NWBO 10-K & 10-Q changes, risk factors and insider trading
Northwest Biotherapeutics Inc. · OTC · Pharmaceutical Preparations · CIK 1072379 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “Maintaining a strong control environment, free of material weaknesses, is dependent on our ability to retain an adequate number of qualified personnel and/or consultants to perform such control activities and other factors. Our management and our independent auditors previously identified a material weakness for the year ended December 31, 2023, which is now considered remediated.”
Largest changes
“Maintaining a strong control environment, free of material weaknesses, is dependent on our ability to retain an adequate number of qualified personnel and/or consultants to perform such control activities and other factors. Our management and our independent auditors previously identified a material weakness for the year ended December 31, 2023, which is now considered remediated.”see in full comparison
“In connection with the preparation of our financial statements for the year ended December 31, 2023, and prior years, our management and our independent auditor identified a material weakness, which involved applying an incorrect valuation method using the market price actually paid for certain convertible notes rather than a Monte Carlo formula, as described more fully in “Item 9A. Controls and Procedures” of Part I of this Form 10-K. We have undertaken and continue to undertake efforts to strengthen our internal controls and have remediated the material weaknesses as previously noted. …”see in full comparison
Problems with the manufacturing facilities, processes or operationssee in full comparisonofat ourcontractSawstonmanufacturer(s)facility could result in a failure to produce, or a delay in producing adequate supplies of our DCVax productcandidates.candidates, as the Sawston facility is currently the only GMP facility manufacturing the Company’s products. A number of factors could cause interruptions or delays, including the inability of a supplier to provide raw materials, equipment malfunctions or failures, damage to a facility due to natural disasters or otherwise, changes in FDA, U.K. or European regulatory requirements or standards that require modifications to our manufacturing processes, action by the FDA, U.K. or European regulators, or by us that results in the halting or slowdown of production of components or finished products due to regulatory issues, ourmanufacturersSawstongoing out of business orfacility failing to produce productas contractually required,asneeded, insufficient technical personnel and/or specialized facilities to produce sufficient products, and/or other factors.AIfnumberitofisfactorsnecessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that couldalsoinvolvecauseincreasedpossible issues about the equivalency of DCVax product produced in different facilities or locations, which could make it necessary for us to perform additional studies and incur additionalfacility costs and/ordelays.increasedBecausecostsmanufacturing processes for our DCVax product candidates are highly complex, require specialized facilities (dedicated exclusivelyrelated toDCVax production) and personnel that are not widely available in the industry, involve equipment and training with long lead times, and are subject to lengthy regulatory approval processes, alternative qualified production capacity may not be available on a timely basis or at all. Also, as noted above, our contract manufacturer(s) could choose to terminate their agreements with us if we are in breach, or if we undergo a change of control. Difficulties, delays or interruptions in themanufacturingand supply and deliveryof ourDCVaxproductsproduct candidatesand couldrequireresultusintodelaysstopinenrollingournew patients into clinical trials, and/or require us to stop the trialsprograms orother programs, stop the treatment of patients in the trials or other programs, increase our costs, damage our reputation and, if our product candidates are approvedapplications forsale,variouscauseregulatoryus to lose revenue or market share if our manufacturers are unable to timely meet market demands.approvals.
“Following our acquisition of Advent, we have operational control and oversight of the manufacturing and related activities at the manufacturing facility in Sawston, UK. We may not manage or oversee the operations effectively. As a result, we may be at risk for issues with capacity limitations and/or supply disruptions. Although we currently expect all essential personnel in Advent to stay onboard and continue the operations, we may be at risk for loss of some key personnel. As a result, we may be at risk for impairment or disruption of the operations in the Sawston, UK facility.”see in full comparison
“We have been in breach of the services agreements with our contract manufacturers on numerous occasions, primarily for untimely payment or non-payment. Our breaches of the services agreements may not be tolerated in the future as they have been in the past, and if we continue to breach the services agreements, for non-payment or otherwise, the contract manufacturers could cease providing services and/or terminate these agreements.”see in full comparison
We rely at present onsee in full comparisonthird-partyone manufacturing facility in Sawston UK. As a result, we may be at risk for issues with capacity limitations and/or supply disruptions. We may need to engage contractmanufacturers.manufacturers for additional capacity and/or back-up or replacement in the event of problems with the Sawston facility. As a result, we may be at risk for issues with manufacturingagreements, capacity limitations and/or supply disruptions,agreements and/or issues with product equivalency.
