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NORTHWEST BIOTHERAPEUTICS INC

For the period ended Mar 31, 2025. Filed May 15, 2025.

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, 2025 · Filed May 15, 2025

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

Extracted filing text, with the paragraph anchors used by the comparison.

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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, Northwest Biotherapeutics Capital Limited, 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 submitted a Marketing Authorization Application (MAA) for regulatory approval in the U.K. in December 2023. The MAA is in process of their review. The Company is also in the process of restarting its DCVax®-Direct program for inoperable tumors.

  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 $19.3 million for the three months ended March 31, 2025. The Company used approximately $9.4 million of cash in its operating activities during the three months ended March 31, 2025.

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, 2025, condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, condensed consolidated statement of stockholders’ deficit for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 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, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025 or for any future interim period. The condensed consolidated balance sheet at December 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, 2024 and notes thereto included in the Company’s annual report on Form 10-K (the “2024 Annual Report”), which was filed with the SEC on March 31, 2025.

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.

Segment Information

The Company operates inone operating segment for the purposes of assessing performance, making operating decisions, and allocating Company resources. The Company’s chief operating decision maker (CODM) is its chief executive officer, who considers net loss to evaluate overall expenses associated with conducting research and development activities, which includes evaluating the progress of ongoing clinical trials and the planning and execution of current and future research and development activities. Further, the CODM reviews and utilizes functional expenses (research and development and general and administrative) as reported in the consolidated statements of operations to manage the Company’s operations. The measure of performance, significant expenses, and other items are each reflected in the consolidated statements of operations. The accounting policies of the Company’s single reportable segment are the same as those for the consolidated financial statements. The level of disaggregation and amounts of significant segment expenses that are regularly provided to the CODM are the same as those presented in the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total assets.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2024 Annual Report.

Recently Adopted Accounting Standards

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 adopted this standard as of January 1, 2025. The adoption of this ASU did not have any material impact on the Company’s quarterly condensed consolidated financial statements.

Recently Issued Accounting Standards Not Yet Adopted

Disaggregation of Income Statement Expenses

In November 2024, the FASB issued ASU No. 2024-03 (“ASU 2024-03”), Disaggregation of Income Statement Expenses (DISE) which requires disaggregated disclosure of income statement expenses for public business entities. The standard requires public business entities to disclose disaggregated information about specific natural expense categories underlying certain income statement expense line items that are considered relevant. The FASB also issued ASU No. 2025-01 (“ASU 2025-01”), Clarifying the Effective Date, which clarifies the adoption date of ASU 2024-03 as annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the potential effect of this accounting standard update on its consolidated financial statements and related disclosures.

  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, 2025 and December 31, 2024 (in thousands):

​​​​​​​​​​​​​
​ · ​ · Fair value measured at March 31, 2025
​ · ​ · ​ · Quoted prices in active · Significant other · Significant
​ · Fair value at · ​ · markets · ​ · observable inputs · ​ · unobservable inputs
​ · ​ · March 31, 2025 · (Level 1) · (Level 2) · (Level 3)
Warrant liability​$1,036​$—​$—​$1,036
Contingent payable derivative liability​​9,481​​—​​—​​9,481
Convertible notes at fair value​35,944​—​—​35,944
Share payable​​693​​—​​—​​693
Total fair value​$47,154​$—​$—​$47,154
​​​​​​​​​​​​​
​ · ​ · Fair value measured at December 31, 2024
​ · ​ · ​ · Quoted prices in active · Significant other · Significant
​ · ​ · Fair value at · ​ · markets · ​ · observable inputs · ​ · unobservable inputs
​ · December 31, 2024 · (Level 1) · (Level 2) · (Level 3)
Warrant liability​$2,219​$—​$—​$2,219
Contingent payable derivative liability​​9,578​​—​​—​​9,578
Convertible notes at fair value​​34,224​​—​​—​​34,224
Share payable​143​—​—​143
Total fair value​$46,164​$—​$—​$46,164

There wereno transfers between Level 1, 2 or 3 during the three-month period ended March 31, 2025.

