NorthWest Biotherapeutics Inc (NWBO)

[Gus McCrae]

I can certainly try. If you haven't already done so, you should read the prior manufacturing contract: DCVAX-L Manufacturing Agreement

What you will see is that this agreement was intended to be used after FDA approval. It has provisions detailing minimum amounts of DCVAX-L was responsible for paying for (like a take-or-pay contract) and provisions explaining how they would go about contracting additional manufacturing capacity if demand required it. So this was already done once. I can't tell you how they modeled minimums and maximums (those amounts were granted confidential treatment), but I sure would like to know what those would be today!

They are somewhere in the process of developing/qualifying the use of flaskworks which will have a very large positive impact in that they will need far fewer cleanrooms for a given quantity of product. That may or may not be possible to use at the yet unknown effective date of when they will presumably be approved to start treating patients.

My personal opinion is that they have not made much progress with Flaskworks yet. They don't even have MHRA certification yet. Further, they have extremely limited financial and employee resource limitations, and I expect that every available resource is focused on MHRA certification and the BLA right now, although I don't see any evidence to suggest that the BLA process has started.

I love the idea of Flaskworks and what it could represent if it is successfully integrated into manufacturing NWBO. Absolutely game changing technology, if it works. However, they only paid a couple million for the technology, and in my experience, that means Flaskworks is just a concept at the moment and will take many millions of dollars and multiple years to move it from concept to production...that's not even taking into account whatever regulatory slowdowns there may be.

I hope I'm wrong about Flaskworks and that it can be integrated much faster than I anticipate. My opinion is based solely on my own professional experience in acquiring small manufacturers with similar "game changing" potential (non-medical devices, so not apples to apples), so it's obviously anecdotal.

Also, I don't mean to suggest that they won't enter into a new agreement with CRL along with the release of TLD or whatever other big news they may eventually share with us. I'm just saying that the whole thing is weird and if I was drafting their disclosures, I would have included a couple sentences outlining why they chose to let the contract expire and what the plan was going forward. They disclosed the bare minimum and left all of us to try to sort it out on our own...standard for them, but unethical, in my opinion. I mean, we still really don't know what the plan is for manufacturing...some of us (the minority, I believe) assume it's all going to be done at Sawston, but why such a big pivot from prior years where there was a commitment to North American manufacturing? I'm telling you, it's impossible that Flaskworks will be ready to ramp Sawston production 5X in the next 18 months. So is it just equivalency concerns, or is it something related to whether they expect FDA approval? These are the questions that trouble me, and if NWBO was doing their job, they would lay all of this out for us as the securities rules and regulations require.