ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read this discussion together with the Financial Statements, related Notes and other financial information included elsewhere in this Form 10-K. The following discussion contains assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors,” and elsewhere in this Form 10-K. These risks could cause our actual results to differ materially from those anticipated in these forward-looking statements.

The following Management’s Discussion and Analysis provides a historical and prospective narrative on the Company’s financial condition, and results of operations for the year ended December 31, 2024 as compared to the year ended December 31, 2023.

We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. Our additional product, DCVax®-Direct, is designed to treat inoperable solid tumors.

Intensive activities continued throughout 2024, including in Q4, in multiple areas including the following:

● planning for possible initial commercialization;

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● extensive litigation activities.

These activities continued to require extensive use of specialized technical and regulatory consultants and legal counsel, with the costs of these services alone totaling about one-third of all costs incurred by the Company for the year (about $18 million). Costs incurred just for the GMP facilities themselves - not including any personnel or program costs - continued to be very expensive (multi millions) as is typically the case for GMP clean room facilities. In addition, some costs that may be minor in other types of businesses are substantial in the Company’s business (e.g., $5 million per year for insurance coverages).

Marketing Authorization Application (MAA) and Inspections. The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections. The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible. As previously reported, the Company plans to announce the results when the MHRA review and decision-making is finished and does not plan to provide interim updates.

Planning for Possible Initial Commercialization. The Company’s contract manufacturer, Advent BioServices, has prepared plans for how the manufacturing of DCVax-L products could be ramped up in the event of potential commercialization using just the existing two manufacturing suites and facilities, and could potentially reach a significant portion of the Glioblastoma patients in the UK. The plans include a transition from a single daily shift of operations to two shifts daily, supply chain considerations and determination of the personnel that would be required. The plans also include potential arrangements for a simplified initial Grade C lab, as described below. Advent estimates that this simplified initial Grade C lab could enable doubling of the production that would be feasible with the existing two manufacturing suites. Arrangements with private clinics have also been developed, as described below, which could potentially assist with initial commercialization. In addition, during 2024, the Sawston facility received its first regulatory inspection under the MIA license that was approved by the MHRA in March 2023 for commercial manufacturing of cell therapy products. This was an important milestone to confirm that the Sawston facility is operating on an ongoing basis at the level required for potential commercial operations

Simplified Grade C Lab in the Sawston Facility. The Sawston facility current has two Grade B labs. Such labs are required to be used for any manufacturing process that involves any open steps (i.e., open to the air). Grade C labs are much less expensive to operate, and allow multiple patients’ products to be manufactured at the same time in the same lab, but may only be used with closed systems. The Flaskworks system is closed and suitable for Grade C labs. The design and engineering works were previously completed for two Grade C labs, but the buildout will require substantial capital. Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs, the Company has held off on raising and using the capital required to build the two Grade C labs. Meanwhile, Advent has devised plans for a simplified initial Grade C lab adjacent to one of the Grade B labs, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. The simplified Grade C lab can be completed for a fraction of the cost and less than half the time for the regular Grade C labs. The Company anticipates potentially proceeding with this in the coming months when appropriate.

Potential Manufacturing in the US. During much of 2024 and Q1 2025, the Company has been in discussions with a series of half a dozen independent parties with GMP facilities in diverse areas of the US, to obtain capacity and availability for potential manufacturing in the US. The manufacturing is initially contemplated to include DCVax-L products and DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh.

Pediatric Brain Cancer Trial. The Company worked throughout the year to obtain engagement of pediatric neurosurgeons and neuro-oncologists for the pediatric trial that is legally required in connection with the MAA application for adult patients. The clinicians requested substantial changes in the trial design and plans that had been approved by MHRA. After a long process, a new trial design was agreed by the clinicians. The Company plans to obtain MHRA approval of the new design and move forward with the trial in due course.

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Applications for Approval in Additional Countries Beyond the UK. During Q4 2024, the Company engaged specialized consultants to review the regulatory requirements for submission of an application for product approval in certain additional countries beyond the UK, review the MAA package that the Company submitted in the UK, and determine what changes or additions would be needed to adapt the MAA package for certain other applications. The Company’s work with these consultants is ongoing.

Reimbursement. The Company has been working with its specialized reimbursement consultants to evaluate the categories of review processes which could potentially apply to the Company’s DCVax-L product for Glioblastoma brain cancer (GBM). The Company and its consultants are gathering information needed for the health economics and outcomes (HEO) analyses, and analyses of the relevant clinical landscape.

Compassionate Use Program. The Company receives an ongoing stream of requests from patients and physicians for compassionate use of its DCVax products for a variety of cancers and patient situations. The Company has been operating a Specials program in the UK for a number of years to try to help brain cancer patients where it can. During 2024, the Company established collaborations with several private clinics in London to enable the Specials program to be expanded and increased. The Company is in the process of making the operational arrangements to implement these clinic collaborations for an expanded program. The Company is also working on significant cost reductions. The Company believes that having these private clinic arrangements in place will also be quite helpful for initial potential commercialization.

DCVax-Direct Manufacturing. The Company’s contract manufacturer, Advent BioServices has completed the long process of developing the DCVax-Direct manufacturing process in the UK and is ready to proceed with production of DCVax-Direct for clinical trials commencing in Q2 2025. This process has taken nearly two years, in between priority work related to the MAA, and has involved a number of stages including technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, identification and evaluation of commercially available systems to substitute for the TFF system previously used for the DCVax-Direct production, engineering runs and data generation to confirm comparability, etc.

New DCVax-Direct Product (DCVax-DR). Advent has also completed the long process of developing a new formulation of DCVax-Direct (referred to as DCVax-DR). As previously reported, it was necessary to develop second version of DCVax-Direct because of a persistent worldwide shortage of a key ingredient in the original DCVax formulation (an immune booster ingredient). Developing the second formulation required research into a range of other candidate ingredients to identify ones with sufficiently similar properties or immunological results, testing to determination the appropriate amount and methods of incorporating such candidate ingredients, further testing and data generation to confirm comparability, and development of new SOPs and other regulatory documents. In parallel, Advent has also undertaken extensive efforts to secure supplies of the original booster ingredient, and has found a suitable source. The Company plans to have Advent produce the original formulation of DCVax-Direct as well as the DCVax-DR formulation, and to test both in further clinical trials for optimal results.

DCVax-Direct Clinical Trials. The Company has been preparing for resumption of clinical trials of DCVax-Direct for quite a while, and plans to conduct those trials in the U.S. The Company has been working with clinicians for months to design the first two trials (one pediatric, one adult). The protocol for the first trial has been drafted, discussed and agreed with the clinicians and is in late stage review by the clinicians and their institution. The protocol for the second trial has been drafted and is undergoing discussion and modifications with the clinicians. The Company plans to submit both studies to the FDA in Q2 2025, and plans to announce the details after they have been cleared by the FDA. These trials have particularly been designed to be compact and streamlined, using Simon’s two-stage designs to start small and then expand if encouraging results are seen, and focusing on tumor response (shrinkage) endpoints which have a much faster timeframe than time-to-event endpoints such as overall survival, which do not require any control arms and which can be much smaller and more economical trials for value creation. The Company’s prior Phase 1 trial at MD Anderson covered 13 diverse types of solid tumors in very late stage patients with multiple inoperable tumors who had failed all standard treatments. The trial results were very encouraging and the Company is building on those results in several ways for the upcoming trials.

Clinical Trials With Roswell and Pittsburgh IP. The Company has been working with Dr. Kalinski and leading clinicians to develop arrangements for clinical trials of two dendritic cell treatments from the portfolios in-licensed by the Company from Roswell Park and the University of Pittsburgh. One of the DC treatments involves loading DCs with abnormal tumor blood vessel antigens (TBVA), and the other involves intra-tumoral injection of unloaded dendritic cells (similar to the Company’s DCVax-Direct but with the DCs prepared differently and having different properties). Each of these two products is anticipated to be applicable to most types of solid tumors. The DCs loaded with TBVA have already been tested in a Phase 1 trial for melanoma and the results were encouraging. The trials being planned will utilize Simon’s two-stage designs in order to start small and then expand only if encouraging results are seen. These trials

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will also use Simon’s two stage designs and will focus on tumor response endpoints in order to be compact and efficient. These trials are separate from the investigator-sponsored trials in the portfolios licensed from Roswell and Pittsburgh.

