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Doc logic
Re: Bright Boy post# 703414
Wednesday, July 03, 2024 9:56:25 AM
Post#
703476
of 703507
Bright Boy,
Seems strange that Mr. Bigger hasn’t figured out that the kind of revenues we all want to see won’t come until Flaskworks is fully deployed and running, whether at Sawston, CRL locations or elsewhere and that won’t be until FDA is considering a submission. The time frame he was looking for is longer than anticipated because of delays in Flaskworks development and validation. The kind of potential speculative price for the platform comes when Direct results start being reported and manufacturing hurdles for L and Direct are fully cleared. It was hyperopia who mentioned issues beyond just MAA approval that would be limiting factors. Maybe Mr. Bigger should pay more attention to what is being posted on this board to come up with a better time frame for expected results. Best wishes.
https://gritdaily.com/cancer-therapy-oncovirs-hiltonol/
https://www.laweekly.com/oncovir-inc-is-pushing-the-boundaries-of-medical-innovation-with-hiltonol/
iclight : sorry you were not around when this Nature paper was published 5/8/24.10 year efficacy for dcvax l plus poly iclc.
Check out the Allen Turner tweet here.
☑️Long-term survivors have now been followed for over 10 years
— Allen Turner (@AllenTurner206) May 8, 2024
☑️OS (placebo: 7.7 months, poly-ICLC: 52.5 months, and resiquimod: 16.7 months)
☑️PFS (placebo: 5.5 months, poly-ICLC: 31.4 months and resiquimod: 8.1 months)#DCVax #Mercidencel $NWBO https://t.co/ef3TaWGUFH
iclight : sorry you were not around when this Nature paper was published 5/8/24.10 year efficacy for dcvax l plus poly iclc.
Check out the Allen Turner tweet here.
☑️Long-term survivors have now been followed for over 10 years
— Allen Turner (@AllenTurner206) May 8, 2024
☑️OS (placebo: 7.7 months, poly-ICLC: 52.5 months, and resiquimod: 16.7 months)
☑️PFS (placebo: 5.5 months, poly-ICLC: 31.4 months and resiquimod: 8.1 months)#DCVax #Mercidencel $NWBO https://t.co/ef3TaWGUFH
Wednesday, July 03, 2024 4:09:22 AM
Post#
703434
of 703450
Here is the start of a story that might not be make believe.
As a precursor I grew up in a family that came close to proving out a billion dollar mining operation ..one hole away. We had family breakfasts of what we would do with 100 mill
The reason I bring that up is because in the 80s and 90s investors could believe in getting rich in a mining stock and later tech stocks internet stocks in 2000...
Anyway the game wasn't rigged until around 2006 or therabouts where they allowed blatant shorting and allowing traders not to have to cover short positions it is a company goes bankrupt.
Any I digress with my history lesson.
The huge point I want to get across is there's not a story stock around that anyone gives a shit about or is interesting.
TSLA kind of kool Nvida woowee but their success is also woorisome the other leaders just make money but are boring.
Biggest gold ever mine discovered... takes advantage of the indigenous population
Now introduce our story stock complete with a history of David versus Goliath.
"Its interesting that Hiltonol/polyicl was not mentioned at the agm. And if you Google the query Hiltonol is it FDA approved it states
The supplied Hiltonol for use in commercial production and sale of any combination production will be completed grade and meet US FDA requirements for commercial product use. BOOM!
LAWSUIT:
"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."
TECHNOLGY:
"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."
ROSWELL:
"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."
ASM:
"in person or by proxy on all business to come before this meeting.
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 .
LP.Bye."
@TommyBaxendale
·Jun 13
This list has been posted elsewhere before, but I felt in the lull period (read excruciating wait 😅) prior to the MHRA approval of DCVax-L it was prudent to make an update to keep in perspective the runway of potential catalysts that $NWBO have in store in the next ~18mths... 🧵
To begin with, as a refresh of recent hurdles already achieved:
1) UK MHRA MAA submitted ✅ on 20th Dec with 'validation Passed' on 24th Jan & 'confirmation of Validation' 7th Mar via the MHRA's 150 Day Assessment, although it is contentious about when the clock actually begins!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
2) Flaskworks (FW) Update PR 6th Feb ✅. Prototype & optimisation phase completed. FW Unit supplier chosen. Build of GMP-grade units underway. Validation & qualification (equivalence testing) to be undertaken by Advent after 'several mths'. FW patent coverage even more extensive.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
3) Nature Communications publication of the DCVax + Poly-ICLC (NCT01204684) trial ✅. Results published 8th May 2024 here:
https://nature.com/articles/s41467-024-48073-y
Trial powered for biomarkers, but noted survival benefits are outstanding. Not just GBM but especially for Grade III Gliomas too.
From nature.com
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
4) In terms of funding, NWBO secured another Fife loan from Streeterville Capital 26th Apr for $11m: https://x.com/peter_brit/status/1786302506072465726
more recently on Jun 4th attracted it's first major institutional investor in SIO Cap Mgmt who bought 8.125m shares for $3.25m:
·
Jun 5
💰Meet Michael Castor, Managing Director of Sio Capital Management and newest NWBO institutional investor💰
$NWBO
June 4, 2024 8-K
“On June 4, 2024, Northwest Biotherapeutics, Inc. (the “Company”) entered into a Stock Purchase Agreement (SPA) with SIO Capital Management
Show more
Quote
hoffmann6383
@hoffmann6383
·
Jun 5
💰Meet Michael Castor, Managing Director of Sio Capital Management and newest NWBO institutional investor💰
$NWBO
June 4, 2024 8-K
“On June 4, 2024, Northwest Biotherapeutics, Inc. (the “Company”) entered into a Stock Purchase Agreement (SPA) with SIO Capital Management
Show more
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
Now on to more speculatory matters and what cld be going to happen in the short & medium terms based on things we have been told by NWBO & the courthouse, plus matters astute longs with astonishing depths of due diligence have sussed out could potentially be on the cards:
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
5) New Drug Submission (NDS) to Health Canada's Health Products & Food Branch (HPFB). Rumoured to already be in process, but with no confirmation. It could occur before/ after MHRA approval and either as a stand alone submission or as part of a regulatory partnership process.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
6) UK MHRA Marketing Approval.
Ultimately the spark we are all waiting for to light the proverbial fuse!
From today, timelines range from just 10 days all the way to 113 days remaining... The fact is, we just dont know and entirely are at the behest of the MHRA inspectors.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
So while we patiently wait, please consider the following catalysts that (some or all) could potentially ensue once #DCVax-L's first regulatory approval has been issued:
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
7) Synergistic buy-out-of/ mergers or strategic partnerships with combo treatment patent holders:
- Oncovir: Poly-ICLC (Hiltonol) as per Nature article above
- Revimmune (Owned by NWBO CEO): Interleukin-7, which supports, expands, & maintains T cell response initiated by DCVax
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
8) Partnership announcement with Merck to coincide with the publication of results from the DCVax + Poly-ICLC + Keytruda (NCT04201873) trial.
Primary Completion Date est 1st Aug 2024 and had unpublished interim results with a ~65% SURVIVAL at >26mths for rGBM patients in 2022!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
9) Besides Merck, it is not beyond reasonable inference that NWBO will partner with other BP too. There are +9 other big pharma cos who have PD-1/ PD-L1 inhibitors who wld no-doubt like to expand the number of indications their treatments are approved for via combo with DCVax...
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
... After all DCVax is shown to be tumour & tissue agnostic. Being personalised, it targets all the specific & unique biomarkers, peptides, antigens & neoantigens specific to each patient’s own cancer tumour(s). DCVax turns cold tumours hot, something BP have failed with so far!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
Moreover, recent language the company has been using this year in 10-Qs & PRs suggests they intend to build a franchise platform for the DCVax IP:
'Build a strong franchise'
'Build a broad franchise in dendritic cell-based immunotherapies'
This suggests multiple franchisees!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
NWBO cld ultimately franchise out the use of DCVax and FW tech to different BP franchisees to use on different indications & in due course not just solid tumour cancers.
Dendritic cells show therapeutic potential for a very wide range of conditions involving immune dysregulation.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
10) Publication of data from the UK Specials Program & other Compassionate Use data released (400++ patients showing agnostic applicability and outstanding survival statistics with little to no side effects).
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
11) With Approval, we could well see the announcement of new financing deals, which will prevent further share dilution and pump much needed funding into new trials; the resumption of DCVax-Direct research; expedited FW rollout; Advent expansion and a lot more.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
12) After any of 👆 news it is expected that as daily share vol increases the shorts will finally be forced to begin covering. The legal short position is back up to 55m & naked shorts remains unknown but are likely to be exceptional!
A short squeeze is not out of the question!
13) By this time (if not b4!) the motion to dismiss the NWBO court case against 7 Market Makers should have been thrown out. Whether the case then settles or goes to trial isn't important at this stage, what's important is the market reaction to the news, which sld be v positive!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
... and a resulting court imposed trading injunction is not out of the question, which would remove most of the tools available to the shorts to continue manipulating the share price.
14) Eligibility to uplist to NYSE or NASDAQ should have now been met, which upon completion...
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
15) Will undoubtedly lead to an institutional capital flood as a very substantial amount of capital would now meet in-house compliance criteria previously restricted by trading on the OTC.
16) With this comes proper 'respected' analyst & (finally) +ve media coverage of NWBO!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
17) Within 3 months of MHRA Approval it is expected that UK NICE will approve coverage of DCVax-L on the NHS for at least nGBM and rGBM.
This could be quicker as NICE have stated they aim to provide a decision on or around the same date as MHRA approval.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
18) Publication of the Study by NCI (NIH) using genetic profiling analysis into 'GBM Molecular Characteristics & Immune Microenvironment Associated w/ Survival Outcomes in Patients Treated w/ DC Vaccination' based on data taken from the DCVax-L P3 trial.
https://ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
19) Combo Therapy Patent Approval (of both DCVax-L & DCVax-Direct with Checkpoint Inhibitors). At present (Feb 16th 2024 ) the status is "Grant of patent is Intended" by the European Patent Office (EPO) EP14859634.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
20) Flaskworks Approval. After positive equivalence testing comes regulatory approval! The strategic importance of this cannot be understated! FW is a revolution in DC therapy prdn systems. The benefits over manual prdn are very substantial. And the device can be licensed out!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
21) With FW approved, the mass manufacture of DCVax really begins properly at Advent Bioservices and preparations begin at CRL/ Amplify Bio and elsewhere.
With this comes what we have all been waiting for...
REVENUES!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
22) FDA BLA Submission. It is possible the company are waiting for FW Approval (and needed funding, and prior MHRA approval) prior to their FDA submission.
23) Submissions for other regulatory body Marketing Approvals (potentially via Project Orbis/ IRP/ Access Consortium)
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
24) Charles River Laboratories CDMO contract for N.America announced. Possibly contracts with Amplify Bio too for CRO (proteomics analysis) & CDMO.
There are a few other CDMOs with links to Linda Powers which have also been ID'd that cld also be used for DCVax manufacturing.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
25) Announcement of multiple new basket Combination treatment Trials for both DCVax-L & DCVax-Direct to treat multiple other solid tumour cancers, both operable & inoperable! Possibly with different franchisees licensed to use of DCVax-L and/or -Direct for different indications.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
26) UCLA Brain SPORE Project 1 (Combo Trial) started: DCVax + PD-1 (Keytruda) + Poly-ICLC (Hiltonol) + CSFR-1 (Pexidartinib) Commences.
uclahealth.org
Research Projects
Learn about the research activities at the UCLA SPORE in Brain Cancer, which include research projects and seed grant programs.
·
Jun 13
26) UCLA Brain SPORE Project 1 (Combo Trial) started: DCVax + PD-1 (Keytruda) + Poly-ICLC (Hiltonol) + CSFR-1 (Pexidartinib) Commences.
uclahealth.org
Research Projects
Learn about the research activities at the UCLA SPORE in Brain Cancer, which include research projects and seed grant programs.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
27) Commencement of the 2 pediatric trials approved under the DCVax-L Pediatric Investigation Plan (PIP) as required by the UK MHRA: One for newly diagnosed pediatric high grade glioma (HGG), and the other for recurrent pediatric HGG.
nwbio.com
Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA: PIP...
BETHESDA, Md., August 23, 2022 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced...
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
28) Funding for and potential beginning of DIPG (Diffuse Intrinsic Pontine Glioma) trial using DCVax-Direct (as DIPG is generally inoperable so DCVax-Direct needed instead of DCVax-L) possibly using Clearpoint Neuro Delivery System.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
29) FDA BLA Approval and other Orbis/ IRP/ Access Consortium pathway country approvals for DCVax-L.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
Thereafter, there are a number of important medium to longer term catalysts (or serendipitous catalysts) which should not be ignored. In no particular order these are:
30) Possible Inclusion by and funding from Biden's CancerX Moonshot program
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
31) Massive settlement from the Citadel et al Court Case with potential use of the funds for a Share Buyback/ Dividend Issue.
32) Massive expansion in Off-Label usage of DCVax-L
33) Wall Street Acceptance & Leading Bank Analyst Coverage
34) Further updates to NWBO Patent Moat!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
35) The Approval of DCVax-L for Tissue Agnostic Indications plus the Approval of DCVax-Direct & the start of unlocking & licensing the Neoantigen Database alluded to in Marnix Bosch's 2023 ASCO presentation.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
36) DCVax-X. The development of treatments beyond solid tumour Cancers: Infectious Diseases, Haematological Cancers; Autoimmune Diseases (tolerogenic DCs); Neurodegenerative Diseases; Anti-Senescence and more
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
26) UCLA Brain SPORE Project 1 (Combo Trial) started: DCVax + PD-1 (Keytruda) + Poly-ICLC (Hiltonol) + CSFR-1 (Pexidartinib) Commences.
uclahealth.org
Research Projects
Learn about the research activities at the UCLA SPORE in Brain Cancer, which include research projects and seed grant programs.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
27) Commencement of the 2 pediatric trials approved under the DCVax-L Pediatric Investigation Plan (PIP) as required by the UK MHRA: One for newly diagnosed pediatric high grade glioma (HGG), and the other for recurrent pediatric HGG.
nwbio.com
Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA: PIP...
