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I was not expecting any announcements at the ASM, that has not been the case in the past, so I certainly didn't expect any real news, certainly not TLD. I was a bit disappointed overall though. I enjoyed the in-person meetings. They always made me feel better because the Board/Management are able to better convey their passion for what they are doing. At the in-person meetings it is also more than just Linda Powers talking. I have never found her to be a compelling speaker, which is fine, she has more important qualities. Still, having just her speak on video isn't as motivating. At least at the last ASM they told us where they were and gave us an idea of what was happening next. I didn't get any real sense of where they are today. Blinded? Unblinded? Almost to the finish line? Barely started? The only thing we know is not to expect any news for at least a couple of months. Oh, and I like the cookies at the in-person meetings!
None of this changes my feelings about the chances of success or determination to continue to hold on. Just not inspiring. After a year of COVID, another 13 months of waiting after suggestions that TLD was imminent, and entreaties to be patient and hang in there, I could have used a touch of inspiration. Would I prefer that they spent their time on getting TLD out and DC-Vax approved than giving me a pat on the head? Sure. But both would be nice. :)
As to deciding whether or not to sell now? That is easy. Not worth the risk or the conversion of long-term shares into short-term ones for $0.45 a share.
Nope, I did it myself.
Northwest Biotherapeutics, Inc Annual Shareholder Meeting
Tuesday, May 18, 2021
16:30 EDT – Start meeting
Agenda
- Introduction of Directors and Officers
- Meeting Call to Order
- Explanation of three proposals
- Discuss proposals
- Open/Close polls
- Announce Results
- Adjourn formal business of meeting
Following the meeting, a discussion of questions submitted by shareholders.
Officers and Directors present: (16:33)
- Linda Powers
- Les Goldman
- Dr. Alton Boynton
- Jerry Jasinowski
- Dr. Navid Malik
- Ambassador Cofer Black
- Dr. Marnix Bosch
- Jean Davis
- David Innes
Also present, Lisa Porter from the transfer agent (Computer Share Trust).
There are 613,953,464 shares represented at the meeting of a total of 842,289,193 issued shares [for a total of 72.89%] and therefore a quorum of shares issued as of the close of business on March 26, 2021.
The three proposals:
1. To elect Jerry Jasinowski to our Board of Directors to serve as Class II Director for a term of three years. Proposal PASSED.
2. Advisory vote to approve executive compensation. Proposal PASSED.
3. Appointment of Cherry Bekaert LLP as independent registered accounting firm for the fiscal years ending December 31, 2021 and 2020. Proposal PASSED.
16:47 – Concluded business and meeting is adjourned.
_______________________________________________________________
The following may contain forward-looking statements.
Linda Powers: "We received a number of questions from various questions from shareholders. Not surprisingly they grouped into several main categories of subject matter about five subject matter categories and one question about ASCO.
"The subject matter categories were: The process for the Phase III trial results; Question about whether we’ll be presenting at ASCO; Questions about the DC-Vax Direct program; Question about a patents; Questions about Sawston; and about Flaskworks.
"We have bundled the questions into these subject-matter categories in order to make it feasible to walk through some informal discussion of them and I will walk through that discussion now. And we appreciate the shareholders sending in these questions."
1. Phase III trial Results
"So first of all is the process for Phase III trial results. We know everyone is very anxious to see the results of the trial. As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care. To put this in context, this is a fourteen-year long, Phase III trial. It’s really important that the review process be of the highest quality. We really appreciate the patience of our long-term investors. We do understand how hard it is to be patient after all this time. But we do ask that you continue to be patient because we serve you best by moving carefully and thoroughly through all the stages of the process that we’ve outlined. So that’s what we have been doing and we will finish doing. That’s really all I can say at this moment about the Phase III trial process."
2. ASCO
"The next subject that came up relates to ASCO, the big ASCO conference, big annual conference. And I think everybody knows that the ASCO conference will be virtual this year. We plan to be a sponsor and exhibitor again this year, we have been for a good number of years now. Seven or eight or nine, something like that, anyway a good number of years. But it’s come to our attention that rumors and even some claims have been circulating that we would be presenting the Phase III results at ASCO. And that’s simply not the case. It’s not accurate and those rumors and claims are unfounded. And we think it’s very important to clarify this. We’re not presenting the Phase III trial results at ASCO."