The following table presents changes in Level 3 liabilities measured at fair value for the three-month period ended March 31, 2025. 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 · Payable · At Fair Value · Total
Balance - January 1, 2025​$2,219​$9,578​$143​$34,224​$46,164
Additional share payable​​—​​—​​625​​—​​625
Issuance of convertible notes at fair value​​—​​—​​—​​2,200​​2,200
Redemption of share payable​​—​​—​​(98)​​—​​(98)
Additions from debt extinguishment​​—​​—​​—​​5,642​​5,642
Debt repayment​​—​​—​​—​​(525)​​(525)
Debt conversion​​—​​—​​—​​(1,900)​​(1,900)
Change in fair value​​(1,183)​​(97)​​23​​(3,697)​​(4,954)
Balance - March 31, 2025​$1,036​$9,481​$693​$35,944​$47,154

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities, share payable, and contingent conversion feature (excluding the piggy-back right, which was based on key milestone estimates, see Note 7 for piggy-back rights) that are categorized within Level 3 of the fair value hierarchy as of March 31, 2025 and

December 31, 2024 is as follows. The liability relates to the remaining redemption feature which, like the convertible notes at fair value, includes discount factors that are unobservable inputs and proprietary in nature.

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​As of March 31, 2025
​ · Share Payable · Warrant Liability · ​
Strike price​$0.24​$0.25​
Contractual term (years)​0.03​​0.32​
Volatility (annual)​59%​60%
Risk-free rate​1.8%​4.3%
Dividend yield (per share)​0%​0%
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · As of December 31, 2024 · ​
​ · Share Payable · Warrant Liability
Strike price​$0.25​$0.25​
Contractual term (years)​​0.08​0.58​
Volatility (annual)​​60%66%
Risk-free rate​​4.3%4.2%
Dividend yield (per share)​​0%0%
  1. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three months ended March 31, 2025 and 2024 (in thousands).

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the three months ended
​ · ​ · March 31,
​ · 2025 · 2024
Research and development​$365​$1,009
General and administrative​20​​155
Total stock-based compensation expense​$385​$1,164

The total unrecognized stock compensation (primarily for consultants) cost was approximately $1.5 million as of March 31, 2025 and will be recognized over the next 1.8 years.

Stock Options

The following table summarizes stock option activity for options during the three months ended March 31, 2025 (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, 2025316,826​$0.35​5.0​$3,932
Granted​250​​0.25​5.0​​—
Outstanding as of March 31, 2025317,076​$0.35​4.8​$10
Options vested (1)282,984​$0.33​4.7​$10
(1)183 million of the 283 million stock options are subject to agreements (the “Blocker Letter Agreements”) under which they are subject to a restriction that the options may only be exercised if the Company has sufficient authorized shares available for issuance.

Restricted Stock Awards

Advent SOW 6

There wasno stock based compensation related to Statement of Work #6 (“SOW 6”) recognized during the three months ended March 31, 2025 and 2024. As previously reported, Advent previously achieved all of the 10 one-time milestones (i.e., for all six workstreams that were 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 SOW 6.

As of March 31, 2025,1.5 million shares related to the milestone for completion and submission of the MAA 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, 2025 and December 31, 2024 (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · March 31, · December 31, · Estimated
​ · ​ · 2025 · ​ · 2024 · ​ · Useful Life
Leasehold improvements​$18,397​$17,973Lesser of lease term or estimated useful life
Office furniture and equipment​569​5313-5 years
Computer and manufacturing equipment and software​3,316​3,1603-5 years
Land in the United Kingdom​88​85NA
​​22,370​21,749NA
Less: accumulated depreciation​(6,082)​(5,553)
Total property, plant and equipment, net​$16,288​$16,196

Depreciation and amortization expense was approximately $0.4 million and $0.4 million for the three months ended March 31, 2025, and 2024, respectively.

  1. Outstanding Debt

The following two tables summarize outstanding debt as of March 31, 2025 and December 31, 2024, respectively (amount in thousands, except per share amounts):