BETHESDA, Md., August 23, 2022 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced...
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
28) Funding for and potential beginning of DIPG (Diffuse Intrinsic Pontine Glioma) trial using DCVax-Direct (as DIPG is generally inoperable so DCVax-Direct needed instead of DCVax-L) possibly using Clearpoint Neuro Delivery System.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
29) FDA BLA Approval and other Orbis/ IRP/ Access Consortium pathway country approvals for DCVax-L.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
Thereafter, there are a number of important medium to longer term catalysts (or serendipitous catalysts) which should not be ignored. In no particular order these are:
30) Possible Inclusion by and funding from Biden's CancerX Moonshot program
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
31) Massive settlement from the Citadel et al Court Case with potential use of the funds for a Share Buyback/ Dividend Issue.
32) Massive expansion in Off-Label usage of DCVax-L
33) Wall Street Acceptance & Leading Bank Analyst Coverage
34) Further updates to NWBO Patent Moat!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
35) The Approval of DCVax-L for Tissue Agnostic Indications plus the Approval of DCVax-Direct & the start of unlocking & licensing the Neoantigen Database alluded to in Marnix Bosch's 2023 ASCO presentation.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
Jun 13
36) DCVax-X. The development of treatments beyond solid tumour Cancers: Infectious Diseases, Haematological Cancers; Autoimmune Diseases (tolerogenic DCs); Neurodegenerative Diseases; Anti-Senescence and more
Jun 13
36) DCVax-X. The development of treatments beyond solid tumour Cancers: Infectious Diseases, Haematological Cancers; Autoimmune Diseases (tolerogenic DCs); Neurodegenerative Diseases; Anti-Senescence and more
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
37) and no doubt more I havent thought of. Feel free to leave your comments with additional ideas.
At $0.41 this is astonishingly undervalued and this list should exemplify plenty of reasons to wait the course.
·
Jun 17
38) Sth unforeseen for 👆 $NWBO Catalysts
alphavestcapital.com
@alphavestcap
$nwbo
@alphavestcap
What ASM salients are not posted below ?
https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/
1)MHRA(and NICE) 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.
2)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.
3)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.
4) 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.
5)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.
6)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.
7)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.
8) 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.
9)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.
10)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.
11)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 inlicensed.
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.
12) 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.
13) 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.
14)DC Vax direct very near and
1:13:29?–?1:13:38
dear to our hearts we have been eager to restart this program for a long time and
1:13:38?–?1:13:44
we the first thing of course that we need to do is restart the manufacturing as it
1:13:44?–?1:13:53
turns out and this will be something that will will make a public announcement
1:13:53?–?1:13:57
when the time is right in any time that you do a technology transfer process
1:13:57?–?1:14:06
because that product was only ever produced in the US by parties who are no
1:14:06?–?1:14:12
longer there and so we had to do a technology transfer process to the
1:14:12?–?1:14:19
sauce and facility whenever you do a technology transfer process you have to
1:14:19?–?1:14:24
draft a whole new set of SOP standard operating procedures regulatory
1:14:24?–?1:14:30
documents all of that and usually a technology transfer especially for a
1:14:30?–?1:14:37
cell therapy is a minimum of at least six months of work and then we've had
1:14:37?–?1:14:42
two additional challenges which I think we're we're on our way to having behind
1:14:42?–?1:14:51
us one that related to the machine that we use for the first stage of the
1:14:51?–?1:14:57
process and one which related to some key ingredients in the process and when
1:14:57?–?1:15:03
we come to that announcement we'll sort of explain all that but suffice it to
1:15:03?–?1:15:08
say restarting the manufacturing process is a significant priority for us in this
1:15:08?–?1:15:16
going forward period and you'll be hearing from us about that and then once
1:15:16?–?1:15:21
we've got the manufacturing restarted okay then we come to the last grouping
15)MHRA has been wonderful.
0:12:55?–?0:12:57
They have given us rapid turnarounds more than we could have expected or hoped for in
0:12:57?–?0:13:05
the steps that we've had with them so far.
0:13:05?–?0:13:08
That doesn't necessarily predict anything, but it's been a really great experience so
0:13:08?–?0:13:14
far.
16) And NICE HAS BEEN wonderful.
17)
this we want to focus particularly on clinical trials where tumor response
1:19:46?–?1:19:55
meaning tumor shrinkage can be the endpoint as opposed to overall survival
1:19:55?–?1:20:02
being the endpoint why because if you're going to see tumor shrinkage from a
1:20:02?–?1:20:07
treatment you can typically potentially see it in a matter of months and
1:20:07?–?1:20:12
survival takes years and years and we've just got done conducting one of the
1:20:12?–?1:20:18
biggest one of the longest well you know a real a major landmark in the field in
1:20:18?–?1:20:27
18)
we're quite open to partnering I just I gave you a couple examples earlier of
1:21:08?–?1:21:13
potential partnering especially now that we have this this tool chest of all these
1:21:13?–?1:21:19
more technologies but we're open to partnering we'd like to be where we see
1:21:19?–?1:21:27
a partnering that could have either strategic value or financial value for
1:21:27?–?1:21:34
both and as we think about it a partnering could be a regional partnering
1:21:34?–?1:21:40
geographic region we have made a point of filing our IP and maintaining our IP in
1:21:40?–?1:21:47
countries wide range of countries and we try to build for the day when it would
1:21:47?–?1:21:55
be useful for type of partnering or it could be partnering for particular
1:21:55?–?1:22:01
application so we we will be open to that and see what makes sense last but
1:22:01?–?1:22:09
19)
not least of some folks have asked about up listing certainly everyone would love
1:22:09?–?1:22:15
to be on a national exchange rather than the OTC and we do realize we do know
1:22:15?–?1:22:20
that you guys are having difficulties some of you with the brokers and they're
1:22:20?–?1:22:25
making it difficult sometimes with our shares while we're on the OTC so we we
1:22:25?–?1:22:33
will be looking for when the strategic timing is right we're not quite there
1:22:33?–?1:22:40
yet but we will be looking for that so as we look at the going forward period
1:22:40?–?1:22:46
so let me close with just a couple of concluding comments first of all I've
1:22:46?–?1:22:53
20)
just reminding you again but we have said in every presentation we are eager
1:19:07?–?1:19:14
to combine DC Vax L with these other combinations and so one of our many
1:19:14?–?1:19:22
priorities for the going forward period is to do one or more of those
1:19:22?–?1:19:28
combinations and we've received considerable interest from various
1:19:28?–?1:19:36
parties for that so we are looking forward to that one thing I will say
1:19:36?–?1:19:41
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nwbio.com
Audio of NWBIO 2023 Annual Shareholders Meeting - Northwest Biotherapeutics
The Company appreciated the large turnout at the Annual Meeting on Saturday June 29, 2024, both in person and virtually through the audio link. We were pleased to share a recap of some of the strong...
10:12 AM · Jul 2, 2024
·
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Dawson Meirowitz
@dcvaxdaw
·
2h
Fine job of excerpting.
It’s like you weren’t there when you were.
BonjongoKid-🎾ServeBot
@BonjongoKid
·
42m
That statement is in of itself a bit confusing to me. Is it $nwbo that's supposed to be providing turn-arounds to the MRHA wrt RFIs or is it the other way around? Or is she (LindaP) not referring to the MAA application? If not about MAA application at this stage, then why not?
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) July 2, 2024
What ASM salients are not posted below ?https://t.co/hdsaCQEah5
1)MHRA(and NICE) 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…
17
JUN
2024
Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise
BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.
The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.
As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.
The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing “real world” experience.
“We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies,” commented Linda Powers, the Company’s CEO. “We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well.”
The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).
ABOUT NORTHWEST BIOTHERAPEUTICS
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
DISCLAIMER
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
*****
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
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Phone: 240-497-9024
Please post the email addresses for the top three decision makers of the 100 largest biotech funds in the world.
https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/
need full transcript , please.
https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/
ASM salients:
https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/
1)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.
2)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.
3)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.
4) 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.
5)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.
6)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.
7)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.
8) 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.
9)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.
10)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.
11)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 inlicensed.
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.
12) 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.
13) 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.
14)DC Vax direct very near and
1:13:29?–?1:13:38
dear to our hearts we have been eager to restart this program for a long time and
1:13:38?–?1:13:44
we the first thing of course that we need to do is restart the manufacturing as it
1:13:44?–?1:13:53
turns out and this will be something that will will make a public announcement
1:13:53?–?1:13:57
when the time is right in any time that you do a technology transfer process
1:13:57?–?1:14:06
because that product was only ever produced in the US by parties who are no
1:14:06?–?1:14:12
longer there and so we had to do a technology transfer process to the
1:14:12?–?1:14:19
sauce and facility whenever you do a technology transfer process you have to
1:14:19?–?1:14:24
draft a whole new set of SOP standard operating procedures regulatory
1:14:24?–?1:14:30
documents all of that and usually a technology transfer especially for a
1:14:30?–?1:14:37
cell therapy is a minimum of at least six months of work and then we've had
1:14:37?–?1:14:42
two additional challenges which I think we're we're on our way to having behind
1:14:42?–?1:14:51
us one that related to the machine that we use for the first stage of the
1:14:51?–?1:14:57
process and one which related to some key ingredients in the process and when
1:14:57?–?1:15:03
we come to that announcement we'll sort of explain all that but suffice it to
1:15:03?–?1:15:08
say restarting the manufacturing process is a significant priority for us in this
1:15:08?–?1:15:16
going forward period and you'll be hearing from us about that and then once
1:15:16?–?1:15:21
we've got the manufacturing restarted okay then we come to the last grouping
15)MHRA has been wonderful.
0:12:55?–?0:12:57
They have given us rapid turnarounds more than we could have expected or hoped for in
0:12:57?–?0:13:05
the steps that we've had with them so far.
0:13:05?–?0:13:08
That doesn't necessarily predict anything, but it's been a really great experience so
0:13:08?–?0:13:14
far.
16) And NICE HAS BEEN wonderful.
17)
this we want to focus particularly on clinical trials where tumor response
1:19:46?–?1:19:55
meaning tumor shrinkage can be the endpoint as opposed to overall survival
1:19:55?–?1:20:02
being the endpoint why because if you're going to see tumor shrinkage from a
1:20:02?–?1:20:07
treatment you can typically potentially see it in a matter of months and
1:20:07?–?1:20:12
survival takes years and years and we've just got done conducting one of the
1:20:12?–?1:20:18
biggest one of the longest well you know a real a major landmark in the field in
1:20:18?–?1:20:27
18)
we're quite open to partnering I just I gave you a couple examples earlier of
1:21:08?–?1:21:13
potential partnering especially now that we have this this tool chest of all these
1:21:13?–?1:21:19
more technologies but we're open to partnering we'd like to be where we see
1:21:19?–?1:21:27
a partnering that could have either strategic value or financial value for
1:21:27?–?1:21:34
both and as we think about it a partnering could be a regional partnering
1:21:34?–?1:21:40
geographic region we have made a point of filing our IP and maintaining our IP in
1:21:40?–?1:21:47
countries wide range of countries and we try to build for the day when it would
1:21:47?–?1:21:55
be useful for type of partnering or it could be partnering for particular
1:21:55?–?1:22:01
application so we we will be open to that and see what makes sense last but
1:22:01?–?1:22:09
19)
not least of some folks have asked about up listing certainly everyone would love
1:22:09?–?1:22:15
to be on a national exchange rather than the OTC and we do realize we do know
1:22:15?–?1:22:20
that you guys are having difficulties some of you with the brokers and they're
1:22:20?–?1:22:25
making it difficult sometimes with our shares while we're on the OTC so we we
1:22:25?–?1:22:33
will be looking for when the strategic timing is right we're not quite there
1:22:33?–?1:22:40
yet but we will be looking for that so as we look at the going forward period
1:22:40?–?1:22:46
so let me close with just a couple of concluding comments first of all I've
1:22:46?–?1:22:53
20)
just reminding you again but we have said in every presentation we are eager
1:19:07?–?1:19:14
to combine DC Vax L with these other combinations and so one of our many
1:19:14?–?1:19:22
priorities for the going forward period is to do one or more of those
1:19:22?–?1:19:28
combinations and we've received considerable interest from various
1:19:28?–?1:19:36
parties for that so we are looking forward to that one thing I will say
1:19:36?–?1:19:41
It will after the approval.
Les said fifteen types of cancers were treated with DCVax-L through UK compassionate use program. "Most of them blockbuster drugs"
Which BP wouldn't want franchise?
The Danish Dude
Re: Legend431 post# 703182
Tuesday, July 02, 2024 2:53:08 AM
Post#
703188
of 703209
NWBO had these milestones since October 2020 where share price was at $2.51. At that time we had 400 million LESS shares than today.
October 2020: NWBO announced the data lock for their Phase III trial of DCVax-L for Glioblastoma
December 2021: UK Manufacturing License
March 2022: Positive Top-Line Results
August 2022: Regulatory Approval for Pediatric Plan
December 2023: Submission of MAA
February 2024: Moving towards the production of GMP-compliant units?
March 2024: Board Appointment
May 2024: Nature article about results of DCvax-L in combo with poly-iclc: Enhanced Immune Response, Improved Survival, Safety and Biomarker Identification
June 2024: Exclusive In-License of Dendritic Cell Technology
August 2024: Primary completion date for SPORE 1 combo trial at UCLA with DCvax-L and Keytruda
The share price has dropped by 83.67% from October 2020 to today. In the same period, the number of shares outstanding has increased by 50%. This indicates that while dilution has played a significant role, the share price drop is much larger than the dilution alone would suggest.
Let's calculate
Decline Scenario (Average Price $0.75):
Shares Issued: 400 million
Average Share Price: $0.75
Total Money Raised: $300 million
Rise Scenario (Average Price $3.75):
Average Share Price: $3.75
Total Money Needed to Raise: $300 million (same as in the decline scenario)
Equivalent Shares Needed: 80 million
Summary
In the Decline Scenario: NWBO issued 400 million shares at an average price of $0.75 to raise $300 million.
If the Share Price Rose from $2.51 to $5: NWBO would have only needed to issue 80 million shares at an average price of $3.75 to raise the same $300 million.
320 MILLION SHARES DILUTED EXTRA DUE TO SPOOFING!
Now who to blame for those additional 320 million shares of dilution?
