NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

So, the first item of business today is the election of two members to our board of directors to serve as class one directors for a term of three years that will last until the third annual meeting after his or her election, which is expected to be held in 2026 or until his or her successor is elected and duly qualified.
The directors who are standing for election as nominated by the board of directors and as set forth in the proxy statement are Dr. Al Boynton and Ambassador Cofer Black.
The board unanimously recommends a vote for the class one director nominees.
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 Bekert LOP as our independent registered public accounting firm for the fiscal year ending December 31, 2024.

The board unanimously recommends a vote for this proposal.

The third proposal is for ratification of the same option awards that were made in 2020 to the named executive officers and for which stockholders have already voted in favor in an advisory vote in 2021 at the annual meeting and in a ratification vote in 2022 at the annual meeting.

The board unanimously recommends a vote for this proposal.

The fourth proposal is ratification of the same option awards that were made in 2020 to the non-executive directors on the board of directors and that were previously reported and previously approved by stockholders at the 2022 annual meeting.

The board unanimously recommends a vote for this proposal.

The fifth proposal is an advisory vote to approve executive compensation.

The board unanimously recommends a vote for this proposal.

That concludes the description of 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 the meeting and you have not voted or 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.

And we've already collected the votes cast by stockholders during this meeting.

So that's been completed.

The polls are now closed.

That concludes our formal business and concludes the formal portion of the annual meeting.

Ms. Aultig, would you please announce the preliminary results of the vote?

On the motion for the election of Dr. Alison Boyden and Ambassador Jacober Black, a majority of the votes cast at this meeting voted for the re-election of Dr. Alison Boyden and Ambassador Jacober Black, our class one directors.

On the motion to ratify the appointment of Cherry Beckert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024, a majority of the votes cast respect to this proposal at this meeting voted in favor of the ratification of Cherry Beckert LLP.

On the motion to ratify the same stock option award that were made in 2020 to the named executive officers and for which the stockholders already voted in favor in an advisory vote at the 2021 annual meeting and in a ratification vote at the 2022 annual meeting, a majority of the votes cast with respect to this proposal by disinterested stockholders at this meeting voted in favor of this proposal.

On the motion to ratify the same option award that were made in 2020 to the non-executive directors on the board of directors and that were previously reported and previously approved by stockholders at the 2022 annual meeting, a majority of the votes cast with respect to this proposal by disinterested stockholders at this meeting voted in favor of this proposal.

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 that first, that the proposed class one directors have been duly elected.

Second, the appointment of Cherry Beckert as the company's independent registered public accounting firm for the fiscal year ending 2024 has been duly ratified.

Third, that the same stock option awards that were made in 2020 to the named executive officers and for which the stockholders already voted in favor in an advisory vote at the 2021 annual meeting and in a ratification vote at the 2022 annual meeting have been duly ratified.

Fourth, that the same option awards that were made in 2020 to the non-executive directors on the board of directors and that were previously reported and previously approved by stockholders at the 2022 annual meeting have been duly ratified.

And fifth, 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 8K filed with the SEC, Securities and Exchange Commission.

I would now like to take this opportunity for an information discussion, informal information discussion in regard to questions submitted by stockholders in advance of the meeting.

We may have to make this point.

We may make forward-looking statements during this discussion and our actual results may differ materially from those forward-looking statements.

We should not rely upon forward-looking statements and you should read Northwest Biotherapeutic Inc's periodic filing with the U.S. Securities and Exchange Commission for a non-exclusive list of risk factors related to our business and operations that could cause actual results to differ materially from any forward-looking statements provided during this meeting and discussion.

And now, without further ado, we'll transition into that discussion.

So I'll give you a little more informal, right?

This is meant to be a discussion of questions that we're aware of that shareholders have submitted or shareholders have raised with us.

Before I dive into the discussion, I think all of us at Northwest, I speak for all of us, want to really thank all the stockholders for the tremendous voter turnout and the tremendous number of shares voted for this annual meeting.

We really appreciate it and we really appreciate the positive votes and we're just tremendously thankful and appreciative for that.

We've got a lot to discuss today and we hope you're going to find it exciting and you're going to leave the meeting feeling as excited as we do about the progress we've been making and what our plans look like going forward.

We plan to spend up to about an hour in this discussion and I will go through a lot of information that we've collected and that we think covers most of the questions that we're aware of that have come from shareholders.

So I'm going to start by, I'm going to talk about the MAA, about developments at the Saucon facility, about progress with Flaskworks, also going to talk about some of the new exciting IP that we've acquired and an update on our groundbreaking lawsuit against the folks that we believe have been manipulating our stock price.

So that'll be a kind of recap of where have we come in the last 18 months since the last annual meeting of shareholders, it's been a busy period.

After reviewing the, recapping the past 18 months, we're going to look forward and I'll describe our planning and our priorities for the next approximately 18 months and we hope that you'll find that exciting with a lot of anticipated growth areas and potential progress.

So I'm going to just go through some of these particular subject areas for the last 18 months.

So recapping where we've come to over the last 18 months, first of all, near and dear to all of our hearts is the MAA for the commercial approval application for the commercial approval of our DCVEX-L product for glioblastoma brain cancer in the UK.

