UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact name of registrant as specified in its charter)
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
(
(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.
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).
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.
| ☒ | Accelerated filer |
| ☐ | |
Non-accelerated filer |
| ☐ | Smaller reporting company |
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| Emerging growth company |
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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 |
As of May 8, 2023, the total number of shares of common stock, par value $0.001 per share, outstanding was
NORTHWEST BIOTHERAPEUTICS, INC.
FORM 10-Q
TABLE OF CONTENTS
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Item 1. | Condensed Consolidated Interim Financial Statements (Unaudited) | |
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Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 | 3 | |
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Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022 | 6 | |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 | |
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2
PART I - FINANCIAL INFORMATION
NORTHWEST BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
| March 31, |
| December 31, | |||
2023 | 2022 | |||||
(Unaudited) | ||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses and other current assets |
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Total current assets |
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Non-current assets: |
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Property, plant and equipment, net |
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Construction in progress | | | ||||
Right-of-use asset, net | | | ||||
Indefinite-lived intangible asset | | | ||||
Goodwill | | | ||||
Other assets |
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Total non-current assets |
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TOTAL ASSETS | $ | | $ | | ||
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LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable and accrued expenses | $ | | $ | | ||
Accounts payable and accrued expenses to related parties and affiliates |
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Convertible notes, net |
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Notes payable, net |
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Contingent payable derivative liability | | | ||||
Warrant liability |
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Investor advances | | | ||||
Share liability | | | ||||
Lease liabilities | | | ||||
Total current liabilities |
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Non-current liabilities: |
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Notes payable, net of current portion, net |
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Lease liabilities, net of current portion | | | ||||
Total non-current liabilities |
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Total liabilities |
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COMMITMENTS AND CONTINGENCIES (Note 12) |
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Mezzanine equity: |
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Series C Convertible Preferred Stock, | | |||||
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Stockholders’ deficit: |
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Preferred stock ($ | ||||||
Common stock ($ |
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Additional paid-in capital |
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Stock subscription receivable |
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Accumulated deficit |
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Accumulated other comprehensive income |
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Total stockholders’ deficit |
| ( |
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TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT | $ | | $ | | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
NORTHWEST BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(Unaudited)
For the three months ended | ||||||
March 31, | ||||||
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| 2023 |
| 2022 | ||
Revenues: | ||||||
Research and other | $ | | $ | | ||
Total revenues | | | ||||
Operating costs and expenses: |
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Research and development | | | ||||
General and administrative | | | ||||
Total operating costs and expenses | | | ||||
Loss from operations | ( | ( | ||||
Other income (expense): |
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Change in fair value of derivative liabilities | | | ||||
Change in fair value of share liabilities | ( | — | ||||
(Loss) gain from extinguishment of debt | ( | | ||||
Interest expense | ( | ( | ||||
Foreign currency transaction gain (loss) | | ( | ||||
Total other income (loss) | | ( | ||||
Net loss | ( | ( | ||||
Deemed dividend related to warrant modifications | ( | — | ||||
Net loss attributable to common stockholders | $ | ( | $ | ( | ||
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Other comprehensive income (loss) |
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Foreign currency translation adjustment | ( | | ||||
Total comprehensive loss | $ | ( | $ | ( | ||
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Net loss per share applicable to common stockholders |
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Basic | $ | ( | $ | ( | ||
Diluted | $ | ( | $ | ( | ||
Weighted average shares used in computing basic loss per share | | | ||||
Weighted average shares used in computing diluted loss per share | | | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
NORTHWEST BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(in thousands)
(Unaudited)
For the Three Months Ended March 31, 2023 | ||||||||||||||||||||||||||
Mezzanine equity | Accumulated | |||||||||||||||||||||||||
Series C Covertible | Additional | Other | Total | |||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Subscription | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
| Shares |
| Amount |
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| Shares |
| Par value |
| Capital |
| Receivable |
| Deficit |
| Income |
| Deficit | ||||||||
Balances at January 1, 2023 |
| | $ | | | $ | |
| $ | |
| $ | ( | $ | ( |
| $ | | $ | ( | ||||||
Issuance of Series C convertible preferred stock for cash | | | — | — | — | — | — | — | — | |||||||||||||||||
Issuance of Series C convertible preferred stock in lieu of debt redemption |
| | | — | — | — | — | — | — | — | ||||||||||||||||
Series C convertible preferred stock conversion |
| ( | ( | | | | — | — | — | | ||||||||||||||||
Warrants exercised for cash | — | — | | | | — | — | — | | |||||||||||||||||
Cashless stock options exercise | — | — | | | ( | — | — | — | — | |||||||||||||||||
Reclassification of warrant liabilities to stockholders’ deficit | — | — | — | — | | — | — | — | | |||||||||||||||||
