NORTHWEST BIOTHERAPEUTICS INC
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
View on SEC.govAbout this filing
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.
Sep 30, 2025 · Filed Nov 14, 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 2025-06-30; filed 2025-08-14.
0001410578-25-001825
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001104659-25-112676
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 88 previous paragraphs and 86 current paragraphs.
47 unchanged; 29 reworded; 10 added; 10 removed; 2 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 (10)
Current report
Management Change. The unexpected passing of the Company’s Senior Vice President and General Counsel necessitated a transition period while other personnel took on new and/or additional roles.
Current report
Advent Acquisition. The Company negotiated an agreement to acquire Advent BioServices. The negotiations were completed and the acquisition agreement was entered into, with the closing to occur after certain conditions were fulfilled.
Current report
Development of the Sawston, UK Facility. The Company and Advent continued refining the design and engineering of the simplified C lab, and continued working with contractors to prepare for the construction works. The Company and Advent also continued working to source key equipment required for the C lab in ways to avoid the 10-12 month procurement backlog. For example, Advent was able to arrange for two major foundational pieces of equipment, which cost nearly $1 million each when purchased new. One of these pieces of equipment had been given up by another biotech company and the other was new; both were obtained for less than half price and without the 10-12 month procurement waiting time.
Current report
Manufacturing in the US for In-licensed Technologies. Based upon further assessments of the two candidate GMP manufacturing locations in the US which the Company had previously narrowed down to as finalists, the Company finalized its selection and undertook contract negotiations to secure the selected location and to allocate operational responsibilities. The Company continued the hiring process for personnel with the special types of expertise and prior experience needed for the initial core operating team for this location.
Current report
Potential Compassionate Use Programs in the US. The Company continued to explore the potential for expanded access/compassionate use in the US, particularly under state laws. The Company is pursing multiple potential hospital arrangements.
Current report
DCVax-Direct Program. The Company developed new DCVax-Direct clinical trial plans to supersede the clinical trials plans for which the IND packages were previously being developed, in order to take account of developments in the field. The manufacturing and product-related portions of the IND packages have already been completed. The Company is continuing its analyses to select additional
Current report
treatment elements from the portfolios in-licensed from Roswell Park, Pittsburgh and others to include in the new clinical trial designs (e.g., pre-conditioning regimens before the dendritic cell therapy; booster agents accompanying the dendritic cell therapy; multiple routes of administration).
Current report
For the three months ended September 30, 2025 and 2024, general and administrative expenses were $7.1 million and $7.0 million, respectively. The expenses were consistent compared to the same period of last year.
Current report
We recognized a non-cash loss of $3.3 million and a non-cash loss of $1.6 million for the three months ended September 30, 2025 and 2024, respectively. The non-cash revaluation loss in 2025 was mainly due to the amendment to certain liability classified warrants. The extension of the maturity date of the warrants increased the fair value of the warrants. The non-cash loss in 2024 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.
Current report
Nine months Ended September 30, 2025 and 2024
Removed paragraphs (10)
Previous report
Comments on Potential New MHRA Policies. In the UK, the MHRA issued a draft Guideline of important potential new policies under which clinical trials would be allowed to use external controls instead of within-study placebo arms, especially for severe or rare diseases, and the MHRA called for public comments during the second quarter. The Company worked together with physician collaborators, patient groups, statisticians, academics and political representatives to help mobilize public comments.
Previous report
Manufacturing in the Sawston, UK Facility. Building upon the design and engineering work in preceding months, the Company and Advent developed an improved design and configuration for the simplified Grade C lab. The Company and Advent also negotiated the construction arrangements and undertook preparations to enable construction to begin in the third quarter. The Company and Advent undertook strategic planning for consolidation of the operations in the London GMP facility and the Sawston GMP facility, to reduce overall costs and increase capacity in Sawston. The Company and Advent also undertook strategic planning for operations in the Sawston facility to increase the focus and resources on ramp-up of manufacturing relative to other operations such as product and process development (PD) now that years of intensive PD work for the MAA and the DCVax-Direct program have been completed by Advent.
Previous report
Manufacturing in the US for In-licensed Technologies. The Company continued its progress on developing manufacturing capacity in the US for technologies that the Company has in-licensed. (The Sawston facility is handling the manufacturing of the Company’s DCVax-L and DCVax-Direct products for global use.) After extensive discussions in prior quarters with GMP facilities in several states, the Company selected two locations as the finalist candidates for development the US manufacturing capacity. The Company progressed with contract negotiations in both locations, and anticipates reaching an agreement in the near term. The Company also undertook personnel screening and selection processes for the specialized expertise required, and has secured certain initial key anchor personnel. The Company is in the process of negotiations with key equipment suppliers.
