NORTHWEST BIOTHERAPEUTICS INC

1. Organization and Description of Business

Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks LLC, 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 27, 2025, the Company entered into an agreement to acquire Advent BioServices Ltd, a contract development and manufacturing organization (CDMO) and related party that manufactures the Company’s DCVax products. Upon the closing of that acquisition on October 24, 2025, Advent became an additional wholly owned subsidiary of the Company.

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 the process of review by the Medicines and Healthcare Products Regulatory Agency (MHRA). The Company is also in the process of restarting its DCVax®-Direct program for inoperable tumors.

2. Financial Condition, Going Concern and Management Plans

The Company has incurred annual net operating losses since its inception. The Company had a net loss of $61.6 million for the nine months ended September 30, 2025. The Company used approximately $30 million of cash in its operating activities during the nine months ended September 30, 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.

3. Summary of Significant Accounting Policies

Basis of Presentation

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

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 September 30, 2025, condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, condensed consolidated statement of stockholders’ deficit for the three and nine months ended September 30, 2025 and 2024, and the condensed consolidated statements of cash flows for the nine months ended September 30, 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 and nine months ended September 30, 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

Intangibles - Goodwill and Other - Internal-Use Software

In September 2025, the FASB issued ASU No. 2025 - 06, Intangibles - Goodwill and Other - Internal - Use Software (“ASU 2025 – 06”), which amends the guidance for accounting for software costs to reflect current software development practices, including iterative and agile methodologies, by removing references to development stages. It also clarifies the criteria for capitalization, which begins when both of the following occur: (1) management has authorized and committed to funding the software project and (2) it is probable that the project will be completed and the software will be used to perform the function intended. ASU 2025 - 06 is effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Early adoption is permitted. The amendments may be applied either prospectively, retrospectively, or utilizing a modified transition approach. The Company is currently assessing the impact of ASU 2025 - 06 on its condensed consolidated financial statements and disclosures.

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.

4. Fair Value Measurements

In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the fair value of liabilities related to certain 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 September 30, 2025 and December 31, 2024 (in thousands):

There wereno transfers between Level 1, 2 or 3 during the three-month and nine-month period ended September 30, 2025.

The following table presents changes in Level 3 liabilities measured at fair value for thenine-month period ended September 30, 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).

A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities and share payable that are categorized within Level 3 of the fair value hierarchy on the initial issuance date during the nine months ended September 30, 2025 and 2024, and remeasured as of July 26, 2025 (the reclassification date), September 30, 2025 and December 31, 2024 are as follows. The contingent payable derivative liability related to the remaining redemption feature which, like the convertible notes at fair value, included discount factors that were unobservable inputs and proprietary in nature.

5. Stock-based Compensation

The following table summarizes total stock-based compensation expense for the three and nine months ended September 30, 2025 and 2024 (in thousands).

The total unrecognized stock compensation (primarily for consultants) cost was approximately $0.9 million as of September 30, 2025 and will be recognized over the next 1.5 years.

Stock Options

The following table summarizes stock option activity for options during the nine months ended September 30, 2025 (amount in thousands, except per share number):

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 nine months ended September 30, 2025 was as follows:

Restricted Stock Awards

Advent SOW 6

There wasno stock based compensation related to Statement of Work #6 (“SOW 6”) recognized during the three and nine months ended September 30, 2025 and 2024. As previously reported, Advent previously achieved all of the 10 one-time milestones (i.e., for allsix 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 September 30, 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 September 30, 2025 and December 31, 2024 (in thousands):

Depreciation and amortization expense was approximately $1.3 million and $1.3 million for the nine months ended September 30, 2025, and 2024, respectively.

7. Outstanding Debt

The following two tables summarize outstanding debt as of September 30, 2025 and December 31, 2024, respectively (amount in thousands, except per share amounts):

• 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 November 7, 2026. The March Commercial Loan carries an original issue discount of $0.5 million.

On June 26, 2025, the Company entered into a Commercial Loan Agreement (the “June Commercial Loan”) with a commercial lender for an aggregate principal amount of $2.2 million. The June 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 June Commercial Loan is amortized in 14 installments starting on February 26, 2026. The June Commercial Loan carries an original issue discount of $0.2 million.

