NORTHWEST BIOTHERAPEUTICS INC
For the period ended Sep 30, 2024. Filed Nov 12, 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.
Sep 30, 2024 · Filed Nov 12, 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 2024-06-30; filed 2024-08-09.
0001410578-24-001278
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001410578-24-001879
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of 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 83 current paragraphs.
43 unchanged; 23 reworded; 17 added; 21 removed; 1 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 (17)
Current report
MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Current report
Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.
Current report
Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.
Current report
Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.
Current report
Collaborations: Complementary or Synergistic Technologies. The Company has also been pursuing ongoing efforts to identify and develop collaborations with other companies who have technologies that the Company believes may be complementary to the Company’s DCVax technologies (for example for combination treatment regimens) or may be synergistic with the Company’s technologies (for example, to enhance DCVax products). The Company completed negotiations and entered into a contract with a company that has a complementary immunotherapy agent, and the two companies have been engaged for a number of months in joint development of trial designs and selection of candidate cancers for a combination treatment clinical trial. The companies are particularly focusing on trial designs in which the primary endpoint will be tumor response (shrinkage), with potential timeframes in months, rather than time-to-event survival outcomes, with timeframes in years. The Company anticipates potentially being ready to submit an IND for such a combination trial to regulators during Q1 of next year.
Current report
The Company has also completed negotiations and entered into a contract with a company that has an immune booster agent that may have the potential to further increase the potency of DCVax products. The contract provides for material supply and in vitro testing of the booster agent with DCVax products. If the in vitro testing is successful, the parties plan to enter into a license of the booster agent to NWBio. The parties jointly designed the program of experiments, and the experiments were carried out and completed by the Flaskworks team. The parties are now evaluating the results and developing plans for further experiments.
Current report
Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January. For the same reasons as described above in connection with the planned combination treatment trial, the Company plans to focus DCVax-Direct clinical trial designs on tumor response endpoints with potential timeframes of months rather than survival endpoints with timepoints of years. The preparations to date involve technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, engineering runs and comparability testing. In addition, new development work has been carried out to develop a second version of DCVax-Direct because there is a worldwide shortage of one key ingredient of the original DCVax-Direct (an immune booster ingredient). The Company and Advent have been working together to evaluate other potential immune booster agents -- both their properties in the manufacturing process and their effects immunologically -- to identify an alternative booster agent that can be suitable and is available for production of new batches of DCVax-Direct. Advent is continuing to conduct final engineering runs for validation of the new SOPs, processes and formulation. The Company has entered into SOW 8 with Advent covering the work involved in restarting the DCVax-Direct program. SOW 8 is structured so that Advent only receives compensation for the work in the form of milestone payments and only after the applicable work has been successfully completed (see Note 13).
Current report
Ongoing and Expanded Phase 2 Clinical Trials Under the Roswell & Pittsburgh Portfolios. As previously reported, the Company entered into exclusive licenses from Roswell Park Cancer Center and the University of Pittsburgh, covering a large portfolio dendritic cell technologies developed over the course of more than 27 years of work by a leading team of dendritic cell experts, as well as 5 new patent families. The in-licensed technologies in the combined portfolios are currently in three Phase 2 clinical trials that are fully funded by grants and fully being carried out by the investigators. These Phase 2 trials are ongoing and one of them has been approved for a significant expansion in scope by the grant funding agency. That trial is testing an in-licensed dendritic cell treatment in melanoma that is refractory (unresponsive) to checkpoint inhibitor drugs. That dendritic cell treatment aims at a set of targets on abnormal blood vessels that are associated with tumors. As such, that dendritic cell treatment is anticipated to be tumor-agnostic and potentially applicable to most types of solid tumors. The expansion of the trial scope that has been approved is to add refractory lung, breast and bladder cancers to the trial in addition to refractory melanoma.