Management or the market makers having spoofed the share price, because come on ... you are not that stupid that you really DO BELIEVE, that the share price of $0.41 is indicative of a free and healthy functioning financial market?
320 million shares. Wow ... that makes for a hefty su,. when damages are going to be calculated when the lawsuit goes to discovery mode.
But back to your initial calculation of what NWBO's share price should be on approval.
There's the spoofed price and the fair price.
And of course a dismissal of MTD would be changing the landscape completely regarding continuing spoofing and whether NWBO can injunction market makers trade with NWBO.
So let's just initially see, how that goes.
But we can conclude, that your $1 number of dismissal of lawsuit is at best laughable, since its premise relies on having completely forget/chosen to forget, the effect of spoofing.
And I can assure you, NWBO and LP are never going to do deals, that don't adhere to a fair measured value, where the spoofing effect has been removed from the equation.
Being a fudder yourself, I can understand where your bias comes from, not least the kind of financial incentives it is founded upon.
So specifically for our NHS, DCVAX-L will never be a widely used prescriptive treatment for Doctors here.
Nemesis18
That must be why NICE are having such great cooperation with NWBO and why british politicians in their Pathway to a Cure report from 2023 had 3 recommendations regarding brain cancer, the top two having with DCvax-L to do, recommending MHRA to approve and NICE to reimburse DCvax-L.
Must be a bitch to constantly have to promote a viewpoint that is so laughable. And even worse, to do it on a daily basis. Money is a great incentive. Speaking of being greedy.
I can recommend you to read up on the subject.
You actually MIGHT be able to gain some knowledge regarding matters you seem to have viewpoints on.
PATHWAY TO A CURE REPORT
Bullish
BULLISH
ATL-DC is DCVax-L
learningcurve2020
Very rough but around £25,000 per patient.
A total of 14,999 patients were admitted to hospital between the last three months of 2012 and up to the end of 2019, of which we were able to assign costs to 14,691 patients. Total inpatient cost was over £321 million (34% of which was attributed to direct costs of spells of neurosurgery, chemotherapy, and radiotherapy). 14,528 patients had outpatient care, of which we were able to assign costs to 14,419 patients. Total outpatient cost was over £92 million (41% of which was attributed to chemotherapy and radiotherapy).
https://academic.oup.com/neuro-oncology/article/24/Supplement_4/iv2/6730599
The Cost of Treating Adult Glioblastoma Patients in England
Nour Kanso, Radvile Mauricaite, Kerlann Le Calvez, Matt Williams
Neuro-Oncology, Volume 24, Issue Supplement_4, October 2022, Page iv2, https://doi.org/10.1093/neuonc/noac200.006
Published: 01 October 2022
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Abstract
AIMS
The GlioCova dataset uses linked English national cancer data on all 51,775 adult primary brain tumour patients diagnosed between 2013-2018, of which 15,277 patients were diagnosed with a cranial glioblastoma. Here we present data on the direct care costs of treatment, based on secondary care data.
METHOD
We examined data on inpatient and outpatient care for all cranial glioblastoma patients in the dataset. We used the NHS HRG4+ Reference Costs Grouper 2017-2018 to assign costs standardised to 2017-2018.
RESULTS
A total of 14,999 patients were admitted to hospital between the last three months of 2012 and up to the end of 2019, of which we were able to assign costs to 14,691 patients. Total inpatient cost was over £321 million (34% of which was attributed to direct costs of spells of neurosurgery, chemotherapy, and radiotherapy). 14,528 patients had outpatient care, of which we were able to assign costs to 14,419 patients. Total outpatient cost was over £92 million (41% of which was attributed to chemotherapy and radiotherapy).
CONCLUSION
The estimated secondary care costs for adult glioblastoma patients in England were over £414 million for patients diagnosed between 2013-2018, but do not include patient out-of-pocket costs, primary care, social care, or end of life care costs. Future work will examine variation in care and costs and extend it to the wider brain tumour cohort. We also hope these data will help make the economic argument for improvements in care for brain tumour patients. More information on GlioCova: https://blogs.imperial.ac.uk/gliocova/about-gliocova/
Monday, July 01, 2024 5:23:22 PM
Thanks bear trap... didn't use a program, so this kind of thing does take awhile. Honestly, I do it for myself as it helps me to drill in the details I might otherwise miss. And that's been the case with all of the transcribing I've done over the years (LL, Robert Prins, and of course, LP). But... once it's done, it only makes sense to share it because I know it'll be helpful to some, and is a good reference point for all of us in the future.
Yes, as far as the inspections go, they could have begun. I'm looking to the August Q2 filing to give us some additional insights.
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Present Continuous Tense | Examples & Exercises
Published on July 10, 2023 by Jack Caulfield. Revised on September 29, 2023.
The present continuous (also called the present progressive) is a verb tense used to refer to a temporary action that is currently taking place. It can also describe future plans (e.g., “I am throwing a party next week”).
The present continuous is formed by combining a form of the auxiliary verb “be” with the present participle (“-ing” form) of another verb (e.g., “I am swimming”).
present continuous forms table
Table of contents
How to use the present continuous
The present continuous uses different forms of the verb “be” depending on the person of the subject. The first person uses “am” the third person singular uses “is,” and all other persons use “are.” The verb is often contracted with the subject (e.g., “I’m,” “she’s,” “we’re”). The form of the other verb doesn’t change; it’s always the present participle (“-ing” form).
The present continuous describes an action or process that is ongoing (continuous). It is most commonly used to talk about actions that are currently happening and about future plans and intentions.
Examples: How to use the present continuous
Please keep the noise down. The baby is sleeping.
I am flying to Germany in three weeks.
We are investigating a crime.
When are you graduating from university?
There are also some other contexts where you may encounter the present continuous. It can be used to:
Describe some new trend or development that differs from a past state
Describe a process of change over time
Emphasize (in combination with the adverb “always”) that something happens over and over again
Examples: How to use the present continuous
Fewer people are eating meat nowadays.
My ankle is slowly recovering from a sprain.
Why are you always comparing yourself to others?
Check for common mistakes
Use the best grammar checker available to check for common mistakes in your text.
grammar-checker-common-mistakes
When you shouldn’t use the present continuous
You may have noticed that all the verbs used in the present continuous tense in the examples above describe an action or process—these are called dynamic verbs. The present continuous tense normally requires a dynamic verb.
Verbs that instead describe a state of being such as emotion, belief, perception, or possession are called stative verbs. Some examples include “prefer,” “appear,” “exist,” and “own.” Stative verbs should not be used in the present continuous tense.
I am believing that love at first sight is existing.
I believe that love at first sight exists.
I am owning many books.
I own many books.
Note that some verbs can be either stative or dynamic, depending on the specific sense in which they are used.
For example, the verb “think” may describe a fixed opinion or belief (in which case it’s stative) or a process of thought or consideration (in which case it’s dynamic).
I am thinking that Rajit will arrive tomorrow.
I think that Rajit will arrive tomorrow.
I think about going for a bike ride at the weekend.
I am thinking about going for a bike ride at the weekend.
Present continuous vs. present simple
If you’re unsure whether to use the present continuous (e.g., “is running”) or the present simple (e.g., “runs”) in a sentence, apply the following rules:
To describe something that’s in the process of happening right now, use the present continuous.
To describe a habit, general truth, or fixed situation or state, use the present simple.
Examples: Present continuous vs. present simple
I’m working at the moment; can I call you back later?
I am good at math.
Toby is looking at the clouds.
Regular exercise contributes to bodily and mental health, so I work out regularly.
When describing events in the near future, the two tenses can often be used interchangeably, but there are still some distinctions:
The present continuous refers to an action someone is about to perform or to a future event or plan (not necessarily very specific or clearly defined).
The present simple refers to a clearly defined and official plan for the (near) future or to a regularly scheduled event that will repeat in the future.
Examples: Present continuous vs. present simple for describing future events
We are going to the grocery store. Do you want anything?
The party officially starts at 5:30 p.m., but some of us are meeting for drinks beforehand.
The trains to Paris depart once every two hours throughout the day.
Present continuous vs. present perfect continuous
Another tense that’s sometimes confused with the present continuous is the present perfect continuous (e.g., “has been writing”). These tenses should not be used interchangeably.
Like the present continuous, the present perfect continuous also typically refers to an action that is currently ongoing. But there are two key differences that distinguish it from the present continuous:
It emphasizes the fact that a current action extends into the past and is often used alongside an adverbial phrase that specifies when the action started (e.g., “since July” or “all week”).
It can also refer to a completed action, as long as it was completed only recently.
Examples: Present perfect continuous
I have been traveling around Asia for the last three months.
It has been raining all day, but it just stopped.
I’ve been drinking a lot of coffee since I gave up on soda.
Check for common mistakes
Use the best grammar checker available to check for common mistakes in your text.
grammar-checker-common-mistakes
How to form negatives
You can create a negative statement in the present continuous by inserting the adverb not between the two verbs. The adverb is often contracted with the first verb (as “aren’t” or “isn’t”), but this is not done in the first person (“amn’t” is not a word in standard English).
Examples: Negative present continuous
I am not going to the party.
Paulus isn’t paying attention to the teacher.
We aren’t getting very far like this, are we?
How to form questions
Yes–no questions are formed in the present continuous by placing the auxiliary verb (“is,” “are,” or “am”) first, followed by the subject and then the present participle (“-ing” verb).
Examples: Present continuous questions
Are you helping with the renovations?
Is Barry meeting us at the gallery?
Other kinds of questions are formed using wh-words (interrogative pronouns such as “who” and interrogative adverbs such as “why”). Follow the same word order as above, but with the wh-word added at the start of the sentence.
Examples: Present continuous questions with wh-words
What are we doing tomorrow?
Why am I worrying about things I can’t control?
When is he planning to arrive?
How to form the passive voice
The passive voice creates a sentence in which the subject is not the person or thing carrying out an action, but rather the person or thing being acted upon.
In the present continuous, the passive voice consists of the subject, a form of “be” (“is,” “are,” or “am”), the present participle “being,” and finally the past participle of the verb describing the action.
Examples: Present continuous passive constructions
We are being followed by the police!
My house is being renovated next week.
All the proposals are being carefully considered.
Exercises: Present simple vs. present continuous
Test your understanding of the difference between the present simple and the present continuous with the exercises below. Fill in one of the two options in each sentence.
Practice questions Answers and explanations
I _______ every morning before work. [run/am running]
Kevin _______ the kitchen right now. [cleans/is cleaning]
Humans _______ about 12 times per minute. [blink/are blinking]
The train _______ at 12 p.m. every day. [leaves/is leaving]
Allie _______ at the moment. [studies/is studying]
Other interesting language articles
If you want to know more about nouns, pronouns, verbs, and other parts of speech, make sure to check out some of our other language articles with explanations and examples.
Nouns & pronouns
Common nouns
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Frequently asked questions about the present continuous tense
What is the “-ing” form of a verb?
When do we use the present continuous?
What is the simple present form of be?
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Jack Caulfield
Jack Caulfield
Jack is a Brit based in Amsterdam, with an MA in comparative literature. He writes for Scribbr about his specialist topics: grammar, linguistics, citations, and plagiarism. In his spare time, he reads a lot of books.
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“We have said in all of our public presentations about the trial results that it is very exciting to see the survival extensions with DCVAx-L by itself as a monotherapy, and version 1.0 of the DCVax-L technology. We are eager to build on that with combinations of DC Vax-L because it has such a benign safety profile. Due to its broad-spectrum mechanism of action, we believe it will be eminently combinable with most other types of treatments. You can imagine combining it with checkpoint inhibitor drugs, targeted therapies, chemotherapy, and any variety of other therapies. We have some collaborations underway, and at the appropriate time, we will announce them when they are significant and finalized.”
- Linda Powers
@d_stock07734
·
Tons of possible combinations. Every possible combinations that have efficacy on solid tumors will bring the collaborators big bucks.
Daiichi Sankyo doesn't seem like making any big profit from PLX3397. But in combining with DCVax-L, PLX3397 will bring Daiichi huge revenue.
Show more
Discover more
@FlemmingBruce
320 million of "needn't to be" diluted shares since 2020. Can you calculate the damages market makers have done?
@FlemmingBruce
320 million of "needn't to be" diluted shares since 2020. Can you calculate the damages market makers have done?
What would a fair settlement price be? Or ... fine?
From investorshub.advfn.com
Justin Keister MS DABR
@justinkeister5
·
3h
Sounds more appropriate for a non-toxic, potentially tissue agnostic solid tumor therapy. Enjoyed adding at .40 yesterday.
$NWBO
Quote
Gregory Zivic, MD
@metacollectiveG
·
5h
$NWBO Remember: Kite was bought for $12 bn in 2017. They had applied for one indication for B Cell Lymphomas that had relapsed after SOC, a small indication. Through 2023 only 13,000 patients treated. We’ll get off the OTC and grow quickly, be worth 4 x’s Kite was; or more.
Tom Smithy
@Bigsky716
·
19h
I suspect this is bigger than what anyone realizes. LP does not use this language lightly.
Regarding in-licensing
"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."
$NWBO
Future
@Doc_Hieu
·
13h
https://medicine.yale.edu/news-article/1st-arpa-h-grant-mrna-based-anti-cancer-and-anti-microbial-vaccine-development/
Read this and appreciate that #NWBO is years ahead in methods of culturing high yields of dendritic cells (DCs) and also highly effective DCs [with patents]. They are also solving the closed manufacturing process. The holy grail is the dendritic cell.
medicine.yale.edu
1st ARPA-H Grant: mRNA-Based Anti-Cancer and Anti-Microbial Vaccine Development
Cancer vaccines utilizing mRNA vaccine technology have such potential that ARPA-H, a newly established White House-originated program, has made it the focus of
The flagship Wellington fund of Ken Griffin’s Citadel was up 8.1% at the end of June © FT montage/Bloomberg
Big-name hedge funds Citadel and Millennium have made solid gains in the first half of the year, extending a strong run for so-called multi-manager firms that are increasingly dominant in the industry.
The flagship Wellington fund of Ken Griffin’s Citadel was up 8.1 per cent at the end of June, while Izzy Englander’s hedge fund Millennium was up 6.9 per cent, according to people who have seen the numbers.
