NorthWest Biotherapeutics Inc (NWBO)

[Baxers]

Given yesterday's PR I thought I would circle back to this post and given what we now know about NWBO's now planned apheresis set up at The Welbeck Hospital, what this might mean in terms of operational timelines. Ultimately, whether the choice to setup inside a hospital could help reduce the regulatory load and expedite matters.

From my previous post, my hypothesis was the timeline should look something like this:

Phase 1 (Months 0-6): Fit out the clinic. Secure CQC registration & HTA Satellite (of Advent) status.
Phase 2 (Month 6-18): Open for Private patients & Compassionate Use/ Trial participants only. Use these patients to generate the data and SOP proof required for JACIE Certification (which would likely be mandatory before the NHS could funnel NHS patients through this clinic).
Phase 3 (Month 18+): Apply for and achieve JACIE accreditation. Once achieved begin servicing NHS-funded patients efficiently.

Based on the PR, the fit out should be completed by June and 'the licence applications are being pursued in parallel'. To begin operations CQC and HTA certifications need to be in place and since they are setting up inside The London Welbeck Hospital, I believe they have substantially de-risked and expedited this initial Phase 1 because they will be able to lean on Welbeck's existing CQC infrastructure. The HTA literally has a verbatim "Hub & Satellite Model" so this application can routinely be made as a satellite of Advent's existing HTA licence (literally regulatory speaking, the clinic would draw the blood on behalf of Advent Bioservices), which as a simple variation of an existing licence so should be quick. Therefore, hitting that June target for baseline operational legality should hopefully be highly realistic.

So lets say Phase 2 (the Operational Phase) begins 1st July 2026. Once this begins JACIE Certification usually requires 12 months of operations and data collection (The Welbeck Hospital does not presently have JACIE) before the application can be made. By integrating into a hospital that already has mature medical QMS and auditing procedures, NWBO might (and I stress might!) be able to argue that the system is already mature, rather than starting the 12-month clock from absolute zero so, if there was a perceived NHS need things could possibly be sped-up. But that is purely speculative, so speculation aside NWBO realistically will be able to apply for JACIE in July 2027. Unfortunately, in true UK regulatory style this JACIE application process is - it would seem - not a rapid one and usually takes somewhere between 10-16 months to complete. Therefore, without cutting any corners, this clinic wouldn't be able to service NHS patients until around May 2028 at the earliest.

That might explain why the PR focused on compassionate use patients. Either way, this in-house setup removes a critical bottleneck for private paying customers from both the UK and overseas. This streamlined setup will help ensure private revenues ramp up quickly while we await NICE coverage for the NHS.

Furthermore, along with the cryostorage service offering at Advent, this apheresis service will provide a not-insignificant revenue stream for the company outside of DCVax-L. From the PR, this Welbeck clinic is slated to have a capacity of 4 patients per day. Assuming they run just 5 days a week (PR specifically states more days and hours/ day are possible), then that is minimum 80 collection slots per month. Even if NWBO only uses 20 slots a month for their own DCVax compassionate use/private patients, they have 60 slots remaining. These slots can be sold either to (i) other biotechs for 3rd party patient collection for £2500-5000 per slot or (ii) for ~£3,000 each selling healthy donor Leukopaks. This equates to ~£180,000 in gross monthly revenue, effectively turning this clinic awaiting JACIE into a highly profitable standalone business significantly helping NWBO's cash burn.