Northwest Biotherapeutics
Annual Meeting of Stockholders
December 29, 2025
Unabridged Transcript
Holders with the report of the election results. Following the completion, how long was the meeting procedure for that was laid out in the proxy, and then after the informal Q and A discussion, we will adjourn and close the Annual Meeting.
At this time, I will start the formal business of this meeting by introducing the directors and officers in attendance, along with some senior managers.
So my name is Linda Powers. I am Chair of the Board, President and CEO, Chief Financial and Accounting Officer, and it’s my pleasure to welcome you here today. I will preside as Chair of today’s meeting.
I have asked Dr. Al Boynton, who is Chief Scientific Officer and Secretary of the Company, to serve as Secretary of the meeting.
Our directors, officers, and senior manager who is present today include Dr. Al Boynton, who I just mentioned is Chief Scientific Officer and Secretary and Co-Founder of the Company, and Mr. Pat Sarma, a director, both attending virtually. We have Dr. Navid Malik here with us, and we have Ambassador Cofer Black here with us, Dr. Monica Bosch, our Chief Technical Officer, also attending virtually. Mr. Thomas Cooper from Computershare, who will serve as Inspector of the meeting, and Mr. Dave Innes, who is Head of Investor Relations and has also undertaken an important role, stepping in for Les Goldman, who, as you know, we lost this year.
So now let’s turn to our formal agenda, as set forth in our corporate governance documents. Only matters to be discussed and acted upon by the stockholders in the formal voting portion of this meeting are set forth in the proxy statement.
This meeting is being held pursuant to the Notice of Annual Meeting of Stockholders, which was mailed to you, along with both a copy and a notice of internet availability of our proxy statement and an Annual Report on Form 10-K for the fiscal year ended December 31, 2024. This mailing was sent on or about November 29, 2025 to the stockholders of record of the Company at the close of business on November 14, 2025.
Is there a motion to order the Notice of Meeting filed with the records of this meeting?
I move that the Notice of the meeting be filed with the minutes of this meeting.
And I second that motion.
Thank you, and there being no objection, the Notice of the meeting is ordered filed with the minutes of this meeting.
Will the Secretary please present the affidavit of mailing of the Notice of the meeting?
These are the affidavits of mailing, and they indicate that a copy of the notice was duly mailed to each stockholder of record on or about November 29, 2025.
The Secretary is directed to file the affidavits with the minutes of this meeting.
Will the Secretary please report how many stockholders are present in person or by proxy?
There are now present the holders of approximately 1,192,487,345 shares of common and preferred C stock, in person and by proxy, out of a total of 1,540,682,082 shares of common and preferred stock issued and outstanding as of the record date. Each share of common stock entitles the record holder to one vote on each matter to be voted upon. Each share of preferred stock is convertible to 25 shares of common stock, and hence entitles the record holder to 25 votes on each matter to be voted upon. This constitutes more than a majority of the shares of the Company’s common and preferred stock issued and outstanding and entitled to vote at this meeting, and there is therefore a quorum present.
Dr. Boynton, will you please present a certified list of stockholders of the Company?
I will now entertain a motion to dispense with the calling of the roll.
I move that the calling of the roll be dispensed with, and I second the motion.
Thank you. There being no objection, it is ordered that the calling of the roll be dispensed with under the power granted to me by the bylaws of the Company.
I hereby designate Thomas Cooper as Inspector of Election to count the votes presented to the meeting in person or by proxy. I have requested the Inspector of Election to submit their oath as Inspector, and I direct the Secretary to attach the same to the minutes of the meeting.
Copies of the 2024 Annual Report to stockholders have already been sent to all stockholders, and I therefore ask for a motion to dispense with the reading of the Annual Report and to order it accepted and filed.
I move that the reading of the Annual Report be dispensed with, and that the Annual Report be accepted and filed with the minutes of the meeting. I second the motion. Thank you.
There being no objection, it is ordered that the reading of the Annual Report be waived and that the Annual Report be accepted and filed with the minutes of this meeting.
Thomas Cooper has been appointed as Inspector of Election and will ascertain the number of shares outstanding and the voting power of each. It will determine the shares represented at the meeting and the validity of the proxies and ballots. It will count all votes and determine the results of the voting.
Most stockholders have already voted by proxy, and your proxy votes have been tallied.
Registered stockholders who are present here at the Annual Meeting may vote during the meeting by completing a ballot. If you are a registered stockholder and you have already voted by proxy, there’s no need to vote by ballot today unless you’d like to change your vote. I will ask our team to pass out ballots now for anyone who has not voted yet or wishes to change their vote. Please raise your hand if you would like a ballot to vote.
