NORTHWEST BIOTHERAPEUTICS INC
For the period ended Jun 30, 2024. Filed Aug 9, 2024.
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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.
Jun 30, 2024 · Filed Aug 9, 2024
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 2024-03-31; filed 2024-05-10.
0001410578-24-000741
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-09.
0001410578-24-001278
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 67 previous paragraphs and 88 current paragraphs.
39 unchanged; 21 reworded; 22 added; 7 removed; 0 previous and 6 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
Intellectual Property and Collaborations. During the second quarter, the Company completed the exclusive in-license of a portfolio of dendritic cell (DC) technologies and clinical programs from the prestigious Roswell Park Comprehensive Cancer Center (Roswell). The license was the culmination of more than 2 years of discussions and negotiations, and builds on a portfolio licensed last year from another institution that included years of foundational work. Together, the packages include intellectual property generated over many years, as well as 5 new patent families just filed last year, by a leading group of dendritic cell experts. The IP includes enhanced versions of DC products, immune boosters and conditioning regimens to help reprogram the TME (tumor microenvironment) and help increase a patient's responsiveness to immune therapies. The packages also include clinical data and documents that will save time and resources and help avoid the Company having to reinvent the wheel.
Current report
The in-licensed technologies in the combined packages are now in three Phase 2 trials that are fully funded by grants and fully being carried out by the investigators. Two of these trials opened earlier this year. The third trial just opened within the last couple of weeks and has already begun enrolling as well. The Company believes that the in-license of these two portfolios constitutes a major step toward the Company's goal of building a leading dendritic cell franchise.
Current report
Apart from the new in-licenses from Roswell, the Company's patent portfolio expanded substantially during the second quarter. The portfolio includes patents developed by the Company itself and patents under in-licenses from parties other than Roswell. In regard to the Flaskworks technologies, 5 new patents were allowed and 1 new patent issued during the quarter. In regard to the dendritic cell technologies and related IP, 1 new patent was allowed and issue fees were paid for 4 new patents that were allowed in the first quarter. The Company believes that its patent portfolio is a significant asset, both for the Company's medical products and as a separate asset in and of itself.
Current report
Pipeline. A number of activities have been under way to expand the Company's pipeline. A major focus is on preparations for restart of the DCVax-Direct program. Extensive work by Advent BioServices is ongoing for this restart. The manufacturing process for DCVax-Direct is materially different than for DCVax-L. Restart of the program requires a technology transfer process for transfer of the process to the U.K., development of new sets of SOPs (Standard Operating Procedures) for DCVax-Direct in the Sawston facility and development of U.K. regulatory documents, training of personnel, numerous engineering runs both informally for practice and formally to validate the process, comparability testing and analyses of both the process and the products produced. Certain new development work has also been necessary, relating to the equipment and system for the DCVax-Direct manufacturing and relating to certain key ingredients of the product.
Current report
As noted above, the portfolio acquired from Roswell is also contributing to pipeline expansion. Two of the 3 Phase 2 trials involving IP in-licensed from Roswell are in cancers beyond those for which the Company has conducted trials itself. One of the trials is in melanoma that is refractory to checkpoint inhibitor drugs. Another is in brain metastases of breast cancer. The newest trial is in ovarian cancer. These 3 Phase 2 trials are open for enrollment and actively progressing. These 3 Phase 2 trials constitute a substantial pipeline in and of themselves.
Current report
Flaskworks. The design work to make the Flaskworks system GMP-compatible was completed. This work focused on two key areas: the ability to clean the machines to the level of sterility required for GMP operations, and additional safety features for protection of the operators in the GMP setting. The Flaskworks team and Advent BioServices also continued to work with the specialized contractor on additional modifications to reduce the footprint of the GMP-compatible Flaskworks system, to enable more systems to fit into the planned Grade C labs and enable further increases in the production capacity.
Current report
Annual Shareholder Meeting. Preparations for the Annual Shareholder Meeting, the Proxy and the voting process were a major focus of activity during the second quarter of 2024. The Annual Meeting was held on June 29, 2024. The Company's shareholders approved all of the items slated for votes, including re-election of directors, re-appointment of the Company's auditor, re-approval/ratification of options awarded in 2020 to management and directors, and approval on an advisory basis of 2023 management compensation.
Current report
Litigation. The Company's litigation against certain market makers continued to progress during the second quarter of 2024. The case is described in Part II - Item 1, Legal Proceedings, below.
