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NORTHWEST BIOTHERAPEUTICS, INC.
FORM 10-K
TABLE OF CONTENTS
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PART I
This Report on Form 10-K for Northwest Biotherapeutics, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions, and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Item 1A of this Report, including the uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate safety and efficacy in larger-scale clinical trials, the risk that we will not obtain approval to market our products, the risks associated with dependence upon key personnel and the need for additional financing. We do not assume any obligation to update forward-looking statements as circumstances change.
Unless the context otherwise requires, “Northwest Biotherapeutics,” the “Company,” “we,” “us,” “our” and similar names refer to Northwest Biotherapeutics, Inc. DCVax® is a registered trademark of the Company.
ITEM 1. BUSINESS.
Overview
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 candidate, 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 candidate, 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 have been working on preparations for Phase II trials of DCVax-Direct as resources permit.
The DCVax Technology
Our platform technology, DCVax, is a personalized immune therapy that uses a patient’s own dendritic cells, or DCs, the master cells of the immune system, as the therapeutic agent. The patient’s DCs are obtained through a blood draw, or leukapheresis. The DCs are then activated and loaded with biomarkers (“antigens”) from the patient’s own tumor. For DCVax-L, the antigen loading process takes place during the manufacturing of the product. For DCVax-Direct, the antigen loading process takes place in situ in the tumor after the product is directly injected into the patient’s inoperable tumor. The loading of antigens into the DCs “educates” the DCs about what the immune system needs to target.
Manufacturing of DCVax
We use a batch manufacturing technology for our DCVax products, and we believe this manufacturing approach is a key part of the practicality of our product and its economic feasibility. Generally, we are able to produce enough doses for the patient’s treatment regimen through just one manufacturing process. When a batch of DCVax product has been made, we then cryopreserve it.
Both of these technologies, the personalized batch manufacturing for each patient and the cryopreservation, are essential elements of our manufacturing model and product economics. Together, they enable us to usually incur the high costs of manufacturing just one time for each patient, and then store the multi-year or multi-dose quantity of product, frozen, in single doses. This makes DCVax effectively an “off the shelf” product for the patient after the initial manufacturing, even though it is personalized, and we anticipate that this will enable the pricing of DCVax to be in line with other new cancer drugs. We also believe that both economies of scale and automation will further enhance the product economics. The manufacturing process today is also rapid: about eight days for DCVax-L,
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and seven days for DCVax-Direct, followed by quality control and release testing (including a sterility test that may take a couple of weeks).
As previously reported, we have been developing a manufacturing facility in Sawston, U.K. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have anticipated potential capacity to produce dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The buildout of Phases 1A and 1B of the facility have been completed. We also continue to conduct activities in the GMP (clean room) facility in London.
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.
During 2024, the Company’s Flaskworks subsidiary and a specialized contractor developed a GMP-compatible prototype of the Flaskworks system for a “closed” manufacturing process for DCVax-L. Another prototype, with smaller dimensions, had been developed in 2023. The Company has determined that the smaller prototype will be preferable, to enable more units to fit in each manufacturing lab. Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients. As previously reported, the Company views the Flaskworks program and system as a centerpiece of efforts toward scale-up for potential commercial operations.
The initial production capacity occupies only a limited portion of the total space in the Sawston facility. In light of this, and in light of our obligation in connection with the buildout loan from the Cambridge development authority to make the Sawston facility benefit the regional business ecosystem and not just us, on December 31, 2021 we entered into a sub-lease for a small portion of the space to our contract manufacturer, Advent BioServices. For further details, please see Note 9 below. It is anticipated that, as and when feasible, the subleased space may enable some production of third-party cell therapy products. Such production of other products will fulfill the loan-related commitment to the Cambridge authority, will help support the capital-intensive Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility.
All of the development activities and licensing for the Sawston facility have been carried out or managed by Advent BioServices, which is also the contract operator of the facility.
Intellectual Property and Orphan Drug Designation
We have an integrated strategy for protection of our technology through both patents and other mechanisms, such as Orphan Drug status. As of December 31, 2024, we have 48 issued patents, including national validations in certain European countries, and 60 pending patent applications worldwide, grouped into 7 patent families. Of these, 38 issued patents, including validations in European countries, and 37 pending patent applications directly relate to our DCVax products. In the United States and Europe, some of our patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing. For example, in the United States, we have two issued patents and three pending patent applications that relate to the composition and/or use of our DCVax products. We also have other US patents and applications that cover, among other things, manufacturing methods we believe leads to obtaining optimally activated dendritic cells for treating advanced cancers and an automated system which we believe will help enable the scale-up of production for large numbers of patients on a cost-effective basis. Similarly, in Europe, we have two patents, validated as 15 national patents, issued and three pending patent applications with the European Patent Office (“EPO”) that cover our DCVax products, and other patents and applications that cover aspects such as manufacturing, and the automated system. In Japan, we have three issued patents and four pending patent applications relating to our DCVax products, as well as manufacturing related patents. Patents have been granted or are pending in other foreign jurisdictions which may be potential future markets for our DCVax products.
During 2024, 6 new patents were issued to us as part of our DCVax worldwide patent portfolio, in addition to 10 new patents related to the Flaskworks IP portfolio. The newly issued patents cover methods for manufacturing dendritic cells related to our DCVax products, as well as encompassing certain methods of use and compositions which may be potential future markets for related DCVax products.
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Additionally, with the acquisition of Flaskworks, we gained ownership of a portfolio of patents and patent applications which include those held by Flaskworks as well as patents and patent applications exclusively licensed by Flaskworks from Northeastern University. The portfolio includes a total of thirteen patent families, with issued patents and pending applications worldwide. Collectively these patents and patent applications cover key aspects of the design and function of automated cell culture systems.
The expiration dates of the issued US patents in our portfolio involved in our current business range from 2026 to 2036 and pending applications may involve longer time periods. The expiration date of the issued European patent involved in our current business is 2036, and pending applications may involve longer time periods. For some of the earlier dates, we plan to seek extensions of the patent life, and believe we have reasonable grounds for doing so.
Also, during 2024, prosecution continued in various patents and patent applications exclusively in-licensed from various academic institutions. These include patents and patent applications related to enhanced versions of dendritic cells (certain vaccine compositions, immunogenic peptide antigens, and cell - based immunotherapy compositions and methods for their use.
In addition to our patent portfolio, we have obtained Orphan Drug designation for our lead product, DCVax-L for glioma brain cancers. Such designation brings with it a variety of benefits, including potential market exclusivity for seven years in the US and ten years in Europe if our product is the first of its type to reach the market.
This market exclusivity applies regardless of patents (i.e., even if the company that developed it has no patent coverage on the product). In addition, the time period for such market exclusivity does not begin to run until product sales begin. In contrast, the time period of a patent begins when the patent is filed and runs down during the years while the product is going through development and clinical trials.
Competition
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. A large and growing number of companies are actively involved in the research and development of immune therapies or cell-based therapies for cancer. In addition, many big pharma companies are rapidly commercializing checkpoint inhibitor drugs to “take the brakes off” patients’ immune responses to cancer. Other novel technologies for cancer are approved and commercially available, such as the Optune electro-therapy device, various biologics and various oncolytic virus therapies and gene therapies. Additionally, many companies are actively involved in the research and development of monoclonal antibody-based and bi-specific or tri-specific antibody-based cancer therapies. Currently, a substantial number of antibody-based drugs are approved for commercial sale for cancer therapy, and a large number of additional ones are under development. Many other third parties compete with us in developing alternative therapies to treat cancer, including: biopharmaceutical companies; biotechnology companies; pharmaceutical companies; academic institutions; and other research organizations, as well as some medical device companies.
We face extensive competition from companies developing new treatments for brain cancer. These include a variety of immune therapies, as mentioned above, as well as a variety of small molecule drugs and biologics. There are also a number of existing drugs used for the treatment of brain cancer that may compete with our product, including, Avastin® (Roche Holding AG), Gliadel® (Eisai Co. Ltd.), and Temodar® (Merck & Co., Inc.), as well as the Optune electro-therapy device (Novocure) and oncolytic viruses. Both checkpoint inhibitor drugs and T cell-based therapies are pursuing clinical trials for solid tumors, including brain cancer, as well.
Most of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing and sales than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly if they enter into collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel and collaborators, as well as in acquiring technologies complementary to our programs, and in obtaining sites for our clinical trials and enrolling patients.
Corporate Information
We were formed in 1996 and incorporated in Delaware in July 1998. Our principal executive offices are located in Bethesda, Maryland, and our telephone number is (240) 497-9024. Our website address is www.nwbio.com. The information on our website is not part of this report. We have included our website address as a factual reference and do not intend it to be an active link to our website.
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Available Information
Our website address is www.nwbio.com. We make available, free of charge through our website, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports as soon as is reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission (the “SEC”), but other information on our website is not incorporated into this report. The SEC maintains an Internet site that contains these reports at www.sec.gov.
Human Capital
The Company continues to operate with a lean staff, supplementing its full-time employees with consultants with various expertise. The Company began the year with 25 full-time employees (FTEs) and ended the year on December 31, 2024 with 25 FTEs. As in the past, the Company relied upon specialists in the areas of manufacturing, construction and construction management, clinical trial management, data validation and analysis, scientific advisory, regulatory advisory, legal, financial accounting and tax, and information technology. For the Company’s international operations in the UK, the Company relies on a contracted workforce. To attract and retain talent, the Company offers a competitive pay and benefits package.
ITEM 1A. RISK FACTORS
Our business, financial condition, operating results and prospects are subject to the following material risks. Additional risks and uncertainties not presently foreseeable to us may also impair our business operations. If any of the following risks actually occurs, our business, financial condition or operating results could be materially adversely affected. In such case, the trading price of our common stock could decline, and our stockholders may lose all or part of their investment in the shares of our common stock.
Risks Related to our Operations
We will need to raise substantial funds, on an ongoing basis, for general corporate purposes and operations, including our clinical trials. Such funding may not be available or may not be available on acceptable terms.
We will need substantial additional funding, on an ongoing basis, in order to continue execution of our clinical trials, to move our product candidates towards commercialization, to continue prosecution and maintenance of our large patent portfolio, to continue development and optimization of our manufacturing and distribution arrangements, and for other corporate purposes. Any financing, if available, may include restrictive covenants and provisions that could limit our ability to take certain actions, preference provisions for the investors, and/or discounts, warrants, anti-dilution rights, the provision of collateral, or other incentives. Any financing will involve issuance of equity and/or debt, and such issuances will be dilutive to existing shareholders. There can be no assurance that we will be able to complete any of the financings, or that the terms for such financings will be acceptable. If we are unable to obtain additional funds on a timely basis or on acceptable terms, we may be required to curtail or cease some or all of our operations at any time.
We are likely to continue to incur substantial losses and may never achieve profitability.
Since inception, we have had net cash outflows (losses) from operations. We may never achieve or sustain profitability.
Our auditors have issued a “going concern” audit opinion.
Management has determined and our independent auditors have indicated in their report on our December 31, 2024 financial statements that there is substantial doubt about our ability to continue as a going concern. We have received such a “going concern” opinion each of the preceding years for more than a decade. A “going concern” opinion indicates that the financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result if we do not continue as a going concern. Therefore, you should not rely on our consolidated balance sheet as an indication of the amount of proceeds that would be available to satisfy claims of creditors, and potentially be available for distribution to stockholders, in the event of liquidation.
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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 a company with a novel technology and unproven business strategy, an evaluation of our business and prospects is difficult.
We are still in the process of developing our product candidates through clinical trials. Our technology is novel and involves mobilizing the immune system to fight a patient’s cancer. Immune therapies have been pursued by many parties for decades, and have experienced many failures. In addition, our technology involves personalized treatment products, a new approach to medical products that involves new product economics and business strategies, which have not yet been shown to be commercially feasible or successful. We have not yet gone through scale-up of our operations to commercial scale. The novelty of our technology, product economics, and business strategy, and the limited scale of our operations to date, makes it difficult to assess our prospects for generating revenues commercially in the future.
We will need to expand our management and technical personnel as our operations progress, and we may not be able to recruit such additional personnel and/or retain existing personnel.
As of December 31, 2024, we had a total of 25 full-time employees. Of this group, only four 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.
In order to fully perform all these diverse functions, at many sites across the U.S. and in Europe, we may need to expand our management, technical and other personnel. However, with respect to management and technical personal, the pool of such personnel with expertise and experience with living cell products, such as our DCVax immune cell product, is very limited. In addition, we are a small company with limited resources, our business prospects are uncertain and our stock price is volatile. For some or all of such reasons, we may not be able to recruit all the management, technical and other personnel we need, and/or we may not be able to retain all of our existing personnel. In such event, we may have to continue our operations with a small team of personnel, and our business and financial results may suffer.
We rely at present on third-party contract manufacturers. As a result, we may be at risk for issues with manufacturing agreements, capacity limitations and/or supply disruptions, and/or issues with product equivalency.
We rely 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
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clinical trials and our compassionate treatment programs, including Advent BioServices, Cognate BioServices and the Fraunhofer Institute.
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.
Our intention is for the Sawston, U.K. facility to manufacture DCVax products for both the UK and other regions. However, this may not turn out to be feasible, for regulatory, operational and/or logistical reasons. It is also unclear whether or how Brexit will affect or interfere with these plans in regard to Europe.
Problems with the manufacturing facilities, processes or operations of our contract manufacturer(s) could result in a failure to produce, or a delay in producing adequate supplies of our DCVax product candidates. 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 manufacturers going out of business or failing to produce product as contractually required, insufficient technical personnel and/or specialized facilities to produce sufficient products, and/or other factors. 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. 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 DCVax product candidates could require us 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 our manufacturers are unable to timely meet market demands.
The manufacturing of our product candidates will have to be greatly scaled up for commercialization, and neither we nor our contract manufacturers have experience with such scale-up.
As is the case with any clinical trial, our Phase III clinical trial of DCVax-L for GBM involves a number of patients that is a small fraction of the number of potential patients for whom DCVax-L may be applicable in the commercial market. The same will be true of our other clinical programs with DCVax-L or other DCVax product candidates. If our DCVax-L and/or other DCVax product candidates are approved for commercial sale, it will be necessary to greatly scale up the volume of manufacturing, far above the level needed for clinical trials. Neither we nor our contract manufacturers have experience with such scale-up. In addition, there are likely only a few consultants or advisors in the industry who have such experience and can provide guidance or assistance, because active immune therapies such as DCVax are a fundamentally new category of product in two major ways: these active immune therapy products consist of living cells, not chemical or biologic compounds, and the products are personalized. To our knowledge, very few such products have successfully completed the necessary scale-up for commercialization. For example, Dendreon Corporation encountered substantial difficulties trying to scale up the manufacturing of its Provenge® product for commercialization. To our knowledge, even the CAR-T products which are being commercialized have so far only scaled up to moderate product volumes.
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The necessary specialized facilities, equipment and personnel may not be available or obtainable for the scale-up of manufacturing of our product candidates.
The manufacture of living cells requires specialized facilities, equipment and personnel which are entirely different than what is required for the manufacturing of chemical or biologic compounds. Scaling up the manufacturing of living cell products to volume levels required for commercialization will require enormous amounts of these specialized facilities, equipment and personnel - especially where, as in the case of our DCVax product candidates, the product is personalized and must be made for each patient individually. Since living cell products are so new, and have barely begun to reach commercialization, the supply of the specialized facilities and personnel needed for them is not widely available and therefore is in the process of being developed. However, there has been a sharp increase in the demand for these specialized facilities and personnel, as large numbers of companies seek to develop T cell and other immune cell products. It may not be possible for us or our manufacturers to obtain all of the specialized facilities and personnel needed for commercialization of our DCVax product candidates, or even for further sizeable trials. This could delay or halt our commercialization and/or further substantial trials.
We are anticipating that the production systems developed by Flaskworks may play an important role in enabling scale-up of production and reducing the number of GMP (clean room) suites and personnel needed for scale-up. However, the Flaskworks systems are still undergoing development and optimization, and have not been operated at commercial scale to date. It could turn out that the Flaskworks systems are not capable of or suitable for substantial scale-up, or not acceptable to regulatory authorities for such scale-up. It could also turn out that deployment the Flaskworks system does not reduce the number of GMP suites and personnel needed for DCVax production as anticipated.
Our technology is novel, involves complex immune system elements, and may not prove to be effective.
Data already obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily predict the results that will be obtained from later pre-clinical studies and clinical trials. Over the course of several decades, there have been many different immune therapy product designs - and many product failures and company failures. To our knowledge, to date, only a couple of active immune therapies have been approved by the FDA, including one dendritic cell therapy and a couple of CAR-T cell therapies. The human immune system is complex, with many diverse elements, and the state of scientific understanding of the immune system is still limited. Some immune therapies previously developed by other parties showed surprising and unexpected toxicity in clinical trials. Other immune therapies developed by other parties delivered promising results in early clinical trials but failed in later stage clinical trials.
Although we believe the Phase III trial results are positive and encouraging, other parties, including doctors, patients, regulators and/or payers may not view the trial results positively. Further, although the safety profile of our DCVax-L product was excellent in both the Phase 3 clinical trial and the early-stage clinical trials, toxicity may be seen as we treat larger numbers of patients. If such toxicity occurs, it could limit, delay or stop further clinical development or commercialization of our DCVax-L product.
We have only conducted the Phase I portion of our first-in-man Phase I/II clinical trial with our DCVax Direct product, after prior early-stage trials with DCVax-L and DCVax-Prostate. Although the early results have not indicated any significant toxicity, we do not yet know what efficacy or toxicity DCVax-Direct may show in a larger sample of human patients. This product may not ultimately be found to be effective, and/or it may be found to be toxic, which could limit, delay or stop clinical development or commercialization of DCVax-Direct.
Clinical trials for our product candidates are expensive and time consuming, and their outcome is uncertain.
The process of obtaining and maintaining regulatory approvals for new therapeutic products is expensive, lengthy and uncertain. Costs and timing of clinical trials may vary significantly over the life of a project owing to any or all of the following non-exclusive reasons:
| ● | the duration of the clinical trial; |
| ● | the number of sites included in the trials; |
| ● | the countries in which the trial is conducted; |
| ● | the length of time required and ability to enroll eligible patients; |
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| ● | the number of patients that participate in the trials; |
| ● | the number of doses that patients receive; |
| ● | the drop-out or discontinuation rates of patients; |
| ● | per patient trial costs; |
| ● | third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; |
| ● | our final product candidates having different properties in humans than in laboratory testing; |
| ● | the need to suspend or terminate our clinical trials; |
| ● | insufficient or inadequate supply or quality of necessary materials to conduct our trials; |
| ● | potential additional safety monitoring, or other conditions required by the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies; |
| ● | problems engaging independent review Boards, or IRBs, to oversee trials or in obtaining and maintaining IRB approval of studies; |
| ● | the duration of patient follow-up; |
| ● | the efficacy and safety profile of a product candidate; |
| ● | the costs and timing of obtaining regulatory approvals; and |
| ● | the costs involved in enforcing or defending patent claims or other intellectual property rights. |
Late-stage clinical trials, such as our Phase III clinical trial for GBM patients, are especially expensive, typically requiring tens or hundreds of millions of dollars, and take years to reach their outcomes. Such outcomes often fail to reproduce the results of earlier trials. It is often necessary to conduct multiple late-stage trials (including multiple Phase III trials) in order to obtain sufficient results to support product approval, which further increases the expense and time involved. Sometimes trials are further complicated by changes in requirements while the trials are under way (for example, when the standard of care changes for the disease that is being studied in the trial, or when there are changes in the scientific understanding of the disease or the treatment, and/or changes in the competitive landscape.) For example, while the Company’s lead program, the Phase III clinical trial of DCVax-L for brain cancer, has been under way, there has been a very large proliferation of new treatments in various stages of development, as well as some new product approvals, for brain cancer. Any of our current or future product candidates could take a significantly longer time to gain regulatory approval than we expect, or may never gain approval, either of which could delay or stop the commercialization of our DCVax product candidates.
We have limited experience in conducting and managing clinical trials, or collecting, confirming and analyzing trial data, and we rely on third parties to conduct these activities.
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 analyses 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.
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We may fail to comply with regulatory requirements.
Our success will be dependent upon our ability, and our collaborative partners’ abilities, to maintain compliance with regulatory requirements in multiple countries, including current good manufacturing practices, or cGMP, and safety reporting obligations. The failure to comply with applicable regulatory requirements can result in, among other things, fines, injunctions, civil penalties, total or partial suspension of regulatory approvals, refusal to approve pending applications, recalls or seizures of products, operating and production restrictions and criminal prosecutions.
Regulatory approval of our product candidates may be withdrawn at any time.
After any regulatory approval has been obtained for medicinal products (including any early or conditional approval), the product and the manufacturer are subject to continual review, including the review of adverse experiences and clinical results that are reported after our products are made available to patients, and there can be no assurance that such approval will not be withdrawn or restricted. Regulators may also subject approvals to restrictions or conditions, or impose post-approval obligations on the holders of these approvals, and the regulatory status of such products may be jeopardized if such obligations are not fulfilled. If post-approval studies are required, such studies may involve significant time and expense.
The manufacturer and manufacturing facilities we use to make any of our products will also be subject to periodic review and inspection by the FDA, MHRA, EMA or other regulators, as applicable. The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. We will continue to be subject to the FDA, the U.K. Medicines and Healthcare Products Regulatory Agency, or MHRA, the European Medicines Agency, or EMA, and other regulatory requirements, as applicable, governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and submission of safety and other post-market information for all of our product candidates, even those that the FDA, MHRA, EMA, or another regulator, as applicable, had approved. If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, restriction, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse consequences.
Our operations under early access programs may not be successful.
There is not much accumulated or available experience, information or precedents in regard to early access programs, especially for new types of treatments such as immune therapies. Establishing operations under an early access program will require us to establish and implement new operational, contractual, financial and other arrangements with physicians, hospitals, patients and others. We may not be successful in establishing and implementing such arrangements, and/or such arrangements may not be financially satisfactory or viable.
We may not be successful in negotiating reimbursement.
If our DCVax-L product obtains regulatory approval for commercialization, such commercialization will be difficult and may not be feasible unless we obtain coverage by health insurance and/or national health systems for reimbursement of our product price. Obtaining such coverage by health insurance and/or national health systems will be difficult, and we do not have experience with such processes. Our DCVax-L product is a fully personalized, individual product and, as such, is expected to be expensive. In addition, our DCVax-L product involves a cost structure (with much of the costs upfront, in connection with the manufacturing of the personalized DCVax-L product for a patient) that is different than traditional drugs and may require different reimbursement arrangements. These factors may make our negotiations for reimbursement more difficult. We may not be successful in negotiating or obtaining reimbursement or obtaining it on acceptable or viable terms.
Our product candidates will require a different distribution model than conventional therapeutic products, and this may impede commercialization of our product candidates.
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, 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
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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.
Our product candidates will require different marketing and sales methods and personnel than conventional therapeutic products. Also, we lack sales and marketing experience. These factors may result in significant difficulties in commercializing our product candidates.
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.
The availability and amount of potential reimbursement for our product candidates by government and private payers is uncertain and may be delayed and/or inadequate.
The availability and extent of reimbursement by governmental and/or private payers is essential for most patients to be able to afford expensive treatments, such as cancer treatments. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payers tend to follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours, as there have been very few products similar to ours to date., We are aware of only a couple of active immune therapies that have reached the stage of reimbursement decision making processes, including one dendritic cell therapy and a couple of CAR-T cell therapies. Although CMS has approved coverage and reimbursement for a couple of these products, and private payers seem to be following suit in the US, there remain substantial questions and concerns about reimbursement for these products, especially outside the US.
Reimbursement agencies in Europe can be even more conservative than CMS in the U.S. A number of cancer drugs which have been approved for reimbursement in the U.S. have not been approved for reimbursement in certain European countries, and/or the level of reimbursement approved in Europe is lower than in the U.S. Reportedly, in Europe reimbursement for certain immune therapies was initially declined, and reportedly involved difficult negotiations. The same could happen with respect to our DCVax products.
Various factors could increase the difficulties for our DCVax products to obtain reimbursement. Costs and/or difficulties associated with the reimbursement of Provenge and/or T cell therapies could create an adverse environment for reimbursement of other immune therapies, such as our DCVax products. Approval of other competing products (drugs and/or devices) for the same disease indications could make the need for our products and the cost-benefit balance seem less compelling. The cost structure of our product is not a typical cost structure for medical products, as the majority of our costs are incurred up front, when the manufacturing of the personalized product is done. Our atypical cost structure may not be accommodated in any reimbursement for our products. If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and sell our product candidates will be adversely affected.
The manner and level at which reimbursement is provided for services related to our product candidates (e.g., for administration of our product to patients) are also important. If the reimbursement for such services is inadequate, that may lead to physician resistance and adversely affect our ability to market or sell our products.
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The methodology under which CMS makes coverage and reimbursement determinations is subject to change, particularly because of budgetary pressures facing the Medicare program. For example, the Medicare Prescription Drug, Improvement, and Modernization Act, or Medicare Modernization Act, enacted in 2003, provided for a change in reimbursement methodology that has reduced the Medicare reimbursement rates for many drugs, including oncology therapeutics. The Affordable Care Act may also result in changes in reimbursement arrangements that adversely affect the prospects for reimbursement of our products.
In markets outside the U.S., the prices of medical products are subject to direct price controls and/or to reimbursement with varying price control mechanisms, as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the U.S. Some jurisdictions operate positive and/or negative list systems under which products may only be marketed once a reimbursement price has been agreed. Other countries allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. Accordingly, in markets outside the U.S., the reimbursement for our products may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenues and profits.
