  

Operating cash flows from operating leases

$

$

(162)

$

(162)

Weighted-average remaining lease term – operating leases

 

10.2

 

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 nine months ended September 30, 2020 and 2019, respectively.

Maturities of the operating leases, excluding short-term leases, are as follows:

    

U.K

    

U.S

    

Total

Remaining three months ended December 31, 2020

$

161

$

167

$

328

Year ended December 31, 2021

644

84

728

Nine months ended December 31, 2021

    

$

611

Year ended December 31, 2022

644

644

978

Year ended December 31, 2023

644

644

987

Year ended December 31, 2024

644

644

893

Thereafter

8,990

8,990

9,615

Total

11,727

251

11,978

13,084

Less present value discount

(6,992)

(89)

(7,081)

(7,354)

Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2020

$

4,735

$

162

$

4,897

Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2021

$

5,730

Manufacturing Services Agreements

Advent BioServices

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 Advent Agreement provides for manufacturing of DCVax-L products at an existing facility in London. The Agreement is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The Advent Agreement 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. Either party may terminate the MSA on twelve months’ notice, to allow for transition arrangements by both parties.

On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for U.K. Facility Development Activities and Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent develops Statements of Work (“SOWs”) for the U.K. Facility Development Activities and Compassionate Use Program Activities, and delivers those SOWs to the Company for review and approval. After an SOW is 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 U.K. 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 Ancillary Services Agreement had an original term of 8 months, which ended in July 2020. The Company extended the term by 12 months, and did not make any other changes.

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German Tax Matter

The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015.  During those years, NWBio, Inc. sent funds to NWBio GmbH to pay for operating expenses and costs associated with the Phase III clinical trial.  The German tax authorities have asserted that the subsidiary should have charged NWBio parent company a 10% profit margin on top of these costs, that they will deem that such a profit margin was charged by the subsidiary (even though it was not) and that they will tax this deemed profit margin, -- even thoughalthough neither NW Bio, Inc. nor NW Bio GmbH made any profit during the period in question (or at any other time), and even though the funds provided by NW Bio, Inc. were used by NW Bio GmbH entirely for operating expenses and clinical trial costs.

In addition, the German tax authorities are seeking to deem that all of the funds provided by NW Bio Inc. to NW Bio GmbH during 2013-2015 They have also made claims for operating expenses and clinical trial costs were distributed back to NW Bio Inc. as a “dividend” by NW Bio GmbH – even though all of the funds were, in fact, used for operating expenses and clinical trial costs in Germany, and no funds were ever distributed back to NW Bio Inc. as a “dividend” from NW Bio GmbH.  

Based upon the supposed deemed “dividend” of the entire funds provided by NW Bio Inc. to NW Bio GmbH during 2013-2015, the German tax authorities are seeking to impose withholding tax on this entire amount, plusother taxes including penalties and interest for the deemed withholding tax being overdue.  Under the US-German Tax Treaty, if we were to pay this withholding tax, we are supposed to then receive a refund of this tax (though not the interest and penalties).interest.

The deemed “profit margin” never existed, and the deemed “dividend” also never existed -- both of these assessments are contrary to the facts.  Although it is late in the administrative process, we have mobilized additional tax and accounting experts both in Germany and in the US to assist us in objecting to these deemed assessments and taxes and in seeking to have them withdrawn or overruled.   We plan to fight these assessments through the administrative procedures with the German tax authorities and, if necessary, the German tax court. However, in parallel, we are also pursuing settlement with the German tax authorities for an immaterial sum. In July, the Company received a subpoena from the SEC requesting more information.  We are cooperating with this query.