During the nine months ended September 30, 2025, the Company issued approximately 72.7 million shares of common stock with a fair value of $20 million to certain Note Payable lenders in lieu of cash payments of $15.3 million of debt, including $1.6 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 designated pricing period (the “Share payable”). During the nine months ended September 30, 2025, the Company settled $1 million of Share payables. The Company recognized an approximately $1.0 million and $3.7 million debt extinguishment loss respectively during the three and nine months ended September 30, 2025 from the Note Payable debt redemption.

Convertible Notes

During the nine months ended September 30, 2025, the Company modified a convertible note that was originally issued in February 2024 by extending the maturity dates and reducing the conversion price (the “Amended Convertible Note”). The modifications were accounted for as a debt extinguishment. As a result, the Company recognized approximately $49,000 of debt extinguishment gain during the nine months ended September 30, 2025 from this debt amendment.

In addition, the Company converted $1.1 million of the Amended Convertible Note, including $58,000 accrued interest, into 5.6 million shares of common stock at a conversion price of $0.20 per share.

Convertible Notes at Fair Value

During the nine months ended September 30, 2025, the Company entered into severaltwo-year convertible notes andone-year convertible notes (collectively the “Convertible Notes”) with multiple individual investors (the “Holders”) with an aggregate principal amount of$12.8 million. Of the total$12.8 million,$3 million was exchanged from a previously executed non-dilutive financial instrument. The fair value of the Convertible Notes on the issuance date was approximately$14.4 million. The Company recognized a loss of$1.6 million upon the issuance of the Convertible Notes, which was calculated at the difference between the principal amount and the fair value of the Convertible Notes. The Convertible Notes bear interest at 11% per annum and are convertible into common shares between$0.19 and$0.245 per share at the Holder’s option. In addition, the Holders have an alternative option to convert the Long-term Convertible Notes and the Short-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) at each reporting period.

During the nine months ended September 30, 2025, the Company modified certain existing convertible notes by (i) extending the maturity dates; (ii) reducing the conversion price, (iii) increase the interest rate, and (iv) granting the notes holders the right to further extend the maturity date of the notes for 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$2.5 million and$11 million of debt extinguishment loss during the three and nine months ended September 30, 2025 from these convertible note debt amendments.

During the nine months ended September 30, 2025, the Company converted$0.5 million of certain convertible notes that were originally issued in February 2025 into 2.5 million shares of common stock at conversion price of$0.21 per share.

Yorkville Note

As previously disclosed, on December 19, 2024, the Company entered into a Standby Equity Purchase Agreement (“SEPA”) with YA II PN, LTD (“Yorkville”). Upon entry into the SEPA, the Company issued Yorkville a$5.0 million convertible promissory note for net proceeds of$4.7 million after a 7% original issue discount (the “December Yorkville Note”). During the nine months ended September 30, 2025, the Company issued 21.5 million shares of common stock to convert$5.0 million of the December Yorkville Note. As of September 30, 2025, the December Yorkville Note was fully converted.

On June 30, 2025, the Company and Yorkville entered into a supplemental agreement (the “SEPA Supplemental Agreement”) to increase the amount of convertible promissory notes allowed to be issued by$3.0 million (the “Additional Pre-Paid Advance Amount”). On June 30, 2025, the Company issued Yorkville a$3.0 million convertible promissory note for net proceeds of$2.9 million after a 5% original issue discount (the “June Yorkville Note”). The June Yorkville Note does not bear interest and matures on June 30, 2026. The June Yorkville Note is convertible into the Company’s common Stock at a conversion price equal to the lower of (i)$0.2932 per share (the “Fixed Price”), or (ii) a price per share equal to 95% of the lowest daily VWAP during the 5 consecutive trading days immediately prior to the conversion date (the “Variable Price”). The amounts of such conversions are limited to$0.8 million in any given calendar month unless the conversion price is above$0.2932 per share.

The Company elected the FVO to fair value the June Yorkville Note on the issuance date and will subsequently remeasure at the end of each reporting period. The estimated fair value of the June Yorkville Note on the issuance date was approximate$3.8 million. The Company recognized a loss of$0.8 million upon the issuance of the June Yorkville Note, which was calculated at the difference between the principal amount and the fair value of the note. During the nine months ended September 30, 2025, the Company issued 4.7 million shares of common stock to convert$1.1 million of the June Yorkville Note. As of September 30, 2025, the fair value of the remaining June Yorkville Note was$2.4 million, which was included in Convertible notes at fair value on the consolidated balance sheets.

For the three months ended September 30, 2025 and 2024, interest expense related to outstanding debt totaled approximately$2.6 million and$1.7 million including amortization of debt discounts totaling$0.4 million and$0.5 million, respectively.