Competition in the biotechnology and biopharmaceutical industry is intense, rapidly expanding and most of our competitors have substantially greater resources than we do.
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. A growing number of other companies, such as Juno, Kite, Sotio, AiVita, Mendus, Medicenna and many others, are actively involved in the research and development of immune therapies or cell-based therapies for cancer. In addition, other novel technologies for cancer are under development or commercialization, such as checkpoint inhibitor drugs (which are being rapidly developed by numerous big pharma companies including BMS, Merck, Pfizer, Astra Zeneca, Roche and others) and various T cell-based therapies (which are also being rapidly developed by numerous companies with extraordinary resource backing), as well as the electro-therapy device of NovoCure. Additionally, many companies are actively involved in the research and development of monoclonal antibody-based cancer therapies. Currently, a substantial number of antibody-based products are approved for commercial sale for cancer therapy, and a large number of additional ones are under development, including late-stage trials. Many other third parties compete with us in developing alternative therapies to treat cancer, including: biopharmaceutical companies; biotechnology companies; pharmaceutical companies; academic institutions; and other research organizations, as well as some medical device companies (e.g., NovoCure and MagForce Nano Technologies AG).
We face extensive competition from companies developing new treatments for brain cancer. These include a variety of immune therapies, as mentioned above (including T cell-based therapies and checkpoint inhibitor drugs), as well as a variety of small molecule drugs and biologics drugs. There are also a number of existing drugs used for the treatment of brain cancer that may compete with our product, including, Avastin® (Roche Holding AG), Gliadel® (Eisai Co. Ltd.), and Temodar® (Merck& Co., Inc.), as well as NovoCure’s electrotherapy device.
Most of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing and sales than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly if they enter into collaborative arrangements with large and established companies.
These third parties compete with us in recruiting and retaining qualified scientific and management personnel and collaborators, as well as in acquiring technologies complementary to our programs, and in obtaining sites for our clinical trials and enrolling patients.
Our competitors may complete their clinical development more rapidly than we and our products do, may develop more effective or affordable products, or may achieve earlier or longer patent protection or earlier product marketing and sales. Any products developed by us may be rendered obsolete and non-competitive.
Competing generic medicinal products may be approved.
In the E.U., there exists a process for approval of generic biological medicinal products once patent protection and other forms of data and market exclusivity have expired. Arrangements for approval of generic biologics products exist in the U.S. as well, and the FDA has begun approving bio-similar products. Other jurisdictions may approve generic biologic medicinal products as well. If generic biologic medicinal products are approved, competition from such products may substantially reduce sales of our products.
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We may be exposed to potential product liability claims, and our existing insurance may not cover these claims, in whole or in part. In addition, insurance against such claims may not be available to us on reasonable terms in the future, if at all.
Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing, marketing, sale and use of therapeutic products. We have insurance coverage, but this insurance may not cover any claims made. In the future, insurance coverage may not be available to us on commercially reasonable terms (including acceptable cost), if at all. Insurance that we obtain may not be adequate to cover claims against us. Regardless of whether they have any merit or not, and regardless of their eventual outcome, product liability claims may result in substantially decreased demand for our product candidates, injury to our reputation, withdrawal of clinical trial participants or physicians, and/or loss of revenues. Thus, whether or not we are insured, a product liability claim or product recall may result in losses that could be material.
We may be subject to environmental regulatory requirements, and could fail to meet such requirements, and we do not carry insurance against environmental damage or injury claims.
We may need to store, handle, use and dispose of controlled hazardous, radioactive and biological materials in our business. Our development activities may result in our becoming subject to regulatory requirements, and if we fail to comply with applicable requirements, we could be subject to substantial fines and other sanctions, delays in research and production, and increased operating costs. In addition, if regulated materials were improperly released at our current or former facilities or at locations to which we send materials for disposal, we could be liable for substantial damages and costs, including cleanup costs and personal injury or property damages, and we could incur delays in research and production and increased operating costs.
Insurance covering certain types of claims of environmental damage or injury resulting from the use of these materials is available but can be expensive and is limited in its coverage. We have no insurance specifically covering environmental risks or personal injury from the use of these materials and if such use results in liability, our business may be seriously harmed.
Collaborations play an important role in our business and could be vulnerable to competition or termination.
We work with scientists and medical professionals at a variety of academic and other institutions, some of whom have conducted research for us or have assisted in developing our research and development strategy. These scientists and medical professionals are collaborators, not our employees. They may have commitments to, or contracts with, other institutions or businesses (including competitors) that limit the amount of time they have available to work with us. We have little control over these individuals. We can only expect that they devote time to us and our programs as required by any license, consulting or sponsored research agreements we may have with them. In addition, these individuals may have arrangements with other companies to assist in developing technologies that may compete with our products. If these individuals do not devote sufficient time and resources to our programs, or if they provide substantial assistance to our competitors, our business could be seriously harmed.
The success of our business strategy may partially depend upon our ability to develop and maintain our collaborations and to manage them effectively. Due to concerns regarding our ability to continue our operations or the commercial feasibility of our personalized DCVax product candidates, these third parties may decide not to conduct business with us or may conduct business with us on terms that are less favorable than those customarily extended by them. If either of these events occurs, our business could suffer significantly.
We may have disputes with our collaborators, which could be costly and time consuming. Failure to successfully defend our rights could seriously harm our business, financial condition and operating results. We intend to continue to enter into collaborations in the future. However, we may be unable to successfully negotiate any additional collaboration and any of these relationships, if established, may not be scientifically or commercially successful.
Our business could be adversely affected by new legislation and/or product related issues.
Changes in applicable legislation and/or regulatory policies or discovery of problems with the product, production process, site or manufacturer may result in delays in bringing products to market, the imposition of restrictions on the product’s sale or manufacture, including the possible withdrawal of the product from the market, or may otherwise have an adverse effect on our business.
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Our business could be adversely affected by animal rights activists.
Our business activities have involved animal testing and could involve further such testing, as such testing is required before new medical products can be tested in clinical trials in human patients. Animal testing has been the subject of controversy and adverse publicity. Some organizations and individuals have attempted to stop animal testing by pressing for legislation and regulation in these areas. To the extent that the activities of such groups are successful, our business could be adversely affected. Negative publicity about us, our pre-clinical trials and our product candidates could also adversely affect our business.
Multiple late-stage clinical trials of DCVax-L for GBM, our lead product, may be required before we can obtain regulatory approval.
Typically, companies conduct multiple late-stage clinical trials of their product candidates before seeking product approval. Our current Phase III 331-patient clinical trial of DCVax-L for GBM is our first late-stage trial. We may be required to conduct additional late-stage trials with DCVax-L for GBM before we can obtain product approval. This would substantially delay our commercialization, and might not be possible to carry out, due to development and/or approval of competing products, lack of funding, and/or other factors. In addition, our Phase III trial of DCVax-L was placed on a partial clinical hold for new screening for enrollment in 2015. Although the FDA lifted its hold in February 2017 as previously reported by the Company, the Company had already closed enrollment with 331 of the planned 348 patients. Since we did not enroll the last 17 of the planned 348 patients, this could adversely affect the statistical and other analyses of our Phase III trial results and could make it more difficult to seek product approval or more likely that further trials could be required. In addition, a rapidly growing number of products are under development for brain cancer, including immunotherapies such as checkpoint inhibitor drugs and T cell-based therapies, and some (e.g., NovoCure’s device) have been approved in the U.S. It is possible that the standard of care for brain cancer could change before we are able to seek approval for commercialization. This could necessitate further clinical trials with our DCVax-L product candidate for brain cancer, which may not be feasible.
We may not receive regulatory approvals for our product candidates or there may be a delay in obtaining such approvals.
Our products and our ongoing development activities are subject to regulation by regulatory authorities in the countries in which we and our collaborators and distributors wish to test, manufacture or market our products. For instance, the FDA will regulate our product in the U.S. and equivalent authorities, such as the MHRA and EMA will regulate in Europe and other jurisdictions. Regulatory approval by these authorities will be subject to the evaluation of data relating to the quality, efficacy and safety of the product for its proposed use, and there can be no assurance that the regulatory authorities will find our data sufficient to support product approval of DCVax-L or DCVax-Direct. In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. The statistical analysis plan that we submitted to regulators for the Phase III trial embodies a different primary endpoint and secondary endpoint than did the original Protocol for the trial. Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
The time period required to obtain regulatory approval varies between countries. In the U.S., for products without “Fast Track” status, it can take up to 18 months after submission of an application for product approval to receive the FDA’s decision. Even with Fast Track status, FDA review and decision can take up to 12 months. At present, we do not have Fast Track status for our lead product, DCVax-L for GBM. We may apply for Fast Track status, but there can be no assurance that FDA will grant us such status for DCVax-L.
Different regulators may impose their own requirements and may refuse to grant, or may require additional data before granting, an approval, notwithstanding that regulatory approval may have been granted by other regulators. Regulatory approval may be delayed, limited or denied for a number of reasons, including clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements as well as case load at the regulatory agency at the time.
We may not obtain or maintain the benefits associated with orphan drug status, including market exclusivity.
Although our lead product, DCVax-L for GBM, has been granted orphan drug status in both the U.S. and the E.U., we may not receive the benefits associated with orphan drug designation (including the benefit providing for market exclusivity for a number of years). This may result from a failure to maintain orphan drug status or result from a competing product reaching the market that has an orphan
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designation for the same disease indication. Under U.S. and E.U. rules for orphan drugs, if such a competing product reaches the market before ours does, the competing product could potentially obtain a scope of market exclusivity that limits or precludes our product from being sold in the U.S. for seven years or from being sold in the E.U. for ten years. Also, in the E.U., even after orphan status has been granted, that status is re-examined shortly prior to the product receiving any regulatory approval. The EMA must be satisfied that there is evidence that the product offers a significant benefit relative to existing therapies, in order for the therapeutic product to maintain its orphan drug status. Accordingly, our product candidates will have to re-qualify for orphan drug status prior to any potential product approval in the E.U. and may have to do so elsewhere as well.
Our intellectual property rights may be overturned, narrowed or blocked, and may not provide sufficient commercial protection for our product candidates, or third parties may infringe upon our intellectual property.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Patent laws afford only limited protection and may not protect our rights to the extent necessary to sustain any competitive advantage we may have. In addition, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States, and we may encounter significant problems in protecting our proprietary rights in those countries. Moreover, patents and patent applications relating to living cell products are relatively new, involve complex factual and legal issues, and are largely untested in litigation - and as a result, are uncertain. Our pending and future patent applications may not result in patents being issued which adequately protect our technology or products or which effectively prevent others from commercializing the same or competitive technologies and products. As a result, we may not be able to obtain meaningful patent protection for our commercial products, and our business may suffer as a result. Third parties may challenge our existing patents, and such challenges could result in overturning or narrowing some of our patents. Even if our patents are not challenged, third parties could assert that their patents block our use of technology covered by some or all of our patents.
As of December 31, 2024, we had 48 issued patents, including European validations, and 60 pending patent applications worldwide relating to some of our product candidates and related matters such as manufacturing processes. The issued patents expire at various dates from 2026 to 2036. Our issued patents may be challenged, and such challenges may result in reductions in scope, cancellations or invalidations. Our pending patent applications may not result in issued patents. Moreover, our patents and patent applications do not cover all of our product candidates, and may not be sufficient to prevent others from using substantially similar technologies or from developing competing products. We also face the risk that others may independently develop similar or alternative technologies, or design around our patented technologies. As a result, no assurance can be given that any of our pending or future patent applications will be granted, that the scope of any patent protection currently granted or that may be granted in the future will exclude competitors or provide us with competitive advantages, that any of the patents that have been or may be issued to us will be held valid if subsequently challenged, or that other parties will not claim rights to or ownership of our patents or other proprietary rights that we hold.
We have taken security measures (including execution of confidentiality agreements) to protect our proprietary information, especially proprietary information that is not covered by patents or patent applications. These measures, however, may not provide adequate protection for our trade secrets or other proprietary information. In addition, others may independently develop substantially equivalent proprietary information or techniques or otherwise gain access to our trade secrets.
We may be exposed to claims or lawsuits that our products infringe patents or other proprietary rights of other parties.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market, sell our product candidates, and use our proprietary technologies without infringing the proprietary rights of third parties. We have not conducted a comprehensive freedom-to-operate review to determine whether our proposed business activities or use of certain of the technology covered by patent rights owned by us would infringe patents issued to third parties.
There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. The patent landscape is especially uncertain in regard to cell therapy products, as it involves complex legal and factual questions for which important legal principles remain unresolved. We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference proceedings, Inter Partes Reexamination, or Post Grant Review before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially
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reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages. If the infringement is found to be willful, we could be liable for treble damages. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
We have already been exposed to one patent lawsuit by a large company, which we vigorously defended. Our defense resulted in the plaintiff withdrawing nearly all of the claims it filed, and in settlement of the last claims without our paying the plaintiff anything. However, the litigation was expensive and time consuming. In the past, we have also been exposed to claims (without a lawsuit) by a competitor asserting or implying (and commentaries by third parties based on the claims by our competitor) that a patent issued to our competitor covers our products. We obtained and publicly reported legal advice that those claims were without merit. However, in the future, we could again be exposed to claims by third parties - with or without merit - that our products infringe their intellectual property rights.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
DCVax is our only technology in clinical development.
Unlike many pharmaceutical companies that have a number of products in development, and which utilize many different technologies, we are dependent on the success of our DCVax platform technology. While the DCVax technology has a wide scope of potential use and is embodied in several different product lines for different clinical situations, if the core DCVax technology is not effective or is toxic or is not commercially viable, our business could fail. We do not currently have other technologies that could provide alternative support for us.
Risks Related to our Common Stock
The market price of our common stock is volatile and can be adversely affected by several factors.
The share prices of publicly traded biotechnology and emerging pharmaceutical companies, particularly companies without consistent product revenues and earnings, can be highly volatile and are likely to remain highly volatile in the future. The price which investors may realize in sales of their shares of our common stock may be materially different than the price at which our common stock is quoted and will be influenced by a large number of factors, some specific to us and our operations, and some unrelated to our operations. Such factors may cause the price of our stock to fluctuate frequently and substantially. Such factors may include large purchases or sales of our common stock, shorting of our stock, positive or negative events, commentaries or publicity relating to our company, management or products, or other companies, management or products, including other immune therapies for cancer or immune therapies or cancer therapies generally, positive or negative events relating to healthcare and the overall pharmaceutical and biotech sector, the publication of research by securities analysts and changes in recommendations of securities analysts, legislative or regulatory changes, and/or general economic conditions. In the past, shareholder litigation, including class action litigation, has been brought against other companies that experienced volatility in the market price of their shares and/or unexpected or adverse developments in their business. Whether or not meritorious, litigation brought against a company following such developments can result in substantial costs, divert management’s attention and resources, and harm the company’s financial condition and results of operations.
Our Common Stock is considered a “penny stock” and may be difficult to sell.
The Commission has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to specific exemptions. Historically, the price of our
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Common Stock has fluctuated greatly. As of the date of this filing, the market price of our common stock is less than $5.00 per share, and therefore is a “penny stock” according to Commission rules. The “penny stock” rules impose additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors (generally those with assets in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 together with their spouse). For transactions covered by these rules, the broker-dealer must make a special suitability determination for the purchase of securities and have received the purchaser’s written consent to the transaction before the purchase. Additionally, for any transaction involving a penny stock, unless exempt, the broker-dealer must deliver, before the transaction, a disclosure schedule prescribed by the Commission relating to the penny stock market. The broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent disclosing recent price information on the limited market in penny stocks. These additional burdens imposed on broker-dealers may restrict the ability or decrease the willingness of broker-dealers to sell our common stock and may result in decreased liquidity for our common stock and increased transaction costs for sales and purchases of our common stock as compared to other securities.
The requirements of the Sarbanes-Oxley Act of 2002 and other U.S. securities laws impose substantial costs and may drain our resources and distract our management.
We are subject to certain of the requirements of the Sarbanes-Oxley Act of 2002, as well as the reporting requirements under the Exchange Act. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls over financial reporting. We have tested and concluded that we have remediated the identified material weaknesses in our internal controls that were reported over the years. The substantial efforts and resources the Company has invested achieved remediation of the previously identified weaknesses. However, requirements continue to become more stringent, requiring even more time and resources to be invested to maintain a controlled environment, which is difficult for a small company like ours. Continued additional investments and management time to meet these requirements will be necessary since control weaknesses raise the risk of future material errors in the company’s financial statements. We may not be able to maintain effective controls over time. If we have material weaknesses in the future, this may subject us to SEC enforcement action, which could include monetary fines or other equitable remedies that could be detrimental to the ongoing business of the Company.
We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on your investment in our common stock must come from increases in the market price of our common stock.
We have not paid any cash dividends on our common stock to date in our history, and we do not intend to pay cash dividends on our common stock in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our business. Also, any credit agreements which we may enter into with institutional lenders may restrict our ability to pay dividends. Therefore, any return on your investment in our capital stock must come from increases in the fair market value and trading price of our common stock. Such increases in the trading price of our stock may not occur.
Our certificate of incorporation and bylaws and Delaware law, have provisions that could discourage, delay or prevent a change in control.
Our certificate of incorporation and bylaws and Delaware law contain provisions which could make it more difficult for a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders. We are authorized to issue up to 100,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without further action by stockholders. The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. No preferred stock is currently outstanding. The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.
Provisions of our certificate of incorporation and bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals or tender offers or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:
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We are also subject to Section 203 of the Delaware General Corporation Law which, subject to certain exceptions, prohibits “business combinations” between a publicly-held Delaware corporation and an “interested stockholder,” which is generally defined as a stockholder who becomes a beneficial owner of 15% or more of a Delaware corporation’s voting stock for a three-year period following the date that such stockholder became an interested stockholder.
A substantial number of shares of common stock may be sold in the market, which may depress the market price for our common stock.
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, 1,328.6 million shares of our common stock are issued and outstanding. In addition, as of December 31, 2024, 4.1 million shares of our common stock are issuable upon exercise of outstanding warrants, and 130.0 million shares of our common stock are issuable upon exercise of outstanding options.
We may have claims and lawsuits against us that may result in adverse outcomes.
From time to time, we may be subject to a variety of claims and lawsuits. In the past, we were engaged in several shareholder litigations. We believed that that the claims were without merit, fought them vigorously and resolved them. We have also had several small litigations, for example relating to certain payables. Litigation and claims are subject to inherent uncertainties, and adverse rulings or outcomes could occur, and/or could lead to further claims or litigation. Adverse outcomes or further litigation could result in significant monetary damages or injunctive relief that could adversely affect our business and may divert management time and attention from our business.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 1C. CYBERSECURITY
We operate in the biotechnology sector, which is subject to various
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ITEM 2. PROPERTIES
Our corporate headquarters are located at 4800 Montgomery Lane, Bethesda, Maryland, where we lease and occupy an aggregate of approximately 7,097 square feet of office space. The lease covering this property is currently scheduled to expire in August 2026.
Our research and development operations are mainly based in Sawston, U.K., where we lease and occupy an aggregate of approximately 88,000 square feet of building. The lease covering this property is currently scheduled to expire in December 2038.
We believe that our existing facilities are adequate for our immediate needs and that, should it be needed, additional space can be leased to accommodate any future growth.
ITEM 3. LEGAL PROCEEDINGS
On December 1, 2022, we filed a Complaint in the United States District Court for the Southern District of New York against certain market makers. The Complaint alleges that the defendants engaged in manipulation of the Company’s stock, in violation of the Securities Exchange Act of 1934 and common law fraud, over a period of years. On March 20, 2023, the defendants filed a Motion to Dismiss the Complaint. On April 10, 2023 we filed an Amended Complaint against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., and Virtu Americas LLC (Northwest Biotherapeutics Inc. v. Canaccord, et al., No. 1:22-cv-10185-GHW-GWG).
Following defendant’s filing of a new Motion to Dismiss (MTD) and various filings on both sides, an oral argument on defendants’ latest Motion to Dismiss was held on November 14, 2023. The Magistrate Judge issued an 85-page Recommendation and Results Opinion (R&R) for review by the Senior Judge. The Magistrate Judge found that the Company had adequately plead all of the elements of its claim of market manipulation, with the exception of producing enough details for calculating actual damages, known as loss causation. On that basis, he granted defendant’s motion to dismiss without prejudice, subject to the Company’s right to replead on just the question of loss causation, finding that such a filing would “not be futile”.
On February 14, 2024, the Senior Judge issued an opinion accepting all the recommendations and findings of the R&R, and gave the Company 30 days to file this limited repleading amendment on loss causation and damages no later than March 15, 2024. On March 15, 2024, the Company filed their more detailed repleading on loss causation and damages. At the end of March, defendants asked for the right to object to the Judge’s findings against them on December 29, 2023 and February 14, 2024. This motion was denied. The defendants then asked for leave to file a new MTD. That motion was granted with a 30-day filing requirement for defendants and a 30-day response time for the Company.
On May 1, 2024, the defendants’ filed a new MTD the Company’s amended repleading complaint, containing the new section on loss causation and damages. On May 31, 2024, the Company responded to the defendants’ new MTD, supporting the Magistrate Judge’s and Senior Judge’s previous opinions, and rejecting the defendants’ objections to the Company’s loss causation repleading and damage formulae.
On June 14, 2024, the defendants filed their last response to the Company’s comments on May 31, 2024, concerning the defendant’s latest MTD. They also asked the Court to schedule an oral argument on the issues raised by these last two filings. The Court never answered the defendants’ request for an oral argument. On January 31, 2025, the Magistrate Judge issued his second R&R dismissing in part the defendants latest MTD on the basis of plaintiff’s having met the requirements of dismissal based on short-term damages but did not approve it based on the pleadings to date based on longer-term damages.
On February 14, 2025, both Plaintiffs and Defendants filed their respective comments on this latest R&R from the Magistrate Judge and on February 28, 2025, each party filed comments on the other parties February 14, 2025 filings. On March 5, 2025, defendants once again filed a motion seeking an oral argument on the most recent issues raised in the Magistrate Judge’s R&R, and on March 6, 2025, Senior Judge Woods denied the motion in writing without prejudice.
On March 26, 2025, Senior Judge Woods issued his opinion adopting Magistrate Stein’s R&R. The next step will be a status conference with the Court to set the discovery schedule for the case.
As previously reported, three stockholders filed in the Delaware Court of Chancery three similar derivative lawsuits against the Company and certain of its directors and officers, including J. Cofer Black, Alton L. Boynton, Leslie J. Goldman, Jerry Jasinowski, Navid Malik,
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and Linda F. Powers (the “Individual Defendants”), alleging the Individual Defendants (i) breached their fiduciary duties, and (ii) were unjustly enriched by director and officer compensation awarded in 2020 to the Individual Defendants—notwithstanding the fact that approximately 90% of shareholders voted to approve the Company’s executive compensation (the same compensation that these three stockholders are seeking to challenge) twice (both through its Say on Pay vote at the Company’s Annual Meeting in 2021, and again in a binding vote at the Company’s Annual Meeting in 2022) and approximately 90% of shareholders also voted to approve the director awards at the 2022 Annual Meeting. On March 31, 2022, the Delaware Court of Chancery consolidated these actions into a single action under the caption In re Northwest Biotherapeutics, Inc. Stockholder Litigation (the “Derivative Action”). The descriptions and summary of the lawsuit herein are qualified in their entirety by reference to the proceedings in the Derivative Action, and are described in greater detail by the Company’s June 3, 2024 Definitive Proxy (the “2024 Proxy”).
On December 30, 2022, following the shareholder approvals at the December 2022 Annual Meeting, the Plaintiff filed an Amended Complaint asserting that the shareholder votes should be deemed ineffective. On February 22, 2023, the Individual Defendants and the Company filed a Motion to Dismiss the Amended Complaint. On November 17, 2023, the court issued an oral decision denying the Motion to Dismiss. On December 20, 2023, the Company filed an answer to the Consolidated Amended Complaint. On December 28, 2023, the Individual Defendants, represented by separate counsel, filed their response to the Consolidated Amended Complaint.
On June 3, 2024, the Company filed the 2024 Proxy which, among other things, asked shareholders to ratify the 2020 option awards that are the subject of the Derivative Action at the Company’s 2024 annual meeting of shareholders (the “2024 Annual Meeting”). On June 20, 2024, the court stayed proceedings in the Derivative Action in light of the potential ratifying effects of the 2024 Annual Meeting. At the Company’s 2024 Annual Meeting, held on June 29, 2024, shareholders holding 88.13% of the shares voted in favor of Proposal 3 (ratification of the 2020 option awards granted to the Company’s four senior executives) and stockholders holding 88.05% of the shares voted in favor of Proposal 4 (ratification of the 2020 option awards granted to the Company’s non-employee directors). On June 30, 2024, the Individual Defendants filed an amended answer to the Consolidated Amended Complaint and have asserted that the claims in the Derivative Action are barred, in whole or in part, by ratification because the Company’s disinterested stockholders ratified the challenged option awards at the 2024 Annual Meeting. The parties are currently seeking guidance from the court regarding the proceedings. On October 31, 2024, the Court gave approval for the parties to file summary judgment motions regarding the effectiveness of stockholder ratification. The Court also permitted discovery regarding ratification.