Current report
We recognized a non-cash gain of $2.4 million and a non-cash gain of $0.1 million for the three months ended June 30, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of June 30, 2024 and 2023 compared to March 31, 2024 and 2023. In addition, the warrant liability related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”) expired as of June 11, 2024, which resulted $0.9 million non-cash gain from change in fair value.
Current report
We recognized approximately $0.9 million and $0.5 million debt extinguishment loss during the three months ended June 30, 2024 and 2023 from the debt redemption, respectively.
Current report
Six Months Ended June 30, 2024 and 2023
Current report
We recognized a net loss of $36.2 million and $25.1 million for the six months ended June 30, 2024 and 2023, respectively.
Current report
Research and Development Expense
Current report
General and Administrative Expense
Current report
For the six months ended June 30, 2024 and 2023, general and administrative expenses were $17.8 million and $14.5 million, respectively. The increase in 2024 was primarily related to an increase of $2.7 million in legal expenses.
Current report
the warrant liability related to certain conditional rights to independently purchase shares from the Company in a future raise of capital (the “Piggy-back Rights”) expired as of June 11, 2024, which resulted $0.9 million non-cash gain from change in fair value.
Current report
Debt Extinguishment
Current report
During the six months ended June 30, 2023, we issued approximately 15.2 million shares of common stock with a fair value of $9.6 million to certain lenders in lieu of cash payments of $7.4 million of debt, including $0.7 million accrued interest. In addition, pursuant to exchange agreements executed with various holders, the Company is required to potentially issue additional common stock (the "Share liability") if the stock price is less than the price defined in the exchange agreement as of the true-up date. During the six months ended June 30, 2023, we extinguished Share liabilities of $1.1 million and recognized an additional $0.6 million of Share liabilities. We recognized an approximately $1.8 million debt extinguishment loss during the six months ended June 30, 2023 from the debt redemption.
Current report
During the six months ended June 30, 2023, we issued approximately 56,000 shares of Series C preferred stock at fair value of $1.0 million to certain lenders in lieu of cash payments of $0.9 million debt, including $0.1 million accrued interest. We recognized an approximately $0.1 million debt extinguishment loss.
Current report
Interest Expense
Current report
Foreign currency transaction loss
Current report
We received approximately $2.9 million net proceeds from issuance of 8.1 million shares of common stock during the six months ended June 30, 2024.
Removed paragraphs (7)
Previous report
The Company’s programs and operations continue to be impacted by supply chain issues and backlogs which, surprisingly, have still not substantially resolved. These involve service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The Company is hopeful that the various backlog circumstances will improve over the course of 2024.
Previous report
MAA Application*.* As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.
Previous report
Flaskworks*.* The Flaskworks team and Advent BioServices continued to work with the specialized contractor on the development of the GMP-grade units of the Flaskworks system. Two key areas of focus in the work have been the ability to clean the machines to GMP requirements and additional safety features for protection of the operators in the GMP setting. Enabling all parts of the machines to be cleanable to the level of sterility required for GMP operations has required changing certain materials to achieve acceptable surface properties, constructing housings around certain portions of the machines or otherwise eliminating nooks and crannies while not interfering with the movements of the machines, and other such development aspects. The Company believes the work is on track for the GMP adaptation work to be finished in the near future, and the first GMP units to be delivered to the Company soon after that.
Previous report
Intellectual Property and Collaborations. As previously reported, the Company filed new patent applications relating to the Flaskworks system, which the Company believes will be an important factor for facilitating scale - up and commercialization of DCVax - L products. In addition, multiple new patents were granted and 1 new patent was allowed from patent applications previously filed. The Company continued working with certain intellectual property that it has in - licensed as previously reported, on preparations for expansion of the Company’s pipeline with certain new clinical programs when bandwidth and resources permit. The Company also continued discussions and negotiations during the first quarter of 2024 relating to collaborations which the Company believes will help it build a broad franchise in dendritic cell-based immunotherapies.
Previous report
Litigation*.* Significant amounts of Company bandwidth and resources were spent on litigations during the first quarter of 2024 (and to date in the second quarter of 2024). The cases are described in Part II - Item 1, Legal Proceedings, below.
Previous report
Annual Shareholder Meeting. The Company plans to conduct its Annual Shareholder Meeting before the end of June 2024.
Previous report
We recognized an approximately $1.4 million debt extinguishment loss during the three months ended March 31, 2023 from the debt redemption.