3. DC-Vax Direct
"Third subject, DC-Vax Direct. We were quite pleased to receive several questions about our DC-Vax Direct technology. And about whether we plan to do anything further with that. The short answer is ‘Definitely, Absolutely, Yes.’ We certainly do plan to. At present, as I just explained a few minutes ago, our whole intense focus is on DC-Vax L and the Phase III trial results, as you would want it to be. But it’s worth remembering that the extended survival results that we saw in the Phase I trial with DC-Vax Direct, which if you remember was thirteen different types of advanced, solid-tumor, inoperable cancers in that trial. And those extended-survival results in that trial were quite encouraging. We reported those, that information at ASCO several years ago. So, we’ve been mentioning in our quarterly and annual reports, we do plan to proceed with Phase II trials with DC-Vax Direct after the Phase III results, the process of getting to the Phase III results is completed and as soon as time and resources permit. ‘Cause as I just said, first the focus is DC-Vax L. But there is a tremendous need for new treatments and approaches for inoperable metastatic cancers. There’s so many treatments in development for cancer but there’s so little for patients who are at that kind of a stage of advanced, inoperable cancer. Definitely ‘yes’ we will be reactivating the DC-Vax Direct program."
4. Patents
"Next question was about patents. We received a question and we are pleased to report that ‘yes we did receive a new patent’ relating to our DC-Vax Direct process that’s recently been approved in the US. What’s very nice is the US was the first country to approve it. So we’re excited about that. That patent covers certain aspects of optimizing DC-Vax Direct, the DC-Vax Direct product for enhanced potency. That’s what that’s about. So the answer is ‘yes we did receive that patent, it was approved in the US.’"
5. Sawston
"The next category of subject matter that was asked about was the Sawston, UK facility. I think probably a number of the questions came before our announcement, our press release last week which was on this subject. And I hope everybody had a chance to see our press release last week. Because it was announcing that a quite important milestone was reached. The milestone was the completion and the submission to the UK regulatory authority, the FDA of the UK, of the whole application package for the initial licensing of the Sawston facility. I think everyone knows, but just to provide the background, all facilities that produce medical products for human patients are required to be licensed by the regulator in that country. Every facility has to go through this. And the application that was submitted and that we announced last week as we said in the announcement, was the culmination of more than two years of work by a large team and a whole lot of expert consultants. So that was a quite important step, a quite important milestone. Looking ahead, looking forward, we are hopeful that the process, the next steps are for the regulatory authority to make an on-site inspection, in person of the facility. There’s some lead-time for scheduling that, there’s some time involved in the regulatory authority writing up the results after the inspection and if there is anything to address then having that be addressed. So we are hopeful that that process those steps will proceed quickly over the coming months. And we hope to have the initial license for the Sawston facility by around the end of the third quarter this year. Something in that time frame. Once we have the initial license, then we expect to begin producing vaccine products for our existing programs as we’ve been doing at the small facility in London that we’ve been using up ‘til now. So that’s the update on the Sawston facility and the discussion related to the questions we got on that."
6. Flaskworks
"Our last subject for discussion today relates to questions we received about Flaskworks. As we have described in various announcements and filings, we believe the Flaskworks system has the potential to significantly enhance our product economics and our production capacity. So at present, DC-Vax products, like other immune cell therapies, CAR-Ts, cell therapies, and others, NK, CAR-NKs, all these immune cell therapies, they’re made in extremely costly, specialized facilities that are called GMP facilities, which stands for Good Manufacturing Practice, and they’re made by hand by specialized technicians. The GMP facilities require all sorts of specialized infrastructure, all of the air has to be sterile, goes through so many air changes per minute, per hour the technicians who work there have to wear space suits. It’s very expensive to develop these facilities in the first place and to operate them on an ongoing basis. The Flaskworks system is designed to make two fundamental improvements. First of all, it closes the manufacturing process, which means that the steps of the process take place inside machines and since they’re not exposed to the air, there’s not a need for sterile air, the space suits, and all that special infrastructure. So that takes a whole lot of cost, a huge cost out of the equation for the product cost of the DC-Vax products, or it is anticipated that it will, it should. Second, the Flaskworks system automates the steps so that the machines are doing it so it is not being done by hand by specialized technicians. This is really important to enable scale-up to large production quantities for large numbers of patients. So that’s a little recap of, you know we’ve had some questions about what the Flaskworks system will do, how will it benefit us and I think those are very significant benefits. So in terms of progress or status, the Flaskworks teams has been working intensively toward some key milestones, which we built into the acquisition agreement last year when we acquired Flaskworks. And the initial focus of the milestones is on applying the Flaskworks system to the production of DC-Vax L products. So, once again, that’s a reflection of that’s and a part of our company-wide priority focus on the DC-Vax L program for the time being. As we announced last week, we anticipate that the initial practice runs with the Flaskworks system for the DC-Vax L product may begin at the Sawston facility during this summer. And what’ll happen after that is that after sufficient practice runs have been done and any optimization work has been completed, then the Flaskworks system will go through a similar validation process and regulatory process as what our existing manufacturing is currently going through. So it will be the same type of process, that was another question that we got."