Flaskworks System. During 2024, the Company’s Flaskworks team and Advent, together with a specialized external contractor, completed the design work for a GMP-compatible second prototype of its system for closed preparation of DCVax-L products. An initial prototype had been completed in 2023. The second prototype included upgraded functionality, however it was also considerably larger than the first prototype as a result, and the effect would be to reduce the number of systems that could fit in each Grade C lab and hence reduce the amount of products that could be produced. After further evaluations, the Company decided to go forward with the first prototype. The Company has arranged for another specialized external contractor (in the UK), has brought that contractor up to speed and has that contractor standing by to fabricate GMP units of the first prototype as soon as the Company is ready. The Flaskworks units will only be usable in the Grade C labs, and hence are not useful until the Grade C labs have been constructed, validated and are operational. Since the timeframe for fabricating the Flaskworks units is much shorter than the timeframe for buildout of the Grade C labs (including the simplified initial Grade C lab), the Company has been holding off on proceeding with the fabrication until closer to the time when the initial Grade C lab will be operational.

Commercial Collaborations. The Company has undertaken discussions and negotiations with a number of companies who have products that could serve as booster agents either in the manufacturing of DCVax products or in combination treatment regimens with DCVax or both. The Company has completed a License and Supply Agreement with a company for one such agent, which is a TLR (toll like receptor) agonist, and the Company is now in the process of collaborating with that Company to design a clinical trial of a combination treatment regimen. The Company has already identified lead investigators for this trial, and anticipates submitting the IND for this trial to the FDA in Q2 2025. The Company plans to announce the trial when the IND has been cleared by the FDA. The Company is also testing this TLR agonist in its internal lab research on enhanced versions of DCs, as described below.

The Company has been in discussions since mid-2024 with a different company to in-license a different type of booster agent – one that big pharma has been trying for years to develop as a treatment itself. The Company executed a Material Transfer Agreement with that company and has been testing samples of this agent in internal lab research as described below. The Company has also been in negotiations since early Q4 2024 for potential acquisition of another company with a dendritic cell related technology. The Company hopes to complete these negotiations during Q2 or Q3 2025.

Internal Lab Research on Booster Agents. The Company has developed a substantial portfolio of agents that have already been in-licensed or are in discussions for in-licensing, and that may further boost the potency of the dendritic cells in DCVax products. The Company believes that administering an extra potent DCVax treatment may be helpful in its clinical trials going forward, as those trials will be focusing on tumor response (shrinkage) endpoints.

The Company has been conducting lab research in-house in its Flaskworks facility to test the effects of these booster agents alone and in combination, in both DCVax-L and DCVax-Direct products. The results have differed in the DCVax-L dendritic cells vs. the DCVax-Direct dendritic cells, and have varied according to the dose, the timing, the combinations and other factors. It appears that some of this research may potentially create some new IP. The Company plans to continue this lab research while the initial clinical trials of DCVax-Direct get under way, and then plans to select the most useful booster agent(s) or combination(s) to produce enhanced versions of DCVax products for testing in additional trial cohorts.

Intellectual Property. The Company continued to devote substantial resources to building its patent portfolio as a key part of building its franchise in dendritic cell technologies. During 2024, 6 new patents were issued to us related to DCVax products and processes, and 10 new patents were issued or allowed relating to Flaskworks technologies. As of December 31, 2024, we had built an overall portfolio of more than 55 issued patents (including European validations) and more than 65 pending patent applications (including European validations) worldwide, grouped into a number of patent families. In addition, the Company is continuing to in-licensed patents developed by others which it believes add further breadth and strategic value.

Positive Progress in Litigation. Throughout 2024, the Company devoted significant amounts of bandwidth and resources to litigation activities, and the Company plans to continue doing so. The Company believes the litigation activities are making important progress. See Item 1, Legal Proceedings, above.

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Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues and expenses.

On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses and stock-based compensation. We based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates.

Fair Value of Financial Instruments

ASC 820, Fair Value Measurements, provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.

The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.

Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.

The Company accounts for the issuance of common stock purchase warrants issued in connection with the equity offerings in accordance with the provisions of ASC 815, Derivatives and Hedging (“ASC 815”). The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company accounts for certain common stock warrants outstanding as a liability at fair value and adjusts the instruments to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in its Consolidated Statements of Operations and Comprehensive Loss. The fair value of the warrants issued by the Company has been estimated using Monte Carlo simulation and or a Black Scholes model. The warrant liabilities are valued using Level 3 valuation inputs (see Note 4).

Derivative Financial Instruments

The Company has derivative financial instruments that are not hedges and do not qualify for hedge accounting. Changes in the fair value of these instruments are recorded in other income (expense), on a net basis in the Consolidated Statements of Operations and Comprehensive Loss.

The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. As a result of entering into a convertible debt instrument (see Note 7) for which such instrument contained a variable conversion feature with no floor price, the Company has adopted a sequencing policy as described below within Note 3 in accordance with ASC 815-40-35-12 “Derivatives and Hedging” (provides comprehensive guidance on derivative and hedging transactions) whereby all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors.

Impairment of Long-Lived Assets

The Company assesses its long-lived assets for impairment whenever facts and circumstances indicate that the carrying amounts may not be fully recoverable. To analyze recoverability, the Company projects undiscounted net future cash flows over the remaining lives

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of such assets. If these projected cash flows are less than the carrying amounts, an impairment loss would be recognized, resulting in a write-down of the assets with a corresponding charge to earnings. The impairment loss is measured based upon the difference between the carrying amounts and the fair values of the assets. Assets to be disposed of are reported at the lower of the carrying amounts or fair value less cost to sell. Management determines fair value using the discounted cash flow method or other accepted valuation techniques.

As of December 31, 2024 and 2023, the undiscounted net future cash flows of the U.K. property were greater than the carrying value. Therefore, no impairment loss was considered necessary.

Sequencing

The Company adopted a sequencing policy under ASC 815-40-35 whereby in the event that reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to (i) the Company’s inability to demonstrate it has sufficient authorized shares as result of certain financial instrument with a potentially indeterminable number of shares due to a variable conversion feature with no floor, or (ii) the company committing more shares than authorized, all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest maturity date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy.

Modification of Equity Classified Warrants

A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.

Convertible Notes under Fair Value Option

The Company accounts for certain convertible notes issued from August to October 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred.

Stock Based Compensation

Share-based compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award using the Black-Scholes option-pricing model and is recognized over the service period required for the award.

We estimate the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

Expected Term - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the simplified method, which is the half-life from vesting to the end of its contractual term.

Expected Volatility - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.

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Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield available on U. S. Treasury zero-coupon issues with an equivalent remaining term.

Expected Dividend - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.

We recognize forfeitures when they occur.

Recently Adopted Accounting Standards

Improvements to Reportable Segment Disclosures

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, “Improvements to Reportable Segment Disclosures (Topic 280)” which is intended to improve reportable segment disclosure requirements, primarily through incremental disclosures of segment information on an annual and interim basis for all public entities. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. The ASU is to be applied retrospectively to all prior periods presented in the financial statements and is effective for our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and interim periods thereafter. The Company adopted this guidance with no material impact on its consolidated financial statements, and our expanded disclosures are included below under “Segment Information.”

Recently Issued Accounting Standards Not Yet Adopted

Improvements to Income Tax Disclosures

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

Results of Operations

Operating costs:

Our operating costs and expenses consist primarily of research and development (R&D) expenses. R&D expenses include clinical trial expenses, and increased costs after completion of a Phase III trial, especially for the extensive preparations, and teams of expert consultants, required for an application for product approval.

In addition to clinical trial and post-trial costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, manufacturing process development, quality control process development, and related matters. Additional substantial costs relate to the development and expansion of manufacturing capacity.

Our operating costs also include the costs of preparations for the launch of new or expanded clinical trial programs, such as our anticipated trials of combination treatment regimens. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other.