Beneficial stockholders whose shares are held through an intermediary are not able to vote during the Annual Meeting. Beneficial stockholders are required to submit any votes prior to the Annual Meeting pursuant to the two voting options provided in the Notice of meeting of the Annual Meeting of Stockholders and in the proxy statement. The first voting option was to vote prior to the meeting through their bank, broker, or proxy solicitor. The second option was to fill out the voter information form included in the proxy materials, submit the VIF to Broadridge, receive a legal proxy from Broadridge, and then submit such proxy to Computershare before 5:00 p.m. Eastern Time on Friday, December 19.
I have received Thomas Cooper’s written oath of office as Inspector of Election. The Secretary will file this oath with the minutes of the meeting.
Mr. Cooper has a list of stockholders who are entitled to vote at this meeting. I have also been presented with evidence from Computershare and Broadridge Financial Solutions that notice of this meeting was properly given to all stockholders of record as of the close of business, November 14, 2025.
Mr. Cooper, have you determined whether a quorum is present at this meeting?
I’ve determined that there are stockholders represented at this meeting, in person or by proxy, holding shares representing at least a majority of the votes entitled to be cast at this meeting, which is sufficient for a quorum and for transacting business of this meeting.
Thank you. I find that a quorum is present for the purpose of conducting this meeting. Only stockholders of record on our books at the close of business on November 14, 2025 are entitled to vote at this meeting, either in person or by proxy, on all business to come before the meeting.
So the first item of business today is the election of one member to our Board of Directors to serve as a Class II director for a term of three years that will last until the third annual meeting after his election, which is expected to be held in 2027, or until his successor is elected and duly qualified.
The director standing for election as nominated by the Board of Directors, and as set forth in the proxy statement, is Mr. Pat Sarma. The Board unanimously recommends a vote for the Class II director nominee. There were no director nominations by stockholders submitted prior to this meeting in accordance with the bylaws. Therefore, I declare the nominations closed.
The second item of business is to ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2025. The Board unanimously recommends a vote for this proposal.
The third proposal is to approve an amendment to our Amended and Restated Certificate of Incorporation, as amended, to increase our authorized shares of common stock from 1.7 billion to 2.6 billion, par value 0.001 per share. The Board unanimously recommends a vote for this proposal.
The fourth proposal is to approve, on an advisory basis, the Company’s executive compensation. The Board unanimously recommends a vote for this proposal.
That concludes a description of the matters to be voted on at this meeting. We will close the polls on all matters shortly.
Many stockholders have already submitted their proxies. As a reminder, if you are a registered stockholder present at this Annual Meeting and you have not voted or you wish to change your vote, please do so now by completing a ballot. If you’ve already voted and do not wish to change your vote, you need not take any further action.
We will now collect any votes cast by registered stockholders during this Annual Meeting. If you have a ballot to turn in, please hold it up and I’ll ask our team to collect it.
Okay, the polls are now closed. That concludes our formal business and concludes the formal portion of the Annual Meeting.
Mr. Cooper, would you please announce the preliminary results of the vote.
On the motion for election of Mr. Sarma, a majority of the votes cast with respect to this proposal at the meeting voted in favor.
On the motion to ratify the appointment of Cherry Bekaert LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, a majority of the votes cast with respect to this proposal at this meeting voted in favor of the ratification of Cherry Bekaert LLP.
On the motion to approve the amendment of the Amended and Restated Certificate of Incorporation, as amended, to increase the authorized shares of common stock from 1,700,000,000 shares to 2,600,000,000 shares, par value 0.001 per share, the common stock, a majority of the votes cast with respect to this proposal at the meeting voted in favor of increasing the number of authorized shares.
On the motion to approve, on an advisory basis, the Company’s executive compensation, a majority of the votes cast with respect to this proposal at this meeting voted in favor of the Company’s executive compensation.
Thank you. I declare: Number one, that the proposed Class II director has been duly elected. Number two, the appointment of Cherry Bekaert LLP as the Company’s independent registered public accounting firm for the fiscal year ending 2025 has been duly ratified. Number three, the proposal to increase the number of authorized shares of common stock has been duly approved. And number four, that the proposal to approve on an advisory basis the Company’s executive compensation has been duly approved.
I direct that the results of the voting be incorporated into the minutes of this meeting.