Issuance of common stock for conversion of debt and accrued interest | — | — | | | | — | — | — | | |||||||||||||||||
Stock-based compensation | | | — | — | | — | — | — | | |||||||||||||||||
Reclass earned but unissued milestone shares from equity to liability | — | — | — | — | ( | — | — | — | ( | |||||||||||||||||
Net loss |
| — | — | — | — |
| — |
| — | ( |
| — | ( | |||||||||||||
Warrants modfication |
| — | — | — | — | | — | — | — | | ||||||||||||||||
Deemed dividend related to warrants modification |
| — | — | — | — | ( | — | — | — | ( | ||||||||||||||||
Cumulative translation adjustment |
| — | — | — | — |
| — |
| — | — |
| ( | ( | |||||||||||||
Balances at March 31, 2023 |
| | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | $ | ( | |||||||||
For the three months ended March 31, 2022 | ||||||||||||||||||||
Accumulated | ||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||
Common Stock | Paid-in | Subscription | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||
| Shares |
| Par value |
| Capital |
| Receivable |
| Deficit |
| Income |
| Deficit | |||||||
Balances at January 1, 2022 | | $ | | $ | | $ | ( | $ | ( | $ | | $ | ( | |||||||
Issuance of common stock for cash |
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| — |
| — |
| — |
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Warrants exercised for cash | | | | — | — | — | | |||||||||||||
Reclassification of warrant liabilities related to warrants exercised for cash | — | — | | — | — | — | | |||||||||||||
Cashless warrants exercise | | — | — | — | — | — | — | |||||||||||||
Reclassification of warrant liabilities related to cashless warrants exercise | — | — | | — | — | — | | |||||||||||||
Issuance of common stock conversion of debt and accrued interest | | | | — | — | — | | |||||||||||||
Stock-based compensation |
| | — | |
| — |
| — |
| — |
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Net loss | — | — | — | — | ( | — | ( | |||||||||||||
Cumulative translation adjustment |
| — | — | — |
| — |
| — |
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Balances at March 31, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | | $ | ( | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
NORTHWEST BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
For the three months ended | ||||||
March 31, | ||||||
| 2023 |
| 2022 | |||
Cash Flows from Operating Activities: |
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Net loss | $ | ( | $ | ( | ||
Reconciliation of net loss to net cash used in operating activities: | ||||||
Depreciation and amortization | | | ||||
Amortization of debt discount | | | ||||
Change in fair value of derivatives | ( | ( | ||||
Change in fair value of share liability | | — | ||||
Loss (gain) from extinguishment of debt | | ( | ||||
Amortization of operating lease right-of-use asset | | | ||||
Stock-based compensation for services | | | ||||
Subtotal of non-cash charges | ( | | ||||
Changes in operating assets and liabilities: | ||||||
Prepaid expenses and other current assets | ( | ( | ||||
Other non-current assets | ( | | ||||
Accounts payable and accrued expenses | | | ||||
Related party accounts payable and accrued expenses | ( | ( | ||||
Lease liabilities | | | ||||
Net cash used in operating activities | ( | ( | ||||
Cash Flows from Investing Activities: | ||||||
Purchase of equipment and construction in progress | ( | ( | ||||
Net cash used in investing activities | ( | ( | ||||
Cash Flows from Financing Activities: | ||||||
Proceeds from issuance of Series C convertible preferred stock | | — | ||||
Proceeds from issuance of common stock | — | | ||||
Proceeds from exercise of warrants | | | ||||
Proceeds from investor advance | | — | ||||
Proceeds from issuance of notes payable, net | | | ||||
Repayment of notes payable | ( | ( | ||||
Net cash provided by financing activities | | | ||||
Effect of exchange rate changes on cash and cash equivalents | ( | | ||||
Net decrease in cash and cash equivalents | ( | ( | ||||
Cash and cash equivalents, beginning of the period | | | ||||
Cash and cash equivalents, end of the period | $ | | $ | | ||
Supplemental disclosure of cash flow information | ||||||
Interest payments on notes payable | $ | ( | $ | ( | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
NORTHWEST BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
For the three months ended | ||||||
March 31, | ||||||
| 2023 |
| 2022 | |||
Supplemental schedule of non-cash investing and financing activities: |
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Cashless warrants and stock options exercise | $ | | $ | — | ||
Reclassification of warrant liabilities related to warrants exercised for cash | $ | — | $ | | ||
Reclassification of warrant liabilities to stockholders’ deficit | $ | | $ | — | ||
Reclassification of warrant liabilities related to cashless warrants exercise | $ | — | $ | | ||
Reclass earned but unissued milestone shares from equity to liability | $ | | $ | — | ||
Issuance of common stock for conversion of debt and accrued interest | $ | | $ | | ||
Issuance of Series C convertible preferred stock in lieu of debt redemption | $ | | $ | — | ||
Series C convertible preferred stock conversion | $ | | $ | — | ||
Capital expenditures included in accounts payable | $ | | $ | | ||
Capital expenditures included in accounts payable and accrued expenses to related parties and affiliates | $ | — | $ | | ||
Reclassification between shares payable and equity | $ | — | $ | | ||
Deemed dividend related to warrant modification | $ | | $ | — | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
1. Organization and Description of Business
Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks, Aracaris Ltd, Aracaris Capital, Ltd, Northwest Biotherapeutics B.V., and NW Bio GmbH (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company has wholly owned subsidiaries in Boston, the U.K., the Netherlands and Germany. On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®.
The Company relies upon contract manufacturers for production of its DCVax products, research and development services, distribution and logistics, and related services, in compliance with the Company’s specifications and the applicable regulatory requirements.
The Company has completed a Phase 3 clinical trial of its DCVax®-L product for glioblastoma brain cancer, has publicly reported the results in a peer reviewed publication in a medical journal as well as at a medical conference, and is working on prerequisites and preparations for filing an application for regulatory approval of the product.
2. Financial Condition, Going Concern and Management Plans
The Company has incurred annual net operating losses since its inception. The Company had a net loss of $
The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all.
Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date of this filing. The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, however, they do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
3. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated. Certain immaterial reclassifications have been made to prior period amounts to conform to the current period presentation.