Full comparison: every changed paragraph (21)
Maintaining a strong control environment, free of material weaknesses, is dependent on our ability to retain an adequate number of qualified personnel and/or consultants to perform such control activities and other factors. Our management and our independent auditors previously identified a material weakness for the year ended December 31, 2023, which is now considered remediated.
In connection with the preparation of our financial statements for the year ended December 31, 2023, and prior years, our management and our independent auditor identified a material weakness, which involved applying an incorrect valuation method using the market price actually paid for certain convertible notes rather than a Monte Carlo formula, as described more fully in “Item 9A. Controls and Procedures” of Part I of this Form 10-K. We have undertaken and continue to undertake efforts to strengthen our internal controls and have remediated the material weaknesses as previously noted. We designed and implemented remediation measures to address the material weakness previously identified during the quarter ended December 31, 2023, which was due solely to the material weakness over the valuation of debt and derivative liabilities which primarily involved applying an incorrect valuation method using the market price actually paid for certain convertible notes rather than using a Monte Carlo valuation formula. In light of the material weakness, we enhanced our valuation of debt and derivative liability processes. Based on the actions taken, as well as the evaluation of the design of the new controls, management concluded that the material weakness was remediated as of March 31, 2024 and were operating effectively as of December 31, 2024.
If we do not successfully maintain a strong control environment this could lead to heightened risk for financial reporting mistakes and irregularities, and/or lead to a loss of public confidence in our internal controls that could have a negative effect on the market price of our common stock. In addition, our ability to retain or attract qualified individuals to serve on our Board and to take on key management or other roles within our Company is uncertain.
As of December 31, 2024,2025, we had a total of 25105 full-time employees. Of this group, only fourthree employees are considered Management. Additional personnel are retained on a consulting or contractor basis. Many biotech companies would typically have a larger number of employees by the time they reach late-stage clinical trials. Such trials and other programs require extensive management capabilities, activities and skill sets, including scientific, medical, regulatory (for FDA and foreign regulatory counterparts), manufacturing, distribution and logistics, site management, reimbursement, business, financial, legal, public relations outreach to both the patient community and physician community, intellectual property, administrative, regulatory (SEC), investor relations and other resources.
We rely at present on third-partyone manufacturing facility in Sawston UK. As a result, we may be at risk for issues with capacity limitations and/or supply disruptions. We may need to engage contract manufacturers.manufacturers for additional capacity and/or back-up or replacement in the event of problems with the Sawston facility. As a result, we may be at risk for issues with manufacturing agreements, capacity limitations and/or supply disruptions,agreements and/or issues with product equivalency.
WeUntil relyour acquisition of Advent BioServices, we relied upon specialized contract manufacturers, operating in specialized GMP (clean room) manufacturing facilities, to produce all of our DCVax products. We have worked with several such manufacturers, in several different locations, during various periods of our clinical trials and our compassionate treatment programs, including Advent BioServices,BioServices (prior to its acquisition by the Company), Cognate BioServices and the Fraunhofer Institute.
Following our acquisition of Advent, we have operational control and oversight of the manufacturing and related activities at the manufacturing facility in Sawston, UK. We may not manage or oversee the operations effectively. As a result, we may be at risk for issues with capacity limitations and/or supply disruptions. Although we currently expect all essential personnel in Advent to stay onboard and continue the operations, we may be at risk for loss of some key personnel. As a result, we may be at risk for impairment or disruption of the operations in the Sawston, UK facility.
We will need to enter into new contractual agreements for manufacturing at our Sawston, U.K. facility and new agreements for commercial production in any locations. We may encounter difficulties reaching such agreements, or the terms of such agreements may not be favorable. Following negotiations, if it is necessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that could involve increased facility costs and/or increased costs related to manufacturing of our products and could result in delays in our programs or applications for various regulatory approvals. In addition, after such contracts are in place, the third-party contractors may have capacity limitations and/or supply disruptions, and as a client we may not be able to prevent such limitations or disruptions, and not be able to control or mitigate the impact on our programs.