On December 2, 2024, the Individual Defendants filed their motion for summary judgment and brief in support thereof, arguing that the court should enter judgment in favor of the Individual Defendants on the basis of the stockholders’ June 29, 2024 ratification vote. On January 21, 2025, the Plaintiff—who held approximately 0.00089% of the Company’s outstanding shares of stock as of the ratification record date—served discovery requests. On February 14, 2025, the Court issued a letter opinion ruling that allowing Plaintiff to proceed with “full-blown, plenary discovery” would “defeat[] the purpose” of ratification, because that approach “fails to recognize that the [ratification] vote fundamentally altered the factual landscape of the case.” The Court concluded that “the most efficient framework for addressing the effect of the [ratification] vote” is for the Plaintiff to “serve requests for production of documents that seek to obtain the same types of materials regarding the vote that they could have obtained using [8 Del. C. § 220],” then “file an amended and supplemental complaint that pleads [his] bases for challenging the effectiveness of the vote.” As a result of its decision, the Court denied the Individual Defendants’ motion without prejudice.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
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PART II
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUERS PURCHASES OF EQUITY SECURITIES
Market for Common Equity and Related Stockholder Matters
Our common stock trades on OTCQB under the trading symbols “NWBO” effective December 19, 2016. No assurance can be given that an active market will exist for our common stock.
As of March 28, 2025, there were approximately 46,428 holders of record of our common stock. Such holders may include any broker or clearing agencies as holders of record, and in such cases exclude the individual stockholders whose shares are held by such brokers or clearing agencies.
Dividend Policy
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all future earnings, if any, to fund the ongoing development and growth of our business. We do not currently anticipate paying any cash dividends in the foreseeable future.
Recent Sales of Unregistered Securities
During the year ended December 31, 2024, the Company issued the following equity securities pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, or the provisions of Rule 506 of Regulation D promulgated under the Securities Act. Except as set forth in such note, the Company did not utilize an underwriter or a placement agent for any of these offerings of its securities. The proceeds were used for general corporate purposes.
During the year ended December 31, 2024, the Company issued an aggregate of 0.8 million shares of Series C convertible preferred stock (the “Series C Shares”) to accredited investors for gross proceeds of approximately $8.2 million.
During the year ended December 31, 2024, the Company converted 1.5 million shares of Series C Shares to 38.2 million common shares.
During the year ended December 31, 2024, the Company issued 0.4 million shares of common Shares at fair value of $0.2 million to a consultant for services provided.
During the year ended December 31, 2024, the Company received $1.5 million cash from the exercise of outstanding warrants with a weighted average exercise price of $0.24 per share. The Company issued approximately 6.5 million shares of common stock upon these warrant exercises.
During the year ended December 31, 2024, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately 3.1 million shares of common stock upon exercise of 4.8 million warrants at exercise prices between $0.20 and $0.34 per share, and 0.7 million options at exercise prices of $0.35 per share.
During the year ended December 31, 2024, the Company issued approximately 53.0 million shares of common stock with a fair value of $19.4 million to certain lenders in lieu of cash payments of $14.8 million of debt, including $1.7 million of accrued interest, and settled $1.0 million true-up provision.
During the year ended December 31, 2024, the Company converted $2.7 million convertible notes including $0.2 million accrued interest into 0.5 million Series C preferred shares.
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ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read this discussion together with the Financial Statements, related Notes and other financial information included elsewhere in this Form 10-K. The following discussion contains assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors,” and elsewhere in this Form 10-K. These risks could cause our actual results to differ materially from those anticipated in these forward-looking statements.
The following Management’s Discussion and Analysis provides a historical and prospective narrative on the Company’s financial condition, and results of operations for the year ended December 31, 2024 as compared to the year ended December 31, 2023.
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. Our additional product, DCVax®-Direct, is designed to treat inoperable solid tumors.
Intensive activities continued throughout 2024, including in Q4, in multiple areas including the following:
| ● | active engagement in the Marketing Authorization Application (MAA) review process and inspections; |
| ● | planning for possible initial commercialization; |
| ● | completion, in collaboration with leading clinicians, of the trial design and protocol for the pediatric brain cancer trials to fulfill the legal requirement for pediatric applications in connection with the MAA for the adult applications; |
| ● | initial assessments of the specific regulatory requirements for applications for product approval in additional countries beyond the UK; |
| ● | working with specialized consultants on preparations for reimbursement evaluation processes; |
| ● | potential expansion of the scope of the Company’s compassionate use program through private clinics; |
| ● | completion of technology transfer and process development for the DCVax-Direct manufacturing processes to meet UK regulatory requirements (with the DCVax-Direct products able to be supplied globally); |
| ● | development of streamlined Grade C lab plan for the Sawston facility with faster timeframe and substantially reduced capital cost; |
| ● | completion of process development for a new and potentially enhanced version of the DCVax-Direct product; |
| ● | design of initial DCVax-Direct clinical trials, in collaboration with leading clinicians, and completion of drafting of initial protocols for upcoming IND submissions; |
| ● | negotiations with multiple independent parties for potential manufacturing in the U.S.; |
| ● | clinical development activities for initial applications of IP from the portfolio in-licensed from Roswell Park at mid-year; |
| ● | completion of an upgraded Flaskworks machine for GMP prototypes, and plans to reduce the dimensions and footprint; |
| ● | commercial collaborations: completion of a License and Supply Agreement with a company for a TLR agonist booster agent; negotiations in process with other companies for in-license of a different type of booster agent; and negotiations in process for a possible acquisition; |
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| ● | internal lab research evaluating multiple booster agents for use (alone or in combinations) with DCVax-L and/or DCVax-Direct, and generating potential new intellectual property; |
| ● | vigorous prosecution of patent applications; numerous new patents granted or allowed; |
| ● | extensive litigation activities. |
These activities continued to require extensive use of specialized technical and regulatory consultants and legal counsel, with the costs of these services alone totaling about one-third of all costs incurred by the Company for the year (about $18 million). Costs incurred just for the GMP facilities themselves - not including any personnel or program costs - continued to be very expensive (multi millions) as is typically the case for GMP clean room facilities. In addition, some costs that may be minor in other types of businesses are substantial in the Company’s business (e.g., $5 million per year for insurance coverages).
Marketing Authorization Application (MAA) and Inspections. The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections. The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible. As previously reported, the Company plans to announce the results when the MHRA review and decision-making is finished and does not plan to provide interim updates.
Planning for Possible Initial Commercialization. The Company’s contract manufacturer, Advent BioServices, has prepared plans for how the manufacturing of DCVax-L products could be ramped up in the event of potential commercialization using just the existing two manufacturing suites and facilities, and could potentially reach a significant portion of the Glioblastoma patients in the UK. The plans include a transition from a single daily shift of operations to two shifts daily, supply chain considerations and determination of the personnel that would be required. The plans also include potential arrangements for a simplified initial Grade C lab, as described below. Advent estimates that this simplified initial Grade C lab could enable doubling of the production that would be feasible with the existing two manufacturing suites. Arrangements with private clinics have also been developed, as described below, which could potentially assist with initial commercialization. In addition, during 2024, the Sawston facility received its first regulatory inspection under the MIA license that was approved by the MHRA in March 2023 for commercial manufacturing of cell therapy products. This was an important milestone to confirm that the Sawston facility is operating on an ongoing basis at the level required for potential commercial operations
Simplified Grade C Lab in the Sawston Facility. The Sawston facility current has two Grade B labs. Such labs are required to be used for any manufacturing process that involves any open steps (i.e., open to the air). Grade C labs are much less expensive to operate, and allow multiple patients’ products to be manufactured at the same time in the same lab, but may only be used with closed systems. The Flaskworks system is closed and suitable for Grade C labs. The design and engineering works were previously completed for two Grade C labs, but the buildout will require substantial capital. Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs, the Company has held off on raising and using the capital required to build the two Grade C labs. Meanwhile, Advent has devised plans for a simplified initial Grade C lab adjacent to one of the Grade B labs, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. The simplified Grade C lab can be completed for a fraction of the cost and less than half the time for the regular Grade C labs. The Company anticipates potentially proceeding with this in the coming months when appropriate.
Potential Manufacturing in the US. During much of 2024 and Q1 2025, the Company has been in discussions with a series of half a dozen independent parties with GMP facilities in diverse areas of the US, to obtain capacity and availability for potential manufacturing in the US. The manufacturing is initially contemplated to include DCVax-L products and DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh.
Pediatric Brain Cancer Trial. The Company worked throughout the year to obtain engagement of pediatric neurosurgeons and neuro-oncologists for the pediatric trial that is legally required in connection with the MAA application for adult patients. The clinicians requested substantial changes in the trial design and plans that had been approved by MHRA. After a long process, a new trial design was agreed by the clinicians. The Company plans to obtain MHRA approval of the new design and move forward with the trial in due course.
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Applications for Approval in Additional Countries Beyond the UK. During Q4 2024, the Company engaged specialized consultants to review the regulatory requirements for submission of an application for product approval in certain additional countries beyond the UK, review the MAA package that the Company submitted in the UK, and determine what changes or additions would be needed to adapt the MAA package for certain other applications. The Company’s work with these consultants is ongoing.
Reimbursement. The Company has been working with its specialized reimbursement consultants to evaluate the categories of review processes which could potentially apply to the Company’s DCVax-L product for Glioblastoma brain cancer (GBM). The Company and its consultants are gathering information needed for the health economics and outcomes (HEO) analyses, and analyses of the relevant clinical landscape.
Compassionate Use Program. The Company receives an ongoing stream of requests from patients and physicians for compassionate use of its DCVax products for a variety of cancers and patient situations. The Company has been operating a Specials program in the UK for a number of years to try to help brain cancer patients where it can. During 2024, the Company established collaborations with several private clinics in London to enable the Specials program to be expanded and increased. The Company is in the process of making the operational arrangements to implement these clinic collaborations for an expanded program. The Company is also working on significant cost reductions. The Company believes that having these private clinic arrangements in place will also be quite helpful for initial potential commercialization.
DCVax-Direct Manufacturing. The Company’s contract manufacturer, Advent BioServices has completed the long process of developing the DCVax-Direct manufacturing process in the UK and is ready to proceed with production of DCVax-Direct for clinical trials commencing in Q2 2025. This process has taken nearly two years, in between priority work related to the MAA, and has involved a number of stages including technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, identification and evaluation of commercially available systems to substitute for the TFF system previously used for the DCVax-Direct production, engineering runs and data generation to confirm comparability, etc.
New DCVax-Direct Product (DCVax-DR). Advent has also completed the long process of developing a new formulation of DCVax-Direct (referred to as DCVax-DR). As previously reported, it was necessary to develop second version of DCVax-Direct because of a persistent worldwide shortage of a key ingredient in the original DCVax formulation (an immune booster ingredient). Developing the second formulation required research into a range of other candidate ingredients to identify ones with sufficiently similar properties or immunological results, testing to determination the appropriate amount and methods of incorporating such candidate ingredients, further testing and data generation to confirm comparability, and development of new SOPs and other regulatory documents. In parallel, Advent has also undertaken extensive efforts to secure supplies of the original booster ingredient, and has found a suitable source. The Company plans to have Advent produce the original formulation of DCVax-Direct as well as the DCVax-DR formulation, and to test both in further clinical trials for optimal results.
DCVax-Direct Clinical Trials. The Company has been preparing for resumption of clinical trials of DCVax-Direct for quite a while, and plans to conduct those trials in the U.S. The Company has been working with clinicians for months to design the first two trials (one pediatric, one adult). The protocol for the first trial has been drafted, discussed and agreed with the clinicians and is in late stage review by the clinicians and their institution. The protocol for the second trial has been drafted and is undergoing discussion and modifications with the clinicians. The Company plans to submit both studies to the FDA in Q2 2025, and plans to announce the details after they have been cleared by the FDA. These trials have particularly been designed to be compact and streamlined, using Simon’s two-stage designs to start small and then expand if encouraging results are seen, and focusing on tumor response (shrinkage) endpoints which have a much faster timeframe than time-to-event endpoints such as overall survival, which do not require any control arms and which can be much smaller and more economical trials for value creation. The Company’s prior Phase 1 trial at MD Anderson covered 13 diverse types of solid tumors in very late stage patients with multiple inoperable tumors who had failed all standard treatments. The trial results were very encouraging and the Company is building on those results in several ways for the upcoming trials.
Clinical Trials With Roswell and Pittsburgh IP. The Company has been working with Dr. Kalinski and leading clinicians to develop arrangements for clinical trials of two dendritic cell treatments from the portfolios in-licensed by the Company from Roswell Park and the University of Pittsburgh. One of the DC treatments involves loading DCs with abnormal tumor blood vessel antigens (TBVA), and the other involves intra-tumoral injection of unloaded dendritic cells (similar to the Company’s DCVax-Direct but with the DCs prepared differently and having different properties). Each of these two products is anticipated to be applicable to most types of solid tumors. The DCs loaded with TBVA have already been tested in a Phase 1 trial for melanoma and the results were encouraging. The trials being planned will utilize Simon’s two-stage designs in order to start small and then expand only if encouraging results are seen. These trials
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will also use Simon’s two stage designs and will focus on tumor response endpoints in order to be compact and efficient. These trials are separate from the investigator-sponsored trials in the portfolios licensed from Roswell and Pittsburgh.
Flaskworks System. During 2024, the Company’s Flaskworks team and Advent, together with a specialized external contractor, completed the design work for a GMP-compatible second prototype of its system for closed preparation of DCVax-L products. An initial prototype had been completed in 2023. The second prototype included upgraded functionality, however it was also considerably larger than the first prototype as a result, and the effect would be to reduce the number of systems that could fit in each Grade C lab and hence reduce the amount of products that could be produced. After further evaluations, the Company decided to go forward with the first prototype. The Company has arranged for another specialized external contractor (in the UK), has brought that contractor up to speed and has that contractor standing by to fabricate GMP units of the first prototype as soon as the Company is ready. The Flaskworks units will only be usable in the Grade C labs, and hence are not useful until the Grade C labs have been constructed, validated and are operational. Since the timeframe for fabricating the Flaskworks units is much shorter than the timeframe for buildout of the Grade C labs (including the simplified initial Grade C lab), the Company has been holding off on proceeding with the fabrication until closer to the time when the initial Grade C lab will be operational.
Commercial Collaborations. The Company has undertaken discussions and negotiations with a number of companies who have products that could serve as booster agents either in the manufacturing of DCVax products or in combination treatment regimens with DCVax or both. The Company has completed a License and Supply Agreement with a company for one such agent, which is a TLR (toll like receptor) agonist, and the Company is now in the process of collaborating with that Company to design a clinical trial of a combination treatment regimen. The Company has already identified lead investigators for this trial, and anticipates submitting the IND for this trial to the FDA in Q2 2025. The Company plans to announce the trial when the IND has been cleared by the FDA. The Company is also testing this TLR agonist in its internal lab research on enhanced versions of DCs, as described below.
The Company has been in discussions since mid-2024 with a different company to in-license a different type of booster agent – one that big pharma has been trying for years to develop as a treatment itself. The Company executed a Material Transfer Agreement with that company and has been testing samples of this agent in internal lab research as described below. The Company has also been in negotiations since early Q4 2024 for potential acquisition of another company with a dendritic cell related technology. The Company hopes to complete these negotiations during Q2 or Q3 2025.
Internal Lab Research on Booster Agents. The Company has developed a substantial portfolio of agents that have already been in-licensed or are in discussions for in-licensing, and that may further boost the potency of the dendritic cells in DCVax products. The Company believes that administering an extra potent DCVax treatment may be helpful in its clinical trials going forward, as those trials will be focusing on tumor response (shrinkage) endpoints.
The Company has been conducting lab research in-house in its Flaskworks facility to test the effects of these booster agents alone and in combination, in both DCVax-L and DCVax-Direct products. The results have differed in the DCVax-L dendritic cells vs. the DCVax-Direct dendritic cells, and have varied according to the dose, the timing, the combinations and other factors. It appears that some of this research may potentially create some new IP. The Company plans to continue this lab research while the initial clinical trials of DCVax-Direct get under way, and then plans to select the most useful booster agent(s) or combination(s) to produce enhanced versions of DCVax products for testing in additional trial cohorts.
Intellectual Property. The Company continued to devote substantial resources to building its patent portfolio as a key part of building its franchise in dendritic cell technologies. During 2024, 6 new patents were issued to us related to DCVax products and processes, and 10 new patents were issued or allowed relating to Flaskworks technologies. As of December 31, 2024, we had built an overall portfolio of more than 55 issued patents (including European validations) and more than 65 pending patent applications (including European validations) worldwide, grouped into a number of patent families. In addition, the Company is continuing to in-licensed patents developed by others which it believes add further breadth and strategic value.
Positive Progress in Litigation. Throughout 2024, the Company devoted significant amounts of bandwidth and resources to litigation activities, and the Company plans to continue doing so. The Company believes the litigation activities are making important progress. See Item 1, Legal Proceedings, above.
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Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues and expenses.
On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses and stock-based compensation. We based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates.
Fair Value of Financial Instruments
ASC 820, Fair Value Measurements, provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
The Company accounts for the issuance of common stock purchase warrants issued in connection with the equity offerings in accordance with the provisions of ASC 815, Derivatives and Hedging (“ASC 815”). The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company accounts for certain common stock warrants outstanding as a liability at fair value and adjusts the instruments to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in its Consolidated Statements of Operations and Comprehensive Loss. The fair value of the warrants issued by the Company has been estimated using Monte Carlo simulation and or a Black Scholes model. The warrant liabilities are valued using Level 3 valuation inputs (see Note 4).
Derivative Financial Instruments
The Company has derivative financial instruments that are not hedges and do not qualify for hedge accounting. Changes in the fair value of these instruments are recorded in other income (expense), on a net basis in the Consolidated Statements of Operations and Comprehensive Loss.
The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. As a result of entering into a convertible debt instrument (see Note 7) for which such instrument contained a variable conversion feature with no floor price, the Company has adopted a sequencing policy as described below within Note 3 in accordance with ASC 815-40-35-12 “Derivatives and Hedging” (provides comprehensive guidance on derivative and hedging transactions) whereby all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors.
Impairment of Long-Lived Assets
The Company assesses its long-lived assets for impairment whenever facts and circumstances indicate that the carrying amounts may not be fully recoverable. To analyze recoverability, the Company projects undiscounted net future cash flows over the remaining lives
27
of such assets. If these projected cash flows are less than the carrying amounts, an impairment loss would be recognized, resulting in a write-down of the assets with a corresponding charge to earnings. The impairment loss is measured based upon the difference between the carrying amounts and the fair values of the assets. Assets to be disposed of are reported at the lower of the carrying amounts or fair value less cost to sell. Management determines fair value using the discounted cash flow method or other accepted valuation techniques.
As of December 31, 2024 and 2023, the undiscounted net future cash flows of the U.K. property were greater than the carrying value. Therefore, no impairment loss was considered necessary.
Sequencing
The Company adopted a sequencing policy under ASC 815-40-35 whereby in the event that reclassification of contracts from equity to liabilities is necessary pursuant to ASC 815 due to (i) the Company’s inability to demonstrate it has sufficient authorized shares as result of certain financial instrument with a potentially indeterminable number of shares due to a variable conversion feature with no floor, or (ii) the company committing more shares than authorized, all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors. While temporary suspensions are in place to keep the potential exercises beneath the number authorized, certain instruments are classified as liabilities, after allocating available authorized shares on the basis of the earliest maturity date of potentially dilutive instruments. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees, nonemployees or directors are not subject to the sequencing policy.
Modification of Equity Classified Warrants
A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.
Convertible Notes under Fair Value Option
The Company accounts for certain convertible notes issued from August to October 2023 on an instrument-by-instrument basis under the fair value option (“FVO”) election of ASC Topic 825, Financial Instruments (“ASC 825”). The convertible notes accounted for under the FVO election are each debt host financial instruments containing embedded features wherein the entire financial instrument is initially measured at its issue-date estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the estimated fair value of the convertible notes are recorded as a component of Other (expense) income in the consolidated statements of operations, except that the change in estimated fair value attributable to a change in the instrument-specific credit risks is recognized as a component of other comprehensive income. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred.
Stock Based Compensation
Share-based compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award using the Black-Scholes option-pricing model and is recognized over the service period required for the award.
We estimate the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Expected Term - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the simplified method, which is the half-life from vesting to the end of its contractual term.
Expected Volatility - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
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Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield available on U. S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
We recognize forfeitures when they occur.
Recently Adopted Accounting Standards
Improvements to Reportable Segment Disclosures
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, “Improvements to Reportable Segment Disclosures (Topic 280)” which is intended to improve reportable segment disclosure requirements, primarily through incremental disclosures of segment information on an annual and interim basis for all public entities. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. The ASU is to be applied retrospectively to all prior periods presented in the financial statements and is effective for our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and interim periods thereafter. The Company adopted this guidance with no material impact on its consolidated financial statements, and our expanded disclosures are included below under “Segment Information.”
Recently Issued Accounting Standards Not Yet Adopted
Improvements to Income Tax Disclosures
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.
Results of Operations
Operating costs:
Our operating costs and expenses consist primarily of research and development (R&D) expenses. R&D expenses include clinical trial expenses, and increased costs after completion of a Phase III trial, especially for the extensive preparations, and teams of expert consultants, required for an application for product approval.
In addition to clinical trial and post-trial costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, manufacturing process development, quality control process development, and related matters. Additional substantial costs relate to the development and expansion of manufacturing capacity.
Our operating costs also include the costs of preparations for the launch of new or expanded clinical trial programs, such as our anticipated trials of combination treatment regimens. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other.
Our operating costs also include legal and accounting costs in operating the Company.
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The foregoing operating costs include the costs for Flaskworks’ ongoing operations and intellectual property filings, and the operations of our subsidiaries in the U.K., the Netherlands and Germany.
Research and development:
R&D expenses include costs for substantial external scientific personnel, technical and regulatory advisers, and others, costs of laboratory supplies used in our internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial operation and management when we are actively engaged in clinical trials.
Because we are a company with no commercial product sales revenue, we do not allocate research and development costs on a project basis. We adopted this policy, in part, due to the unreasonable cost burden associated with accounting at such a level of detail and our limited number of financial and personnel resources.
General and administrative:
General and administrative expenses include personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal services, property and equipment and amortization of stock options and warrants.
For the Years Ended December 31, 2024 and, 2023
We recognized a net loss of $83.8 million and $62.6 million for the years ended December 31, 2024 and 2023.
Net cash used in operations was $57.0 million and $53.6 million for the years ended December 31, 2024 and 2023, respectively.
Research and development expense
For the years ended December 31, 2024 and 2023, research and development expense were $34.9 million and $27.7 million, respectively. The breakdown of this increase in R&D expenses in 2024 as compared to 2023 was primarily related to a net increase in expenses of approximately:
| ● | $2.4 million for the ramp up toward resumption of DCVax-Direct production, |
| ● | $2.2 million for the costs of prosecuting the MAA application at the MHRA in 2024 |
| ● | $1.4 million for specialized scientific testing, |
| ● | $0.8 million for manufacturing cost increases in the Specials-Compassionate Treatment program, and |
| ● | $0.1 million increase in stock-based compensation |
for a total year over year increase of approximately $7.2 million in Research and Development expenditures involving substantial progress on some of the Company’s most important programs.
General and Administrative Expense
General and administrative expenses were $33.0 million and $29.7 million for the years ended December 31, 2024 and 2023, respectively.
The increase of $3.3 million in 2024 compared to 2023 was mainly related to an increase of $3.8 million in legal expenses, which was partially offset by a decrease of $0.4 million related to stock-based compensation.
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Change in Fair Value of Derivatives
We recognized a non - cash gain of $0.4 million and $3.6 million for the years ended December 31, 2024 and 2023, respectively. The gain was primarily due to the decrease of our closing stock price as of December 31, 2024 compared to December 31, 2023. The higher gain in 2023 was mainly due to the non-cash revaluation gain recognized as of January 9, 2023, when we reclassed all warrants from liability classified to equity classified. The stock price on January 9, 2023 and December 31, 2022 was $0.71 and $0.78 per share, respectively.
Change in Fair Value of Convertible Notes
We recognized a non-cash gain of $7.7 million and a non-cash loss of $2.0 million from the change in fair value of the convertible notes during the year ended December 31, 2024 and 2023, respectively. The gain during the year ended December 31, 2024 was primarily due to the decrease of stock price as of December 31, 2024 compared to December 31, 2023. The loss during the year ended December 31, 2023 was primarily due to the increase in the stock price as of December 31, 2023 compared to the stock price on the issuance dates in August and September 2023.
Debt Extinguishment
We recognized approximately $14.4 million and $5.4 million debt extinguishment loss during the year ended December 31, 2024 and 2023, respectively, from debt redemptions and debt amendments. The increase during the year ended December 31, 2024 compared to the year ended December 31, 2023 was mainly due to multiple amendments on the existing convertible notes at fair value which resulted an aggregate debt extinguishment loss of $8.7 million.
Loss from Issuance of Debt
During the year ended December 31, 2024, we recognized an $0.8 million loss from the issuance of the Yorkville Note, which we elected to account for under the FVO. The estimated fair value of the Yorkville Note on the issuance date was approximately $5.8 million, which resulted in a loss of $0.8 million calculated at the difference between the principal amount and the fair value of the Yorkville Note.
Loss from warrant modification
During the years ended December 31, 2024, we recognized an $0.8 million loss from warrant modifications related to an amendment to certain warrants that were liability classified and such amendment was in conjunction with an equity offering.
Interest expense
During the years ended December 31, 2024 and 2023, we recorded interest expense of $7.8 million and $5.2 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Foreign currency transaction (loss) gain
During the years ended December 31, 2024 and 2023, we recognized foreign currency transaction loss of $1.5 million and a gain of $2.0 million, respectively. The loss was due to the strengthening of U.S. dollar relative to the British pound sterling and vice versa for the gain.