That concludes the formal business of our meeting. Having concluded the formal business, we have no other business that was properly brought before the Annual Meeting of Stockholders.
Within four business days, we will provide the final voting results in a Form 8-K filed with the Securities and Exchange Commission.
I would now like to take this opportunity for an informational discussion of questions submitted by stockholders in advance of our Annual Meeting.
Let me start by saying that this is going to be an informal discussion. It’s going to contain forward-looking statements. And we need to be clear in our disclaimer that all statements other than statements of historical fact are forward-looking statements. So we expect, we hope, we plan, we anticipate. All of these are forward-looking statements. You should not rely upon forward-looking statements.
You should read our SEC filings that contain a non-exhaustive list of risk factors. There are lots of factors, risk factors, and other factors that can cause actual results to differ materially from our forward-looking statements and whatever we may currently anticipate. So just solid, solid on the table and very clear for everyone.
As you will have seen in the proxy document itself, we had a procedure for anybody who wanted to submit questions, to submit questions before the Annual Meeting. With our active shareholder base, we received dozens of questions. So this is good. We appreciate the interest, the questions, input.
We reviewed all of these dozens of questions. Let me say that this informal discussion that we’re going to have about those questions, and our comments and remarks about them, is unusual. Most public companies don’t have any kind of lengthy or substantive discussion like this at their annual meeting. It’s a question or two from an analyst and it’s over in ten minutes.
But we really do appreciate your interest, your activity, your involvement, and especially all of you guys here in the room who have traveled in the middle of holidays to be here.
So we’re going to go through probably about 40 to 45 minutes of really getting into some of these questions, again with forward-looking statements.
Not surprisingly, there was a lot of overlap in the questions. In the dozens of questions we received, broadly speaking, they grouped into roughly four categories, and I’m going to talk about them and respond in the four groupings.
So the first grouping, no surprises, questions about the MHRA process, our application for approval, our DCVax-L process, and other applications that we might make in other countries and so forth.
Second category, questions about our DCVax-Direct technology and clinical trial plans, and likewise about the Roswell and Pittsburgh technology portfolios and our clinical trial plans and activities there, and compassionate use.
Third category, broadly manufacturing related subjects, subjects relating to the Sawston facility, the Advent acquisition, the manufacturing group that we’re developing in Pittsburgh, and the Flaskworks machines, and where that whole thing stands.
Fourth category, final category, what you might broadly describe as business strategy: why are we raising the ceiling by 900 million shares, what are we going to do with that, what’s our thinking about partnering, be it partnering with big pharma or others, and what about expansion of the management team and succession.
Okay, so I’ve got to sift through these fairly quickly, but I think fairly comprehensively, and I hope that will give people a feel for what they were asking with the questions.
Okay, first, MHRA.
There’s very limited in what I can say. The first thing I can say, and it’s quite important, is that we are really, really gratified by how much work and how much resources the agency is devoting to our case. They’re doing an enormous amount of work on our case, inspections and analyses and so forth. And our advisors have commented on this too, and have expressed to us that they are impressed with the amount of resources being devoted. So that’s a positive, and we’re gratified by it.
The second thing is, I can say that we are continuing to be actively engaged. We are going through cycles of questions, follow-up questions, requests for clarification, requests for additional data, information. Those are the cycles that we’re going through.
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.
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.
One last question that came in about MHRA was: why do we go to the UK anyway? Just as a reminder, we have a large footprint and a long history in the UK of very priority treatment there. Our product was the first product that ever received designation as a Promising Innovative Medicine, a PIM, and the UK Health Ministry put out its own press release about that when that happened some years ago. Our trial was selected and included in the national priority portfolio of the NIH portfolio of priority clinical trials for the country and so on. And perhaps most importantly, we were attracted by a very accelerated potential pathway for approval, as everyone is so well aware at this point, the so-called 150-day pathway.
So, long history, good experience, attractive accelerated pathway. So there we are. We are where we are. We need to get through this and finish it.
In terms of what comes next, we currently anticipate, of course, we want to come to the US and Canada as soon as the UK process is finished. Our understanding is that the Canadian process and form and format and all of that is very similar to the UK. US is different, but that’s what we will do next.
In terms of why we will do that after the UK process finishes instead of doing everything all at once, frankly speaking, doing each one of these application processes is incredibly intensive and expensive. We’re spending $12 million a year on consultants. We have literally armies of consultants: regulatory, statistical, CMC, all the different areas. It is extremely intensive and expensive.
