NORTHWEST BIOTHERAPEUTICS INC
For the period ended Dec 31, 2025. Filed Apr 15, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Apr 15, 2026
NWBO$0.19-0.6%Stored close · as of Jun 30, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001410578-25-000598
Item 7. Management’s Discussion and Analysis of Financial Condition And Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-04-15.
0001104659-26-043806
Item 7. Management’s Discussion and Analysis of Financial Condition And Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 115 previous paragraphs and 110 current paragraphs.
57 unchanged; 24 reworded; 29 added; 33 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 29 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (29)
Current report
Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.
Current report
During 2025, the Company continued its progress on multiple fronts, including the following:
Current report
MAA Application. Much of the Company’s time and resources were devoted to active engagement in the MAA review process. The Company continued to work with large teams of consultants on this process. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Current report
Management Change. The Company’s Senior Vice President and General Counsel passed away unexpectedly. Other Company personnel took on new and/or additional roles in his place.
Current report
Advent Acquisition. On October 24, 2025, the Company completed its acquisition of Advent BioServices Ltd. (Advent). Advent then became a wholly owned subsidiary of the Company. The Company believes the acquisition will facilitate efficiencies and scale-up of its manufacturing capacity.
Current report
UK Clinics. The Company pursued clinic arrangements or collaborations in the UK to secure dedicated leukapheresis capacity, including potential in-house operations. Leukapheresis procedures are required to obtain the immune cells for DCVax products and there is a general shortage of capacity in the UK.
Current report
Secondary Manufacturing. The Company has identified a collaboration that could potentially lead to a second source of capacity for DCVax production. If the second source is needed, the Company anticipates that it could be brought online with significant cost savings. The Company is pursuing planning discussions with this party.
Current report
Development of the Sawston, UK Facility. The Company and developed the design and engineering for an initial Grade C lab in the Sawston facility which is anticipated to add double the manufacturing capacity of the two existing Grade B labs combined (thereby tripling the current capacity). Contractors began onsite construction-related activities. Advent recruited substantial additional manufacturing personnel and began their DCVax-specific training, which typically takes about six months. Advent also continued working to source key equipment required for the C lab while seeking ways to mitigate the high costs and 10-12 month procurement backlogs to purchase such equipment new. The Company purchased two major pieces of such equipment which cost nearly $1 million each when purchased new, and the Company is considering purchasing additional key equipment that Advent has found.
Current report
Manufacturing in the US.* *The Company evaluated facilities in multiple states for establishment of GMP manufacturing in the US, both for technologies in-licensed from the University of Pittsburgh and Roswell Park Cancer Center and for DCVax products. The Company finalized its selections and undertook contract negotiations. The negotiations continued through year-end and into the new year. In parallel, the Company continued the hiring process for personnel with the special types of expertise and prior experience, reviewing over 80 candidates in the process during the fourth quarter and preparing an additional recruitment process for the new year.
Current report
Potential Compassionate Use Programs in the US. The Company continues to receive an ongoing stream of patient requests for compassionate use of DCVax therapies for a variety of cancers. The Company has previously treated compassionate use cases involving a variety of solid tumor cancers with its DCVax therapies. The Company believes that those compassionate use cases have been helpful for the patients involved, and have also generated useful real world experience and data. The Company continued to explore the potential for expanded access/compassionate use in the US, particularly under state laws. Over a dozen states have enacted expanded compassionate use legislation, and expanded access programs are also possible at the federal level. The Company continued pursing multiple potential hospital or clinic arrangements for such programs.
Current report
DCVax-Direct Program. A 2-year program of technology transfer to the Company’s Sawston, UK facility and further development of the DCVax-Direct technology there was completed in 2025. Another version of the DCVax-Direct technology was developed using similar biologic components to provide flexibility for the program to proceed despite periods of worldwide shortages of a biologic
Current report
component in the original technology. The Company also developed new DCVax-Direct clinical trial plans to supersede the clinical trials plans for which the IND packages were previously being developed, in order to take account of developments in the field. The manufacturing and product-related portions of the IND packages were completed. The Company determined the initial cancer indications to be addressed in the new clinical trials, and worked with leading clinicians in the US and UK to develop the protocol. The Company continued its analyses of additional treatment elements to potentially include in the trials from among the in-licensed technologies as described below.