Liquidity and Capital Resources
We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of revenues and must cover our operating expenses through debt and equity financings to allow us to continue as a going concern. Our ability to continue as a going concern depends on the ability to obtain adequate capital to fund operating losses until we generate adequate cash flows from operations to fund our operating costs and obligations. If we are unable to obtain adequate capital, we could be forced to cease operations.
We depend upon our ability, and will continue to attempt, to secure equity and/or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Our management determined that there was substantial doubt about our ability
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to continue as a going concern within one year after the consolidated financial statements were issued, and management’s concerns about our ability to continue as a going concern within the year following this report persist.
Contingent Contractual Payment
The following table summarizes our contractual obligations as of December 31, 2024 (in thousands):
Payment Due by Period | ||||||||||||
Less than | 1 to 2 | 3 to 5 | ||||||||||
| Total |
| 1 Year |
| Years |
| Years | |||||
Short term convertible notes payable (1) |
|
|
|
|
| |||||||
6% unsecured |
| $ | 258 | $ | 258 | $ | — | $ | — | |||
8% unsecured | 1,881 | 1,881 | — | — | ||||||||
Short term convertible notes payable at fair value (2) |
| |||||||||||
8% unsecured |
| 1,017 | 1,017 | — | — | |||||||
10% unsecured |
| 574 | 574 | — | — | |||||||
11% unsecured |
| 17,189 | 17,189 | — | — | |||||||
Short term notes payable (3) |
| |||||||||||
0% unsecured |
| 2,140 | 2,140 | — | — | |||||||
6% secured | 262 | 262 | — | — | ||||||||
8% unsecured |
| 12,119 | 12,119 | — | — | |||||||
12% unsecured |
| 978 | 978 | — | — | |||||||
Long term convertible notes payable at fair value (2) |
| |||||||||||
0% unsecured | 5,000 | — | 5,000 | — | ||||||||
11% unsecured |
| 8,824 | — | 8,824 | — | |||||||
Long term notes payable (4) | ||||||||||||
8% unsecured | 14,604 | — | 14,604 | — | ||||||||
Operating leases (5) |
| 3,683 | 885 | 842 | 1,956 | |||||||
Minimum commitment obligation (6) |
| 5,827 | — | 5,827 | — | |||||||
Total |
| $ | 74,356 | $ | 37,303 | $ | 35,097 | $ | 1,956 | |||
| (1) | The obligations related to short-term convertible notes were approximately $2.1 million as of December 31, 2024, which included remaining contractual unpaid interest of $0.2 million. |
| (2) | The obligations related to certain convertible notes at fair value were approximately $32.6 million as of December 31, 2024, which included remaining contractual unpaid interest of $2.3 million. |
| (3) | The obligations related to short-term notes were approximately $15.5 million as of December 31, 2024, which included unpaid interest of $0.9 million. |
| (4) | The obligations related to long-term notes were approximately $14.6 million as of December 31, 2024, which included unpaid interest for the next two years of approximately $1.4 million. |
| (5) | The operating lease obligations during the next two years included approximately $0.4 million for our offices in Maryland and U.K. Approximately £1.1 million ($1.4 million) in lease obligations during the next two years and approximately £1.7 million ($2.1 million) for the next three to five years related to the Vision Centre in the U.K. that we leased back in December 2018. |
| (6) | The minimum commitment obligation included minimum required payments to Advent BioServices under the current Manufacturing Services Agreement. The Manufacturing Services Agreement remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate this agreement without cause upon 12 months’ prior written notice. During the notice period services would still be provided. Minimum required payments for this notice period are anticipated to total approximately £4.5 million ($5.7 million). |
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Operating Activities
We used $57.0 million and $53.6 million in cash for operating activities during the years ended December 31, 2024 and 2023, respectively. The increase in cash used in operating activities was primarily attributable to an increase in clinical trial related expenditures.
Investing Activities
We spent approximately $1.0 million and $3.4 million in cash for purchases of equipment in the U.K. and the build-out of our facility in Sawston, U.K. during the years ended December 31, 2024 and 2023, respectively.
Financing Activities
We received approximately $8.2 million and $13.3 million cash from issuances of 0.8 million and 1.0 million shares of Series C convertible preferred stock during the years ended December 31, 2024 and 2023, respectively.
We received approximately $14.2 million from issuances of common stock during the year ended December 31, 2024.
We received approximately $1.5 million and $1.7 million of cash proceeds from the exercise of warrants and options during the years ended December 31, 2024 and 2023, respectively.
We received approximately $14.0 million and $20.0 million in cash proceeds from the issuance of multiple notes payable during the years ended December 31, 2024 and 2023, respectively.
We received approximately $20.0 million and $13.3 million cash proceeds from issuance of convertible notes payable to individual lenders during the year ended December 31, 2024 and 2023, respectively.
We received $50,000 and $5.0 million from issuance of non-dilutive funding agreements during the year ended December 31, 2024 and 2023, respectively.
We made aggregate debt payments of $1.4 million and $0.4 million during the years ended December 31, 2024 and 2023, respectively.
We made repayment of $0.2 million of investor advances during the year ended December 31, 2023.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not Applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The full text of our audited consolidated financial statements as of December 31, 2024 and 2023 and for the fiscal years ended December 31, 2024 and 2023, begins on page F-1 of this Annual Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We, the management of Northwest Biotherapeutics, Inc. (the “Company”), are responsible for establishing and maintaining adequate internal control over financial reporting of the Company.
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We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including to our Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure.
As required by Rule 13a-15 under the Exchange Act, our management, including our Chief Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2024. In making this assessment, the Company’s management used the criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
Our management concluded that as of December 31, 2024, our disclosure controls and procedures were effective.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management of the Company, including our CEO and Principal Financial and Accounting Officer, assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2024. Based on this assessment, we determined that we have effectively designed and implemented, consistently performed, and tested the functioning of these controls. Accordingly, we concluded that the Company’s internal control over financial reporting was effective as of December 31, 2024.
Attestation Report on Internal Control over Financial Reporting
This annual report on Form 10-K does not include an attestation report of our independent registered public accounting firm because we qualified as a “smaller reporting company and non-accelerated filer.”
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
DIRECTORS
Name |
| Age |
| Position |
Linda F. Powers |
| 69 |
| Class III Director, Chairperson, President and Chief Executive Officer, |
J. Cofer Black |
| 74 |
| Class I Director |
Dr. Alton L. Boynton |
| 79 |
| Class I Director, Chief Scientific Officer |
Pat Sarma |
| 79 |
| Class II Director |
Dr. Navid Malik |
| 55 |
| Class III Director |
Director Biographies
Linda F. Powers. Ms. Powers has served as the Chairperson of our Board of Directors since her appointment on May 17, 2007, Chief Executive Officer and President since June 8, 2011 and Chief Financial and Accounting Officer since June 8, 2020. Ms. Powers served as a managing director of Toucan Capital Fund II from 2001 to 2010, and Toucan Capital Fund III from 2010 to 2018. She also has over 20 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers is or was previously a Board member of the Rosalind Franklin Society, M2GEN (an affiliate of Moffitt Cancer Center) and the Chinese Biopharmaceutical Association. She was the Chair of the Maryland Stem Cell Research Commission for the first two years of the state’s stem cell funding program, and has served an additional 14 years on the Commission. Ms. Powers served for several years on a Steering Committee of the National Academy of Sciences, evaluating government research funding, and was appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. For more than six years, Ms. Powers taught an annual internal course at the National Institutes of Health for the bench scientists and technology transfer personnel on the development and commercialization of medical products. Ms. Powers serves on the boards of several private biotechnology companies. Ms. Powers holds a B.A. from Princeton University, where she graduated magna cum laude and Phi Beta Kappa. She also earned a J.D., magna cum laude, from Harvard Law School. We believe Ms. Powers’ background and experience make her well qualified to serve as a Director.
J. Cofer Black. Ambassador Black was appointed to the Board of Directors in January 2016. Ambassador Black is an internationally renowned U.S. government leader and expert in cybersecurity, counterterrorism and national security. In addition to serving on company and bank boards, he presently serves as an independent consultant. Between 2009 and 2016, he served as Vice President for Global Operations at Blackbird Raytheon Technologies, a division of Raytheon Company, a NYSE-listed security company. From 2004 until 2008, he provided strategic guidance and business development as Vice Chairman of Blackwater Worldwide and as Chairman of Total Intelligence Solutions. During 2002 – 2005, he was appointed by the President of the United States to serve as the Ambassador, Coordinator for Counterterrorism, reporting directly to the Secretary of State for developing, coordinating and implementing American counterterrorism policy. Prior to his role as Ambassador, he served a 28-year career in the Central Intelligence Agency, reaching Senior Intelligence Service (SIS-4) level as Director, Counterterrorist Center (D/CTC), where he managed 1,300 professional personnel and an annual operational budget of more than one billion dollars. Ambassador Black is experienced representing the United States at the Head of State level, managing media as a diplomatic spokesperson and in public speaking as keynote speaker both as a senior U.S. Government official and business leader. Ambassador Black has received numerous awards and recognitions throughout his career, including the Distinguished Intelligence Medal (the CIA’s highest award for achievement). Ambassador Black received a B.A. in International Affairs from the University of Southern California in 1973 and an M.A. in International Affairs from the University of Southern California in 1974. We believe Ambassador Black’s background and experience in business management and information technology make him well qualified to serve as a Director.
Alton L. Boynton, Ph.D. Dr. Boynton co-founded our Company, has served as our Chief Scientific Officer and a Director since our inception in 1998, was appointed our Chief Operating Officer in August 2001, was appointed President in May 2003, and served as Chief Executive Officer from June 2007 to June 2011. Prior to founding our Company, Dr. Boynton headed the Molecular Oncology research lab at the Pacific Northwest Research Foundation (the original foundation of Bill Hutchinson, from which the Fred Hutchinson Cancer Center was spun off). Dr. Boynton also served as Director of the Department of Molecular Medicine of Northwest Hospital from 1995 to 2003 where he coordinated the establishment of a program centered on carcinogenesis. Prior to joining Northwest Hospital, Dr. Boynton was Associate Director of the Cancer Research Center of Hawaii, The University of Hawaii, where he also held the positions
35
of Director of Molecular Oncology of the Cancer Research Center and Professor of Genetics and Molecular Biology. Dr. Boynton received his Ph.D. in Radiation Biology from the University of Iowa in 1972. We believe Dr. Boynton’s background and experience make him well qualified to serve as a Director.
Pat Sarma. Mr. Sarma was appointed to the Board of Directors in March 2024. Mr. Sarma brings decades of experience as a business executive and as a venture capital investor. One of the companies he founded and built was American Megatrends Inc. (AMI), which developed hardware, software and firmware components of PC-based systems. AMI developed the AMIBIOS firmware program for IBM-PC compatibility. The BIOS (Basic Input Output System) is the heart of PC-compatibility and all application programs access the BIOS in reading from or writing to peripheral units such as drives, keyboards, mouse, etc. AMI also developed, among other software, the AMI RAID Controller and Management software that was the fastest performer in the industry during the 1990’s and early 2000’s. Mr. Sarma’s interests in AMI were acquired in 2001, and thereafter he became a venture capital investor in the private equity markets. He was an owner for a number of years of the N.J. Devils team in the National Hockey League, and has invested in a diverse range of industries including medical and environmental companies. Mr. Sarma received a Master’s Degree in Industrial Engineering and Operations Research from Georgia Tech and a Bachelor’s Degree in Mechanical Engineering from the University of Madras. We believe that Mr. Sarma’s background and experience make him well qualified to serve as a director.
Dr. Navid Malik. Dr. Malik was appointed to the Board of Directors in April 2012. Dr. Malik is currently Head of Research and an Executive Director at The Life Sciences Division, a UK Investment Bank (since 2018). From January 2012 to December 2015, Dr. Malik was previously the Head of Life Sciences Research at Cenkos Securities Plc. in the U.K., an institutional stockbroking securities firm. From September 2011 through January 2012, Dr. Malik was the Head of Life Sciences Research at Sanlam (Merchant Securities), a global financial services firm. Dr. Malik was Partner and Head of Life Sciences at Matrix Investment Banking Division, Matrix Group, a financial services firm in London, from December 2008 through September 2011. Dr. Malik was a Senior Pharmaceuticals and Biotechnology Analyst at Wimmer Financial LLP from September 2008 through December 2008, and was the Senior Life Sciences Analyst at Collins Stewart Plc from January 2005 through September 2008. In 2011, Dr. Malik was awarded two StarMine Awards (awarded each year by Thomson Reuters and the Financial Times): Number One Stock Picker in the European Pharmaceutical Sector, and Number Two Stock Picker in the U.K. and Ireland Healthcare Sector. Dr. Malik holds a Ph.D. in Drug Delivery within Pharmaceutical Sciences, as well as degrees in Biomedical Sciences Research (M.Sc.) and Biochemistry and Physiology (B.Sc., joint honors). Dr. Malik also holds an MBA in finance from the City University Business School, London. We believe that Dr. Malik’s extensive experience in the life sciences fields and investment banking sector make him well qualified to serve as a Director.
EXECUTIVE OFFICERS
The following table sets forth information regarding the Company’s current executive officers.
Name |
| Age |
| Position |
Linda F. Powers |
| 69 |
| Class III Director, Chairperson, President and Chief Executive Officer, Chief Financial and Accounting Officer |
Dr. Alton L. Boynton |
| 79 |
| Class I Director, Chief Scientific Officer |
Leslie J. Goldman |
| 79 |
| Senior Vice President, General Counsel |
Dr. Marnix L. Bosch |
| 65 |
| Chief Technical Officer |
Linda F. Powers. Please see “Director Biographies” above.
Alton L. Boynton, Ph.D. Please see “Director Biographies” above.
Leslie J. Goldman joined us in June 2011, and serves as Senior Vice President and General Counsel. In this capacity, Mr. Goldman has responsibility for legal matters, investor relations and financing activities. Prior to joining us, Mr. Goldman was a partner at the law firm of Skadden, Arps for over 30 years, specializing in a wide array of advanced technologies and their commercialization. Mr. Goldman also serves as an advisor to a number of other technology companies. In addition, for eight years, Mr. Goldman served as Chairman of the Board of a group of TV stations in four mid-size cities across the country. Mr. Goldman received a B.A. from the University of Michigan in 1967 and a J.D. from the University of Michigan in 1970.
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Marnix L. Bosch, Ph.D. joined us in 2000, and serves as our Chief Technical Officer. In this capacity, Dr. Bosch plays a key role in the preparation and submission of our regulatory applications, as well as ongoing development of our product lines, and ongoing development and/or acquisition of new technologies. Dr. Bosch led the process of designing the protocols, and managed the successful preparation and submission of our Investigational New Drug (IND) applications for FDA approval to conduct clinical trials for prostate cancer, brain cancer, ovarian cancer and multiple other cancers. He also led the processes for other regulatory submissions in both the U.S. and abroad (including the successful applications for orphan drug status in both the U.S. and Europe for DCVax-L for brain cancer). He spearheaded the development of our manufacturing and quality control processes. Prior to joining us in 2000, Dr. Bosch worked at the Dutch National Institutes of Health (RIVM) as head of the Department of Molecular Biology, as well as in academia as a professor of Pathobiology. He has authored more than 40 peer-reviewed research publications in immunology and virology, and is an inventor on several patent applications on dendritic cell product manufacturing.
CORPORATE GOVERNANCE
Board Leadership Structure
The Board believes that Ms. Powers’ service as both Chairperson of the Board and Chief Executive Officer is in the Company’s and our stockholders’ best interests. Ms. Powers possesses detailed and in-depth knowledge of the issues, opportunities and challenges facing us, and is thus, we believe, best positioned to develop Company strategies, business plans and priorities, and corresponding Board agendas that ensure that the Board’s time and attention are focused on the most critical matters. The Company has multiple major programs under way, with operations and infrastructure on two continents, which require heightened efficiency and involvement between the Board and management. Ms. Powers’ combined role enables decisive leadership, and, we believe, facilitates this efficiency and involvement. In March 2024, Mr. Pat Sarma was appointed to the Board to replace Mr. Jerry Jasinowski, who retired for medical reasons.
Board of Directors’ Role in Risk Oversight
The Board plays an active role in risk oversight of our Company. The Board does not have a formal risk management committee, but administers this oversight function through various standing committees of the Board of Directors and/or through the full Board. The Audit Committee maintains responsibility for oversight of financial reporting-related risks, including those related to our accounting, auditing and financial reporting practices. The Audit Committee also reviews reports and considers any material allegations regarding potential violations of our Company’s Code of Conduct. The Compensation Committee oversees risks arising from our compensation policies and programs and has responsibility for evaluating and approving our executive compensation and benefit plans, policies and programs. The Company also performed an enterprise-wide risk assessment as well as an enterprise-wide fraud risk assessment during 2021 and will continue to update such assessments on an annual basis.
Audit Committee
The Audit Committee has responsibility for recommending the appointment of our independent accountants, supervising our finance function (which includes, among other matters, our investment activities), reviewing our internal accounting control policies and procedures, and providing the Board such additional information and materials as it may deem necessary to make the Board aware of significant financial matters which require the attention of the Board. The Audit Committee discusses the financial statements with management, approves filings made with the SEC and maintains the necessary discussions with the Company’s independent accountants. The Audit Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.
The Audit Committee currently consists of Dr. Malik and Mr. Sarma. Our Board of Directors has determined that Mr. Sarma, the Chairman of the Audit Committee, qualifies as an “audit committee financial expert” as defined by the SEC. Our Board has determined that each member of the Audit Committee is “independent” within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules as well as pursuant to the additional test for independence for audit committee members imposed by SEC regulation and Section 5605(c)(2)(A) of the Nasdaq Stock Market Rules. The Audit Committee is established in accordance with Section 3(a)(58)(A) of the Exchange Act.
Compensation Committee
The Compensation Committee is responsible for determining the overall compensation levels of our executive officers and administering our equity compensation plans. The Compensation Committee currently consists of Dr. Malik, Ambassador Black and Mr.Sarma. Our
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Board of Directors has determined that each member of the Compensation Committee is “independent” under the current listing standards of Nasdaq. The Compensation Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.
Conflicts Committee
The Conflicts Committee is responsible for review and evaluation of related party matters including related party transactions. The Conflicts Committee currently consists of Ambassador Black, Mr. Sarma and Dr. Malik. Our Board of Directors has determined that each member of the Conflicts Committee is “independent” within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules. The Conflicts Committee acts under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/. The Conflicts Committee does not delegate its authority pursuant to its written charter.
Nominations Committee
The Nominations Committee is responsible for assisting the Board of Directors in, among other things, effecting Board organization, membership and function, including: identifying qualified Board nominees; and effecting the organization, membership and function of Board committees, including composition and recommendation of qualified candidates and reviewing the Company’s Corporate Governance Guidelines. The Nominations Committee shall identify and evaluate the qualifications of all candidates for nomination for election as directors. Potential nominees are identified by the Board of Directors based on the criteria, skills and qualifications that have been recognized by the Nominations Committee. While our nomination policy does not prescribe specific diversity standards, the Nominations Committee and its independent members seek to identify nominees who have a variety of perspectives, professional experience, education, difference in viewpoints and skills, and personal qualities that will result in a well-rounded Board of Directors. The Nominations Committee operates under a written charter, which is posted on our website at www.nwbio.com/board-committee-charters/.
The Nominations Committee currently consists of Dr. Malik and Ambassador Black. The Board of Directors has determined that each member of the Nominations Committee is “independent” under the current listing standards of Nasdaq. The Board of Directors has adopted a written charter setting forth the authority and responsibilities of the Nominations Committee.
Information Regarding Meetings of the Board and Committees
The business of our Company is under the general oversight of our Board, as provided by the laws of Delaware and our bylaws. During 2024, the Board held 13 meetings and also conducted business by written consent. During 2024, the Audit Committee held 4 meetings and the Conflicts Committee held 3 meetings; and the Compensation Committee held 2 meetings. The Nominations Committee did not hold any meetings. Each person who was a director during 2024 attended at least 75% of the 13 Board meetings. We do not have a formal written policy with respect to Board members’ attendance at our annual meeting of stockholders. All five of our directors attended our last annual meeting of stockholders.
Code of Conduct
We have an established Code of Conduct applicable to all Board members, executive officers, employees and contractors. Our Code of Conduct is posted on our website at www.nwbio.com.
Insider Trading Policy
We have
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ITEM 11. EXECUTIVE COMPENSATION
EXECUTIVE COMPENSATION
Compensation Discussion and Analysis
Overview
This Compensation Discussion and Analysis describes the compensation program for the Company’s principal executive and principal financial officer, and our three most highly compensated executive officers other than our principal executive and financial officer who were serving as executive officers as of December 31, 2024. We refer to these individuals as our “named executive officers” or “NEOs.”
For purposes of this executive compensation discussion, the names and positions of our named executive officers for the 2024 fiscal year were:
| ● | Linda F. Powers, President and Chief Executive Officer, Chief Financial and Accounting Officer; |
| ● | Leslie Goldman, Senior Vice President and General Counsel; and |
| ● | Marnix L. Bosch, Ph.D., Chief Technical Officer. |
Philosophy and Objectives
Our success is highly dependent on our ability to attract, engage and retain executive officers who possess the skills, competencies and passion that are consistent with our vision. To this end, our compensation program has been developed with the following overarching principles in mind:
| ● | the pay of our NEOs should balance incentivizing performance, building stockholder value and ensuring retention; |
| ● | our executive compensation program should enable us to recruit, develop, motivate and retain top talent. |
Periodically, the Compensation Committee reviews the objectives and components of our executive compensation program to assess whether they continue to align with these principles.
Risk Management and Mitigation
The Compensation Committee also considers whether our compensation policies and practices could affect our risk profile and whether such compensation policies and practices could potentially encourage excessive risk taking by our employees. In considering these issues, the Compensation Committee has not found that our compensation policies and other policies generally raised undue risks for the Company or potentially could encourage excessive risk taking by our employees.
Elements of 2024 Compensation
Base Salary
Base salary is the fixed portion of an executive’s annual compensation. The Compensation Committee does not use a formulaic approach when setting an executive officer’s base salary. The Committee considers the nature and responsibility of the NEO’s position and, where applicable, the executive’s performance of multiple roles that would typically be held by separate executives (with separate compensation) at other companies. The Committee takes account of the NEOs’ compensation history, and that payment of bonuses has tended to be substantially delayed. The Committee also considers the Company’s progress and management’s recommendations about compensation.
The Compensation Committee typically reviews base salaries on an annual basis. The Committee deliberates and reaches recommendations and decisions without management present.
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For 2024, the Compensation Committee and Board did not make any increase in the base salaries of the NEOs.
Annual Bonus Awards
Our NEOs are eligible to receive an annual bonus in respect of their individual performance and the performance of the Company. The Company determines Annual Bonus Awards based upon progress achieved in the Company’s programs (including clinical development, manufacturing, intellectual property and finances) and progress toward potential eventual commercialization, as well as the individual’s roles and contributions toward the progress. The performance and progress achieved during a given year are evaluated after the end of that calendar year, and bonuses for the given year are determined based upon that evaluation
For 2024, the Compensation Committee and Board have not yet determined bonuses for the NEOs. They plan to do so in due course.
Equity Awards
The Company did not make any equity compensation awards to the NEOs in 2024. The Company has made no equity awards to NEOs since option awards were last granted in 2020.
Overall in the 14 years since 2011, the Company has only made equity awards in 2018 and 2020 to two of its NEOs (Ms. Powers and Mr. Goldman), and has only made equity awards to the other NEO (Dr. Bosch) in 2012, 2017 and 2020 in these 14 years.
The equity pool reserved for employees and directors established under the Company’s Equity Compensation Plan remains in place. The pool includes 20% of the Company’s securities, some of which have been issued to employees and directors and some of which remain available in the pool. The Company has been advised by an independent compensation consultant that it is not uncommon for pre-commercial biotech companies to set aside 15-20% of their equity in a pool for employees and directors.
Other Compensation Plans
401(k) Plan. The NEOs are eligible to participate in employee benefit plans and programs, including long-term disability, to the same extent as the Company’s other full-time employees, subject to the terms and eligibility requirements of those plans. The NEOs are also eligible to participate in our 401(k) plan, subject to limits imposed by the Internal Revenue Code, to the same extent as the Company’s other full-time employees.
Other Benefits. We do not maintain any defined benefit pension plans or any nonqualified deferred compensation plans.
Limited Perquisites. Perquisites or other personal benefits are not a significant component of the compensation to our NEOs. We provide only limited perquisites to our NEOs, such as coverage of phone and internet costs.
Employment Agreements. The Company entered into employment agreements with each of Ms. Powers, Mr. Goldman and Dr. Bosch in 2011. The 2011 agreements have expired. The Company entered into a new employment agreement with Dr. Bosch, which is currently in effect. The Company plans to enter into new employment agreements with Ms. Powers and Mr. Goldman in due course.
Process for Setting Executive Compensation
Compensation Committee Review
Our Compensation Committee reviews the elements of our NEOs’ total compensation during the year, as described above. An external compensation consultant has been engaged. In making compensation decisions, the Committee may rely upon advice from the compensation consultant as well as its own judgment after reviewing relevant information.
The Compensation Committee does not use a formulaic approach when setting a NEO’s base salary. The Committee considers various factors, including the nature and responsibility of the NEO’s position; where applicable, the executive’s performance of multiple roles that would typically be held by separate executives (with separate compensation) at other companies; the executive’s performance; and the Company’s progress. The Committee takes account of the NEO’s compensation history, and the fact that payment of bonuses has tended to be substantially delayed. The Committee also considers management’s recommendations about compensation.