We have been in breach of the services agreements with our contract manufacturers on numerous occasions, primarily for untimely payment or non-payment. Our breaches of the services agreements may not be tolerated in the future as they have been in the past, and if we continue to breach the services agreements, for non-payment or otherwise, the contract manufacturers could cease providing services and/or terminate these agreements.
Problems with the manufacturing facilities, processes or operations ofat our contractSawston manufacturer(s)facility could result in a failure to produce, or a delay in producing adequate supplies of our DCVax product candidates.candidates, as the Sawston facility is currently the only GMP facility manufacturing the Company’s products. A number of factors could cause interruptions or delays, including the inability of a supplier to provide raw materials, equipment malfunctions or failures, damage to a facility due to natural disasters or otherwise, changes in FDA, U.K. or European regulatory requirements or standards that require modifications to our manufacturing processes, action by the FDA, U.K. or European regulators, or by us that results in the halting or slowdown of production of components or finished products due to regulatory issues, our manufacturersSawston going out of business orfacility failing to produce product as contractually required,asneeded, insufficient technical personnel and/or specialized facilities to produce sufficient products, and/or other factors. AIf numberit ofis factorsnecessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that could alsoinvolve causeincreased possible issues about the equivalency of DCVax product produced in different facilities or locations, which could make it necessary for us to perform additional studies and incur additionalfacility costs and/or delays.increased Becausecosts manufacturing processes for our DCVax product candidates are highly complex, require specialized facilities (dedicated exclusivelyrelated to DCVax production) and personnel that are not widely available in the industry, involve equipment and training with long lead times, and are subject to lengthy regulatory approval processes, alternative qualified production capacity may not be available on a timely basis or at all. Also, as noted above, our contract manufacturer(s) could choose to terminate their agreements with us if we are in breach, or if we undergo a change of control. Difficulties, delays or interruptions in the manufacturing and supply and delivery of our DCVaxproducts product candidatesand could requireresult usin todelays stopin enrollingour new patients into clinical trials, and/or require us to stop the trialsprograms or other programs, stop the treatment of patients in the trials or other programs, increase our costs, damage our reputation and, if our product candidates are approvedapplications for sale,various causeregulatory us to lose revenue or market share if our manufacturers are unable to timely meet market demands.approvals.
In the event of problems with our Sawston facility, it may be necessary for us to enter into new agreements for production in any locations, as contract services or otherwise. We may encounter difficulties reaching such agreements, or the terms of such agreements may not be favorable. In addition, after such contracts are in place, the third-party contractors may have capacity limitations and/or supply disruptions, and as a client we may not be able to prevent such limitations or disruptions, and not be able to control or mitigate the impact on our programs. A number of factors could also cause possible issues about the equivalency of DCVax product produced in different facilities or locations, which could make it necessary for us to perform additional studies and incur additional costs and delays. Because manufacturing processes for our DCVax product candidates are highly complex, require specialized facilities (dedicated exclusively to DCVax production) and personnel that are not widely available in the industry, involve equipment and training with long lead times, and are subject to lengthy regulatory approval processes, alternative qualified production capacity may not be available on a timely basis or at all.
Difficulties, delays or interruptions in the manufacturing and supply and delivery of our DCVax product candidates could require us to stop treating patients commercially if our product candidates are approved for sale, to stop enrolling new patients into clinical trials, and/or require us to stop the trials or other programs, stop the treatment of patients in the trials or other programs, increase our costs, damage our reputation and, if our product candidates are approved for sale, cause us to lose revenue or market share if we are unable to timely meet market demands.
We rely on third parties to assist us, on a contract services basis, in managing and monitoring all of our clinical trials as well as the collection, confirmation and analysis of the trial data. We do not have experience conducting late-stage clinical trials, or collecting, validating and analyzing trial data by ourselves without third party service firms, nor do we have experience in supervising such third parties in managing late - stage, multi-hundred patient clinical trials, and collecting, validating and analyzing the data, other than in our current Phase III trial for GBM. Our lack of experience and/or our reliance on these third-party service firms may result in delays or failure to complete these trials and/or the data collection, validation and analysesanalysis successfully or on time. If the third parties fail to perform, we may not be able to find sufficient alternative suppliers of those services in a reasonable time period, or on commercially reasonable terms, if at all.