It is still too early at this point to determine what tax amounts may ultimately be owed. In July, NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments of the German tax authorities. During the subsequent period, NW Bio GmbH has received a demand for payment of the previous assessment and penalties from Leipzig enforcement officials. However, recently NW Bio GmbH received a response from the tax authorities responsible for calculating a revised assessment, which indicated that the tax authorities are open to negotiations and provided a significantly reduced proposed assessment if NW Bio GmbH is interested in settling the matter. NW Bio GmbH is reviewing the offer and has been requested to respond by January 15, 2021. If the offer is not accepted there can be no assurance that the German tax authorities will agree to further discussionsagreed in principle with the Company’s proposed revised approach and to approaches undersettlement offer. The Company has provided and accrued for the German-USfollowing proposed settlement and is awaiting formal acceptance.  The proposed tax treaty and OECD Transfer Pricing that would result in our calculations that there is no, or minimal, tax liability. Given the parallel tracks we are employing, the Company is not currently able to reasonably estimate the amount that NW Bio GmbH may ultimately have to pay for this matter. For the three years at issue, the German Tax authorities have offered to settle for a tax of less than €500,000 (approximate $585,000settlement offer includes €346,000 (approximately $406,000 as of September 30,December 31, 2020) plus penalties, as well as a withholding tax that should be fully refundablefor the years under audit, with an addition of €101,000 (approximately $118,000) for the more recent years to date. Penalties and interest on the Company of approximately €2.2 million (approximate $2.6 million as of September 30, 2020).proposed amounts are still under negotiation. After considering further proceedings (including application of the US-German tax treaty),negotiations, under its evaluation under ASC 740, it is the view of the Company currently that it is not more likely than not that the resolution of these tax matters will ultimately result in a net material charge to the Company.

13.11. Revision to Prior Period Financial Statements

During the course of preparing the quarterly report on Form 10-Q for the three and nine month periodmonths ended September 30, 2020 and 2019, the Company identified an error in its accrual and capitalization related to the Sawston Facility and research and development costs under the Advent Ancillary Services Agreement. This  resulted in an understatement of construction in progress of $1.5 million as of December 31, 2019, and an understatement of accounts payable and accrued expenses to related parties and affiliates of $3.0 million as of December 31, 2019.   For the three and nine months ended

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

September 30, 2019, this also resulted in an understatement of research and development expense of approximately $0.1 million and $0.4 million, respectively.

The Company concluded that the error was not material to any prior annual period and the error had no material impact to any prior interim period. Nevertheless, the Company has revised its historical consolidated financial statements to properly reflect research and development expenses, capitalization of construction in progress and accrued liabilities in the prior periods.

The effect of thethese revisions to the consolidated financial statements is as follows (amounton the March 31, 2020 period was an overstatement of net income of $100,000 for research and development expenses related to services provided during the period and an understatement of $405,000 in thousands):accrued liabilities related to capital expenditures on the balance sheet.

Consolidated Balance Sheet

As of December 31, 2019

As Previously

 

    

  Reported 

    

Adjustments

    

As Revised

Construction in progress

$

171

$

1,514

$

1,685

Total non-current assets

 

5,929

 

1,514

 

7,443

TOTAL ASSETS

$

9,129

$

1,514

$

10,643

 

  

 

  

 

  

Accounts payable and accrued expenses to related parties and affiliates

$

842

$

3,002

$

3,844

Total current liabilities

 

41,194

 

3,002

 

44,196

Total liabilities

 

52,696

 

3,002

 

55,698

 

  

 

  

 

  

Accumulated deficit

 

(839,907)

 

(1,488)

 

(841,395)

Total stockholders' deficit

 

(43,567)

 

(1,488)

 

(45,055)

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

$

9,129

$

1,514

$

10,643

Consolidated Statement of Operations

For the three months ended

For the nine months ended

September 30, 2019

September 30, 2019

As Previously

As Previously

 

    

  Reported 

    

Adjustments

    

As Revised

    

  Reported 

    

Adjustments

    

As Revised

Research and development expenses

$

3,409

$

129

$

3,538

$

9,704

$

388

$

10,092

Total operating costs and expenses

 

7,049

 

129

 

7,178

 

22,372

 

388

 

22,760

Loss from operations

 

(6,456)

 

(129)

 

(6,585)

 

(20,859)

 

(388)

 

(21,247)

Net loss

$

(6,242)

$

(129)

$

(6,371)

$

(26,969)

$

(388)

$

(27,357)

Total comprehensive loss

$

(5,350)

$

(129)

$

(5,479)

$

(25,946)

$

(388)

$

(26,334)

Consolidated Statement of Cash Flows

For the nine months ended

September 30, 2019

As Previously

 

    

  Reported 

    

Adjustments

    

As Revised

Cash Flows from Operating Activities:

  

  

  

Net loss

$

(26,969)

$

(388)

$

(27,357)