​​​​​​​​​​​​​​​​​​​​​
​ · ​ · 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​​1,355​​(1)​—​1,354
​​​​​​​​​​​1,490​​(1)​​—​​1,489
Short term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
0% unsecured​1/19/2026​​0%​Variable​​3,100​​—​​307​​3,407
8% unsecured​Various​​8%$0.27​​1,000​​—​​157​​1,157
11% unsecured​Various​​11%$0.21 - $0.32​​15,225​​—​​3,111​​18,336
​​​​​​​​​​​19,325​​—​​3,575​​22,900
Short term notes payable​​​​​​
0% unsecured​On Demand​​0%​N/A​​2,140​​—​​—​​2,140
6% secured3/25/2025​6%N/A​182​—​—​182
8% unsecuredVarious​8%N/A​17,555​(798)​—​16,757
12% unsecuredOn Demand​12%N/A​563​—​—​563
​​​​​​​​​​20,440​(798)—​19,642
Long term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
11% unsecured​Various​​11%$0.20 - $0.38​​10,765​​—​​2,279​​13,044
​​​​​​​​​​​10,765​​—​​2,279​​13,044
Long term notes payable​​​​​​​
8% unsecuredVarious​8%N/A​7,710​(641)​—​7,069
​​​​​​​​​​​​​​​​​​​​
​​​​​​​​​​​​​​​​​​​​​
Ending balance as of March 31, 2025​​​​​​​​​$59,730​$(1,440)​$5,854​$64,144
(1)This note was paid in full on April 25, 2025.
​​​​​​​​​​​​​​​​​​​​​
​ · ​ · 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​2/21/2025​​8%$0.50*​1,760​​(25)​​—​​1,735
​​​​​​​​​​​1,895​​(25)​​—​​1,870
Short term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
8% unsecured​2/15/2025​​8%$0.27​​1,000​​—​​95​​1,095
10% unsecured​1/11/2025​​10%$0.35​​500​​—​​46​​546
11% unsecured​Various​​11%$0.26-$0.46​​15,250​​—​​1,433​​16,683
​​​​​​​​​​​16,750​​—​​1,574​​18,324
​​​​​​​​​​​​​​​​​​​​​
Short term notes payable​​​​​​​​
0% unsecured​On Demand​​0%​N/A​​2,140​​—​​—​​2,140
6% secured​3/25/2025​​6%​N/A​​247​​—​​—​​247
8% unsecuredVarious​8%N/A​11,660​(424)​—​11,236
12% unsecuredOn Demand​12%N/A​563​—​—​563
​​​​​​​​​​14,610​(424)—​​14,186
​​​​​​​​​​​​​​​​​​​​​
Long term convertible notes at fair value​​​​​​​​​​​​​​​​​​​​
0% unsecured​1/19/2026​​0%​Variable​​5,000​​—​​918​​5,918
11% unsecured​Various​​11%$0.29-$0.38​​8,565​​—​​1,417​​9,982
​​​​​​​​​​​13,565​​—​​2,335​​15,900
Long term notes payable​​​​​​​​​​​​​​​​​​​​
8% unsecuredVarious​8%N/A​13,210​(814)​—​12,396
​​​​​​​​​​​​​​​​​​​​​
Ending balance as of December 31, 2024​​​​​​​​​$60,030​$(1,263)​$3,909​$62,676
  • These convertible notes are convertible into Series C preferred shares at $12.50 per share. Each Series C preferred share is convertible into common shares after a 30-day restriction period. The conversion price in common share equivalent is $0.50 per share.

Notes Payable

On March 7, 2025, the Company entered into a Commercial Loan Agreement (the “March Commercial Loan”) with a commercial lender for an aggregate principal amount of $5.5 million. The March 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 March Commercial Loan is amortized in 14 installments starting on May 7, 2026. The March Commercial Loan carries an original issue discount of $0.5 million.

During the three months ended March 31, 2025, the Company issued approximately 27.9 million shares of common stock with a fair value of 7.3 million to certain lenders in lieu of cash payments of $6.2 million of debt, including $1.1 million of accrued interest. In addition, the Company has extinguished certain debt pursuant to exchange agreements executed with various holders pursuant to which the Company issues common stock at a price based on a limited pricing period (the “Share payable”). During the three months ended March 31, 2025, the Company settled $0.1 million of Share payables and accrued $0.6 million of Share payables. The Company recognized an approximately $1.6 million debt extinguishment loss during the three months ended March 31, 2025 from the debt redemption.

Convertible Notes

During the three months ended March 31, 2025, the Company modified an existing $1.7 million convertible note by extending the maturity dates and reducing the conversion price (the “Amended Convertible Note”). The modification was accounted for as a debt extinguishment as the conversion feature of the amended note was substantially different from the original terms. As a result, the Company recognized approximately $6,000 of debt extinguishment gain during the three months ended March 31, 2025 from this debt amendment.

In addition, the Company converted $0.4 million of the Amended Convertible Note including $31,000 accrued interest into 2.1 million shares of common stock at a conversion price of $0.20 per share.