While those figures lag behind a 15 per cent gain for the S&P 500 stock index over the same period, they eclipse the 5.2 per cent gain made by hedge funds on average to the end of May, according to data provider Hedge Fund Research.
Multi-manager hedge funds typically employ tens or hundreds of teams of traders across a variety of asset classes and strategies, all controlled by a centralised risk system that is designed to prevent big losses.
Citadel and Millennium, which manage $63bn and $67.7bn in assets respectively, both aim to make money for investors even when broader asset markets are down. They profited, for instance, in 2022 when the S&P 500 fell 19.4 per cent.
The two groups declined to comment.
Investors have clamoured to invest in the multi-manager sector — which also includes the likes of Steve Cohen’s Point72, Balyasny and smaller rivals such as Eisler — in the hope of adding steady returns to their portfolios.
Unlike many hedge funds, multi-manager firms tend to pass on their costs, such as office rents, salaries and client entertainment, to investors, while also charging them a performance fee.
This has helped drive a war for talent in the sector, leading to enormous bonuses and other incentives for the top portfolio managers.
Rival Schonfeld Strategic Advisors had a particularly strong first half of the year, with its main Partners Fund gaining 10.3 per cent, although it was up just 3 per cent last year. The firm declined to comment.
Citadel and Millennium’s half-year performance, if it continues, would put them on course to beat their returns last year. In 2022 Citadel was up 38.1 per cent in its main fund, making it the most successful hedge fund of all time. Millennium was up 25.9 per cent in 2020.
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @ATLnsider @BrianEgolf2 @glen_bwrhr42 @SmithOnStocks1
— alphavestcapital.com (@alphavestcap) July 2, 2024
The flagship Wellington fund of Ken Griffin’s Citadel was up 8.1% at the end of June © FT montage/Bloomberg
Big-name hedge funds Citadel and Millennium have made solid…
dstock07734
Re: Bright Boy post# 702458
Sunday, June 30, 2024 12:54:10 AM
Post#
702491
of 703076
I was amazed that LP mentioned about ARPA-H's first grant of $25m was about research on dendritic cell vaccine. We have been laser focusing on DC vaccine. I don't recall this grant was mentioned on this board. However, not only did LP know the nature of the grant, she also knew the amount of the grant. I suspect it has special significance for the longs.
https://medicine.yale.edu/news-article/1st-arpa-h-grant-mrna-based-anti-cancer-and-anti-microbial-vaccine-development/
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.
sentiment_stocks
Member Level
Re: dennisdave post# 702520
Sunday, June 30, 2024 7:06:08 PM
Post#
702745
of 703037
Below is a transcript of LP's "Looking Forward" section regarding the timeline. I'll work on other parts, but I wanted to get this out there in the event that no one else has yet. I think it helps to have the entirety of this section available.
That was 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 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 going forward, 18 months or so. What are our priorities that we’re going to be focusing on. 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 them.
Needless to say, our top priority, our laser focus is to complete the process and hopefully obtain our first commercial approval the UK. Hopefully approval of the MAA. We’re all underway. We believe MHRA is following the 150 day 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. 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 questions, they’ll ask for supplementary information, all of that, and we will try to respond as fast as we can, which is why we’re trying to guess what they might ask and to already be kind of prepared. 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 additional information. The third stage is approximately 70 days of further review and reaching a decision.
Again, the timelines are approximate. As far as we’ve seen, there is not an equivalent thing in the UK that’s similar to a PDFUA date in the U.S. You know, under the legislation in the U.S., the 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 time frames 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 approximate timelines. I mentioned, with a lot of emphasis and a lot of discussion about the inspections… if they’re going to inspect every one and everything. Those are going to be going on all during this MAA review process. And those will have to be completed before an MAA decision can be rendered. So there’s going to be extensive inspections and it’s going to be going on during this period.
So we’re going to follow the typical practice of biotech and pharma companies which is we’re not going to be provide interim step, blow by blow, they asked us this, we answered that. They asked us the next thing, we answered that. No, we’re not going to 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 we’re going to be taking. Linda Powers, June 29, 2024
Personally, I think that last part is important because she's stating, in fact, rather doubling down in stating, that they are not going to tell us at what stage they are at. I know it seems as if she is speaking as if some of these things (RFI and Inspections) haven't happened, and that may be the case. But describing to us in some detail what they haven't had happen yet somewhat flies in the face of her last statement, so we have to consider that she is carefully describing the steps the MHRA follows and giving some details, so that we as shareholders can understand the entire process better.
And as I know Meirluc made the point yesterday... how can the company think they're in this 150 day timeline, and additionally add in the 60 clock off, and not even have reached the first 80 days before a clock off, almost 157 days later from January 24, or 115 days later, if one takes the timeline forward from March 3? Either they weren't given the 150 timeline, and they're instead in the typical NWBO taking forever timeline, or they are in it. And if they're in it, it really doesn't make sense that the MHRA, who have been so rapid in their previous responses (according to LP - e.g. the PIP plan took half the time) and have been so wonderful to work with, would be slogging along at a pace that's almost twice as long (first 80 days had turned into either 115 to 157 days).
Also... no worries about the inspections question... I thought perhaps you'd found something citing that they had to be completed before the RFI was done. We'll all just continue to stumble along and try to make sense out of where they may be at in the process.
sentiment_stocks
Member Level
Re: sentiment_stocks post# 702745
Monday, July 01, 2024 12:59:42 AM
Post#
702799
of 702822
Well, I got through transcribing the second portion of the ASM regarding the Looking Forward Section. I'll paste that below (some of it will be a repeat), but for future reference, this will be a better post to refer to. When I'm done, I'll paste all of it, and then I'll place it in the reference section for the board.
Looking Forward
That was 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 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 going forward, 18 months or so. What are our priorities that we’re going to be focusing on. 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 them.
Needless to say, our top priority, our laser focus is to complete the process and hopefully obtain our first commercial approval the UK. Hopefully approval of the MAA. We’re all underway. We believe MHRA is following the 150 day 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. 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 questions, they’ll ask for supplementary information, all of that, and we will try to respond as fast as we can, which is why we’re trying to guess what they might ask and to already be kind of prepared. 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 additional information. The third stage is approximately 70 days of further review and reaching a decision.
Again, the timelines are approximate. As far as we’ve seen, there is not an equivalent thing in the UK that’s similar to a PDFUA date in the U.S. You know, under the legislation in the U.S., the 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 time frames 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 approximate timelines. I mentioned, with a lot of emphasis and a lot of discussion about the inspections… if they’re going to inspect every one and everything. Those are going to be going on all during this MAA review process. And those will have to be completed before an MAA decision can be rendered. So there’s going to be extensive inspections and it’s going to be going on during this period.
So we’re going to follow the typical practice of biotech and pharma companies which is we’re not going to be provide interim step, blow by blow, they asked us this, we answered that. They asked us the next thing, we answered that. No, we’re not going to 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 we’re going to be taking.
Okay, that’s our big priority area, of course. Another big priority in this grouping of top priorities is preparations for commercial launch. 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 going to be pursuing the buildout process for the Grade 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… a part of this preparation for commercialization will be finishing the process that we described with the Flaskworks machine. So now that the adaptation for clinical grade GMP, that 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. They’re practice runs. They’ll have to do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the DCVax products produced by the existing manual process… because they have to demonstrate to the regulator not only that the Flaskworks 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 there’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 give approval.
And this will be going on, these are all things going on in parallel. Right? So this’ll be going on over the coming months at the same time that the MAA process is going on, and the same time as the inspections are going on, and so it’s not stretching out to infinity, it’s parallel.
What else on this? I think that’s enough.
We definitely, we need to do some mundane things like expand out operating arrangements. We need to expand our contractual arrangements for leukephersis blood draw slots. You have to contract for those. And you have to pay for those. So it’s a little bit of chicken and egg, or a calibration as you want to have enough slots but you don’t want to get to 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. It’s just a lot of mundane things to do, but 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 DCVax? That’s something on which we will work with expert advisors and it will be important, obviously. And again, all of these tracks are going in parallel.
Okay. After the MAA, and the commercialization… 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. They’re 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 imagine a government agency that’s been so supportive 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 DCVax 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 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 start getting applications put together… and that’ll be another thing 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 DCVax, 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 management person at other companies. And I’m really proud that we’ve been able todo that, but 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. We want to be highly selective, but we plan to substantially expand the management team.
Okay, the last item in our top grouping of top priorities is what I’ve already mentioned which is to 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 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 use 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 sequential rather simultaneous, which is actually a good thing… it’ll kind of reduce the bandwidth and resource requirement on us. So that’ll be proceeding.
We, as you can imagine from what I’ve already discussed, will be pursuing buildout and equipment of the first grade C lab, the one with the “magic closed system” in the Sassoon facility. We will do on Flaskworks 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 installed on a pilot basis in Sawston. And now we have to go through all the usual steps. You 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 off in the future, it’ll be parallel underway. Advent will be doing all of this. So fortunately, it won’t be us.
DCVax-Direct. Very near and dear to our hearts. We have been eager to restart this program for a long time. And the first thing, of course, that we need to do is restart the manufacturing. As it turns out, and this will be something we’ll make a public announcement when the time is right… anytime that you do a technology transfer process… because that product was only ever produced in the U.S. by parties who are no longer there… and so we had to do a technology transfer process to the Sawston facility. Whenever you do a technology transfer process, you have to draft a whole new set of “SOP”s, standard operating procedures, regulatory documents, all of that, and usually a technology transfer, especially for cell therapy, it is a minimum of at least six months of work, and then we’ve had two additional challenges, which I think we’re on our way to having behind us… one that related to the machine that we used for the first stage of the process… and one which related to some key ingredients in the process. 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, 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 was a Phase 1 trial which was conducted at MD Anderson. We treated 13 different types of solid tumors. Very diverse: pancreatic, breast, sarcoma, 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. DCVax-Direct. So that was really encouraging in a Phase 1 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, there is not very much for you, as a patient. And DCVax-Direct is wonderful technology because it’s directly injected into the tumor, the tumor that 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 table, whatever, that are inoperable, but with image guidance, any form of image guidance, physician’s 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’re not aware, of any treatment like it that’s had the kind of encouraging results that the Phase 1 trial did at MD Anderson and in these patients. So we are very eager to get going again with that program. So that is another priority.
We also have said in all of our presentations about the results… now switching back to DCVax-L… lysate, for tumors that are operable… we’ve said in all our public presentations about the trial results that this is very exciting to see the survival extensions with DCVax-L by itself as a monotherapy, and version 1.0 of the DCVax-L technology. And that we are eager to build on that with combinations of DCVax-L. And because DCVax-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 eminently combinable with most other types of treatments. You can imagine combining it with checkpoint inhibitor drugs, with targeted therapies, with chemotherapies, any variety type of therapy.
So we have some collaboration discussions underway, and at the appropriate time… because we only announce things when they are significant and they’re done, right?… we don’t say, given our forward perspectives, quite unusual for us, but, again, these are forward-looking statements… everybody knows that, right?… I’m just reminding you again… but we’ve said in every presentation we are eager to combine DCVax-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’re 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… a major landmark in the field, in our opinion… but we would now like to do some more focused, faster path tumor shrinkage endpoint trials. So we are, as we evaluate, we have so many opportunities in front of us now, really the challenge is choosing, right? And so we’ve gotta steer ourselves to the extent that we can towards that direction, tumor shrinkage endpoints.
Two last points before we’re done, done, done… partnering. We’ve had some questions, various questions, from shareholders. We’re quite open to partnering. I gave you a couple examples earlier of potential partnering especially now that we have this tool chest of all these in-licensing 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, or 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 a wide range of countries. And we try our best to build for the day when it would be useful for a type of partnering. Or it could be partnering for a particular type of application. So we will be open to that and see what makes sense.
Last but not least, some folks have asked about uplisting. 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 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.
Let me close with just a couple of concluding comments. First of all, I tried to give you a flavor of a lot of different areas without being here until 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 different further on company than we were 18 months ago. And we’re proud of that. And we hope that you are finding that exciting, too.
Second comment I have is there’s no guarantees, but we believe that we are well-positioned to get a favorable result and get our first approval and begin commercialization. So, that’s all we can say is we believe that we are well-positioned, but, you know, 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, and we’ve been working on these for years, in order to build for the day that’s now arriving. So 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, that can facilitate the commercialization. Also, we believe that at this point with the careful in-licensing that we’ve built a tool chest that just has tremendous growth opportunities to work with. I’ll say again, we are painfully aware that the share prices does not, at least currently not yet, reflect this progress that we’ve made that I’m describing. And I’ve said, now several times repeatedly, we know how frustrating that is. I will say that 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 artificially manipulating and holding the shares down, and if we can work to attract some additional institutional investors like our recent one for which we’re 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 began with, which is we’re so appreciative of all the vote you guys cast. It was a phenomenal turnout, really impressive turnout, and we’re so grateful for all the positive votes. And thank you, we’re all done!
Chiugray
Re: eagle8 post# 701955
Saturday, June 29, 2024 1:38:56 PM
Post#
702081
of 702778
Eagle,
Thanks. I totally agree this is the evolution of cancer therapies. I believe this is the year it will be realized that DCVax, in its ability to leverage the immune system and optimize thru drug adjuvants, will be the technology platform that cures cancer.
From today's cancer drugs to the DCVax technology platform
- from tumor specific to tissue and organ agnostic
- from single/few targets to holistically targeting all cancer and genetic anomalies
- from "drug" to "broad-spectrum cancer vaccine"
- from significant risk of major toxicity to non-toxic profile
- from toxicity risk that requires a second set of drugs to prevent side-effects to non-toxic and to immediately start gaining in quality-of-life
- from by-passing the immune system's checks-and-balances to leveraging the thymus and spleen to screen out destroy self-reactive/autoimmune immune cells at the start
- from not addressing metastases and recurrence to creating a robust immune system that does
hyperopia
Re: sentiment_stocks post# 702745
Sunday, June 30, 2024 9:12:06 PM
Post#
702774
of 702776
Thanks for the partial transcript senti. It can cause confusion when Linda (and Les last month) say that they believe that the MHRA is following the “150-day pathway,” which has now taken over 150 days since the application was submitted in December, and (I believe) validated in January. I think this simply means that they believe that the application is being processed on the MHRA’s accelerated pathway.