Previous report
Potential Compassionate Use Programs in the US. The Company has had a compassionate use program in the UK for a number of years, and believes that those compassionate use cases have been helpful for the patients involved and have generated real world data that is quite useful. As previously reported, the Company is expanding its existing compassionate use program with additional clinics
Previous report
and doctors. The Company is also interested in undertaking a compassionate use program in the US when feasible. The Company has noted that well over a dozen US states have enacted expanded compassionate use legislation, including during this year to date, and that expanded access programs are also possible at the federal level. The Company is actively exploring the potential for expanded access/ compassionate use in the US.
Previous report
DCVax-Direct Program. As previously reported, the Company has been developing INDs for the initial clinical trials with the Company’s new DCVax-Direct product. The manufacturing and product-related portions of the IND packages have been completed. The clinical portions are being further refined (including with respect to the selection of booster agent(s) as described below) in consultation with clinician/investigators. The Company is evaluating the potential to include certain technology elements in-licensed from Roswell Park, and is considering testing the treatments in ovarian cancer, building upon the positive results of the Company’s prior trial in late-stage ovarian cancer (for which there is a severe unmet need for new treatment options). The Company plans to proceed with the initial trial in the coming months.
Previous report
Enhanced DCVax-Direct Products and Presentation. The Company made its first public presentation of some of the results of its ongoing internal research, testing 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 presented these results at the New York Academy of Sciences in June. The Company is in the process of finalizing its decisions about which booster agent(s) and which enhanced DCVax-Direct products to test in the DCVax-Direct clinical trials pursuant to the INDs described above.
Previous report
For the three months ended June 30, 2025 and 2024, general and administrative expenses were $7.5 million and $9.7 million, respectively. The decrease was mainly related to a reduction in legal costs due to certain reimbursements and reduction in scientific conference expenses.
Previous report
We recognized a non-cash gain of $0.7 million and $2.4 million for the three months ended June 30, 2025 and 2024, respectively. The non-cash revaluation gain was mainly due to the decrease of stock price and remaining life of certain liability classified warrants.
Previous report
Six Months Ended June 30, 2025 and 2024
Reworded paragraphs (29)
Previous wording
During the second quarter of 2025, the Company continued its progress on multiple fronts, including the following.
Current wording
During the third quarter of 2025, the Company continued its progress on multiple fronts, including the following.
Previous wording
MAA Application. The Company and its teams of consultants continued to devote a large portion of their time to active engagement in the MAA process during the second quarter. 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. Much of the Company’s time and resources were devoted to active engagement in the MAA review process. The Company continued to work with large teams of consultants on this process. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Previous wording
Litigation Progress. The Company’s lawsuit against certain market makers entered the long-awaited discovery phase during the second quarter. The Company is expanding its activities related to the case, and expects to further ramp up its activities in the coming months. The Company believes that the discovery process will potentially yield very important information, and the Company plans to continue pursuing the case vigorously. See Part II Item 1, Legal Proceedings, below.
Current wording
Litigation Progress. The discovery period continued in the Company’s lawsuit against certain market makers. The Company increased its pursuit of documents and information from the defendants, and anticipates further ramping up in the coming months. The Company also added counsel with substantial experience in market manipulation cases. The Company believes that the discovery process may yield very important information, and the Company plans to continue pursuing the case vigorously. See Part II Item 1, Legal Proceedings, below.
Previous wording
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
Current wording
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.
Previous wording
We recognized a net loss of $15.4 million and $17.9 million for the three months ended June 30, 2025 and 2024, respectively.
Current wording
We recognized a net loss of $26.8 million and $19.4 million for the three months ended September 30, 2025 and 2024, respectively.
Previous wording
For the three months ended June 30, 2025 and 2024, research and development expenses were $7.4 million and $8.3 million, respectively. The decrease in 2025 was primarily related to the decrease in stock-based compensation.
Current wording
For the three months ended September 30, 2025 and 2024, research and development expenses were $7.5 million and $8.1 million, respectively. The decrease in 2025 was primarily related to the decrease in manufacturing cost in the Specials-Compassionate Treatment program and stock-based compensation.
Previous wording
We recognized a non-cash gain of $2.4 million and a non-cash loss of $0.2 million change in fair value of the convertible notes during the three months ended June 30, 2025 and 2024, respectively. The non-cash gain was resulted from the decrease of the Company’s stock price as of the date of remeasurement compared to prior period. The non-cash loss was resulted from the increase of the Company’s stock price as of the date of remeasurement compared to prior period.
