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NORTHWEST BIOTHERAPEUTICS INC

For the period ended Mar 31, 2024. Filed May 10, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 10, 2024

NWBO$0.19-0.6%Stored close · as of Jun 30, 2026

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Notes to Condensed Consolidated Financial Statements

  1. Organization and Description of Business

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

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

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

  1. 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 $18.3 million for the three months ended March 31, 2024. The Company used approximately $12.4 million of cash in its operating activities during the three months ended March 31, 2024.

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

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

  1. Summary of Significant Accounting Policies

Basis of Presentation

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

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

condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 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, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at March 31, 2024 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, 2023 and notes thereto included in the Company’s annual report on Form 10-K (the “2023 Annual Report”), which was filed with the SEC on March 5, 2024.

Use of Estimates

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

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

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2023 Annual Report.

Recently Issued Accounting Standards Not Yet Adopted

Compensation - Stock Compensation

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

Improvements to Income Tax Disclosures

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

Recently Issued Accounting Standards, Adopted

Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions

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

For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company adopted ASU 2022-03 effective January 1, 2024. The adoption of this guidance did not have a material impact on its condensed consolidated financial statements.

  1. Fair Value Measurements

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

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

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

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

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

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, 2024 and December 31, 2023 (in thousands):

​​​​​​​​​​​​​
​ · ​ · Fair value measured at March 31, 2024
​ · ​ · ​ · Quoted prices in active · Significant other · Significant
​ · Fair value at · ​ · markets · ​ · observable inputs · ​ · unobservable inputs
​ · ​ · March 31, 2024 · (Level 1) · (Level 2) · (Level 3)
Warrant liability​$913​$—​$—​$913
Contingent payable derivative liability​​9,099​​—​​—​​9,099
Convertible notes at fair value​16,496​—​—​16,496
Share liability​​120​​—​​—​​120
Total fair value​$26,628​$—​$—​$26,628
​​​​​​​​​​​​​
​ · ​ · Fair value measured at December 31, 2023
​ · ​ · ​ · Quoted prices in active · Significant other · Significant
​ · ​ · Fair value at · ​ · markets · ​ · observable inputs · ​ · unobservable inputs
​ · December 31, 2023 · (Level 1) · (Level 2) · (Level 3)
Warrant liability​$944​$—​$—​$944
Contingent payable derivative liability​​9,188​​—​​—​​9,188
Convertible notes at fair value​​12,771​​—​​—​​12,771
Share liability​483​—​—​483
Total fair value​$23,386​$—​$—​$23,386

There wereno transfers between Level 1, 2 or 3 during the three-month period ended March 31, 2024.

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

​​​​​​​​​​​​​​​​
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · Convertible · ​ · ​ · ​
​ · ​ · Warrant · ​ · Contingent Payable · ​ · Share · ​ · ​ · Notes · ​ · ​ · ​
​ · Liability · Derivative Liability · Liability · ​ · At Fair Value · Total
Balance - January 1, 2024​$944​$9,188​$483​$12,771​$23,386
Additional share liability​​—​​—​​117​​—​​117
Issuance of convertible notes at fair value​​—​​—​​—​​5,500​​5,500
Redemption of share liability​​—​​—​​(586)​​—​​(586)
Change in fair value​​(31)​​(89)​​106​​(1,775)​​(1,789)
Balance - March 31, 2024​$913(1)$9,099​$120​$16,496​$26,628
(1)The remaining balance of $0.9 million in warrant liability as of March 31, 2024 was related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”). The Company accounted for the Piggy-back Rights as a freestanding financial instrument, which was classified as a liability at fair value on the Condensed Consolidated Balance Sheet.

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

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​As of March 31, 2024
​​Share​Contingent Payable​
​​Liability​Derivative Liability​
Strike price​$0.44​$0.52*
Contractual term (years)​0.04​1.0
Volatility (annual)​74%73%
Risk-free rate​5.5%5.2%
Dividend yield (per share)​0%0%
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · As of December 31, 2023 · ​
​ · Share · Contingent Payable
​ · Liability · ​ · Derivative Liability
Strike price​$0.64​$0.70*
Contractual term (years)​​0.1​1.0​
Volatility (annual)​​71%71%
Risk-free rate​​5.6%5.2%
Dividend yield (per share)​​0%0%
*The strike price assumes the current stock price as of March 31, 2024 and December 31, 2023.
  1. Stock-based Compensation

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

​​​​​​​
​ · ​ · For the three months ended
​ · ​ · March 31,
​ · 2024 · 2023
Research and development​$1,009​$296
Research and development - related party​​​​​​
Milestones achieved (1)​​—​​520
Future milestones (2)​​—​​100
General and administrative​155​​17
Total stock-based compensation expense​$1,164​$933

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

(1)During the quarter ended March 31, 2023, the Company recognized the remaining $0.5 million stock-based compensation related to the achieved milestone (obtaining a commercial manufacturing license from the MHRA) and accrued for 3.0 million shares that will become issuable for this milestone. The Company has previously recognized $1.6 million stock - based compensation as of December 31, 2022.
(2)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 $0.1 million.