For the nine months ended September 30, 2025 and 2024, interest expense related to outstanding debt totaled approximately$6.0 million and$4.9 million including amortization of debt discounts totaling$1.3 million and$1.6 million, respectively.

8. Net Loss per Share Applicable to Common Stockholders

Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share would be computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. Because of the net loss from operations for each period, inclusion of such securities in the computation of loss per share would be anti-dilutive and thus they are excluded. Potentially dilutive weighted average common shares include common stock potentially issuable under the Company’s convertible notes and preferred stock, warrants and vested and unvested stock options.

The following securities were not included in the diluted net loss per share calculation because their effect was anti-dilutive as of the periods presented (in thousands):

9. Related Party Transactions

Advent BioServices, Ltd. (“Advent”) was a related party based in the U.K., which carried out the Company’s product development, manufacturing, cryostorage and distribution on a contract services basis. As previously reported, the Company entered into an Agreement to acquire Advent on August 27, 2025, and the acquisition closed on October 24, 2025. Upon the closing, Advent became a wholly owned subsidiary. The following sections describe the contractual arrangements between the Company and Advent prior to the acquisition, and the operational activities and milestones pursuant to those contracts.

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) periodic specialized programs such as the program related to the MAA pre-requisites, drafting and submission. The Company also executed a 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 was covered by a separate contract. The ongoing manufacturing in the London facility was covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility was covered by an Ancillary Services Agreement entered into on November 18, 2019. Each periodic specialized program was covered by an SOW that set forth the role and activities to be undertaken by Advent for that program, and provided for milestone payments upon completion of key elements of the program.

The Ancillary Services Agreement established a structure under which the Company and Advent negotiated and agreed 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 was agreed and approved by the Company, Advent would proceed with, or continue, the applicable services and would invoice the Company pursuant to the SOW. Since both the facility development and the compassionate use program involved pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement was on the basis of costs incurred plus fifteen percent. The SOWs could 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 has extended the term year byyear, to July 2024, to July 2025 and to July 2026.

SOW 8

On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that was incorporated into the Ancillary Services Agreement that was originally entered into dated November 8, 2019 and was extended as described above. SOW 8 covered 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 consisted solely of one-time cash milestone payments for each stage of the work and Advent would only receive the compensation when the applicable work was 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 included the following 5 one-time milestones with corresponding milestone payments (which were only payable after the milestone had been achieved):

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

Review of documents, specifications and data from the 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 September 30, 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 September 30, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.6 million as of September 30, 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 September 30, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.8 million as of September 30, 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, and process performance qualifications. For technology transfer into the clean rooms, each employee operator individually must pass 3 consecutive and successful aseptic process simulations in the clean room and also 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 September 30, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.5 million as of September 30, 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 September 30, 2025, this milestone had not been fully completed. Advent had completed the new IND CMC section (comprising part of this milestone) but the new IND had not yet been submitted to and approved by regulators (comprising the other part of this milestone). The Company had an accrued liability of $0.4 million as of September 30, 2025 related to this milestone.

The following table summarizes total research and development costs from Advent for the three and nine months ended September 30, 2025 and 2024, respectively (in thousands).

Advent BioServices Sublease Agreement

On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent (see Note 12).

During the three months ended September 30, 2025 and 2024, the Company recognized sub-lease income of $36,000 and $36,000, respectively.

During the nine months ended September 30, 2025 and 2024, the Company recognized sub-lease income of $109,000 and $109,000, respectively.

Related Party Accounts Payable

As of September 30, 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.

10. Preferred Stock

Series C Convertible Preferred Stock

During the nine months ended September 30, 2025, approximately 0.1 million Series C Shares with a book value of $1.8 million were converted into 3.3 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.

11. Stockholders’ Deficit

Common Stock

During the nine months ended September 30, 2025, the Company received $17.3 million from the issuance of 78.5 million shares of common stock.

Stock Purchase Warrants

The following is a summary of warrant activity for the nine months ended September 30, 2025 (dollars in thousands, except per share data):

Warrant Modifications

During the nine months ended September 30, 2025, the Company amended certain warrants whereby, among other terms, 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.

The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $1.2 million for the nine months ended September 30, 2025, 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.