Our DCVax product candidates consist of living human immune cells. Such products are entirely different from chemical or biologic drugs, and require different handling, distribution and delivery than chemical or biologic drugs. One crucial difference is that the biomaterial ingredients (immune cells and tumor tissue) from which we make DCVax products and the finished DCVax products themselves are subject to time constraints in the shipping and handling. The biomaterial ingredients come from the medical centers to the manufacturing facility fresh and not frozen,frozen; and must arrive within a certain window of time and in usable condition. Performance failures by the medical center or the courier company can result in biomaterials that are not usable, in which case it may not be possible to make DCVax product for the patient involved. The finished DCVax products are frozen and must remain frozen throughout the process of distribution and delivery to the medical center or physician’s office, until the time of administration to the patient, and cannot be handled at room temperature until then or their viability will be lost. In addition, our DCVax product candidates are personalized and they involve ongoing treatment cycles over several years for each patient. Each product shipment for each patient must be tracked and managed individually. For all of these reasons, among others, we will not be able to simply use the distribution networks and processes that already exist for conventional drugs. It may take time for shipping companies, hospitals, pharmacies and physicians to adapt to the requirements for handling, distribution and delivery of these products, which may adversely affect our commercialization.
The commercial success of any of our product candidates will depend upon the strength of our sales and marketing efforts. We do not have a marketing or sales force and have no experience in marketing or sales of products like our lead product, DCVax-L for GBM, or our additional product, DCVax-Direct. To fully commercialize our product candidates, we will need to recruit and train marketing staff and a sales force with technical expertise and ability to manage the distribution of our DCVax-L for GBM. As an alternative, we could seek assistance from a corporate partner or a third-party services firm with a large distribution system and a large direct sales force. However, since our DCVax products are living cell, immune therapy products, and these are a fundamentally new and different type of product than are on the market today, we would still have to train such partner’s or such services firm’s personnel about our products and would have to make changes in their distribution processes and systems to handle our products. We may be unable to recruit and train effective sales and marketing forces or our own, or of a partner or a services firm, and/or doing so may be more costly and difficult than anticipated. Such factors may result in significant difficulties in commercializing our product candidates, and we may be unable to generate significant revenues.
However, since our DCVax products are living cell, immune therapy products, and these are a fundamentally new and different type of product than are on the market today, we would still have to train such partner’s or such services firm’s personnel about our products and would have to make changes in their distribution processes and systems to handle our products. We may be unable to recruit and train effective sales and marketing forces or our own, or of a partner or a services firm, and/or doing so may be more costly and difficult than anticipated. Such factors may result in significant difficulties in commercializing our product candidates, and we may be unable to generate significant revenues.
●provide the Board of Directors with the ability to alter the bylaws without stockholder approval;
●establish staggered terms for board members;
●place limitations on the removal of directors; and
●provide that vacancies on the Board of Directors may be filled by a majority of directors in office, although less than a quorum.
Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to decline. A substantial majority of the outstanding shares of our common stock are freely tradable without restriction or further registration under the Securities Act. As of December 31, 2024,2025, 1,328.61,567.4 million shares of our common stock are issued and 1,555.4 million shares of our common stock are outstanding. In addition, as of December 31, 2024,2025, 4.10.4 million shares of our common stock are issuable upon exercise of outstanding warrants, and 130.095 million shares of our common stock are issuable upon exercise of outstanding options.
Management's Discussion & Analysis (MD&A)
New heading “Business Combination”
New heading “Change in Fair Value of Share Payable”
Removed heading “Improvements to Reportable Segment Disclosures”
Removed heading “Improvements to Income Tax Disclosures”
Largest changes
“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. …”see in full comparison
“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. …”see in full comparison
“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. …”see in full comparison
“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. …”see in full comparison
Full comparison: every changed paragraph (76)
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.
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.
IntensiveDuring activities2025, the Company continued throughoutits 2024,progress including in Q4, inon multiple areasfronts, including the following:
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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 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.
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).
Business Combination
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
We recognized a net loss of $83.8$60.2 million and $62.6$83.8 million for the years ended December 31, 20242025 and 2023.2024, respectively.