Our operating costs also include legal and accounting costs in operating the Company.

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The foregoing operating costs include the costs for Flaskworks’ ongoing operations and intellectual property filings, and the operations of our subsidiaries in the U.K., the Netherlands and Germany.

Research and development:

R&D expenses include costs for substantial external scientific personnel, technical and regulatory advisers, and others, costs of laboratory supplies used in our internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial operation and management when we are actively engaged in clinical trials.

Because we are a company with no commercial product sales revenue, we do not allocate research and development costs on a project basis. We adopted this policy, in part, due to the unreasonable cost burden associated with accounting at such a level of detail and our limited number of financial and personnel resources.

General and administrative:

General and administrative expenses include personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal services, property and equipment and amortization of stock options and warrants.

For the Years Ended December 31, 2024 and, 2023

We recognized a net loss of $83.8 million and $62.6 million for the years ended December 31, 2024 and 2023.

Net cash used in operations was $57.0 million and $53.6 million for the years ended December 31, 2024 and 2023, respectively.

Research and development expense

For the years ended December 31, 2024 and 2023, research and development expense were $34.9 million and $27.7 million, respectively. The breakdown of this increase in R&D expenses in 2024 as compared to 2023 was primarily related to a net increase in expenses of approximately:

● $2.4 million for the ramp up toward resumption of DCVax-Direct production,

● $1.4 million for specialized scientific testing,

● $0.1 million increase in stock-based compensation

for a total year over year increase of approximately $7.2 million in Research and Development expenditures involving substantial progress on some of the Company’s most important programs.

General and Administrative Expense

General and administrative expenses were $33.0 million and $29.7 million for the years ended December 31, 2024 and 2023, respectively.

The increase of $3.3 million in 2024 compared to 2023 was mainly related to an increase of $3.8 million in legal expenses, which was partially offset by a decrease of $0.4 million related to stock-based compensation.

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Change in Fair Value of Derivatives

We recognized a non - cash gain of $0.4 million and $3.6 million for the years ended December 31, 2024 and 2023, respectively. The gain was primarily due to the decrease of our closing stock price as of December 31, 2024 compared to December 31, 2023. The higher gain in 2023 was mainly due to the non-cash revaluation gain recognized as of January 9, 2023, when we reclassed all warrants from liability classified to equity classified. The stock price on January 9, 2023 and December 31, 2022 was $0.71 and $0.78 per share, respectively.

Change in Fair Value of Convertible Notes

We recognized a non-cash gain of $7.7 million and a non-cash loss of $2.0 million from the change in fair value of the convertible notes during the year ended December 31, 2024 and 2023, respectively. The gain during the year ended December 31, 2024 was primarily due to the decrease of stock price as of December 31, 2024 compared to December 31, 2023. The loss during the year ended December 31, 2023 was primarily due to the increase in the stock price as of December 31, 2023 compared to the stock price on the issuance dates in August and September 2023.

Debt Extinguishment

We recognized approximately $14.4 million and $5.4 million debt extinguishment loss during the year ended December 31, 2024 and 2023, respectively, from debt redemptions and debt amendments. The increase during the year ended December 31, 2024 compared to the year ended December 31, 2023 was mainly due to multiple amendments on the existing convertible notes at fair value which resulted an aggregate debt extinguishment loss of $8.7 million.

Loss from Issuance of Debt

During the year ended December 31, 2024, we recognized an $0.8 million loss from the issuance of the Yorkville Note, which we elected to account for under the FVO. The estimated fair value of the Yorkville Note on the issuance date was approximately $5.8 million, which resulted in a loss of $0.8 million calculated at the difference between the principal amount and the fair value of the Yorkville Note.

Loss from warrant modification

During the years ended December 31, 2024, we recognized an $0.8 million loss from warrant modifications related to an amendment to certain warrants that were liability classified and such amendment was in conjunction with an equity offering.

Interest expense

During the years ended December 31, 2024 and 2023, we recorded interest expense of $7.8 million and $5.2 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.

Foreign currency transaction (loss) gain

During the years ended December 31, 2024 and 2023, we recognized foreign currency transaction loss of $1.5 million and a gain of $2.0 million, respectively. The loss was due to the strengthening of U.S. dollar relative to the British pound sterling and vice versa for the gain.

Liquidity and Capital Resources

We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of revenues and must cover our operating expenses through debt and equity financings to allow us to continue as a going concern. Our ability to continue as a going concern depends on the ability to obtain adequate capital to fund operating losses until we generate adequate cash flows from operations to fund our operating costs and obligations. If we are unable to obtain adequate capital, we could be forced to cease operations.

We depend upon our ability, and will continue to attempt, to secure equity and/or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Our management determined that there was substantial doubt about our ability

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to continue as a going concern within one year after the consolidated financial statements were issued, and management’s concerns about our ability to continue as a going concern within the year following this report persist.

Contingent Contractual Payment

The following table summarizes our contractual obligations as of December 31, 2024 (in thousands):

Payment Due by Period

Less than 1 to 2 3 to 5

Total 1 Year Years Years

Short term convertible notes payable (1)

6% unsecured $ 258 $ 258 $ — $ —

Short term convertible notes payable at fair value (2)

Short term notes payable (3)

6% secured 262 262 — —

Long term convertible notes payable at fair value (2)

Long term notes payable (4)

Minimum commitment obligation (6) 5,827 — 5,827 —

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Operating Activities

We used $57.0 million and $53.6 million in cash for operating activities during the years ended December 31, 2024 and 2023, respectively. The increase in cash used in operating activities was primarily attributable to an increase in clinical trial related expenditures.

Investing Activities

We spent approximately $1.0 million and $3.4 million in cash for purchases of equipment in the U.K. and the build-out of our facility in Sawston, U.K. during the years ended December 31, 2024 and 2023, respectively.

Financing Activities

We received approximately $8.2 million and $13.3 million cash from issuances of 0.8 million and 1.0 million shares of Series C convertible preferred stock during the years ended December 31, 2024 and 2023, respectively.

We received approximately $14.2 million from issuances of common stock during the year ended December 31, 2024.

We received approximately $1.5 million and $1.7 million of cash proceeds from the exercise of warrants and options during the years ended December 31, 2024 and 2023, respectively.

We received approximately $14.0 million and $20.0 million in cash proceeds from the issuance of multiple notes payable during the years ended December 31, 2024 and 2023, respectively.

We received approximately $20.0 million and $13.3 million cash proceeds from issuance of convertible notes payable to individual lenders during the year ended December 31, 2024 and 2023, respectively.

We received $50,000 and $5.0 million from issuance of non-dilutive funding agreements during the year ended December 31, 2024 and 2023, respectively.

We made aggregate debt payments of $1.4 million and $0.4 million during the years ended December 31, 2024 and 2023, respectively.

We made repayment of $0.2 million of investor advances during the year ended December 31, 2023.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not Applicable.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The full text of our audited consolidated financial statements as of December 31, 2024 and 2023 and for the fiscal years ended December 31, 2024 and 2023, begins on page F-1 of this Annual Report on Form 10-K.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We, the management of Northwest Biotherapeutics, Inc. (the “Company”), are responsible for establishing and maintaining adequate internal control over financial reporting of the Company.

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We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including to our Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure.

As required by Rule 13a-15 under the Exchange Act, our management, including our Chief Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2024. In making this assessment, the Company’s management used the criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).

Our management concluded that as of December 31, 2024, our disclosure controls and procedures were effective.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management of the Company, including our CEO and Principal Financial and Accounting Officer, assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2024. Based on this assessment, we determined that we have effectively designed and implemented, consistently performed, and tested the functioning of these controls. Accordingly, we concluded that the Company’s internal control over financial reporting was effective as of December 31, 2024.

Attestation Report on Internal Control over Financial Reporting

This annual report on Form 10-K does not include an attestation report of our independent registered public accounting firm because we qualified as a “smaller reporting company and non-accelerated filer.”

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B. OTHER INFORMATION

None.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

None.

