UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K/A

 

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

 

For the fiscal year ended December 31, 2019

 

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

 

For the transition period from ______to _______

 

Commission File Number: 001-35737

 

NORTHWEST BIOTHERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 94-3306718
(State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.)

 

4800 Montgomery Lane, Suite 800, Bethesda, MD 20814

(Address of principal executive offices) (Zip Code)

 

(240) 497-9024

(Registrant's telephone number)

 

N/A

(Former Name, Former Address and Former Fiscal Year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class: Trading Symbol(s): Name of each exchange on which registered:
Common Stock, par value $0.001 per share NWBO OTCQB

 

Securities registered pursuant to Section 12(g) of the Act: None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x

 

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 (the “Exchange Act”) 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 x 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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a 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 x
Non-accelerated filer ¨ Smaller reporting company x
    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 x

 

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. ¨

 

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $138,133,000 on June 30, 2019. As of March 14, 2020, the registrant had 648,717,833 shares of common stock outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

None.

 

 

 

 

 

TABLE OF CONTENTS

 

 

Item        
    PART II    
9A   Controls and Procedures   1
    PART IV    
15.   Exhibits, Financial Statement Schedules   5

 

 

 

 

EXPLANATORY NOTE

  

 

Northwest Biotherapeutics, Inc.  (“Northwest,” the “Company,” “we,” “our” or “us”) is filing this Amendment No. 1 on Form 10-K/A (this “Amendment”) to amend our Annual Report on Form 10-K for the year ended December 31, 2019 (the “Form 10-K”), originally filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 16, 2020. As a result of a material weakness in internal control over financial reporting that existed as of December 31, 2019 that was not identified until the Company was preparing its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, the Company is amending Part II, Item 9A “Controls and Procedures” with respect to (a) the Company’s conclusions regarding the effectiveness of (i) the Company’s disclosure controls and procedures and (ii) its internal control over financial reporting, and (b) Marcum LLP’s related attestation report on the Company’s internal control over financial reporting. The material weakness in internal controls over financial reporting is also reported in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020.

 

In accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the Company is including with this Amendment currently dated certifications as Exhibits 31.1 and 32.1. We are also filing an updated Consent of Independent Registered Public Accounting Firm. Accordingly, Part IV, Item 15, “Exhibits and Financial Statement Schedules” is amended to include the currently dated certifications and consent as exhibits.

 

Except as described in this Explanatory Note, this Amendment does not reflect events occurring after the date of the filing of the Form 10-K, nor does it amend, modify or otherwise update any other information in the Form 10-K. Among other things, forward-looking statements made in the Form 10-K have not been revised to reflect events that occurred or facts that became known to us after filing of the Form 10-K, and any such forward-looking statements should be read in their historical context. Accordingly, this Amendment should be read in conjunction with the Form 10-K and with the Company’s filings with the SEC subsequent to the filing of the Form 10-K.

 

Notwithstanding the existence of the material weakness described in Part II. Item 9A – “Controls and Procedures,” the Company believes that the consolidated financial statements in the Form 10-K fairly present, in all material respects, the Company’s financial position, results of operations and cash flows as of the dates, and for the periods, presented, in conformity with U.S. generally accepted accounting principles.

  

 

  

PART II

 

Item 9A. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures (As Revised)

 

In connection with the filing of our original Form 10-K on March 16, 2020, our management, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of December 31, 2019, concluded that our disclosure controls and procedures were effective.

 

Subsequent to that evaluation, management re-evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2019 and concluded that, because of a material weakness identified in our internal control over financial reporting in regard to foreign taxes, discussed below, our disclosure controls and procedures were not effective as of December 31, 2019.

 

Management Report on Internal Control over Financial Reporting (As Revised)

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with U.S. generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that:

 

(i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;

  

(ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our consolidated financial statements in accordance with U.S. generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and

 

(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statements.

 

- 1 -

 

 

In connection with the preparation of the original Form 10-K, filed on March 16, 2020, our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2019. In conducting its assessment, our management used the criteria issued by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework in 2013. Based on this assessment, our management concluded that, as of December 31, 2019, our internal control over financial reporting was effective based on those criteria.

