NORTHWEST BIOTHERAPEUTICS INC
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
NWBO$0.19-0.6%Stored close · as of Jun 30, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001410578-24-001879
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001410578-25-001333
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 83 previous paragraphs and 66 current paragraphs.
39 unchanged; 18 reworded; 9 added; 21 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Manufacturing Scale-Up in the Sawston, UK Facility. The Company and Advent proceeded with detailed planning for buildout and equipping of the simplified C lab in the Sawston, UK facility, including contractor and vendor arrangements. Advent devised arrangements to obtain essential equipment for the C lab quickly, and avoid the delivery lead times of 10-12 months. The simplified C lab will enable a substantial scale-up of production capacity in Sawston. As previously reported, the simplified Grade C lab will be adjacent to an existing Grade B lab, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. This will enable the simplified Grade C lab to be completed for a fraction of the cost and less than half the time for regular Grade C labs.
Current report
Manufacturing in the US. The Company continued its discussions with GMP facilities in several states to obtain capacity and availability for potential manufacturing in the US. The Company anticipates reaching an agreement during this summer. The manufacturing is initially contemplated to include DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh, and then DCVax products.
Current report
DCVax-Direct Program. The Company believes it is on track to submit the initial INDs during Q2 of this year, as previously projected, for clinical trials of the Company’s new DCVax-Direct product. The trials are designed to be compact and streamlined, by using Simon two-stage designs to start small (e.g., with just 12-20 patients) and then expand if encouraging results are seen, and by focusing on tumor response endpoints. These trials are the culmination of two years of technology transfer and process development work to establish manufacturing for DCVax-Direct products in Sawston, and to develop a new version of DCVax-Direct to replace an ingredient for which there is a persistent worldwide shortage. During Q1, the final stages of the process were being carried out, including engineering runs and validations.
Current report
Enhanced DCVax-Direct Products and Upcoming Presentation. The Company continued its internal testing of certain immune booster agents that it has in-licensed, to identify the most useful booster agent(s) and combination(s) of agents for enhanced DCVax-Direct products. The Company currently anticipates making a presentation about this at a scientific conference in June. The Company is also in discussions with clinicians about which version(s) of enhanced DCVax-Direct products should be selected and for which cancers for the initial clinical trials.
Current report
Clinical Trials With Roswell and Pittsburgh Technologies. The Company has continued working with Dr. Kalinski and leading clinicians to develop arrangements for compact Simon 2-stage clinical trials of two dendritic cell treatments from the Roswell and Pittsburgh portfolios: DCs loaded with abnormal tumor blood vessel antigens (TBVA), and intra-tumoral injection of unloaded DCs (prepared differently than the Company’s DCVax-Direct products). The US manufacturing arrangements described above will need to be completed to supply the products for these trials.
Current report
Technology Targeting In Vivo DCs. While the clinical trials of the Roswell/Pittsburgh DC technologies are waiting for the US manufacturing agreement to be reached and implemented, the Company has identified another technology in the Roswell/Pittsburgh portfolios that could proceed with clinical testing in the meantime. This technology is designed to mobilize the “endogenous” (resident) DCs inside the patient’s body through cytokine conditioning regimens. The treatment agents are biologics, not cells themselves. As a comparison: for DCVax-L, the DC precursor cells are matured and activated ex vivo in the manufacturing facility, and are also “educated” ex vivo by exposure to tumor material in the manufacturing facility. For DCVax-Direct, the maturation and activation take place ex vivo, but the “education” takes place in vivo when the DCs are injected into the tumor and are exposed to the tumor material there. With the cytokine conditioning regimens, all of the steps take place in vivo in the patient’s body. The Company believes this technology can complement the Company’s cell therapies (for example, where patients have exhausted their DCVax doses).
Current report
Compassionate Use Programs. The Company continues to receive an ongoing stream of patient requests for compassionate use of DCVax therapies for a variety of cancers. The Company has previously treated compassionate use cases involving a variety of solid tumor cancers with its DCVax therapies. The Company believes that those compassionate use cases have been helpful for the patients involved, and have also generated useful real world data. The Company is expanding its compassionate use programs.
Current report
Litigation Progress. The Company continued to vigorously pursue its lawsuit against certain market makers. The Company received a favorable Report and Recommendation from the Magistrate on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: loss causation. The Company also received a favorable decision from the court related to the Defendants’ Motion to Dismiss the Company’s Complaint. The case will now proceed into the long-awaited discovery stage. The Company believes the litigation activities are making important progress, and the Company plans to continue pursuing the cases vigorously. See Part II Item 1, Legal Proceedings, below.