Related party accounts payable and accrued expenses

 

(3,800)

 

388

 

(3,412)

Net cash used in operating activities

$

(25,881)

$

$

(25,881)

Supplemental schedule of non-cash investing and financing activities:

 

  

 

  

 

  

Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates

$

$

710

$

710

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

14.12. Subsequent Events

Registered Offering

On October 12, 2020, the Company entered into financings totaling approximately $11.9 million (the “Offering”). The financings were comprised of:

Approximate $10 million from an offering at $0.816 per share (based upon the average 10 day closing price ending on October 12, 2020) of newly registered common stock of approximately 12.2 million shares with 30% warrants with an exercise price of $2.00 per share and an exercise period of 12 months (following a 3-month suspension after issuance), and
Approximate $1.9 million from a convertible note which is convertible at $0.85 per share (the “Note”). The Note carries no warrants unless it is converted. If, and only to the extent, the Note is converted it will carry 30% warrants with an exercise price of $2.00 per share and an exercise period of 12 months (following a 3-month suspension after issuance)
All of the new warrants issued in the Offering are suspended until January 15, 2021.

In addition, as part of these agreements, certain investors who have existing outstanding warrants that have not yet been suspended are now suspending approximately 3.5 million additional existing warrant exercise shares until January 15, 2021.

In consideration for the suspension of the 3.5 million existing warrant shares as part of the Offering, the Company issued approximately 261,000 warrants with an exercise price of $2.00 per share and an exercise period of 12 months (following a 3-month suspension after issuance). These suspension consideration warrants are also suspended until the same January date.

Warrant and Option Adjustments

Approximately 171 million warrants and options were previously suspended and not exercisable until November 1, 2020, as reported by the Company in May 2020. On October 31, 2020, the Company further extended the suspension of approximately 157 million of those 171 million warrants and options through December 15, 2020.

Furthermore, other holders agreed to new suspensions of approximately 21 million additional warrants (in addition to the 157 million suspended as noted above) through December 15, 2020, making for a total of approximately 178 million suspensions through December 15, 2020.

Still another 96 million warrants (beyond the 178 million described above) were also suspended earlier in connection with other new share purchases. Consequently, a total of approximately 274 million warrants and options were suspended through December 15, 2020.

In consideration for the forgoing suspensions, the Company agreed to extend the exercise period of each suspended warrant by the same amount of time as the suspension period, and provided for approximately 5 million warrants to be issued to the holders of the 178 million suspended warrants and options.  To date, the Company has issued such warrant consideration to some of the holders of suspended warrants and options, and is in ongoing discussions with the other holders.  

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NORTHWEST BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED STATEMENTS

Warrants Exercised for Cash and Cashless Warrants Exercise

Between October and December 2020, the Company received $4.3 million from the exercise of warrants with an exercise price between $0.153 and $0.50. The Company issued approximately 12.8April 2021, 8.7 million shares of common stock were issued upon these warrant exercises.

Between Octoberexercises of $1.7 million and November 2020, certain warrants allowing for cashless exercise were exercised, with exercise prices between $0.22 and $0.52. The Company issued approximately 0.9 million sharesthe conversion of common stock upon 1.3 million warrant exercises.

Debt Conversion

Between October and November 2020, the Company converted approximately $4.7 million outstanding debt and interest into approximately 15.6 million shares of common stock.

Flaskworks Shares Issuance

On December 1, 2020, the Company issued 1.5 million shares of common stock based upon the Flaskworks team having completed a significant milestone, in accordance with the Rights Issuance Agreement entered on August 28, 2020.$0.8 million.

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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, 20192020 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

The Company isWe 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 thatin which the tumor can be surgically removed. We recentlyhave completed oura 331-patient international Phase III trial of DCVax-L for newly diagnosed GlioblastomeGlioblastoma multiforme brain cancer (GBM).

As previously reported, the data collection and confirmation process was completedconducted by the independent contract research organization (CRO) who managed the trial and by other independent service firms, and we reachedfirms. On October 5, 2020, the Company announced that Data Lock for the Phase III trial on October 4, 2020.   As explained in our prior announcements, following Data Lock the independent statisticians conducthad been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the raw data andby independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for publication in a scientific publicationjournal and for public announcement. During this process, any questions or comments from the expertsThis series of processes is under way. It is anticipated that public announcement will be addressed as part of the preparation of the results for publication and public reporting.follow these processes.

