NORTHWEST BIOTHERAPEUTICS INC
For the period ended Mar 31, 2026. Filed May 15, 2026.
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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, 2026 · Filed May 15, 2026
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 2025-09-30; filed 2025-11-14.
0001104659-25-112676
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001104659-26-062661
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 86 previous paragraphs and 75 current paragraphs.
37 unchanged; 16 reworded; 22 added; 30 removed; 3 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 (22)
Current report
UK Strategic Advisor. As previously reported, the Company engaged a new Strategic Advisor, Dr. Annalisa Jenkins. Dr. Jenkins has extensive experience in big pharma, biotech and medical innovation, and is a key opinion leader in the UK and globally. Dr. Jenkins will advise and help the Company advance the development of its DCVax cancer vaccines. The Company believes that Dr. Jenkins’ experience, advice and involvement will be a valuable resource.
Current report
UK Clinic*.* As also previously reported, the Company’s pursuit of clinic arrangements or collaborations in the UK culminated in the Company establishing a clinic arrangement with the London Welbeck Hospital in the Harley Street medical district in London. During the first quarter, the Company secured a contractor and proceeded with buildout. The clinic includes two leukapheresis units, each of which can conduct two procedures per day for a total of 4 patients per day. The clinic may also offer extended hours and weekend operations. There is a general shortage of leukapheresis capacity in the UK, and such procedures are needed for T cell products as well as for dendritic cell products. The buildout is anticipated to be completed by June and the Company is pursuing applications for the required licenses.
Current report
Development of the Sawston, UK Facility. The Company and Advent continued the development process for the initial Grade C lab in the Sawston facility. The Company and Advent worked with advisers and the construction firm to modify the C lab design so as to increase its capacity and enable faster pace of certain operations. The development activity involving construction work was paused; the engineering work was ongoing.
Current report
Secondary Manufacturing in the UK. The Company continued discussions for a collaboration that could potentially lead to a second DCVax production operation in another region of the UK, using an existing established GMP facility with training of the personnel to be conducted by Advent. Since this secondary facility would not require buildout and is located in a relatively low-cost area, the
Current report
Company anticipates that it could be brought online rapidly and economically. The Company is pursuing planning discussions with the party in charge of the facility.
Current report
Manufacturing in the US – DCVax Products and Kalinski aDC1 Products. The Company has been pursuing separate parallel tracks to develop manufacturing in the US of the Company’s DCVax-L products and of the aDC1 products pursuant to the technologies of Dr. Kalinski that the Company has in-licensed. For the production of DCVax-L products, during the first quarter the Company completed the selection of a US company, contract negotiations and entered into a technology transfer agreement for development of DCVax-L manufacturing capacity by the US company. The Standard Operating Procedures (SOPs) used in the UK are being adapted to the US facilities and operations, and training began during the first quarter. The Company anticipates that the required engineering runs and validations will be completed during the summer.
Current report
For the production of Kalinski aDC1 products, the Company is working primarily to develop its own GMP manufacturing operation in the US, although it is also in discussions with a contractor for such production as an alternative. The Company has been in ongoing negotiations since last year to secure lease arrangements for a suitable GMP facility. In the meantime, during the first quarter the Company completed the lengthy recruitment process and hired the key manager to lead the aDC1 manufacturing operations.
Current report
Development Activity With In-Licensed Technologies. An updated trial design and IND package for an initial clinical trial of the Kalinski technology involving the Company were completed during the first quarter. The lead medical institution for the clinical trial has been determined and the IND package has been submitted to the Institutional Review Board (IRB) there. The Company anticipates submission to the FDA in the second quarter.
Current report
*UK Property Development.*The Company owns a 17-acre parcel of land on the edge of Sawston, UK which is located across the road from the Company’s manufacturing facility and adjacent to existing residential neighborhoods. The Company owns unencumbered fee title to the land. There is a pressing shortage of housing in the region and the Local Council is conducting a review of the land and zoning in the area. The Company’s property is not currently zoned for housing development despite its location on the edge of the town and adjacent to other residential areas. If zoned for residential development, the Company has been advised that its property would be extremely valuable. During the first quarter, the Company worked with a team of advisers to develop an application for rezoning of its property and submitted the application as part of the Local Council review process.
Current report
Litigation Progress. The Company continued vigorously pursuing documents and information both from the defendants and from third parties in the discovery stage of its litigation in New York against certain market makers. On April 30, 2026, the Company and one of the lesser defendants agreed to resolve the Company’s case against that defendant by settlement. The parties so notified the Court. The settlement is confidential. The funds are being held in escrow while the Company pursues discussions with other lesser defendants about resolution of the case against them. The Company anticipates that the funds will be released from escrow when the discussions with the lesser defendants have been completed. See Part II Item 1, Legal Proceedings, below.
Current report
Settlement Gain
Current report
During the three months ended March 31, 2026, the Company recognized a $2.25 million gain related to the Delaware litigation settlement.
Current report
We recognized a non-cash gain on the change in fair value of derivatives of $9.4 million and $1.3 million for the three months ended March 31, 2026 and 2025, respectively. The non-cash gain of $9.4 million for the three months ended March 31, 2026, resulted from a fair value adjustment to the contingent note payable. Based on current assessments, the achievement of the underlying performance conditions required for payment is not probable prior to the note’s expiration on May 21, 2026. Consequently, the fair value of the liability was reduced to zero as of March 31, 2026. The gain in the three months ended March 31, 2025 was mainly due to the non-cash revaluation gain for certain warrants that were reclassified as liabilities as of December 2024.