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The Compensation Committee typically reviews base salaries on an annual basis. The Committee deliberates and reaches recommendations and decisions without management present. However, at the Committee’s request, the CEO may review with the Committee the performance of the other executive officers. Our Compensation Committee gives substantial weight to the CEO’s evaluations and recommendations because she is particularly able to assess the other executive officers’ performance and contributions.
Independent Compensation Consultant
The evaluations and analyses for the 2024 base salaries for the Company’s NEOs were done internally, and not by a compensation consultant. However, a compensation consultant has been engaged to assist in the compensation process going forward.
Compensation Committee Report
The compensation committee has reviewed and discussed the compensation discussion and analysis included in this Annual Report on Form 10-K with management and, based on such review and discussions, the compensation committee recommended to our board of directors that the compensation discussion and analysis be included in the Company’s Annual Report on Form 10-K for filing with the SEC.
The foregoing report has been furnished by the Compensation Committee.
Dr. Navid Malik (Chairperson)
Cofer Black
Pat Sarma
Summary Compensation Table
The following table sets forth certain information concerning compensation paid to or accrued for our executive officers, referred to as our Named Executive Officers (NEOs), during the years ended December 31, 2024 and 2023.
|
|
|
| Option |
| |||||||||
Salary | Bonus | Awards | Total | |||||||||||
Name and Principal Position |
| Year |
| ($) |
| ($) (1) |
| ($) |
| ($) | ||||
Linda F. Powers |
| 2024 | $ | 925,000 | $ | — | $ | — | $ | 925,000 | ||||
Chairperson, President & Chief Executive Officer |
| 2023 | $ | 925,000 | $ | 300,000 | (2) | $ | — | $ | 1,225,000 | |||
Leslie Goldman |
| 2024 | $ | 725,000 | $ | — | $ | — | $ | 725,000 | ||||
Senior Vice President and General Counsel |
| 2023 | $ | 725,000 | $ | 250,000 | (3) | $ | — | $ | 975,000 | |||
Marnix L. Bosch, Ph.D. |
| 2024 | $ | 453,600 | $ | — | $ | — | $ | 453,600 | ||||
Chief Technical Officer |
| 2023 | $ | 453,600 | $ | 180,000 | (4) | $ | — | $ | 633,600 | |||
| (1) | The Company plans to award performance bonuses for NEOs for 2024, but these bonuses have not yet been determined. |
| (2) | This 2023 bonus has been approved but has not been paid to date. |
| (3) | This 2023 bonus has been approved but has not been paid to date. |
| (4) | Dr. Bosch was relocated to our subsidiary in Netherlands effective August 1, 2019. His current annual salary is 420,000 euros, which is equivalent to approximately $454,000. Dr. Bosch’s compensation is paid in Euros and therefore varies based on the exchange rate. The compensation amounts paid to Dr. Bosch presented in the table above are determined by multiplying the amount of euros paid by the average exchange rate of $1.08 per euro for both fiscal 2024 and 2023. The 2023 bonus for Dr. Bosch has been approved but only a portion of it ($110,000) has been paid to date. |
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Outstanding Equity Awards at Fiscal Year-End
The following table shows outstanding stock option awards classified as exercisable and un-exercisable as of December 31, 2024:
| Securities Underlying Unexercised Option Awards | ||||||||
Number of | Number of | Option | |||||||
Unexercised | Unexercised | Exercise | Option | ||||||
Options (#) | Options | Price | Expiration | ||||||
Name and Principal Position | Exercisable (1) |
| (#) Unexercisable |
| ($) |
| Date | ||
Linda F. Powers | 39,200,000 | (2) | — | $ | 0.23 | 5/28/2028 | |||
Chairperson, President & Chief Executive Officer, | 10,770,429 | (3) | — | $ | 0.35 | 7/2/2030 | |||
Chief Financial and Accounting Officer |
| 32,558,724 | (3) | — | $ | 0.35 |
| 12/1/2030 | |
| 11,789,879 | (4) | — | $ | 0.55 |
| 9/2/2030 | ||
|
| ||||||||
Leslie Goldman |
| 24,500,000 | (5) | — | $ | 0.23 |
| 5/28/2028 | |
Senior Vice President and General Counsel |
| 6,731,518 | (6) | — | $ | 0.35 |
| 7/2/2030 | |
| 21,822,937 | (6) | — | $ | 0.35 |
| 12/1/2030 | ||
| 5,894,939 | (7) | — | $ | 0.55 |
| 9/2/2030 | ||
|
| ||||||||
Marnix Bosch |
| 7,740,182 | (8) | — | $ | 0.25 |
| 6/13/2027 | |
Chief Technical Officer |
| 10,798,729 | (9) | — | $ | 0.35 |
| 7/2/2030 | |
| 16,630,726 | (10) | — | $ | 0.35 |
| 12/1/2030 | ||
| (1) | Ms. Powers and Mr. Goldman are subject to a voluntary blocking agreement under which they cannot exercise any options, warrants or other derivative securities unless they provide the Company at least 61 days’ advance notice. |
| (2) | On May 28, 2018, we granted 39,200,000 stock options to Ms. Powers for service during a number of years. The options are exercisable at a price of $0.23 per share, and have a 10-year exercise period. 50% of the options vested on the grant date, and 50% vested over a 24-month period in equal monthly installments. Following entry into previous securities suspension agreements in 2021, Ms. Powers entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities unless Ms. Powers provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
| (3) | On July 2, 2020, we granted 10,770,429 stock options to Ms. Powers for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. Following entry into previous securities suspension agreements, in 2021 Ms. Powers entered into a voluntary blocking agreement with the Company under which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities, unless Ms. Powers provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
On July 2, 2020, we granted 32,558,724 stock options to Ms. Powers for service during several years. These options were subject to certain vesting requirements which have been fulfilled. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. Following entry into previous securities suspension agreements, in 2021, Ms. Powers entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities, unless Ms. Powers provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended.
| (4) | On September 2, 2020, we granted 11,789,879 stock options to Ms. Powers for service during several years. These options were subject to certain vesting requirements, which have been fulfilled. The options are exercisable at a price of $0.55 per share, and have a 10-year exercise period. Following entry into previous securities suspension agreements, in 2021, Ms. Powers entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities, unless Ms. Powers provides the Company at least 61 days’ advance notice. As |
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| a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
| (5) | On May 28, 2018, we granted 24,500,000 stock options to Mr. Goldman for service during a number of years. The options are exercisable at a price of $0.23 per share, and have a 10-year exercise period. 50% of the options vested on the grant date, and 50% vested over a 24-month period in equal monthly installments thereafter. Following entry into previous securities suspension agreements, in 2021, Mr. Goldman entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Mr. Goldman cannot exercise or convert any options, warrants or other derivative securities, unless Mr. Goldman provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
| (6) | On July 2, 2020, we granted 6,731,518 stock options to Mr. Goldman for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. These options were fully vested upon grant. Following entry into previous securities suspension agreements, in 2021 Mr. Goldman entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Mr. Goldman cannot exercise or convert any options, warrants or other derivative securities, unless Mr. Goldman provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
On July 2, 2020, we granted 21,822,937 stock options to Mr. Goldman for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. These options are subject to certain vesting requirements. Following entry into previous securities suspension agreements, in 2021 Mr. Goldman entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Mr. Goldman cannot exercise or convert any options, warrants or other derivative securities, as applicable, to acquire shares of the Company’s common stock, unless Mr. Goldman provides the Company at least 61 days’ advance notice. As a result, such derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended.
On January 14, 2021, Mr. Goldman assigned 20,000,000 options that were granted on July 2, 2020 to The Goldman NWBIO GRAT Trust for no consideration. On April 28, 2022, Sue Goldman, Trustee of The Goldman NWBIO GRAT Trust transferred 12,709,287 options to Mr. Goldman in satisfaction of the first annuity amount due to Mr. Goldman. As of December 31, 2022, 7,290,713 options were remaining in The Goldman NWBIO GRAT Trust.
| (7) | On September 2, 2020, we granted 5,894,939 stock options to Mr. Goldman for service during several years. These options were subject to certain vesting requirements, which have been fulfilled. The options are exercisable at a price of $0.55 per share, and have a 10-year exercise period. Following entry into previous securities suspension agreements, in 2021 Mr. Goldman entered into a voluntary blocking agreement on an ongoing rolling basis with the Company under which Mr. Goldman cannot exercise or convert any options, warrants or other derivative securities, unless Mr. Goldman provides the Company at least 61 days’ advance notice. |
| (8) | On June 13, 2017, we awarded 7,940,182 options to Dr. Bosch under the 2007 Stock Plan for service during several years. The options are exercisable at a price of $0.25 per share, and had a 5-year exercise period. 50% of the options vested on the grant date, and 50% vested over a 24-month period in equal monthly installments. On January 14, 2018, we extended the exercise period of the options from 5-year to 10-year. In 2021, Dr. Bosch entered into a securities suspension agreement with the Company that (i) suspended the exercisability of the vested options and (ii) made no changes to the other terms of such securities. The suspension agreement covered 20,429,456 options. The suspension agreement expired on January 12, 2023. |
On March 29, 2023, Dr. Bosch cashless exercised 200,000 options.
| (9) | On July 2, 2020, we granted 10,798,729 stock options to Dr. Bosch for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. These options were fully vested upon grant. Dr. Bosch entered into a securities suspension agreement with the Company that (i) suspended the exercisability of the vested options and (ii) made no changes to the other terms of such securities. The suspension agreement expired on January 12, 2023. Dr. Bosch received no consideration for entry into such arrangement. |
| (10) | On July 2, 2020, we granted 16,630,726 stock options to Dr. Bosch for service during several years. The options are exercisable at a price of $0.35 per share, and have a 10-year exercise period. 50% of these options were vested on the grant date, with the remainder vesting in monthly installments over one year. Dr. Bosch entered into a securities suspension agreement with the Company that (i) |
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| suspended the exercisability of 13,165,992 of the vested options and (ii) made no changes to the other terms of such securities. The suspension agreement expired on January 12, 2023. Dr. Bosch received no consideration for entry into such arrangement. |
Option Exercises and Stock Vested
No options were vested during 2024 for any of our Named Executive Officers, and none were exercised by our Named Executive Officers.
Potential Payments on Termination or Change in Control
The Company does not currently have any arrangements that would trigger payments upon termination of a NEO or upon a change in control of the Company. However, the Company plans to enter into employment agreements with Ms. Powers and Mr. Goldman in due course which may contain such arrangements.
CEO Pay Ratio Disclosure
We are providing the following information about the relationship of the annual total compensation of our employees and the annual total compensation of our CEO. Based on the information for fiscal year 2024, we reasonably estimate that the ratio of our CEO’s annual total compensation to the annual total compensation of our median employee (including three full-time contractors) was 5.7:1. Our pay ratio estimate has been calculated in a manner consistent with Item 402(u) of Regulation S-K using the data and assumptions summarized below.
We identified the median employee by examining the 2024 annual base salary compensation for all individuals, excluding our CEO. We identified our median compensation employee by examining total compensation paid for fiscal year 2024 to all individuals, excluding Ms. Powers, who were employed by us on December 31, 2024, the last day of our fiscal year based on payroll records. No assumptions, adjustments or estimates were made in respect of total compensation, except that we annualized the compensation of any employee that was not employed with us for all of fiscal year 2024.
Once we identified our median employee, we calculated such employee’s annual total compensation for 2024 in accordance with the requirements of Item 402(c)(2)(x) of Regulation S-K, resulting in that employee’s annual total compensation of $162,000. The median employee’s annual total compensation includes annualized base salary during the fiscal year ended December 31, 2024. We calculated the compensation for personnel in the UK and Canada using the applicable average currency exchange rates of $1.30 per GBP and $0.74 per CAD for fiscal year 2024.
With respect to the CEO, we used the amount reported as total compensation in the Summary Compensation Table included in this annual report on Form 10-K. Any estimates and assumptions used to calculate total annual compensation are described in footnotes to the Summary Compensation Table.
Pay Versus Performance
As required by Item 402(v) of Regulation S-K, we are providing the following information regarding the relationship between executive compensation and our financial performance for each of the last two completed calendar years. In determining the “compensation actually paid” to our named executive officers (“NEOs”), we are required to make various adjustments to amounts that have been previously reported in the Summary Compensation Table in previous years, as the SEC’s valuation methods for this section differ from those required in the Summary Compensation Table.
The following tables and related disclosures provide information about (i) the total compensation (“SCT Total”) of our principal executive officer (“PEO”) and our non-PEO Named Executive Officers (collectively, the “Other NEOs”) as presented in the Summary Compensation Table, (ii) the “compensation actually paid” (“CAP”) to our PEO and our Other NEOs, as calculated pursuant to Item 402(v), (iii) certain financial performance measures, and (iv) the relationship of the CAP to those financial performance measures.
Pay Versus Performance Table
The amounts set forth below under the headings “Compensation Actually Paid to PEO” and “Average Compensation Actually Paid to Non-PEO NEOs” have been calculated in a manner consistent with Item 402(v) of Regulation S-K. Use of the term “compensation
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actually paid” is required by the SEC’s rules, and as a result of the calculation methodology required by the SEC, such amounts differ from compensation actually received by the individuals for the fiscal years listed below.
In calculating the compensation actually paid amounts reflected in these columns, the fair value or change in fair value, as applicable, of the equity award adjustments included in such calculations were computed in accordance with FASB ASC Topic 718. The valuation assumptions used to calculate such fair values did not materially differ from those disclosed at the time of grant. During fiscal years 2024, 2023 and 2022, the PEO was Linda Powers, and the non-PEO NEOs were Les Goldman and Marnix Bosch.
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|
|
| Value of Initial |
| ||||||||||||
Average Summary | Fixed $100 | |||||||||||||||||
Summary | Compensation | Average | Investment Based | |||||||||||||||
Compensation | Compensation | Table Total for | Compensation | On Total | ||||||||||||||
Table Total for | Actually Paid to | Non-PEO | Actually Paid to | Shareholder | Net Loss | |||||||||||||
Year | PEO | PEO (1) | NEOs | Non-PEO NEOs (2) | Return (3) | (in thousands) | ||||||||||||
2024 | $ | 925,000 | $ | 925,000 | $ | 589,000 | $ | 589,000 | $ | 39 | $ | (83,778) | ||||||
2023 | $ | 1,225,000 | $ | 1,225,000 | $ | 804,000 | $ | 804,000 | $ | 100 | $ | (62,599) | ||||||
2022 | $ | 1,100,000 | $ | 1,100,000 | $ | 711,000 | $ | 711,000 | $ | 111 | $ | (105,032) | ||||||
| (1) | The amounts listed as “compensation actually paid” have not, in fact, all been actually paid. The amounts listed include the PEO bonuses for 2023 totaling $300,000 that have been approved but have not been paid. |
The following table sets forth the adjustments made to the SCT total for each year represented in the pay versus performance table to arrive at “compensation actually paid” to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
SCT Total to CAP Reconciliation |
| 2024 |
| 2023 |
| 2022 | |||
SCT Total for PEO | $ | 925,000 | $ | 1,225,000 | $ | 1,100,000 | |||
(Less): Aggregate value for stock awards and option awards included in SCT Total for the covered fiscal year |
| — |
| — |
| — | |||
Outstanding and unvested awards: |
|
|
|
|
|
| |||
Add: Fair value at year end of awards granted during the covered fiscal year that were outstanding and unvested at the covered fiscal year end |
| — |
| — |
| — | |||
Add: Change in fair value as of fiscal year-end, compared to prior fiscal year-end, of awards granted in any prior fiscal year that are outstanding and unvested as of the end of the fiscal year |
| — |
| — |
| — | |||
Awards granted and vesting in the same year: |
|
|
|
|
|
| |||
Add: Vesting date fair value of awards granted and vested during the covered fiscal year |
| — |
| — |
| — | |||
Awards vesting in current fiscal year but granted in prior fiscal year: |
|
|
|
|
|
| |||
Add: Change in fair value as of vesting date, compared to prior fiscal year-end, of awards granted in any prior fiscal year for which all vesting conditions were satisfied at fiscal year-end or during the fiscal year |
| — |
| — |
| — | |||
Compensation Actually Paid to PEO | $ | 925,000 | $ | 1,225,000 | $ | 1,100,000 | |||
| (2) | The amounts listed as “compensation actually paid” have not, in fact, all been actually paid. The amounts listed include the NEO bonuses for 2023 totaling $320,000 for Mr. Goldman and Dr. Bosch that have been approved but have not been paid. |
45
The following table sets forth the adjustments made to the SCT total for each year represented in the pay versus performance table to arrive at “compensation actually paid” to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
SCT Total to CAP Reconciliation |
| 2024 |
| 2023 |
| 2022 | |||
Average SCT Total for Non-PEO NEOs | $ | 589,000 | $ | 804,000 | $ | 711,000 | |||
(Less): Aggregate value for stock awards and option awards included in SCT Total for the covered fiscal year |
| — |
| — |
| — | |||
Outstanding and unvested awards: |
|
|
|
|
|
| |||
Add: Fair value at year end of awards granted during the covered fiscal year that were outstanding and unvested at the covered fiscal year end |
| — |
| — |
| — | |||
Add: Change in fair value as of fiscal year-end, compared to prior fiscal year-end, of awards granted in any prior fiscal year that are outstanding and unvested as of the end of the fiscal year |
| — |
| — |
| — | |||
Awards granted and vesting in the same year: |
|
|
|
|
|
| |||
Add: Vesting date fair value of awards granted and vested during the covered fiscal year |
| — |
| — |
| — | |||
Awards vesting in current fiscal year but granted in prior fiscal year: |
|
|
|
|
|
| |||
Add: Change in fair value as of vesting date, compared to prior fiscal year-end, of awards granted in any prior fiscal year for which all vesting conditions were satisfied at fiscal year-end or during the fiscal year |
| — |
| — |
| — | |||
Compensation Actually Paid to Non-PEO NEOs | $ | 589,000 | $ | 804,000 | $ | 711,000 | |||
| (3) | The amounts reported represent the Total Shareholder Return for each applicable year calculated based on a fixed investment of $100 in the Company for the period starting December 31, 2021, through the end of the listed year on the same cumulative basis as is used in Item 201(e) of Regulation S-K. Historical stock performance is not necessarily indicative of future stock performance. |
46
Relationship Between CAP Amounts and Performance Measures
The following charts show graphically the relationships over the past two years of the CAP Amounts for the PEO and the Other NEOs as compared to our (i) cumulative total shareholder return and (ii) net loss.
While the Compensation Committee makes executive compensation decisions in consideration of a variety of factors, including corporate and individual performance, the decisions of the Compensation Committee and Board of Directors in 2024, 2023 and 2022 were made independently of these.
47
Compensation Committee Interlocks and Insider Participation
None of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on our board of directors.
Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
The Company does not have any formal policy that requires the Company to grant, or avoid granting, stock options at particular times. The timing of any equity grants to executive officers or directors in connection with new hires, promotions, or other non-routine grants is tied to the event giving rise to the award (such as an executive officer’s commencement of employment or promotion effective date), and the Company does not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.
During the year ended December 31, 2024, there were no equity grants made to our executive officers during any period beginning four business days before the filing of a periodic report or current report disclosing material non-public information and ending one business day after the filing or furnishing of such report with the Securities and Exchange Commission.
48
DIRECTOR COMPENSATION
The following table sets forth certain information concerning compensation paid or accrued to our non-executive directors during the years ended December 31, 2024 and 2023.
|
| Fees Earned |
|
|
| ||||||
or | Option |
| |||||||||
Paid in Cash | Awards | Total | |||||||||
Name |
| Year |
| ($) |
| ($) |
| ($) | |||
Dr. Navid Malik |
| 2024 | $ | 150,000 | $ | — | $ | 150,000 | |||
| 2023 | $ | 150,000 | $ | — | $ | 150,000 | ||||
J. Cofer Black |
| 2024 | $ | 150,000 | $ | — | $ | 150,000 | |||
| 2023 | $ | 150,000 | $ | — | $ | 150,000 | ||||
Pat Sarma (1) |
| 2024 | $ | 118,145 | $ | — | $ | 118,145 | |||
Jerry Jasinowski |
| 2024 | $ | 28,226 | $ | — | $ | 28,226 | |||
| 2023 | $ | 150,000 | $ | — | $ | 150,000 | ||||
| (1) | Mr. Sarma’s compensation in the above table reflects a partial year of service. He was appointed to the Board as a non-executive director in March 2024, following Mr. Jasinowski’s retirement for medical reasons. As a non-executive director Mr. Sarma is entitled to receive compensation on the same basis as the Company’s other non-executive directors. |
The non-executive independent directors were compensated on a monthly basis $12,500 ($150,000 annually) for their consistent availability on short notice, participation in the frequent meetings of the board of directors, leadership of at least one board committee, participation on multiple committees of the Board, commitment to corporate governance initiatives, and frequent consultations with management on operational matters. The Company owed Mr. Jasinowski $178,226 as of December 31, 2024.
Ms. Powers and Dr. Boynton are executives of the Company and do not receive separate compensation for their services as a Director.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS-EQUITY COMPENSATION PLAN INFORMATION
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table presents information regarding the beneficial ownership of our common stock as of February 28, 2025 by:
| ● | each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of any class of our equity securities; |
| ● | our directors and nominees for director; |
| ● | each of our Named Executive Officers, as defined in Item 402(a)(3) of Regulation S-K; and |
| ● | our directors and executive officers as a group. |
Shares of common stock beneficially owned and the respective percentages of beneficial ownership of common stock assume the exercise of all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable or exercisable within 60 days of February 28, 2025. Shares issuable pursuant to the exercise of stock options and warrants exercisable on or prior to the date 60 days after February 28, 2025 are deemed outstanding and held by the holder of such options or warrants for computing the percentage of outstanding common stock beneficially owned by such person, but are not deemed outstanding for computing the percentage of outstanding common stock beneficially owned by any other person.
49
Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and the entities named in the table have sole voting and investment power with respect to all shares of common stock that they beneficially own, subject to applicable community property laws, if any. The table below is based upon the information supplied by our transfer agent, Computershare Trust Company, N.A., the Company’s records and from Schedules 13D and 13G filed with the SEC.
Except as otherwise noted, the address of the individuals in the following table is c/o Northwest Biotherapeutics, Inc., 4800 Montgomery Lane, Suite 800, Bethesda, MD 20814.
| Amount and Nature of |
| Percent of class of |
| |
Name and address of beneficial owner | Beneficial Ownership | Common Stock (1) |
| ||
Directors and Officers: |
|
|
|
| |
Alton L. Boynton, Ph.D. |
| 979,254 |
| * | % |
Marnix L. Bosch, Ph.D., M.B.A. |
| 35,298,794 |
| 2.5 | % |
Linda F. Powers (2) |
| 29,411,759 |
| 2.2 | % |
Leslie Goldman (3) |
| 172,742 |
| * | % |
Dr. Navid Malik |
| 23,349,393 |
| 1.7 | % |
J. Cofer Black |
| 6,484,433 |
| * | % |
Pat Sarma |
| 12,535,165 |
| * | % |
All executive officer s and directors as a group (7 persons) |
| 108,231,540 |
| 7.6 | % |
* | Less than 1% |
| (1) | Percentage represents beneficial ownership percentage of common stock calculated in accordance with SEC rules and does not equate to voting percentages. Based upon 1,366,163,803 shares of Common Stock issued and outstanding as of February 28, 2025. Beneficial ownership is determined in accordance with the rules of the SEC. In computing the number of shares of common stock beneficially owned and the percentage of ownership of such person, we deemed to be outstanding all shares of Common Stock subject to options and warrants currently exercisable or convertible, or exercisable or convertible within 60 days of February 28, 2025. However, we did not deem such shares outstanding for the purpose of computing the percentage ownership of any other person. |
| (2) | Consists of 29,411,759 shares of common stock held by Ms. Powers. Ms. Powers also holds 56,992,773 warrants (the majority acquired from a third party, and the rest acquired in past years, as previously reported, from the Company in connection with loans by Ms. Powers to the Company when such loans were needed to help the Company to survive). Ms. Powers holds 39,200,000 options awarded in 2018 for service during part of that year and a number of preceding years, and 55,119,032 options awarded in 2020 for service during several years. In 2021, Ms. Powers entered into a voluntary blocking agreement with the Company pursuant to which Ms. Powers cannot exercise or convert any options, warrants or other derivative securities, as applicable, unless Ms. Powers provides the Company at least 61 days’ advance notice. As a result, such options, warrants and other derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
| (3) | Consists of 172,742 shares of common stock held by Mr. Goldman. Mr. Goldman also holds 643,043 warrants acquired in past years, as previously reported, from the Company in connection with loans by Mr. Goldman to the Company when such loans were needed to help the Company to survive. Mr. Goldman holds 24,500,000 options awarded in 2018 for service during part of that year and a number of preceding years, and 34,449,394 options awarded in 2020 for service during several years. In 2021, Mr. Goldman entered into a voluntary blocking agreement with the Company under which Mr. Goldman cannot exercise or convert of any options, warrants or other derivative securities, as applicable, to acquire shares of the Company’s common stock, unless Mr. Goldman provides the Company at least 61 days’ advance notice. As a result, such options, warrants and other derivative securities are not considered “beneficially owned” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended. |
50
EQUITY COMPENSATION PLAN INFORMATION
On May 29, 2020, the Board of Directors of the Company approved a new equity compensation plan (the “Plan”). The Company’s prior plan was adopted in 2007, was updated in amended and restated plans that were approved by shareholders in 2012 and 2013, and expired in 2017 (the “Prior Plan”).