As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the resurgencewaves of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise,for COVID, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatoryregulatory processes have been similarly focused on COVID-19COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain final data,analyses, and the firms conducting the analytics for that final data (such as IDH mutation status), continue toanalyses have had only limited operations. Even logistical matters such as the shipping of tissue slidesmaterials have been and continue to be, subjected to substantial restrictions and delays.

On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system to close and automate the manufacturing of cell therapy products such as DCVax®. The Company acquired 100% of the ownership, and Flaskworks became a wholly-owned subsidiary of the Company. Flaskworks was previously owned by its technical founders and Corning Inc. The technical team from Flaskworks joined the Company as part of the Acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs. The Company’s primary focus at present is on its DCVax-L program and completionbuildout of the Phase III trialSawston, UK facility has been designed to proceed in phases, as modules, both for efficiency in the timing of DCVax-L for Glioblastoma brain cancer. capital costs and to allow flexibility in operations and usage. The Company anticipates that implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.

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Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. As resources permit, theThe Company is working on preparations for Phase II trials of DCVax-Direct, including discussions with key institutions in regard to trial design and trial preparations. The Company has stopped the DCVax-Direct contract manufacturing preparation activities at present, while the trial design activities and preparations with the trial sites continue.

On October 5, 2020, the Company announced that it had reached Data Lock for the Phase III trial and that a series of steps and processes would follow. These processes included analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for

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publication in a scientific journal and public announcement.  This series of processes is under way.  It is anticipated that public announcement will follow these processes.

We are continuing to negotiate and enter into agreements with warrant and option holders to extend earlier suspensions, enter into additional new suspensions, and/or determine compensation for suspensions, to assist us in maintaining reasonable capacity for additional financings if needed prior to the next shareholders’ meeting.  Going forward, we may enter into further agreements, as appropriate, at least until the next shareholders’ meeting, with our investors and/or officers and directors.resources permit.

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 maycould differ from these estimates.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.

Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2019 and Note 12 Leases to the condensed consolidated financial statements in this accompanying Form 10-Q. Other than the changes related to the accounting for goodwill and intangible assets, our2020. 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, 2019. Our critical accounting policy for goodwill and intangible asset  is detailed in Note 3.

Revision of Previously Issued Unaudited Financial Statements

We have revised certain previously reported non-material financial information for the three and nine months ended September 30, 2019 in this Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including but not limited to information within the Results of Operations section.

See Note 13, Revision to Prior Period Financial Statements, in Item 1, Financial Statements, for additional information related to the revision, including descriptions of the misstatements and the non-material impact on our unaudited condensed consolidated financial statements.2020.

Results of Operations

Operating costs:

Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses, which increase when we are actively participating in clinical trials and especially when we are in a large ongoing international phase III trial or we are completing such a large international trial, and undertaking substantial one-time expenses such as for final site visits, query resolutions, statistical work for the Statistical Analysis Plan, preparations for data analyses and other activities related to completion and assessment of the trial.trial and its results. The operating costs also include administrative expenses associated with trials, and increase as such operating activities grow.

In addition to clinical trial related costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, and related matters. Going forward, we are also incurring large amounts of costs to carry out and complete statistical analyses, process validation work, final data collection and validation, and other work associated with the processesmoving towards preparing for locking, unblinding and analyzing the trial results. We are also incurring substantial expenses to develop our Sawston, U.K. facility, prepare for regulatory inspection and certification of the facility and prepare for manufacturing validation and scale-up.

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Following our acquisition of Flaskworks, our operating costs now include the costs for its ongoing operations and.and its intellectual property filings.

Our operating costs also include the costs of preparations for the launch of new or expanded clinical trial programs, such as our planned Phase II clinical trials. 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. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, forin both the US and Europe.

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

Research and development:

Discovery and preclinical research and development 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.

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Because we are a pre-revenue company, we do not allocate research and development 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.