Current report
Change in Fair Value of Share Payable
Current report
We recognized a non-cash gain of $0.2 million and a non-cash loss of $23,000 from the change in fair value of share payable during the three months ended March 31, 2026 and 2025, respectively. The fluctuations were mainly due to the movement of our stock price.
Current report
Inducement expense
Current report
We recognized an inducement expense of $87,000 related a convertible note that had an inducement conversion during the three months ended March 31, 2026.
Current report
Cash Flows
Current report
During the three months ended March 31, 2026 and 2025, total operating costs and expenses were approximately $11.4 million and $17.7 million, respectively. Net cash outflows from operations were approximately $12.5 million (including payments for prior periods’ accounts payables) and $9.4 million, respectively. The increase in cash used in operating activities was primarily attributable to the strengthening of the British Pound relative to the U.S. Dollar.
Current report
During the three months ended March 31, 2026 and 2025, cash used in investing activities were approximately $0.1 million and $0.1 million, respectively.
Current report
We received approximately $2.9 million and $5.1 million of cash from issuance of common shares during the three months ended March 31, 2026 and 2025, respectively.
Current report
We made aggregate payments of approximately $0.7 million to the seller in connection with the Advent acquisition in October 2025 during the three months ended March 31, 2026.
Removed paragraphs (30)
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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
Previous 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).
Previous report
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 report
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 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.
Previous 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.
Previous report
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 report
Nine months Ended September 30, 2025 and 2024
Previous report
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 report
Research and Development Expense
Previous report
General and Administrative Expense
Previous report
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 report
Debt Extinguishment
Previous report
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 report
Loss from Issuance of Debt
Previous report
Interest Expense
Previous report
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 report
Foreign currency transaction gain (loss)
Previous report
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 report
Cash Flow
Previous report
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 report
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 report
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 report
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 report
We received $50,000 from issuance of non-dilutive funding agreements during the nine months ended September 30, 2024.
Reworded paragraphs (16)
Previous wording
During the third quarter of 2025, the Company continued its progress on multiple fronts, including the following.
Current wording
During the first three months of 2026, the Company continued its progress on multiple fronts, including the following:
Previous 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.
Current wording
MAA Application. Much of the Company’s time and resources continued to be devoted to active engagement in the MAA review process during the first quarter. 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
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.
Current wording
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 and required for ongoing interaction with the regulatory agency while the application undergoes review.
Previous 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.
Current wording
We recognized a net loss of $3.1 million and $19.3 million for the three months ended March 31, 2026 and 2025, respectively.
Previous 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.
Current wording
For the three months ended March 31, 2026 and 2025, research and development expenses were $4.9 million and $8.4 million, respectively. The decrease in 2026 was primarily related to a decrease in the costs related to the MAA application at the MHRA, a decrease in stock based compensation to external consultants and the acquisition of Advent in the 4 th quarter in 2025.
Previous 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.
Current wording
For the three months ended March 31, 2026 and 2025, general and administrative expenses were $6.5 million and $9.3 million, respectively. The decrease was mainly related to a reduction in legal costs.
Previous 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.
Current wording
We recognized a non-cash gain of $5.2 million and $3.7 million for the change in fair value of the convertible notes during the three months ended March 31, 2026 and 2025, respectively. The non-cash gains resulted from the decrease of the Company’s stock price. In addition, the increased gain during the three months ended March 31, 2026 was also attributable to a change in certain assumptions used in the valuation of the convertible notes.
Previous 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.
Current wording
We recognized approximately $4.8 million and $7.3 million debt extinguishment loss during the three months ended March 31, 2026 and 2025, respectively, from debt redemptions and debt amendments. The decrease during the three months ended March 31, 2026 compared to last year in the same period was due to less volume of debt amendments.
Previous 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.
Current wording
We recognized approximately $0.7 million loss from issuance of certain convertible notes, which we elected to account for under the FVO during the three months ended March 31, 2026. The loss was calculated as the difference between the principal amount and the fair value of these convertible notes.
Previous 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.
Current wording
During the three months ended March 31, 2026 and 2025, we recognized interest expense of $2.3 million and $1.6 million, respectively. The increase in interest expense in 2026 was mainly related to the issuance costs related to certain convertible notes issued in March 2026, which we elected to account for under the FVO.
Previous 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.
Current wording
During the three months ended March 31, 2026 and 2025, we recognized foreign currency transaction loss of $1.3 million and a gain of $1.9 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to British pound sterling and vice versa for the loss.
Previous 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.
Current 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.
Previous 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.
Current wording
We received approximately $7.5 million and $2.2 million of cash from issuance of convertible notes to individual lenders during the three months ended March 31, 2026 and 2025, respectively.
Previous 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.
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 $23,000 and $1.5 million of cash from the exercise of warrants during the nine months ended September 30, 2025 and 2024, respectively.
Current wording
We received approximately $6,000 and $17,000 of cash from the exercise of warrants during the three months ended March 31, 2026 and 2025, respectively.
Previous 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.
Current wording
We made aggregate debt payments of $0.5 million and $0.6 million during the three months ended March 31, 2026 and 2025, respectively.
Rearranged previous paragraphs (3)
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 $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.