Replies to post #684848 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

beartrap, my answers to your questions about the Sawston manufacturing facility:

For starters, the total size of the Sawston facility is 88,345 square feet on two floors.

1) How many cleansuites were in the 1A lab buildout?

In the 1A buildout, which is 4,400 square feet, there are 2 manufacturing suites, with 7 cleanrooms; 2 Grade B, 3 Grade C, and 2 Grade D. This breakdown was from Catapult’s 2022 Manufacturing Report.

2) How many clean suites are in the newly completed 1B lab?

There are 2 manufacturing suites which are a total of about 4,000 square feet, but the number or type of cleanrooms, are unknown (to me), and this information wasn’t given in Catapult’s 2023 Manufacturing Report. However, what has been stated in various public documents, is the 1B buildout includes a sterility and QC testing lab, a large Grade C process development lab, and multiple Grade C cleanrooms where the Flaskworks systems will be deployed. Another interesting nugget, according to last month’s 10k, this Grade C process development space will also be used “for future work on next-generation technologies, including as part of collaborations that are under development.”

3 ) Where does the 1,000 patients per month that Dr. Bosch stated in a presentation fit into this construction picture - before or after they begin to use 1B?

I believe this 1,000 patients per month number, from Dr. Bosch’s ASCO presentation, was just a theoretical potential number, based on the total size of Sawston, if the entire facility was built out. Northwest Bio has stated that from the initial manufacturing suites in the 1A buildout (5% of the total space), it could produce enough for about 40-45 patients per month (using the current, but soon-to-be, former manual method).

4) Finally, do we know for a fact if Sawston is now using 1B suites?

Northwest Bio has stated that the 1B expansion, which began in 2022, was completed in the 2nd quarter last year, and the Grade C process development space has been utilized for the Flaskworks’ development work. When the GMP-grade Flaskworks units are/were delivered, they are being installed, qualified, and validated in the grade C cleanrooms in the 1B suites. The 10k said this: “Engineering and technical analyses were carried out for development of new Grade C labs in which the Flaskworks system may be deployed at lower cost and greater quantities of production than the existing manufacturing processes in Grade B labs.”

5) The Flaskworks PR states that "up to 12" Eden units can go in each patient lab, so if we have these answers, which I know some were trying to figure out, we can project revenue.

I think there are probably at least 3 or 4 Grade C cleanrooms in the 1B manufacturing suites, so maybe 40 to 50 Flaskworks units could initially be installed there this spring. And, as of last summer, there were further expansion plans, but it’s unknown if or when this work started. I suppose some wild guesses could be made, but I personally don’t think enough variables are known to project revenue yet.