Current wording
We recognized a non-cash loss of $15,000 and a non-cash gain of $3.1 million change in fair value of the convertible notes during the three months ended September 30, 2025 and 2024, respectively. The stock price was consistent as of September 30, 2025 and June 30, 2025. The non-cash gain resulted from the decrease of the Company’s stock price as of the date of re-measurement compared to the prior period.
Previous wording
We recognized approximately $11.8 million and $3.1 million debt extinguishment loss during the six months ended June 30, 2025 and 2024 from debt redemptions and debt amendments, respectively. The increase during the six months ended June 30, 2025 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $8.5 million.
Current wording
We recognized approximately $4.0 million and $6.8 million debt extinguishment loss during the three months ended September 30, 2025 and 2024 from debt redemptions and debt amendments, respectively. The decrease during the three months ended September 30, 2025 compared to last year was due to the less fluctuation in the stock price.
Previous wording
During the three months ended June 30, 2025, we recognized an $0.8 million loss from the issuance of the June Yorkville Note, which we elected to account for under the FVO. The estimated fair value of the June Yorkville Note on the issuance date was approximately $3.8 million, which resulted in a loss of $0.8 million calculated at the difference between the principal amount and the fair value of the June Yorkville Note.
Current wording
During the three months ended September 30, 2025, we recognized an $1.6 million loss from the issuance of three convertible notes, which we elected to account for under the FVO. The estimated fair value of the convertible notes on the issuance date was approximately $5.1 million, which resulted in a loss of $1.6 million calculated at the difference between the aggregate principal amount of $3.5 million and the fair value of these three convertible notes.
Previous wording
During the three months ended June 30, 2025 and 2024, we recognized interest expense of $1.8 million and $1.7 million, respectively. The increase in interest expense in 2025 was mainly related to an increase of outstanding debt balance.
Current wording
During the three months ended September 30, 2025 and 2024, we recognized interest expense of $2.6 million and $2.1 million, respectively. The increase in interest expense in 2025 was mainly related to an increase in outstanding debt balance.
Previous wording
During the three months ended June 30, 2025 and 2024, we recognized foreign currency transaction gain of $3.6 million and a loss of $45,000, 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 September 30, 2025 and 2024, we recognized foreign currency transaction loss of $0.8 million and a gain of $2.8 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
We recognized a net loss of $34.7 million and $36.2 million for the six months ended June 30, 2025 and 2024, respectively.
Current wording
We recognized a net loss of $61.6 million and $55.6 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
For the six months ended June 30, 2025 and 2024, research and development expenses were $15.8 million and $16.2 million, respectively. The decrease in 2025 was primarily related to the decrease in stock-based compensation and offset by an increased cost related to MAA application at the MHRA and the resumption of DCVax-Direct production.
Current wording
For the nine months ended September 30, 2025 and 2024, research and development expenses were $23.2 million and $24.4 million, respectively. The decrease in 2025 was primarily related to the decrease in stock-based compensation and offset by increased cost related to MAA application at the MHRA and the resumption of DCVax-Direct production.
Previous wording
For the six months ended June 30, 2025 and 2024, general and administrative expenses were $16.8 million and $17.8 million, respectively. The decrease was mainly related to a reduction in stock-based compensation and scientific conference expenses. an increase in legal expenses.
Current wording
For the nine months ended September 30, 2025 and 2024, general and administrative expenses were $23.9 million and $24.8 million, respectively. The decrease was mainly related to a reduction in stock-based compensation and scientific conference expenses and offset by an increase in legal expenses.
Previous wording
We recognized a non-cash gain of $2.0 million and $2.5 million for the six months ended June 30, 2025 and 2024, respectively. The gain was primarily due to the decrease of our closing stock price as of June 30, 2025 and 2024 compared to December 31, 2024 and 2023.
Current wording
We recognized a non-cash loss of $1.3 million and a non-cash gain of $0.9 million for the nine months ended September 30, 2025 and 2024, respectively. The non-cash revaluation loss in 2025 was mainly due to the amendment to certain liability classified warrants. The extension of the maturity date of the warrants increased the fair value of the warrants. The non-cash gain in 2024 was primarily due to the decrease of our closing stock price as of September 30, 2025 and 2024 compared to December 31, 2024 and 2023.
Previous wording
We recognized $6.1 million and $1.5 million non-cash gain from change in fair value of the convertible notes during the six months ended June 30, 2025 and 2024, respectively. The non-cash gain resulted from the decrease of the Company’s stock price.
Current wording
We recognized $6.1 million and $4.6 million non-cash gains from change in fair value of the convertible notes during the nine months ended September 30, 2025 and 2024, respectively. The non-cash gains resulted from the decrease of the Company’s stock price.