And during this past period, key things that have been accomplished relating to this, first of all, as you may recall, there were quite a few very significant prerequisites that we had to complete before we were even eligible to apply.

That was in addition to the clinical trial results from our phase three trial.

So we had to get three licenses for the Sauston facility.

We had to get the initial license, we had to get a human tissue authority license, and then most importantly, we had to get the MIA commercial license.

And that license, which was obtained in March of last year, was one of the first that's been granted for cell therapies in the UK.

All of those licenses, the work was done and the license was obtained by Advent Bioservices that worked with us.

Another key prerequisite that we had to do before being eligible to apply with the MAA related to pediatric treatments.

We had to have a pediatric investigation plan, a PIP, which seems like a very English term.

And the PIP had to be submitted to the regulator and approved by the regulator, MHRA.

And so that was accomplished.

And in fact, was accomplished in what we understand to be approximately half the usual amount of time.

MHRA has been wonderful.

They have given us rapid turnarounds more than we could have expected or hoped for in the steps that we've had with them so far.

That doesn't necessarily predict anything, but it's been a really great experience so far.

So completing all of those prerequisites, there were a lot of preparations as well that kind of are surrounding context of the application itself.

Pulling together the enormous, I mean, it's just an enormous paper exercise, the trial master file, I don't even, I mean, I'm told it's a couple hundred linear feet of paper.

I've seen it.

I haven't measured it.

It's ginormous and you cannot have any gaps.

And when the inspectors come and they say, I want to see the lab tests for patient X at clinical trial site Y, you have to be on top of that and go right to it and pull that page right out and be ready for them.

And we're talking an enormous trial master file.

This phase three trial was one of the largest clinical trials of a cell therapy product, particularly a personalized cell therapy product that anybody has conducted.

And the trial master file is correspondingly enormous.

That's just an example to give you a flavor.

There's just such an enormous amount, particularly to prepare for inspections.

And that's a common theme you're going to hear.

We have been working our tails off with teams of consultants because everybody's going to be inspected.

We the sponsor are going to be inspected, the contract research organization who conducted the trial is going to be inspected.

The document, the trial master files, its own inspection, the independent database company that held the database for the trial will be inspected.

The hospital sites selected ones that were trial sites are going to be inspected.

So what I just described as the glimpse, the example of the trial master file, every one of these parties has to have everything ship shake.

And when they come with inspectors, our understanding from our advisors is they will send a team of inspectors, two, three, four inspectors, and they'll stay for a week.

That is a big undertaking.

So we've been spending enormous amounts of time with all our teams of consultants preparing for all of those things.

And we have gone through audits, mock inspections, we hire people who used to be inspectors for regulatory agents and are now consultants.

And we've gone through mock inspections and each cycle is several months and we get a report and then fix those things.

And so anyway, that gives you a bit of a flavor.

The drafting of the MAA package itself was a year long process.

As everybody knows, it was our Christmas present last year to ourselves and everybody got it submitted on December 20th, this past year, and had been working with medical writers since the fall of the year before it was a multi-thousand page submission.

And then in the period since the submission, of course, there's been post-filing support.

One of the things we are trying to do working with consultants, a little bit like the practice inspections, we're trying to guess, we're trying to predict what kind of questions might MHRA ask us about the package we submitted and what kind of supplementary information might they ask us for so that to the extent possible, to whatever extent we've guessed right with the guidance from all our advisors who are experts in this, that will enable us to do a faster turnaround time.

That's the whole idea.

We want to try to keep the momentum and keep up with rapid turnaround time.

So that's a big area.

As I think you know, also during this past 18 months, we conducted and carried out and then publicly presented all the results of our Mechanism of Action studies.

These were studies about the underlying biology of how DCVACS works.

And our Chief Technical Officer, Dr. Bosch, presented all that information in a company presentation during ASCO last year, and it was tremendously important because it showed with the underlying biology that DCVACS is what we've always hypothesized, is that it gave support for the hypothesis that it's a broad spectrum treatment.

We reported that in the examples that were studied in those Mechanism of Action studies, the dendritic cells were picking up from the tumor's tissue sample, the lysate, and presenting to the T cells over 600 different tumor targets.

So when we say it's a broad spectrum treatment, that gives you a flavor of it, and those Mechanism of Action studies were really important to add more scientific underpinning that supports the clinical trial results that we've seen in the patients and help support our MAA.

And it was very important, we use proteomics technologies that are relatively recently developed.

Proteomics, a study of the proteins, active agents, are not as far along as genomic tools, and so we were using quite recent technologies in doing these studies, and that was really important.

On another front, we do continue to follow our patients from the Phase III trial.

We do still have patients alive.

I'll remind you that the last patient was enrolled in November of 2015.

We also have continuing our ongoing compassionate use program.

We have not had as much activity in that while we've been so occupied with the MAA, but that program continues to give us really valuable real world experience.

In a clinical trial, you try to do everything as cookie cutter as possible, as homogeneous, the same as possible, but that is not the way the real world is.

And so the compassionate use program has been so valuable for us because we've gained a tremendous amount, and we still are gaining tremendous amount of real world experience, basically practicing for when we're able to be commercial.

So we have patients who their tumor tissue sample isn't in the condition that it's supposed to be, or it hasn't been frozen quite the right way, or it was frozen several years ago, or the patients are way outside the age range.