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

Stock Options

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

​​​​​​​​​​​
​​​​​​​Weighted Average​​​
​ · ​ · ​ · ​ · Weighted · ​ · Remaining · ​ · ​ · ​
​ · ​ · Number of · ​ · Average · ​ · Contractual Life · ​ · Total Intrinsic
​ · Shares · Exercise Price · (in years) · Value
Outstanding as of January 1, 2024317,076​$0.35​6.0​$114,097
Granted​500​​0.53​4.2​​—
Cashless exercised​(650)​​0.35​—​​—
Outstanding as of March 31, 2024316,926​$0.35​5.8​$59,173
Options vested (1)280,514​$0.33​5.8​$55,534

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

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

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

​ · ​ · ​ · ​ · ​
​​For the three months ended​
​​March 31,​
​2024
Exercise price​$0.53​
Expected term (years)​2.1​
Expected stock price volatility​73%
Risk-free rate​4.5%
Dividend yield (per share)​0%

Restricted Stock Awards

Advent SOW 6

There wasno stock based compensation recognized during the three months ended March 31, 2024. As previously reported, the Company previously achieved all of the 10 one-time milestones (i.e., for allsix workstreams that are prerequisites for a MAA application for product approval, for obtaining allthree licenses required for the Sawston facility, and for the completion of key portions of the MAA application) pursuant to the Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company.

As of March 31, 2024,1.5 million shares related to the completed milestone (submission of the application to MHRA for approval) had not been issued and the fair value of the shares of$1.1 million remained accrued in accounts payable and accrued expenses to related parties and affiliates.

6. Property, Plant and Equipment

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

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · March 31, · December 31, · Estimated
​ · ​ · 2024 · ​ · 2023 · ​ · Useful Life
Leasehold improvements​$17,867​$17,785Lesser of lease term or estimated useful life
Office furniture and equipment​527​4873-5 years
Computer and manufacturing equipment and software​3,055​2,7763-5 years
Land in the United Kingdom​85​86NA
​​21,534​21,134NA
Less: accumulated depreciation​(4,266)​(3,856)
Total property, plant and equipment, net​$17,268​$17,278

Depreciation expense was approximately $0.4 million and $0.3 million for the three months ended March 31, 2024, and 2023, respectively.

  1. Outstanding Debt

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

​​​​​​​​​​​​​​​​​​​​​
​ · ​ · Stated · ​ · ​ · ​ · ​ · ​ · ​ · Fair · ​
​ · ​ · ​ · ​ · Interest · ​ · Conversion · ​ · ​ · ​ · ​ · Remaining · ​ · Value · ​ · Carrying
​ · ​ · Maturity Date · ​ · Rate · ​ · Price · ​ · Face Value · ​ · Debt Discount · ​ · Adjustment · ​ · Value
Short term convertible notes payable · ​ · ​ · ​ · ​ · ​ · ​
6% unsecuredDue​6%$3.09​$135​$—​$—​$135
8% unsecuredVarious​​8%$0.20-$0.50*​5,246​​(269)​—​4,977
10 % unsecured​7/11/2024​​10%$0.50*​500​​—​​—​​500
​​​​​​​​​​​5,881​​(269)​​—​​5,612
Short term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
11% unsecured​Various​​11%$0.40 - $0.49*​16,250​​—​​246​​16,496
​​​​​​​​​​​​​​​​​​​​​
Short term notes payable​​​​​​
8% unsecuredVarious​8%N/A​11,399​(404)​—​10,995
12% unsecuredOn Demand​12%N/A​562​—​—​562
6% secured3/25/2025​6%N/A​568​—​—​568
​​​​​​​​​​12,529​(404)—​12,125
Long term notes payable​​​​​​​
8% unsecuredVarious​8%N/A​11,005​(790)​—​10,215
​​​​​​​​​​​​​​​​​​​​
​​​​​​​​​​​​​​​​​​​​​
Ending balance as of March 31, 2024​​​​​​​​​$45,665​$(1,463)​$246​$44,448