In December 2018, recognizing the importance of manufacturing to the Company’s future commercialization, the Company’s Board approved an option pool for external manufacturing personnel with options exercisable for 5.5 million shares. The Company has worked with several manufacturing groups to date. As the Company has progressed towards Data Lock and unblinding of the Phase 3 trial results, the Company has reviewed its manufacturing arrangements and incentives, and contemplated the arrangements needed to start preparing for possible commercialization.  As part of that process, the Company implemented the award of the 5.5 million options approved in 2018 to Advent BioServices as part of the option grants described in Note 6 above. The exercise price and exercise period determined by the Board in December 2018 for this manufacturing pool were $0.25 per share and ten years. The Company’s option grants described in Note 6 above also included certain other key manufacturing personnel and consultants in the U.K. and Germany.

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, 2021 and 2020 and 2019

We recognized a net loss of $194.1$4.1 million and $6.4net income of $2.7 million for the three months ended September 30,March 31, 2021 and 2020, and 2019, respectively.

Research and Development Expense

For the three months ended SeptemberMarch 30, 20202021 and 2019,2020, research and development expense was $17.7$6.9 million and $3.5$3.9 million, respectively. The increase was mainly related to an increase of $14.2$3.7 million stock-based compensation that represented vesting of a portion of previously issued securities, and that was recognized in research and development.development expense.

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The following table summarizesWe incurred approximately $1.7 million and $1.4 million in expenses incurred (i.e., amounts invoiced and accrued, which have only been partly paid) tofrom related parties during the three months ended September 30,March 31, 2021 and 2020, and 2019 (amount in thousands):

For the three months ended

September 30, 

    

2020

    

2019

(As Revised)

Advent BioServices

$

1,435

$

1,347

respectively.

General and Administrative Expense

General and administrative expenses were $29.3$12.9 million and $2.8$4.5 million for three months ended September 30,March 31, 2021 and 2020, and 2019, respectively. The increase was mainly related to an increase of $24.4$5.7 million stock-based compensation  that represented vesting of a portion of previously issued securities, and that was recognized in general and administrative.

Legal Expenses

Legal costs were $1.1 million for the three months ended September 30, 2020 versus $0.8 million for the three months ended September 30, 2019. The slight increase in legal costs is within a normal fluctuation range for our need for legal services.administrative expense

Change in fair value of derivatives

During the three months ended September 30,March 31, 2021 and 2020, and 2019, we recognized a non-cash lossgain of $139$17.6 million and non-cash gain of $2.5$12.9 million, respectively. The loss was primarily due to the increase of our stock price as of September 30, 2020 ($0.77 per share) compared to June 30, 2020 ($0.34 per share). The gain last year was primarily due to the decrease of our stock price as of September 30, 2019March 31, 2021 ($0.251.49 per share) compared to June 30,December 31, 2020 ($1.53 per share), and decrease of our stock price as of March 31, 2020 ($0.15 per share) compared to December 31, 2019 ($0.260.21 per share).

Loss from extinguishment of debt

During the three months ended September 30,March 31, 2021, approximately $4.8 million debt and interest was converted into 4.5 million shares of common stock and 0.8 million warrants. The fair value of common stock and warrants were

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approximately $6.7 million. We also extinguished approximately $1.9 embedded derivative liability from the note conversion.

During the three months ended March 31, 2020, we converted debt of approximately $4.9$1.4 million principal and $0.5$0.4 million accrued interest into approximately 20.112.4 million shares of common stock and 5.3 million warrants at fair value of $11.4$2.4 million. We also extinguished $3.8 million embedded derivative liabilities, wrote off $0.9 million unamortized debt discount and made some debt amendment upon the conversion. We recorded an approximate $3.0$0.6 million debt extinguishment loss from the conversion.

During the three months ended September 30, 2019, we recorded a loss from extinguishment of debt of $0.5 million. The debt extinguishment loss was related to debt conversions, where the fair value of common stock exceeded the book value of the debt on the date of conversion.

Interest Expense

During the three months ended September 30,March 31, 2021 and 2020, and 2019, we recorded interest expense of $5.5$1.4 million and $0.7$0.6 million, respectively.

Foreign currency transaction gain (loss)

During the three months ended September 30,March 31, 2021 and 2020, and 2019, we recognized foreign currency transaction loss of $1.2$0.7 million and gain of $0.9$1.1 million, respectively. The gain was due to the less strengthening of the U.S. dollar relative to the British pound sterling. The loss waslosses were due to the strengthening of the U.S. dollar relative to the British pound sterling.