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PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

DIRECTORS

Name Age Position

J. Cofer Black 74 Class I Director

Dr. Alton L. Boynton 79 Class I Director, Chief Scientific Officer

Pat Sarma 79 Class II Director

Dr. Navid Malik 55 Class III Director

Director Biographies

Linda F. Powers. Ms. Powers has served as the Chairperson of our Board of Directors since her appointment on May 17, 2007, Chief Executive Officer and President since June 8, 2011 and Chief Financial and Accounting Officer since June 8, 2020. Ms. Powers served as a managing director of Toucan Capital Fund II from 2001 to 2010, and Toucan Capital Fund III from 2010 to 2018. She also has over 20 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers is or was previously a Board member of the Rosalind Franklin Society, M2GEN (an affiliate of Moffitt Cancer Center) and the Chinese Biopharmaceutical Association. She was the Chair of the Maryland Stem Cell Research Commission for the first two years of the state’s stem cell funding program, and has served an additional 14 years on the Commission. Ms. Powers served for several years on a Steering Committee of the National Academy of Sciences, evaluating government research funding, and was appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. For more than six years, Ms. Powers taught an annual internal course at the National Institutes of Health for the bench scientists and technology transfer personnel on the development and commercialization of medical products. Ms. Powers serves on the boards of several private biotechnology companies. Ms. Powers holds a B.A. from Princeton University, where she graduated magna cum laude and Phi Beta Kappa. She also earned a J.D., magna cum laude, from Harvard Law School. We believe Ms. Powers’ background and experience make her well qualified to serve as a Director.

J. Cofer Black. Ambassador Black was appointed to the Board of Directors in January 2016. Ambassador Black is an internationally renowned U.S. government leader and expert in cybersecurity, counterterrorism and national security. In addition to serving on company and bank boards, he presently serves as an independent consultant. Between 2009 and 2016, he served as Vice President for Global Operations at Blackbird Raytheon Technologies, a division of Raytheon Company, a NYSE-listed security company. From 2004 until 2008, he provided strategic guidance and business development as Vice Chairman of Blackwater Worldwide and as Chairman of Total Intelligence Solutions. During 2002 – 2005, he was appointed by the President of the United States to serve as the Ambassador, Coordinator for Counterterrorism, reporting directly to the Secretary of State for developing, coordinating and implementing American counterterrorism policy. Prior to his role as Ambassador, he served a 28-year career in the Central Intelligence Agency, reaching Senior Intelligence Service (SIS-4) level as Director, Counterterrorist Center (D/CTC), where he managed 1,300 professional personnel and an annual operational budget of more than one billion dollars. Ambassador Black is experienced representing the United States at the Head of State level, managing media as a diplomatic spokesperson and in public speaking as keynote speaker both as a senior U.S. Government official and business leader. Ambassador Black has received numerous awards and recognitions throughout his career, including the Distinguished Intelligence Medal (the CIA’s highest award for achievement). Ambassador Black received a B.A. in International Affairs from the University of Southern California in 1973 and an M.A. in International Affairs from the University of Southern California in 1974. We believe Ambassador Black’s background and experience in business management and information technology make him well qualified to serve as a Director.

Alton L. Boynton, Ph.D. Dr. Boynton co-founded our Company, has served as our Chief Scientific Officer and a Director since our inception in 1998, was appointed our Chief Operating Officer in August 2001, was appointed President in May 2003, and served as Chief Executive Officer from June 2007 to June 2011. Prior to founding our Company, Dr. Boynton headed the Molecular Oncology research lab at the Pacific Northwest Research Foundation (the original foundation of Bill Hutchinson, from which the Fred Hutchinson Cancer Center was spun off). Dr. Boynton also served as Director of the Department of Molecular Medicine of Northwest Hospital from 1995 to 2003 where he coordinated the establishment of a program centered on carcinogenesis. Prior to joining Northwest Hospital, Dr. Boynton was Associate Director of the Cancer Research Center of Hawaii, The University of Hawaii, where he also held the positions

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of Director of Molecular Oncology of the Cancer Research Center and Professor of Genetics and Molecular Biology. Dr. Boynton received his Ph.D. in Radiation Biology from the University of Iowa in 1972. We believe Dr. Boynton’s background and experience make him well qualified to serve as a Director.

Pat Sarma. Mr. Sarma was appointed to the Board of Directors in March 2024. Mr. Sarma brings decades of experience as a business executive and as a venture capital investor. One of the companies he founded and built was American Megatrends Inc. (AMI), which developed hardware, software and firmware components of PC-based systems. AMI developed the AMIBIOS firmware program for IBM-PC compatibility. The BIOS (Basic Input Output System) is the heart of PC-compatibility and all application programs access the BIOS in reading from or writing to peripheral units such as drives, keyboards, mouse, etc. AMI also developed, among other software, the AMI RAID Controller and Management software that was the fastest performer in the industry during the 1990’s and early 2000’s. Mr. Sarma’s interests in AMI were acquired in 2001, and thereafter he became a venture capital investor in the private equity markets. He was an owner for a number of years of the N.J. Devils team in the National Hockey League, and has invested in a diverse range of industries including medical and environmental companies. Mr. Sarma received a Master’s Degree in Industrial Engineering and Operations Research from Georgia Tech and a Bachelor’s Degree in Mechanical Engineering from the University of Madras. We believe that Mr. Sarma’s background and experience make him well qualified to serve as a director.

Dr. Navid Malik. Dr. Malik was appointed to the Board of Directors in April 2012. Dr. Malik is currently Head of Research and an Executive Director at The Life Sciences Division, a UK Investment Bank (since 2018). From January 2012 to December 2015, Dr. Malik was previously the Head of Life Sciences Research at Cenkos Securities Plc. in the U.K., an institutional stockbroking securities firm. From September 2011 through January 2012, Dr. Malik was the Head of Life Sciences Research at Sanlam (Merchant Securities), a global financial services firm. Dr. Malik was Partner and Head of Life Sciences at Matrix Investment Banking Division, Matrix Group, a financial services firm in London, from December 2008 through September 2011. Dr. Malik was a Senior Pharmaceuticals and Biotechnology Analyst at Wimmer Financial LLP from September 2008 through December 2008, and was the Senior Life Sciences Analyst at Collins Stewart Plc from January 2005 through September 2008. In 2011, Dr. Malik was awarded two StarMine Awards (awarded each year by Thomson Reuters and the Financial Times): Number One Stock Picker in the European Pharmaceutical Sector, and Number Two Stock Picker in the U.K. and Ireland Healthcare Sector. Dr. Malik holds a Ph.D. in Drug Delivery within Pharmaceutical Sciences, as well as degrees in Biomedical Sciences Research (M.Sc.) and Biochemistry and Physiology (B.Sc., joint honors). Dr. Malik also holds an MBA in finance from the City University Business School, London. We believe that Dr. Malik’s extensive experience in the life sciences fields and investment banking sector make him well qualified to serve as a Director.

EXECUTIVE OFFICERS

The following table sets forth information regarding the Company’s current executive officers.

Name Age Position

Dr. Alton L. Boynton 79 Class I Director, Chief Scientific Officer

Leslie J. Goldman 79 Senior Vice President, General Counsel

Dr. Marnix L. Bosch 65 Chief Technical Officer

Linda F. Powers. Please see “Director Biographies” above.

Alton L. Boynton, Ph.D. Please see “Director Biographies” above.

Leslie J. Goldman joined us in June 2011, and serves as Senior Vice President and General Counsel. In this capacity, Mr. Goldman has responsibility for legal matters, investor relations and financing activities. Prior to joining us, Mr. Goldman was a partner at the law firm of Skadden, Arps for over 30 years, specializing in a wide array of advanced technologies and their commercialization. Mr. Goldman also serves as an advisor to a number of other technology companies. In addition, for eight years, Mr. Goldman served as Chairman of the Board of a group of TV stations in four mid-size cities across the country. Mr. Goldman received a B.A. from the University of Michigan in 1967 and a J.D. from the University of Michigan in 1970.