The Plan is substantially similar to the Prior Plan. The Plan has a 10-year life, and allows for awards to employees, directors and consultants of the Company, as did the Prior Plan. The Plan allows for any type of equity security to be awarded, as did the Prior Plan. The awards and their terms (including vesting) will be determined by the Board and applicable Committees, as was the case under the Prior Plan. The Plan establishes a pool of potential equity compensation equal to twenty percent of the outstanding securities of the Company, which is on an evergreen basis as under the Prior Plan.
On February 25, 2022, the Company amended its existing Plan, which was adopted in 2020 as previously reported. The amendment provides that the possible forms of awards under the Plan include awards paid in cash or awards paid in a combination of cash and equity, in addition to the existing provisions for awards made in any form of equity. The amendment also clarifies that a delegation of authority from the Board to a Committee may be either a general delegation or a delegation for a specific occasion.
ITEM 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Advent BioServices, Ltd.
Advent BioServices, Ltd. (“Advent”) is a related party based in the U.K. and owned by Toucan Holdings, which is controlled by our Chairperson and Chief Executive Officer, Linda F. Powers. Advent was previously the U.K. branch of Cognate until it was spun off from Cognate in 2016 and became independent. Advent provides manufacturing and related services for production of DCVax-L products.
The Company has three operational programs with Advent: (a) an ongoing development and manufacturing program at the GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston GMP facility, and (c) periodic specialized programs such as the program related to the MAA pre-requisites, drafting and submission. The Company has also executed a new SOW #8 covering the work required to establish the DCVax-Direct program in the U.K. and manufacture DCVax-Direct products for global use.
Each of the operational programs is covered by a separate contract. The ongoing manufacturing in the London facility is covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility is covered by an Ancillary Services Agreement entered into on November 18, 2019. Each periodic specialized program is covered by an SOW that sets forth the role and activities to be undertaken by Advent for that program, and provides for milestone payments upon completion of key elements of the program.
The Ancillary Services Agreement establishes a structure under which the Company and Advent negotiate and agree upon the scope and terms for Statements of Work (“SOWs”) for facility development activities and compassionate use program activities, as well as for the periodic specialized programs. After an SOW is agreed and approved by the Company, Advent will proceed with, or continue, the applicable services and will invoice the Company pursuant to the SOW. Since both the facility development and the compassionate use program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus fifteen percent. The SOWs may involve ongoing activities or specialized one-time projects and related one-time milestone payments The Ancillary Services Agreement was to end in July 2023, but the Company extended the term by 12 months to July 2024, and it was further extended for an additional year until July 2025.
SOW 8
On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that was incorporated into the Ancillary Services Agreement. SOW 8 covers the work required to establish the DCVax-Direct program in the U.K and manufacture DCVax-Direct products for global use. Under SOW 8, the compensation consists solely of one-time milestones for each stage of the work and Advent will only receive the compensation when the applicable work is successfully completed. (When the Company previously contracted with a different company for restart of DCVax-Direct manufacturing, the contract required payment as work was
51
performed, regardless of whether the work was successful or not, as is typical for such contract services. The other company did not succeed in producing any DCVax-Direct products meeting the specifications.)
SOW 8 includes 5 one-time milestones with corresponding milestone payments:
(a) Basic Technology Transfer, New SOPs & Regulatory Documents.
Review of documents, specifications and data from prior DCVax-Direct program conducted by Cognate BioServices. Development of a new set of SOPs for DCVax-Direct production in Sawston and new regulatory documents for the UK. Initial implementation in Sawston; many engineering runs. Data generation for comparability analyses of both the process and the product. Milestone payment of £0.55 million (approximately $0.7 million) upon completion.
(b) Process Development: TFF System vs. Other Systems.
Evaluation of the TFF system used in the prior DCVax-Direct manufacturing. Evaluation of the remaining TFF equipment from the prior program, parts needed to re-establish functional TFF systems, potential sourcing and timelines. Evaluation of remaining disposables from the prior program, requirements for new molds to enable new production of disposables (which are used for each manufacturing run with the TFF system), production arrangements for new disposables, development of new sealing method for disposables, potential sourcing and timelines for disposables. Identification and evaluation of commercially available systems to potentially substitute for TFF system. Engineering runs. Data generation for comparability analyses of TFF system vs. others. Milestone payment of £0.45 million (approximately $0.6 million) upon completion.
(c) Process Development: Existing and New Product Composition.
Worldwide search for sourcing of BCG (1 of 2 essential reagents/ingredients required for DCVax-Direct besides the DCs), due to a severe worldwide shortage. Evaluation of the BCG mechanism of action (MoA) in DCVax-Direct, search for other agents that could have similar MoA or effects, with similar safety profile too. Sourcing of other agents, testing and selection of other agents for a new DCVax-Direct product composition. Many engineering runs. Data generation for comparability analyses of new reagents vs BCG and new composition of DCVax-Direct vs prior composition. Milestone payment of £0.60 million (approximately $0.8 million) upon completion.
(d) Technology Transfer: Clean Room Implementation.
After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, process performance qualifications. For technology transfer into the clean rooms, each operator must pass 3 consecutive and successful aseptic process simulations in the clean room and 3 consecutive and successful PQQ runs at scale in the clean room; microbial analysis (sterility, endotoxin, mycoplasma all need to pass); growth promotion tests; validation of all equipment used after being placed in the clean room; validation of all cell analysis assays used via flow cytometry and validation of the fill and finish protocols. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.
(e) New IMPD and New IND.
Draft a new IMPD (Investigational Medicinal Product Dossier) for the revised DCVax-Direct product composition and production process, containing all changes to the manufacturing system, reagents and product composition, processes, sources and/or Mechanism of Action vs those used in the prior DCVax-Direct program. Also draft a new IND (CMC section), for the first clinical trial with the new manufacturing process and new product composition. Obtain the first approval or clearance of the new IND by a regulator. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.
As of December 31, 2024, milestones (a) (b) and (c) as described above were completed.
SOW 6
SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the three licenses required for the Sawston facility, (b) successful completion of each of six one-time workstreams
52
and (c) completion of drafting key portions of an application for product approval (see Note 5 for additional description regarding SOW 6). The milestone incentives were a combination of cash and stock, and were not paid until the milestone was achieved and earned.
During the year ended December 31, 2023, the Company paid an aggregate of $5.0 million in cash, of which $1.0 million was related to two milestones that were completed and fully expensed in 2022, but was unpaid as of December 31, 2022, $4.0 million was payment for four completed one-time milestones (MAA workstream for Mechanism of Action, obtaining a commercial manufacturing license from the MHRA in March 2023 and completion of drafting key portions of the application and submission of the application to MHRA for product approval). The Company issued 4.5 million common shares as a result of completion of the two one-time milestones (obtaining a commercial manufacturing license from the MHRA and completion of drafting the application) at fair value of $3.2 million, of which $0.6 million was recognized during the year ended December 31, 2023 and $2.6 million had already been recognized (but not paid) in 2022.
Related-Party Transaction Approval Policy
The company maintains a written Related-Party Transactions Policy. Under SEC rules, related-party transactions are those transactions to which we are or may be a party in which the amount involved exceeds the lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years, and in which any of our directors or executive officers or any other related person had or will have a direct or indirect material interest, excluding, among other things, compensation arrangements with respect to employment or board membership. Any transactions with any person who is, or at any time since the beginning of the Company’s fiscal year was, a director or executive officer or a nominee to become a director of the Company, any person who is known to be the beneficial owner of more than 5% of any class of the Company’s voting securities, any immediate family member or person sharing the household of any of the foregoing persons, any firm, corporation or other entity in which any of the foregoing persons is a partner or principal, is subject to approval or ratification in accordance with the procedures of the Company’s Related-Party Transaction Policy.
Conflicts Committee
The Conflicts Committee of the Board reviews and approves all related-party matters and transactions for potential conflicts of interests and reasonableness, as described in the Corporate Governance Matters section above. The Conflicts Committee’s one-time review and approval of any series of similar related-party transactions (such as a series of transactions governed by a single contract) suffices to satisfy this policy with respect to each and every transaction in the series.
DIRECTOR INDEPENDENCE
Our Board of Directors has undertaken a review of the independence of our directors and has determined that a majority of the Board consists of members who are currently “independent” as that term is defined within the meaning of Section 5605(a)(2) of the Nasdaq Stock Market Rules. The Board of Directors has determined that Mr. Malik, Mr. Sarma and Ambassador Black are independent. In addition, Jerry Jasinowski, who retired as a director on March 8, 2024, was independent during his service on the Board of Directors.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees Paid to Independent Public Accountants
Cherry Bekaert has served as our independent public accounting firm for the fiscal years ended December 31, 2020 through 2024.
Audit Fees
The aggregate fees billed for the fiscal years ended December 31, 2024 for professional services rendered by Cherry Bekaert for the audit of our annual financial statements for 2024, and the review our financial statements included in our quarterly reports on Form 10-Q for 2024 was $611,000.
The aggregate fees billed for the fiscal years ended December 31, 2023 for professional services rendered by Cherry Bekaert for the audit of our annual financial statements for 2023, an independent audit of the Company’s internal controls for 2023, and the review our financial statements included in our quarterly reports on Form 10-Q for 2023 was $614,000.
53
Audit-Related Fees
There were no fees billed in the fiscal years ended December 31, 2024 and 2023 for assurance and related services rendered by Cherry Bekaert related to the performance of the audit or review of our financial statements.
Tax and Other Non-Audit Professional Services
There were no fees billed in the fiscal years ended December 31, 2024 and 2023 for professional services rendered by Cherry Bekaert for tax related services or other non-audit professional services fees.
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services
Consistent with SEC policies and guidelines regarding audit independence, the Audit Committee is responsible for the pre-approval of all audit and permissible non-audit services provided by our principal accountants on a case-by-case basis. Our Audit Committee has established a policy regarding approval of all audit and permissible non-audit services provided by our principal accountants. Our Audit Committee pre-approves these services by category and service. Our Audit Committee pre-approved all of the services provided by our principal accountants during the fiscal years ended December 31, 2024 and 2023.
54
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The Exhibits listed below are identified by numbers corresponding to the Exhibit Table of Item 601 of Regulation S-K. The Exhibits designated by an asterisk (*) are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15.
EXHIBIT INDEX
Exhibit Number |
| Description |
3.1 |
| |
3.2 |
| |
3.3 |
| |
3.5 |
| |
3.6 |
| |
3.61 | ||
3.7 |
| |
3.8 |
| |
3.9 |
| |
3.91 | ||
3.92 | ||
4.1 |
| |
4.2 |
| |
4.3 |
| |
10.1 |
| |
10.2 |
| |
10.3 |
| Contract Relating to Sale of Spicers, Sawston, Cambridge, dated as of December 5, 2018, by and between Aracaris Capital Limited and Huawei Technologies Research & Development (UK) Limited. |
10.4 |
| |
10.5 | Equity Compensation Plan, dated May 29, 2020 and as amended on February 25, 2022. | |
10.6 | ||
10.7 |
55
10.8 | ||
10.9 |
| |
10.10 |
| |
10.11 |
| |
19.1 |
| |
21.1 | ||
23.1 | ||
31.1 | ||
32.1 | ||
101.INS | Inline XBRL Instance Document. | |
101.SCH |
| Inline XBRL Schema Document. |
101.CAL |
| Inline XBRL Calculation Linkbase Document. |
101.DEF |
| Inline XBRL Definition Linkbase Document. |
101.LAB |
| Inline XBRL Label Linkbase Document. |
101.PRE |
| Inline XBRL Presentation Linkbase Document. |
104 | Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit) |
ITEM 16.FORM 10–K SUMMARY
None.
56
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
NORTHWEST BIOTHERAPEUTICS, INC. (Registrant) | ||
Date: March 31, 2025 | By: | /s/ Linda F. Powers |
Linda F. Powers, | ||
President and Chief Executive Officer Principal Executive Officer Principal Financial and Accounting Officer | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Signature |
| Title |
| Date |
/s/ Linda F. Powers | President and Chief Executive Officer | March 31, 2025 | ||
Linda F. Powers | Principal Executive Officer | |||
Principal Financial and Accounting Officer | ||||
/s/ Alton L. Boynton | Director | March 31, 2025 | ||
Alton L. Boynton | ||||
/s/ Navid Malik | Director | March 31, 2025 | ||
Dr. Navid Malik | ||||
/s/ Pat Sarma | Director | March 31, 2025 | ||
Pat Sarma | ||||
/s/ J. Cofer Black | Director | March 31, 2025 | ||
J. Cofer Black |
57
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
NORTHWEST BIOTHERAPEUTICS, INC.
INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Northwest Biotherapeutics, Inc.
Bethesda, Maryland
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Northwest Biotherapeutics, Inc. and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive loss, stockholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the consolidated results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s evaluations of the events and conditions and management’s plans regarding those matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
F-2
Critical Audit Matter Description
As disclosed in Notes 4, 5, 7, 10, and 11 to the consolidated financial statements, the Company had various debt, derivative, mezzanine equity and equity transactions, including both related party and non-related party stock-based compensation and convertible notes elected to be carried at fair value, where management evaluated required accounting considerations, significant estimates, and judgements around certain features, the possibility of conversion or redemption, and the valuation of certain components of the financings, including the valuation around certain freestanding and embedded derivatives. Certain features were initially measured at fair value and have been subsequently remeasured to fair value at each reporting period.
There is no current observable market for these types of features and, as such, the Company determined the fair value of the freestanding instruments or embedded derivatives using the Black-Scholes-Merton model, Lattice-based models or the Monte Carlo option pricing model, as applicable, to measure the fair value of the debt and/or equity instrument both with and without the derivative liability features. As a result, a high degree of auditor judgment and effort was required in performing audit procedures to evaluate the various components of these instruments.
How the Critical Audit Matter was Addressed in the Audit
Our principal audit procedures performed to address this critical audit matter included the following:
| ● | We obtained and understanding of the internal controls and processes in place related to the debt, derivative liabilities, mezzanine equity and equity transactions, including both related party and non-related party stock-based compensation and convertible notes elected to be carried at fair value. |
| ● | We obtained a listing of all debt, derivative liabilities, mezzanine equity and equity transactions, including both related party and non-related party stock-based compensation and convertible notes elected to be carried at fair value, and management’s accounting analysis supporting these transactions. We evaluated the conclusions reached to ensure these were recorded in accordance with the relevant accounting guidance. |
| ● | We identified and evaluated the accounting considerations in determining the nature of the various features and weighting of evidence, the potential bifurcation of these instruments, and considerations related to the determination of the fair value of the various debt and equity instruments and the conversion and redemption features that include valuation models and assumptions utilized by management. We reviewed the fair value models used, significant assumptions, and underlying data used in the models and evaluated whether the estimates and assumptions were consistent with audit evidence obtained. |
| ● | We evaluated the disclosures surrounding debt, derivative liabilities, mezzanine equity and equity transactions, including both related party and non-related party stock-based compensation and convertible notes elected to be carried at fair value, to ensure these were disclosed in accordance with the relevant accounting guidance. |
/s/
We have served as the Company’s auditor since 2021.
March 31, 2025
F-3
NORTHWEST BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| December 31, |
| December 31, | |||
2024 | 2023 | |||||
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses and other current assets |
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Total current assets |
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Non-current assets: |
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Property, plant and equipment, net |
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Right-of-use asset, net | | | ||||
Indefinite-lived intangible asset | | | ||||
Goodwill | | | ||||
Other assets |
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Total non-current assets |
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TOTAL ASSETS | $ | | $ | | ||
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LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable and accrued expenses | $ | | $ | | ||
Accounts payable and accrued expenses to related parties and affiliates |
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Convertible notes, net |
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Convertible notes at fair value |
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Notes payable, net |
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Contingent payable derivative liability | | | ||||
Warrant liability |
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Investor advances | | | ||||
Share payable | | | ||||
Lease liabilities | | | ||||
Total current liabilities |
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Non-current liabilities: |
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Convertible notes at fair value, net of current portion | | — | ||||
Notes payable, net of current portion, net |
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Lease liabilities, net of current portion | | | ||||
Contingent payment obligation | | | ||||
Total non-current liabilities |
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Total liabilities |
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COMMITMENTS AND CONTINGENCIES (Note 12) |
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Mezzanine equity: | ||||||
Series C Convertible Preferred Stock, | | | ||||
Stockholders’ deficit: |
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Preferred stock ($ | ||||||
Common stock ($ |
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Additional paid-in capital |
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Stock subscription receivable |
| ( |
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Accumulated deficit |
| ( |
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Accumulated other comprehensive income |
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Total stockholders’ deficit |
| ( |
| ( | ||
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ DEFICIT | $ | | $ | | ||
See accompanying notes to the consolidated financial statements
F-4
NORTHWEST BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
For the year ended | ||||||
December 31, | ||||||
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| 2024 |
| 2023 | ||
Revenues: |
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$ | | $ | | |||
Total revenues | |
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Operating costs and expenses: |
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Research and development | |
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General and administrative | |
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Total operating costs and expenses | |
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Loss from operations | ( |
| ( | |||
Other income (expense): |
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Change in fair value of derivative liabilities | |
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Change in fair value of share payable | | ( | ||||
Change in fair value of convertible notes | | ( | ||||
Loss from extinguishment of debt | ( |
| ( | |||
Loss from issuance of debt | ( | — | ||||
Loss from warrant modifications | ( | — | ||||
Interest expense | ( |
| ( | |||
Foreign currency transaction gain (loss) | ( |
| | |||
Total other expense | ( |
| ( | |||
Net loss | ( | ( | ||||
Deemed dividend related to warrant modifications | ( | ( | ||||
Net loss attributable to common stockholders | $ | ( | $ | ( | ||
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Other comprehensive income (loss) |
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Foreign currency translation adjustment | |
| ( | |||
Total comprehensive loss | $ | ( | $ | ( | ||
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Net loss per share applicable to common stockholders |
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Basic and diluted | $ | ( | $ | ( | ||
Weighted average shares used in computing basic and diluted loss per share | | | ||||
See accompanying notes to the consolidated financial statements
F-5
NORTHWEST BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
(in thousands)
Mezzanine equity | Accumulated | |||||||||||||||||||||||||
Series C Convertible | Additional | Other | Total | |||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Subscription | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
| Shares |
| Amount |
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| Shares |
| Par value |
| Capital |
| Receivable | Deficit |
| Income (Loss) |
| Deficit | |||||||||
Balances at January 1, 2023 |
| | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | $ | ( | |||||||||
Issuance of Series C convertible preferred stock for cash | | | — | — | - | — | — | — | — | |||||||||||||||||
Issuance of Series C convertible preferred stock in lieu of debt redemption | | | — | — | - | — | — | — | — | |||||||||||||||||
Series C convertible preferred stock conversion | ( | ( | | | | — | — | — | | |||||||||||||||||
Warrants and stock options exercised for cash | — | — | | | | — | — | — | | |||||||||||||||||
Cashless warrants and stock options exercise | — | — | | | ( | — | — | — | — | |||||||||||||||||
Reclassification of warrant liabilities to stockholders' deficit | — | — | — | — | | — | — | — | | |||||||||||||||||
Issuance of common stock for conversion of debt and accrued interest | — | — | | | | — | — | — | | |||||||||||||||||
Stock-based compensation | | | | | | — | — | — | | |||||||||||||||||
Reclass earned but unissued milestone shares from equity to liability | — | — | — | — | ( | — | — | — | ( | |||||||||||||||||
Net loss | — | — | — | — | - | — | ( | — | ( | |||||||||||||||||
Warrant modifications | — | — | — | — | | — | — | — | | |||||||||||||||||
Deemed dividend related to warrant modifications | — | — | — | — | ( | — | — | — | ( | |||||||||||||||||
Cumulative translation adjustment | | | | | | | | ( | ( | |||||||||||||||||
Balances at December 31, 2023 | | | | | | ( | ( | | ( | |||||||||||||||||
Issuance of Series C convertible preferred stock for cash | | | — | — | - | — | — | — | — | |||||||||||||||||
Series C convertible preferred stock conversion | ( | ( | | | | — | — | — | | |||||||||||||||||
Issuance of common stock for cash, net | — | — | | | | — | — | — | | |||||||||||||||||
Warrant exercised for cash | — | — | | | | — | — | — | | |||||||||||||||||
Cashless warrants and stock options exercise | — | — | | | ( | — | — | — | — | |||||||||||||||||
Issuance of common stock for conversion of debt and accrued interest | — | — | | | | — | — | — | | |||||||||||||||||
Issuance of Series C preferred stock for conversion of debt and accrued interest | | | — | — | - | — | — | — | — | |||||||||||||||||
Stock-based compensation | — | — | | — | | — | — | — | | |||||||||||||||||
Issuance of common stock as commitment fee | — | — | | | | — | — | — | | |||||||||||||||||
Net loss | — | — | — | — | - | — | ( | — | ( | |||||||||||||||||
Warrant modifications | — | — | — | — | | — | — | — | | |||||||||||||||||
Deemed dividend related to warrants modifications | — | — | — | — | ( | — | — | — | ( | |||||||||||||||||
Reclassification of equity classified warrants to liabilities | — | — | — | — | ( | — | — | — | ( | |||||||||||||||||
Cumulative translation adjustment | — | — | — | — | - | — | — | | | |||||||||||||||||
Balances at December 31, 2024 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | $ | ( | ||||||||||
See accompanying notes to the consolidated financial statements
F-6
NORTHWEST BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For the years ended | ||||||
December 31, | ||||||
| 2024 |
| 2023 | |||
Cash Flows from Operating Activities: |
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Net loss | $ | ( | $ | ( | ||
Reconciliation of net loss to net cash used in operating activities: |
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Depreciation and amortization | |
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Amortization of debt discount | |
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Change in fair value of derivatives | ( |
| ( | |||
Change in fair value of share payable | ( |
| | |||
Change in fair value of convertible notes | ( | | ||||
Loss from extinguishment of debt | |
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Loss from issuance of debt | | — | ||||
Amortization of operating lease right-of-use asset | |
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Stock-based compensation for services | |
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Warrant modifications associated with convertible notes under fair value option | | | ||||
Loss from warrant modifications | | — | ||||
Non-cash financing cost | | — | ||||
Subtotal of non-cash charges | |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets | |
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Other non-current assets | ( |
| ( | |||
Accounts payable and accrued expenses | |
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Related party accounts payable and accrued expenses | |
| ( | |||
Lease liabilities | | | ||||
Net cash used in operating activities | ( |
| ( | |||
Cash Flows from Investing Activities: |
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Purchase of equipment and construction in progress | ( |
| ( | |||
Net cash used in investing activities | ( |
| ( | |||
Cash Flows from Financing Activities: |
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Proceeds from issuance of Series C convertible preferred stock | |
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Proceeds from issuance of common shares | |
| — | |||
Proceeds from exercise of warrants | | | ||||
Proceeds from investor advance | |
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Proceeds from issuance of notes payable, net | | | ||||
Proceeds from issuance of convertible notes payable, net | |
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Proceeds from contingent payment obligation | |
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Repayment of notes payable | ( |
| ( | |||
Repayment of convertible notes payable | ( |
| — | |||
Repayment of investor advances | — | ( | ||||
Net cash provided by financing activities | |
| | |||
Effect of exchange rate changes on cash and cash equivalents | |
| ( | |||
Net increase (decrease) in cash and cash equivalents | |
| ( | |||
| ||||||
Cash and cash equivalents, beginning of the year | |
| | |||
Cash and cash equivalents, end of the year | $ | | $ | | ||
Supplemental disclosure of cash flow information |
| |||||
Interest payments on notes payable | $ | ( | $ | ( | ||
See accompanying notes to the consolidated financial statements
F-7
NORTHWEST BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For the years ended | ||||||
December 31, | ||||||
| 2024 |
| 2023 | |||
Supplemental schedule of non-cash activities: |
| |||||
Cashless warrants and stock options exercise | $ | | $ | | ||
Reclassification of warrant liabilities to stockholders' deficit | $ | — | $ | | ||
Reclassification of equity classified warrants to warrant liabilities | $ | | $ | — | ||
Issuance of common stock for conversion of debt and accrued interest | $ | | $ | | ||
Issuance of Series C preferred stock for conversion of debt and accrued interest | $ | | $ | — | ||
Series C convertible preferred stock conversions | $ | | $ | | ||
Capital expenditures included in accounts payable | $ | | $ | | ||
Issuance of Series C convertible preferred stock in lieu of debt redemption | $ | — | $ | | ||
Deemed dividend related to warrant modifications | $ | | $ | | ||
Debt discount related to warrant modifications | $ | | $ | | ||
Offering cost related to warrant modification associated with a security purchase agreement | $ | | $ | — | ||
Reclassification between contingent payment obligation and convertible notes payable at fair value | $ | | $ | — | ||
Reclassification of investor advances to convertible notes payable | $ | — | $ | | ||
Reclassification of investor advances to stockholders' deficit | $ | — | $ | | ||
Reclass earned but unissued milestone shares from equity to liability | $ | — | $ | | ||
Right-of-use asset recognized in exchange for lease liability | $ | $ | — | |||
See accompanying notes to the consolidated financial statements
F-8
1. Organization and Description of Business
Northwest Biotherapeutics, Inc. and its wholly owned subsidiaries Flaskworks, Northwest Biotherapeutics Limited (formerly known as Aracaris Ltd), Northwest Biotherapeutics Capital Limited (formerly known as Aracaris Capital Limited), Northwest Biotherapeutics B.V., and NW Bio GmbH (collectively, the “Company”, “we”, “us” and “our”) were organized to discover and develop innovative immunotherapies for cancer. The Company has developed DCVax® platform technologies for both operable and inoperable solid tumor cancers. The Company has wholly owned subsidiaries in Boston, the U.K., the Netherlands and Germany. On August 28, 2020, the Company acquired Flaskworks, LLC (“Flaskworks”), a company that has developed a system designed to close and automate the manufacturing of cell therapy products such as DCVax®.