Conclusion
"That brings me in conclusion to the end of our subject grouping categories for informal discussion today. I hope this discussion has been interesting and helpful. I will say on behalf of the whole Northwest Bio team, we’d really like to express again our appreciation for everyone’s patience and understanding and I’ll just conclude by assuring everyone again that we will continue to press forward to complete the six-stage process of . . . or multi-stage process that we originally outlined that the Phase III trial results need to go through to be reviewed and analyzed in a high-quality process. So I’d like to thank everyone for attending and wish everyone a nice day and that brings our meeting to an end."
End of meeting: 17:04
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155111548 - 2020 ASM (4/18/2020)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146542058 - 2019 ASM (2/2/2019)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140376617 - 2018 Special Meeting (4/27/18)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137853117 - 2018 ASM (1/21/18)
Control numbers didn't work last year either. Not sure how early you can get in.
The link to the LiveStream is in the proxy materials.
The website is www.meetingcenter.io/292908674. Once in the Computershare Meeting Center, your user ID will be the control number on the proxy card sent to you, and the password will be NWBO2021.
Meeting starts at 16:30 EDT.
The ASM:
www.meetingcenter.io/292908674. Once in the Computershare Meeting Center, your user ID will be the control number on the proxy card sent to you, and the password will be NWBO2021
You need the control number sent with your proxy materials.
Ike's Happy Thought of the Day:
About 12-18 months ago NWBO mentioned a plan to do a series of press releases, one building on another, something that never happened. It sort of sounded like something they were planning rather imminently, like last Spring. Anyway, it has occurred to me that the Flaskworks and Sawston press releases may have been part of that plan, followed by release of the TLD. Whether things took longer than expected (exceedingly likely) or the SAB or others made the decision to postpone the release of TLD pending some other event, that never happened.
Then today, they send out a PR about applying to MHRA a week ago. While I get that it is an important step, I am unclear as to why the sudden PR after a dearth of updates. So perhaps this is just the start of their PR blitz, which will continue on through next week?
Anyway, just a pleasant thought for the day. Perhaps not as exciting as the shorts' endless hypotheticals about maybe the company spent $10 MMs so they could continue to make $100Ks or pointing to rat studies or something.
I agree. I understand that people like the thought of a buyout because it means instant reward and an end to the wait. However, as I feel I have expressed on numerous occasions, I don't see it as being in the best interests of NWBO or Linda Powers and the management team. I also seriously doubt that any offer is really going to hit NWBO's potential worth.
Linda Powers has made clear in the past the desire to control NWBO's future and to ensure that DC-Vax is available to the patients who need it. It is not necessarily in BP's interests to have that happen as long as Keytruda and the rest of the swill they push can be sold. BP is not in the business of individualize medicine, they are in the business of pill distribution whether you need the pill or not and whether or not it actually benefits you.
I have asked the question in the past as to what NWBO gets from a buyout. About a year or so ago the answer was expertise and influence in the approval process and to a lesser extent some indicated the belief that Big Pharma could contribute to production and distribution.
If they wanted approval assistance, they should have paired up with someone a year ago. It seems pretty clear that they are happy to go it alone and deal with the somewhat unique, or at least novel, issues the DC-Vax trial offers.
With Sawston and Flaskworks, it is pretty clear that NWBO is at least as capable, and probably far more capable, of producing and distributing DC-Vax as any BP would be or will be in the foreseeable future.
Maybe there will be a partnership but I think a buyout is extremely unlikely. Just my personal, barely-informed thoughts.
A. I thought these ambulance chaser attorney's were cheap and
B. Would the fact a lawsuit was filed prohibit him from discussing the details of the pending suit?
Question for the lawyers. Is there anyway to sue ferstain to essentially gag him?
She's selling her book so...
Maybe the book came out to explain why DC's are worth continued testing and consideration in compassionate use...That a trial failure doesn't mean abandon the approach.