Reworded paragraphs (21)
Previous wording
During the first quarter of 2024, the Company continued its progress on multiple fronts, including the following.
Current wording
During the first half of 2024, the Company continued its progress on multiple fronts, including the following.
Previous wording
As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete.
Current wording
MAA Application. As previously reported, the Company has been working intensively with teams of consultants on activities related to the review of the Company's Marketing Authorization Application (MAA) by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). The overall process includes an initial review process, a clock stop period when the review process stops while the applicant addresses questions and requests for additional information, then additional review processes as well as inspections. 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
Preparations for Regulatory Inspections*.* As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.
Current wording
Preparations for Regulatory Inspections. As previously reported, preparations for regulatory inspections associated with the MAA have been a major focus of the Company’s activities this year to date, including mock inspections. Inspections by MHRA are scheduled to take place in both the U.S. and the U.K.
Previous wording
Sawston Facility*.* The Company has commenced the design and build works for the construction of the first Grade C cleanroom at the Sawston facility and the contractor is onsite. The Company expects the Grade C cleanrooms to be important for scale - up, as they will accommodate the “closed” Flaskworks system, and be able to manufacture a number of patients’ products in the lab at the same time. In contrast, with the existing “open” process in the Grade B cleanrooms, products must be manufactured for one patient at a time and the whole lab must be cleaned and sterilized between each patient’s process. Since construction work in the facility can directly and/or indirectly impact the existing cleanrooms in the facility (e.g., by generating a lot of dust and particles) and prevent the existing Grade B cleanrooms from being able to operate in accordance with GMP sterility standards, the Company has been working with Advent BioServices and contractors to arrange for the construction work to take place as much as possible during periodic scheduled shutdowns of the existing clean rooms for deep cleaning and special maintenance which are required for GMP compliance.
Current wording
Sawston Facility. The Company continued the planning and design work for the first Grade C cleanroom at the Sawston facility. The Company expects the Grade C cleanrooms to be important for scale-up, as they will accommodate the “closed” Flaskworks system, and be able to manufacture a number of patients’ products in the lab at the same time.
Previous wording
Pediatric Glioma Clinical Trials*.* The Company continued its discussions with physicians about the two planned trials of DCVax - L for pediatric gliomas. The arrangements for the trials have not yet been finalized.
Current wording
Pediatric Glioma Clinical Trials. The Company continued its discussions with physicians about the two planned trials of DCVax-L for pediatric gliomas and reached conceptual agreement with the physicians.
Previous wording
We recognized a net loss of $18.3 million and $10.7 million for the three months ended March 31, 2024 and 2023, respectively.
Current wording
We recognized a net loss of $17.9 million and $14.4 million for the three months ended June 30, 2024 and 2023, respectively.
Previous wording
For the three months ended March 31, 2024 and 2023, general and administrative expenses were $8.1 million and $7.0 million, respectively. The increase in 2024 was mainly related to an increase of $0.9 million in legal expenses.
Current wording
For the three months ended June 30, 2024 and 2023, general and administrative expenses were $9.7 million and $7.6 million, respectively. The increase in 2024 was mainly related to an increase of $1.9 million in legal expenses.
Previous wording
During the three months ended March 31, 2024 and 2023, we recorded interest expense of $1.5 million and $1.0 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 June 30, 2024 and 2023, we recognized interest expense of $1.7 million and $1.3 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Previous wording
During the three months ended and March 31, 2024 and 2023, we recognized foreign currency transaction loss of $0.7 million and gain of $0.9 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to the British pound sterling. The gain was due to the weakening of the U.S. dollar relative to the British pound sterling.
Current wording
During the three months ended and June 30, 2024 and 2023, we recognized foreign currency transaction loss of $45,000 and gain of $0.7 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to the British pound sterling. The gain was due to the weakening of the U.S. dollar relative to the British pound sterling.
Previous wording
For the three months ended March 31, 2024 and 2023, research and development expenses were $7.9 million and $6.9 million, respectively. The increase in 2024 was mainly related to an increase of $0.7 million in stock-based compensation which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023.
Current wording
For the six months ended June 30, 2024 and 2023, research and development expenses were $16.2 million and $13.1 million, respectively. The increase in 2024 was mainly related to an increase of $2.7 million to unrelated external service providers, of which $1.6 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.
