Thoughts on the Annual Shareholder Meeting:
While management was careful not to give away any specific information that could potentially be used against them, I think they still gave a candid, general idea of what they’ve been working on, where they are, and what are some of the next steps. There has been some important progress made this past year, but much remains, and I think 2023 will be a very pivotal year for the company, with many years of work finally culminating in the first regulatory approval of DCVax.
Preliminary
It’s clear that the company has the support of the majority of investors, with every item on the proxy passing. (this, despite all the negative postings by the supposed shareholders on this board voting no) By the way, while I voted yes on everything else, I do not support the excessive share grab (~20% of the company) by Linda Powers and others, but it never matters. I would like to reward them for their hard work with a reasonable amount of shares, (5-10% of the company) but we were not given that choice. I’ll be curious to see the actual vote totals.
Sawston
Now we know that Sawston was inspected in the beginning October and Advent is far along in their corrective actions, so I anticipate that the commercial manufacturing license will be granted this month, or possibly next. We also now know that construction on phase 1b (expanding Advent’s production development space, and adding more cleanrooms) has been on-going for months.
Marketing applications
Before the meeting, I posed the question: “has Northwest Bio requested or received any accelerated approval pathways from any regulator?” The Common Technical Documents of the marketing approval application (except parts of the first module) are the same for most jurisdictions, so Northwest Bio could request accelerated approval from each country’s regulator, and file separate applications in each country, or potentially they could have simultaneous review of the application by the different countries if they are participating in the FDA’s Project Orbis. Linda’s language that “we have teams of specialized consultants for the different portions of the application package” is consistent with a rolling review in the UK (which I think is highly likely), but it’s still unclear what route(s) Northwest Bio plans to take, only that they “plan to be strategic about filing in multiple places.”
The timing of the final submission of the marketing application is also uncertain, but it seems they are reasonably close (2-3 months?) per this language; “And so on this front, as on the overall picture that we still have more to do. There's still a ways to go on all the document work, but we have come a long way already.” and “It can take an entire year to put an application together . . . we’ve been working on portions of it, as I said, all year long.”
Flaskworks
I posed this question online, but also asked an acquaintance who was attending the meeting, if he could ask, “Is Flaskworks’ Eden system a part of the commercial license application?” He matter of factly said, “there’s no need to ask, it’s not.” I was a bit surprised, and asked how he “knew” this, and he replied that he has provided capital to the company before, and remains in contact. He didn’t have any specific knowledge exactly where Flaskworks is in the development process, or how long it would take for the comparability process.
The testing of multiple versions of the system with high-flow perfusion, slow-rate perfusion, and static culture, that Linda described, was simply part of the performance qualification process, so not really news to me. Knowing now that the inspection of Sawston didn’t occur in September when Advent was hiring for multiple computer validation, and software/firmware script writing positions, along with Flaskworks hiring of product development engineers whose responsibilities include “Identifying design improvements and integrating technology for monitoring cell culture to ensure reliability” could indicate that Flaskworks was still working on the biosensors, and in-process controls with Advent, and the software data integration with Autolomous’ Manufacturing Execution System that is deployed at Sawston, and required for the commercial process. The language used by Flaskworks, “to ensure reliability” sounds like additional commercial validation work was necessary.
Like everything else Northwest Bio is working on, the commercial development of the Flaskworks’ system has taken longer than I expected. As I’ve said previously, there is a relatively short regulatory process to get it approved for use in the commercial manufacturing process once it can repeatedly and reliably produce a highly similar product, so I’m still optimistic that it will be approved by the same time that DCVax is approved.
So many of us are left to speculate about what’s going on with the company, while others are apparently “in the know.” This can be frustrating, but I understand that it’s common that investment bank analysts have access to management, and have knowledge about the companies they cover, that retail investors don’t.
reality check
Northwest Bio’s technology, their associated scientific advisors, and medical doctors, have always been on par or better than anything from Big Pharma, but this shareholder meeting was another reminder that Northwest Bio is still a tiny company that is under resourced and almost, but not quite, ready for prime time. They are continually behind schedule of where I, and many others, think they should be. There are many examples of this but a couple highlighted during the meeting; the contractor that is now working on all the patient data files that Linda described, could have been tasked and finished with this work over a year ago, rather than still working on them over the past few months. Northwest Bio has a single supplier for a critical manufacturing component, and when that supplier is lost, they must vet another supplier which takes many months, while Big Pharma companies have many suppliers who have been properly vetted, and they can simply switch without causing delays.
Northwest Bio would benefit greatly from the resources that a strategic partner would provide, but are unwilling to make a deal that doesn’t properly value their technology, and they seem willing to wait until they’re better positioned to negotiate more favorable terms. This may not happen until they have received marketing approval, an uplisting on a major stock exchange, and have received the institutional investment support, as well as the proper media exposure, that their treatment warrants. The good news is that it appears that this is finally the year that those important milestones will be reached, and there is a plan to achieve these milestones, possibly without the help from Big Pharma. I know that Linda and Les have access to a significant amount of private capital, but may be waiting to access it until a marketing application has been submitted (and possibly approved) and Northwest Bio is finally ready for commercialization, which may be in conjunction with an uplist. This could gain the institutional support and analyst coverage that would bring the needed major media attention, which could propel Northwest Bio to the next level (and out of the control of the current market manipulators).
Shareholders are clearly not being told everything that the company is planning, and working on, so I do anticipate a few pleasant surprises this year.