For the years ended December 31, 20242025 and 2023,2024, research and development expense were $34.9$28.8 million and $27.7$34.9 million, respectively. The breakdown of this increasedecrease in R&D expenses in 2024 as compared to 20232025 was primarily related to athe net increasedecrease in expensesstock-based compensation, the costs related to the MAA application at the MHRA and the acquisition of approximately:Advent in the 4th quarter in 2025.
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.
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.
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.
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.
Change in Fair Value of Share Payable
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.
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.
We recognized a non-cash gain of $7.7$25.6 million and a non-cash loss of $2.0$7.7 million from the change in fair value of the convertible notes during the year ended December 31, 20242025 and 2023,2024, respectively. The gainnon-cash duringgains theresulted year ended December 31, 2024 was primarily due tofrom the decrease of the Company’s stock price as of December 31, 2024 compared to December 31, 2023.price. The loss during the year ended December 31, 2023 was primarily due to the increase in the stocknon-cash pricegains asin 2025 was attributable to a change in certain assumptions used in the valuation of December 31, 2023 compared to the stockconvertible price on the issuance dates in August and September 2023.notes.
What changed in the latest 10-Q
Risk Factors
Applicable risk factors are set forth in the Company’s report on Form 10-K for the fiscal year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Change in Fair Value of Derivatives”
New heading “Change in Fair Value of Share Payable”
New heading “Change in Fair Value of Convertible Notes”
New heading “Debt Extinguishment”
New heading “Loss from Issuance of Debt”
New heading “Interest Expense”
New heading “Foreign currency transaction gain (loss)”
New heading “Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development Expense”
New heading “General and Administrative Expense”
Largest changes
“Litigation Progress. The Company continued vigorously pursuing documents and information both from the defendants and from third parties in the discovery stage of its litigation in New York against certain market makers. On April 30, 2026, the Company and one of the lesser defendants agreed to resolve the Company’s case against that defendant by settlement. The parties so notified the Court. The settlement is confidential. The funds are being held in escrow while the Company pursues discussions with other lesser defendants about resolution of the case against them. …”see in full comparison
Full comparison: every changed paragraph (59)
During the firstsecond three monthsquarter of 2026, the Company continued its progress on multiple fronts, including the following:
Collaborations. The Company pursued collaboration discussions in certain countries where the Company believes that development and potential commercialization could proceed more rapidly and efficiently with a partner. As previously reported, the Company entered into an MOU for a potential collaboration with one of the largest pharmaceutical companies in the Kingdom of Saudi Arabia. The Company is continuing those discussions with a view to reaching a definitive agreement. The Company is also continuing other discussions.
Statistical Analyses and BNOS Presentation. As previously reported, the Company worked closely with a team of independent statisticians to analyze the data from the Phase 3 trial of DCVax-L for glioblastoma, applying multiple statistical methodologies and using individual patient data (IPD) comparators. This had been envisaged in the Statistical Analysis Plan (SAP) for the trial but the Company had been unable to gain access to IPD at the time of the original analysis of the trial results despite extensive efforts. The results of these IPD analyses were all directionally consistent and indicated that the magnitude of the survival extension associated with DCVax-L was substantially greater than the original analysis of the trial results had shown. The Company presented this work at the annual meeting of the British Neuro Oncology Society (BNOS) at the beginning of July 2026.
UK Leukapheresis Capacity. The Company continued it efforts to develop expanded capacity for leukapheresis procedures. The Company pursued discussions with certain parties who have existing leukapheresis facilities, to secure further capacity without capital expenditure. In parallel, the Company also continued pursuing the development of its own leukapheresis unit in the London Welbeck Hospital and pursuing the necessary licenses for the operation of that unit.
UK Manufacturing Capacity. The Company began exploring the potential for conducting the tumor lysate stage of the manufacturing process in additional facilities to enable an increase in the production capacity in the Sawston facility before the completion of the Grade C lab. The Company continued discussions for a collaboration that could potentially lead to a second DCVax production operation in another region of the UK, using an existing established GMP facility. The Company also pursued a grant funding program for non-dilutive capital for development of capacity in the Sawston facility.