We have patients in their 80s and upper 80s.

So lots of real world circumstances that's really been valuable for us, and I think it's been very valuable for the patients too, which is quite important.

And we are learning lessons.

We have some very nice long-term survivors, eight, nine, 10 years, and so we are learning lessons from the cases of long-term survivors as well.

Okay, another huge area of activity over these past 18 months has been in the Sausten facility, the development of it, not just the licenses, which I've already touched on, but let me just for a moment of history here, remind everybody, the very first manufacturer of ADC-VAX-L product for a patient in the Sausten facility, product number one ever, was manufactured in February of 2022, just two, and there's a press release about it.

You can find it on our website.

Just two and a half years later, look at where we are.

We've completed the phase 1A build out, the phase 1B build out.

We have worked with specialized architects and engineers to design the grade C labs that I'll talk about in a minute that will be for the build out going forward.

We've gotten, Advent has gotten all three of those licenses, and we're working on commercial readiness.

Less than two and a half years from the first product ever made, GMP in that facility.

That's been a huge area of work.

We're very proud of that progress, and it's a valuable facility.

One of the things we've mentioned that you may remember from our press release earlier this year about the progress in the FlaskWorks system, which I'll come to in a second, is that the traditional type of clean rooms in a GMP, good manufacturing practice, clinical grade manufacturing facility, are what the Europeans call grade B labs.

The letter B as in boy.

We would call them class 10,000 in the US.

These are the high level sterility.

An entire air change of the whole suite, 60 times every hour, i.e. a full air change every one minute.

Technicians wearing spacesuits, special water, special environmental systems, no particulates, whatever, all of that.

Those are the traditional ones.

They're super expensive to build.

They're super expensive to operate.

What we are transitioning to now, and we're able to do this because of the FlaskWorks system, is we're transitioning to grade C labs, which would roughly be more like class 100,000 in the US.

In other words, it's a lower level of rigor and sterility.

You can only do that when your whole manufacturing process is done in a closed way.

The word closed is a magic word in the world of medical manufacturing.

When your process is closed, that means it's all kept within a machine or within a bag or within a flask or something that's not open to the air.

Because once it's open to the air, it's no longer closed, and then the air has to be basically perfect, and that's very expensive.

The FlaskWorks system has enabled us to transition first to being a closed system for the manufacturing steps, and also to start the process of automation, which is a separate thing and an additional benefit.

As we look towards the further development of the Sauston facility, we are moving into all grade C labs from here on out.

Another huge difference, just to crystallize it for you, is in the grade B labs, the more rigorous, sterile ones, you can only produce one patient's product at a time and have to clean the whole suite in between each product.

Imagine that, and that's on top of all the special air and everything that I just said.

That's because you're doing a procedure in there that at least partially is open.

That's why the word closed is such a magic word.

In the grade C lab, because everything is, magic word, closed, the regulars allow you to manufacture product for multiple patients at the same time in the same suite.

You can begin to see the efficiency is so important.

This whole area has been a big amount of focus for us and work.

There's a lot of aspects.

It's not simple to change your planning from grade B labs to grade C labs, because not only is the size and the configuration so forth different, even the load on the building is different.

Oddly, some of the load is more problematic, more challenging structurally for grade C labs than for grade B labs, which I was surprised about.

But anyway, a lot of work, big area, tremendous progress over the last 18 months.

Just before we leave that subject, in terms of capacity, our current anticipation, and this is based on assessments by the advent folks who are the experts, is that we anticipate that each of the grade C labs should be able to, with two shifts operating, produce about 1,000 or 1,100 patients' products per year per grade C lab.

We anticipate, we're so fortunate this building is very large and it's about close to 88,000 square feet on two floors.

We anticipate, ultimately, when the building is fully built out, if it's fully built out with C labs, with our current understanding, and the engineers don't change things, we anticipate being able to, up to potentially 15,000 patients a year with all grade C labs in the rest of the building.

So you can start to see, even if we get part of the way towards 15,000 a year, that is an enormous amount of patients, especially for personalized cell therapies.

My understanding is, for example, the big companies who bought the CAR T cell technologies in their first years of commercial operations made 50 patients' products.

Having the eventual capacity to make up to 15,000 patients would be absolutely enormous.

We also have been doing a lot of preparations of the nuts and bolts of things that would be needed for commercial operations.

I won't take time on that, but just to give you one glimpse of it, again, giving you flavor, we have established an existing today.

We have controlled clinical-grade cryo storage for three million vials of doses.

So three million is a pretty good amount to start with.

Part of all this is not just the physical aspects of building out this Austin facility, but there's a step that you have to go through for any medical product for a human patient, and that is after you manufacture the product, it has to go through product release and it has to go through quality control tests using quality control assays or tests or analyses that have been approved by the regulator.

You have to test the sterility, the purity, the potency, the composition, all of that of your product.

But you also have to check that all during the manufacturing process, all of those regulatory requirements were met.

So you have to check the readouts from the environmental monitoring system to make sure that the number of particles in the air in the suite during the entire seven-day process stayed below the maximum allowed.

I mean, it's enormous.

And the manual way of doing product release is for a certified person, they're called a QP, a qualified person, to manually review all those records.