 

Subsequent to that evaluation, management re-evaluated the effectiveness of our internal control over financial reporting as of December 31, 2019 and concluded that, because of a material weakness identified in regard to foreign taxes, our internal control over financial reporting was not effective as of December 31, 2019.

 

This oversight was in connection with an ongoing tax issue between our German subsidiary and German tax authorities concerning an audit of the subsidiary’s tax returns for 2013 – 2015. The matter is described in the Company’s Form 10-Q for the quarter ended March 31, 2020, filed contemporaneously with this amendment.

 

The material weakness in internal control over financial reporting resulted because we did not formally document our evaluation of a potential contingency under ASC-740 regarding potential tax assessments in Germany on our subsidiary to support the evaluation of materiality and need for disclosure. The Company is in the process of improving its procedures, 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.

 

We did not revise our consolidated financial statements for prior periods for the disclosure of the contingency for the potential German tax assessments based on our belief that the effect of the lack of the disclosure was not material to the financial statements taken as a whole. Therefore, we believe that, notwithstanding the material weakness discussed above, the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2019 present fairly, in all material respects, our financial position, results of operations and cash flows for the periods presented.

 

Changes in Internal Control over Financial Reporting

 

Except as noted above, there were no changes in internal controls over financial reporting (as defined in Rule 13a−15(f) promulgated under the Exchange Act) that occurred during our fourth fiscal quarter that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

 

Inherent Limitations on Disclosure Controls and Procedures

 

The effectiveness of our disclosure controls and procedures is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the soundness of our systems and the possibility of human error. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions and the risk that the degree of compliance with policies or procedures may deteriorate over time. Because of these limitations, there can be no assurance that any system of disclosure controls and procedures, no matter how well conceived, will prevent all errors or ensure that all material information will be made known in a timely manner to the appropriate levels of management.

 

Inherent Limitations on Internal Control

 

Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations, including the possibility of human error and circumvention by collusion or overriding of control. Accordingly, even an effective internal control system may not prevent or detect material misstatements on a timely basis. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that the controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate. Accordingly, our internal control over financial reporting is designed to provide reasonable assurance of achieving its objectives.

  

- 2 -

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

ON INTERNAL CONTROL OVER FINANCIAL REPORTING

 

To the Shareholders and Board of Directors of

Northwest Biotherapeutics, Inc. and Subsidiaries

 

Adverse Opinion on Internal Control over Financial Reporting

 

We have audited Northwest Biotherapeutics, Inc.’s (the "Company") internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. In our opinion, because of the effect of the material weakness described in the following paragraph on the achievement of the objectives of the control criteria, the Company has not maintained effective internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated balance sheets as of December 31, 2019 and 2018 and the related consolidated statements of operations and comprehensive loss, changes in shareholders’ deficit, and cash flows and the related notes for each of the two years in the period ended December 31, 2019 of the Company and our report dated March 16, 2020, except for the restatement as to the effectiveness of internal control over financial reporting for the material weakness related to ineffective designed controls over the evaluation and conclusion of contingencies under ASC 740, as to which the date is June 23, 2020, expressed an unqualified opinion on those financial statements.

 

In our report dated March 16, 2020, we expressed an unqualified opinion on the effectiveness of the Company's internal control over financial reporting. As described below, the Company subsequently identified a material weakness in its internal control over financial reporting. Accordingly, management has revised its assessment about the effectiveness of the Company's internal control over financial reporting, and our present opinion on the effectiveness of the Company's internal control over financial reporting as of June 23, 2020, as presented herein, is different from that expressed in our previous report.

 

A material weakness is a control deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis. The following material weakness has been identified and included in Management's Annual Report on Internal Control Over Financial Reporting (As Revised):

 

Management does not have adequate controls over financial reporting resulting from ineffectively designed controls over the evaluation and conclusion of contingencies under ASC 740.

 

This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the fiscal December 31, 2019 consolidated financial statements, and this report does not affect our report dated March 16, 2020 on those financial statements.

