Replies to post #805098 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Slave1, thank you for providing the transcript of the ASM.

[barnstormer]

Thanks Slave. Appreciated.

[learningcurve2020]

The idea that after two years MHRA would not tell the CEO of a struggling biotech allegedly using its limited resources to gear up, is the biggest BS line ever.

>>We don’t have a way to predict how much further time it’s going to take. I know that’s what we all want to know. We all want to know the crystal ball, and we do too, but we simply do not have a way to predict how much further time it’s going to take at this point.

[learningcurve2020]

More nonsense. So she can’t provide examples? The advisor (Consultant) just gave her a line. All the seekers here can’t find one either.

>>What is noteworthy, and I would say this is based on what our UK advisors have said to us, we don’t have firsthand knowledge, but our advisors have said that there are quite a number of other companies who are in the situation that we’re in and are very long into the application process, can be as much as two years like we are. It’s not just us. That is a comfort factor, and it was helpful to hear that from our advisors. I don’t have firsthand knowledge, but they’re experts and they see the landscape.

[learningcurve2020]

LOL. Exactly how does a launch occur without reimbursement? She’s talking out her…

>>In terms of how we would plan to do a launch, if I have to say, when and if we got an approval, how would we do the launch? We will certainly intensively pursue the reimbursement process. But of course, we won’t wait for that. We would launch as soon as we get approval.

[learningcurve2020]

Ten years and a steady stream of inquires. LOL. Sell me this pen. This is typical LP speak that never goes anywhere.

>>Lastly on the clinical is compassionate use. Our compassionate use program is ongoing. We have a steady stream of inquiries and requests that come in. We’re in the process now of expanding to additional doctors. A number of doctors have become interested, and we’re also in exploratory discussions with a private hospital chain that has numerous locations.

[learningcurve2020]

Anyone want to take a stab at how this could possibly take two years? Answer -$$$

>>That was the culmination of two years of technology transfer from the US to UK

[learningcurve2020]

I’d never imagine a CEO who lost her shareholders all of their cash and spent close to a billion dollars over the years would or could say such a thing.🤦‍♀️🤷‍♀️

>>Getting the specialized equipment for these labs is the devil. Lead times for procuring them can be 10 to 12 months, and some of the equipment costs close to a million dollars per machine. I mean, just think about the sheer capital expenditure.

Thankfully, Advent was able to find a new machine and a nearly new machine that we’ve already purchased, and that were bought for about half of the price and without that long lead time.

[learningcurve2020]

That’s it?…That’s the question? Can’t make it up. Awful stuff.

>>And one more particular question that was asked is Advent. Now, basically, does Northwest have full control of the DCVax manufacturing, including personnel, processes, and quality systems? Answer, yes. Advent is a wholly owned subsidiary of Northwest.

[learningcurve2020]

Ahahahahahaha! Sure LP. Well hear from you again in a year and a half or so.

>>Now it’s really important I want to address the fear mongering that I believe has gone on a bit about, oh my goodness, they’re just going to willy nilly issue 900 million shares in the next two weeks, or in a crazy short period of time. No. We’re definitely not going to do it.

Let me put it in perspective. Our burn rate in 2023 and 2024 was particularly high, very intensive years, in the low 50 millions. It’s down substantially this year. But if we kept up that same burn rate, and we did all equity financing, and the price was still in the 24, 25 cent range, it would take years to use those shares.

And we’re not going to do all equity financing, and we certainly hope that our share price is not going to stay at 24, 25 cents. We plan to focus on non-dilutive.

So no to the fear mongerers. We are not going to just burn through a whole bunch of shares at a crazy, fast pace.

[learningcurve2020]

But she can’t assign a value to it, of course. Some very happy lawyers I bet though.

>>And we’ve worked hard, and we spent a lot of money to file our patents and prosecute them and maintain them in all these various countries so that we would have the ability to do these kind of deals. And that was a lot of money. We spend well over a million dollars, approaching one and a half million dollars a year, on patent costs alone. We have a large patent portfolio.

[learningcurve2020]

So no interviews just hire the consultants if things work out. Got it. How incredibly lazy…and expensive.

>>The expansion of the management team is a very high priority for the management team. We would really like to have more of us. And what I am really happy to be able to tell you is the first wave of that management team expansion is already ready.

We already have senior managers who have been working with us for anywhere from six months to several years in positions technically as consultants, and when and if we receive an approval, they will just step seamlessly into doing the same role, but as an employee of Northwest.

And the personnel that we have who have been working in these consulting capacities are in the clinical, medical area, finance, accounting, and operations. So each one of the major areas. So that right there is already the first immediate expansion of the management team, and we have more on our radar screen, and that of course includes succession aspects.

[learningcurve2020]

In other words “OK, Later shareholders, we’ll talk sometime in 2027”. Got it. What a joke. Same old walk up a down escalator.

>>but I think it gives you a pretty exhaustive understanding of where we are, both where we are now and where we’re planning to go in the coming calendar quarters.

