NORTHWEST BIOTHERAPEUTICS INC
For the period ended Jun 30, 2025. Filed Aug 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.
Jun 30, 2025 · Filed Aug 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 2025-03-31; filed 2025-05-15.
0001410578-25-001333
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 66 previous paragraphs and 88 current paragraphs.
37 unchanged; 23 reworded; 21 added; 6 removed; 0 previous and 7 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 (21)
Current 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.
Current 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.
Current 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.
Current 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.
Current 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.
Current report
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 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.
Current report
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 report
Loss from Issuance of Debt
Current report
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 report
Six Months Ended June 30, 2025 and 2024
Current report
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 report
Research and Development Expense
Current report
General and Administrative Expense
Current report
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 report
Debt Extinguishment
Current report
Loss from Issuance of Debt
Current report
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 report
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 report
Interest Expense
Current report
Foreign currency transaction gain (loss)
Removed paragraphs (6)
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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).
Previous 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.
Reworded paragraphs (23)
Previous wording
During the first three months of 2025, the Company continued its progress on multiple fronts, including the following.
Current wording
During the second 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 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.
Current 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.
Previous wording
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 wording
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 wording
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 wording
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 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.
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
Previous 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.
Current 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.
Previous 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.
Current wording
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 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.
Current 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.
Previous 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.
Current 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.
Previous wording
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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of revenues and must cover our operating expenses through debt and equity financings to allow us to continue as a going concern. Our ability to continue as a going concern depends on the ability to obtain adequate capital to fund operating losses until we generate adequate cash flows from operations to fund our operating costs and obligations. If we are unable to obtain adequate capital, we could be forced to cease operations.
Current wording
We have experienced recurring losses from operations since inception. We have not yet established an ongoing source of material 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
We received $50,000 from issuance of non-dilutive funding agreements during the three months ended March 31, 2024.
Current wording
We received $50,000 from issuance of non-dilutive funding agreements during the six months ended June 30, 2024.
Previous wording
We made aggregate debt payments of $0.6 million during the three months ended March 31, 2025.
Current 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.
Rearranged current paragraphs (7)
Current report — wording carried from 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.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
Change in Fair Value of Derivatives
Current report — wording carried from elsewhere
Change in Fair Value of Convertible Notes
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.