US Manufacturing Capacity. The technology transfer process for development of DCVax-L manufacturing capacity in a US company was completed, and the basic engineering runs and validation were undertaken and recently completed. For production of the Kalinski aDC1 products, the Company’s negotiations for lease arrangements for a suitable GMP facility continued. In light of the challenges encountered in reaching suitable lease arrangements for production of the Kalinski products, the Company anticipates making arrangements for a parallel process of technology transfer to the US company to which the technology transfer for production of DCVax-L products has been completed.
UK Strategic Advisor. As previously reported, the Company engaged a new Strategic Advisor, Dr. Annalisa Jenkins. Dr. Jenkins has extensive experience in big pharma, biotech and medical innovation, and is a key opinion leader in the UK and globally. Dr. Jenkins will advise and help the Company advance the development of its DCVax cancer vaccines. The Company believes that Dr. Jenkins’ experience, advice and involvement will be a valuable resource.
UK Clinic. As also previously reported, the Company’s pursuit of clinic arrangements or collaborations in the UK culminated in the Company establishing a clinic arrangement with the London Welbeck Hospital in the Harley Street medical district in London. During the first quarter, the Company secured a contractor and proceeded with buildout. The clinic includes two leukapheresis units, each of which can conduct two procedures per day for a total of 4 patients per day. The clinic may also offer extended hours and weekend operations. There is a general shortage of leukapheresis capacity in the UK, and such procedures are needed for T cell products as well as for dendritic cell products. The buildout is anticipated to be completed by June and the Company is pursuing applications for the required licenses.
Development of the Sawston, UK Facility. The Company and Advent continued the development process for the initial Grade C lab in the Sawston facility. The Company and Advent worked with advisers and the construction firm to modify the C lab design so as to increase its capacity and enable faster pace of certain operations. The development activity involving construction work was paused; the engineering work was ongoing.
Secondary Manufacturing in the UK. The Company continued discussions for a collaboration that could potentially lead to a second DCVax production operation in another region of the UK, using an existing established GMP facility with training of the personnel to be conducted by Advent. Since this secondary facility would not require buildout and is located in a relatively low-cost area, the Company anticipates that it could be brought online rapidly and economically. The Company is pursuing planning discussions with the party in charge of the facility.
Manufacturing in the US – DCVax Products and Kalinski aDC1 Products. The Company has been pursuing separate parallel tracks to develop manufacturing in the US of the Company’s DCVax-L products and of the aDC1 products pursuant to the technologies of Dr. Kalinski that the Company has in-licensed. For the production of DCVax-L products, during the first quarter the Company completed the selection of a US company, contract negotiations and entered into a technology transfer agreement for development of DCVax-L manufacturing capacity by the US company. The Standard Operating Procedures (SOPs) used in the UK are being adapted to the US facilities and operations, and training began during the first quarter. The Company anticipates that the required engineering runs and validations will be completed during the summer.
For the production of Kalinski aDC1 products, the Company is working primarily to develop its own GMP manufacturing operation in the US, although it is also in discussions with a contractor for such production as an alternative. The Company has been in ongoing negotiations since last year to secure lease arrangements for a suitable GMP facility. In the meantime, during the first quarter the Company completed the lengthy recruitment process and hired the key manager to lead the aDC1 manufacturing operations.
Development Activity With In-Licensed Technologies. An updated trial design andThe IND package forwas anfurther initialupdated and its clinical trialprotocol of the Kalinski technology involving the Company were completed during the first quarter. The lead medical institution for the clinical trialcomponent has been determinedawaiting review and theapproval IND package has been submitted toby the Institutional Review Board (IRB) there. The Company anticipates submission to the FDA inas soon as the secondIRB quarter.approval is completed.
UK Property Development. The Company and its advisers made headway in continuing to work toward the reclassification and increased valuation of the property owned by the Company on the edge of Sawston, UK. The property is now considered to be in an in-between classification, which the Company has been advised has more than doubled the prior value of the property.
Litigation Progress. The Company continued vigorously pursuing discovery in its litigation in New York against certain market makers. Among other steps, the Company continued seeking certain trading information and trading algorithms. The Company believes that the Court’s recent order requiring the defendants to produce their trading algorithms is quite significant. The Company plans to continue its vigorous pursuit of the case. See Part II Item 1, Legal Proceedings, below.