[learningcurve2020]

This line is so funny it makes me cry. What’s she saying exactly? I think she’s saying don’t worry we won’t use it all up in six months but it could take two years. LOL. And she seems confident the stock can hold here even though she never mentions ROI. Just crazy stuff.

>>Let me put it in perspective. Our burn rate in 2023 and 2024 was particularly high, very intensive years, in the low 50 millions. It’s down substantially this year. But if we kept up that same burn rate, and we did all equity financing, and the price was still in the 24, 25 cent range, it would take years to use those shares.

And we’re not going to do all equity financing, and we certainly hope that our share price is not going to stay at 24, 25 cents. We plan to focus on non-dilutive.

So no to the fear mongerers. We are not going to just burn through a whole bunch of shares at a crazy, fast pace.

[GoodGuyBill]

Thanks Slave1. I had a family crisis today and could not listen to the ASM. I took your meeting minutes and ran it through AI for a detailed summary:

Northwest Biotherapeutics (NWBO) – Annual Shareholder Meeting Summary (Dec 29, 2025)
(Based strictly on the transcript from InvestorsHub)

1. Formal Meeting Proceedings
Attendance & Setup
-Linda Powers presided as Chair, CEO, CFO, and CAO.
-Directors present: Dr. Al Boynton, Pat Sarma (virtually), Dr. Navid Malik, Ambassador Cofer Black, Dr. Monica Bosch (virtually).
-Inspector of Elections: Thomas Cooper (Computershare).
-Investor Relations: Dave Innes (stepping in after Les Goldman’s passing).

Quorum & Voting Mechanics
-1.19B shares represented out of 1.54B outstanding — quorum established.
-Preferred C shares carry 25 votes each.
-Proxies largely submitted in advance; ballots collected only from registered shareholders present.

Items Voted On — All Approved
-Election of Pat Sarma as Class II Director (term through 2027).
-Ratification of Cherry Bekaert LLP as auditor for FY 2025.
-Increase in authorized shares from 1.7B ? 2.6B.
-Advisory approval of executive compensation.
-Final results to be filed in an 8-K within four business days.

2. Informal Q&A Session (˜45 minutes)
Linda Powers grouped dozens of shareholder questions into four major categories:

Category 1 — Regulatory Pathway (MHRA, FDA, Canada)
MHRA Review Status
-NWBO is in active cycles of questions, clarifications, and data requests.
-MHRA is devoting “enormous” resources to the application — advisors confirm this is unusual and positive.
-NWBO cannot predict timing; other companies are also stuck in multi-year review cycles.

Why the UK First?
-Long UK history:
--First-ever PIM (Promising Innovative Medicine) designation.
--Included in national priority clinical trial portfolio.-
--Access to the 150-day accelerated pathway.

Next Steps After UK
-File in Canada (similar format to UK).
-File in US (different format).

Reason for sequential filings:
-Each application is intensive and expensive (~$12M/year in consultants).
-Priority is securing first approval.

Positive Industry Trends
-MHRA draft guidance supporting external controls becoming permanent.
-Regulators (including FDA) increasingly embracing real-world evidence — important because NWBO has hundreds of compassionate-use patients.

Launch Strategy
-Launch immediately upon approval, not waiting for reimbursement.
-UK brain cancer surgeries are concentrated in ~10 centers, making rollout manageable.
-Grade B suites alone are sufficient for initial launch; Grade C suite not required for approval or launch.
-Launch financing expected to use non-dilutive structures (royalty or non-convertible debt).

Category 2 — Clinical Programs (DCVax-Direct, Roswell/Pittsburgh, Compassionate Use)
DCVax-Direct
-Manufacturing is fully ready; tech transfer and validation completed in spring 2025.
-IND package’s CMC section is already written.

Phase 2 indication selected:
-Non-brain solid tumor, “below the neck.”
-Lead institutions in US and UK are “jumping up and down” to start.
-NWBO is delaying initiation due to cost tradeoffs:
-Priority spending is MHRA approval + Sawston buildout.

Roswell Park & Pittsburgh IP Portfolio
-Represents 25 years of dendritic cell research by Dr. Kalinski.
-Academic trials temporarily paused due to Kalinski’s move back to Pittsburgh — no impact on NWBO’s license.

NWBO’s first company-sponsored trial:
-Ovarian cancer combination trial using polarized Alpha-DC1 cells.
-Builds on prior encouraging ovarian cancer data from NWBO’s earlier pilot.

Compassionate Use
-Program ongoing and expanding.
-New doctors and a private hospital chain in discussions.
-Plan to offer compassionate use for most solid tumors in 2026.
-Plan to add DCVax-Direct to compassionate use.

Category 3 — Manufacturing (Sawston, Advent, Pittsburgh, Flaskworks)
Sawston Facility
-Two existing Grade B suites are sufficient for launch.