8
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company uses to prepare its annual audited consolidated financial statements. The condensed consolidated balance sheet as of March 31, 2023, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2023 and 2022, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2023 and 2022, and the condensed consolidated statements of cash flows for the three months ended March 31, 2023 and 2022 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three months ended March 31, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 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, 2022 and notes thereto included in the Company’s annual report on Form 10-K (the “2022 Annual Report”), which was filed with the SEC on February 28, 2023.
Use of Estimates
In preparing condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.
On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets, and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic (“COVID-19”) and the COVID-19 control responses.
Significant Accounting Policies
There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2022 Annual Report other than those discussed below.
Sequencing
The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares. Certain contracts were classified as liabilities as the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy.
On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from
9
Modification of Equity Classified Warrants
A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt offering, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.
Recently Issued Accounting Standards Not Yet Adopted
Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions
In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820.
For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.
The Company is still evaluating the impact of this pronouncement on the consolidated financial statements.
4. Fair Value Measurements
In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the fair value of liabilities related to certain outstanding warrants, certain embedded conversion features associated with convertible debt and the contingent payable to Cognate BioServices on a recurring basis to determine the fair value of these liabilities. ASC 820 establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below:
Level 1 - Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date.
Level 2 - Quoted prices in markets that are not active or inputs which are either directly or indirectly observable.
Level 3 - Unobservable inputs for the instrument requiring the development of assumptions by the Company.
10
The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of March 31, 2023 and December 31, 2022 (in thousands):
Fair value measured at March 31, 2023 | ||||||||||||
|
| Quoted prices in active |
| Significant other |
| Significant | ||||||
| Fair value at | markets | observable inputs | unobservable inputs | ||||||||
March 31, 2023 |
| (Level 1) |
| (Level 2) |
| (Level 3) | ||||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Contingent payable derivative liability | | — | — | | ||||||||
Share liability |
| |
| — |
| — |
| | ||||
Total fair value | $ | | $ | — | $ | — | $ | | ||||
Fair value measured at December 31, 2022 | ||||||||||||
|
| Quoted prices in active |
| Significant other |
| Significant | ||||||
Fair value at | markets | observable inputs | unobservable inputs | |||||||||
| December 31, 2022 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Embedded redemption option |
| |
| — |
| — |
| | ||||
Contingent payable derivative liability | | — | — | | ||||||||
Share liability |
| |
| — |
| — |
| | ||||
Total fair value | $ | | $ | — | $ | — | $ | | ||||
There were
The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands).
Warrant | Embedded | Contingent Payable | Share | ||||||||||||
| Liability |
| Redemption Option |
| Derivative Liability |
| Liability |
| Total | ||||||
Balance - January 1, 2023 | $ | | $ | | $ | | $ | | $ | | |||||
Additional share liability | — | — | — | | | ||||||||||
Redemption of share liability | — | — | — | ( | ( | ||||||||||
Reclassification of warrant liabilities | ( | — | — | — | ( | ||||||||||
Change in fair value | ( | ( | ( | | ( | ||||||||||
Balance - March 31, 2023 | $ | | (1) | $ | — | $ | | $ | | $ | | ||||
| (1) | The remaining balance of $ |
On January 9, 2023, the Company reclassified the fair value of the warrant liability of $
11
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 January 9, 2023 (the reclassification date), March 31, 2023 and December 31, 2022 is as follows:
As of January 9, 2023 | As of March 31, 2023 | |||||||||
Warrant | Share | Contingent Payable | ||||||||
| Liability |
| Liability |
| Derivative Liability | |||||
Strike price | $ | | $ | | * | $ | | * | ||
Contractual term (years) |
|
|
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Volatility (annual) |
| | % | | % | | % | |||
Risk-free rate |
| | % | | % | | % | |||
Dividend yield (per share) |
| | % | | % | | % | |||
As of December 31, 2022 |
| |||||||||
| Warrant |
| Share |
| Contingent Payable |
| ||||
| Liability |
| Liability | Derivative Liability |
| |||||
Strike price | $ | | $ | | * | $ | | * | ||
Contractual term (years) |
|
| ||||||||
Volatility (annual) |
| | % | | % |
| | % | ||
Risk-free rate |
| | % | | % |
| | % | ||
Dividend yield (per share) |
| | % | | % |
| | % | ||
| * | The strike price assumes the current stock price as of March 31, 2023 and December 31, 2022. |
The key unobservable inputs for Piggy-back rights that was included in the warrant liability as of March 31, 2023 and December 31, 2022 was the assumption of the estimated remaining life which was based on the estimate of next qualified financing.
5. Stock-based Compensation
The following table summarizes total stock-based compensation expense for the three months ended March 31, 2023 and 2022 (in thousands).