Well, that can take up to 30 person hours to do that.

And that's one thing if a batch of product is like a million tablets, but a batch of product of a personalized therapy is one patient.

So that would have been a bottleneck if you manufacture the product and you can't release it to be used in a patient.

So we started close to five years ago now, Advent has worked with a company, they've developed a system and the system, I won't bore you with the details, we'll have more to say about it in the coming weeks and months.

But the system essentially automates the product release process and removes that as, or hopefully, potentially removes that as a bottleneck, certainly greatly improves over the manual process.

So again, huge area of work.

Yeah, I'm taking too much time, so I have to hurry up.

Flash Court, I'll just say 18 months ago, they had only developed one approach for the system.

It was a good approach.

It was attractive as part of why we acquired them from Corning, but wasn't necessarily specifically as optimized as we would like it to be.

So over these 18 months more, they developed two other fundamentally different approaches to the automation, the closing magic word and automation of the manufacturing.

Did extensive testing comparative, evaluated, how did the cells do, were the cells stressed with one approach or another, was the yield better, all that kind of thing you would imagine, selected the best approach, developed, optimized a non-GMP, non-clean room version of the machine, and then went through and just in this year to date, we've done the adaptation of that to go into the clean room, which you have to use different materials and you have to use some different mechanics and so forth that I won't go into.

So that adaptation work for GMP was recently finished, there are a couple of improvements that we are doing to streamline, and then those units are about to be ordered shortly.

So that's the clinical grade machines.

Les is going to, I guess, make a couple of comments about the role.

Most of this work that I've described has either been carried out or driven by Advent.

So we know that stockholders had some questions about Advent and how our arrangements with Advent are, how we pay them, what the structure is, and Les is going to give you just a minute or two on that.

Thank you.

Advent provides a range of contract services to Northwest that is very important and significant in terms of having people on the ground in the UK able to do things like manage the complete development of this Saucon facility, prepare for and draft all the sections of the MAA from a scientific perspective and the writing, on-site detailed science, oversee the functionality and the actual work done on the Compassionate Treatment Program, again, all under contract to Northwest.

Substantial inputs, as Linda indicated, into the development of the classwork system.

It involves a lot of collaboration and a lot of testing and a lot of, it's been amazing how much work has been done and how great the people there have done on that.

And the way that Advent is finishing up, even right now, things like the restart of DCVAX Direct, which will be coming up and has done, I'll put a lot of work on that in the last seven, eight months, and let me take on and state how we compensate them under these contracts and that is, that the payment structure provides a pass-through of all baseline costs.

And a fee, if you will, for the administration of it all, which is a 15% on top of that cost.

But Advent doesn't really realize any gain on any of that until they meet the milestones like getting the MAA in or getting the facility going for the next phase of the C services.

And so we find that that kind of an approach is very favorable to us and to Advent because of the assemblage of all the capability, not only on manufacturing, but on the experimentation and the work that has to be done on the science side.

And so that kind of a compensation is something that allows us to get services that would be far less costly than if we had to go to a third-party provider that we didn't have this close intimate relationship with and it makes a lot of sense and it's been a great relationship and we monitor all of these inputs very carefully and I oversee that and we just want to give you a flavor of how all that works, a large chunk of what we pay to Advent is just pass-through costs of the work that they're doing with their personnel and the various contractors that they bring in to do things like get the facility put together or to do the C layups.

Thanks.

So we have two more large subjects to finish up the recap of the last 18 months.

Having gone over the MAA and the Sawson facility and the FOSS works and all that, now I'd like to turn to talking for a minute about intellectual property and collaboration.

That's been a significant area of activity for us.

We've reached completion on some things that we're quite excited about.

So I'll talk for just a minute, a couple of minutes about that subject and then I'll finish by talking briefly about our lawsuit and the progress of our lawsuit against the parties who we believe are manipulating our stock and we'd like that to stop.

A little understatement of the millennium, right?

Okay.

Intellectual property.

Let me start with the big picture point.

Our goal is to build a franchise in dendritic cell technologies.

We want to build a leading and preferably the leading franchise in this area.

The mainstream thundering herd hasn't yet fully recognized the special capabilities of dendritic cells, but it's starting to happen more and more.

If you noticed, for example, when the federal government created a new agency modeled on DARPA, the Defense Advanced Research Projects Agency, which they call ARPA-H for health and wellness research project, the very first grant that this elite technologies of the future agency awarded was a large $25 million grant for dendritic cell technologies in academic setting.

And that's just one glimpse, but increasingly people are beginning to recognize the special capabilities of dendritic cells.

So we are working busily to build a dominant franchise in the meantime, before the thundering herd arrives or while they're on their way.

So we have quietly, and you may or may not have noticed, but in our 10K and 10Qs, we have been quietly reporting that we have been in-licensing technologies that we think will be valuable for the future in building this franchise.

Now, just recently, we announced one that was particularly big, I mean, ginormous.

And that's the arrangement, the in-licensing package that we did from Roswell Park.

But if you noticed, even in that announcement, we explained that that package from Roswell covered seven years of work by this leading research group on dendritic cell technologies.

But we had also completed last year an in-license of a package of the original, older foundational work that that group had spent 17 years developing at another institution.