Process optimization underway:
-More staff,
-Streamlining steps outside B suites,
-Potential two-shift operations.
-Grade C Suite
-Original plan: two large, expensive C suites.

New plan:
-simplified C suite near loading docks — less than half the cost.
-Contractor selected; site prep done; construction expected to start January and finish in ~6 months.
-Even one simplified C suite will have >2× the capacity of both Grade B suites combined.

Equipment Procurement
-Long lead times (10–12 months) and high cost (~$1M per machine).
-Advent secured one new and one nearly new machine at half price and without long delays.

Advent Control
-Advent is a wholly owned subsidiary; NWBO has full control over personnel, processes, and quality systems.
-Pittsburgh Manufacturing

Will manufacture:
Kalinski dendritic cell products,
DCVax-L and DCVax-Direct for trials and compassionate use.
Commercial production will remain at Sawston.

Flaskworks
-Prototype complete; GMP version needed.
-Initial engineering team made unwanted redesigns (too large).
-Two new engineering teams now working on GMP version through first half of 2026.
-Goal: synchronize Flaskworks readiness with Grade C suite readiness.

Category 4 — Business Strategy (Shares, Partnering, Management Expansion)
-Authorized Shares Increase (1.7B ? 2.6B)
-Purpose: flexibility for major financing negotiations.

Powers emphasized:
-No intention to “willy-nilly” issue 900M shares.
-At historical burn rates and share prices, it would take years to use that many shares.
-NWBO intends to prioritize non-dilutive financing.
-Partnering

Regional partnerships:
-NWBO is already in exploratory discussions for a regional deal.
-Patent portfolio maintained globally at ~$1.5M/year to support such deals.

Big Pharma partnerships:
-NWBO is “thrilled” at the prospect.
-Combination trials (e.g., checkpoint inhibitors + DCVax) are viewed as the gateway.
-Management Expansion & Succession

First wave of expansion already lined up:
-Senior managers in clinical, medical, finance, accounting, and operations.
-Currently consultants; will convert to employees upon approval.
-Additional hires and succession planning are active priorities.

Closing
-Meeting adjourned at 2:57 PM.
-Final voting results to be filed in an 8-K within four business days.

[maverick_1]

Thanks to the deployment from The Emergency Medical Doctor’s Tool kit

[hyperopia]

Thoughts on the Shareholder Meeting: Part 1

Overall impression:
I thought this was a very positive and informative meeting. The problem with having meetings every 18 months or so, is that there is a lot of information that has to be crammed into the brief meeting, and not all questions can be answered, or answered thoroughly. (many of mine were not)

After the last shareholder meeting, I came away knowing that it’s still going to take some time (more than a year) before commercial production begins as they still had a lot of prep work ahead, and hadn’t even started on the ground work, ie. construction on the grade-C cleanrooms, ordering the GMP Flaskworks equipment, increased staffing, or even starting on a pricing model required for reimbursement. Nothing happens quickly in this industry, and often many steps are necessary well before results are seen.

After this shareholder meeting today, I came away with the distinct impression that they definitely didn’t think that they would still be waiting this long for approval, and they are finally ready to begin moving forward with commercialization, new clinical trials, building partnerships, and Linda outlined a few areas where the ground work has already been laid. They are definitely acting like a company that is anticipating DCVax approval no matter what their forward looking statements said.

On the MAA and future applications:
Not much information could be given on the current process with the MHRA except that they are still in the Q & A process until they aren’t. While it sounds like Canada and the US will be the next applications filed, I personally doubt that we are going to hear much about either in the near future. I think Linda only discussed it because it’s a reasonable question that was asked, and while that may be the current plan, I just don’t think additional filings will happen until maybe the end of the year.

They really don’t want to bite off more than they can chew, and it sounds like the initial manufacturing in the US is only going to be for investigational use for Dr. Kalinski’s polarized Alpha DC1 in connection with the University of Pittsburgh. It will probably take the first half of the year to get manufacturing up and running in the US again for Dr. Kalinski’s clinical trial, which seems to be the immediate priority since there are development obligations with the licensing agreement (which was signed eighteen months ago).

Commercial manufacturing for DCVax-L in the US will be a much larger undertaking, and will require considerable funding, a large facility, close to a year for technology transfer to the new facility, additional equipment, additional staffing, dedicated leukapheresis facilities, etcetera, etcetera. I think this is why Linda made it a point to say that “commercial production will take place at the Sawston facility.” They simply are not ready to support a marketing application in the US and Canada at this time (unless there is a partner or licensee).

It doesn’t surprise me that the EU wasn’t mentioned in the marketing application plans as initial production in the simplified Grade C lab at Sawston will barely handle the demand from the UK. They probably won’t be able to apply for marketing approval in the EU until after they have the funds to build the two large C labs that were previously put on hold, and construction on those will likely take at least a year.

Clinical trials:

[hyperopia]

Thank you for the transcript Slave1 - that was really fast and it saved me considerable time.