UK Property Development. The Company owns a 17-acre parcel of land on the edge of Sawston, UK which is located across the road from the Company’s manufacturing facility and adjacent to existing residential neighborhoods. The Company owns unencumbered fee title to the land. There is a pressing shortage of housing in the region and the Local Council is conducting a review of the land and zoning in the area. The Company’s property is not currently zoned for housing development despite its location on the edge of the town and adjacent to other residential areas. If zoned for residential development, the Company has been advised that its property would be extremely valuable. During the first quarter, the Company worked with a team of advisers to develop an application for rezoning of its property and submitted the application as part of the Local Council review process.
Litigation Progress. The Company continued vigorously pursuing documents and information both from the defendants and from third parties in the discovery stage of its litigation in New York against certain market makers. On April 30, 2026, the Company and one of the lesser defendants agreed to resolve the Company’s case against that defendant by settlement. The parties so notified the Court. The settlement is confidential. The funds are being held in escrow while the Company pursues discussions with other lesser defendants about resolution of the case against them. The Company anticipates that the funds will be released from escrow when the discussions with the lesser defendants have been completed. See Part II Item 1, Legal Proceedings, below.
Three Months Ended MarchJune 31,30, 2026 and 2025
We recognized a net loss of $3.1$9.2 million and $19.3$15.4 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively.
For the three months ended MarchJune 31,30, 2026 and 2025, research and development expenses were $4.9$5.7 million and $8.4$7.4 million, respectively. The decrease in 2026 was primarily related to a decrease in the costs related to the MAA application atand its review by the MHRA, a decrease in stock basedstock-based compensation to external consultants and the acquisition of Advent in the 4th quarter in 2025.
For the three months ended MarchJune 31,30, 2026 and 2025, general and administrative expenses were $6.5$6.7 million and $9.3$7.5 million, respectively. The decrease was mainly related to a reduction in legal costs.
Change in Fair Value of Derivatives
The derivative liability associated with the contingent note payable was zero as of June 30, 2026. We did not recognize any expense related to change in fair value of derivatives during the three months ended June 30, 2026.
We recognized a non-cash gain of $0.7 million for the three months ended June 30, 2025. The non-cash revaluation gain was mainly due to the decrease of stock price and remaining life of certain liability classified warrants. We did not recognize any change in fair value of derivatives for the three months ended June 30, 2026.
Change in Fair Value of Share Payable
We recognized a non-cash gain of $64,000 and a non-cash loss of $0.2 million from the change in fair value of share payable during the three months ended June 30, 2026 and 2025, respectively. The fluctuations were mainly due to the movement of our stock price.
Change in Fair Value of Convertible Notes
We recognized a non-cash gain of $6.4 million and $2.4 million for the change in fair value of the convertible notes during the three months ended June 30, 2026 and 2025, respectively. The non-cash gains resulted from the decrease of the Company’s stock price. In addition, the increased gain during the three months ended June 30, 2026 was also attributable to a change in certain assumptions used in the valuation of the convertible notes.
Debt Extinguishment
We recognized approximately $2.2 million and $4.5 million debt extinguishment loss during the three months ended June 30, 2026 and 2025, respectively, from debt redemptions and debt amendments. The decrease during the three months ended June 30, 2026 compared to last year in the same period was due to less volume of debt amendments.
Loss from Issuance of Debt
We recognized approximately $0.8 million loss from issuance of certain convertible notes, which we elected to account for under the FVO during the three months ended June 30, 2025. The loss was calculated as the difference between the principal amount and the fair value of these convertible notes.
Interest Expense
During the three months ended June 30, 2026 and 2025, we recognized interest expense of $1.8 million and $1.8 million, respectively.
Foreign currency transaction gain (loss)
During the three months ended June 30, 2026 and 2025, we recognized foreign currency transaction loss of $0.1 million and a gain of $3.6 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to British pound sterling and vice versa for the loss.
Six Months Ended June 30, 2026 and 2025
We recognized a net loss of $12.3 million and $34.7 million for the six months ended June 30, 2026 and 2025, respectively.
Research and Development Expense
For the six months ended June 30, 2026 and 2025, research and development expenses were $10.6 million and $15.8 million, respectively. The decrease in 2026 was primarily related to a decrease in the costs related to the MAA application and its review by the MHRA, a decrease in stock-based compensation to external consultants and the acquisition of Advent in the 4th quarter in 2025.