And we have in-licensed both of those packages.

And we purposefully stayed in stealth mode while we put all the pieces together.

Because we believe in our own analysis that the sum is greater than the parts.

And those two packages together have some just wonderful things in them.

They include enhanced versions of dendritic cells.

They also include technologies that are complementary to, to use with dendritic cells, for example, in a combination treatment regimen in a trial.

Or agents to just be immune booster agents, that kind of thing.

And if you think about it, interestingly, this collection of new tools or technologies gives us a lot of growth opportunities, which we can use together with our existing DCVAX platforms, which, as you know, we have two versions of the platform, DCVAX L for operable tumors, DCVAX Direct, that you haven't heard much about recently, but which will be coming up again now, I'm happy to say, for inoperable tumors.

We can use these complementary technologies with our own DCVAX platforms.

We can even use them with other kinds of agents.

You can use a conditioning regimen, for example, that's meant to condition the patient to have more of a response to immune therapies, or is meant to, as people like to say, reprogram the tumor microenvironment to be more conducive to an immune response.

You can use those with any type of agent.

So we could do partnering with other companies who have biologics or targeted therapies or checkpoint inhibitors that could either be with the dendritic cells included or with just the other agents.

So we start to have a pipeline that has complementary things, but has many permutations and combinations that we can do.

And obviously, one of the really nice things about the package, and we were surprised because people maybe didn't quite register, but as we said in our announcement, there are two phase two trials currently underway with these technologies that we unlicensed.

And these two clinical trials are fully funded by grants and they're being fully carried out by the investigators.

So we don't pay anything and we don't do anything.

But these are the results of technologies that we now have.

So those will be going along in the background in parallel while we're busily working on the MAA and all of that.

And if they produce positive encouraging results, we will then take them on into the phase three.

And we think Roswell, which is an absolute top tier, if you don't know, it's a very prestigious institution, very top tier cancer center, we think they've done a marvelous job of developing the technologies at the research stage and at the early clinical trial stage and even now into the mid stage clinical trials.

And we're really gratified that they chose us to pass the baton to take it forward for late stage clinical trial and hopefully eventually the commercialization.

So these are some of the intellectual property, but we've been quietly in licensing quite a number of different pieces of technology that we feel will be useful building blocks in building our franchise.

And we've also been putting some collaborations in place.

We haven't announced those yet, but those will be something that will be coming along.

Okay, so that's the last section for the past and we went way longer than we're supposed to here is our lawsuit against the seven market makers.

You know, all of us, I don't have, I mean, I hardly have to say this, but all of us are unbelievably frustrated that the share price is not yet reflecting the value that we are working to build.

And we believe that our stock has been manipulated and we, we, that was going on for many years and we were very anxious to try to take some action to do something about it, but we had to bide our time and meticulously collect evidence and so forth, because the bar is extremely high, you, the degree of detail that you have to put in a complaint is hard to even describe.

It's, it's, I mean, and our, so we did bide our time until we had what we believe is a very strong case put together.

We filed that in December of 2022.

So just before the last annual meeting and it has gone through a whole lot of back and forth skirmishes, all of them relating to the defendant's effort to have the case dismissed and never go anywhere by filing a motion to dismiss.

And we are very gratified that the magistrate and the court have found that the pleadings in our complaint have been sufficient on all but one of the elements that we have to plead and that's in process, I'll come back to that.

So what they found already is that our pleadings are sufficient to pleading that the defendants engaged in manipulation of our stock and that they did so with science enter with the intent to damage Northwest.

Now again, we're at the pleading stage.

So the court has only said that we have adequately plead this, but that's a very, very big deal because these cases that the companies who've been the victims or targets or never have pretty much not been able to get anywhere trying to seek redress with this kind of case because you have to be able to articulate all the minute details of the transactions that you allege involve the manipulation, and you have to do that first before you can get to the stage of discovery, but you can't get the information unless you get discovery.

So it's kind of like when you get out of school and you can't get your first job until you have experience, but you can't get experience until you have your first job.

And so for years and years, decades, victim companies have been unable to get over that bar.

And I encourage you guys to read the complaint, read it when you want to go to sleep, but our complaint details thousands of transactions down to the millisecond.

We're very proud of this and a lot of work went into that and we've been vigorously pursuing this case.

The only element that the magistrate and the court said that we hadn't pled sufficiently was one element, which is referred to as lost causation, saying, okay, well, if they did manipulate our stock and they did have the intention to harm us, what's the connection between their bad behavior and what damage we say that we incurred, they had to be able to connect the dots.

And there's a time element to it, like, was it the same day?

Was it within 24 hours?

Is there a lingering effect that lasts for all of that complexity?

So the court and the magistrate specifically gave us permission to amend our complaint to strengthen the pleading claims on that one element.

We've done that, it's been submitted, the defendants made their objections, we did our reply.

So now we're just waiting for the magistrate to evaluate all this and give their report and recommendation, which then subsequently the court will act on like before.

So I know it feels like it's taking a long time because it's been a year and a half since we filed a complaint and we've been fighting.

We try to press the schedule as much as we can.

But actually, this is pretty good pace is from what we understand.

It's in line with other cases of this type and actually a little bit faster even than some other cases of this type.