Current report
Intellectual Property. The Company’s intellectual property (IP) portfolio continued to grow during Q3 2024, complementing the Company’s growing pipeline. Patents from 3 different patent families developed by the Company were granted or allowed in several countries, particularly Europe. Patents from 2 different patent families which are part of the Roswell and Pittsburgh in-licenses were granted in the U.S. and elsewhere. New divisional applications were also filed to extend the scope of patents from 2 different patent families, in Europe and elsewhere. In regard to the Flaskworks technologies and IP, 5 new patents were allowed in the U.S. and elsewhere, from 4 different patent families, during Q3 2024. In addition, 4 new patents were issued in the U.S. during Q3 2024, which had been allowed during Q2 2024, and a 5 th patent elsewhere was also issued. The Company believes that the ongoing expansion of its IP portfolio is an important and valuable part of building a leading franchise in dendritic cell technologies.
Current report
Litigation. In the Company’s lawsuit against certain market makers, the Company is awaiting the Magistrate’s Report and Recommendation on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: i.e., loss causation. The Magistrate and the Court already previously determined that all but this one of the required elements were sufficiently alleged in the Company’s Complaint, and the Court invited the Company to file expanded allegations about the loss causation element. The Company submitted expanded claims earlier this year, the parties’ filings were finished in June, and the parties are now waiting to receive the Magistrate’s recommendation.
Current report
For the three months ended September 30, 2024 and 2023, research and development expenses were $8.1 million and $7.2 million, respectively. The increase in 2024 was mainly related to an increase of $1.2 million cost incurred from Advent with extensive ongoing work related to the MAA and review process, which was offset by a decrease of $0.5 million related to stock-based compensation.
Current report
We recognized a non-cash loss of $1.6 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively. The loss was primarily due to the change of valuation inputs. The healthcare market yield curve rate that was used in the pricing model was significantly decreased as of September 30, 2024 compared to the value as of June 30, 2024. The rate was about the same level as of September 30, 2023 compared to the value as of June 30, 2023.
Current report
We recognized approximately $6.8 million and $1.8 million debt extinguishment loss during the three months ended September 30, 2024 and 2023 from debt redemptions and debt amendments, respectively. The increase during the three months ended September 30, 2024 compared to last year was due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.
Current report
Foreign currency transaction gain (loss)
Current report
Nine months ended September 30, 2024 and 2023
Current report
We recognized approximately $9.9 million and $3.6 million debt extinguishment loss during the nine months ended September 30, 2024 and 2023 from the debt redemption and debt amendments, respectively. The increase during the nine months ended September 30, 2024 compared to last year was mainly due to multiple amendments on the existing convertible notes which resulted a debt extinguishment loss of $5.6 million.
Current report
Foreign currency transaction gain (loss)
Removed paragraphs (21)
Previous report
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 report
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 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous report
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 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.
Previous 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.
Previous report
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 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.
Previous 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.
Previous report
Foreign currency transaction loss
Previous report
Six Months Ended June 30, 2024 and 2023
Previous 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.
Previous report
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 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.
Previous 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.
Previous report
Foreign currency transaction loss
Reworded paragraphs (23)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not place undue reliance on these forward-looking statements.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not rely upon on these forward-looking statements.
Previous wording
During the first half of 2024, the Company continued its progress on multiple fronts, including the following.
Current wording
During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.
Previous 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.
Current wording
We recognized a net loss of $19.4 million and $23.5 million for the three months ended September 30, 2024 and 2023, respectively.
Previous 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.
Current wording
For the three months ended September 30, 2024 and 2023, general and administrative expenses were $7.0 million and $7.0 million, respectively.
Previous wording
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 wording
We recognized a non-cash gain of $3.1 million and a non-cash loss of $4.9 million change in fair value of the convertible notes during the three months ended September 30, 2024 and 2023. The non-cash gain was resulted from the decrease of the Company’s stock price and the non-cash loss was resulted from the increase of the Company’s stock price.
Previous 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.
Current wording
During the three months ended September 30, 2024 and 2023, we recognized interest expense of $2.1 million and $1.7 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Previous 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.
Current wording
During the three months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.8 million and a loss of $1.7 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.
Previous wording
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 wording
We recognized a net loss of $55.6 million and $48.6 million for the nine months ended September 30, 2024 and 2023, respectively.
Previous 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.