The Company relies upon contract manufacturers for production of its DCVax products, research and development services, distribution and logistics, and related services, in compliance with the Company’s specifications and the applicable regulatory requirements.
The Company has completed a Phase 3 clinical trial of its DCVax®-L product for glioblastoma brain cancer, has publicly reported the results in a peer reviewed publication in a medical journal as well as at a medical conference, and submitted a Marketing Authorization Application (MAA) for regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. in December 2023. The MAA is in the process of undergoing MHRA review.
2. Financial Condition, Going Concern and Management Plans
The Company has incurred annual net operating losses since its inception. The Company had a net loss of $
The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all.
Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date of this filing. The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
3. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements of the Company were prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and include the assets, liabilities, revenues and expenses of the wholly owned subsidiaries in Germany, United Kingdom and Netherlands. All intercompany transactions and accounts have been eliminated in consolidation.
Consolidation
The Company’s policy is to consolidate all entities in which it can vote a majority of the outstanding voting stock. In addition, the Company consolidates entities that meet the definition of a variable interest entity (“VIE”) for which the Company is the primary beneficiary, if any. The primary beneficiary is the party who has the power to direct the activities of a VIE that most significantly impact the entity’s economic performance and who has an obligation to absorb losses of the entity or a right to receive benefits from the entity that could potentially be significant to the VIE.
F-9
As of December 31, 2024 and 2023, the Company did not consolidate any VIE’s as the Company has concluded that it is not the primary beneficiary.
Use of Estimates
In preparing consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.
On an ongoing basis, the Company evaluates its estimates and judgments, including valuing equity securities in share-based payment arrangements, estimating the fair value of financial instruments recorded as derivative liabilities, useful lives of depreciable assets and whether impairment charges may apply. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash accounts in a financial institution, which at times may exceed the Federal depository insurance coverage (“FDIC”) of $
Property, Plant and Equipment
Property and equipment are stated at cost. Depreciation and amortization are provided for using straight-line methods, in amounts sufficient to charge the cost of depreciable assets to operations over their estimated service lives. Repairs and maintenance costs are charged to operations as incurred.
Costs for capital assets not yet placed into service are capitalized as construction in progress on the consolidated balance sheets and will be depreciated once placed into service.
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 undiscounted net future 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.
Goodwill and Intangible Assets
Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. The Company’s intangible asset with an indefinite life is related to in-process research and development (“IPR&D”) programs acquired in the Flaskworks Acquisition, as the Company expects future research and development on these programs to provide the Company with substantial benefit for a period that extends beyond the foreseeable horizon. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite lived and would then be amortized based on their respective estimated useful lives at that point in time.
The Company has
F-10
annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values.
Fair Value of Financial Instruments
ASC 820, Fair Value Measurements, provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
The Company accounts for the issuance of common stock purchase warrants issued in connection with the equity offerings in accordance with the provisions of ASC 815, Derivatives and Hedging (“ASC 815”). The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company accounts for certain common stock warrants outstanding as a liability at fair value and adjusts the instruments to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in its Consolidated Statements of Operations and Comprehensive Loss. The fair value of the warrants issued by the Company has been estimated using Monte Carlo simulation and or a Black Scholes model. The warrant liabilities are valued using Level 3 valuation inputs (see Note 4).
Derivative Financial Instruments
The Company has derivative financial instruments that are not hedges and do not qualify for hedge accounting. Changes in the fair value of these instruments are recorded in other income (expense), on a net basis in the Consolidated Statements of Operations and Comprehensive Loss.
The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. As a result of entering into a convertible debt instrument (see Note 7) for which such instrument contained a variable conversion feature with no floor price, the Company’s sequencing policy is described below in Note 3 whereby all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors.
Convertible Notes under Fair Value Option
The Company accounts for certain convertible notes 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.
F-11
Contingent Payable Derivative Liability
During the year ended December 31, 2019, the Company entered into a settlement agreement with Cognate BioServices, resolving past matters and providing for the restart of DCVax®-Direct Production.
As part of this overall settlement, the Company also provided a contingent note payable (the “Contingent Payable Derivative”) of $
On a quarterly basis, management makes estimates for key performance milestones and uses the expected dates as the inputs for valuation. The fair value of the Contingent Payable Derivative has been estimated using Monte Carlo simulation, which are valued using Level 3 valuation inputs.
Leases
The Company recognizes a lease asset for its right to use the underlying asset and a lease liability for the corresponding lease obligation. The Company determines whether an arrangement is or contains a lease at contract inception. Operating leases with a duration greater than one year are included in right-of-use assets, lease liabilities, and lease liabilities, net of current portion in the Company’s consolidated balance sheets. Right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. The incremental borrowing rate represents the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease. The Company considers a lease term to be the non-cancelable period that it has the right to use the underlying asset.
The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. Lease expense is recognized on a straight-line basis over the expected lease term. Variable lease expenses are recorded when incurred.
Foreign Currency Translation and Transactions
The Company has operations in the United Kingdom, Netherlands in addition to the U.S. The Company translated its foreign subsidiaries’ assets and liabilities, including the German subsidiary which the Company previously had operations, into U.S. dollars using end of period exchange rates, and revenues and expenses are translated into U.S. dollars using weighted average rates. Foreign currency translation adjustments are reported as a separate component of accumulated other comprehensive income (loss) within stockholders’ equity deficit.
The Company converts intercompany receivables and payables denominated in other than the Company’s functional currency at the exchange rate as of the balance sheet date. The resulting transaction exchange gains or losses related to intercompany receivable and payables, are included in other income and expense.
Comprehensive Loss
The Company reports comprehensive loss and its components in its consolidated financial statements. Comprehensive loss consists of net loss and foreign currency translation adjustments, affecting stockholders’ equity deficit that, under U.S, GAAP, is excluded from net loss.
Revenue Recognition
The Company recognizes revenue in accordance with the terms stipulated under the applicable service contract. In various situations, the Company receives certain credits against invoices for manufacturing of patient treatments by its contract manufacturer. These payments are assessed and recognized in accordance with ASC 606 in the period when the performance obligation has been met.
F-12
Accrued Outsourcing Costs
Substantial portions of the Company’s preclinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors (collectively “CROs”). These CROs generally bill monthly or quarterly for services performed, or bill based upon milestones achieved. For clinical studies, expenses are accrued when services are performed. The Company monitors patient enrollment, the progress of clinical studies and related activities through internal reviews of data that is tracked by the CROs under contractual arrangements, correspondence with the CROs and visits to clinical sites.
Research and Development Costs
Research and development costs are charged to operations as incurred and consist primarily of clinical trial related costs (including costs for collection, validation and analysis of trial results), related party manufacturing costs, consulting costs, contract research and development costs, clinical site costs and compensation costs, and costs related to regulatory filings such as the Marketing Authorization Application filed in the UK.
Income Taxes
The Company evaluates its tax positions and estimates its current tax exposure along with assessing temporary differences that result from different book to tax treatment of items not currently deductible for tax purposes. These differences result in deferred tax assets and liabilities on the Company’s Consolidated Balance Sheets, which are estimated based upon the difference between the financial statement and tax bases of assets and liabilities using the enacted tax rates that will be in effect when these differences reverse. In general, deferred tax assets represent future tax benefits to be received when certain expenses previously recognized in the Company’s Consolidated Statements of Comprehensive Loss become deductible expenses under applicable income tax laws or loss or credit carryforwards are utilized. Accordingly, realization of the Company’s deferred tax assets is dependent on future taxable income against which these deductions, losses and credits can be utilized.
The Company must assess the likelihood that the Company’s deferred tax assets will be recovered from future taxable income, and to the extent the Company believes that recovery is not more likely than not, the Company must establish a valuation allowance. Management judgment is required in determining the Company’s provision for income taxes, the Company’s deferred tax assets and liabilities and any valuation allowance recorded against the Company’s net deferred tax assets. Excluding foreign operations, the Company recorded a full valuation allowance at each balance sheet date presented because, based on the available evidence, the Company believes it is more likely than not that it will not be able to utilize all of its deferred tax assets in the future. The Company intends to maintain the full valuation allowance until sufficient evidence exists to support the reversal of the valuation allowance.
Stock-Based Compensation
The Company measures stock-based compensation to employees, consultants, and Board members at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the requisite service period of the award. For awards that have a performance condition, compensation cost is measured based on the fair value of the award on the grant date, the date performance targets are established, and is expensed over the requisite service period for each separately vesting tranche when achievement of the performance condition becomes probable. The Company assess the probability of the performance conditions being met on a continuous basis. Forfeitures are recognized when they occur.
The Company estimates the fair value of stock option grants that do not contain market-based vesting conditions using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Expected Term - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the simplified method, which is the half-life from vesting to the end of its contractual term.
Expected Volatility - The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
F-13
Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield available on U. S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The Company is also required to make estimates as to the probability of achieving the specific performance conditions. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s consolidated results of operations.
Debt Extinguishment
The Company accounts for the income or loss from extinguishment of debt by comparing the difference between the reacquisition price and the net carrying amount of the debt being extinguished and recognizes this as gain or loss when the debt is extinguished. The gain or loss from debt extinguishment is recorded in the consolidated statements of operations under “other income (expense)” as loss from extinguishment of convertible debt.
Sequencing
The Company adopted a sequencing policy whereby in the event that reclassification of contracts from equity to liabilities is necessary due to 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 the variable conversion feature with no floor, or the company committing more shares than authorized. 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 related to compensation to the Company’s employees, nonemployees or directors are not subject to the sequencing policy.
Modification of Equity Classified Warrants
A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.
Loss per Share
Basic loss per share is computed on the basis of the weighted average number of shares outstanding for the reporting period. Diluted loss per share is computed on the basis of the weighted average number of common shares plus dilutive potential common shares outstanding using the treasury stock method. Diluted weighted average shares reflect the dilutive effect, if any, of potential common shares. To the extent their effect is dilutive, employee equity awards and other commitments to be settled in common stock are included in the calculation of diluted income per share based on the treasury stock method. Potential common shares are excluded from the calculation of dilutive weighted average shares outstanding if their effect would be anti-dilutive at the balance sheet date based on a treasury stock method or due to a net loss.
Segment Information
The Company operates in one operating segment for the purposes of assessing performance, making operating decisions, and allocating Company resources. The Company’s chief operating decision maker (CODM) is its chief executive officer, who considers net loss to evaluate overall expenses associated with conducting research and development activities, which includes evaluating the progress of ongoing clinical trials and the planning and execution of current and future research and development activities. Further, the CODM
F-14
reviews and utilizes functional expenses (research and development and general and administrative) as reported in the consolidated statements of operations to manage the Company’s operations. The measure of performance, significant expenses, and other items are each reflected in the consolidated statements of operations. The accounting policies of the Company’s single reportable segment are the same as those for the consolidated financial statements. The level of disaggregation and amounts of significant segment expenses that are regularly provided to the CODM are the same as those presented in the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total assets.
Recently Adopted Accounting Standards
Improvements to Reportable Segment Disclosures
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, “Improvements to Reportable Segment Disclosures (Topic 280)” which is intended to improve reportable segment disclosure requirements, primarily through incremental disclosures of segment information on an annual and interim basis for all public entities. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. The ASU is to be applied retrospectively to all prior periods presented in the financial statements and is effective for our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and interim periods thereafter. The Company adopted this guidance with no material impact on its consolidated financial statements, and our expanded disclosures are included below under “Segment Information.”
Recently Issued Accounting Standards Not Yet Adopted
Improvements to Income Tax Disclosures
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.
F-15
4. Fair Value Measurements
In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the fair value of liabilities related to certain embedded conversion feature associated with its warrant liability, convertible debt, share payable, and contingent payable to Cognate BioServices on a recurring basis to determine the fair value of these liabilities. The Company has also elected the FVO for certain financial instruments, such as convertible notes.
The following table classifies the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy as of December 31, 2024 and December 31, 2023 (in thousands):
Fair value measured at December 31, 2024 | ||||||||||||
|
| Quoted prices in active |
| Significant other |
| Significant | ||||||
Fair value at | markets | observable inputs | unobservable inputs | |||||||||
December 31, 2024 | (Level 1) | (Level 2) | (Level 3) | |||||||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Contingent payable derivative liability | | — | — | | ||||||||
Convertible notes at fair value | | — | — | | ||||||||
Share payable |
| |
| — |
| — |
| | ||||
Total fair value | $ | | $ | — | $ | — | $ | | ||||
Fair value measured at December 31, 2023 | ||||||||||||
|
| Quoted prices in active |
| Significant other |
| Significant | ||||||
Fair value at | markets | observable inputs | unobservable inputs | |||||||||
December 31, 2023 | (Level 1) | (Level 2) | (Level 3) | |||||||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Contingent payable derivative liability |
| |
| — |
| — |
| | ||||
Convertible notes at fair value |
| |
| — |
| — |
| | ||||
Share payable | | — | — | | ||||||||
Total fair value | $ | | $ | — | $ | — | $ | | ||||
There were
F-16
The following table presents changes in Level 3 liabilities measured at fair value for the years ended December 31, 2024 and 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs (in thousands).
Convertible | ||||||||||||||||||
Warrant | Embedded | Contingent Payable | Share | Notes At | ||||||||||||||
| Liability |
| Redemption Option |
| Derivative Liability |
| Payable |
| Fair Value |
| Total | |||||||
Balance - January 1, 2023 | $ | | $ | | $ | | $ | | $ | — | $ | | ||||||
Additional share payable | — | — | — | | — | | ||||||||||||
Issuance of convertible notes at fair value | — | — | — | — | | | ||||||||||||
Redemption of share payable | — | — | — | ( | — | ( | ||||||||||||
Reclassification of warrant liabilities | ( | — | — | — | — | ( | ||||||||||||
( | ( | | | | ( | |||||||||||||
Balance – December 31, 2023 | | — | | | | | ||||||||||||
Additional share payable | — | — | — | | — | | ||||||||||||
Additional warrant liabilities as a result of reclassification | | — | — | — | — | | ||||||||||||
Issuance of convertible notes at fair value | — | — | — | — | | | ||||||||||||
Redemption of share payable | — | — | — | ( | — | ( | ||||||||||||
Additions from debt extinguishment | — | — | — | — | | | ||||||||||||
Debt repayment | — | — | — | — | ( | ( | ||||||||||||
( | — | | ( | ( | ( | |||||||||||||
Balance - December 31, 2024 | $ | | $ | — | $ | | $ | | $ | | $ | | ||||||
A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Company’s warrant liabilities, share payable, and contingent conversion feature (excluding the piggy-back right, which was based on key milestone estimates, see Note 7 for piggy-back rights) that are categorized within Level 3 of the fair value hierarchy as of December 31, 2024 and December 31, 2023 is as follows. The contingent conversion option of the contingent payable expired during the year ended December 31, 2024. The liability relates to the remaining redemption feature which, like the convertible notes at fair value, includes discount factors that are unobservable inputs and proprietary in nature.
As of December 31, 2024 | |||||||
| Share |
| Warrant |
| |||
Payable | Liability | ||||||
Strike price | $ | | $ | | |||
Contractual term (years) |
| | | ||||
Volatility (annual) |
| | % | | % | ||
Risk-free rate |
| | % | | % | ||
Dividend yield (per share) |
| | % | | % | ||
| As of December 31, 2023 | ||||||
Share | Contingent Payable | ||||||
Payable |
| Derivative Liability |
| ||||
Strike price | $ | | $ | | * | ||
Contractual term (years) |
| |
| | |||
Volatility (annual) |
| | % |
| | % | |
Risk-free rate |
| | % |
| | % | |
Dividend yield (per share) |
| | % |
| | % | |
* The strike price assumes the current stock price as of December 31, 2023.
F-17
5. Stock-Based Compensation
The following table summarizes total stock-based compensation expense recognized for the years ended December 31, 2024 and 2023 (in thousands).
| For the years ended | |||||
December 31, | ||||||
| 2024 |
| 2023 | |||
Research and development | $ | | $ | | ||
Research and development - related party |
|
| ||||
Milestones achieved (1) | — | | ||||
General and administrative (2) | |
| | |||
Total stock-based compensation expense | $ | | $ | | ||
| (1) | The related party amounts were for milestone incentives that were earned (as detailed below in Restricted Stock Awards). |
| (2) | The general and administrative expense during the years ended December 31, 2024 and 2023 is related to the applicable vesting portion of stock options awards and restricted shares to employees and consultants. |
The total unrecognized compensation cost was approximately $
Stock Options
Equity Compensation Plan
On May 29, 2020, the Board of Directors of the Company approved a new equity compensation plan (the “Plan”). The Company’s prior plan was adopted in 2007, was updated in amended and restated plans that were approved by shareholders in 2012 and 2013 and expired in 2017 (the “Prior Plan”).
The Plan is substantially similar to the Prior Plan. The Plan has a 10-year life, and allows for awards to employees, directors and consultants of the Company. The Plan allows for any type of equity security to be awarded, as did the Prior Plan. The awards and their terms (including vesting) will be determined by the Board and applicable Committees, as was the case under the Prior Plan. The Plan established a pool of potential equity compensation equal to twenty percent of the outstanding securities of the Company, which is on an evergreen basis as under the Prior Plan.
On February 25, 2022, the Company amended its existing Equity Compensation Plan, which was adopted in 2020 as previously reported. The amendment provides that the possible forms of awards under the Plan include awards paid in cash or awards paid in a combination of cash and equity, in addition to the existing provisions for awards made in any form of equity. The amendment also clarifies that a delegation of authority from the Board to a Committee may be either a general delegation or a delegation for a specific occasion.
F-18
The following table summarizes stock option activity for the Company’s option plans during the years ended December 31, 2024 and 2023 (in thousands, except per share amounts):
|
|
| Weighted |
| ||||||
Weighted | Average | |||||||||
Average | Remaining | Total | ||||||||
Number of | Exercise | Contractual | Intrinsic | |||||||
Shares | Price | Life (in years) | Value | |||||||
Outstanding as of January 1, 2023 |
| | $ | |
| $ | | |||
Granted (1) | | | — | |||||||
Cash exercised | ( | | — | — | ||||||
Cashless exercised | ( | | — | — | ||||||
Expired | ( | | — | — | ||||||
Outstanding as of December 31, 2023 |
| |
| |
| | ||||
Granted (2) |
| |
| |
|
| — | |||
Cashless exercised |
| ( | |
| — | — | ||||
Expired | ( | | — | — | ||||||
Outstanding as of December 31, 2024 | | $ | | | ||||||
Options vested (3) |
| | $ | |
| $ | | |||
| (1) | During the year ended December 31, 2023, the Company granted |
| (2) | During the year ended December 31, 2024, the Company granted |
| (3) | Of the total |
During the year ended December 31, 2023, the Company reversed approximately $
The Black-Scholes option pricing model is used to estimate the fair value of stock options granted. The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2024 and 2023:
| For the years ended | ||||||
December 31, | |||||||
| 2024 |
| 2023 |
| |||
Exercise price | $ | | $ | | |||
Expected term (years) |
| ||||||
Expected stock price volatility | | % |
| | % | ||
Risk-free rate | | % | | % | |||
Dividend yield (per share) | | % |
| | % | ||
Restricted Stock Awards
Advent SOW 6
As previously reported, during April 2022, the Company’s Board approved, and the Company entered into a Statement of Work #6 (the “SOW 6”) with Advent BioServices, a related party of the Company, which was originally for
F-19
portions of the application for approval. The SOW provides for baseline costs and for one-time milestone incentives for successful completion of each of the workstreams, for the completion and submission of each application for product approval, and for obtaining regulatory approval of each of the three Sawston licenses. The milestone incentives will be a combination of cash and stock and are not paid until they are achieved. As also previously reported, the Company amended the SOW 6 on September 26, 2022 (the “Amended SOW 6”) to (1) extend the service period through September 30, 2023, and (2) clarify the assessment and application of the milestones, and (3) add a sixth workstream. (The potential cost for all unearned stock awards for milestones not yet achieved was re-measured on the modification date and was further re-measured until the respective dates the milestone awards were achieved and the stock awards were earned.)
On September 26, 2023, the Company further amended the SOW 6 (the “Second Amended SOW 6”) to extend the service period through March 31, 2024. On April 1, 2024, the Second Amended SOW 6 was further extended through September 30, 2024 (the “Third Amended SOW 6”) and again on October 1, 2024, the third Amended SOW 6 was extended to June 30, 2025. As of the amendment date, the remaining unvested one-time milestone for submission of the application to MHRA for approval of DCVax-L was accounted as a Type I modification (probable to probable under FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). The previously remaining unrecognized compensation expense for total $
During the year ended December 31, 2023, the remaining milestones were all completed, including those related to the workstream for Mechanism of Action, obtaining the commercial manufacturing license from the MHRA, completion of key portions of the application and submission of application for product approval to MHRA.
There was
Staff Employee Compensation
In August 2023, the Company issued
Other Service Agreements
During year ended December 31, 2024, the Company issued
During year ended December 31, 2023, the Company issued
F-20
6. Property, Plant and Equipment
Property, plant and equipment consist of the following at December 31, 2024 and 2023 (in thousands):
| December 31, |
| December 31, |
| Estimated | |||
2024 | 2023 | Useful Life | ||||||
Leasehold improvements | $ | | $ | |
| |||
Office furniture and equipment |
| |
| |
| |||
Computer and manufacturing equipment and software |
| |
| |
| |||
Land in the United Kingdom | | | NA | |||||
|
| |
| | NA | |||
Less: accumulated depreciation |
| ( |
| ( |
|
| ||
Total property, plant and equipment, net | $ | | $ | |
|
| ||
Depreciation expense was approximately $
7. Outstanding Debt
2024 Activities
The following tables summarize outstanding debt as of December 31, 2024 (in thousands):
|
| Stated |
|
|
|
| Fair |
| |||||||||||||
Interest | Conversion | Remaining | Value | Carrying | |||||||||||||||||
Maturity Date | Rate | Price | Face Value | Debt Discount | Adjustment | Value | |||||||||||||||
Short term convertible notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
6% unsecured |
|
| | % | $ | | $ | | $ | — | $ | — | $ | | |||||||
8% unsecured |
|
| | % | $ | | * | | ( | — | | ||||||||||
| |
| ( |
|
| — | | ||||||||||||||
Short term convertible notes at fair value |
|
|
|
|
|
|
|
|
|
| |||||||||||
8% unsecured | | % | $ | | | — | | | |||||||||||||
10% unsecured | | % | $ | | | — | | | |||||||||||||
11% unsecured |
|
| | % | $ |
| |
| — |
| |
| | ||||||||
| — | | | ||||||||||||||||||
Short term notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
0% unsecured |
|
| | % |
| N/A |
| |
| — |
| — |
| | |||||||
6% secured |
|
| | % |
| N/A |
| |
| — |
| — |
| | |||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| — |
| | |||||||
12% unsecured |
|
| | % |
| N/A |
| |
| — |
| — |
| | |||||||
| |
| ( |
|
| — | | ||||||||||||||
Long term convertible notes at fair value |
|
|
|
|
|
|
|
|
|
|
|
| |||||||||
0% unsecured |
|
| | % |
| Variable |
| |
| — |
| |
| | |||||||
11% unsecured |
|
| | % |
| $ |
| |
| — |
| |
| | |||||||
| |
| — |
|
| | | ||||||||||||||
Long term notes payable | |||||||||||||||||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| — |
| | |||||||
|
|
|
| ||||||||||||||||||
Ending balance as of December 31, 2024 | $ | | $ | ( | $ | | $ | | |||||||||||||
*These convertible notes are convertible into Series C preferred shares at $
F-21
Notes Payable
On April 26, 2024, the Company entered into a Commercial Loan Agreement (the “April Commercial Loan”) with a commercial lender for an aggregate principal amount of $
On September 27, 2024, the Company entered into a promissory note agreement (the “Note”) with an individual investor (the “Holder”) for principal amount of $
On October 18, 2024, the Company entered into a Commercial Loan Agreement (the “October Commercial Loan”) with a commercial lender for an aggregate principal amount of $
During the year ended December 31, 2024, the Company issued approximately
Convertible Notes
On February 21, 2024, the Company entered into several
As consideration for entering into the package of February Convertible Notes for $
During the year ended December 31, 2024, the Company modified the terms of existing $
During the year ended December 31, 2024, the Company converted $
Convertible Notes at Fair Value
During the year ended December 31, 2024, the Company entered into several
F-22
shares between $
During the year ended December 31, 2024, the Company entered into several
As consideration for entering the 2024 Two-Year Dual Convertible Notes, the Company also agreed to amend certain existing warrants to extend the term of the warrant maturity date for an additional 5 months. As a result of electing the FVO, issuance costs related to the convertible notes are expensed as incurred. Therefore, the incremental change in fair value resulting from the warrant amendment for $
The Company elected the FVO to fair value the convertible notes described above under the guidance in ASC 825. The convertible notes at fair value are required to be remeasured using level 3 fair value measurements (see Note 4).