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

​​​​​​​​​​​​​​​​​​​​​
​ · ​ · Stated · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · ​ · ​ · Interest · ​ · Conversion · ​ · ​ · ​ · ​ · Remaining · ​ · Fair Value · ​ · Carrying
​ · ​ · Maturity Date · ​ · Rate · ​ · Price · ​ · Face Value · ​ · Debt Discount · ​ · Adjustment · ​ · Value
Short term convertible notes payable · ​ · ​ · ​ · ​ · ​ · ​
6% unsecuredDue​6%$3.09​$135​$—​$—​$135
8% unsecured​Various​​8%$0.50-$0.70*​3,486​​(356)​​—​​3,130
10% unsecured​7/11/2024​​10%$0.50*​500​​—​​—​​500
​​​​​​​​​​​4,121​​(356)​​—​​3,765
Short term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
11% unsecured​Various​​11%$0.40-$0.49*​10,750​​—​​2,021​​12,771
​​​​​​​​​​​​​​​​​​​​​
Short term notes payable​​​​​​​​
8% unsecuredVarious​8%N/A​3,539​(157)​—​3,382
12% unsecuredOn Demand​12%N/A​562​—​—​562
​​​​​​​​​​4,101​(157)—​​3,944
Long term notes payable​​​​​​​​​​​​​​​​​​​​
8% unsecuredVarious​8%N/A​21,224​(1,485)​—​19,739
6% secured3/25/2025​​6%​N/A​​573​——​​573
​​​​​​​​​​​21,797​​(1,485)​​—​​20,312
​​​​​​​​​​​​​​​​​​​​​
Ending balance as of December 31, 2023​​​​​​​​​$40,769​$(1,998)​$2,021​$40,792

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

Promissory Note

During the three months ended March 31, 2024, the Company issued approximately 6.9 million shares of common stock with a fair value of $4.0 million to certain lenders in lieu of cash payments of $2.7 million of debt, including $0.3 million of accrued interest. In addition, pursuant to exchange agreements executed with various holders, the Company is required to potentially issue additional common stock (the “Share liability”) if the stock price is less than the price, defined in the exchange agreement as of the true-up date (the “True-up Price”), or the lender is required to return common shares to the Company (the “Share receivable”) if the stock price is greater than the True-up Price as of the true-up date. During the three months ended March 31, 2024, the Company extinguished Share liabilities of $0.6 million and recognized additional $0.1 million in Share liabilities. The Company recognized an approximately $0.8 million debt extinguishment loss during the three months ended March 31, 2024 from the debt redemption.

Convertible Notes

On February 21, 2024, the Company entered into severalone-year convertible notes (the “February Convertible Notes”) with multiple investors (the “Holders”) with an aggregate principal amount of $1.8 million for a purchase price of $1.6 million. The February Convertible Notes bear interest at 8% per annum and are convertible into Series C preferred shares at $12.50 per share at the Holders’ sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock.

As consideration for entering into the package of February Convertible Notes for $1.8 million as described above, the Company amended the Holders’ existing convertible notes and warrants, whereby the maturity date of certain notes and warrants were extended, the conversion price of certain notes were reduced, and the exercise prices of certain warrants were reduced. These amendments in January and February of 2024 involving 16 tranches warrants and 10 debt instruments were accounted for as both debt modification and debt extinguishment. The Company recognized approximately $1.4 million of debt extinguishment losses during the three months ended March 31, 2024 from these debt amendments.

Convertible Notes at Fair Value

During the three months ended March 31, 2024, the Company entered into severalone-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of$5.5 million. The Convertible Notes bear interest at 11% per annum and are convertible into Series C preferred shares between$10.00 and$11.50 per share at the Holder’s sole option. The Series C preferred shares are convertible into common stock 30 days after the debt conversion date. Each Series C preferred share is convertible into 25 shares of common stock. In addition, the Holders have an alternative option to convert the Convertible Notes into a non-dilutive financial instrument, which has the same terms at those in the non-dilutive funding agreements as described in Note 12.

The Company elected the FVO to fair value the Convertible Notes under the guidance in ASC 825. The convertible notes at fair value are required to be remeasured using level 3 fair value measurements (see Note 4).