As a reminder, the MHRA created this new 150-day pathway in 2020 after BREXIT, with the intention to further accelerate the EMA’s accelerated assessment of 210 days. Unfortunately, COVID occurred at nearly the same time as BREXIT, which caused regulatory agencies to prioritize COVID treatments which, (along with staffing shortages) created a massive backlog that it has yet to fully recover from. Other than COVID treatments, no application has been processed even close to the 150-210 day timeline. Even though a serious effort to clear this backlog began last year, in January the backlog was over 1100 marketing applications, and it was still over 800 as of April. Last year, Dr. Hopper, the Deputy Director of Innovative Medicines at the MHRA, said that she hoped that timelines could return to 210 days this year.
As Linda described, it has been routine (and expected) to receive information requests from the MHRA during a very active back and forth with the agency during the application review. The company has been anticipating and answering these requests as promptly as possible to minimize any delay in the MHRA’s assessment. I don’t believe that Les or Linda have really tipped their hand to say exactly where Northwest Bio is in the review process; however, the discussion of inspections (and length of time since applying) indicates to me, that the MHRA is likely on the back half of assessment. Nothing that I’ve heard to date, has led me to change my prediction that an approval decision is most likely in the 3rd quarter, but the unknown seems to be the MHRA’s ability to process applications in a timely manner.
Bright Boy: AVC's best guess as to the market size available to Sawston:
- 4500 newly diagnosed GBM patients annually.
-5x(22500) that for recurrent GBM patients whose initial therapy has failed, and they need dc vax to hopefully prevent death.
-100,000s of other(13) solid tumor newly diagnosed cancer patients annually.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174683057
Bright Boy
Sunday, June 30, 2024 3:20:26 PM
And you know what else??? She said we could scale to 15000 treatments per year! Do you realize that's a $3 billion a year business!! AND when I was asked where are all those patients going to come from and I said ," From the GBM patient population" and my friend said, "But there are only 3 or 4000 patients annually in the UK diagnosed with GBM", I realized that very few people know that Northwest is applying for 2 separate therapies, Newly Diagnosed GBM and Recurrent GBM meaning that any GBNM patient that tried other failed therapies could now use the DCVax-L vaccine to treat their condition!! People, People, People!!!! That's a lot of revenue AND I'll bet that 15000 patients might be conservative !!!
Cheers,
BB
Astavakra: First, the MHRA will cancel the application(all 1.7 million pages will be burned in the mhra dumpster) on a dime if LP comments on the true current status . Therefore, the present for her comments yesterday on the MAA appliation are based on its status as of 12-18 months ago. Such past , present , future time stratification is endemic to 3-C chess.
Re: Dan88 post# 702591
Sunday, June 30, 2024 12:33:55 PM
Post#
702639
of 702648
Note Linda also said during the meeting, we believe MHRA is following the 150-day process but no confirmation of that yet which I can also interpret her statement as MHRA is following the 150-day review process, but since we have passed the 150 days and have not received approval yet, so there is indeed no conformation as of today.
I believe it would be legitimate for LP to say that she believes MHRA are following the 150-day process even if we have received a RFI because a 60-day clock off period is intrinsic to the 150-day protocol. Should it be called a 210-day period then? No, MHRA are saying that they aim to complete their business on MAA in 150 days and will still do so if they request more information, but they will get a time-out while the request is being satisfied.
Yes, Linda was being vaguer than most of us would have liked, but, as you say, for good reason. Her aim is not to torture and delude shareholders. If anything, she was extremely positive and encouraging without revealing exactly where MAA stands. She is carrying on as if Failure Is Not An Option. I'm going to try to do the same over the next two months. Putting various breadcrumbs together, I'm thinking later in August or early September. In the meanwhile, I'll keep in mind the positive developments going on beyond our view.
In the case of a novel biologic undergoing a 150-day accelerated review for marketing authorization application (MAA) in the UK, inspections or a Request for Information (RFI) may not always be necessary if the therapy has been used for ten years as a compassionate treatment for a specific cancer indication in the country.
The need for inspections or RFIs during the MAA process depends on several factors, including the existing knowledge and data available for the therapy, its safety profile, and the level of scrutiny required by the regulatory authority. If the biologic has been used for a significant period and there is already substantial data and evidence supporting its safety and efficacy, the need for additional inspections or RFIs may be reduced.
However, it is important to note that each MAA is evaluated on a case-by-case basis, and the regulatory authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, has the discretion to request inspections or RFIs if deemed necessary to ensure the therapy's safety and quality.
The purpose of inspections is to assess the manufacturing facilities and processes involved in producing the biologic, ensuring compliance with Good Manufacturing Practice (GMP) standards. RFIs, on the other hand, may be requested to seek additional information or clarification on specific aspects of the MAA, such as clinical trial data or risk management plans.
Ultimately, the decision to conduct inspections or request RFIs during the accelerated review process will depend on the regulatory authority's assessment of the available data, the therapy's history of use, and the level of confidence in its safety and efficacy.— ChatGPT
Kap10jak
Re: veeets post# 702588
Sunday, June 30, 2024 12:44:57 PM
Post#
702643
of 702648
I think this might be why LP seems so upbeat. While waiting for approval she is in the process of developing franchise opportunities similar to Roswell Park agreement that may become even more valuable in the future than DCVAX-L alone. If she is able to lay out her strategy and convince a few big investors NWBO could take off even before DCVAX is approved. Different Dendritic cell formulas and combination therapies could be the answer to so many diseases and NWBO could have their hand in a lot of developments.
salients:
-☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
-
☑️last 18 months developed two new flaskworks systems to close and automate the process, selected the best approach, developed and optimized a non GMP version, GMP work finished, improvements being made, units about to be ordered shortly
-☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
-☑️payment structure provides a passthrough of all baseline costs plus fee for administration (15%)
☑️Roswell Park in-licensing covered 7 years of work for leading dendritic cell group. Last year in-licensed 17 years of work that this group did before moving to roswell, but kept it secret until recently. Packages include enhanced versions of dendritic cells and complimentary technology, combination treatment regiments in a trial or agents to be immune booster agents.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
☑️"DCVax-Direct will be coming up again now"
quietly in-licensing to buildout franchise
☑️working on collaborations but haven't announced those yet. they will be coming
☑️Advent handling restart of DCVax Direct
-✅obtain first commercial approval in the UK. we believe the MHRA is following the 150 day process, but no confirmation of that
-➡️the MHRA delivers questions throughout the review process which consists of an initial 80 day review, a 60 day clock off, and a 3rd stage approximately 70 days of further review and reaching a decision, timelines are approximate.
-➡️anticipate commercialization using existing grade b labs
-✅Applying for approval for reimbursement
-➡️"MHRA has fastest process that we know of"
-✅we need to expand management team rather substantially
-✅DCVax-Direct: first need to restart manufacturing, will make PR when time is right, anytime you do a technology transfer process (was only ever produced in US by parties no longer there) you have to draft a new set of SOPs, regulatory documents. A technology transfer is a minimum of 6 months of work.
-☑️working on collaborations but haven't announced those yet. they will be coming (sounds like combo trial partnerships)
-✅general approach - want to focus on clinical trials where tumor shrinkage can be the endpoint as opposed to OS being the endpoint. Why? B/c trials are shorter.
-✅partnering: open to partnering.
-✅uplisting: not quite there yet. want to be strategic on timing
aeKusterer
$nwbo
In this post I'll include my notes for the ASM and I'll follow it up with some thoughts.
FORMAL MEETING
To elect two members to our Board of Directors to serve as a Class I Directors for a term of three years;
✅PASSED
?
2. To ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024;
?
✅PASSED
3. To ratify the same 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;
✅PASSED
?
4. To ratify 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;
✅PASSED
?
5. To approve, on an advisory basis, the Company’s executive compensation; and
✅PASSED
INFORMAL DISCUSSION
Discussion by Linda Powers unless noted otherwise
MAA
☑️Prerequisites done
☑️NWBO continues to prepare for the inspections including any questions and requests for more information that the MHRA might have
sorry, came late so missed some of this section
Sawston/Flaskworks
☑️In 2.5 years Sawston has completed phase 1A and 1B buildout
☑️Worked with architects and engineers to buildout c-labs.
☑️flaskworks allows grade c-labs. can only do this when process is closed, meaning it is all kept within a machine/bag/flask
☑️using grade c labs from here on out
☑️current anticipated capacity of Flaskworks per advent, 1,000-1,100 vaccines per year per grade c lab
☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
☑️companies that bought car-t products were only able to initially produce 60 per year
☑️cryostorage for 3m vials at sawston
☑️Advent & 3rd party made system to automate product release process which will speed up the manual process that takes up to 30 person hours
☑️last 18 months developed two new flaskworks systems to close and automate the process, selected the best approach, developed and optimized a non GMP version, GMP work finished, improvements being made, units about to be ordered shortly
Les Goldman on Advent
☑️Advent provides a range of contract services to NWBO. Write sections of MAA, run compassionate use program, help in development of flaskworks system.
☑️Advent handling restart of DCVax Direct
☑️payment structure provides a passthrough of all baseline costs plus fee for administration (15%)
☑️approach is beneficial to both Advent and NWBO
allows NWBO to get services that are far less costly versus going to a 3rd party provider
☑️A large chuck of pay to Advent is pass through costs.
Les Goldman hands mic back to Linda Powers
IP & Collaboration
☑️Goal is to build a franchise in dendritic cell technologies
☑️NWBO wants to be the leader in this area
☑️BP and govt are beginning to recognize viability of dendritic cells
☑️Roswell Park in-licensing covered 7 years of work for leading dendritic cell group. Last year in-licensed 17 years of work that this group did before moving to roswell, but kept it secret until recently. Packages include enhanced versions of dendritic cells and complimentary technology, combination treatment regiments in a trial or agents to be immune booster agents.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
☑️"DCVax-Direct will be coming up again now"
quietly in-licensing to buildout franchise
☑️working on collaborations but haven't announced those yet. they will be coming
Spoofing Lawsuit
☑️frustrated that the share price not yet reflecting the value they are working to build
☑️our stock has been manipulated for many years
☑️had to collect evidence to be able to file lawsuit, high degree of detail was required
☑️been in MTD battle
☑️magistrate and court said pleadings were sufficient minus one element
☑️court said NWBO sufficiently plead d's manipulated stock and did so with scienter
☑️needed formula for loss causation
☑️waiting for magistrate to evaluate all of this
☑️trying to recoup damages and to get manipulation to stop
Break
Three Levels of Priority
FIRST TIER PRIORITIES
✅obtain first commercial approval in the UK. we believe the MHRA is following the 150 day process, but no confirmation of that
➡️the MHRA delivers questions throughout the review process which consists of an initial 80 day review, a 60 day clock off, and a 3rd stage approximately 70 days of further review and reaching a decision, timelines are approximate.
➡️there is not an equivalent thing to a PDUFA date in the UK as there is in the USA
➡️the inspections will be ongoing throughout this whole process
➡️NWBO is not going to provide interim step, blow by blow. NWBO will PR the result when the process if finished. this is the standard approach
✅preparations for commercial launch
➡️anticipate commercialization using existing grade b labs
➡️finishing process with flaskworks, get units ordered, have them delivered, advent will then need to conduct practice/engineering runs at sawston, collect data, compare to manual process data
➡️flaskworks is going on in parallel
➡️need to expand contractual arrangements for leukapheresis blood draw, expand staff to handle logistics, and lots of additional mundane tasks that need to be done
➡️need to determine pricing model, will work with expert advisors
✅Applying for approval for reimbursement
➡️process handled by NICE in the UK
➡️have to make economic model, in grouping of top priority in coming 18 month period
✅applications for approval in other countries - "anxious to submit"
➡️"MHRA has fastest process that we know of"
➡️a partial headstart on other applications - clinical study report (includes data on all patients, even beyond brain cancer)
✅we need to expand management team rather substantially
➡️each member has been handling multiple roles, we need to ramp up....as soon as we can achieve it
✅Pursue Spoofing Lawsuit
SECOND TIER PRIORITIES
✅initiate pediatric glioma trial (not required for approval for adult medicine)
➡️proceeding with 1 of 2 first, sequentially, reduce resource requirement on NWBO
✅pursuing buildout of c-labs
✅flaskworks - finish process
✅product release system - developed from scratch, deployed in pilot version in london lab and then about 1 year ago was installed in sawston, has to go through practice runs and show equivalency
✅DCVax-Direct: first need to restart manufacturing, will make PR when time is right, anytime you do a technology transfer process (was only ever produced in US by parties no longer there) you have to draft a new set of SOPs, regulatory documents. A technology transfer is a minimum of 6 months of work.
THIRD TIER PRIORITIES
✅eager to get clinical trials underway - did early p1 direct, md anderson, 13 different types of cancers, solid tumors. Patients were in bad shape. very encouraging results. directly injected into tumor that can't be removed b/c too many or where it is located.
back to DCVax-L
✅eager to build on results of p3 trial with combinations. benign safety profile. can combine with all sorts of drugs. discussions are underway. Want to do 1 ore more of those combinations. Interest from various parties in this respect.
✅general approach - want to focus on clinical trials where tumor shrinkage can be the endpoint as opposed to OS being the endpoint. Why? B/c trials are shorter.
✅partnering: open to partnering.
✅uplisting: not quite there yet. want to be strategic on timing
CLOSING
✅tremendous progress in the last 18 months
✅no guarantees, but believe well positioned for the first approval
✅built an in-licensing toolchest with tremendous opportunities
✅share price does not yet reflect this progress
✅if we can continue making progress, and making progress against parties artificially keeping share price down and attract more institutions like the recent one then ultimately the market will recognize the value
$NWBO
I wanted to get these thoughts out while they're fresh on my mind and before talking with anyone. So, without further ado, my unfiltered initial impressions of the ASM comments:
✅I'm glad all of the resolutions passed. Not that I'm happy about the awards, but for the sole reason it could end the litigation and the resource drain on NWBO, I'm happy.
✅It appears we are still in phase 1 of the MAA process with the MHRA. LP said every company can expect a RFI and NWBO has yet to receive one, but are preparing for such eventuality. I stand by my former comments on where we are at in the approval process. LP all but confirmed my suspicions.