During the year ended December 31, 2024, the Company modified certain convertible notes by (i) extending the maturity dates; (ii) reducing the conversion price, and (iii) granting the notes holders the right to further extend the maturity date of the notes from a period of time not to exceed
Yorkville Note
On December 19, 2024, the Company entered into a Standby Equity Purchase Agreement (“SEPA”) with YA II PN, LTD (“Yorkville”) (see Note 11). Upon entry into the SEPA, the Company issued Yorkville a $
The Company elected the FVO to fair value the Yorkville Note on the issuance date and will subsequently remeasure at end of each reporting period. The estimated fair value of the Yorkville Note on the issuance date was approximate $
F-23
2023 Activities
The following tables summarize outstanding debt as of December 31, 2023 (in thousands):
|
| Stated |
|
|
|
| Fair |
| |||||||||||||
Interest | Conversion | Remaining | Value | Carrying | |||||||||||||||||
Maturity Date | Rate | Price | Face Value | Debt Discount | Adjustment | Value | |||||||||||||||
Short term convertible notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
6% unsecured |
|
| | % | $ | | $ | | $ | — | $ | — | $ | | |||||||
8% unsecured |
|
| | % | $ | * |
| |
| ( |
| — |
| | |||||||
10% unsecured |
|
| | % | $ | | * |
| |
| — |
| — |
| | ||||||
| | ( |
| — |
| | |||||||||||||||
Short term convertible notes at fair value |
|
|
|
|
|
|
|
|
|
| |||||||||||
11% unsecured |
|
| | % | $ | * |
| |
| — |
| |
| | |||||||
Short term notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| — |
| | |||||||
12% unsecured |
|
| | % |
| N/A |
| |
| — |
| — |
| | |||||||
| |
| ( |
|
| — |
| | |||||||||||||
Long term notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
8% unsecured |
|
| | % |
| N/A |
| |
| ( |
| — |
| | |||||||
6% secured |
|
| | % |
| N/A |
| |
| — |
| — |
| | |||||||
| |
| ( |
|
| — |
| | |||||||||||||
| |||||||||||||||||||||
Ending balance as of December 31, 2023 | $ | | $ | ( | $ | | $ | | |||||||||||||
*These convertible notes are convertible into Series C preferred shares at $
Promissory Notes
On March 2, 2023, the Company entered into a Commercial Loan Agreement (the “March Commercial Loan”) with a commercial lender for an aggregate principal amount of $
On November 10, 2023, the Company entered into another Commercial Loan Agreement (the “November Commercial Loan”) with the same commercial lender for an aggregate principal amount of $
During the year ended December 31, 2023, the Company issued approximately
During the year ended December 31, 2023, the Company issued approximately
During the year ended December 31, 2023, the Company recognized $
F-24
Convertible Notes
In April 2023, the Company entered into several
On July 11, 2023, the Company entered into a
During the year ended December 31, 2023, the Company entered into several additional
As additional consideration for entering into the April Convertible Notes and the 2023 One-Year Convertible Notes (“2023 Short-Term Convertible Notes”), the Company also agreed to amend some of the holders’ existing outstanding warrants. The exercise price of certain existing warrants was amended from $
Convertible Notes at Fair Value
From August to October 2023, the Company entered into several
One of the 2023 Dual Convertible Notes also contains a conversion feature to allow the holder to convert the outstanding debt in lieu of cash payment to purchase common shares via cash exercise of the holder’s existing warrants. In addition, the Company also agreed to amend the holder’s existing warrants to extend the term of the warrant maturity date for an additional three months.
The Company elected the FVO to fair value the 2023 Dual Convertible Notes. The fair value of the Convertible Notes was approximately $
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Interest Expense Summary
The following table summarizes total interest expenses related to outstanding debt for the years ended December 31, 2024 and 2023, respectively (in thousands):
For the years ended | ||||||
December 31, | ||||||
| 2024 |
| 2023 | |||
Interest expenses related to outstanding notes: |
|
| ||||
Contractual interest | $ | | $ | | ||
Amortization of debt discount |
| |
| | ||
Issuance costs | | | ||||
Total interest expenses related to outstanding notes |
| |
| | ||
Other interest expenses |
| |
| | ||
Total interest expense | $ | | $ | | ||
The following table summarizes the principal amounts of the Company’s debt obligations as of December 31, 2024 (in thousands):
Payment Due by Period | ||||||||||||
Less than | 1 to 2 | 3 to 5 | ||||||||||
| Total |
| 1 Year |
| Years |
| Years | |||||
Short term convertible notes payable | ||||||||||||
6% unsecured | $ | | $ | | $ | — | $ | — | ||||
8% unsecured | | | — | — | ||||||||
Short term convertible notes payable at fair value |
| |||||||||||
8% unsecured | | | — | — | ||||||||
10% unsecured | | | — | — | ||||||||
11% unsecured | | | — | — | ||||||||
Short term notes payable | ||||||||||||
0% unsecured | | | — | — | ||||||||
6% secured | | | — | — | ||||||||
8% unsecured | | | — | — | ||||||||
12% unsecured | | | — | — | ||||||||
Long term convertible notes payable at fair value | ||||||||||||
0% unsecured | | — | | — | ||||||||
11% unsecured | | — | | — | ||||||||
Long term notes payable | ||||||||||||
8% unsecured | | — | | — | ||||||||
Total | $ | | $ | | $ | | $ | — | ||||
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8. Net Loss per Share Applicable to Common Stockholders
The following securities were not included in the diluted earnings (loss) per share calculation because their effect was anti-dilutive as of the periods presented (in thousands):
For the years ended | ||||
December 31, | ||||
| 2024 |
| 2023 | |
Series C convertible preferred stock | | | ||
Common stock options | | | ||
Common stock warrants - equity classified | | | ||
Common stock warrants - liability classified | | — | ||
Convertible notes and accrued interest | |
| | |
Potentially dilutive securities | | | ||
9. Related Party Transactions
Advent BioServices Services Agreement
The Company has
Each of the operational programs is covered by a separate contract. The ongoing manufacturing in the London facility is covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility is covered by an Ancillary Services Agreement entered into on November 18, 2019. Each periodic specialized program is covered by an SOW that sets forth the role and activities to be undertaken by Advent for that program, and provides for milestone payments upon completion of key elements of the program.
The Ancillary Services Agreement establishes a structure under which the Company and Advent negotiate and agree upon the scope and terms for Statements of Work (“SOWs”) for facility development activities and compassionate use program activities, as well as for the periodic specialized programs. After an SOW is agreed and approved by the Company, Advent will proceed with, or continue, the applicable services and will invoice the Company pursuant to the SOW. Since both the facility development and the compassionate use program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus
SOW 8
On November 8, 2024, the Company entered into a Statement of Work #8 (“SOW 8”) with Advent that is incorporated into the Ancillary Services Agreement that was originally entered into dated November 8, 2019 and was extended on July 8, 2024. SOW 8 covers the work required to establish the DCVax-Direct program in the U.K and manufacture DCVax-Direct products for global use. Under SOW 8, the compensation consists solely of one-time cash milestone payments for each stage of the work and Advent will only receive the compensation when the applicable work is successfully completed. (When the Company previously contracted with a different company for restart of DCVax-Direct manufacturing, the contract required payment as work was performed, regardless of whether the work was successful or not, as is typical for such contract services. The other company did not succeed in producing any DCVax-Direct products meeting the specifications.)
SOW 8 includes the following 5 one-time milestones with corresponding milestone payments (which are only payable after the milestone has been achieved):
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(a) Basic Technology Transfer, New SOPs & Regulatory Documents.
Review of documents, specifications and data from prior DCVax-Direct program conducted by Cognate BioServices. Development of a new set of SOPs for DCVax-Direct production in Sawston and new regulatory documents for the UK. Initial implementation in Sawston; many engineering runs. Data generation for comparability analyses of both the process and the product. Milestone payment of £
As of December 31, 2024, this milestone had been completed and paid.
(b) Process Development: TFF System vs. Other Systems.
Evaluation of the TFF system used in the prior DCVax-Direct manufacturing. Evaluation of the remaining TFF equipment from the prior program, parts needed to re-establish functional TFF systems, potential sourcing and timelines. Evaluation of remaining disposables from the prior program, requirements for new molds to enable new production of disposables (which are used for each manufacturing run with the TFF system), production arrangements for new disposables, development of new sealing method for disposables, potential sourcing and timelines for disposables. Identification and evaluation of commercially available systems to potentially substitute for TFF system. Engineering runs. Data generation for comparability analyses of TFF system vs. others. Milestone payment of £
As of December 31, 2024, this milestone had been completed but had not yet been paid. The Company recognized an accrued liability of $
(c) Process Development: Existing and New Product Composition.
Worldwide search for sourcing of BCG (1 of 2 essential reagents/ingredients required for DCVax-Direct besides the DCs), due to a severe worldwide shortage. Evaluation of the BCG mechanism of action (MoA) in DCVax-Direct, search for other agents that could have similar MoA or effects, with similar safety profile too. Sourcing of other agents, testing and selection of other agents for a new DCVax-Direct product composition. Many engineering runs. Data generation for comparability analyses of new reagents vs BCG and new composition of DCVax-Direct vs prior composition. Milestone payment of £
As of December 31, 2024, this milestone had been completed but had not yet been paid. The Company recognized an accrued liability of $
(d) Technology Transfer: Clean Room Implementation.
After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, process performance qualifications. For technology transfer into the clean rooms, each operator must pass 3 consecutive and successful aseptic process simulations in the clean room and 3 consecutive and successful PQQ runs at scale in the clean room; microbial analysis (sterility, endotoxin, mycoplasma all need to pass); growth promotion tests; validation of all equipment used after being placed in the clean room; validation of all cell analysis assays used via flow cytometry and validation of the fill and finish protocols. Milestone payment of £
As of December 31, 2024, this milestone had not yet been completed. The Company recognized an accrued liability of $
(e) New IMPD and New IND.
Draft a new IMPD (Investigational Medicinal Product Dossier) for the revised DCVax-Direct product composition and production process, containing all changes to the manufacturing system, reagents and product composition, processes, sources and/or Mechanism of Action vs those used in the prior DCVax-Direct program. Also draft a new IND (CMC section), for the first clinical trial with the
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new manufacturing process and new product composition. Obtain the first approval or clearance of the new IND by a regulator. Milestone payment of £
As of December 31, 2024, this milestone had not been completed. The Company recognized an accrued liability of $
SOW 6
SOW 6 provides for ongoing baseline costs for manufacturing at the Sawston facility and one-time milestone incentives for (a) regulatory approval of each of the three licenses required for the Sawston facility, (b) successful completion of each of the six workstreams and (c) completion of drafting key portions of an application for product approval (see Note 5 for additional description regarding SOW 6). The milestone incentives are a combination of cash and stock, and are not paid until the milestone is achieved and earned.
During the year ended December 31, 2023, the Company paid an aggregate of $
The following table summarizes total research and development costs from Advent for the years ended December 31, 2024 and 2023, respectively (in thousands).
For the years ended December 31, | ||||||
| 2024 |
| 2023 | |||
Advent BioServices |
|
|
|
| ||
Manufacturing cost in London | $ | | $ | | ||
Manufacturing cost at Sawston facility |
| |
| | ||
SOW 6 one-time milestones - Shares |
|
|
|
| ||
Expensed and paid (milestone complete) (1) |
| — |
| | ||
Expensed and due, but unpaid (milestone complete) (2) |
| — |
| | ||
SOW 6 one-time milestones - Cash |
|
|
|
| ||
Expensed and paid (milestone complete) (3) | — | | ||||
Expensed and due, but unpaid (milestone complete) (4) |
| — |
| | ||
SOW 8 one-time milestones - Cash |
|
|
|
| ||
Expensed and paid (milestone complete) (5) |
| |
|
| ||
Expensed and due, but unpaid (milestone complete) (6) |
| |
| — | ||
Expensed but unpaid, not yet due (milestone not yet complete) (7) | | — | ||||
$ | | $ | | |||
(1) | The payment for the year ended December 31, 2023 covered 2 one-time milestones: obtaining a commercial manufacturing license from the MHRA and drafting key portions of the application for product approval. |
(2) | The expense for the year ended December 31, 2023 covered the one-time milestone for submission of the application for product approval. |
(3) | The payment for the year ended December 31, 2023 covered 3 one-time milestones: Mechanism of Action, obtaining a commercial manufacturing license from the MHRA and drafting key portions of the application for product approval. |
(4) | The expense for the year ended December 31, 2023 covered the one-time milestone for submission of the application for product approval. |
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(5) | The expense for the year ended December 31, 2024 covered the one-time milestone: Basic technology transfer, new SOPs & regulatory documents. |
(6) | The expense for the year ended December 31, 2024 covered 2 one-time milestones: 1) Process development: TFF system vs. other systems, and 2) Process development: existing and new product composition. |
(7) | The expense for the year ended December 31, 2024 covers 2 one-time milestones: 1) Technology transfer: clean room implementation, and 2) Draft new IMPD (Investigational Medicinal Product Dossier) and new IND (CMC section). |
Advent BioServices Sublease Agreement
On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately
During the years ended December 31, 2024 and 2023,the Company recognized sub-lease income of $
Related Party Accounts Payable
As of December 31, 2024 and 2023, there were outstanding unpaid accounts payable and accrued expenses owed to Advent as summarized in the following table (in thousands). These unpaid amounts are part of the Related Party expenses reported in the above section.
| December 31, 2024 |
| December 31, 2023 | |||
Advent BioServices - amount invoiced but unpaid | $ | | $ | | ||
Advent BioServices - amount accrued but unpaid (1) | | | ||||
$ | | $ | | |||
| (1) | This includes $ |
10. Preferred Stock
Series C Convertible Preferred Stock
On July 20, 2022, the Company filed a Certificate of Elimination with the Secretary of State of the State of Delaware with respect to the Company’s Series A Preferred Stock and Series B Preferred Stock pursuant to which both series were eliminated and returned to the status of authorized and unissued preferred shares of the Company, as there are no longer any Series A or Series B Preferred shares outstanding.
Also on July 20, 2022, the Company filed the Certificate of Designations for Series C Preferred Stock (the “Series C Certificate of Designations”) with the Secretary of State of the State of Delaware, setting forth the terms of the Series C Preferred Stock. The Series C Certificate of Designations, effective as of July 20, 2022, that was created out of the authorized and unissued shares of preferred stock
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of the Company, provides for
The Company determined that the Series C Shares contain contingent redemption provisions allowing redemption by the holder upon certain defined events (“deemed liquidation events”). As the event that may trigger the redemption of the Series C Shares is not solely within the Company’s control, the Series C Shares are classified as mezzanine equity (temporary equity) in the Company’s consolidated balance sheets.
2024 Activities
During the year ended December 31, 2024, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of
During the year ended December 31, 2024, the Company converted $
During the year ended December 31, 2024, approximately
2023 Activities
During the year ended December 31, 2023, the Company entered into various Subscription Agreements (the “Series C Subscription Agreements”) with certain investors (the “Series C Investors”). Pursuant to the Series C Subscription Agreements, the Company issued the Series C Investors an aggregate of
During the year ended December 31, 2023, the Company issued approximately
During the year ended December 31, 2023, approximately
11. Stockholders’ Deficit
Common Stock
On January 9, 2023, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from
2024 Activities
On June 4, 2024, the Company entered into a Stock Purchase Agreement with SIO Capital Management LLC (SIO), for SIO’s purchase of
In addition to the June Offering, during the year ended December 31, 2024, the Company issued total
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On December 19, 2024, the Company entered into a Standby Equity Purchase Agreement (“SEPA”) with YA II PN, LTD (“Yorkville”). Pursuant to the SEPA, subject to certain conditions and limitations, the Company has the option, but not the obligation, to issue and sell to Yorkville up to $
During the year ended December 31, 2024, the Company received $
During the year ended December 31, 2024, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately
During the year ended December 31, 2024, the Company issued approximately
2023 Activities
During the year ended December 31, 2023, the Company received $
During the year ended December 31, 2023, certain options and warrants holders elected to exercise some of their options and warrants pursuant to cashless exercise formulas. The Company issued approximately
During the year ended December 31, 2023, the Company issued approximately
Stock Purchase Warrants
The following is a summary of warrant activity for the years ended December 31, 2024 and 2023 (in thousands, except per share data):
| Number of |
| Weighted Average |
| Remaining | ||
Warrants | Exercise Price | Contractual Term | |||||
Outstanding as of January 1, 2023 |
| | $ | |
| ||
Warrants exercised for cash |
| ( |
| |
|
| |
Cashless warrants exercise |
| ( | |
| |||
Warrants expired and cancellation | ( | |
| ||||
Outstanding as of December 31, 2023 |
| | |
| |||
Warrants granted (1) |
| |
| |
|
| |
Warrants exercised for cash | ( | |
| ||||
Cashless warrants exercise |
| ( |
| |
|
| |
Outstanding as of December 31, 2024 (2) | | $ | | ||||
| (1) | Warrants granted to the placement agent. |
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| (2) | At December 31, 2024, of the approximately |
Warrant Modifications
During the year ended December 31, 2024 and 2023, the Company amended multiple equity classified warrants whereby the maturity dates of certain warrants were extended for an additional approximately 3 months. The value of these modifications was calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions.
For the year ended |
| ||||||
December 31, 2024 |
| ||||||
| Post-modification |
| Pre-modification |
| |||
Exercise price | $ | | $ | | |||
Expected term (in years) |
|
| |||||
Volatility |
| | % |
| | % | |
Risk-free interest rate |
| | % |
| | % | |
Dividend yield |
| % |
| % | |||
For the year ended | |||||||
December 31, 2023 | |||||||
| Post-modification |
| Pre-modification |
| |||
Exercise price | $ | | $ | | |||
Expected term (in years) |
|
| |||||
Volatility |
| | % |
| | % | |
Risk-free interest rate |
| | % |
| | % | |
Dividend yield |
| | % |
| | % | |
During the year ended December 31, 2024 and 2023, the incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $
Warrant Reclassification
On December 23, 2024, in connection with entering into a stock purchase agreement with an individual investor (the “Investor”), the Company amended the Investor’s existing
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12. Commitments and Contingencies
Operating Lease- Lessee Arrangements
The Company has operating leases for corporate offices in the U.S. and U.K., and for manufacturing facilities in the U.K. The Leases with an initial term of 12 months or less are not recorded in the balance sheet. The Company has elected the
On August 22, 2024, the Company extended its office lease in the U.S for additional
At December 31, 2024, the Company had operating lease liabilities of approximately $
Operating Lease- Lessor Arrangements
On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent, a related party as discussed in Note 8. The Agreement permits use by Advent of a portion of the space in the Sawston facility which is leased by the Company under a separate head lease with a different counterparty that commenced on December 14, 2018. The Company subleased approximately
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The following summarizes quantitative information about the Company’s operating leases (in thousands):
For the year ended | |||||||||
December 31, 2024 | |||||||||
| U.K |
| U.S |
| Total | ||||
Lease cost | |||||||||
Operating lease cost | $ | | $ | | $ | | |||
Short-term lease cost | | — | | ||||||
Variable lease cost | — | | | ||||||
Sub-lease income | ( | — | ( | ||||||
Total | $ | | $ | | $ | | |||
|
|
|
| ||||||
Other information |
|
|
| ||||||
Right of use assets exchanged for new operating lease liabilities | $ | — | $ | | $ | | |||
Operating cash flows from operating leases | $ | ( | $ | ( | $ | ( | |||
Weighted-average remaining lease term – operating leases | |||||||||
Weighted-average discount rate – operating leases | | % | | % |
| ||||
For the year ended | |||||||||
December 31, 2023 | |||||||||
| U.K |
| U.S |
| Total | ||||
Lease cost |
|
|
|
|
|
| |||
Operating lease cost | $ | | $ | | $ | | |||
Short-term lease cost |
| |
| — |
| | |||
Variable lease cost |
| — |
| |
| | |||
Sub-lease income | ( | — | ( | ||||||
Total | $ | | $ | | $ | | |||
|
|
|
| ||||||
Other information |
|
|
|
|
|
| |||
Operating cash flows from operating leases | $ | ( | $ | ( | $ | ( | |||
Weighted-average remaining lease term – operating leases |
|
|
|
| |||||
Weighted-average discount rate – operating leases |
| | % |
| | % |
|
| |
The Company recorded lease costs as a component of general and administrative expense during the years ended December 31, 2024 and 2023.
Maturities of our operating leases, excluding short-term leases and sublease agreement, are as follows:
Year ended December 31, 2025 |
| $ | |
Year ended December 31, 2026 | | ||
Year ended December 31, 2027 | | ||
Year ended December 31, 2028 | | ||
Year ended December 31, 2029 | | ||
Thereafter | | ||
Total | | ||
Less present value discount | ( | ||
Operating lease liabilities included in the Consolidated Balance Sheet at December 31, 2024 | $ | |
F-35
Maturities of our operating leases under the sublease agreement, are as follows:
Year ended December 31, 2025 |
| $ | |
Year ended December 31, 2026 |
| | |
Year ended December 31, 2027 |
| | |
Year ended December 31, 2028 |
| | |
Year ended December 31, 2029 |
| | |
Thereafter |
| | |
Total | $ | |
Advent BioServices Services Agreement
On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The MSA provides for manufacturing of DCVax-L products at an existing facility in London. The MSA is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The MSA provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity reserved exclusively for DCVax production and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. The MSA remains in force until five years after the first commercial sales of DCVax-L products pursuant to a marketing authorization, accelerated approval or other commercial approval, unless cancelled. Either party may terminate the MSA on
On November 8, 2024, the Company entered into SOW 8 with Advent, which was incorporated into the Ancillary Services Agreement that was originally entered into dated November 8, 2019 and was extended on July 8, 2024. The milestone incentives are one-time cash milestones and are not paid until they are achieved and earned, as described in Note 9.
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German Tax Matter
The German tax authorities have audited our wholly owned subsidiary, NW Bio GmbH, for 2013-2015. The NW Bio GmbH submitted substantial documentation to refute certain aspects of the assessments and the German tax authorities agreed in principle with the Company’s proposed revised approach and settlement offer. A final settlement bill was received from the German Tax Authority confirming that only a portion of the original bill was owed, €
Other Contingent Payment Obligations
During the year ended December 31, 2024, the Company entered into a non-dilutive funding agreement with an individual investor, pursuant to which the Company received funding of $
During the year ended December 31, 2023, the Company entered into certain non-dilutive funding agreements with multiple investors, pursuant to which the Company received funding of $
These agreements are accounted for under ASC 470 and are recognized as contingent payment obligations on the Company’s consolidated balance sheet. The Company’s payment obligations only apply when such gain contingency is received by the Company.
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13. Income Taxes
No provision was made for U.S. taxes on undistributed foreign earning as such earnings are considered to be permanently reinvested. It is not practicable to determine the amount of additional tax, if any that might be payable on those earnings if repatriated.
The tax effects of temporary differences and tax loss and credit carry forwards that give rise to significant portions of deferred tax assets and liabilities at December 31, 2024 and 2023 are comprised of the following (in thousands):
| As of December 31, 2024 |
| As of December 31, 2023 | |||
Deferred tax asset | ||||||
Net operating loss carryforwards | $ | | $ | | ||
Research and development credit carryforwards | | | ||||
Stock based compensation and other | | | ||||
Capitalized research and experimental expenses | | | ||||
Total deferred tax assets | | | ||||
Valuation Allowance | ( | ( | ||||
Deferred tax asset, net of allowance | $ | — | $ | — | ||
The Company has identified the United States, Maryland, Germany and United Kingdom as significant tax jurisdictions.
The Company’s U.S. net operating loss (“NOL”) carryforwards for tax purposes as of December 31, 2024, are approximately $
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and taxing strategies in making this assessment. In case the deferred tax assets will not be realized in future periods, the Company has provided a valuation allowance for the full amount of the deferred tax assets at December 31, 2024 and 2023.
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The expected tax expense (benefit) based on the U.S. federal statutory rate is reconciled with actual tax expense (benefit) as follow
(dollars in thousands):
| As of December 31, 2024 |
| As of December 31, 2023 |
| |
Statutory federal income tax rate |
| | % | | % |
State taxes, net of federal tax benefit |
| | % | | % |
Tax rate differential on foreign income |
| ( | % | | % |
Derivative gain or loss |
| | % | | % |
Expiration of net operating losses |
| ( | % | ( | % |
Other permanent items and true ups |
| ( | % | ( | % |
R&D Credit |
| | % | | % |
Change in rate |
| | % | | % |
Change in valuation allowance |
| ( | % | ( | % |
Income tax provision (benefit) |
| | % | | % |
| As of December 31, 2024 |
| As of December 31, 2023 | |||
Federal |
|
|
|
| ||
Current | $ | | $ | | ||
Deferred |
| ( |
| ( | ||
State |
|
|
|
| ||
Current |
| |
| | ||
Deferred |
| ( |
| ( | ||
Foreign |
|
|
|
| ||
Current |
|
|
|
| ||
Deferred |
| ( |
| | ||
Change in valuation allowance |
| |
| | ||
Income tax provision (benefit) | $ | | $ | | ||
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. As of December 31, 2024 and 2023, there were no uncertain tax positions. The Company’s policy for recording interest and penalties associated with uncertain tax positions is to record such expense as a component of income tax expense. There were
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14. Subsequent Events
Between January 1, 2025 and March 28, 2025, the Company received $
Between January 1, 2025 and March 28, 2025, the Company issued approximately
Between January 1, 2025 and March 28, 2025, the Company entered into several
On March 7, 2025, the Company entered into a Commercial Loan Agreement (the “2025 Commercial Loan”) with a commercial lender for an aggregate principal amount of $
Between January 1, 2025 and March 28, 2025, the Company issued approximately
Between January 1, 2025 and March 28, 2025, the Company converted $
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