Current report
Enhanced DCVax Products. The Company continued its internal testing of certain immune booster agents that it has identified and/or in-licensed, to identify the most useful booster agent(s) and combination(s) of agents for enhanced DCVax products. The Company made its first public presentation about this at a scientific conference at the NY Academy of Sciences. The internal research and testing has continued to progress since then, and the Company anticipates making further presentations. The Company is in discussions with clinicians about which version(s) of enhanced DCVax products should be selected and for which cancers for the initial clinical trials.
Current report
Clinical Trials With In-Licensed Technologies. The Company has continued working with Dr. Kalinski to develop arrangements for clinical trials of his dendritic cell (DC) technologies that have been in-licensed. Certain program changes were necessitated by Dr. Kalinski’s move back from Roswell Park Cancer Center to the University of Pittsburgh, where he had previously been for many years, and necessitated by certain investigators for the planned trials also moving institutions. US manufacturing arrangements are being developed as described above to supply the products for these trials. The potential trial plans under development include both trials built around DC products manufactured ex vivo and trials targeting in vivo mobilization of endogenous DCs using only certain biologics, which are part of the in-licensed portfolios of Dr. Kalinski’s technologies.
Current report
Litigation Progress. The Company’s litigation in New York against certain market makers reached a key milestone during 2025: the court’s decision on the defendants’ Motion to Dismiss the Company’s Complaint trying to prevent the case from proceeding. The court’s decision allowed the case to go forward into the long-awaited discovery period. The Company has been vigorously pursuing documents and information both from the defendants and from third parties. The Company also added counsel with substantial experience in market manipulation cases. The Company plans to continue pursuing its case vigorously. See Item 1, Legal Proceedings, above.
Current report
Business Combination
Current report
The Company allocates the fair value of the purchase consideration of a business acquisition to tangible and intangible assets acquired and liabilities assumed based upon their estimated fair values at the acquisition date. The excess of the fair value of purchase consideration over the fair values of assets acquired and liabilities assumed is recognized as goodwill. To the extent the fair value of net assets acquired, including identified intangible assets, exceeds the purchase price, a bargain purchase gain is recognized. Assets acquired and liabilities assumed from contingencies are also recognized at fair value if the fair value can be determined during the measurement period, which is no more than one year from the acquisition date. Results of operations of an acquired business are included in the consolidated statement of operations from the date of acquisition.
Current report
In November 2024, the FASB issued ASU No. 2024-03 (“ASU 2024-03”), Disaggregation of Income Statement Expenses (DISE) which requires disaggregated disclosure of income statement expenses for public business entities. The standard requires public business entities to disclose disaggregated information about specific natural expense categories underlying certain income statement expense line items that are considered relevant. The FASB also issued ASU No. 2025-01 (“ASU 2025-01”), Clarifying the Effective Date, which clarifies the adoption date of ASU 2024-03 as annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the potential effect of this accounting standard update on its consolidated financial statements and related disclosures.
Current report
In September 2025, the FASB issued ASU No. 2025 - 06, Intangibles - Goodwill and Other - Internal - Use Software (“ASU 2025 – 06”), which amends the guidance for accounting for software costs to reflect current software development practices, including iterative and agile methodologies, by removing references to development stages. It also clarifies the criteria for capitalization, which begins when both of the following occur: (1) management has authorized and committed to funding the software project and (2) it is probable that the project will be completed and the software will be used to perform the function intended. ASU 2025 - 06 is effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Early adoption is permitted. The amendments may be applied either prospectively, retrospectively, or utilizing a modified transition approach. The Company is currently assessing the impact of ASU 2025 - 06 on its condensed consolidated financial statements and disclosures.