RE: Bacchus1 -
No idea how much people get paid or the exact arrangement. I suspect for most people it isn't much, especially the ones who just repeat the same drivel over and over again.
Places like Mechanical Turk (https://www.mturk.com/) used to have assignment postings to submit product and service reviews, so I assume there is a similar arrangement here.
I thought it odd that they were not doing it on a Saturday like the last few years. Good for me as I am traveling that Saturday.
I doubt that they will announce anything significant at the ASM but I suppose one never knows.
The proxy states Virtual, at 16:30 EDT. I got the e-mail but hadn't had a chance to read through the materials.
ASM: Tuesday May 18, 2021.
Any details yet on when, where, and if it will be virtual?
I'm simply stating reality. This OTC company seems to purposely run on fumes with a constant warning to shareholders. The tld is over due by either 3 years or 6 months, depending on who you talk to. Warrant holders are exiting at a pricy billion dollar market cap which usually spells rug pull.
I put in a 1.17 bid to start. I think nwbo has been red like 21 of last 23 sessions, while market explodes.
Waiting to see some real panic selling.
No, it is my contention that they did not spend years planning something that is too full of unknowns to accurately plan for in detail. I think I made clear in my post that that was my specific point.
People tend to procrastinate or simply prioritize things by what is most important, critical, or time-sensitive. So they wait until something needs to be done before doing it, especially if they are underfunded or low on resources. You don't want the product to fail because you spent all of your time planning out how to tell everyone it succeeded instead of making it succeed.
In the 70s my father was working as a systems manager at a Fortune 5 company with a 1-digit Class-A IP address. Every year in December they would plot out their computer storage requirements for the following year. Every year they ran out of storage by February. This was not some under-funded Biotech firm, this was a massive corporation with unlimited resources. People invariably underestimate how long things are going to take and how much they need in terms of resources. They make assumptions about other people's timelines that are wildly inaccurate. If you don't believe me, get your kitchen remodeled and tell me how long that takes.
Personally, I would far prefer that the company simply tell us where they are in the process than how long they believe the next step will take but I seem very much in the minority on that. People here are constantly clamoring for dates as to when things will be done and deride the company for not providing timing they claim the company should know. But given their predictions in the past, it seems pretty clear to me that the company has no real idea when things will happen.
They had years to formulate a gameplan for dissemination of information to their shareholders and the markets as a whole. She time after time said September. Then after years of careful planning decided to announce TLD would come out timed with a journal publication?
I completely agree with you about Linda Powers. I have always felt that she and the others were dedicated to getting DC-Vax to the masses. It is why I feel that a buyout is extremely unlikely.
Wealth =/= Morality
It is a common misconception that wealthy people don't need to steal or commit fraud and thus it makes no sense for them to do so. Wealthy people are the biggest crooks out there. Becoming a billionaire is a lot easier when you are a crook.
Wealthy people, especially those who grew up with wealth, disproportionately believe that they are special and not subject to the rules by which others must abide. If daddy can fix your tickets or get your DWIs and battery charges swept under the rug, then there aren't really any consequences for wrong-doing, are there?
None of this is to say that Linda Powers is a crook or is dishonest, it is simply to say that just because she is wealthy does not reduce the chances of her committing fraud.
Sorry, I read the original PR but then was looking at the chart that said 450-500 and my brain recalled the mention of monthly. I know this is going to be hard for people to believe but I actually made a mistake! I thought that I made a mistake once before back in 1996, but I was wrong. So sorry if I need to be tossed off the board, guess I don't fit in with all of the perfect people here. :(
450 - 500 vaccines capacity will certainly make a big difference.
About $1B revenue annually if each vaccine is set at $200,000 initially.
Thanks BSB!
So if I am understanding this, it is further proof that the trial failed, the CEO is the worst ever, and the stock is part of an elaborate pump-and-dump scheme in which they hire dozens of highly-qualified individuals, acquire a company to vastly increase production ability, upgrade a facility to vastly increase production, run a decade-long Phase III trial, con some of the world's foremost oncologists, and get RAs to modify endpoints and existing approval mechanisms. As evidence by the fact that their website went down a couple of times, or something.
Anyone wondering if this loan is good news or bad need look no further than the sudden increase of 'bears' posting on here and the move to drop the PPS. Same old lame posts about criminality, poor CEO performance, a certain drop in share price, asking misleading questions that take facts out of context, straw man arguments, and false equivalences.