Current report
For the three months ended March 31, 2025 and 2024, research and development expenses were $8.4 million and $7.9 million, respectively. The increase in 2025 was primarily related to an increased cost related to MAA application at the MHRA and the resumption of DCVax-Direct production, and offset by a decrease in stock-based compensation.
Removed paragraphs (21)
Previous report
Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.
Previous report
Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.
Previous report
Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.
Previous report
Collaborations: Complementary or Synergistic Technologies. The Company has also been pursuing ongoing efforts to identify and develop collaborations with other companies who have technologies that the Company believes may be complementary to the Company’s DCVax technologies (for example for combination treatment regimens) or may be synergistic with the Company’s technologies (for example, to enhance DCVax products). The Company completed negotiations and entered into a contract with a company that has a complementary immunotherapy agent, and the two companies have been engaged for a number of months in joint development of trial designs and selection of candidate cancers for a combination treatment clinical trial. The companies are particularly focusing on trial designs in which the primary endpoint will be tumor response (shrinkage), with potential timeframes in months, rather than time-to-event survival outcomes, with timeframes in years. The Company anticipates potentially being ready to submit an IND for such a combination trial to regulators during Q1 of next year.
Previous report
The Company has also completed negotiations and entered into a contract with a company that has an immune booster agent that may have the potential to further increase the potency of DCVax products. The contract provides for material supply and in vitro testing of the booster agent with DCVax products. If the in vitro testing is successful, the parties plan to enter into a license of the booster agent to NWBio. The parties jointly designed the program of experiments, and the experiments were carried out and completed by the Flaskworks team. The parties are now evaluating the results and developing plans for further experiments.
Previous report
Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January. For the same reasons as described above in connection with the planned combination treatment trial, the Company plans to focus DCVax-Direct clinical trial designs on tumor response endpoints with potential timeframes of months rather than survival endpoints with timepoints of years. The preparations to date involve technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, engineering runs and comparability testing. In addition, new development work has been carried out to develop a second version of DCVax-Direct because there is a worldwide shortage of one key ingredient of the original DCVax-Direct (an immune booster ingredient). The Company and Advent have been working together to evaluate other potential immune booster agents -- both their properties in the manufacturing process and their effects immunologically -- to identify an alternative booster agent that can be suitable and is available for production of new batches of DCVax-Direct. Advent is continuing to conduct final engineering runs for validation of the new SOPs, processes and formulation. The Company has entered into SOW 8 with Advent covering the work involved in restarting the DCVax-Direct program. SOW 8 is structured so that Advent only receives compensation for the work in the form of milestone payments and only after the applicable work has been successfully completed (see Note 13).
Previous report
Ongoing and Expanded Phase 2 Clinical Trials Under the Roswell & Pittsburgh Portfolios. As previously reported, the Company entered into exclusive licenses from Roswell Park Cancer Center and the University of Pittsburgh, covering a large portfolio dendritic cell technologies developed over the course of more than 27 years of work by a leading team of dendritic cell experts, as well as 5 new patent families. The in-licensed technologies in the combined portfolios are currently in three Phase 2 clinical trials that are fully funded by grants and fully being carried out by the investigators. These Phase 2 trials are ongoing and one of them has been approved for a significant expansion in scope by the grant funding agency. That trial is testing an in-licensed dendritic cell treatment in melanoma that is refractory (unresponsive) to checkpoint inhibitor drugs. That dendritic cell treatment aims at a set of targets on abnormal blood vessels that are associated with tumors. As such, that dendritic cell treatment is anticipated to be tumor-agnostic and potentially applicable to most types of solid tumors. The expansion of the trial scope that has been approved is to add refractory lung, breast and bladder cancers to the trial in addition to refractory melanoma.
Previous report
Intellectual Property. The Company’s intellectual property (IP) portfolio continued to grow during Q3 2024, complementing the Company’s growing pipeline. Patents from 3 different patent families developed by the Company were granted or allowed in several countries, particularly Europe. Patents from 2 different patent families which are part of the Roswell and Pittsburgh in-licenses were granted in the U.S. and elsewhere. New divisional applications were also filed to extend the scope of patents from 2 different patent families, in Europe and elsewhere. In regard to the Flaskworks technologies and IP, 5 new patents were allowed in the U.S. and elsewhere, from 4 different patent families, during Q3 2024. In addition, 4 new patents were issued in the U.S. during Q3 2024, which had been allowed during Q2 2024, and a 5 th patent elsewhere was also issued. The Company believes that the ongoing expansion of its IP portfolio is an important and valuable part of building a leading franchise in dendritic cell technologies.