For the three months ended | ||||||
March 31, | ||||||
| 2023 |
| 2022 | |||
Research and development | $ | | $ | | ||
Research and development - related party | — | — | ||||
Milestones achieved (1) | | — | ||||
Future milestones (2) | | — | ||||
General and administrative |
| |
| | ||
Total stock-based compensation expense | $ | | $ | | ||
The related party amounts were for milestone incentives that either were earned or are deemed probable to be achieved in the future and become issuable at that time (as detailed below in Restricted Stock Awards).
| (1) | During the quarter ended March 31, 2023, the Company recognized the remaining $ |
| (2) | This is related to a one-time milestone (drafting key portions of the application for product approval) that is anticipated to be achieved and earned in the future. The Company recognized and expensed (but did not issue shares for) the pro-rata portion of the remaining potential milestone stock awards during the quarter ended March 31, 2023, of $ |
12
The total unrecognized compensation cost was approximately $
Stock Options
The following table summarizes stock option activity for the Company’s option plans during the three months ended March 31, 2023 (amount in thousands, except per share number):
Weighted Average | ||||||||||
Weighted | Remaining | |||||||||
Number of | Average | Contractual Life | Total Intrinsic | |||||||
| Shares |
| Exercise Price |
| (in years) |
| Value | |||
Outstanding as of January 1, 2023 |
| | $ | | $ | | ||||
Cashless exercised | ( | | — | — | ||||||
Outstanding as of March 31, 2023 |
| | $ | | $ | | ||||
Options vested (1) |
| | $ | | $ | | ||||
| (1) | An aggregate |
Restricted Stock Awards
During April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, for
As of December 31, 2022,
During the
For the remaining one-time milestone that is anticipated to be achieved and earned in the future, the Company recognized and expensed (but did not issue) the pro-rata portion of the remaining potential milestone stock awards during the three months ended March 31, 2023, of $
13
Other Service Agreement
On March 16, 2023, the Company issued
6. Property, Plant and Equipment
Property, plant and equipment consist of the following at March 31, 2023 and December 31, 2022 (in thousands):
| March 31, |
| December 31, |
| Estimated | |||
2023 | 2022 | Useful Life | ||||||
Leasehold improvements | $ | | $ | |
| |||
Office furniture and equipment |
| |
| |
| |||
Computer and manufacturing equipment and software |
| |
| |
| |||
Land in the United Kingdom |
| |
| |
| NA | ||
| |
| |
| NA | |||
Less: accumulated depreciation |
| ( |
| ( |
|
| ||
Total property, plant and equipment, net | $ | | $ | |
|
| ||
Construction in progress | $ | | $ | |
|
| ||
Depreciation expense was approximately $
14
7. Notes Payable
The following two tables summarize outstanding debt as of March 31, 2023 and December 31, 2022, respectively (amount in thousands):
|
| Stated |
|
|
|
| |||||||||||
Interest | Conversion | Remaining | Carrying | ||||||||||||||
Maturity Date | Rate | Price | Face Value | Debt Discount | Value | ||||||||||||
Short term convertible notes payable |
|
|
|
|
|
|
|
|
|
|
|
| |||||
6% unsecured |
|
| | % | $ | | $ | | $ | — | $ | | |||||
| — | | |||||||||||||||
Short term notes payable |
|
|
|
|
|
|
|
|
|
|
| ||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| | |||||
9% unsecured |
|
| | % |
| N/A |
| |
| — |
| | |||||
12% unsecured |
|
| | % |
| N/A |
| |
| — |
| | |||||
| |
| ( |
|
| | |||||||||||
Long term notes payable | |||||||||||||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| | |||||
6% secured |
| | % | N/A | |
| — |
|
| | |||||||
| ( | | |||||||||||||||
|
|
| |||||||||||||||
Ending balance as of March 31, 2023 | $ | | $ | ( | $ | | |||||||||||
Stated | Embedded |
| ||||||||||||||||||
Interest | Conversion | Remaining | Redemption | Carrying | ||||||||||||||||
| Maturity Date |
| Rate |
| Price |
| Face Value |
| Debt Discount |
| Option |
| Value | |||||||
Short term convertible notes payable | ||||||||||||||||||||
6% unsecured |
|
| | % | $ | | $ | | $ | — | $ | — | $ | | ||||||
| |
| — |
| — | | ||||||||||||||
Short term notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
8% unsecured | | % | N/A | | ( | | | |||||||||||||
9% unsecured | | % | N/A | | — | — | | |||||||||||||
12% unsecured | | % | N/A | | — | — | | |||||||||||||
| |
| ( |
| | | ||||||||||||||
Long term notes payable | ||||||||||||||||||||
8% unsecured | | % | N/A | | ( | — | | |||||||||||||
6% secured | | % | N/A | | — | — | | |||||||||||||
| ( | — | | |||||||||||||||||
Ending balance as of December 31, 2022 | $ | | $ | ( | $ | | $ | | ||||||||||||
On March 2, 2023, the Company entered into a Commercial Loan Agreement (the “Commercial Loan”) with a commercial lender for an aggregate principal amount of $
During the three months ended March 31, 2023, the Company issued approximately
During the three months ended March 31, 2023, the Company recognized $
15
During the three months ended March 31, 2023, the Company issued approximately
For the three months ended March 31, 2023 and 2022, interest expense related to notes payable totaled approximately $
8. Net Loss per Share Applicable to Common Stockholders
Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share would be computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Because of the net loss from operations for each period, inclusion of such securities in the computation of loss per share would be anti-dilutive and thus they are excluded. Potentially dilutive weighted average common shares include common stock potentially issuable under the Company’s convertible notes and preferred stock, warrants and vested and unvested stock options.