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Marnix L. Bosch, Ph.D. joined us in 2000, and serves as our Chief Technical Officer. In this capacity, Dr. Bosch plays a key role in the preparation and submission of our regulatory applications, as well as ongoing development of our product lines, and ongoing development and/or acquisition of new technologies. Dr. Bosch led the process of designing the protocols, and managed the successful preparation and submission of our Investigational New Drug (IND) applications for FDA approval to conduct clinical trials for prostate cancer, brain cancer, ovarian cancer and multiple other cancers. He also led the processes for other regulatory submissions in both the U.S. and abroad (including the successful applications for orphan drug status in both the U.S. and Europe for DCVax-L for brain cancer). He spearheaded the development of our manufacturing and quality control processes. Prior to joining us in 2000, Dr. Bosch worked at the Dutch National Institutes of Health (RIVM) as head of the Department of Molecular Biology, as well as in academia as a professor of Pathobiology. He has authored more than 40 peer-reviewed research publications in immunology and virology, and is an inventor on several patent applications on dendritic cell product manufacturing.

CORPORATE GOVERNANCE

Board Leadership Structure

The Board believes that Ms. Powers’ service as both Chairperson of the Board and Chief Executive Officer is in the Company’s and our stockholders’ best interests. Ms. Powers possesses detailed and in-depth knowledge of the issues, opportunities and challenges facing us, and is thus, we believe, best positioned to develop Company strategies, business plans and priorities, and corresponding Board agendas that ensure that the Board’s time and attention are focused on the most critical matters. The Company has multiple major programs under way, with operations and infrastructure on two continents, which require heightened efficiency and involvement between the Board and management. Ms. Powers’ combined role enables decisive leadership, and, we believe, facilitates this efficiency and involvement. In March 2024, Mr. Pat Sarma was appointed to the Board to replace Mr. Jerry Jasinowski, who retired for medical reasons.

Board of Directors’ Role in Risk Oversight

The Board plays an active role in risk oversight of our Company. The Board does not have a formal risk management committee, but administers this oversight function through various standing committees of the Board of Directors and/or through the full Board. The Audit Committee maintains responsibility for oversight of financial reporting-related risks, including those related to our accounting, auditing and financial reporting practices. The Audit Committee also reviews reports and considers any material allegations regarding potential violations of our Company’s Code of Conduct. The Compensation Committee oversees risks arising from our compensation policies and programs and has responsibility for evaluating and approving our executive compensation and benefit plans, policies and programs. The Company also performed an enterprise-wide risk assessment as well as an enterprise-wide fraud risk assessment during 2021 and will continue to update such assessments on an annual basis.

Audit Committee

The Audit Committee has responsibility for recommending the appointment of our independent accountants, supervising our finance function (which includes, among other matters, our investment activities), reviewing our internal accounting control policies and procedures, and providing the Board such additional information and materials as it may deem necessary to make the Board aware of significant financial matters which require the attention of the Board. The Audit Committee discusses the financial statements with management, approves filings made with the SEC and maintains the necessary discussions with the Company’s independent accountants. The Audit Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.

The Audit Committee currently consists of Dr. Malik and Mr. Sarma. Our Board of Directors has determined that Mr. Sarma, the Chairman of the Audit Committee, qualifies as an “audit committee financial expert” as defined by the SEC. Our Board has determined that each member of the Audit Committee is “independent” within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules as well as pursuant to the additional test for independence for audit committee members imposed by SEC regulation and Section 5605(c)(2)(A) of the Nasdaq Stock Market Rules. The Audit Committee is established in accordance with Section 3(a)(58)(A) of the Exchange Act.

Compensation Committee

The Compensation Committee is responsible for determining the overall compensation levels of our executive officers and administering our equity compensation plans. The Compensation Committee currently consists of Dr. Malik, Ambassador Black and Mr.Sarma. Our

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Board of Directors has determined that each member of the Compensation Committee is “independent” under the current listing standards of Nasdaq. The Compensation Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.

Conflicts Committee

The Conflicts Committee is responsible for review and evaluation of related party matters including related party transactions. The Conflicts Committee currently consists of Ambassador Black, Mr. Sarma and Dr. Malik. Our Board of Directors has determined that each member of the Conflicts Committee is “independent” within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules. The Conflicts Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/. The Conflicts Committee does not delegate its authority pursuant to its written charter.

Nominations Committee

The Nominations Committee is responsible for assisting the Board of Directors in, among other things, effecting Board organization, membership and function, including: identifying qualified Board nominees; and effecting the organization, membership and function of Board committees, including composition and recommendation of qualified candidates and reviewing the Company’s Corporate Governance Guidelines. The Nominations Committee shall identify and evaluate the qualifications of all candidates for nomination for election as directors. Potential nominees are identified by the Board of Directors based on the criteria, skills and qualifications that have been recognized by the Nominations Committee. While our nomination policy does not prescribe specific diversity standards, the Nominations Committee and its independent members seek to identify nominees who have a variety of perspectives, professional experience, education, difference in viewpoints and skills, and personal qualities that will result in a well-rounded Board of Directors. The Nominations Committee operates under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.

The Nominations Committee currently consists of Dr. Malik and Ambassador Black. The Board of Directors has determined that each member of the Nominations Committee is “independent” under the current listing standards of Nasdaq. The Board of Directors has adopted a written charter setting forth the authority and responsibilities of the Nominations Committee.

Information Regarding Meetings of the Board and Committees

The business of our Company is under the general oversight of our Board, as provided by the laws of Delaware and our bylaws. During 2024, the Board held 13 meetings and also conducted business by written consent. During 2024, the Audit Committee held 4 meetings and the Conflicts Committee held 3 meetings; and the Compensation Committee held 2 meetings. The Nominations Committee did not hold any meetings. Each person who was a director during 2024 attended at least 75% of the 13 Board meetings. We do not have a formal written policy with respect to Board members’ attendance at our annual meeting of stockholders. All five of our directors attended our last annual meeting of stockholders.

Code of Conduct

We have an established Code of Conduct applicable to all Board members, executive officers, employees and contractors. Our Code of Conduct is posted on our website at www.nwbio.com.

Insider Trading Policy

We have adopted an insider trading policy that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, as well as applicable listing standards. Our insider trading policy applies to directors, officers, and employees and prohibits the trading of our securities on the basis of material, nonpublic information. For additional details, please refer to the information under the heading “Insider Trading Policy” in our Code of Conduct, which we filed as Exhibit 19.1 to this Annual Report on Form 10-K.

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ITEM 11. EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION

Compensation Discussion and Analysis

Overview

This Compensation Discussion and Analysis describes the compensation program for the Company’s principal executive and principal financial officer, and our three most highly compensated executive officers other than our principal executive and financial officer who were serving as executive officers as of December 31, 2024. We refer to these individuals as our “named executive officers” or “NEOs.”

For purposes of this executive compensation discussion, the names and positions of our named executive officers for the 2024 fiscal year were:

● Leslie Goldman, Senior Vice President and General Counsel; and

● Marnix L. Bosch, Ph.D., Chief Technical Officer.

Philosophy and Objectives

Our success is highly dependent on our ability to attract, engage and retain executive officers who possess the skills, competencies and passion that are consistent with our vision. To this end, our compensation program has been developed with the following overarching principles in mind:

Periodically, the Compensation Committee reviews the objectives and components of our executive compensation program to assess whether they continue to align with these principles.

Risk Management and Mitigation

The Compensation Committee also considers whether our compensation policies and practices could affect our risk profile and whether such compensation policies and practices could potentially encourage excessive risk taking by our employees. In considering these issues, the Compensation Committee has not found that our compensation policies and other policies generally raised undue risks for the Company or potentially could encourage excessive risk taking by our employees.

Elements of 2024 Compensation

Base Salary

Base salary is the fixed portion of an executive’s annual compensation. The Compensation Committee does not use a formulaic approach when setting an executive officer’s base salary. The Committee considers the nature and responsibility of the NEO’s position and, where applicable, the executive’s performance of multiple roles that would typically be held by separate executives (with separate compensation) at other companies. The Committee takes account of the NEOs’ compensation history, and that payment of bonuses has tended to be substantially delayed. The Committee also considers the Company’s progress and management’s recommendations about compensation.