Convertible Notes at Fair Value

During the three months ended March 31, 2025, the Company entered into severaltwo-year convertible notes (the “Long-term Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of$2.2 million. The Long-term Convertible Notes bear interest at 11% per annum and are convertible into common shares between$0.20 and$0.245 per share at the Holder’s sole option. In addition, the Holders have an alternative option to convert the Long-term 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 described above 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).

During the three months ended March 31, 2025, the Company modified certain existing convertible notes by (i) extending the maturity dates; (ii) reducing the conversion price, and (iii) granting the notes holders the right to further extend the maturity date of the notes from a period of time not to exceed 24 months. The modifications were accounted for as a debt extinguishment as the conversion feature of the amended notes were substantially different from the original terms. As a result, the Company recognized approximately$5.6 million of debt extinguishment loss during the three months ended March 31, 2025 from these debt amendments.

During the three months ended March 31, 2025, the Company converted$1.9 million of certain convertible notes that were originally issued in December 2024 into 8.0 million shares of common stock at a weighted average conversion price of$0.24 per share.

For the three months ended March 31, 2025 and 2024, interest expense related to outstanding debt totaled approximately$1.6 million and$1.5 million including amortization of debt discounts totaling$0.3 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,
​ · 2025 · 2024
Series C convertible preferred stock​22,599​32,420
Common stock options​317,076​316,926
Common stock warrants - equity classified​60,422​97,040
Common stock warrants - liability classified​32,497​—
Convertible notes and accrued interest​137,26760,929
Potentially dilutive securities​569,861​507,315
  1. Related Party Transactions

The Company hasthree 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) periodic specialized programs such as the program related to the MAA pre-requisites, drafting and submission. The Company has also executed a new SOW #8 covering the work required to establish the DCVax-Direct program in the U.K. and manufacture DCVax-Direct products for global use (see Note 13).

Each of the 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. Each periodic specialized program is covered by an SOW that sets forth the role and activities to be undertaken by Advent for that program, and provides for milestone payments upon completion of key elements of the program.

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, as well as for the periodic specialized programs. 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 Ancillary Services Agreement was to end in July 2023, but the Company extended the term by 12 months to July 2024, and it was further extended for an additional year until July 2025.

SOW 8

On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that is incorporated into the Ancillary Services Agreement that was originally entered into dated November 8, 2019 and was extended on July 8, 2024. SOW 8 covers the work required to establish the DCVax-Direct program in the U.K and manufacture DCVax-Direct products for global use. Under SOW 8, the compensation consists solely of one-time cash milestone payments for each stage of the work and Advent will only receive the compensation when the applicable work is successfully completed. (When the Company previously contracted with a different company for restart of DCVax-Direct manufacturing, the contract required payment as work was performed, regardless of whether the work was successful or not, as is typical for such contract services. The other company did not succeed in producing any DCVax-Direct products meeting the specifications.)

SOW 8 includes the following 5 one-time milestones with corresponding milestone payments (which are only payable after the milestone has been achieved):

(a) Basic Technology Transfer, New SOPs & Regulatory Documents.

Review of documents, specifications and data from prior DCVax-Direct program conducted by Cognate BioServices. Development of a new set of SOPs for DCVax-Direct production in Sawston and new regulatory documents for the UK. Initial implementation in Sawston; many engineering runs. Data generation for comparability analyses of both the process and the product. Milestone payment of £0.55 million (approximately $0.7 million) upon completion.

As of March 31, 2025, this milestone had been completed and paid.

(b) Process Development: TFF System vs. Other Systems.

Evaluation of the TFF system used in the prior DCVax-Direct manufacturing. Evaluation of the remaining TFF equipment from the prior program, parts needed to re-establish functional TFF systems, potential sourcing and timelines. Evaluation of remaining disposables from the prior program, requirements for new molds to enable new production of disposables (which are used for each manufacturing run with the TFF system), production arrangements for new disposables, development of new sealing method for disposables, potential sourcing and timelines for disposables. Identification and evaluation of commercially available systems to potentially substitute for TFF system. Engineering runs. Data generation for comparability analyses of TFF system vs. others. Milestone payment of £0.45 million (approximately $0.6 million) upon completion.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.6 million as of March 31, 2025 related to this milestone.

(c) Process Development: Existing and New Product Composition.