From our perspective, the single most important and most valuable thing for the Company is to get that first approval, and we are laser focused on finishing the process and doing our best to get that first approval. Again, forward-looking statement, but our perspective is that everything else is facilitated by getting the first approval. So that’s the reason.
Noteworthy, we think, is that while we’ve been going through this very, very, very long process, there have been a number of really important developments taking place in the field, moving in our direction. You’ve probably seen these.
For example, in May of this year, the MHRA issued a draft guidance document that would give permission for clinical trials to start using external controls, and MHRA received public comment all through the summer. Our understanding is it received lots of comments, very positive. And our understanding is that in the early fall, the MHRA announced that it now plans to make that formal and indefinite. That’s huge. That’s amazing, given how much controversy there has been over that subject.
Another example has been multiple regulators, including US FDA, including just very recently, coming out with new and modernized policies to embrace and start increasing the use of real-world data and real-world evidence. We’ve treated, for example, hundreds of compassionate use patients, and that real-world data is increasingly valuable as the policies move in the direction of embracing and supporting use of that data in regulatory decision making processes.
So anyway, some positive developments we think are quite important while we’ve been going through the UK process.
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.
One of the things that’s very handy, so to speak, about brain cancer is the treatment of brain cancer clinically is very concentrated. So for example, in the UK, a country of 65 million people, the vast majority of surgeries to remove brain tumors take place at only about ten hospital centers in the entire UK. So eminently manageable with an in-house team, which we would plan to do. So that would be our approach.
Another question that I think there seems to have been some confusion about is: we do not need to have completed the first Grade C suite. This has been a big development, very important stage for us to be underway with preparations and moving towards the construction of the first Grade C suite. But we are perfectly able to launch, and would currently anticipate launching, with just the two existing Grade B suites. That’s plenty with which to do an initial launch. We do not need to have the Grade C lab finished yet. We of course want the Grade C lab as soon as possible for additional capacity, but I would like to clear that up and put any confusion to rest.
We also are aware that it’s very typical to need a surge of launch funding, a surge of financing to deal with the surge of costs associated with an initial launch. We very much plan to focus as intensively as possible on non-dilutive structures for that. The two typical structures that we’re familiar with are either royalty-based financing or debt-based structures, non-convertible debt-based structures. Suffice it to say we’re mindful of launch funding needs and focused on non-dilutive approaches.
That completes the category one kind of subjects.
Moving into the clinical programs now.
DCVax-Direct, as a reminder, and we’ve reported this in our periodic filings, the manufacturing of DCVax-Direct is ready to go. It has been since last spring. That was the culmination of two years of technology transfer from the US to UK and certain updates and changes that had to be made due to certain ingredients availability. That whole two years, and the engineering runs, the testing, the validation, is all done in the spring of this year. So that’s ready to go.
We can make DCVax-Direct tomorrow morning or this afternoon.
Along with that, the IND package, you always put together a so-called IND, investigational new drug package. That’s how you apply for regulatory permission to do any clinical trial. And a big portion of an IND package is the so-called CMC, chemistry, manufacturing and control. That’s all the product and manufacturing issues. That’s what’s contained in the CMC.
That section of the IND package is already written. So not only are we ready to make the product, that whole section of the package is already done and written.
We have gone through a lengthy selection process. We’ve selected what the first cancer will be for the Phase 2. This is a follow-on, remember, from the Phase 1 trial that we previously did at MD Anderson with the original DCVax-Direct. And that trial was an all-comers trial and we treated 13 diverse types of solid tumors.
So now, as we move into Phase 2, of course, we need to zero in on a particular cancer. We’ve selected that indication. It is a non-brain cancer. It is below the neck. And the lead institutions in both the US and UK are on board. In fact, they’re jumping up and down. I think we have a really good indication, which is, unfortunately for patients, very bad and really needs something new and different.
So anyway, the lead institutions have been involved in protocol development. Protocol outline. A portion of the IND section is done.
So suffice it to say, overall summary, we’re pretty much all dressed up and ready to go.
However, we have been hesitating to pull the trigger on proceeding because Phase 2 trials, especially ones designed and powered robustly, are quite expensive. And right now, our two laser focus areas for allocating our funding are the MHRA process, all those consultants and everything that we talked about, and the Sawston facility, the Grade C lab and ramping up manufacturing capacity, as well as ramping up manufacturing capacity in the US, in the Pittsburgh group, and I’ll come to that more in the next group.
So I know it’s a tradeoff between progress versus more burn rate, which means dilution. And we know that is a very sensitive subject for all of us. So that’s where we are on DCVax-Direct.