Previous report
Litigation. In the Company’s lawsuit against certain market makers, the Company is awaiting the Magistrate’s Report and Recommendation on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: i.e., loss causation. The Magistrate and the Court already previously determined that all but this one of the required elements were sufficiently alleged in the Company’s Complaint, and the Court invited the Company to file expanded allegations about the loss causation element. The Company submitted expanded claims earlier this year, the parties’ filings were finished in June, and the parties are now waiting to receive the Magistrate’s recommendation.
Previous report
For the three months ended September 30, 2024 and 2023, research and development expenses were $8.1 million and $7.2 million, respectively. The increase in 2024 was mainly related to an increase of $1.2 million cost incurred from Advent with extensive ongoing work related to the MAA and review process, which was offset by a decrease of $0.5 million related to stock-based compensation.
Previous report
We recognized a non-cash loss of $1.6 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively. The loss was primarily due to the change of valuation inputs. The healthcare market yield curve rate that was used in the pricing model was significantly decreased as of September 30, 2024 compared to the value as of June 30, 2024. The rate was about the same level as of September 30, 2023 compared to the value as of June 30, 2023.
Previous report
Nine months ended September 30, 2024 and 2023
Previous report
We recognized a net loss of $55.6 million and $48.6 million for the nine months ended September 30, 2024 and 2023, respectively.
Previous report
Research and Development Expense
Previous report
For the nine months ended September 30, 2024 and 2023, research and development expenses were $24.4 million and $20.3 million, respectively. The increase in 2024 was mainly related to an increase of $2.6 million to unrelated external service providers primarily related to the MAA, the review process and inspections, of which $1.1 million was related to stock-based compensation, which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023. Additionally, research and development expenses from Advent was increased by $1.4 million with extensive ongoing work related to the MAA and review process for the nine months ended in September 30, 2024 compared to the same period of last year.
Previous report
General and Administrative Expense
Previous report
For the nine months ended September 30, 2024 and 2023, general and administrative expenses were $24.8 million and $21.6 million, respectively. The increase in 2024 was primarily related to an increase of $3.2 million in legal expenses.
Previous report
We recognized a non-cash gain of $4.6 million and non-cash loss of $4.9 million in change in fair value of the convertible notes during the nine months ended September 30, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of September 30, 2024 compared to December 31, 2023. The loss was primarily due to the increase in the stock price as of September 30, 2023 compared to the stock price on the issuance date during August and September 2023.
Previous report
Debt Extinguishment
Previous report
Interest Expense
Previous report
Foreign currency transaction gain (loss)
Reworded paragraphs (18)
Previous wording
During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.
Current wording
During the first three months of 2025, the Company continued its progress on multiple fronts, including the following.
Previous wording
MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Current wording
MAA Application. The Company and its teams of consultants continued to be actively engaged in the MAA process. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Previous wording
We recognized a net loss of $19.4 million and $23.5 million for the three months ended September 30, 2024 and 2023, respectively.
Current wording
We recognized a net loss of $19.3 million and $18.3 million for the three months ended March 31, 2025 and 2024, respectively.
Previous wording
For the three months ended September 30, 2024 and 2023, general and administrative expenses were $7.0 million and $7.0 million, respectively.
Current wording
For the three months ended March 31, 2025 and 2024, general and administrative expenses were $9.3 million and $8.1 million, respectively. The increase was mainly related to legal costs.
Previous wording
We recognized non-cash gain of $0.9 million and $3.9 million for the nine months ended September 30, 2024 and 2023, respectively. 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.
Current wording
We recognized a non-cash gain of $1.3 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively. The gain was primarily due to the decrease of our closing stock price as of March 31, 2025 and 2024 compared to December 31, 2024 and 2023. The higher gain in 2025 was mainly due to the non-cash revaluation gain recognized as of March 31, 2025 for certain warrants that were reclassified in liability in December 2024.
Previous wording
We recognized a non-cash gain of $3.1 million and a non-cash loss of $4.9 million change in fair value of the convertible notes during the three months ended September 30, 2024 and 2023. The non-cash gain was resulted from the decrease of the Company’s stock price and the non-cash loss was resulted from the increase of the Company’s stock price.
Current wording
We recognized a non-cash gain of $3.7 million and $1.8 million change in fair value of the convertible notes during the three months ended March 31, 2025 and 2024. The non-cash gain was resulted from the decrease of the Company’s stock price.