It's just that the wheels of justice grind slowly, but we are pursuing this vigorously.

So you'll see that and there are no guarantees, but we are optimistic about what the ultimate decision will be about the motion to dismiss, namely, we are optimistic that it will be denied and the case will be allowed to go forward.

We believe our case is meritorious and strong and we believe that the case may be an opportunity to recoup damages and to get what we believe is manipulation to stop.

So this is a big area of effort for us and we just want you guys to know that because we're as frustrated as you are about the situation.

Okay, that was a really long recap of the last 18 months, but looking forward, I can buzz through faster.

We're going to do like a seventh inning stretch, anybody want to do a seventh inning stretch, is that a drink or whatever, a cookie, just had to check which inning it was.

Seventh inning stretch.

Okay, I know it's way too long, it's right there.

I'm going to play it on my electric guitar in the style of Jimmy Devereux.

That's an offer I can't repeat.

It was on my car, car died, my other car has DC bags on it, so it's a very healthy car.

Oh, good for you, I'll tell you what, I kind of longevity, we like, you just got to stick with things you believe in.

I feel like I got one brand was it like trucks.

Yeah, I would love to be able to find an engine like that, that's a win-win for what we do, but it's a win-win for what we do, and I think it's a win-win for what we do, but it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for what we do, and I think it's a win-win for into a break I was not aware there was a break to everybody there's 600 people listening to this we should probably go into a break and then come back is there a time that you are gonna say three minutes or something that people should come back or can we restart?