Nine Months Ended September 30, 2020 and 2019

We recognized a net loss of $249.5 million and $27.4 million for the nine months ended September 30, 2020 and 2019, respectively.

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Research and Development Expense

For the nine months ended September 30, 2020 and 2019, research and development expense was $24.7 million and $10.1 million, respectively. The increase is due to an increase in activities and involvement of external consultants as the Phase 3 trial moved through final data collection and query resolution, independent data validation, and other preparations for Data Lock and analyses. Additionally, we recognized approximately $14.2 million stock-based compensation under research and development during the nine months ended September 30, 2020. As described in Note 10 above, we accrued an additional $0.2 million research and development expense related to Advent compassionate use program.

The following table summarizes expenses incurred (i.e., amounts invoiced and accrued, which have only been partly paid) to related parties during the nine months ended September 30, 2020 and 2019 (amount in thousands):

For the nine months ended

September 30, 

    

2020

    

2019

(As Revised)

Advent BioServices

 

$

4,186

$

4,319

General and Administrative Expense

The Company’s general and administrative expenses were $36.8 million and $9.4 million for nine months ended September 30, 2020 and 2019, respectively. The increase was mainly related to an increase of $24 million stock-based compensation that was recognized in general and administrative.

Legal Expenses

Legal costs were $2.5 million for the nine months ended September 30, 2020 versus $3.3 million for the nine months ended September 30, 2019. The decrease in legal costs reflects a reduction in the need for legal services.

Change in fair value of derivatives

During the nine months ended September 30, 2020 and 2019, we recognized a non-cash loss of $175.2 million and $2.4 million, respectively. The loss was primarily due to the increase of our stock price as of September 30, 2020 ($0.77 per share) compared to December 31, 2019 ($0.21 per share).

Loss from extinguishment of debt

During the nine months ended September 30, 2020, we converted debt of approximately $7.9 million principal and $1.1 million accrued interest into approximately 42.8 million shares of common stock and 5.3 million warrants at fair value of $16 million. We also extinguished $3.8 million embedded derivative liabilities, wrote off $0.9 million unamortized debt discount and made some debt amendment upon the conversion. We recorded an approximate $4.3 million debt extinguishment loss from the conversion.

During the nine months ended September 30, 2019, the Company converted debt of approximately $5.2 million principal and $0.4 million accrued interest into approximately 26.2 million shares of common stock at fair value of $7 million. The Company recorded an approximate $1.5 million debt extinguishment loss from the conversion.

During the nine months ended September 30, 2019, we entered into a settlement agreement with Cognate BioServices to settle certain outstanding invoices. We recorded approximately $1.0 million gain from this settlement.

Interest Expense

During the nine months ended September 30, 2020 and 2019, we recorded interest expense of $7.2 million and $2.3 million, respectively.

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Foreign currency transaction gain (loss)

During the nine months ended September 30, 2020 and 2019, we recognized foreign currency transaction loss of $0.5 million and foreign currency transaction gain of $1.0 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to the British pound sterling. The gain was due to the less strengthening 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.

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 within one year after the condensed 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.

Contingent Contractual Obligations

The following table summarizes our contractual obligations as of September 30, 2020 (amount in thousands):

Payment Due by Period

Less than

1 to 2

3 to 5

    

Total

    

1 Year

    

Years

Years

Short term convertible notes payable (1)

    

  

    

  

  

6% unsecured

 

$

224

$

224

$

$

8% unsecured

569

569

10% unsecured

 

3,128

3,128

Short term convertible notes payable to related party (2)

10% unsecured

 

333

333

Short term notes payable (3)

 

  

  

  

8% unsecured

 

3,013

3,013

10% unsecured

 

329

329

12% unsecured

 

611

611

Long term notes payable (4)

 

  

  

  

8% unsecured

 

7,266

7,266

6% secured

2,076

247

1,829

1% unsecured

403

403

Operating leases (5)

 

13,416

5,758

5,561

2,097

Purchase obligation (6)

 

Total

 

$

31,368

$

14,368

$

13,074

$

3,926

(1)The obligations related to short term convertible notes were approximately $3.9 million as of September 30, 2020, which included remaining contractual unpaid interest of $0.3 million.
(2)The obligations related to short-term convertible notes to related party was approximately $0.3 million as of September 30, 2020, which included remaining contractual unpaid interest of $18,000.
(3)The obligations related to short-term notes were approximately $4 million as of September 30, 2020, which included unpaid interest of $0.3 million.