Previous wording
We recognized approximately $6.8 million and $1.8 million debt extinguishment loss during the three months ended September 30, 2024 and 2023 from debt redemptions and debt amendments, respectively. The increase during the three months ended September 30, 2024 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.
Current wording
We recognized approximately $7.3 million and $2.2 million debt extinguishment loss during the three months ended March 31, 2025 and 2024 from debt redemptions and debt amendments, respectively. The increase during the three months ended March 31, 2025 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.
Previous wording
During the three months ended September 30, 2024 and 2023, we recognized interest expense of $2.1 million and $1.7 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Current wording
During the three months ended March 31, 2025 and 2024, we recognized interest expense of $1.6 million and $1.5 million, respectively. The increase in interest expense in 2025 was mainly related to an increase of outstanding debt balance.
Previous wording
During the three months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.8 million and a loss of $1.7 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.
Current wording
During the three months ended March 31, 2025 and 2024, we recognized foreign currency transaction gain of $1.9 million and a loss of $0.7 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.
Previous wording
During the nine months ended September 30, 2024 and 2023, net cash outflows from operations were approximately $36.8 million and $36.7 million, respectively. The slight increase in cash used in operating activities was primarily attributable to an increase payment in legal costs.
Current wording
During the three months ended March 31, 2025 and 2024, net cash outflows from operations were approximately $9.4 million and $12.4 million, respectively. The decrease in cash used in operating activities was primarily attributable to lower payments for clinical trial related expenditures, insurance costs and certain consulting expenditures.
Previous wording
We spent approximately $0.9 million and $3.0 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the nine months ended September 30, 2024 and 2023, respectively.
Current wording
We spent approximately $0.1 million and $0.2 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the three months ended March 31, 2025 and 2024, respectively.
Previous wording
We received approximately $10.0 million net proceeds from issuance of 33.5 million shares of common stock during the nine months ended September 30, 2024.
Current wording
We received approximately $5.1 million cash from issuance of 22.7 million shares of common stock during the three months ended March 31, 2025.
Previous wording
We received approximately $8.2 million of cash from issuance of 0.8 million shares of Series C convertible preferred stock during the nine months ended September 30, 2024. We received approximately $9.9 million cash from issuance of 0.7 million shares of Series C convertible preferred stock during the nine months ended September 30, 2023.
Current wording
We received approximately $3.6 million cash from issuance of 0.3 million shares of Series C convertible preferred stock during the three months ended March 31, 2024.
Previous wording
We received approximately $9.9 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2024. We received approximately $12.7 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2023.
Current wording
We received approximately $2.2 million and $7.1 million of cash from issuance of convertible notes to individual lenders during the three months ended March 31, 2025 and 2024, respectively.
Previous wording
We received approximately $10.0 million and $10.0 million of cash from the issuance of a loan from a commercial lender during the nine months ended September 30, 2024 and 2023, respectively. We also received $2.0 million of cash from the issuance of a demand note to an individual investor during the nine months ended September 30, 2024.
Current wording
We received approximately $5.0 million of cash from the issuance of a loan from a commercial lender during the three months ended March 31, 2025.
Previous wording
We received approximately $1.5 million and $1.6 million of cash from the exercise of warrants during the nine months ended September 30, 2024 and 2023, respectively.
Current wording
We received approximately $17,000 and $1.3 million of cash from the exercise of warrants during the three months ended March 31, 2025 and 2024, respectively.
Previous wording
We received $50,000 from issuance of non-dilutive funding agreements during the nine months ended September 30, 2024. We received $4.6 million from issuance of non-dilutive funding agreements during the nine months ended September 30, 2023.
Current wording
We received $50,000 from issuance of non-dilutive funding agreements during the three months ended March 31, 2024.
Previous wording
We made aggregate debt payments of $1.1 million and $0.2 million during the nine months ended September 30, 2024 and 2023.
Current wording
We made aggregate debt payments of $0.6 million during the three months ended March 31, 2025.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Change in Fair Value of Derivatives
Previous report — wording carried elsewhere
Change in Fair Value of Convertible Notes
Previous report — wording carried elsewhere
We recognized approximately $9.9 million and $3.6 million debt extinguishment loss during the nine months ended September 30, 2024 and 2023 from the debt redemption and debt amendments, respectively. The increase during the nine months ended September 30, 2024 compared to last year was mainly due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.
Previous report — wording carried elsewhere
During the nine months ended September 30, 2024 and 2023, we recorded interest expense of $5.3 million and $4.0 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Previous report — wording carried elsewhere
During the nine months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.0 million and loss of $0.1 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.