NorthWest Biotherapeutics Inc (NWBO)

[DJPele]

10Q Highlights:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000141057823001633/nwbo-20230630x10q.htm

In June 2023, the Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action of its DCVax technology at an Industry Theater presentation during the ASCO (American Society of Clinical Oncology) conference. The Company is pursuing further analyses by independent experts, and plans to present further information at an appropriate future conference.

The Company is now in the final stages of preparing an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on preparation of the application package as well as related activities. One of the pre-requisites - obtaining regulatory approval of a Pediatric Investigation Plan (PIP) - was completed during 2022 on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial.

The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive.

The Company and Advent are working together to prepare for potential commercial operations. The buildout of Phase 1B of the Sawston facility, which had been under way since last year, has been completed. On July 24, 2023 the Company changed the name of its UK subsidiary from Aracaris Limited to Northwest Biotherapeutics Limited.

The Company’s wholly owned subsidiary, Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including optimizing yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.

The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.

In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.