General and Administrative Expense
For the six months ended June 30, 2026 and 2025, general and administrative expenses were $13.2 million and $16.8 million, respectively. The decrease was mainly related to a reduction in legal costs.
During the threesix months ended MarchJune 31,30, 2026, the Company recognized a $2.25 million gain related to the Delaware litigation settlement.
We recognized a non-cash gain on the change in fair value of derivatives of $9.4 million and $1.3$2.0 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The non-cash gain of $9.4 million for the threesix months ended MarchJune 31,30, 2026, resulted from a fair value adjustment to the contingent note payable. Based on current assessments, the achievement of the underlying performance conditions required for payment iswas not probable prior to the note’s expiration on May 21, 2026. Consequently, the fair value of the liability was reduced to zero as of MarchMay 31,21, 2026. The gain in the threesix months ended MarchJune 31,30, 2025 was mainly due to the non-cash revaluation gain for certain warrants that were reclassified as liabilities as of December 2024.
We recognized a non-cash gain of $0.2$0.3 million and a non-cash loss of $23,000$0.3 million from the change in fair value of share payable during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The fluctuations were mainly due to the movement of our stock price.
We recognized a non-cash gain of $5.2$11.7 million and $3.7$6.1 million for the change in fair value of the convertible notes during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The non-cash gains resulted from the decrease of the Company’s stock price. In addition, the increased gain during the threesix months ended MarchJune 31,30, 2026 was also attributable to a change in certain assumptions used in the valuation of the convertible notes.
We recognized approximately $4.8$6.9 million and $7.3$11.8 million debt extinguishment loss during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, from debt redemptions and debt amendments. The decrease during the threesix months ended MarchJune 31,30, 2026 compared to last year in the same period was due to less volume of debt amendments.
We recognized approximately $0.7 and $0.8 million loss from issuance of certain convertible notes, which we elected to account for under the FVO during the threesix months ended MarchJune 31,30, 2026.2026 and 2025, respectively. The loss was calculated as the difference between the principal amount and the fair value of these convertible notes.
We recognized an inducement expense of $87,000 related a convertible note that had an inducement conversion during the threesix months ended MarchJune 31,30, 2026.
During the threesix months ended MarchJune 31,30, 2026 and 2025, we recognized interest expense of $2.3$4.2 million and $1.6$3.4 million, respectively. The increase in interest expense in 2026 was mainly related to the issuance costs related to certain convertible notes issued in March 2026, which we elected to account for under the FVO.
During the threesix months ended MarchJune 31,30, 2026 and 2025, we recognized foreign currency transaction loss of $1.3$1.5 million and a gain of $1.9$5.5 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to British pound sterling and vice versa for the loss.
During the threesix months ended MarchJune 31,30, 2026 and 2025, total operating costs and expenses were approximately $11.4$23.8 million and $17.7$32.6 million, respectively. Net cash outflows from operations were approximately $12.5$19.7 million (including payments for prior periods’ accounts payables) and $9.4$16.1 million, respectively. The increase in cash used in operating activities was primarily attributable to the strengthening of the British Pound relative to the U.S. Dollar.
During the threesix months ended MarchJune 31,30, 2026 and 2025, cash used in investing activities were approximately $0.1$0.3 million and $0.1$0.4 million, respectively.
We received approximately $2.9$3.0 million and $5.1$12.4 million of cash from issuance of common shares during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.
We received approximately $7.5$8.4 million and $2.2$5.5 million of cash from issuance of convertible notes to individual lenders during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.
We received approximately $5.0$7.0 million ofand cash$7.0 million from the issuance of a loan from a commercial lender during the threesix months ended MarchJune 31,30, 2025.2026 and 2025, respectively.
We received approximately $6,000$20,000 and $17,000 of cash$23,000 from the exercise of warrants during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.
We made aggregate debt payments of $0.5 million and $0.6$0.8 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.
We made aggregate payments of approximately $0.7$1.3 million to the seller in connection with the Advent acquisition in October 2025 during the threesix months ended MarchJune 31,30, 2026.
NWBO insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding NWBO (13F)
None of the 59 investors we track reported a position in their latest 13F.