The following securities were not included in the diluted net loss per share calculation because their effect was anti-dilutive as of the periods presented (in thousands):
For the three months ended | ||||
March 31, | ||||
| 2023 |
| 2022 | |
Series C convertible preferred stock | | — | ||
Common stock options | | | ||
Common stock warrants | | | ||
Convertible notes and accrued interest | |
| | |
Potentially dilutive securities | | | ||
9. Related Party Transactions
The Company had
| ● | Qualifying for and obtaining |
| ● | 6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. |
| ● | Drafting of key portions of the application for product approval itself. |
Each of the
The Ancillary Services Agreement establishes a structure under which the Company and Advent negotiate and agree upon the scope and terms for Statements of Work (“SOWs”) for facility development activities and compassionate use program activities. After an SOW is agreed and approved by the Company, Advent will proceed with, or continue, the applicable services and will invoice the Company pursuant to the SOW. Since both the facility development and the compassionate use program involve pioneering and
16
uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus
SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the 3 licenses required for the Sawston facility, (b) successful completion of each of the 6 workstreams and (c) completion of drafting key portions of an application for product approval. The milestone incentives are a combination of cash and stock, and are not paid until the milestone is achieved and earned.
During the three months ended March 31, 2023, the Company paid an aggregate of $
The following table summarizes total research and development costs from Advent for the three months ended March 31, 2023 and 2022, respectively (in thousands).
For the three months ended | ||||||
March 31, | ||||||
2023 | 2022 | |||||
Advent BioServices |
|
|
|
| ||
Manufacturing cost in London | $ | | $ | | ||
Manufacturing cost at Sawston facility |
| |
| | ||
SOW 6 one-time milestones - Shares |
|
| ||||
Expensed but unpaid (milestone complete) (1) |
| |
| — | ||
Expensed but unpaid, not yet due (milestone not yet complete) (2) |
| |
| — | ||
SOW 6 one-time milestones - Cash |
|
|
|
| ||
Expensed and due, but unpaid (milestone complete) (3) |
| |
| — | ||
Expensed but unpaid, not yet due (milestone not yet complete) (2) |
| |
| — | ||
Total | $ | | $ | | ||
| (1) | This covers the one-time milestone for obtaining a commercial manufacturing license for the Sawston facility. The milestone was achieved and the shares will become issuable following final Board approval. The shares were not issued as of March 31, 2023. |
| (2) | This covers the one-time milestone for drafting key portions of the application for product approval. |
| (3) | This covers two one-time milestones: Mechanism of Action and obtaining a commercial manufacturing license from the MHRA. |
Advent BioServices Sublease Agreement
On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately
17
During the three months ended March 31, 2023, the Company recognized sub-lease income of $
Related Party Accounts Payable
As of March 31, 2023, there was approximately $
As of March 31, 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section.
| March 31, |
| December 31, | |||
2023 | 2022 | |||||
Advent BioServices - amount invoiced but unpaid | $ | | $ | | ||
Advent BioServices - amount accrued but unpaid (1) | | | ||||
Total payable and accrued, but unpaid to Advent BioServices | $ | | $ | | ||
| (1) | This includes $ |
10. Preferred Stock
Series C Convertible Preferred Stock
During the three months ended March 31, 2023, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of
During the three months ended March 31, 2023, the Company issued approximately
During the three months ended March 31, 2023, approximately
The Company determined that the Series C Shares contain contingent redemption provisions allowing redemption by the holder upon certain defined events (“deemed liquidation events”). As the event that may trigger the redemption of the Series C Shares is not solely within the Company’s control, the Series C Shares are classified as mezzanine equity (temporary equity) in the Company’s condensed consolidated balance sheets.
11. Stockholders’ Deficit
Common Stock
On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from
During the three months ended March 31, 2023, the Company received $
18
During the three months ended March 31, 2023, certain options holders elected to exercise some of their options pursuant to cashless exercise formulas. The Company issued approximately
During the three months ended March 31, 2023, the Company issued approximately
Stock Purchase Warrants
The following is a summary of warrant activity for the three months ended March 31, 2023 (dollars in thousands, except per share data):
| Number of |
| Weighted Average |
| Remaining | ||
Warrants | Exercise Price | Contractual Term | |||||
Outstanding as of January 1, 2023 |
| | $ | |
| ||
Warrants exercised for cash |
| ( |
| |
| — | |
Warrants expired and cancellations |
| ( |
| |
| — | |
Outstanding as of March 31, 2023 |
| | $ | |
| ||
The options and warrants held by Ms. Powers and Mr. Goldman are subject to an ongoing suspension on a rolling basis pursuant to the Blocker Letter Agreement.
At March 31, 2023, of the approximately
Warrant Modifications
Between January 10 and March 31, 2023, the Company amended multiple warrants whereby the maturity dates of certain warrants were extended for an additional approximately 3 months. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.