The Compensation Committee typically reviews base salaries on an annual basis. The Committee deliberates and reaches recommendations and decisions without management present.

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For 2024, the Compensation Committee and Board did not make any increase in the base salaries of the NEOs.

Annual Bonus Awards

Our NEOs are eligible to receive an annual bonus in respect of their individual performance and the performance of the Company. The Company determines Annual Bonus Awards based upon progress achieved in the Company’s programs (including clinical development, manufacturing, intellectual property and finances) and progress toward potential eventual commercialization, as well as the individual’s roles and contributions toward the progress. The performance and progress achieved during a given year are evaluated after the end of that calendar year, and bonuses for the given year are determined based upon that evaluation

For 2024, the Compensation Committee and Board have not yet determined bonuses for the NEOs. They plan to do so in due course.

Equity Awards

The Company did not make any equity compensation awards to the NEOs in 2024. The Company has made no equity awards to NEOs since option awards were last granted in 2020.

Overall in the 14 years since 2011, the Company has only made equity awards in 2018 and 2020 to two of its NEOs (Ms. Powers and Mr. Goldman), and has only made equity awards to the other NEO (Dr. Bosch) in 2012, 2017 and 2020 in these 14 years.

The equity pool reserved for employees and directors established under the Company’s Equity Compensation Plan remains in place. The pool includes 20% of the Company’s securities, some of which have been issued to employees and directors and some of which remain available in the pool. The Company has been advised by an independent compensation consultant that it is not uncommon for pre-commercial biotech companies to set aside 15-20% of their equity in a pool for employees and directors.

Other Compensation Plans

401(k) Plan. The NEOs are eligible to participate in employee benefit plans and programs, including long-term disability, to the same extent as the Company’s other full-time employees, subject to the terms and eligibility requirements of those plans. The NEOs are also eligible to participate in our 401(k) plan, subject to limits imposed by the Internal Revenue Code, to the same extent as the Company’s other full-time employees.

Other Benefits. We do not maintain any defined benefit pension plans or any nonqualified deferred compensation plans.

Limited Perquisites. Perquisites or other personal benefits are not a significant component of the compensation to our NEOs. We provide only limited perquisites to our NEOs, such as coverage of phone and internet costs.

Employment Agreements. The Company entered into employment agreements with each of Ms. Powers, Mr. Goldman and Dr. Bosch in 2011. The 2011 agreements have expired. The Company entered into a new employment agreement with Dr. Bosch, which is currently in effect. The Company plans to enter into new employment agreements with Ms. Powers and Mr. Goldman in due course.

Process for Setting Executive Compensation

Compensation Committee Review

Our Compensation Committee reviews the elements of our NEOs’ total compensation during the year, as described above. An external compensation consultant has been engaged. In making compensation decisions, the Committee may rely upon advice from the compensation consultant as well as its own judgment after reviewing relevant information.

The Compensation Committee does not use a formulaic approach when setting a NEO’s base salary. The Committee considers various factors, including the nature and responsibility of the NEO’s position; where applicable, the executive’s performance of multiple roles that would typically be held by separate executives (with separate compensation) at other companies; the executive’s performance; and the Company’s progress. The Committee takes account of the NEO’s compensation history, and the fact that payment of bonuses has tended to be substantially delayed. The Committee also considers management’s recommendations about compensation.

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The Compensation Committee typically reviews base salaries on an annual basis. The Committee deliberates and reaches recommendations and decisions without management present. However, at the Committee’s request, the CEO may review with the Committee the performance of the other executive officers. Our Compensation Committee gives substantial weight to the CEO’s evaluations and recommendations because she is particularly able to assess the other executive officers’ performance and contributions.

Independent Compensation Consultant

The evaluations and analyses for the 2024 base salaries for the Company’s NEOs were done internally, and not by a compensation consultant. However, a compensation consultant has been engaged to assist in the compensation process going forward.

Compensation Committee Report

The compensation committee has reviewed and discussed the compensation discussion and analysis included in this Annual Report on Form 10-K with management and, based on such review and discussions, the compensation committee recommended to our board of directors that the compensation discussion and analysis be included in the Company’s Annual Report on Form 10-K for filing with the SEC.

The foregoing report has been furnished by the Compensation Committee.

Dr. Navid Malik (Chairperson)

Cofer Black

Pat Sarma

Summary Compensation Table

The following table sets forth certain information concerning compensation paid to or accrued for our executive officers, referred to as our Named Executive Officers (NEOs), during the years ended December 31, 2024 and 2023.

Option

Salary Bonus Awards Total

Name and Principal Position Year ($) ($) (1) ($) ($)

(2) This 2023 bonus has been approved but has not been paid to date.

(3) This 2023 bonus has been approved but has not been paid to date.

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Outstanding Equity Awards at Fiscal Year-End

The following table shows outstanding stock option awards classified as exercisable and un-exercisable as of December 31, 2024:

Securities Underlying Unexercised Option Awards

Number of Number of Option

Unexercised Unexercised Exercise Option

Options (#) Options Price Expiration

Name and Principal Position Exercisable (1) (#) Unexercisable ($) Date

On July 2, 2020, we granted 32,558,724 stock options to Ms. Powers for service during several years. These options were subject to certain vesting requirements which have been fulfilled. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. Following entry into previous securities suspension agreements, in 2021, Ms. Powers entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities, unless Ms. Powers provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended.

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On July 2, 2020, we granted 21,822,937 stock options to Mr. Goldman for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. These options are subject to certain vesting requirements. Following entry into previous securities suspension agreements, in 2021 Mr. Goldman entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Mr. Goldman cannot exercise or convert any options, warrants or other derivative securities, as applicable, to acquire shares of the Company’s common stock, unless Mr. Goldman provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended.

On January 14, 2021, Mr. Goldman assigned 20,000,000 options that were granted on July 2, 2020 to The Goldman NWBIO GRAT Trust for no consideration. On April 28, 2022, Sue Goldman, Trustee of The Goldman NWBIO GRAT Trust transferred 12,709,287 options to Mr. Goldman in satisfaction of the first annuity amount due to Mr. Goldman. As of December 31, 2022, 7,290,713 options were remaining in The Goldman NWBIO GRAT Trust.

On March 29, 2023, Dr. Bosch cashless exercised 200,000 options.

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Option Exercises and Stock Vested

No options were vested during 2024 for any of our Named Executive Officers, and none were exercised by our Named Executive Officers.

Potential Payments on Termination or Change in Control

The Company does not currently have any arrangements that would trigger payments upon termination of a NEO or upon a change in control of the Company. However, the Company plans to enter into employment agreements with Ms. Powers and Mr. Goldman in due course which may contain such arrangements.

CEO Pay Ratio Disclosure

We are providing the following information about the relationship of the annual total compensation of our employees and the annual total compensation of our CEO. Based on the information for fiscal year 2024, we reasonably estimate that the ratio of our CEO’s annual total compensation to the annual total compensation of our median employee (including three full-time contractors) was 5.7:1. Our pay ratio estimate has been calculated in a manner consistent with Item 402(u) of Regulation S-K using the data and assumptions summarized below.

We identified the median employee by examining the 2024 annual base salary compensation for all individuals, excluding our CEO. We identified our median compensation employee by examining total compensation paid for fiscal year 2024 to all individuals, excluding Ms. Powers, who were employed by us on December 31, 2024, the last day of our fiscal year based on payroll records. No assumptions, adjustments or estimates were made in respect of total compensation, except that we annualized the compensation of any employee that was not employed with us for all of fiscal year 2024.

Once we identified our median employee, we calculated such employee’s annual total compensation for 2024 in accordance with the requirements of Item 402(c)(2)(x) of Regulation S-K, resulting in that employee’s annual total compensation of $162,000. The median employee’s annual total compensation includes annualized base salary during the fiscal year ended December 31, 2024. We calculated the compensation for personnel in the UK and Canada using the applicable average currency exchange rates of $1.30 per GBP and $0.74 per CAD for fiscal year 2024.

With respect to the CEO, we used the amount reported as total compensation in the Summary Compensation Table included in this annual report on Form 10-K. Any estimates and assumptions used to calculate total annual compensation are described in footnotes to the Summary Compensation Table.