The desperation is almost palpable.
Seems like one gravy train is about to end as a more positive one begins.
Agreed. No sane person would, but criminals do this [REDACTED].
RE: spartex
But you also mention "including a partnership deal, a buyout....". Wouldn't either of those options require release of material information (TLD) to all shareholders/public first?
RE: ahp123 - Answer your own question.
You pose a 'question' assuming facts that are not facts and imply that the only possible explanation is a failed trial. All the while ignoring everything else that has happened both before and after the date you set as your benchmark.
There are a limited number of possibilities for the data, given what we already know from the blinded data. Based solely on the blinded data, DC-Vax can probably show sufficient efficacy to get approved in those countries that have already signified that the endpoints have been changed. Meaning even a worst-case scenario is probably pretty positive.
There are plenty of possible reasons for not disclosing the data, including a partnership deal, a buyout, waiting on publication in a medical journal, etc. I have no idea which if any of these reasons is behind their decision to hold off on public disclosure but I have my guesses based on what they have said and done up to this point.
If the trial failed or the results were far below expectations, then how do you explain everything else they have been doing? Why rush the completion of Sawston? Why buy Flaskworks? Why gear up for production of a treatment that will never be approved?
For those still clinging to their ridiculous pump-and-dump narrative, your posts are totally divorced from reality. Having prosecuted pump-and-dump penny stock schemes, I can tell you that no one spends more than a decade building up a company and running a bunch of clinical trials as part of their p&d. And really, where is the pump? The company isn't flooding us with rosy PRs and cheery estimates a dozen times a day. How about the dump? Why isn't management dumping their tens of millions of shares? I mean really, the company somehow hoodwinked some of the leading oncology practitioners in the world with fake data about a trial they are running for more than a decade? All those fake patients on Facebook and Twitter who what, never had cancer?
Anyone selling their shares right now is a sucker or a bad gambler. We have come way too far and are far too close to the finish unless you are making a tax move or your cash position is too perilous.
Senti, not sure if anyone has mentioned it today but "You rock!" Have a great rest of the day.
VuBru: I like the way you think! :)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159422319
Although you have a lot more detail and specifics, this is exactly what I have been thinking will happen. The stock has closed over $1 every day since October 12, so by mid January it will have done so for three months. I think up-listing and journal publication will coincide and TLD and a conference spot will be around the same time. Maybe announcements about Sawston or other good news around the same time in a blitz.
I can't imagine releasing big news while still on OTC. All just my opinions.
I probably wasn't clear. My issue is with posting a bunch of tweets with nothing but speculation by people (regardless of their credentials) who have no specific knowledge about when, where, or if an article will be published and then suggesting the tweets mean something.
I am not doubting anyone's credentials. I am simply noting that absent some reason to believe that they have inside information about what NWBO is doing and where they are seeking to publish an article, their blind speculation is just that.
It is a bunch of worthless Twitter speculation. None of these people give any indication of actually knowing anything.
David Innes, the Investor Relation contact for NWBO.
RE: PiglyWigly
I don't mind negative posters who have something meaningful to post that they can back up with data, facts, or legitimate insight. I am inclined to take exception with negative posters when they state facts that are not facts, when they speak for me, or when they make statements without being able to back them up. I have the same feelings toward those who make baseless positive predictions ad nauseum.
- - - - -
I have no idea why they are taking this much time to release topline data. I have suspicions, but they are largely uninformed ones. So for the most part I keep them to myself.
I suspect that there is more than one possible, reasonable, explanation for not releasing topline data yet. However, "the data isn't what it's supposed to be," seems at best an unlikely explantaion given the data we have already received.
In addition, if it were true, what exactly is the plan? Why would they be less likely to release the data after 70 days if it were not as good as expected than if it were better than expected? If the data stinks there is no reason not to release it because buy-out talks, publications, etc. are no longer an issue. It will come out eventually and it isn't going to get better, right? They just need to hope the RAs that have already changed the endpoints approve DC-Vax and they can salvage something out of it.
As to being nervous, I am not. I am patient, ever patient. Do I wish they were better at communications and met deadlines? Sure. But I long ago resigned myself to the fact that that is not their forte.
How to spot a conclusory argument:
Look for words like "Of course," "It is undisputed," "Everyone knows," "Obviously," or any mention of "common sense."
Then, no further explanation for why the statement is true.
Example:
Of course it’s a material event and needs to be reported quickly.