 

- 3 -

 

 

Basis for Opinion

 

The Company's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management Annual Report on Internal Control Over Financial Reporting (As Revised). Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

 

Definition and Limitations of Internal Control over Financial Reporting

 

A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

 

Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree of compliance with the policies or procedures may deteriorate.

 

 

/s/ Marcum llp

 

Marcum llp

New York, NY

March 16, 2020, except for the restatement as to the effectiveness of internal control over financial reporting for the material weakness related to ineffective designed controls over the evaluation and conclusion of contingencies under ASC 740, as to which the date is June 23, 2020.

 

- 4 -

 

 

PART IV

 

Item 15. Exhibits and Financial Statement Schedules

 

(a)(3) List of Exhibits

 

 

INDEX TO EXHIBITS

 

Exhibit No.

  Description
     
23.1   Consent of Marcum, LLP, Independent Registered Public Accounting Firm
     
31.1   Certification of the Chief Executive Officer and Principal Financial and Accounting Officer pursuant to §240.13a-14 or §240.15d-14 of the Securities Exchange Act of 1934, as amended
     
32.1   Certification pursuant to 18 U.S.C. Section 1350 (as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002)

 

 

  Filed herewith.

 

- 5 -

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K/A to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

NORTHWEST BIOTHERAPEUTICS, INC.

(Registrant)

   
Date: June 23, 2020 By: /s/ Linda F. Powers
    Linda F. Powers,
   

Chief Executive Officer (Principal Executive Officer)

Principal Financial and Accounting Officer

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report on Form 10-K/A has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

 

Signature   Title   Date
         
/s/ Linda F. Powers   Chief Executive Officer   June 23, 2020
Linda F. Powers  

Principal Executive Officer

Principal Financial and Accounting Officer

   
         
/s/ Alton L. Boynton   Director   June 23, 2020
Alton L. Boynton        
         
/s/ Navid Malik   Director   June 23, 2020
Dr. Navid Malik        
         
/s/ Jerry Jasinowski   Director   June 23, 2020
Jerry Jasinowski        
         
/s/ J. Cofer Black   Director   June 23, 2020
J. Cofer Black        

 

 

 

 

Exhibit 23.1

 

Independent Registered Public Accounting Firm’s Consent

 

We consent to the incorporation by reference in the Registration Statement of Northwest Biotherapeutics, Inc. on Form S-3 [File No. 333-213777 and 333-234248] of our report relating to the effectiveness of the Company’s internal control over financial reporting dated March 16, 2020 (June 23, 2020 as to the effects of the material weakness described in Management’s Report on Internal Control over Financial Reporting (As Revised)), appearing in this Annual Report on Form 10-K/A of Northwest Biotherapeutics, Inc. for the year ended December 31, 2019.

 

/s/ Marcum llp

 

Marcum llp

New York, NY

June 23, 2020

 

 

 

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO

§240.13a−14 or §240.15d−14 of the Securities Exchange Act of 1934, as amended

 

 

I, Linda F. Powers, certify that:

 

(1)         I have reviewed this Amendment No. 1 to Annual Report on Form 10−K of Northwest Biotherapeutics, Inc.;

 

(2)         Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

(3)         Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

(4)         I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15 (f)), for the registrant and have:

 

(a)       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

 

(b)       Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)       Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

(5)         I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):

 

(a)       All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)       Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

 

 

Date: June 23, 2020

 

By: /s/ Linda F. Powers  
  Name: Linda F. Powers  
       
  Title: President and Chief Executive Officer
    Principal Executive Officer  
    Principal Financial and Accounting Officer

 

 

 

  

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with this Amendment No. 1 to Annual Report of Northwest Biotherapeutics, Inc. (the “Company”) on Form 10-K for the year ending December 31, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Linda F. Powers, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)  The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

 

Date: June 23, 2020

 
By: /s/ Linda F. Powers  
  Name: Linda F. Powers  
       
  Title: President and Chief Executive Officer
    Principal Executive Officer  
    Principal Financial and Accounting Officer
 

 

This certification accompanies the Amendment No. 1 to Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Northwest Biotherapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Amendment No. 1 to Annual Report on Form 10-K), irrespective of any general incorporation language contained in such filing.