Pay Versus Performance

As required by Item 402(v) of Regulation S-K, we are providing the following information regarding the relationship between executive compensation and our financial performance for each of the last two completed calendar years. In determining the “compensation actually paid” to our named executive officers (“NEOs”), we are required to make various adjustments to amounts that have been previously reported in the Summary Compensation Table in previous years, as the SEC’s valuation methods for this section differ from those required in the Summary Compensation Table.

The following tables and related disclosures provide information about (i) the total compensation (“SCT Total”) of our principal executive officer (“PEO”) and our non-PEO Named Executive Officers (collectively, the “Other NEOs”) as presented in the Summary Compensation Table, (ii) the “compensation actually paid” (“CAP”) to our PEO and our Other NEOs, as calculated pursuant to Item 402(v), (iii) certain financial performance measures, and (iv) the relationship of the CAP to those financial performance measures.

Pay Versus Performance Table

The amounts set forth below under the headings “Compensation Actually Paid to PEO” and “Average Compensation Actually Paid to Non-PEO NEOs” have been calculated in a manner consistent with Item 402(v) of Regulation S-K. Use of the term “compensation

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actually paid” is required by the SEC’s rules, and as a result of the calculation methodology required by the SEC, such amounts differ from compensation actually received by the individuals for the fiscal years listed below.

In calculating the compensation actually paid amounts reflected in these columns, the fair value or change in fair value, as applicable, of the equity award adjustments included in such calculations were computed in accordance with FASB ASC Topic 718. The valuation assumptions used to calculate such fair values did not materially differ from those disclosed at the time of grant. During fiscal years 2024, 2023 and 2022, the PEO was Linda Powers, and the non-PEO NEOs were Les Goldman and Marnix Bosch.

Value of Initial

Average Summary Fixed $100

Summary Compensation Average Investment Based

Year PEO PEO (1) NEOs Non-PEO NEOs (2) Return (3) (in thousands)

The following table sets forth the adjustments made to the SCT total for each year represented in the pay versus performance table to arrive at “compensation actually paid” to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:

Outstanding and unvested awards:

Awards granted and vesting in the same year:

Awards vesting in current fiscal year but granted in prior fiscal year:

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Outstanding and unvested awards:

Awards granted and vesting in the same year:

Awards vesting in current fiscal year but granted in prior fiscal year:

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Relationship Between CAP Amounts and Performance Measures

The following charts show graphically the relationships over the past two years of the CAP Amounts for the PEO and the Other NEOs as compared to our (i) cumulative total shareholder return and (ii) net loss.

While the Compensation Committee makes executive compensation decisions in consideration of a variety of factors, including corporate and individual performance, the decisions of the Compensation Committee and Board of Directors in 2024, 2023 and 2022 were made independently of these.

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Compensation Committee Interlocks and Insider Participation

None of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on our board of directors.

Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information

The Company does not have any formal policy that requires the Company to grant, or avoid granting, stock options at particular times. The timing of any equity grants to executive officers or directors in connection with new hires, promotions, or other non-routine grants is tied to the event giving rise to the award (such as an executive officer’s commencement of employment or promotion effective date), and the Company does not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.

During the year ended December 31, 2024, there were no equity grants made to our executive officers during any period beginning four business days before the filing of a periodic report or current report disclosing material non-public information and ending one business day after the filing or furnishing of such report with the Securities and Exchange Commission.

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DIRECTOR COMPENSATION

The following table sets forth certain information concerning compensation paid or accrued to our non-executive directors during the years ended December 31, 2024 and 2023.

Fees Earned

or Option

Paid in Cash Awards Total

Name Year ($) ($) ($)

The non-executive independent directors were compensated on a monthly basis $12,500 ($150,000 annually) for their consistent availability on short notice, participation in the frequent meetings of the board of directors, leadership of at least one board committee, participation on multiple committees of the Board, commitment to corporate governance initiatives, and frequent consultations with management on operational matters. The Company owed Mr. Jasinowski $178,226 as of December 31, 2024.

Ms. Powers and Dr. Boynton are executives of the Company and do not receive separate compensation for their services as a Director.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS-EQUITY COMPENSATION PLAN INFORMATION

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table presents information regarding the beneficial ownership of our common stock as of February 28, 2025 by:

● our directors and nominees for director;

● our directors and executive officers as a group.

Shares of common stock beneficially owned and the respective percentages of beneficial ownership of common stock assume the exercise of all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable or exercisable within 60 days of February 28, 2025. Shares issuable pursuant to the exercise of stock options and warrants exercisable on or prior to the date 60 days after February 28, 2025 are deemed outstanding and held by the holder of such options or warrants for computing the percentage of outstanding common stock beneficially owned by such person, but are not deemed outstanding for computing the percentage of outstanding common stock beneficially owned by any other person.

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Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and the entities named in the table have sole voting and investment power with respect to all shares of common stock that they beneficially own, subject to applicable community property laws, if any. The table below is based upon the information supplied by our transfer agent, Computershare Trust Company, N.A., the Company’s records and from Schedules 13D and 13G filed with the SEC.

Except as otherwise noted, the address of the individuals in the following table is c/o Northwest Biotherapeutics, Inc., 4800 Montgomery Lane, Suite 800, Bethesda, MD 20814.

Amount and Nature of Percent of class of

Name and address of beneficial owner Beneficial Ownership Common Stock (1)

Directors and Officers:

Alton L. Boynton, Ph.D. 979,254 * %

All executive officer s and directors as a group (7 persons) 108,231,540 7.6 %

* Less than 1%

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EQUITY COMPENSATION PLAN INFORMATION

On May 29, 2020, the Board of Directors of the Company approved a new equity compensation plan (the “Plan”). The Company’s prior plan was adopted in 2007, was updated in amended and restated plans that were approved by shareholders in 2012 and 2013, and expired in 2017 (the “Prior Plan”).

The Plan is substantially similar to the Prior Plan. The Plan has a 10-year life, and allows for awards to employees, directors and consultants of the Company, as did the Prior Plan. The Plan allows for any type of equity security to be awarded, as did the Prior Plan. The awards and their terms (including vesting) will be determined by the Board and applicable Committees, as was the case under the Prior Plan. The Plan establishes a pool of potential equity compensation equal to twenty percent of the outstanding securities of the Company, which is on an evergreen basis as under the Prior Plan.

On February 25, 2022, the Company amended its existing Plan, which was adopted in 2020 as previously reported. The amendment provides that the possible forms of awards under the Plan include awards paid in cash or awards paid in a combination of cash and equity, in addition to the existing provisions for awards made in any form of equity. The amendment also clarifies that a delegation of authority from the Board to a Committee may be either a general delegation or a delegation for a specific occasion.

ITEM 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

Advent BioServices, Ltd.

Advent BioServices, Ltd. (“Advent”) is a related party based in the U.K. and owned by Toucan Holdings, which is controlled by our Chairperson and Chief Executive Officer, Linda F. Powers. Advent was previously the U.K. branch of Cognate until it was spun off from Cognate in 2016 and became independent. Advent provides manufacturing and related services for production of DCVax-L products.

The Company has three 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.

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 was incorporated into the Ancillary Services Agreement. 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 milestones 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

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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 5 one-time milestones with corresponding milestone payments:

(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.

(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.

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.

(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.

(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 December 31, 2024, milestones (a) (b) and (c) as described above were completed.

SOW 6

SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the three licenses required for the Sawston facility, (b) successful completion of each of six one-time workstreams

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and (c) completion of drafting key portions of an application for product approval (see Note 5 for additional description regarding SOW 6). The milestone incentives were a combination of cash and stock, and were not paid until the milestone was achieved and earned.

During the year ended December 31, 2023, the Company paid an aggregate of $5.0 million in cash, of which $1.0 million was related to two milestones that were completed and fully expensed in 2022, but was unpaid as of December 31, 2022, $4.0 million was payment for four completed one-time milestones (MAA workstream for Mechanism of Action, obtaining a commercial manufacturing license from the MHRA in March 2023 and completion of drafting key portions of the application and submission of the application to MHRA for product approval). The Company issued 4.5 million common shares as a result of completion of the two one-time milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting the application) at fair value of $3.2 million, of which $0.6 million was recognized during the year ended December 31, 2023 and $2.6 million had already been recognized (but not paid) in 2022.