Worldwide search for sourcing of BCG (1 of 2 essential reagents/ingredients required for DCVax-Direct besides the DCs), due to a severe worldwide shortage. Evaluation of the BCG mechanism of action (MoA) in DCVax-Direct, search for other agents that could have similar MoA or effects, with similar safety profile too. Sourcing of other agents, testing and selection of other agents for a new DCVax-Direct product composition. Many engineering runs. Data generation for comparability analyses of new reagents vs BCG and new composition of DCVax-Direct vs prior composition. Milestone payment of £0.60 million (approximately $0.8 million) upon completion.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.8 million as of March 31, 2025 related to this milestone.

(d) Technology Transfer: Clean Room Implementation.

After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, process performance qualifications. For technology transfer into the clean rooms, each operator must pass 3 consecutive and successful aseptic process simulations in the clean room and 3 consecutive and successful PQQ runs at scale in the clean room; microbial analysis (sterility, endotoxin, mycoplasma all need to pass); growth promotion tests; validation of all equipment used after being placed in the clean room; validation of all cell analysis assays used via flow cytometry and validation of the fill and finish protocols. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.

As of March 31, 2025, this milestone had been completed but had not yet been paid. The Company recognized an incremental accrued liability of $0.3 million during the three months ended March 31, 2025. The Company had an accrued liability of $0.5 million as of March 31, 2025 related to this milestone.

(e) New IMPD and New IND.

Draft a new IMPD (Investigational Medicinal Product Dossier) for the revised DCVax-Direct product composition and production process, containing all changes to the manufacturing system, reagents and product composition, processes, sources and/or Mechanism of Action vs those used in the prior DCVax-Direct program. Also draft a new IND (CMC section), for the first clinical trial with the new manufacturing process and new product composition. Obtain the first approval or clearance of the new IND by a regulator. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.

As of March 31, 2025, this milestone had not been completed. The Company recognized an incremental accrued liability of $0.2 million related to a future cash milestone payment that the Company anticipates will be achieved and earned over the course of the contract period during the three months ended March 31, 2025. The Company had an accrued liability of $0.3 million as of March 31, 2025 related to this milestone.

The following table summarizes total research and development costs from Advent for the three months ended March 31, 2025 and 2024, respectively (in thousands).

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the three months ended
​ · ​ · March 31,
​ · 2025 · 2024
Advent BioServices · ​ · ​ · ​ · ​
Manufacturing cost in London​​1,937​$1,726
Manufacturing cost at Sawston facility​3,377​2,652
SOW 8 one-time milestones - Cash​​​​
Expensed and due, but unpaid (milestone complete) (1)​285​—
Expensed but unpaid, not yet due (milestone not yet complete) (2)​200​—
Total​$5,799​$4,378
(1)This covers one-time milestone: Technology transfer: clean room implementation.
(2)This convers one-time milestone: Draft new IMPD (Investigational Medicinal Product Dossier) and new IND (CMC section).

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 $7.44 per square foot based on exchange rate as of March 31, 2025), 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 $736,000) 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, 2025 and 2024, the Company recognized sub-lease income of $36,000 and $36,000, respectively.

Related Party Accounts Payable

As of March 31, 2025 and December 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,
​ · ​ · 2025 · ​ · 2024
Advent BioServices - amount invoiced but unpaid​$3,227​$1,692
Advent BioServices - amount accrued but unpaid (1)​​3,245​​2,760
Total payable and accrued, but unpaid to Advent BioServices​$6,472​$4,452

(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, 2025, 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, 2025, approximately 0.1 million Series C Shares with a book value of $0.9 million were converted into 1.7 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, 2025, the Company received $5.1 million from the issuance of 22.7 million shares of common stock.

Stock Purchase Warrants

The following is a summary of warrant activity for the three months ended March 31, 2025 (dollars in thousands, except per share data):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · Number of · Weighted Average · Remaining
​ · ​ · Warrants · ​ · Exercise Price · ​ · Contractual Term
Outstanding as of January 1, 202594,199​$0.282.20
Warrants exercised for cash(76)​0.23—
Warrants expired and cancellation(1,204)​0.34—
Outstanding as of March 31, 2025 (1)92,919​$0.281.99
(1)At March 31, 2025, of the approximately 93 million total outstanding warrants listed above, approximately 90 million warrants were under Blocker Letter Agreements or suspension agreements.