✅Sawston handling 15k patients/year with fully built grade c labs is encouraging. It's less encouraging that this work on grade c labs has yet to start. It appears the design work is complete but the physical building has yet to start.
✅The flaskworks update was not perfectly clear. LP said the GMP work was finished but they hadn't yet ordered the GMP units because some improvements were being made, i.e. the work is not finished. Recall, that this process of ordering the GMP units was to take "several months" per the February 6, 2024 PR. It's been about 5 months and it appears we have a bit longer to go. After that the GMP units must be validated. It's clear that the flaskworks system will be approved via a variation after DCVax-L will be initially approved using the manual process.
✅It was good for LG to make it clear Advent pay is largely pass through costs plus a 15% fee for administration. It appears NWBO is saving resources by moving forward in this manner than if they had engaged a third party.
✅I'm mixed on the franchise building. It's ambitious. It will require a lot of work, a lot of deal making and a lot of resources, both people and money. NWBO seems to have a good eye for products, see Roswell Park and Flaskworks. Yet, NWBO's track record on execution is slow, painstakingly slow.
✅NWBO looks to be restarting the DCVax-Direct trials. Not clear on how close they are. They talk about the first step being the restarting of manufacturing which can take months. It appears they are still engaged in this process. Very speculative, but I'd say we are looking at '25 for Direct restarting based on the ASM statements.
✅LP tends to get into the painstaking details of every aspect of NWBO. For example, when discussing the direct trials starting back up she goes through exacting detail on what is required to start the trials back up but she doesn't give any clear answer as to where we are at in said process. I don't care about those details, I want to know where we are at! That was a microcosm of a lot of the ASM. Lots of details on stuff that I'd guess most shareholders don't care about but little details on what matters.
✅LP hinted at collaborations they are working on. We've seen this for a year in the 10qs. The positive, NWBO usually completes what they say they are working on. The negative, the timeline it takes to complete said tasks is way longer than anyone expects. These collaborations have been hinted at for over a year now.
✅Spoofing lawsuit is a side story. I'm not going to discuss it here.
✅The details on the preparation for commercial launch are good, but they seem a bit late on a lot of these things. For example, they talk about needing a pricing model and that NICE will need this information. LP stated that they will be working on the pricing model "in the next 18 months". How about the next 1 or 2 months?! My understanding is that NICE is waiting on NWBO's evidence submission before they can proceed with the review process. I wish LP went into more detail with NICE. This part of the discussion was not very encouraging.
✅LP comments on needing to expand the management team was encouraging. This has needed to happen for a while. I'm hopeful that they not only expand the management team, but then put these people in positions best suited to their strengths and allow them the flexibility and resources to succeed, i.e. lets not put an articulate, smart and experienced Innes in a secretarial role.
✅The sequential pediatric trials is nice to hear. It sounds like this will save NWBO resources.
✅LP's comment that the MHRA has "the fastest process that we know of" is bonkers. This is not consistent with the public data I've seen.
✅LP's comments, or lack thereof, about submitting in other countries was discouraging. They don't seem close. I've always said I don't think the FDA submission happens till '25 so I'm not surprised there, but I thought Canada was on the horizon. I'm not so sure anymore.
✅I'm glad to hear we are not close to an uplisting. I'm worried that if we were close that this would mean a r/s.
✅The focus on trials where tumor shrinkage is the endpoint is encouraging. This will save on time and resources.
✅I'm glad they are open to partnering. That is my biggest concern. You look at all of LP's comments about ordering flaskworks machines, starting the pediatric trial(s), starting combination trial(s), building out the management team, build out grade c labs, submitting applications for approval in other jurisdictions, continuing to get patent protection, etc. - IT ALL COSTS MONEY. Right now we are moving at a snails pace b/c we lack resources. A partner could bring those resources. I hope this is more than talk.
✅In the end, I think the biggest thing to look forward to in '24 will be the MHRA approval. I believe it has a great chance of happening and hopefully this event starts to turn around the share price and attract more institutional investment.
This was about what I expected for the ASM. Pretty similar to last year. Some good information, but lacking on guidance.👍️ 0
salients:
-☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
-
☑️last 18 months developed two new flaskworks systems to close and automate the process, selected the best approach, developed and optimized a non GMP version, GMP work finished, improvements being made, units about to be ordered shortly
-☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
-☑️payment structure provides a passthrough of all baseline costs plus fee for administration (15%)
☑️Roswell Park in-licensing covered 7 years of work for leading dendritic cell group. Last year in-licensed 17 years of work that this group did before moving to roswell, but kept it secret until recently. Packages include enhanced versions of dendritic cells and complimentary technology, combination treatment regiments in a trial or agents to be immune booster agents.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
☑️"DCVax-Direct will be coming up again now"
quietly in-licensing to buildout franchise
☑️working on collaborations but haven't announced those yet. they will be coming
☑️Advent handling restart of DCVax Direct
-✅obtain first commercial approval in the UK. we believe the MHRA is following the 150 day process, but no confirmation of that
aeKusterer
$nwbo
In this post I'll include my notes for the ASM and I'll follow it up with some thoughts.
FORMAL MEETING
To elect two members to our Board of Directors to serve as a Class I Directors for a term of three years;
✅PASSED
?
2. To ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024;
?
✅PASSED
3. To ratify the same 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;
✅PASSED
?
4. To ratify 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;
✅PASSED
?
5. To approve, on an advisory basis, the Company’s executive compensation; and
✅PASSED
INFORMAL DISCUSSION
Discussion by Linda Powers unless noted otherwise
MAA
☑️Prerequisites done
☑️NWBO continues to prepare for the inspections including any questions and requests for more information that the MHRA might have
sorry, came late so missed some of this section
Sawston/Flaskworks
☑️In 2.5 years Sawston has completed phase 1A and 1B buildout
☑️Worked with architects and engineers to buildout c-labs.
☑️flaskworks allows grade c-labs. can only do this when process is closed, meaning it is all kept within a machine/bag/flask
☑️using grade c labs from here on out
☑️current anticipated capacity of Flaskworks per advent, 1,000-1,100 vaccines per year per grade c lab
☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
☑️companies that bought car-t products were only able to initially produce 60 per year
☑️cryostorage for 3m vials at sawston
☑️Advent & 3rd party made system to automate product release process which will speed up the manual process that takes up to 30 person hours
☑️last 18 months developed two new flaskworks systems to close and automate the process, selected the best approach, developed and optimized a non GMP version, GMP work finished, improvements being made, units about to be ordered shortly
Les Goldman on Advent
☑️Advent provides a range of contract services to NWBO. Write sections of MAA, run compassionate use program, help in development of flaskworks system.
☑️Advent handling restart of DCVax Direct
☑️payment structure provides a passthrough of all baseline costs plus fee for administration (15%)
☑️approach is beneficial to both Advent and NWBO
allows NWBO to get services that are far less costly versus going to a 3rd party provider
☑️A large chuck of pay to Advent is pass through costs.
Les Goldman hands mic back to Linda Powers
IP & Collaboration
☑️Goal is to build a franchise in dendritic cell technologies
☑️NWBO wants to be the leader in this area
☑️BP and govt are beginning to recognize viability of dendritic cells
☑️Roswell Park in-licensing covered 7 years of work for leading dendritic cell group. Last year in-licensed 17 years of work that this group did before moving to roswell, but kept it secret until recently. Packages include enhanced versions of dendritic cells and complimentary technology, combination treatment regiments in a trial or agents to be immune booster agents.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
☑️"DCVax-Direct will be coming up again now"
quietly in-licensing to buildout franchise
☑️working on collaborations but haven't announced those yet. they will be coming
Spoofing Lawsuit
☑️frustrated that the share price not yet reflecting the value they are working to build
☑️our stock has been manipulated for many years
☑️had to collect evidence to be able to file lawsuit, high degree of detail was required
☑️been in MTD battle
☑️magistrate and court said pleadings were sufficient minus one element
☑️court said NWBO sufficiently plead d's manipulated stock and did so with scienter
☑️needed formula for loss causation
☑️waiting for magistrate to evaluate all of this
☑️trying to recoup damages and to get manipulation to stop
Break
Three Levels of Priority
FIRST TIER PRIORITIES
✅obtain first commercial approval in the UK. we believe the MHRA is following the 150 day process, but no confirmation of that
➡️the MHRA delivers questions throughout the review process which consists of an initial 80 day review, a 60 day clock off, and a 3rd stage approximately 70 days of further review and reaching a decision, timelines are approximate.
➡️there is not an equivalent thing to a PDUFA date in the UK as there is in the USA
➡️the inspections will be ongoing throughout this whole process
➡️NWBO is not going to provide interim step, blow by blow. NWBO will PR the result when the process if finished. this is the standard approach
✅preparations for commercial launch
➡️anticipate commercialization using existing grade b labs
➡️finishing process with flaskworks, get units ordered, have them delivered, advent will then need to conduct practice/engineering runs at sawston, collect data, compare to manual process data
➡️flaskworks is going on in parallel
➡️need to expand contractual arrangements for leukapheresis blood draw, expand staff to handle logistics, and lots of additional mundane tasks that need to be done
➡️need to determine pricing model, will work with expert advisors
✅Applying for approval for reimbursement
➡️process handled by NICE in the UK
➡️have to make economic model, in grouping of top priority in coming 18 month period
✅applications for approval in other countries - "anxious to submit"
➡️"MHRA has fastest process that we know of"
➡️a partial headstart on other applications - clinical study report (includes data on all patients, even beyond brain cancer)
✅we need to expand management team rather substantially
➡️each member has been handling multiple roles, we need to ramp up....as soon as we can achieve it
✅Pursue Spoofing Lawsuit
SECOND TIER PRIORITIES
✅initiate pediatric glioma trial (not required for approval for adult medicine)
➡️proceeding with 1 of 2 first, sequentially, reduce resource requirement on NWBO
✅pursuing buildout of c-labs
✅flaskworks - finish process
✅product release system - developed from scratch, deployed in pilot version in london lab and then about 1 year ago was installed in sawston, has to go through practice runs and show equivalency
✅DCVax-Direct: first need to restart manufacturing, will make PR when time is right, anytime you do a technology transfer process (was only ever produced in US by parties no longer there) you have to draft a new set of SOPs, regulatory documents. A technology transfer is a minimum of 6 months of work.
THIRD TIER PRIORITIES
✅eager to get clinical trials underway - did early p1 direct, md anderson, 13 different types of cancers, solid tumors. Patients were in bad shape. very encouraging results. directly injected into tumor that can't be removed b/c too many or where it is located.
back to DCVax-L
✅eager to build on results of p3 trial with combinations. benign safety profile. can combine with all sorts of drugs. discussions are underway. Want to do 1 ore more of those combinations. Interest from various parties in this respect.
✅general approach - want to focus on clinical trials where tumor shrinkage can be the endpoint as opposed to OS being the endpoint. Why? B/c trials are shorter.
✅partnering: open to partnering.
✅uplisting: not quite there yet. want to be strategic on timing
CLOSING
✅tremendous progress in the last 18 months
✅no guarantees, but believe well positioned for the first approval
✅built an in-licensing toolchest with tremendous opportunities
✅share price does not yet reflect this progress
✅if we can continue making progress, and making progress against parties artificially keeping share price down and attract more institutions like the recent one then ultimately the market will recognize the value
$NWBO
I wanted to get these thoughts out while they're fresh on my mind and before talking with anyone. So, without further ado, my unfiltered initial impressions of the ASM comments:
✅I'm glad all of the resolutions passed. Not that I'm happy about the awards, but for the sole reason it could end the litigation and the resource drain on NWBO, I'm happy.
✅It appears we are still in phase 1 of the MAA process with the MHRA. LP said every company can expect a RFI and NWBO has yet to receive one, but are preparing for such eventuality. I stand by my former comments on where we are at in the approval process. LP all but confirmed my suspicions.
✅Sawston handling 15k patients/year with fully built grade c labs is encouraging. It's less encouraging that this work on grade c labs has yet to start. It appears the design work is complete but the physical building has yet to start.
✅The flaskworks update was not perfectly clear. LP said the GMP work was finished but they hadn't yet ordered the GMP units because some improvements were being made, i.e. the work is not finished. Recall, that this process of ordering the GMP units was to take "several months" per the February 6, 2024 PR. It's been about 5 months and it appears we have a bit longer to go. After that the GMP units must be validated. It's clear that the flaskworks system will be approved via a variation after DCVax-L will be initially approved using the manual process.
✅It was good for LG to make it clear Advent pay is largely pass through costs plus a 15% fee for administration. It appears NWBO is saving resources by moving forward in this manner than if they had engaged a third party.
✅I'm mixed on the franchise building. It's ambitious. It will require a lot of work, a lot of deal making and a lot of resources, both people and money. NWBO seems to have a good eye for products, see Roswell Park and Flaskworks. Yet, NWBO's track record on execution is slow, painstakingly slow.
✅NWBO looks to be restarting the DCVax-Direct trials. Not clear on how close they are. They talk about the first step being the restarting of manufacturing which can take months. It appears they are still engaged in this process. Very speculative, but I'd say we are looking at '25 for Direct restarting based on the ASM statements.
✅LP tends to get into the painstaking details of every aspect of NWBO. For example, when discussing the direct trials starting back up she goes through exacting detail on what is required to start the trials back up but she doesn't give any clear answer as to where we are at in said process. I don't care about those details, I want to know where we are at! That was a microcosm of a lot of the ASM. Lots of details on stuff that I'd guess most shareholders don't care about but little details on what matters.
✅LP hinted at collaborations they are working on. We've seen this for a year in the 10qs. The positive, NWBO usually completes what they say they are working on. The negative, the timeline it takes to complete said tasks is way longer than anyone expects. These collaborations have been hinted at for over a year now.
✅Spoofing lawsuit is a side story. I'm not going to discuss it here.
✅The details on the preparation for commercial launch are good, but they seem a bit late on a lot of these things. For example, they talk about needing a pricing model and that NICE will need this information. LP stated that they will be working on the pricing model "in the next 18 months". How about the next 1 or 2 months?! My understanding is that NICE is waiting on NWBO's evidence submission before they can proceed with the review process. I wish LP went into more detail with NICE. This part of the discussion was not very encouraging.