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

  1. 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,
​ · 2024 · 2023
Series C convertible preferred stock​32,420​35,412
Common stock options​316,926​299,938
Common stock warrants​97,040​140,244
Convertible notes and accrued interest​60,92979
Potentially dilutive securities​507,315​475,673
  1. Related Party Transactions

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

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

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

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

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

​​​​​​​
​ · ​ · For the three months ended
​ · ​ · March 31,
​ · ​ · 2024 · ​ · 2023
Advent BioServices · ​ · ​
Manufacturing cost in London​$1,726​$1,643
Manufacturing cost at Sawston facility​2,652​1,712
SOW 6 one-time milestones - Shares​​​​
Expensed but unpaid (milestone complete) (1)​—​520
Expensed but unpaid, not yet due (milestone not yet complete) (2)​—​100
SOW 6 one-time milestones - Cash​​​​​
Expensed and due, but unpaid (milestone complete) (3)​—​550
Expensed but unpaid, not yet due (milestone not yet complete) (2)​​—​​150
Total​$4,378​$4,675
(1)This covers the one-time milestone for obtaining a commercial manufacturing license from the MHRA. The milestone was achieved but shares were not yet 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 14,459 square feet of the 88,000 square foot building interior space, plus corresponding support space and parking. The lease payments amount under the Agreement aretwo times the amount payable by the Company under the head lease (which is currently £5.75 or approximately $7.26 per square foot based on exchange rate as of March 31, 2024), but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2024. The total lease payments paid by the Company to Huawei for the 88,000 square foot facility, exterior spaces andparking under the head lease are £550,000 (approximately $694,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.

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

Related Party Accounts Payable

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

​​​​​​​
​ · March 31, · December 31,
​ · ​ · 2024 · ​ · 2023
Advent BioServices - amount invoiced but unpaid​$1,633​$1,668
Advent BioServices - amount accrued but unpaid (1)​​1,101​​1,601
Total payable and accrued, but unpaid to Advent BioServices​$2,734​$3,269

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

10. Preferred Stock

Series C Convertible Preferred Stock

During the three months ended March 31, 2024, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of 0.3 million shares of the Company’s Series C convertible preferred stock, par value $0.001 per share (the “Series C Shares”), at a weighted purchase price of $11.77 per share for proceeds of approximately $3.6 million.

During the three months ended March 31, 2024, approximately 0.2 million Series C Shares with a book value of $2.5 million were converted into 5.5 million common shares at a ratio of 1:25.

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

  1. Stockholders’ Deficit

Common Stock

During the three months ended March 31, 2024, the Company received $1.3 million from the exercise of outstanding warrants with a weighted average exercise price of $0.22 per share. The Company issued approximately 5.8 million shares of common stock upon these warrant exercises.

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

Stock Purchase Warrants

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

​​​​​​​​
​ · Number of · Weighted Average · Remaining
​ · ​ · Warrants · ​ · Exercise Price · ​ · Contractual Term
Outstanding as of January 1, 2024105,241​$0.311.83
Warrants exercised for cash(5,831)​0.22—
Cashless warrrants exercise​(2,369)​​0.35​—
Outstanding as of March 31, 202497,040​$0.282.05

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

At March 31, 2024, of the approximately 97 million total outstanding warrants listed above, approximately 92 million warrants were under the Blocker Letter Agreement or suspension agreements.

Warrant Modifications

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

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · Post-modification · Pre-modification
Exercise price​$0.28​$0.31​
Expected term (in years)​2.1​1.8​
Volatility​80%81%
Risk-free interest rate​4.7%4.9%
Dividend yield​0%0%

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

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

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

Operating Lease - Lessor Arrangements

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

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

​​​​​​​​​​
​ · ​ · For the three months ended
​ · ​ · March 31, 2024
​ · U.K · U.S · Total
Lease cost · ​ · ​ · ​
Operating lease cost​$156​$65​$221
Short-term lease cost​13​—​13
Variable lease cost​—​6​6
Sub-lease income​(36)​—​(36)
Total​$133​$71​$205
​​​​​​​​​​
Other information​​​​​​
Operating cash flows from operating leases​$(166)​$(75)​$(241)
Weighted-average remaining lease term – operating leases​7.7​0.4​​
Weighted-average discount rate – operating leases​12%12%​
​​​​​​​​​​
​ · ​ · For the three months ended
​ · ​ · March 31, 2023
​ · U.K · U.S · Total
Lease cost · ​ · ​ · ​
Operating lease cost​$144​$65​$209
Short-term lease cost​23​—​23
Variable lease cost​—​4​4
Sub-lease income​​(36)​​—​​(36)
Total​$131​$69​$200
​​​​​​​​​​
Other information​​​​​​
Operating cash flows from operating leases​$(152)​$(73)​$(225)
Weighted-average remaining lease term – operating leases​8.4​1.1​​
Weighted-average discount rate – operating leases​12%12%​