We got a lot of questions about that, so I’ve given you a lot of detail.
More succinctly, questions we got about the Roswell Park and Pittsburgh, those two big portfolios of intellectual property that we in-licensed last year and the year before, as everybody I’m sure remembers, those portfolios represent an entire career worth of work by one of the top dendritic cell teams and senior scientists in the world. That’s Dr. Pavel Kalinsky, and his team was 17 years of work at Pittsburgh and another eight years of work at Roswell Park, and we in-licensed all of that.
Dr. Kalinski has this year moved back from Roswell to Pittsburgh, which is great, although it does have a little operational challenges.
You may remember that part of the package that came with the portfolio is there are a couple of clinical trials that are academic-led trials and are funded by grants. And the data that comes out from that, and the support for the IP and so forth, is within the scope of our license, and that’s great.
The main focus of the licenses, though, of course, like every license of IP from every university to a company on the planet, is the provisions that relate to the Company’s own development of the IP and the clinical trials that the Company conducts to take that technology forward and eventually get approval, commercial approval, from that.
So in the background, those academic trials are still there. They still have the grants associated with them. But they have temporarily suspended enrollment while the whole move of Dr. Kalinski back from Roswell to Pittsburgh gets sorted out. Thankfully, that has no effect on us, no effect on our license. We don’t have to be in the middle of that. And once they get that sorted out, those trials will resume enrolling again.
Meanwhile, our focus is on our own trials, which are very important. Every license, including ours, has due diligence development obligations. But more than that, we’re really excited to get underway with clinical trials that we think have an optimal design.
And I’m really excited to tell you the first trial is already determined. It’s going to be in relation to an ovarian cancer trial. It’s connected with an academic trial that Dr. Kalinski had already developed and gotten grant funding for, but we’re now bringing in a company-sponsored portion of it.
And this is exciting because it’s going to be a combo trial. Now you remember that we’ve been talking for years about how we’re looking forward to do combination treatments.
The traditional regulatory requirement is you have to go through clinical trials and demonstrate safety and effectiveness of each individual treatment agent first as a monotherapy before you can go and do combos. Dr. Kalinski, well, FDA is a little more flexible with academics than they are with companies. They won’t say that, but they are.
Anyway, this trial has a conditioning regimen, a dendritic cell component, and then another component. And we’re quite excited to get to do the first combination trial with this, with Dr. Kalinski’s dendritic cell polarized Alpha DC ones. So that’s moving along.
And just one last thing to remind you on that: Northwest already has a history itself in ovarian cancer. You may remember that we did a small pilot trial with DCVax-L in ovarian cancer, and it was quite strikingly encouraging at the time. We could only do the small pilot, but the academic collaborators we did that trial with many years ago, who were at Penn, and Penn has a center of excellence in ovarian cancer, they did go onwards and treat some more patients beyond what we could do, and they continued to get good results, and those results have been published.
So it’s very encouraging to have this next stage of clinical development and the combo trial be in an area where we already have prior data indicating that the dendritic cells have done a really nice job, at least in that context.
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.
In the new year, we currently plan to offer compassionate use treatments for most types of solid tumor cancers, not just brain cancer, thanks to the expertise and the interest of these additional doctors. And we also are planning at a certain point to offer DCVax-Direct in addition to DCVax-L for compassionate use. So that will be a very important progression of our compassionate use program.
Okay, that’s the end of the clinical subject.
Just quickly, because we need to wrap up manufacturing.
So I’ve already covered the fact that in Sawston we would have the two existing Grade B suites. These are the super sterile, very burdensome, expensive to operate classic. It’s what has always been used in the past. But now we’re moving towards closed systems so that we don’t have to have such a high level of sterility and burdensomeness.
We’ve been working on various factors to maximize the capacity of those existing suites. Obviously, we have recently hired a number of additional production staff. We’re going through some process development to try to streamline how much of the procedures need to take place in the B suites versus outside, and the potential for two operating shifts.
Now the focus really for the future, of course, is the Grade C labs.
You may remember we initially developed plans, including the full-blown engineering specification and so on, for two quite large Grade C labs that would be in a certain portion of the Sawston facility building. Those were going to be big, and they were going to be pretty expensive because of the infrastructure, the positioning in the building, extra duct work, the HVAC that was extra was needed, and so on.
We still have all those plans, and when we get to that stage of development, we will review them and proceed with them.