✅LP comments on needing to expand the management team was encouraging. This has needed to happen for a while. I'm hopeful that they not only expand the management team, but then put these people in positions best suited to their strengths and allow them the flexibility and resources to succeed, i.e. lets not put an articulate, smart and experienced Innes in a secretarial role.
✅The sequential pediatric trials is nice to hear. It sounds like this will save NWBO resources.
✅LP's comment that the MHRA has "the fastest process that we know of" is bonkers. This is not consistent with the public data I've seen.
✅LP's comments, or lack thereof, about submitting in other countries was discouraging. They don't seem close. I've always said I don't think the FDA submission happens till '25 so I'm not surprised there, but I thought Canada was on the horizon. I'm not so sure anymore.
✅I'm glad to hear we are not close to an uplisting. I'm worried that if we were close that this would mean a r/s.
✅The focus on trials where tumor shrinkage is the endpoint is encouraging. This will save on time and resources.
✅I'm glad they are open to partnering. That is my biggest concern. You look at all of LP's comments about ordering flaskworks machines, starting the pediatric trial(s), starting combination trial(s), building out the management team, build out grade c labs, submitting applications for approval in other jurisdictions, continuing to get patent protection, etc. - IT ALL COSTS MONEY. Right now we are moving at a snails pace b/c we lack resources. A partner could bring those resources. I hope this is more than talk.
✅In the end, I think the biggest thing to look forward to in '24 will be the MHRA approval. I believe it has a great chance of happening and hopefully this event starts to turn around the share price and attract more institutional investment.
This was about what I expected for the ASM. Pretty similar to last year. Some good information, but lacking on guidance.👍️ 0
In this post I'll include my notes for the ASM and I'll follow it up with some thoughts.
FORMAL MEETING
1. To elect two members to our Board of Directors to serve as a Class I Directors for a term of three years;
✅PASSED
?
2. To ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024;
?
✅PASSED
3. To ratify the same 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;
✅PASSED
?
4. To ratify 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;
✅PASSED
?
5. To approve, on an advisory basis, the Company’s executive compensation; and
✅PASSED
INFORMAL DISCUSSION
Discussion by Linda Powers unless noted otherwise
MAA
☑️Prerequisites done
☑️NWBO continues to prepare for the inspections including any questions and requests for more information that the MHRA might have
sorry, came late so missed some of this section
Sawston/Flaskworks
☑️In 2.5 years Sawston has completed phase 1A and 1B buildout
☑️Worked with architects and engineers to buildout c-labs.
☑️flaskworks allows grade c-labs. can only do this when process is closed, meaning it is all kept within a machine/bag/flask
☑️using grade c labs from here on out
☑️current anticipated capacity of Flaskworks per advent, 1,000-1,100 vaccines per year per grade c lab
☑️anticipate building up to 15,000 patients per year with all grade c labs in the rest of the building
☑️companies that bought car-t products were only able to initially produce 60 per year
☑️cryostorage for 3m vials at sawston
☑️Advent & 3rd party made system to automate product release process which will speed up the manual process that takes up to 30 person hours
☑️last 18 months developed two new flaskworks systems to close and automate the process, selected the best approach, developed and optimized a non GMP version, GMP work finished, improvements being made, units about to be ordered shortly
Les Goldman on Advent
☑️Advent provides a range of contract services to NWBO. Write sections of MAA, run compassionate use program, help in development of flaskworks system.
☑️Advent handling restart of DCVax Direct
☑️payment structure provides a passthrough of all baseline costs plus fee for administration (15%)
☑️approach is beneficial to both Advent and NWBO
allows NWBO to get services that are far less costly versus going to a 3rd party provider
☑️A large chuck of pay to Advent is pass through costs.
Les Goldman hands mic back to Linda Powers
IP & Collaboration
☑️Goal is to build a franchise in dendritic cell technologies
☑️NWBO wants to be the leader in this area
☑️BP and govt are beginning to recognize viability of dendritic cells
☑️Roswell Park in-licensing covered 7 years of work for leading dendritic cell group. Last year in-licensed 17 years of work that this group did before moving to roswell, but kept it secret until recently. Packages include enhanced versions of dendritic cells and complimentary technology, combination treatment regiments in a trial or agents to be immune booster agents.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
☑️"DCVax-Direct will be coming up again now"
quietly in-licensing to buildout franchise
☑️working on collaborations but haven't announced those yet. they will be coming
Spoofing Lawsuit
☑️frustrated that the share price not yet reflecting the value they are working to build
☑️our stock has been manipulated for many years
☑️had to collect evidence to be able to file lawsuit, high degree of detail was required
☑️been in MTD battle
☑️magistrate and court said pleadings were sufficient minus one element
☑️court said NWBO sufficiently plead d's manipulated stock and did so with scienter
☑️needed formula for loss causation
☑️waiting for magistrate to evaluate all of this
☑️trying to recoup damages and to get manipulation to stop
Break
Three Levels of Priority
FIRST TIER PRIORITIES
✅obtain first commercial approval in the UK. we believe the MHRA is following the 150 day process, but no confirmation of that
➡️the MHRA delivers questions throughout the review process which consists of an initial 80 day review, a 60 day clock off, and a 3rd stage approximately 70 days of further review and reaching a decision, timelines are approximate.
➡️there is not an equivalent thing to a PDUFA date in the UK as there is in the USA
➡️the inspections will be ongoing throughout this whole process
➡️NWBO is not going to provide interim step, blow by blow. NWBO will PR the result when the process if finished. this is the standard approach
✅preparations for commercial launch
➡️anticipate commercialization using existing grade b labs
➡️finishing process with flaskworks, get units ordered, have them delivered, advent will then need to conduct practice/engineering runs at sawston, collect data, compare to manual process data
➡️flaskworks is going on in parallel
➡️need to expand contractual arrangements for leukapheresis blood draw, expand staff to handle logistics, and lots of additional mundane tasks that need to be done
➡️need to determine pricing model, will work with expert advisors
✅Applying for approval for reimbursement
➡️process handled by NICE in the UK
➡️have to make economic model, in grouping of top priority in coming 18 month period
✅applications for approval in other countries - "anxious to submit"
➡️"MHRA has fastest process that we know of"
➡️a partial headstart on other applications - clinical study report (includes data on all patients, even beyond brain cancer)
✅we need to expand management team rather substantially
➡️each member has been handling multiple roles, we need to ramp up....as soon as we can achieve it
✅Pursue Spoofing Lawsuit
SECOND TIER PRIORITIES
✅initiate pediatric glioma trial (not required for approval for adult medicine)
➡️proceeding with 1 of 2 first, sequentially, reduce resource requirement on NWBO
✅pursuing buildout of c-labs
✅flaskworks - finish process
✅product release system - developed from scratch, deployed in pilot version in london lab and then about 1 year ago was installed in sawston, has to go through practice runs and show equivalency
✅DCVax-Direct: first need to restart manufacturing, will make PR when time is right, anytime you do a technology transfer process (was only ever produced in US by parties no longer there) you have to draft a new set of SOPs, regulatory documents. A technology transfer is a minimum of 6 months of work.
THIRD TIER PRIORITIES
✅eager to get clinical trials underway - did early p1 direct, md anderson, 13 different types of cancers, solid tumors. Patients were in bad shape. very encouraging results. directly injected into tumor that can't be removed b/c too many or where it is located.
back to DCVax-L
✅eager to build on results of p3 trial with combinations. benign safety profile. can combine with all sorts of drugs. discussions are underway. Want to do 1 ore more of those combinations. Interest from various parties in this respect.
✅general approach - want to focus on clinical trials where tumor shrinkage can be the endpoint as opposed to OS being the endpoint. Why? B/c trials are shorter.
✅partnering: open to partnering.
✅uplisting: not quite there yet. want to be strategic on timing
CLOSING
✅tremendous progress in the last 18 months
✅no guarantees, but believe well positioned for the first approval
✅built an in-licensing toolchest with tremendous opportunities
✅share price does not yet reflect this progress
✅if we can continue making progress, and making progress against parties artificially keeping share price down and attract more institutions like the recent one then ultimately the market will recognize the value
$NWBO
I wanted to get these thoughts out while they're fresh on my mind and before talking with anyone. So, without further ado, my unfiltered initial impressions of the ASM comments:
✅I'm glad all of the resolutions passed. Not that I'm happy about the awards, but for the sole reason it could end the litigation and the resource drain on NWBO, I'm happy.
✅It appears we are still in phase 1 of the MAA process with the MHRA. LP said every company can expect a RFI and NWBO has yet to receive one, but are preparing for such eventuality. I stand by my former comments on where we are at in the approval process. LP all but confirmed my suspicions.
✅Sawston handling 15k patients/year with fully built grade c labs is encouraging. It's less encouraging that this work on grade c labs has yet to start. It appears the design work is complete but the physical building has yet to start.
✅The flaskworks update was not perfectly clear. LP said the GMP work was finished but they hadn't yet ordered the GMP units because some improvements were being made, i.e. the work is not finished. Recall, that this process of ordering the GMP units was to take "several months" per the February 6, 2024 PR. It's been about 5 months and it appears we have a bit longer to go. After that the GMP units must be validated. It's clear that the flaskworks system will be approved via a variation after DCVax-L will be initially approved using the manual process.
✅It was good for LG to make it clear Advent pay is largely pass through costs plus a 15% fee for administration. It appears NWBO is saving resources by moving forward in this manner than if they had engaged a third party.
✅I'm mixed on the franchise building. It's ambitious. It will require a lot of work, a lot of deal making and a lot of resources, both people and money. NWBO seems to have a good eye for products, see Roswell Park and Flaskworks. Yet, NWBO's track record on execution is slow, painstakingly slow.
✅NWBO looks to be restarting the DCVax-Direct trials. Not clear on how close they are. They talk about the first step being the restarting of manufacturing which can take months. It appears they are still engaged in this process. Very speculative, but I'd say we are looking at '25 for Direct restarting based on the ASM statements.
✅LP tends to get into the painstaking details of every aspect of NWBO. For example, when discussing the direct trials starting back up she goes through exacting detail on what is required to start the trials back up but she doesn't give any clear answer as to where we are at in said process. I don't care about those details, I want to know where we are at! That was a microcosm of a lot of the ASM. Lots of details on stuff that I'd guess most shareholders don't care about but little details on what matters.
✅LP hinted at collaborations they are working on. We've seen this for a year in the 10qs. The positive, NWBO usually completes what they say they are working on. The negative, the timeline it takes to complete said tasks is way longer than anyone expects. These collaborations have been hinted at for over a year now.
✅Spoofing lawsuit is a side story. I'm not going to discuss it here.
✅The details on the preparation for commercial launch are good, but they seem a bit late on a lot of these things. For example, they talk about needing a pricing model and that NICE will need this information. LP stated that they will be working on the pricing model "in the next 18 months". How about the next 1 or 2 months?! My understanding is that NICE is waiting on NWBO's evidence submission before they can proceed with the review process. I wish LP went into more detail with NICE. This part of the discussion was not very encouraging.
✅LP comments on needing to expand the management team was encouraging. This has needed to happen for a while. I'm hopeful that they not only expand the management team, but then put these people in positions best suited to their strengths and allow them the flexibility and resources to succeed, i.e. lets not put an articulate, smart and experienced Innes in a secretarial role.
✅The sequential pediatric trials is nice to hear. It sounds like this will save NWBO resources.
✅LP's comment that the MHRA has "the fastest process that we know of" is bonkers. This is not consistent with the public data I've seen.
✅LP's comments, or lack thereof, about submitting in other countries was discouraging. They don't seem close. I've always said I don't think the FDA submission happens till '25 so I'm not surprised there, but I thought Canada was on the horizon. I'm not so sure anymore.
✅I'm glad to hear we are not close to an uplisting. I'm worried that if we were close that this would mean a r/s.
✅The focus on trials where tumor shrinkage is the endpoint is encouraging. This will save on time and resources.
✅I'm glad they are open to partnering. That is my biggest concern. You look at all of LP's comments about ordering flaskworks machines, starting the pediatric trial(s), starting combination trial(s), building out the management team, build out grade c labs, submitting applications for approval in other jurisdictions, continuing to get patent protection, etc. - IT ALL COSTS MONEY. Right now we are moving at a snails pace b/c we lack resources. A partner could bring those resources. I hope this is more than talk.
✅In the end, I think the biggest thing to look forward to in '24 will be the MHRA approval. I believe it has a great chance of happening and hopefully this event starts to turn around the share price and attract more institutional investment.
This was about what I expected for the ASM. Pretty similar to last year. Some good information, but lacking on guidance.
attilathehunt
Re: dmb2 post# 702318
Saturday, June 29, 2024 4:26:07 PM
Post#
702325
of 702348
Great post!!
I do not believe she would talk about hiring additional staff unless she was expecting some big dollars coming in...
The next couple of weeks could be very revealing...
Now the the votes are in...A well timed collaboration PR can come any day know since it can't be construed as a way to manipulate the voting.
Hold on to your seats!!
FeMike Great job .Does anyone have a machine that can turn the ASM audio into accurate written word? Thanks.A.E.K.
Re: None
Saturday, June 29, 2024 3:10:30 PM
Post#
702240
of 702344
ASM notes and quotes, typed this on the fly and haven’t proofread so don’t rip me apart. All of my thoughts are in parentheses and quotes are as close as I could get them freetyping.
Linda Powers:
“MHRA has given us rapid turnaround in the steps we have had so far” (seems like this was said more with regard to PIP but maybe MAA is moving quickly as well? )
“we have been working our tails off with teams of consultants because everybody is going to be inspected” (going to be – not yet inspected?)
“our understanding is when they send inspectors they will send a team of inspectors and stay for a week” – (definitely haven’t started inspections yet)
“we do continue to follow patients from the P3 trial and do still have patients alive”
“have not had much activity in compassionate use program (since submitting MAA)….still gaining real world experience, practicing for when we can be commercial…..8, 9, 10 year survivors (in compassionate use?)”
“In terms of capacity – our current anticipation….each of the grade C labs should be able to produce ~1,100 patient products per year per Grade C lab…..ultimately, fully built out building (Advent/Sawston) can produce up to 15,000 patients per year…enormous amount of patients.”