Previous wording
We recognized a non-cash gain of $0.1 million and a non-cash gain of $3.9 million for the three months ended March 31, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of March 31, 2024 and 2023 compared to December 31, 2023 and 2022.
Current wording
We recognized non-cash gain of $2.5 million and $4.0 million for the six months ended June 30, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of June 30, 2024 and 2023 compared to December 31, 2023 and 2022. In addition,
Previous wording
We recognized a non-cash gain of $1.8 million change in fair value of the convertible notes during the three months ended March 31, 2024. The gain was primarily due to the decrease of stock price as of March 31, 2024 compared to December 31, 2023.
Current wording
We recognized a non-cash gain of $1.5 million change in fair value of the convertible notes during the six months ended June 30, 2024. The gain was primarily due to the decrease of stock price as of June 30, 2024 compared to December 31, 2023.
Previous wording
We recognized an approximately $0.8 million debt extinguishment loss during the three months ended March 31, 2024 from the debt redemption, and $1.4 million from the amendments of certain convertible notes and existing warrants (see Note 7).
Current wording
We recognized an approximately $1.7 million debt extinguishment loss during the six months ended June 30, 2024 from the debt redemption, and $1.4 million from the amendments of certain convertible notes and existing warrants (see Note 7).
Previous wording
During the three months ended March 31, 2024 and 2023, net cash outflows from operations were approximately $12.4 million and $11.2 million, respectively. The increase in cash used in operating activities was primarily attributable to an increase in clinical trial related expenditures.
Current wording
During the six months ended June 30, 2024 and 2023, net cash outflows from operations were approximately $28.6 million and $22.8 million, respectively. The increase in cash used in operating activities was primarily attributable to an increase payment in legal costs of $1.9 million and clinical program expenditures of $3.2 million in connection with the MAA.
Previous wording
We spent approximately $0.2 million and $1.3 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the three months ended March 31, 2024 and 2023, respectively.
Current wording
We spent approximately $0.8 million and $2.6 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the six months ended June 30, 2024 and 2023, respectively.
Previous wording
We received approximately $3.6 million of cash from issuance of 0.3 million shares of Series C convertible preferred stock during the three months ended March 31, 2024. We received approximately $2.4 million cash from issuance of 0.1 million shares of Series C convertible preferred stock during the three months ended March 31, 2023.
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. We received approximately $4.8 million cash from issuance of 0.3 million shares of Series C convertible preferred stock during the six months ended June 30, 2023.
Previous wording
We received approximately $7.1 million of cash from issuance of convertible notes to individual lenders during the three months ended March 31, 2024.
Current wording
We received approximately $7.1 million of cash from issuance of convertible notes to individual lenders during the six months ended June 30, 2024. We received approximately $1.1 million of cash from issuance of convertible notes to individual lenders during the six months ended June 30, 2023.
Previous wording
We received approximately $10.0 million of cash from the issuance of a loan from a commercial lender during the three months ended March 31, 2023.
Current 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 six months ended June 30, 2024 and 2023, respectively.
Previous wording
We received approximately $1.3 million and $0.2 million of cash from the exercise of warrants during the three months ended March 31, 2024 and 2023, respectively.
Current wording
We received approximately $1.5 million and $1.6 million of cash from the exercise of warrants during the six months ended June 30, 2024 and 2023, 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. We received $4.1 million from issuance of non-dilutive funding agreements during the six months ended June 30, 2023.
Previous wording
We made aggregate debt payments of $0.1 million during the three months ended March 31, 2023.
Current wording
We made aggregate debt payments of $0.2 million and $0.2 million during the six months ended June 30, 2024 and 2023.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
For the three months ended June 30, 2024 and 2023, research and development expenses were $8.3 million and $6.2 million, respectively. The increase in 2024 was mainly related to an increase of $1.6 million to unrelated external service providers, of which $0.9 million was related to stock-based compensation for such service providers, which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023.
Current report — wording carried from elsewhere
We recognized a non-cash loss of $0.2 million change in fair value of the convertible notes during the three months ended June 30, 2024.
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
During the six months ended June 30, 2024 and 2023, we recorded interest expense of $3.2 million and $2.3 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Current report — wording carried from elsewhere
During the six months ended and June 30, 2024 and 2023, we recognized foreign currency transaction loss of $0.7 million and gain of $1.6 million, respectively. The loss was due to the strengthening of the U.S. dollar relative to the British pound sterling. The gain was due to the weakening of the U.S. dollar relative to the British pound sterling.