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(4)The obligations related to long-term notes were approximately $9.7 million as of September 30, 2020, which included unpaid interest for the next 5 years of approximately $0.4 million.
(5)The operating lease obligations during the next year included $167,000, $4,000 and $34,000 for our offices in Maryland, Germany and London, respectively. Approximately £1 million ($1.4 million) in lease obligations during the next 2 years and approximately £1.5 million ($2.1 million) for the next 3 to 5 years related to the Vision Centre in the U.K. that we leased back in December 2018. We also included approximately $10.9 million of anticipated payments to Advent BioServices, which represents the next 2.3 years’ obligation. The remaining contract term as of September 30, 2020 was approximately 2.3 years under the Manufacturing Services Agreement with Advent.
(6)We have possible contingent obligations to pay certain fees to contract manufacturers if we shut down or suspend programs. For Cognate BioServices (in addition to any other remedies) if we shut down or suspend its DCVax-L program or DCVax-Direct program, the following obligations exist, which are not reflected in the accompanying balance sheets.

For a shut down or suspension of the DCVax-Direct program at Cognate, the Company must give 3 months’ advance notice.

For a shut down or suspension of the DCVax-L program at Cognate, the fee will be as follows:

The fee shall be $3 million in any of the following cases: after the last dose of the last patient enrolled in the Phase III clinical trial for DCVax®-L but before any submission for product approval in any jurisdiction; or after the submission of any application for market authorization but prior to receiving a marketing authorization approval.
At any time after receiving product approval for DCVax®-L in any jurisdiction, the fee shall be $5 million.

While our DCVax programs are ongoing, under our agreements with Cognate we are required to pay certain fees for dedicated production suites or capacity reserved exclusively for DCVax production, and pay for a certain minimum number of patients, whether or not we fully utilize the dedicated capacity and number of patients. The same is the case under our agreement with Advent. On May 21, 2019, we settled certain disputed amounts that had been invoiced to us by Cognate.

For a shut down or suspension of the DCVax-L program at Advent, the Company must give 12 months’ advance notice. During the notice period services would still be performed, to provide a transition period. Minimum required payments for this notice period total approximately £3.8 million ($4.9 million).

As of September 30, 2020, no shut-down or suspension fees were triggered.

Cash Flow

Operating Activities

During the ninethree months ended September 30,March 31, 2021 and 2020, and 2019, net cash outflows from operations were $21.9$13.2 million and $25.9$7.5 million, respectively. The decreaseincrease in cash used in operating activities was primarily attributable to a decreasean increase in clinical trial related expenditures.

Financing Activities

During the nine months ended September 30, 2020, weWe received approximately $16.9$0.7 million cash from issuance of 85.8 million shares of common stock. During the nine months ended September 30, 2019, we received $2.2 million of cash proceeds from the issuance of our common stock and warrants in a registered direct offering.

We received $9.6 million and $2.2 million from the exercise of warrants and options during the ninethree months ended September 30, 2020 and 2019, respectively.March 31, 2021.

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We received approximately $8.6$5.7 million cash from the exercise of warrants and $6.5options during the three months ended March 31, 2020.

We received approximately $10 million cash proceeds from issuances of debt toa loan from a commercial lender and $1 million from a third parties during the nine months ended September 30, 2020 and 2019, respectively.

We received approximately $315,000 in cash proceeds from issuances of debt with a related party, during the ninethree months ended September 30, 2020.March 31, 2021 and 2020, respectively.

We made an aggregate debt payment of approximately $1.7 million during the nine months ended September 30, 2020, including $64,000 to related parties. Our financial statements indicate there is substantial doubt about our ability to continue as a going concern as we are dependent on our ability to obtain ongoing financing and ultimately to generate sufficient cash flow to meet our obligations on a timely basis. We can give no assurance that our plans and efforts to achieve the above steps will be successful.

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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 of development and regulatory certification of manufacturing facilities, and unanticipated developments. The extent of resources available to us will determine which programs can move forward and at what pace.