Related-Party Transaction Approval Policy

The company maintains a written Related-Party Transactions Policy. Under SEC rules, related-party transactions are those transactions to which we are or may be a party in which the amount involved exceeds the lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years, and in which any of our directors or executive officers or any other related person had or will have a direct or indirect material interest, excluding, among other things, compensation arrangements with respect to employment or board membership. Any transactions with any person who is, or at any time since the beginning of the Company’s fiscal year was, a director or executive officer or a nominee to become a director of the Company, any person who is known to be the beneficial owner of more than 5% of any class of the Company’s voting securities, any immediate family member or person sharing the household of any of the foregoing persons, any firm, corporation or other entity in which any of the foregoing persons is a partner or principal, is subject to approval or ratification in accordance with the procedures of the Company’s Related-Party Transaction Policy.

Conflicts Committee

The Conflicts Committee of the Board reviews and approves all related-party matters and transactions for potential conflicts of interests and reasonableness, as described in the Corporate Governance Matters section above. The Conflicts Committee’s one-time review and approval of any series of similar related-party transactions (such as a series of transactions governed by a single contract) suffices to satisfy this policy with respect to each and every transaction in the series.

DIRECTOR INDEPENDENCE

Our Board of Directors has undertaken a review of the independence of our directors and has determined that a majority of the Board consists of members who are currently “independent” as that term is defined within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules. The Board of Directors has determined that Mr. Malik, Mr. Sarma and Ambassador Black are independent. In addition, Jerry Jasinowski, who retired as a director on March 8, 2024, was independent during his service on the Board of Directors.

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

PRINCIPAL ACCOUNTANT FEES AND SERVICES

Fees Paid to Independent Public Accountants

Cherry Bekaert has served as our independent public accounting firm for the fiscal years ended December 31, 2020 through 2024.

Audit Fees

The aggregate fees billed for the fiscal years ended December 31, 2024 for professional services rendered by Cherry Bekaert for the audit of our annual financial statements for 2024, and the review our financial statements included in our quarterly reports on Form 10-Q for 2024 was $611,000.

The aggregate fees billed for the fiscal years ended December 31, 2023 for professional services rendered by Cherry Bekaert for the audit of our annual financial statements for 2023, an independent audit of the Company’s internal controls for 2023, and the review our financial statements included in our quarterly reports on Form 10-Q for 2023 was $614,000.

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Audit-Related Fees

There were no fees billed in the fiscal years ended December 31, 2024 and 2023 for assurance and related services rendered by Cherry Bekaert related to the performance of the audit or review of our financial statements.

Tax and Other Non-Audit Professional Services

There were no fees billed in the fiscal years ended December 31, 2024 and 2023 for professional services rendered by Cherry Bekaert for tax related services or other non-audit professional services fees.

Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services

Consistent with SEC policies and guidelines regarding audit independence, the Audit Committee is responsible for the pre-approval of all audit and permissible non-audit services provided by our principal accountants on a case-by-case basis. Our Audit Committee has established a policy regarding approval of all audit and permissible non-audit services provided by our principal accountants. Our Audit Committee pre-approves these services by category and service. Our Audit Committee pre-approved all of the services provided by our principal accountants during the fiscal years ended December 31, 2024 and 2023.

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ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

The Exhibits listed below are identified by numbers corresponding to the Exhibit Table of Item 601 of Regulation S-K. The Exhibits designated by an asterisk (*) are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15.

EXHIBIT INDEX

ExhibitNumber Description

4.1 Description of Securities

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19.1 Insider Trading Policy

21.1 Subsidiaries of the Registrant.

23.1 Independent Registered Public Accounting Firm’s Consent.

101.INS Inline XBRL Instance Document.

101.SCH Inline XBRL Schema Document.

101.CAL Inline XBRL Calculation Linkbase Document.

101.DEF Inline XBRL Definition Linkbase Document.

101.LAB Inline XBRL Label Linkbase Document.

101.PRE Inline XBRL Presentation Linkbase Document.

ITEM 16.FORM 10–K SUMMARY

None.

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SIGNATURES

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

NORTHWEST BIOTHERAPEUTICS, INC.(Registrant)

Date: March 31, 2025 By: /s/ Linda F. Powers

Linda F. Powers,

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

Signature Title Date

/s/ Linda F. Powers President and Chief Executive Officer March 31, 2025

Linda F. Powers Principal Executive Officer

Principal Financial and Accounting Officer

/s/ Alton L. Boynton Director March 31, 2025

Alton L. Boynton

/s/ Navid Malik Director March 31, 2025

Dr. Navid Malik

/s/ Pat Sarma Director March 31, 2025

Pat Sarma

/s/ J. Cofer Black Director March 31, 2025

J. Cofer Black

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Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

NORTHWEST BIOTHERAPEUTICS, INC.

INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS

Reports of Independent Registered Public Accounting Firm (PCAOB ID 00677) F-2

Consolidated Balance Sheets as of December 31, 2024 and 2023 F-4

Notes to the Consolidated Financial Statements F-9

F-1

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders

Northwest Biotherapeutics, Inc.

Bethesda, Maryland

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Northwest Biotherapeutics, Inc. and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive loss, stockholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the consolidated results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s evaluations of the events and conditions and management’s plans regarding those matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

F-2

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Critical Audit Matter Description

As disclosed in Notes 4, 5, 7, 10, and 11 to the consolidated financial statements, the Company had various debt, derivative, mezzanine equity and equity transactions, including both related party and non-related party stock-based compensation and convertible notes elected to be carried at fair value, where management evaluated required accounting considerations, significant estimates, and judgements around certain features, the possibility of conversion or redemption, and the valuation of certain components of the financings, including the valuation around certain freestanding and embedded derivatives. Certain features were initially measured at fair value and have been subsequently remeasured to fair value at each reporting period.

There is no current observable market for these types of features and, as such, the Company determined the fair value of the freestanding instruments or embedded derivatives using the Black-Scholes-Merton model, Lattice-based models or the Monte Carlo option pricing model, as applicable, to measure the fair value of the debt and/or equity instrument both with and without the derivative liability features. As a result, a high degree of auditor judgment and effort was required in performing audit procedures to evaluate the various components of these instruments.

How the Critical Audit Matter was Addressed in the Audit

Our principal audit procedures performed to address this critical audit matter included the following:

/s/ Cherry Bekaert LLP

We have served as the Company’s auditor since 2021.

Tampa, Florida

March 31, 2025

F-3

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NORTHWEST BIOTHERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

December 31, December 31,

ASSETS

Current assets:

Cash and cash equivalents $ 2,175 $ 2,126

Prepaid expenses and other current assets 1,887 1,999

Non-current assets:

Property, plant and equipment, net 16,196 17,278

Right-of-use asset, net 4,187 4,183

Indefinite-lived intangible asset 1,292 1,292

LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT

Current liabilities:

Accounts payable and accrued expenses $ 16,969 $ 10,244

Contingent payable derivative liability 9,578 9,188

Investor advances 207 7

Lease liabilities 326 314

Non-current liabilities:

Convertible notes at fair value, net of current portion 15,900 —

Notes payable, net of current portion, net 12,396 20,312

Lease liabilities, net of current portion 4,438 4,454

Contingent payment obligation 4,700 4,950

COMMITMENTS AND CONTINGENCIES (Note 12)

Mezzanine equity:

Stockholders’ deficit:

Stock subscription receivable (79) (79)

Accumulated other comprehensive income 3,043 1,536

NWBO US Equity

NWBO · 10-K · period ended 2024-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS-EQUITY COMPENSATION PLAN INFORMATION

ITEM 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 16.FORM 10–K SUMMARY

NWBO US Equity☆

NWBO · 10-K · period ended 2024-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS-EQUITY COMPENSATION PLAN INFORMATION

ITEM 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 16.FORM 10–K SUMMARY

NWBO US Equity