Flaskworks “a few more changes were made and new GMP units are about to be ordered shortly – clinical grade machines”
Leslie Goldman re Advent: “Advent is finishing up the restart of DCVax-Direct…have been working on it for months” (huh??)
Linda Powers:
Re IP and collaboration: “our goal is to build a franchise in dendritic cell technology…(BPs) haven’t recognized potential…we have quietly reporting that we have been inlicensing techs that we think will be valuable. Just recently we announced one…..the package from oswell park….that package covered 7 years of work….we had also completed last year the inlicense of a package of the original older foundation work that the group had spent 17 years developing at another institution….we have inlicensed both of those packages…..those two together include enhanced dendritic cells and techs that are complimentary to dendritic cells perhaps in a combination regiment or agents to be immune booster agents….interestingly, this collection gives us a lot of growth opportunity that can be used together with DCVax-L and DCVax-Direct that you haven’t heard about recently but will be coming up again now I’m happy to say”
“one of the really nice things about the packages, we were surprised (with the response) maybe people didn’t understand – we have two phase 2 trials underway…..these are technologies that we now have. This will be going on in the background (we don’t fund or operate, but we own)….if they are positive, we will be taking them into phase 3”
“we have been putting collaborations in place…we haven’t announced those yet, but they will be coming along…we are in stealth mode”
Re MM Lawsuit: “all of us are frustrated that the share price has not yet reflected the value of what we are building….” 10 minutes on this but nothing interesting that we didn’t already know
LP asks for a 7th inning stretch. Awkward live mic question.
Linda Powers re forward looking 18 months:
“Three groups of priorities moving forward. Top, secondary, and ‘as feasible’….top priority is completion of obtaining the first commercial approval of the MAA in the UK…we believe MHRA is following the 150 day process but we do not have confirmation. The 150 days involves ~3 stages and the timeframe of each stage is approximate. (Stage 1): 80 days of initial review. (Stage 2): ~60 day clock stop when the agency is going to deliver a list of questions to us…we’ve tried to guess what questions they will ask so when we do get them we can respond as quickly as possible (sounds like they have not gotten RFI yet but it is happening) (Stage 3): ~70 days of further review and reaching a decision.”
“I mentioned about the inspections….those are gonna be going on all during this process…those will have to be completed before a decision can be rendered. We are not going to provide interim step (updates)….we are only going to tell the results.”
“Another big priority is preparations for commercial launch…we anticipate we will be beginning commercialization using existing Grade B (not flaskworks) labs…remaining steps for Flaskworks are to get the units ordered, have the units delivered, Advent will conduct a large amount of engineering runs….collect all the data, compare data with data dcvax product produced from existing process to demonstrate to regulator that the machine operates properly and produces the same product....”
Re NICE reimbursement “NICE has been absolutely wonderful to us….they are standing by. They reach out every couple months to check on the status of things. We need an economic model about the cost benefit of DCVax treatment….that for sure will be in our grouping of top priority activities…”
Re other RA’s: “We are anxious to submit applications for approvals in other countries…that will be another thing we will be working on in this (18 month) period.” (disappointing)
“We need to expand the management team”
“last top priority is the lawsuit”
Re: 2nd highest tier of priority:
“PIP glioma trial. Starting the trial is not a prerequisite, only having an approved plan….we just recently finally reached conceptual agreement…will be proceeding with one of the 2 trials first, and the next will be sequential rather than parallel”
“we’ll be pursuing buildout and equipment of the first grade C lab”
“DCVax direct – we have been eager to restart this program for a long time. The first thing we need to do is restart manufacturing. As it turns out, this will be something we will PR when the time is right, any time you do a tech transfer process…that product was only ever produced in the US….we had to do a tech transfer process to the Sawston facility….you have to draft a new set of SOPs, regulatory docs, and usually….it is a minimum of at least 6 months. We’ve had two additional challenges which I think we’re on our way to having behind us…one related to the machine we use for the first stage of the process and one related to key ingredients…restarting the manufacturing process is a significant priority for us…..”
Re last grouping of priorities:
“Once the manufacturing process is restarted, we need to restart clinical trials….early stage trial was Phase 1 conducted at MD Anderson….”
“Eager to build on DCVax-L with combinations. We believe it will be imminently combinable with other types of treatments. We have some collaboration discussions underway and at the appropriate time…..these are forward looking statements….we’ve said we are eager to combine DCVax L with other combos. One of our many priorities is to do one or more of those combinations. We’ve received considerable interest from various parties for that.”
“Our general approach looking forward on clinical trials….we want to focus particularly on clinical trials where tumor response can be the endpoint as opposed to overall survival. You can see this in a matter of months as opposed to survival which takes years….”
“Two last points…partnering, we’ve had questions, we’re quite open to partnering….where we see a partnering that could have strategic or financial value or both (duh)….could be a regional partnering, (IP filler nonsense)….or it could be partnering for an application. We will be open to that and see what makes sense.”
Re: uplisting “everyone would love to be on a national exchange rather than the OTC….we will be looking for when the strategic timing is right, we’re not quite there yet.”
In closing: “we believe we are well positioned to get a favorable result and get our first approval and begin commercialization. We’ll all know…ya know….reasonably soon.”
@ATLnsider
Here are some more reasons that $NWBO #DCVax is significantly superior too & more efficacious than SurVaxM:
newman2021, you are correct that the DCVax-L dendritic cell cancer vaccine does already target survivin. In my opinion, there is absolutely no need or extra benefit for SurVaxM to be added to or combined with DCVax-L. It would be unnecessarily redundant, and it would provide very little, to no additional benefit. It would be like taping a feather (SurVaxM) to a jack-hammer (DCVax-L) thinking the feather (SurVaxM) would add benefit to the jack-hammer (DCvax-L) to breakup rocks (destroy cancerous malignant tumors).
SurVaxM is a GAA peptide-based dendritic cell (DC) vaccine that targets a single (1) Glioblastoma-Associated Antigen (GAA), called Survivin (baculoviral inhibitor of apoptosis repeat containing 5, or BIRC5). Survivin is expressed by 95% of glioblastoma tumors. Unfortunately, for most malignant solid tumor cancer patients, their cancerous tumors are very heterogeneous, and they express dozens, hundreds or even thousands of additional antigens that need to be targeted in order to prevent tumors from escaping, recurring, spreading and metastasizing.
The beauty of DCVax-L is it is personalized and specific to each solid tumor cancer patient, and it is made from Autologous Tumor Lysate (ATL) pulsed Dendritic Cells (DC), taken from each individual patient. DCVax-L is all-encompassing, and it targets 100% of all the patient's own cancerous antigens, peptides and biomarkers, including survivin, but also dozens, hundreds or even thousands more cancerous antigens, peptides and biomarkers:
There are several GAAs that are commonly associated with and over-expressed in malignant gliomas, including: EGFRvIII, HER2, MAGE-1, TRP-2, GP100, and Survivin:
https://ncbi.nlm.nih.gov/pmc/articles/PMC3299309/
(1) Glioblastoma-Associated Antigens (GAAs) —Recently, many efforts have been made to identify tumor-associated proteins as targets of tumor-reactive T cells and to define peptide motifs within these proteins constituting T-cell epitopes. In this paper, we focus on glioblastoma-associated antigens (GAAs), which have already been used for DC-based vaccination trials enrolling GBM patients.GAAs such as EGFRvIII, EphA2, GP100, HER2, MAGE-1, IL-13Ra2, SOX11, and TRP2, which were frequently overexpressed in GBMs were able to initiate immune responses. Other antigens associated with GBM have been described including survivin, WT1, SOX2, AIM2, SART1, SART2, and SART3.
Fortunately, the science, evidence and data is clear. Dr. Linda Liau, Dr. Robert Prins, Dr. Timothy Cloughesy, and others at UCLA conducted a study back in 2014, and have already definitively determined that an Autologous Tumor Lysate (ATL) pulsed Dendritic Cell (DC) vaccine is superior to, and is significantly more effective and provides more of an overall survival benefit than a peptide-based vaccine, like SurVaxM, that only target 1 GAA, or a few peptides, antigens or biomarkers. It is very comforting and reassuring to know that this study was funded in part by Northwest Biotherapeutics:
Acknowledgments
This work was supported in part by NIH/NCI grants K01-CA111402 and RO1-CA123396 (to RMP), R01 CA 112358 (to LML), the Brad Kaminsky Foundation, Cranium Crusaders, the Miles for Hope Foundation, Northwest Biotherapeutics, Inc., the Eli & Edyth Broad Center of Regenerative Medicine and Stem Cell Research at UCLA (to RMP and LML), the STOP Cancer Foundation (RMP), the Ben & Catherine Ivy Foundation (to RMP), and the American Brain Tumor Association (to LL and BF).
Here is what their study showed:
The source of tumor antigen used to load DC was the main distinction between these two trials. The ATL-DC trial utilized autologous, patient-specific proteins derived from primary, digested tumor cells after freeze-thaw cycles. The GAA-DC trial utilized synthetic peptide antigens (TRP-2, gp100, her-2/neu, survivin) known to be expressed by gliomas. While expression of these GAA was not an eligibility criterion for enrollment onto the GAA-DC trial, post-hoc IHC staining confirmed that survivin was expressed uniformly by all tumor samples, while her-2 expression was patchy and variable. Gp100 was not easily detectable by IHC when compared with melanoma (Fig. 1), which is consistent with other recent studies10. TRP-2 was only detectable at the mRNA level, and previously shown to be variably expressed
The median survival of patients on the ATL-DC trial was 34.4 months, while that of patients on the GAA-DC trial was 14.5 months. It is possible that our choice of antigenic targets (survivin, her-2/neu, gp100, TRP-2), or inclusion of PGE2 in the DC maturation cocktail, may have negatively impacted effective anti-tumor immune responses elicited by our GAA-DC vaccination.
In my opinion, the evidence is clear that DCVax-L is exponentially more effective than SurVaxM. NWBio knows this, Dr. Liau, Dr. Prins, Dr. Cloughesy & et al at UCLA know this, and I believe Dr. Pawel Kalinski, Roswell Park, and the University of Pittsburgh also know this. I believe that the in-licensing agreement between NWBio, Dr. Kalinski, Roswell Park, and the University of Pittsburgh, was not for SurVaxM. I believe it was for the IP and technology associated with enhanced versions of dendritic cells and dendritic based therapies, including mature type-1 polarized dendritic cells with enhanced IL-12. Also, conditioning regimens designed to enhance patient responses, and to reprogram the tumor micro-environment (TME). I believe these TME conditioning regimens include: TLR-3 agonist, Type-1 interferon, a chemokine modulating regimen (CKM), interferon alpha,
Here is what the NWBio PR stated regarding the in-license IP from Dr. Pawel Kalinski :
The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174670373
Thanks dstock07734, I forgot to post the link for the study conducted in 2014, by Dr. Linda Liau, Dr. Robert Prins, Dr. Timothy Cloughesy, and et al at UCLA.
This study compared ATL-DC (DCVax-L) to a GAA peptide-based dendritic cell vaccine, like SurVaxM:
https://ncbi.nlm.nih.gov/pmc/articles/PMC3568250/
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174670647
ATLnsider
Re: meirluc post# 701856
Friday, June 28, 2024 3:14:39 PM
Post#
701868
of 701964
meirluc, did you read my post below where Dr. Liau, Dr. Prins, Dr. Cloughesy et al, at UCLA did a study to compare a peptide-based vaccine, like SurVaxM, with DCVax-L? The peptide-based vaccine in their study targeted Survivin and 2 other tumor antigens.
DCVax-L is personalized for each patient, and it already targets the GAA Survivin and dozens or hundreds of other tumor antigens. There is zero need or added benefit for adding SurVaxM.
I would like to get your feedback after you read my post. Also, the link to the study conducted at UCLA is also below:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174670373
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568250/
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
TIME IS RUNNING OUT. THE CLOCK IS TICKING!!!
biosectinvestor
Re: theorysuit post# 7019581.
NWBO owns Sawston;
2. NWBO owns Flaskworks;
3. NWBO using contract manufacturers for craft work done by hand during the trials, allowed the cost of those facilities to be borne by another company, and those employees, while the company could focus only on the production and production line, which is a cost with ANY CDMO and anyone half informed about cell therapies and these microcaps knows that basically everyone who is serious, ultimately contracts that work out if they do not have technology like Flaskworks.
4. Advent was a spinoff from Cognate, which helped develop some of the early technology, and had the personnel and expertise on staff to work with NWBO on some of the original effort to engineer the technology, also a benefit, and Advent continued to have the expertise at low cost, to continue that work in the UK. LP as a private equity fund manager, had funds to develop technology at Cognate independently to seed complimentary companies that could help each other while not having the same risks or challenges. Doing it all in one company in the past bankrupted a lot of these small microcap biotechs creating cell therapies and biologics. So isolating and turning manufacturing into a separate business, in a field that was not yet fully developed, for dendritic cells, was literally a brilliant way to address a market challenge and seed a new sector of development.
5. The company could then tap the Advent knowhow and talent, to create NWBO's own factory and provide it with all of the knowledge to do what Cognate had done at its facilities, but now for NWBO at its own facilities, AND at the same time, they were able to get regional development authority funds to have a symbiotic relationship with the Cambridge community, providing services that did not exist and potentially subsidizing the development of Sawston both with the regional development authority financing and also having what amounts to a local facility for developing the technology in Cambridge. It was well worth the deal. Having Advent means that NWBO can focus on DCVax-L, and Advent can provide those ancillary local development services and pay rent to NWBO while they do so, addressing NWBO's requirement to deliver those services for the low financing costs, but NWBO does not have to have the costs or devote the energies, talent or personnel to do it.
6. Advent has done a spectacular job. The contract is at will, but such relationships are extremely flexible. A buyer will get Sassoon, and they could take Advent too, or buyout the employee contracts, or not take it at all and it would not affect DCVax-L in the slightest because NWBO owns all of the IP and Flaskworks and all of the patents around that.
The effort to plant false ideas and false fears is a constant issue with shorts. It's misinformation and disinformation for profit. But the reality is, disinformation and misinformation can't change reality or facts. Yes, it can convince people of false notions and false ideas. But it has very little to do with anything real.