Previous wording
We recognized approximately $4.5 million and $0.9 million debt extinguishment loss during the three months ended June 30, 2025 and 2024 from debt redemptions and debt amendments, respectively. The increase during the three months ended June 30, 2025 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $2.8 million.
Current wording
We recognized approximately $15.8 million and $9.9 million debt extinguishment loss during the nine months ended September 30, 2025 and 2024 from debt redemptions and debt amendments, respectively. The increase during the nine months ended September 30, 2025 compared to last year was due to multiple amendments on the existing convertible notes.
Previous wording
During the six months ended June 30, 2025, we recognized an $0.8 million loss from the issuance of the June Yorkville Note, which we elected to account for under the FVO. The estimated fair value of the June Yorkville Note on the issuance date was approximately $3.8
Current wording
During the nine months ended September 30, 2025, we recognized $2.4 million loss from the issuance of certain convertible notes, which we elected to account for under the FVO. The estimated fair value of these convertible notes on the issuance date was approximately $8.9 million, which resulted in a loss of $2.4 million calculated at the difference between the principal amount of $6.5 million and the fair value of these convertible notes.
Previous wording
During the six months ended June 30, 2025 and 2024, we recognized interest expense of $3.4 million and $3.2 million, respectively. The increase in interest expense in 2025 was mainly related to an increase of outstanding debt balance.
Current wording
During the nine months ended September 30, 2025 and 2024, we recognized interest expense of $6.0 million and $5.3 million, respectively. The increase in interest expense in 2025 was mainly related to an increase in outstanding debt balance.
Previous wording
During the six months ended June 30, 2025 and 2024, we recognized foreign currency transaction gain of $5.5 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.
Current wording
During the nine months ended September 30, 2025 and 2024, we recognized foreign currency transaction gain of $4.7 million and $2.0 million, respectively. The gains were due to the strengthening of the British pound sterling relative to the U.S. dollar.
Previous wording
During the six months ended June 30, 2025 and 2024, net cash outflows from operations were approximately $16.1 million and $28.6 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.
Current wording
During the nine months ended September 30, 2025 and 2024, net cash outflows from operations were approximately $30 million and $36.8 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 $0.4 million and $0.8 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the six months ended June 30, 2025 and 2024, respectively.
Current wording
We spent approximately $0.6 million and $0.9 million in cash for the purchase of additional equipment and design, engineering and preparations for our build-out in Sawston, UK during the nine months ended September 30, 2025 and 2024, respectively. We also provided a short-term loan of approximately $0.3 million to an unrelated third party in the U.K.
Previous wording
We received approximately $12.4 million and $2.9 million cash from issuance of 56.1 million and 8.1 million shares of common stock during the six months ended June 30, 2025 and 2024, respectively.
Current wording
We received approximately $17.3 million and $10.0 million cash from issuance of 78.5 million and 33.5 million shares of common stock during the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
We received approximately $7.9 million of cash from issuance of 0.7 million shares of Series C convertible preferred stock during the six months ended June 30, 2024.
Current 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.
Previous wording
We received approximately $5.5 million and $7.1 million of cash from issuance of convertible notes to individual lenders during the six months ended June 30, 2025 and 2024, respectively.
Current wording
We received approximately $12.7 million and $9.9 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
We received approximately $7.0 million of cash from the issuance of a loan from a commercial lender during the six months ended June 30, 2025. We received approximately $10.0 million of cash from the issuance of a loan from a commercial lender during the six months ended June 30, 2024.
Current wording
We received approximately $7.0 million of cash from the issuance of a loan from a commercial lender during the nine months ended September 30, 2025. We received approximately $12.0 million of cash from the issuance of a loan from a commercial lender during the nine months ended September 30, 2024.
Previous wording
We received approximately $23,000 and $1.5 million of cash from the exercise of warrants during the six months ended June 30, 2025 and 2024, respectively.
Current wording
We received approximately $23,000 and $1.5 million of cash from the exercise of warrants during the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
We received $50,000 from issuance of non-dilutive funding agreements during the six months ended June 30, 2024.
Current wording
We received $50,000 from issuance of non-dilutive funding agreements during the nine months ended September 30, 2024.
Previous wording
We made aggregate debt payments of $0.8 million and $0.2 million during the six months ended June 30, 2025 and 2024, respectively.
Current wording
We made aggregate debt payments of $1.3 million and $1.1 million during the nine months ended September 30, 2025 and 2024, respectively.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
million, which resulted in a loss of $0.8 million calculated at the difference between the principal amount and the fair value of the June Yorkville Note.