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

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

​​​​
Nine months ended December 31, 2024​$621
Year ended December 31, 2025​656
Year ended December 31, 2026​​656
Year ended December 31, 2027​​656
Year ended December 31, 2028​​656
Thereafter​​6,542
Total​​9,787
Less present value discount​​(5,158)
Operating lease liabilities included in the condensed consolidated balance sheet at March 31, 2024​$4,629

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

​​​​
Nine months ended December 31, 2024$108
Year ended December 31, 2025​145
Year ended December 31, 2026​145
Year ended December 31, 2027​145
Year ended December 31, 2028​145
Thereafter​1,450
Total​$2,138

Advent BioServices Services Agreement

On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The MSA provides for manufacturing of DCVax-L products at an existing facility in London. The MSA is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity reserved exclusively for DCVax production and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. The MSA remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate the MSA ontwelve months’ notice, to allow for transition arrangements by both parties. During the notice period services would still be provided. Minimum required payments for this notice period are anticipated to total approximately £4.5 million ($5.7 million).

German Tax Matter

The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015. The NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €277,000 (approximately $299,000), for corporate taxes, interest, and reduced penalty for the period under audit, which the Company paid on September 2, 2021. The Company also received and paid the final settlement bill from the local authority for trade taxes for the audit period in the amount of €231,000 (approximately $249,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (now approximately $554,000) on reimbursable withholding taxes that had been waived during the settlement process. On December 8, 2021, the Company appealed the assessment of additional late fees. Additionally, the Company requested that NW Bio GmbH be deregistered from the trade register, as it no longer had current operations. The deregistration was granted effective December 31, 2021. Between January 2022 and July 2022, the Company received tax bills for the corporate and trade taxes for the 2016-2020 tax years that totaled approximately €222,000 (approximately $240,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $146,000) of the penalties. The Company offered to pay this reduced penalty if an

extended payment plan was approved. A response was received dated November 14, 2022 indicating that the tax authority would not be able to grant a further deferral of payment of these penalties. In a letter dated December 27, 2022, the Leipzig tax authority sent letters to the former and current managing directors of NW Bio GmbH giving 30 days to respond to a tax liability questionnaire. Based on the responses to the liability questionnaires the tax authorities have currently not directed any further measures against former and current managing directors of NW Bio GmbH with respect to tax liability proceedings. On October 12, 2023 and January 16, 2024, the Company made €189,000 and €189,000 payments, respectively, regarding to the late payment penalty. As of March 31, 2024, the Company accrued for trade tax liability of €155,000 (approximately $168,000) and corporation tax of €99,000 (approximately $107,000). Based on the Company’s current operating state in Germany and the negotiations, the Company believes, based on its evaluation under ASC 740, that the resolution of these tax matters will not likely result in a net material charge to the Company.

Other Contingent Payment Obligation

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

13. Subsequent Events

Between April 1, 2024 and May 8, 2024, the Company received $11.4 million in funding from the sale of preferred shares, proceeds from warrant exercise, and proceeds of debt arrangements.

Between April 1, 2024 and May 8, 2024, the Company issued approximately 0.1 million shares of Series C preferred stock for proceeds of $1.4 million.

Between April 1, 2024 and May 8, 2024, the Company received $9,000 from the exercise of 43,000 outstanding warrants.

Between April 1, 2024 and May 8, 2024, approximately 0.3 million Series C Shares with a book value of $3.5 million were converted into 8.5 million common shares in accordance with their terms at a ratio of 1:25.

Between April 1, 2024 and May 8, 2024, the Company issued approximately 2.8 million shares of common stock to certain lenders in lieu of cash payments of $1.3 million of debt, including $0.1 million of accrued interest. The Company also issued 0.2 million shares of common stock to extinguish $0.1 million outstanding share liability.

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

On April 26, 2024, the Company entered into a Commercial Loan Agreement (the “April Commercial Loan”) with a commercial lender for an aggregate principal amount of $11.0 million. The April Commercial Loan bears interest at 8% per annum with a 22 - month term. There are no principal repayments during the first eight months of the term. The April Commercial Loan is amortized in 14 installments starting on December 26, 2024. The April Commercial Loan carries an original issue discount of $1.0 million.

On April 29, 2024, the Company issued approximately 1.3 million shares of common stock upon cashless exercise of 2.1 million warrants at exercise prices of $0.20 per share.

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