Warrant Modifications

During the three months ended March 31, 2025, the Company amended certain warrants whereby the maturity dates were extended for an additional approximately 3-6 months. The value of these modifications was calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · Post-modification · Pre-modification
Exercise price​$0.28​$0.28​
Expected term (in years)​3.2​2.9​
Volatility​71%71%
Risk-free interest rate​3.9%3.9%
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 $0.3 million which 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.

The Company’s current office lease in the U.K. will expire in July 2025. In January 2025, the Company entered into a new office lease agreement for the U.K. (the “2025 U.K. Office Lease”). The commencement date for the 2025 U.K. Office Lease is expected to be between May 2025 and November 2025, when the buildout of the office is completed and the Company gains the access to the leased property. The 2025 U.K. Office Lease will expire 5 years after the commencement date. As of March 31, 2025, the Company has not taken possession of the premises.

On August 22, 2024, the Company extended its office lease in the U.S for an additional 2 years under an amended agreement. The Company recognized additional $0.4 million ROU assets and lease liabilities for its amended office lease in the U.S.

At March 31, 2025, the Company had operating lease liabilities of approximately $4.9 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 $4.2 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 aretwo times the amount payable by the Company under the head lease (which is currently £5.75 or approximately $7.44 per square foot based on exchange rate as of March 31, 2025), 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 2025. 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 £550,000 (approximately $711,000) 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, 2025
​ · U.K · U.S · Total
Lease cost · ​ · ​ · ​
Operating lease cost​$154​$53​$207
Short-term lease cost​13​—​13
Variable lease cost​—​—​—
Sub-lease income​(36)​—​(36)
Total​$131​$53​$184
​​​​​​​​​​
Other information​​​​​​
Operating cash flows from operating leases​$(164)​$(23)​$(187)
Weighted-average remaining lease term – operating leases​7.2​1.1​—
Weighted-average discount rate – operating leases​12%12%—
​​​​​​​​​​
​ · ​ · 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​$204
​​​​​​​​​​
Other information​​​​​​
Operating cash flows from operating leases​$(166)​$(75)​$(241)
Weighted-average remaining lease term – operating leases​7.7​0.4​—
Weighted-average discount rate – operating leases​12%12%—

The Company recorded lease costs as a component of general and administrative expense during the three months ended March 31, 2025 and 2024, respectively.

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

​​​​
Nine months ended December 31, 2025​$714
Year ended December 31, 2026​863
Year ended December 31, 2027​​673
Year ended December 31, 2028​​673
Year ended December 31, 2029​​673
Thereafter​​6,033
Total​​9,629
Less present value discount​​(4,768)
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2025​$4,861

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

​​​​
Nine months ended December 31, 2025$108
Year ended December 31, 2026​145
Year ended December 31, 2027​145
Year ended December 31, 2028​145
Year ended December 31, 2029​145
Thereafter​1,305
Total​$1,993

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 £4.6 million ($6.1 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 $329,000), 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 $272,000). On November 4, 2021, the Company received a letter from the local tax authorities asking for additional late fees of €513,000 (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 $238,000). On July 27, 2022, the Company was informed that the German Tax Authorities were prepared to waive €135,000 (approximately $145,000) 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 (approximately $201,000) and €189,000 (approximately $207,000) payments, respectively, regarding to the late payment penalty. As of March 31, 2025, 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

As of March 31, 2025, the Company had contingent payment obligation of $4.7 million, which are related to a gain contingency from non-dilutive funding agreements with various investors. 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, 2025 and May 9, 2025, the Company received $5.5 million in funding from the sale of common shares, proceeds from warrant exercise, and proceeds of debt arrangements.

Between April 1, 2025 and May 9, 2025, the Company issued approximately 24.4 million shares of common stock for proceeds of $5.2 million.

Between April 1, 2025 and May 9, 2025, the Company entered into several 2-year convertible notes (the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of $0.3 million. The Convertible Notes bear interest at 11% per annum and are convertible into common shares at $0.19 per share at the Holder’s sole option. 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.

Between April 1, 2025 and May 9, 2025, the Company issued approximately 8.3 million shares of common stock to certain lenders in lieu of cash payments of $2.7 million of debt, including $0.2 million interest. The Company also issued 3.7 million shares of common stock to extinguish $0.9 million outstanding share liability.

Between April 1, 2025 and May 9, 2025, $2 million of convertible note was converted into 9.5 million shares of common stock pursuant to the conversion option.

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