Off-Balance Sheet Arrangements

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

Item 3. Quantitative and Qualitative Disclosures About Market Risk

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

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

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

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

Based on our analysis, as of September 30, 2020,March 31, 2021, the effect of a 100+/- basis point change in interest rates on the value of our financial instruments and the resultant effect on our net loss are considered immaterial.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of March 31, 2021, 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 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.

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Item 4. Controls and ProceduresChanges in Internal Control over Financial Reporting

Evaluation of Disclosure Controls and Procedures

Our management evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15€ and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end of the period covered by this Quarterly Report on Form 10-Q. In designing and evaluating the controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures.

Based on our evaluation, management concluded that, because of a material weakness identified in regard to foreign taxes, our internal control over financial reporting was not effective as of September 30, 2020.

This oversight was in connection with a tax issue between our German subsidiary and German tax authorities relating to the tax years 2013-2015, as explained above. The matter is also described in the Company’s Form 10-K Amended.

The material weaknessNo change in internal control over financial reporting resulted from a deficiency in our disclosure controls as we did not formally document our evaluation of a potential foreign tax contingency related to potential assessments on our German subsidiary under ASC-740 to support the evaluation and determination for disclosure. The Company identified and disclosed this contingency in Q1 2020 rather than in the preceding reporting period.

The Company is in the process of improving its procedures and communication, including translating significant documents itself rather than relying upon the Company’s German tax experts and advisors, and performing more formal analysis of its contingencies. The material weakness will not be considered remediated until the applicable remedial control operates for a sufficient period of time and management has concluded, through testing, that this control is operating effectively. We expect that the remediation of this material weakness will be completed prior to the end of the year 2020.

Changes in Internal Control over Financial Reporting

Other than discussed above, there were no changes in our internal control over financial reportingoccurred during the fiscalmost recent quarter ended September 30, 2020 that havewith respect to our operations, which materially affected, or are reasonablyis reasonable likely to materially affect, our internal controlcontrols over financial reporting.

Part II - Other Information

Item 1. Legal Proceedings

Not Applicable.

Item 1A. Risk Factors

There have been no material changes from theApplicable risk factors previously disclosed in our 2019 Annual Report, except for the risk factors updated below:

A pandemic, epidemic or outbreak of an infectious diseaseare set forth in the United States, United Kingdom, Europe or elsewhere may adversely affect our business.

The COVID-19 situation, and related restrictions and lockdowns, have adversely affected the Company’s programs and are likely to continue to adversely affect them. For example, the processreport on Form 10-K for completion of the final data collection from trial sites for the Phase 3 trial was materially slowed by the inability to perform in-person monitoring visits by the contract research organization, by very limited availability of investigators and staff at trial sites, and by substantially longer timeframes for Institutional Review Board or Ethics Committee meetings and regulatory processes for matters other than COVID-19. The Company has been essentially unable to undertake compassionate use cases during part of March and during Q2 and Q3, due to lockdowns, travel restrictions and hospitals focusing most of their personnel and resources on

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COVID-19 patients. In addition, manufacturing of DCVax products is impeded by personnel being under lockdown. The start of the buildout of the Sawston facility was delayed by the construction sector shutdown and restrictions, and the costs of carrying out the buildout were substantially increased by the need to employ two construction crews to work double shifts. The Company anticipates that such effects of the COVID-19 situation are likely to continue for an extended period of time.2020.

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

None.

Item 3. Defaults Upon Senior Securities

Not Applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Consulting AgreementsNot Applicable

The Company is in the process of entering into expanded agreements with certain Scientific Advisory Board members and certain other key consultants whom the Company anticipates will play important roles in helping the Company prepare for potential applications for regulatory approvals of the DCVax-L product. The agreements are being negotiated around structures that are wholly or partly contingent upon major milestones and will provide substantial incentive compensation.

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Item 6. Exhibits

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

XBRL Instance Document.

 

101.SCH

XBRL Schema Document.

 

101.CAL

XBRL Calculation Linkbase Document.

 

101.DEF

XBRL Definition Linkbase Document.

 

101.LAB

XBRL Label Linkbase Document.

 

101.PRE

XBRL Presentation Linkbase Document.

104

The cover page from the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020,March 31, 2021, 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: January 14,May 17, 2021

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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