NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

The 2 most important sentences in the Q.

"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."



https://twitter.com/alphavestcap/status/1789355402829652006




"I agree. The “validation confirmation” and no need to change anything in the MAA means to me that part is over and only confirmatory inspections and questions to the people involved ."-Zivic

AVC-P.S., With the 5/10/24 Q having de-risked the MAA approval, and the Nature paper having opened the door to RA approval for the commencement of combo trials,who will be the first cancer immunotherapy stategic players to consummate franchise agreements with LP?

https://sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824000741/nwbo-20240331x10q.htm…

https://sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824000133/nwbo-20231231x10k.htm…
@alphavestcap


10-Q (5/10/24)SALIENTS:

1) "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."

2) "The Company does not know when MAA - related inspections may take place."

10-Q-5/10/24: Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 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. Overview We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit. 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. During the first quarter of 2024, the Company continued its progress on multiple fronts, including the following. 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. 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. 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. 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. 23 Table of Contents 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. 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. 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. 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. Annual Shareholder Meeting. The Company plans to conduct its Annual Shareholder Meeting before the end of June 2024. Critical Accounting Policies and Estimates

"I agree. The “validation confirmation” and no need to change anything in the MAA means to me that part is over and only confirmatory inspections and questions to the people involved ."

P.S., With the 5/10/24 Q having de-risked the MAA approval, and the Nature paper having opened the door to RA approval for the commencement of combo trials,who will be the first cancer immunotherapy stategic players to consummate franchise agreements with LP?

https://sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824000741/nwbo-20240331x10q.htm…

https://sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824000133/nwbo-20231231x10k.htm…