| Post-modification |
| Pre-modification |
| |||
Exercise price | $ | | $ | | |||
Expected term (in years) |
|
| |||||
Volatility |
| | % |
| | % | |
Risk-free interest rate |
| | % |
| | % | |
Dividend yield |
| | % |
| | % | |
The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $
12. Commitments and Contingencies
Operating Lease- Lessee Arrangements
The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected the
19
At March 31, 2023, the Company had operating lease liabilities of approximately $
The following summarizes quantitative information about the Company’s operating leases (amount in thousands):
For the three months ended | |||||||||
March 31, 2023 | |||||||||
| U.K |
| U.S |
| Total | ||||
Lease cost |
|
|
|
|
|
| |||
Operating lease cost | $ | | $ | | $ | | |||
Short-term lease cost |
| |
| — |
| | |||
Variable lease cost |
| — |
| |
| | |||
Sub-lease income |
| ( |
| — |
| ( | |||
Total | $ | | $ | | $ | | |||
|
|
| |||||||
Other information |
|
|
|
|
|
| |||
Operating cash flows from operating leases | $ | ( | $ | ( | $ | ( | |||
Weighted-average remaining lease term – operating leases |
|
|
|
| |||||
Weighted-average discount rate – operating leases |
| | % |
| | % |
|
| |
For the three months ended | |||||||||
March 31, 2022 | |||||||||
| U.K |
| U.S |
| Total | ||||
Lease cost |
|
|
|
|
|
| |||
Operating lease cost | $ | | $ | | $ | | |||
Short-term lease cost |
| |
| — |
| | |||
Variable lease cost |
| — |
| |
| | |||
Total | ( | — | ( | ||||||
$ | | $ | | $ | | ||||
Other information |
|
|
|
|
|
| |||
Operating cash flows from operating leases | $ | ( | $ | ( | $ | ( | |||
Weighted-average remaining lease term – operating leases |
|
|
|
| |||||
Weighted-average discount rate – operating leases |
| | % |
| | % |
|
| |
The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2023 and 2022, respectively.
Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows:
Nine months ended December 31, 2023 | $ | | |
Year ended December 31, 2024 |
| | |
Year ended December 31, 2025 | | ||
Year ended December 31, 2026 | | ||
Year ended December 31, 2027 | | ||
Thereafter | | ||
Total | | ||
Less present value discount | ( | ||
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023 | $ | |
20
Maturities of our operating leases under the sublease agreement, are as follows:
Nine months ended December 31, 2023 |
| $ | |
Year ended December 31, 2024 |
| | |
Year ended December 31, 2025 |
| | |
Year ended December 31, 2026 |
| | |
Thereafter |
| | |
Total | $ | |
Advent BioServices Services Agreement
The Company had three operational programs with Advent: (a) an ongoing manufacturing program at the existing GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston facility, and (c) a one-time program for specialized work, organized into 10 sets of one-time milestones, for the following:
| ● | Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing. |
| ● | 6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish. |
| ● | Drafting of key portions of the application for product approval itself. |
On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The MSA provides for manufacturing of DCVax-L products at an existing facility in London. The MSA is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity reserved exclusively for DCVax production and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. The MSA remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate the MSA on
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 Agreement also provides for Statements of Work (SOWs) with operational milestones and related payments. The Ancillary Services Agreement had an original term of
21
The Company entered into SOW 6 with Advent, which was incorporated into the Ancillary Services Agreement on April 1, 2022 and amended it on September 26, 2022. The amended SOW 6 provides for
German Tax Matter
The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015 and assessed additional tax against the subsidiary. NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €
13. Subsequent Events
In April 2023, approximately
On April 19, 2023, the Company the Company issued approximately
On May 8, 2023, the Company received a $
22
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, 2022 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not place undue reliance on these forward-looking statements.
Overview
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.
Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for glioblastoma brain cancer (GBM). As previously reported, the data collection and confirmation process was conducted by the independent contract research organization (CRO) who managed the trial and by other independent service firms, and the data were analyzed by independent statisticians.
On May 10, 2022, top line data from the Phase III trial of DCVax-L were presented in a scientific conference at the New York Academy of Sciences by one of the investigators in the trial. The presentation was made available publicly on a third-party site. On November 17, 2022, the Phase III trial results were reported in a peer reviewed publication in JAMA Oncology, a top scientific and medical journal.
The Company is now working on preparations for an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on pre-requisites for the application, and on portions of the application package itself. One of the pre-requisites - obtaining regulatory approval of a Pediatric Investigation Plan (PIP) - was completed during 2022 on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial.
Additionally, substantial progress was made with the CRO and specialized consultants on preparing the Trial Master File to be inspection-ready for regulators.
Post-COVID difficulties continue to impact the Company’s programs and operations, due to backlogs in the supply chain, at clinical trial sites, and at regulators. The supply chain backlogs include service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The clinical trial site backlogs involve delays for various clinical trial follow-up matters, such as queries and additional documentation. With regulators, committee processes and regulatory processes were focused on COVID matters during the pandemic, and a substantial backlog of non-COVID matters accumulated. The Company is hopeful that the various backlog circumstances will improve in 2023.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.
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.
23
On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses and stock-based compensation. We based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the 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, 2022. Our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022 other than those included below.
Sequencing
The Company adopted a sequencing policy under ASC 815-40-35 to determine if reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate if it has sufficient authorized shares. Certain contracts were classified as liabilities as a the result of the instruments containing a potentially indeterminable number of shares and, most recently, due to the Company entering into agreements providing for the potential issuance of more shares than authorized.. While temporary agreements are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest grant date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy.
On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 1.2 billion to 1.7 billion, par value $0.001 per share. As a result of this increase in authorized shares, the liability-classified warrants were reclassified to equity. Approximate 141 million warrants to purchase shares of the Company’s common stock were classified as liabilities through January 8, 2023.
Modification of Equity Classified Warrants
A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.
Results of Operations
Operating costs:
Our operating costs and expenses consist primarily of research and development (R&D) expenses. R&D expenses include clinical trial expenses, and additional costs related to completion of a trial, including substantial one-time expenses such as final site visits, query resolutions, additional data collection and documentation, and related matters. There are also increased costs after completion of a Phase III trial, such as statistical analyses, document collection and quality control checking of the documents, and preparations for an application for product approval.
In addition to clinical trial and post-trial costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, manufacturing process development, quality control process development, and related matters. Additional substantial costs relate to the development and expansion of manufacturing capacity.