was just only meant to be like a minute but okay so now we're changing focus to forward-looking and let me remind you what I said at the end of the formal meeting which is these are forward-looking statements the actual results could vary materially and for lots of different reasons please read the risk factors in our SEC filings and please don't rely on forward-looking statements so what I'd like to do is just give you a sense of looking ahead now for the for the going forward 18 months or so what are our priorities that we're going to be focusing on and I'm grouping them into three groups our top priorities our second priorities and then our as we can as feasible priorities so I'll give you the three groupings and I'll just describe so needless to say our top priority our laser focus is to complete the process and hopefully obtain our first commercial approval in the UK hopefully approval of the MAA we're well underway we believe MHRA is following the hundred and fifty day process that they have but we don't we do not have confirmation of that we don't have a way to be sure of that to know it for sure but we believe that it the hundred and fifty days quote-unquote involves approximately three stages and the time frame of each stage is approximate so it's not you know on the button the first stage is approximately 80 days of initial review of the application the second stage is approximately 60 day clock stop when the agency is going to deliver a list of questions to us as they do in all these processes it's not just us they'll deliver little questions they'll ask for supplementary information all of that and and we will try to respond as fast as we can which is part of why we're trying to guess what they might ask and try to already kind of prepare the third stage which will come after the 60 day clock stop or however long the clock stop turns out to be to provide all the answers and for additional information the third stage is approximately 70 days of further review and reaching a decision again the the timelines are approximate as far as we've seen there is not an equivalent thing in the UK that's similar to a PDUFA date in the US you know under the legislation in the US you you know FDA can have a target date for giving you a decision we don't have a target date it'll be what it'll be okay and those approximate timeframes of those three stages that I described of course depend also on MHRA's workload and what backlog they have and so forth so that's the approximate process and the approximate timelines you know I mentioned with a lot of emphasis and a lot of discussion about the inspections that they're gonna inspect everyone and everything those are gonna be going on all during this MAA review process and those will have to be completed before an MAA decision can be rendered right so there's gonna be extensive inspections and it's gonna be going on during this period so we the typical thing we are gonna follow the typical practice of biotech and pharma companies which is we are not going to provide interim step blow-by-blow they asked us this we answered that they asked us the next thing we answer that no we're not gonna do the interim steps we're just going to tell the result when the process is finished that's the typical approach and that's the approach that we're gonna be taking okay that's our big priority area of course another big priority in this grouping of top priority is preparations for commercial launch there we've been working on this for years as I've described but there's still a lot to do we're very excited about working on this first off is we anticipate that we will be beginning commercialization using our existing grade B labs so we're gonna be you know pursue pursuing the buildout process for the great C labs as rapidly as we can but we're not counting on that to get started with commercialization we're able to get started with our existing B labs we will and likewise we a part of this preparation for commercialization will be finishing the process that we described with the flask works machine so now that the adaptation for clinical grade GMP at design work has been done the remaining steps are complete the streamlining or condensing some of the portions of it get the units ordered have the units delivered and then advent will need to conduct a large amount of what are referred to as engineering runs their practice runs you have to do practice runs with the flask works machine in this Austin facility collect all the data compare the data with the data from the DC vex products produced by the existing manual process because I have to show they have to demonstrate to the regulator not only that the flask works machine operates properly doesn't shed particles into the clean room air things like that we have to show that it produces a product that's the same or as close to the same as a biologic product can be so they'll be in addition after they do all these engineering runs and they collect all the data they'll do comparability studies equivalency studies and collect the data from that and then all of that will be submitted to the regulator and the regulator will get approval and this will all be going on these are all things all going on in parallel right so this will be going on over the coming months at the same time that the MAA process is going on and the same time that the inspections are going on and so forth so it's not stretching out you know to infinity it's parallel what else on this I think that's a enough we definitely we need to do some mundane things like expand our operating arrangements we need to expand our contractual arrangements for leukophoresis blood draw slots you have to contract for those and you have to pay for those so it's such a little bit of chicken egg or a calibration as you know you want to have enough slots but you don't want to get too far ahead of yourself and have your burn rate get too high before you need it so anyway we'll be calibrating making contract arrangements for more of those slots we will certainly need to expand the staff who will handle logistics you know mundane things like that there's just a lot of mundane things to do but it's it needs to be done among other things is as part of the preparation for commercialization we will need to determine what our pricing model is going to be what's going to be the pricing model for DC VAX that's something on which we will work with expert advisors and but it will be important obviously and again all these tracks going in in parallel okay after the MAA and the commercialization preparation and those activities we also need to go through the process of applying for approval for reimbursement so in the UK that's the process that is handled by nice and nice has been absolutely wonderful to us I cannot say enough things wonderful about nice they've been supportive they've been flexible that are standing by we talk to them they reach out to us every couple of months to check on the status of things I mean I couldn't could imagine a government agency that's been so supportive of as they've been what we will need to do is we'll need to engage specialized consultants to develop what's referred to as a health economics model we have to make an economic model about the cost benefits of the DC VAX treatment and how it fits with their policies and that sort of thing so that for sure will be in our grouping of top priority activities over the as we look forward over the coming 18 month period 12 months whatever of course we are anxious to submit applications for approval in other countries we are very we're very happy to be going through our first process in the UK because they have the fastest process of any that we know of and it's been really great but of course we want to get start getting applications put together and that'll be another thing that we'll be working on during this period and getting those prepared and submitted we have a partial head start on them because one big component of the application anywhere is the clinical study report which is a ginormous document that has the 20 years of efficacy and safety data from every program that's ever been done in DC VAX even programs other than brain cancer so we have a partial head start but applications in other countries will be important and very dear to our hearts we need to expand the management team we need to expand the management team rather substantially as you probably have guessed and as we described in the proxy each of the core members of the senior team has been wearing multiple hats has been fulfilling multiple roles and I mean multiple roles that would each be normally a separate senior management person at other companies and I'm really proud that we've been able to do that but we need to we need to ramp up we've got tremendous opportunity and we need to ramp up so that is going to be a significant focus for us as soon as we can achieve it want to be highly selective but we plan to substantially expand the management team okay the last item in our top grouping of top priority is what I've already mentioned which is continue to vigorously pursue the lawsuit in New York against the parties that we believe have been and are continuing we believe to manipulate our stock okay second grouping of priorities for this going forward period we plan to initiate the pediatric glioma trial just so everybody understands that conducting the trial itself is not specifically a requirement connected to our obtaining approval for our adult medicine what was a requirement it was in fact a prerequisite and it was a requirement in order to for our application to be validated which it has been as we publicly reported we had to have an approved plan we don't have to have completed the trial so we're going to be pursuing that it's been a very long process in the UK it's been a year and a half of discussions with pediatric neurosurgeons or oncologists we actually just recently finally after a year and a half of all this reached conceptual agreement with them we are going to be proceeding with just one of the two pediatric trials first and then the next one will be in sequentially rather than simultaneous which is actually a good thing it'll kind of reduce the bandwidth and resource requirement on us so that will be proceeding we as you can