Warrant Reclassification

As previously reported, on December 23, 2024, in connection with entering into a stock purchase agreement with an individual investor (the “Investor”), the Company amended the Investor’s existing 32.5 million warrants (the “Warrants”) by extending the maturity date and adding an additional restriction to the Investor’s exercisability. Because the Warrants could potentially be settled in cash based on events that are outside the control of the Company, that precluded application of the equity contract scope exception to the Warrants, and the Warrants are classified as a liability.

On July 26, 2025, the Company further extended the maturity date of the Warrants and the potential cash settlement provision was removed. As a result, the Company reclassed the Warrants from liability to equity as of the amendment date for total $3.3 million which represents the fair value of the Warrants as of the amendment date.

12. Commitments and Contingencies

Operating Lease- Lessee Arrangements

The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected 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 prior office lease in the U.K. expired in July 2025. In January 2025, the Company entered into an agreement for a new office lease in the U.K. to begin in late May 2025 (the “2025 U.K. Office Lease”). An additional document, involving a reconstitution schedule, was required in order to complete the lease arrangement. However, the Company decided not to take the space and the parties did not reach agreement on the reconstitution schedule. The Company entered into a side letter with the landlord on July 30, 2025 to finalize the lease exit terms. The Company is required to pay $0.1 million each quarter for a maximum of 2.5 years. Payment will stop upon the property being leased to a new tenant. The company recognized a loss contingency of $1.0 million related to the lease settlement. The Company will recognize any remaining unpaid lease liability as a gain contingency upon the early exit of the lease liability.

The Company’s office lease in the U.S. would have expired in August 2024. However, 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 September 30, 2025, the Company had operating lease liabilities of approximately $4.8 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 $4.3 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 $7.73 per square foot based on exchange rate as of September 30, 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 $739,000) 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):

The Company recorded lease costs as a component of general and administrative expense during the nine months ended September 30, 2025 and 2024, respectively.

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

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

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 provided for manufacturing of DCVax-L products at an existing facility in London. The MSA was structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA provided for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company was 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 utilized the dedicated capacity and number of patients. The MSA was to remain 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 could 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 were anticipated to total approximately £4.7 million ($6.4 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 September 30, 2025, the Company accrued for trade tax liability of €155,000 (approximately $181,000) and corporation tax of €99,000 (approximately $116,000). 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 Obligations

During the nine months ended September 30, 2025, the Company exchanged $3 million from a previously executed non - dilutive financial instrument to a new convertible note (see Note 7). As of September 30, 2025, the Company had contingent payment obligations of $1.7 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

On October 27, 2025, the Company entered into a Commercial Loan Agreement (the “October Commercial Loan”) with a commercial lender for an aggregate principal amount of $5.5 million. The October 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 October Commercial Loan will be amortized in 14 installments starting on June 26, 2026. The October Commercial Loan carries an original issue discount of $0.5 million.

On October 24, 2025, the Company closed the acquisition of Advent BioServices Ltd. (“Advent”). As a result of this acquisition, Advent is now a wholly owned subsidiary of NWBio. Though the acquisition of Advent, the Company is receiving all of Advent’s fixed assets, including extensive cryostorage and other equipment purchased by Advent over the last several years. Intellectual property and other intangibles that Advent had acquired are also included. The Company isnot issuing any shares or other securities in connection with acquiring Advent. On the contrary,19 million of the Company’s securities (13.5 million shares and 5.5 million options) that were previously issued to Advent as payment for contract services are reverting back to the Company along with the acquisition of the other Advent assets. The consideration for the acquisition will be paid in installments overtwo years, with potential acceleration after regulatory approval of the Company’s DCVax®-L product. The consideration consists of a payment of £1.4 million (approximately $1.9 million) and payment of the net amount of accounts payable (“Net AP”) already due from the Company to Advent for services under existing contracts.

On October 9, 2025, the Company entered into an agreement with Lead Plaintiff F. Glenn Schaeffer (“Plaintiff”) for settlement of the Delaware Action. See Part II Item 1, Legal Proceedings, below.

Between October 1, 2025 and November 11, 2025, the Company issued approximately 6.8 million shares of common stock for proceeds of $1.4 million.

Between October 1, 2025 and November 11, 2025, the Company issued approximately 8.5 million shares of common stock to certain lenders in lieu of cash payments of $1.8 million of debt. The Company also issued 1.8 million shares of common stock to extinguish $0.4 million outstanding share liability.

Between October 1, 2025 and November 11, 2025, $1.1 million of convertible notes, including $0.1 million accrued interest were converted into 5.4 million shares of common stock pursuant to their conversion options.