24
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.
Our operating costs also include legal and accounting costs in operating the Company.
The foregoing operating costs include the costs for Flaskworks’ ongoing operations and intellectual property filings, and the operations of our subsidiaries in the U.K., the Netherlands and Germany.
Research and development:
R&D expenses include costs for substantial external scientific personnel, technical and regulatory advisers, and others, costs of laboratory supplies used in our internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial operation and management when we are actively engaged in clinical trials.
Because we are a pre-revenue company, we do not allocate R&D costs on a project basis. We adopted this policy, in part, due to the unreasonable cost burden associated with accounting at such a level of detail and our limited number of financial and personnel resources.
General and administrative:
General and administrative expenses include personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal services, property and equipment and amortization of stock options and warrants.
Three Months Ended March 31, 2023 and 2022
We recognized a net loss of $10.7 million and $14.2 million for the three months ended March 31, 2023 and 2022, respectively.
Research and Development Expense
For the three months ended March 31, 2023 and 2022, research and development expense was $6.9 million and $4.8 million, respectively. The increase in R&D expense in 2023 was related in part to one-time milestone activities under the SOW 6 with Advent BioServices, and in part to increased activities by expert consultants. During the three months ended March 31, 2023, we accrued for 3.0 million shares that will become issuable for completion of a milestone (obtaining a commercial manufacturing license from the MHRA). The fair value of the 3.0 million shares was approximately $2.1 million, of which $0.5 million was recognized during the three months ended March 31, 2023 and $1.6 million had already been recognized in 2022. During the three months ended March 31, 2023, the Company also expensed (but did not pay) an aggregate of $0.5 million related to completed milestones; the Company also expensed (but did not pay) an aggregate of $0.2 million related to future milestone payments and $0.1 million related to fair value of future shares milestone payments that the Company anticipates will be achieved and earned.
General and Administrative Expense
For the three months ended March 31, 2023 and 2022, general and administrative expenses was $7.0 million and $7.9 million, respectively. The decrease in 2023 was mainly related to a decrease of $0.6 million in legal and professional expense and a decrease of $0.1 million in stock-based compensation.
Change in Fair Value of Derivatives
We recognized a non-cash gain of $3.9 million and $0.5 million for the three months ended March 31, 2023 and 2022, respectively. The non-cash gain was primarily due to the decrease of our stock price, Our closing stock prices as of March 31, 2023 and December 31, 2022 were as follows:
March 31, 2023 |
| December 31, 2022 | ||
$ | 0.63 | $ | 0.78 | |
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Debt Extinguishment
During the three months ended March 31, 2023, we issued approximately 8.3 million shares of common stock with a fair value of $5.6 million to certain lenders in lieu of cash payments of $4.1 million of debt, including $0.2 million accrued interest. In addition, pursuant to exchange agreements executed with various holders, the Company is required to potentially issue additional common stock (the “Share liability”) if the stock price is less than the price defined in the exchange agreement as of the true-up date. During the three months ended March 31, 2023, we extinguished Share liabilities of $0.7 million and recognized an additional $0.5 million of Share liabilities. We recognized an approximately $1.3 million debt extinguishment loss during the three months ended March 31, 2023 from the debt redemption.
During the three months ended March 31, 2023, we issued approximately 43,000 shares of Series C preferred stock at fair value of $0.8 million to certain lenders in lieu of cash payments of $0.7 million debt, including $0.1 million accrued interest. We recognized an approximately $0.1 million debt extinguishment loss.
Interest Expense
During the three months ended and March 31, 2023 and 2022, we recorded interest expense of $1.0 million and $1.9 million, respectively. The decrease in interest expense in 2023 was mainly related to a decrease of outstanding debt as a result of the redemption of approximate $18.1 million debt in 2022.
Foreign currency transaction gain (loss)
During the three months ended and March 31, 2023 and 2022, we recognized foreign currency transaction gain of $0.9 million and loss of $1.0 million, respectively. The gain during the three months ended March 31, 2023 was due to the weakening of the U.S. dollar relative to the British pound sterling, while the loss during the three months ended March 31, 2022 was due to the 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 for at least one year after the annual consolidated financial statements were issued, and management’s concerns about our ability to continue as a going concern within the year following this report persist.
Cash Flow
Operating Activities
During the three months ended March 31, 2023 and 2022, net cash outflows from operations were approximately $11.2 million and $13.0 million, respectively. The decrease in cash used in operating activities was primarily attributable to a decrease of $0.8 million in payments to external service providers and a decrease of $0.7 million interest payments to note holders.
Investing Activities
We spent approximately $1.3 million and $58,000 in cash for the purchase of additional equipment and our build out in Sawston, UK during the three months ended March 31, 2023 and 2022, respectively.
Financing Activities
We received approximately $2.4 million of cash from issuance of 0.1 million shares of Series C convertible preferred stock during the three months ended March 31, 2023.
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During the three months ended March 31, 2023, we received approximately $10.0 million in cash proceeds from the issuance of a loan to a commercial lender, and during the three months ended March 31, 2022, we received approximately $0.6 million in cash proceeds from the issuance of multiple loans to individual lenders.
We received approximately $0.2 million and $4.2 million of cash from the exercise of warrants during the three months ended March 31, 2023 and 2022, respectively.
We received approximately $3.1 million of cash from issuance of 4.5 million shares of common stock during the three months ended March 31, 2022.