imagine from what I've already discussed we'll be pursuing build out and equipment of the first grade C lab the one with the magic closed systems in the in the soft and facility we will do on flask works what I've already said which is finish the process I've already described what that involves for the product release system that I described to release a batch of product just in terms of where we are with that so that was developed from scratch starting about five years ago it was deployed in a pilot version in the small GMP lab in London several years ago I believe if I'm remembering correctly it was about three years ago and it went through a pilot testing period in the small GMP lab in the London facility and then I believe about a year ago if I'm remembering correctly was initially it was installed on a pilot basis in Sauston and now we have to go through all the usual steps we have to go through the practice runs it has to be optimized we have to collect data and so on and we always have to show equivalency right we have to show that the system produces an equivalent evaluation as the manual process by a QP a qualified person and again this is another parallel track this isn't you know off you know in the future it will be in parallel underway Advent will be doing all of this so fortunately won't be us um DC Vax direct very near and dear to our hearts we have been eager to restart this program for a long time and we the first thing of course that we need to do is restart the manufacturing as it turns out and this will be something that will will make a public announcement when the time is right in any time that you do a technology transfer process because that product was only ever produced in the US by parties who are no longer there and so we had to do a technology transfer process to the sauce and facility whenever you do a technology transfer process you have to draft a whole new set of SOP standard operating procedures regulatory documents all of that and usually a technology transfer especially for a cell therapy is a minimum of at least six months of work and then we've had two additional challenges which I think we're we're on our way to having behind us one that related to the machine that we use for the first stage of the process and one which related to some key ingredients in the process and when we come to that announcement we'll sort of explain all that but suffice it to say restarting the manufacturing process is a significant priority for us in this going forward period and you'll be hearing from us about that and then once we've got the manufacturing restarted okay then we come to the last grouping of priorities once we have the manufacturing restarted we are very eager to get the clinical trials underway to proceed I guess I don't know to what extent people remember but the early stage trial that we did it was a phase one trial which in which it was conducted at MD Anderson we treated 13 different types of solid tumors very diverse pancreatic breasts our coma lung colorectal I mean very diverse solid tumors with very encouraging survival extensions in patients who were metastatic and had failed every other treatment and were pretty pretty broken DC Vax direct so that was really encouraging in the phase one trial and even today with all the billions that have been spent by the whole pharma and biotech industry on cancer treatments when you have metastatic solid tumors today the years not very much for you as a patient and DC Vax direct is a wonderful technology because it's directly injected into the tumor the tumor they can't be surgically removed either because there's too many of the tumors or because it's located somewhere where you might bleed out on the operating to whatever that are inoperable but you with image guidance any form of image guidance physicians choice you can reach pretty much any location in the patient's body to inject directly into the tumor and even now all these years later we haven't seen I'm not aware maybe it's out there but I'm not aware we aren't aware of any treatment like it that's had the kind of encouraging results that the phase one trial did and MD Anderson in these patients so we are very eager to get get going again with that program so that is another priority we also we have said in all of our presentations about the results of our now switching backs to DC Vax L lysate for tumors that are operable we have said in all of our public presentations about the trial results that this is very exciting to see the survival extensions with DC Vax L by itself as a monotherapy and version 1.0 of the DC Vax L technology and that we are eager to build on that with combinations of DC Vax L and because DC Vax L has such a benign safety profile and because of what its mechanism of action is as a broad spectrum we believe that it will be eminently combinable with most other types of treatments you can imagine combining it with checkpoint inhibitor drugs with targeted therapies with chemotherapies any variety of type of therapy so we we have some collaboration discussions underway and at the appropriate time because we only we only announce things when they're significant and they're done right we don't say you know giving our forward perspective is unusual for us but anyway again these are forward-looking statements everybody knows that right just reminding you again but we have said in every presentation we are eager to combine DC Vax L with these other combinations and so one of our many priorities for the going forward period is to do one or more of those combinations and we've received considerable interest from various parties for that so we are looking forward to that one thing I will say about our general approach as we look forward on further clinical trials is this we want to focus particularly on clinical trials where tumor response meaning tumor shrinkage can be the endpoint as opposed to overall survival being the endpoint why because if you're going to see tumor shrinkage from a treatment you can typically potentially see it in a matter of months and survival takes years and years and we've just got done conducting one of the biggest one of the longest well you know a real a major landmark in the field in our opinion but we would now like to do some more focused faster path tumor shrinkage endpoint trial so we are as we evaluate I mean we have so many opportunities in front of us now really the challenges is choosing right and so we we're gonna steer ourselves as to a six-cent we can towards down that direction tumor shrinkage endpoints two last points before we're done done done partnering we've had some question various questions from shareholders we're quite open to partnering I just I gave you a couple examples earlier of potential partnering especially now that we have this this tool chest of all these more technologies but we're open to partnering we'd like to be where we see a partnering that could have either strategic value or financial value for both and as we think about it a partnering could be a regional partnering geographic region we have made a point of filing our IP and maintaining our IP in countries wide range of countries and we try to build for the day when it would be useful for type of partnering or it could be partnering for particular application so we we will be open to that and see what makes sense last but not least of some folks have asked about up listing certainly everyone would love to be on a national exchange rather than the OTC and we do realize we do know that you guys are having difficulties some of you with the brokers and they're making it difficult sometimes with our shares while we're on the OTC so we we will be looking for when the strategic timing is right we're not quite there yet but we will be looking for that so as we look at the going forward period so let me close with just a couple of concluding comments first of all I've tried to give you a flavor of a lot of different areas without being here till next Tuesday it's been longer than it was supposed to be but all in all I have to say we've made we feel we've made tremendous progress in the last 18 months we're such a we're such a different company further on company than we were 18 months ago and we're proud of that and we hope that you are finding that exciting to second comment is there's no guarantees I have to say this again but we believe that we are well positioned to get a favorable result and get our first approval and begin commercialization so that's that's all we can say is we believe that we're well positioned but you know and we'll all know you know reasonably soon we also believe that the infrastructure and the systems that I've tried to give you a glimpse of without being too boring that we've been working on these for years in order to build for the day that's now arriving show that we have the physical facilities and we also have the operating systems and the strategies that can make this kind of a product you know can facilitate the commercialization also we believe that at this point with the careful in licensing we've built a tool chest that has just tremendous growth opportunities to work with I'll say again we are painfully aware that the share price does not at least currently not yet reflect this progress that we've made that I'm describing and I've said several times now repeatedly we know how frustrating that is I will say we believe that if we can continue making progress in building actual value intrinsic value real value and if we can continue taking action against parties that we believe are we believe are artificially manipulating and holding the shares down and if we can work to attract some additional institutional investors like our recent one that were very gratified we think the combination of those things building intrinsic value fighting back against what we believe is manipulation and attracting institutional investors that ultimately the market will recognize the value we know that we're not there yet and last of all is what I get began with which is we're so appreciative of all the votes that you guys cast it was phenomenal turnout really impressive turnout and we're so grateful for all the positive votes and thank you we're all done I move that the meeting be adjourned over over over over over .

Bye.