Current report
In September 2025, the FASB issued ASU 2025-07. This update clarifies the application of derivative accounting to certain contracts and refines the guidance for share-based noncash consideration received from customers. Specifically, ASU 2025-07 introduces a scope exception for contracts that are not exchange-traded and whose underlying is tied to operations or activities specific to one party. It also clarifies that share-based noncash consideration from a customer should initially be accounted for under Topic 606 until the right to receive or retain such consideration becomes unconditional, at which point financial instruments guidance may apply. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within those fiscal years. Early adoption is permitted. The amendments in ASU 2025-07 should be applied either prospectively or by utilizing a modified retrospective approach. The Company is currently assessing the impact on the Company’s consolidated financial statements and disclosures.
Current report
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. This update clarifies interim disclosure requirements and centralizes such requirements within Topic 270. Among other changes, ASU 2025-11 introduces a disclosure principle requiring entities to provide information about significant events or changes since the end of the last annual reporting period that have a material impact, clarifies when duplicative annual disclosures may be omitted from interim reports, and aligns interim reporting requirements with applicable SEC guidance for registrants. This guidance is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments in ASU 2025-11 should be applied prospectively. The Company is currently assessing the impact on the Company’s consolidated financial statements and disclosures.
Current report
In December 2025, the FASB issued ASU 2025-12, Codification Improvements. This update addresses shareholder suggestions on the Accounting Standards Codification and makes other incremental improvements to U.S. GAAP. The amendments make codification updates to a broad range of topics arising from technical corrections, unintended application of the codification, clarifications and other minor improvements. This guidance is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods within those annual periods. Early adoption is permitted and may be elected on an issue-by-issue basis. The amendments in ASU 2025-12 are to be applied prospectively. The Company is currently assessing the impact on the Company’s consolidated financial statements and disclosures.
Current report
For the years ended December 31, 2025 and 2024, research and development expense were $28.8 million and $34.9 million, respectively. The decrease in 2025 was primarily related to the decrease in stock-based compensation, the costs related to the MAA application at the MHRA and the acquisition of Advent in the 4 th quarter in 2025.
Current report
The decrease was mainly related to a reduction in D&O insurance premium, scientific conference expenses and stock-based compensation. The decreases were offset by an increase in legal expenses.
Current report
We recognized a non-cash loss of $0.2 million and a non-cash gain of $0.4 million for the years ended December 31, 2025 and 2024, respectively. The fluctuations were mainly due to the movement of our stock price.
Current report
Change in Fair Value of Share Payable
Current report
We recognized non-cash loss of $0.4 million and a non-cash gain of $16,000 from the change in fair value of share payable during the year ended December 31, 2025 and 2024, respectively. The fluctuations were mainly due to the movement of our stock price.
Current report
Foreign currency transaction gain (loss)
Current report
We received $0.2 million from investor advance during the year ended December 31, 2024.
Removed paragraphs (33)
Previous report
Intensive activities continued throughout 2024, including in Q4, in multiple areas including the following:
Previous report
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).
Previous report
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.
Previous report
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
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
*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.
Previous report
Sequencing
Previous report
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.
Previous report
Improvements to Reportable Segment Disclosures
Previous report
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.”
Previous report
Improvements to Income Tax Disclosures
Previous report
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:
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
Foreign currency transaction (loss) gain
Previous report
We made repayment of $0.2 million of investor advances during the year ended December 31, 2023.
Reworded paragraphs (24)
Previous wording
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.
Current wording
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.
Previous wording
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).
Current wording
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 and convertible notes 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).
Previous wording
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.
Current wording
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 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.
Previous wording
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.
Current wording
The Company accounts for certain convertible notes issued 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.
Previous wording
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.
Current wording
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company adopted ASU 2023-09 for the year ended December 31, 2025, and applied the new disclosure requirements retrospectively to the all periods presented. Prior period disclosures have been adjusted to reflect the new disclosure requirements. See Note 15, “Income Taxes,” for further detail.
Previous wording
We recognized a net loss of $83.8 million and $62.6 million for the years ended December 31, 2024 and 2023.
Current wording
We recognized a net loss of $60.2 million and $83.8 million for the years ended December 31, 2025 and 2024, respectively.