We made aggregate debt payments of $0.1 million and $4.0 million during the three months ended March 31, 2023 and 2022, respectively.
Other factors affecting our ongoing funding requirements include the number of staff we employ, the number of sites, number of patients and amount of activity in our clinical trial programs, the costs of further product and process development work relating to our DCVax products, the costs of preparations for Phase II trials, the costs of expansion of manufacturing, and unanticipated developments. The extent of resources available to us will determine which programs can move forward and at what pace.
Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Market risk represents the risk of loss that may result from the change in value of financial instruments due to fluctuations in its market price. Market risk is inherent in all financial instruments. Market risk may be exacerbated in times of trading illiquidity when market participants refrain from transacting in normal quantities and/or at normal bid-offer spreads. Our exposure to market risk is directly related to derivatives, debt and equity linked instruments related to our financing activities.
Our assets and liabilities are overwhelmingly denominated in U.S. dollars. We do not use foreign currency contracts or other derivative instruments to manage changes in currency rates. We do not now, nor do we plan to, use derivative financial instruments for speculative or trading purposes. However, these circumstances might change.
The primary quantifiable market risk associated with our financial instruments is sensitivity to changes in interest rates. Interest rate risk represents the potential loss from adverse changes in market interest rates. We use an interest rate sensitivity simulation to assess our interest rate risk exposure. For purposes of presenting the possible earnings effect of a hypothetical, adverse change in interest rates over the 12-month period from our reporting date, we assume that all interest rate sensitive financial instruments will be impacted by a hypothetical, immediate 100 basis point increase in interest rates as of the beginning of the period. The sensitivity is based upon the hypothetical assumption that all relevant types of interest rates that affect our results would increase instantaneously, simultaneously and to the same degree. We do not believe that our cash and equivalents have significant risk of default or illiquidity.
The sensitivity analyses of the interest rate sensitive financial instruments are hypothetical and should be used with caution. Changes in fair value based on a 1% or 2% variation in an estimate generally cannot be extrapolated because the relationship of the change in the estimate to the change in fair value may not be linear. Also, the effect of a variation in a particular estimate on the fair value of financial instruments is calculated independent of changes in any other estimate; in practice, changes in one factor may result in changes in another factor, which might magnify or counteract the sensitivities. In addition, the sensitivity analyses do not consider any action that we may take to mitigate the impact of any adverse changes in the key estimates.
Based on our analysis, as of March 31, 2023, the effect of a 100+/- basis point change in interest rates on the value of our financial instruments and the resultant effect on our net loss are considered immaterial.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of March 31, 2023, of the design and operation of our disclosure controls and procedures, as such terms are defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Based on this evaluation, management concluded that, as of such date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
No change in internal control over financial reporting occurred during the most recent quarter with respect to our operations, which materially affected, or is reasonable likely to materially affect, our internal controls over financial reporting.
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Part II - Other Information
Item 1. Legal Proceedings
On December 1, 2022, we filed a Complaint in the United States District Court for the Southern District of New York against certain market makers. The Complaint alleges that the defendants engaged in manipulation of the Company’s stock, in violation of the Securities Exchange Act of 1934 and common law fraud, over a period of years. On March 20, 2023, the defendants filed a Motion to Dismiss the Complaint. On April 10, 2020 we filed an Amended Complaint against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., and Virtu Americas LLC (Northwest Biotherapeutics Inc. v. Canaccord, et al., No. 1:22-cv-10185-GHW-GWG). The Company plans to pursue this case vigorously.
In February and March, three stockholders filed in the Delaware Court of Chancery three similar derivative lawsuits against the Company and certain of its directors and officers, including J. Cofer Black, Marnix L. Bosch, Alton L. Boynton, Leslie J. Goldman, Jerry Jasinowski, Navid Malik, and Linda F. Powers (the “Individual Defendants”), alleging the Individual Defendants (i) breached their fiduciary duties, and (ii) were unjustly enriched by director and officer compensation awarded to the Individual Defendants—notwithstanding the fact that approximately 90% of shareholders voted to approve of the Company’s executive compensation (the same compensation that these three stockholders are seeking to challenge) through its Say on Pay vote, and the director awards are subject to shareholder approval. On March 31, 2022, the Delaware Court of Chancery consolidated these actions into a single action under the caption In re Northwest Biotherapeutics, Inc. Stockholder Litigation (the “Derivative Action”).
The Company believes these cases are baseless and is vigorously contesting the Derivative Action. On February 22, 2023, the Company filed a Motion to Dismiss the case. The parties fully briefed the motion in April 2023 and oral argument on the motion is scheduled for September 2023.
Item 1A. Risk Factors
Applicable risk factors are set forth in the Company’s report on Form 10-K for 2022.
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
Not Applicable
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Item 6. Exhibits
31.1 |
| |
32.1 | ||
101.INS | Inline XBRL Instance Document. | |
| ||
101.SCH | Inline XBRL Schema Document. | |
| ||
101.CAL | Inline XBRL Calculation Linkbase Document. | |
| ||
101.DEF | Inline XBRL Definition Linkbase Document. | |
| ||
101.LAB | Inline XBRL Label Linkbase Document. | |
| ||
101.PRE | Inline XBRL Presentation Linkbase Document. | |
104 | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, formatted in Inline XBRL (included as Exhibit 101). |
* Filed herewith
** Furnished herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
NORTHWEST BIOTHERAPEUTICS, INC | |||
Dated: May 10, 2023 | 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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