But as we announced in our more recent filings, and I think we first announced it maybe late last year, anyway earlier this year, that we had developed a plan for a simplified C lab to build one on a simplified basis in a different location. It actually happens to be adjacent to the quarantine storage and loading docks, where far less infrastructure work has to be done, and it cut to less than half the cost of the design of the original C lab.
That’s the one where we mentioned in our most recent quarterly report, Q3, that the contractor has already been selected and engaged, already been on site doing the prep work of the site, and we currently anticipate that the physical construction work would get underway at some point by the end of January for that, and then would be around a six-month timeframe to get finished for that.
We’re quite excited about this simplified C lab because even the simplified C lab, one simplified C lab, will have more than double the capacity of the two Grade B labs combined. So that will be a big step forward for us in terms of manufacturing capacity.
We also reported in our recent Q3, this was very important.
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. So we’ve got a good head start on the key equipment for this simplified C lab as well. So that will be a big thing for us to reach the beginning of operations of that first C lab.
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.
Last quick thing, Pittsburgh. We’re developing a group there, principally to do the manufacturing of Dr. Kalinski dendritic cell products, but it will also do Northwest DCVax-L and DCVax-Direct for compassionate use and clinical trial programs. Commercial production, when and if we have the approval, will take place in the Sawston facility. So Pittsburgh will be doing clinical trials, compassionate use, particularly Dr. Kalinski version, but also ours. And then Sawston will continue what it’s been doing.
Flaskworks, the closed system that will be the heart of the operations, the machinery operations of the Grade C labs, the original fully functional prototype was developed more than a year ago, and it’s all set. We just needed to make a GMP version of it.
We had a little temporary diversion where the initial engineers that we hired to do that instead did some redesign work. We reported this in our 10-Qs. The redesign work was not wanted. It made the prototype not useful because it extended the footprint by almost two feet and wouldn’t fit where we needed in the C lab footprint and so on.
We have now got two sets of excellent engineers in the UK. They’re doing analytic work, and that will be over the course of, we currently anticipate, the first half of this year. We’ll be working on that. The idea is to mesh the timing of when the Flaskworks GMP prototypes would be ready for when the Grade C suite is ready for operations. Because the Flaskworks machine, as I said, is the heart of the machinery in the C lab, but you can’t use it in the B lab, so trying to mesh the capital expenditures and the timing.
Okay, that’s it for the construction and manufacturing category.
The last category, sort of business strategy.
Why did we raise the ceiling with the 900 million shares? And what about partnering, and what about management team?
Okay, so our concept with raising the ceiling to 900 million, we wanted to be really clear about having plenty of flexibility, plenty of capacity. We anticipate we’re going to be negotiating some pretty significant financing arrangements if the events that we anticipate to happen are unfolding. And we don’t want to be in a situation, and we don’t think it would be good for the Company to be in a situation, of being constrained and then whoever we’re negotiating with has the leverage to be problematic.
So we think that having plenty of flexibility and plenty of capacity will actually enable us to get better terms and structures, not less good.
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.
Now partnering.
One set of questions was about regional partnering. We have always been quite interested in regional partnering or licensing, for example, for a region, whatever it might be, Asia, Latin America, the Gulf, whatever region it might be.
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.
Well, I’m excited to say that we are already in exploratory discussions, and have been for a bit, in regard to the possibility, just the possibility right now, but exploratory discussions, of a regional deal. So stay tuned for the space. We’re very excited about those discussions, and we’ll see whether they lead to fruition or they don’t.
The other type of partnering that we’re always asked about, of course, is with big pharma or big biotech. And we’re thrilled. We’ve always been interested in that.
One of the things that we think is an important avenue to that is combination trials, combination trials such as with checkpoint inhibitor drugs and so forth, combined with DCVax.
So that’s another reason that we are excited that our first company sponsored trial program that we’re doing with Dr. Kalinski is a combo trial of that type. But we’re very interested in those possibilities, and we think we’re reaching the stage where that sort of thing may be from a possibility.
Last, last, last item is expansion of the management team and succession planning and so forth.
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.
So that brings me to the end. I was a bit longer than what we meant, 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. And I think we’ve covered most of the dozens and dozens of questions that people asked.
So let me bring this to a close and say that having had an opportunity to address questions submitted by stockholders, we now conclude this informal discussion session.
And I move that the meeting be adjourned.
I second.
There being no objection, the Annual Meeting is now closed and adjourned at 2:57 p.m.
Thank you very much, everybody. Russ, you can close the program you.
AI