Previous wording
Net cash used in operations was $57.0 million and $53.6 million for the years ended December 31, 2024 and 2023, respectively.
Current wording
Net cash used in operations was $44.8 million and $57.0 million for the years ended December 31, 2025 and 2024, respectively.
Previous wording
General and administrative expenses were $33.0 million and $29.7 million for the years ended December 31, 2024 and 2023, respectively.
Current wording
General and administrative expenses were $32.5 million and $33.0 million for the years ended December 31, 2025 and 2024, respectively.
Previous wording
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.
Current wording
We recognized non-cash gain of $25.6 million and $7.7 million from the change in fair value of the convertible notes during the year ended December 31, 2025 and 2024, respectively. The non-cash gains resulted from the decrease of the Company’s stock price. The increase in the non-cash gains in 2025 was attributable to a change in certain assumptions used in the valuation of the convertible notes.
Previous wording
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.
Current wording
We recognized approximately $17.4 million and $14.4 million debt extinguishment loss during the year ended December 31, 2025 and 2024, respectively, from debt redemptions and debt amendments. The increase during the year ended December 31, 2025 compared to the year ended December 31, 2024 was mainly due to multiple amendments on the existing convertible notes.
Previous wording
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.
Current wording
We recognized approximately $4.7 million and $0.8 million loss from issuance of certain convertible notes, which we elected to account for under the FVO during the year ended December 31, 2025 and 2024, respectively. The loss was calculated as the difference between the principal amount and the fair value of these convertible notes.
Previous wording
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.
Current wording
During the year ended December 31, 2024, we recognized a $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.
Previous wording
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.
Current wording
During the years ended December 31, 2025 and 2024, we recorded interest expense of $8.7 million and $7.8 million, respectively. The increase in interest expense in 2025 was mainly related to an increase of outstanding debt balance.
Previous wording
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.
Current wording
During the years ended December 31, 2025 and 2024, we recognized foreign currency transaction gain of $4.9 million and a loss of $1.5 million, respectively. The gain was due to the strengthening of British pound sterling relative to the U.S. dollar and vice versa for the loss.
Previous wording
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.
Current wording
We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of revenue 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.
Previous wording
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.
Current wording
We used $44.8 million and $57.0 million in cash for operating activities during the years ended December 31, 2025 and 2024, respectively. The decrease in cash used in operating activities was primarily attributable to lower payments for clinical trial related expenditures, insurance costs and certain consulting expenditures.** **
Previous wording
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.
Current wording
We spent approximately $1.8 million and $1.0 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, 2025 and 2024, respectively. We also provided a short-term loan of approximately $0.3 million to an unrelated third party in the U.K. in connection with certain clinic facilities.
Previous wording
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.
Current wording
We received approximately $8.2 million cash from issuances of 0.8 million shares of Series C convertible preferred stock during the years ended December 31, 2024.
Previous wording
We received approximately $14.2 million from issuances of common stock during the year ended December 31, 2024.
Current wording
We received approximately $19.3 million and $14.2 million from issuances of common stock during the year ended December 31, 2025 and 2024, respectively.
Previous wording
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.
Current wording
We received approximately $23,000 and $1.5 million of cash proceeds from the exercise of warrants and options during the years ended December 31, 2025 and 2024, respectively.
Previous wording
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.
Current wording
We received approximately $12.0 million and $14.0 million in cash proceeds from the issuance of multiple notes payable during the years ended December 31, 2025 and 2024, respectively.
Previous wording
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.
Current wording
We received approximately $19.3 million and $20.0 million cash proceeds from issuance of convertible notes payable to individual lenders during the year ended December 31, 2025 and 2024, respectively.
Previous wording
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.
Current wording
We received $50,000 from issuance of non-dilutive funding agreements during the year ended December 31, 2024.
Previous wording
We made aggregate debt payments of $1.4 million and $0.4 million during the years ended December 31, 2024 and 2023, respectively.
Current wording
We made aggregate debt payments of $1.3 million and $1.4 million during the years ended December 31, 2025 and 2024, respectively.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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