Current wording
For the nine months ended September 30, 2024 and 2023, research and development expenses were $24.4 million and $20.3 million, respectively. The increase in 2024 was mainly related to an increase of $2.6 million to unrelated external service providers primarily related to the MAA, the review process and inspections, of which $1.1 million was related to stock-based compensation, which was mainly related to additional awards that were granted to various key external consultants in the third quarter of 2023. Additionally, research and development expenses from Advent was increased by $1.4 million with extensive ongoing work related to the MAA and review process for the nine months ended in September 30, 2024 compared to the same period of last year.
Previous wording
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 wording
For the nine months ended September 30, 2024 and 2023, general and administrative expenses were $24.8 million and $21.6 million, respectively. The increase in 2024 was primarily related to an increase of $3.2 million in legal expenses.
Previous 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,
Current wording
We recognized non-cash gain of $0.9 million and $3.9 million for the nine months ended September 30, 2024 and 2023, respectively. The higher gain in 2023 was mainly due to the non-cash revaluation gain recognized as of January 9, 2023, when we reclassed all warrants from liability classified to equity classified. The stock price on January 9, 2023 and December 31, 2022 was $0.71 and $0.78 per share, respectively.
Previous 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.
Current wording
We recognized a non-cash gain of $4.6 million and non-cash loss of $4.9 million in change in fair value of the convertible notes during the nine months ended September 30, 2024 and 2023, respectively. The gain was primarily due to the decrease of stock price as of September 30, 2024 compared to December 31, 2023. The loss was primarily due to the increase in the stock price as of September 30, 2023 compared to the stock price on the issuance date during August and September 2023.
Previous wording
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 wording
During the nine months ended September 30, 2024 and 2023, we recorded interest expense of $5.3 million and $4.0 million, respectively. The increase in interest expense in 2024 was mainly related to an increase of outstanding debt balance.
Previous wording
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.
Current wording
During the nine months ended September 30, 2024 and 2023, we recognized foreign currency transaction gain of $2.0 million and loss of $0.1 million, respectively. The gain was due to the strengthening of the British pound sterling relative to the U.S. dollar and vice versa for the loss.
Previous 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.
Current wording
During the nine months ended September 30, 2024 and 2023, net cash outflows from operations were approximately $36.8 million and $36.7 million, respectively. The slight increase in cash used in operating activities was primarily attributable to an increase payment in legal costs.
Previous 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.
Current wording
We spent approximately $0.9 million and $3.0 million in cash for the purchase of additional equipment and our build-out in Sawston, UK during the nine months ended September 30, 2024 and 2023, respectively.
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. 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.
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. We received approximately $9.9 million cash from issuance of 0.7 million shares of Series C convertible preferred stock during the nine months ended September 30, 2023.
Previous wording
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.
Current wording
We received approximately $10.0 million net proceeds from issuance of 33.5 million shares of common stock during the nine months ended September 30, 2024.
Previous 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.
Current wording
We received approximately $9.9 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2024. We received approximately $12.7 million of cash from issuance of convertible notes to individual lenders during the nine months ended September 30, 2023.
Previous wording
We received approximately $10.0 million and $10.0 million of cash from the issuance of a loan from a commercial lender during the six months ended June 30, 2024 and 2023, respectively.
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 nine months ended September 30, 2024 and 2023, respectively. We also received $2.0 million of cash from the issuance of a demand note to an individual investor during the nine months ended September 30, 2024.
Previous 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.
Current wording
We received approximately $1.5 million and $1.6 million of cash from the exercise of warrants during the nine months ended September 30, 2024 and 2023, respectively.
Previous 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.
Current wording
We received $50,000 from issuance of non-dilutive funding agreements during the nine months ended September 30, 2024. We received $4.6 million from issuance of non-dilutive funding agreements during the nine months ended September 30, 2023.
Previous wording
We made aggregate debt payments of $0.2 million and $0.2 million during the six months ended June 30, 2024 and 2023.
Current wording
We made aggregate debt payments of $1.1 million and $0.2 million during the nine months ended September 30, 2024 and 2023.
Rearranged previous paragraphs (1)
Previous report — wording carried 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.