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Annual Shareholder Meeting 2018 notes taken by a share holder IkeEsq:
NWBO 2018 Annual Shareholders Meeting
February 2, 2019 at 13:30 EST
1050 Connecticut Ave, NW, Washington D.C.
In the room: Linda Powers (LP), Cofer Black (CB), Les Goldman (LG), Jerry Jasinowski (JJ), Marnix Bosch (MB), and Dr. Navid Malik (NM)
On the phone: Alan Boynton (AB) and Lisa Porter (Computer Share the transfer agent)
Approximately 30 share-holders in attendance
Total shares outstanding: 519,729,780
Total shares represented: 460,778,896 (Ike note: someone coughed during the 800 which could be off the rest of the numbers are good)
88.6% of shares are present, meaning there is a quorum
Three proposals, no shareholder nominated Directors, all three proposals passed
13:45: Formal Meeting adjourned, informal Q&A begins
(Ike note: Questions are paraphrased, answers in quotes are verbatim quotes, speaker initials in parenthesis)
Question 1: One of the attendees asked why there was no response to her letter to the company in reference to increasing the share price sent in January 2018?
Answer (LP): Unaware of letter, copy presented, LG/LP will respond. (Ike note: It appears based on the conversation that the letter was an offer to provide expertise in raising the stock price based on the attendee’s previous experience as a VP in charge of raising the stock price for a Fortune 500 company) “We would love to have dedicated people and when we get bigger we will certainly look forward to having that.”
Question 2: What is the status of combination trials?
Answer (LP): “I can talk about what we’ve said publicly.. . . What we’ve said publicly is a couple of things. First off, we feel that our technology is very well suited for a lot of combinations. Combinations with checkpoint inhibitors, combinations with targeted agents, it’s really well suited for combinations because of the mechanism of action of how our technology works and because the safety profile is so utterly benign. You know, if you’ve seen other combination trials for example of two checkpoint inhibitors together, the toxicity of that is so high that there’s a 40% dropout rate from the patients just because of the side effects, right? So we are very much looking forward to doing combination trails. There has been public disclosure about two combination trials that we would like to do with DC Vax-L for example. One that we announced publicly was a . . . and its still there on the table for us to go forward with when we are ready . . . it’s a combination trail with DC Vax-L and Keytruda, the checkpoint inhibitor drug of Merck. That trial, which we did announce publicly and has been approved by Merck, and those agreements were signed and all that, but as small as we are we haven’t yet been able to launch that trial in parallel with everything else. But that should be a very interesting trials when we do it. Colo-rectal cancer is the number two cancer, second only to lung cancer. And if you’ve noticed in a lot of the publicity about immune-therapies, there’s been surprisingly little attention to colon cancer. If you also notice in the literature, checkpoint inhibitors, which are the big darlings of the pharma industry right now, have had no effect, none at all, in any patients with colo-rectal cancer except patients who have what’s called MSI, microsatellite instability a particular version of colon cancer, which only 5% of colon patients have. So we think that’s going to be a very interesting combination trial and we are looking forward to the day when we have enough resources and we can go forward with it. The other combination trial that we have said publicly, and actually it wasn’t us that really said it publicly, it was UCLA that said it publicly, is a combination trial together with BMS’s checkpoint inhibitor in brain cancer, and that would be for recurrent brain cancer. Gioblastoma. Our current trial, as you probably remember, phase III trial is for newly diagnosed Gioblastoma. Just to finish on that, that’s the beauty of, in our view, of the DC Vax-L and DC Vax-Direct technologies, they’re platform technologies. We believe, forward-looking statement, will be applicable to any type of solid-tumor cancer. So those are probably the two most tangible ones, those are the ones we talked about publicly. For us it’s a resource and bandwidth issue. Both of them are there to proceed when we have the resources and bandwidth to be able to proceed.”
Question 3: Will NWBO unblind data prior to ASCO?
Answer (LP): "ASCO is certainly a great venue and it's been great for us when the timing has worked out, to be able to, as we did last year we had just announced the first interim data from our phase III trial, three days before ASCO, that just happened to work out beautifully on the timing. And a few years before that we had unveiled our initial DC Vax-Direct data. So we agree with you that it's great when that works. I can't answer your specific question about what is going to be the exact timing of unblinding. What I can tell you is what we said in our press release on November 19th, which was right after the SNO conference and right after that we had announced the updated data from the clinical trial. And we said, here are the steps we have to go through in order to get to unblinding and then what we would do with the unblinded data. And you can look at what those stages are and you can read what we said that each of those stages is a multi-month process. And so you can figure the arithmetic. The first stage, as we said, we have to get the Statistical Analysis Plan developed and then submit it to regulators, and approved by regulators. That doesn't sound like much but it is a ginormous exercise. We are working with teams of experts. Neurosurgeons, neuro-oncologists, radiologists, regulatory advisors, statisticians. All of these advisors in a big team, which is the right way to do it, and there's a lot of complexity, to say the least, about the statistical analysis plan and the statistics that you put in. There's no one way to do it. If you read all the literature, and there's no single cookie-cutter 'this is how you analyze a dataset from a phase III trial, bum, bum, bum.' There's a lot of decisions and choices to be made and stitched together into a coherent plan. You can perhaps understand from the description I just gave you, which I don't think rises to material by itself, description of what goes into the process, why we say that each stages is a multi-month process. Because you go through that process with two-dozen experts, and then you go through the process again in regulatory approval of that statistical analysis plan. And remember, we're in four separate countries with four separate regulators. Which, yes, it is more complex and takes longer, but also means we have multiple chances to win. So it's worth, and we believe very strongly it's worth the extra effort and expense and time and so forth. So I know it's really frustrating.
In parallel, and yes, people ask us all the time, 'are you at least doing things in parallel when you can?' Yes, we are. That thought has occurred to us. What we're doing in parallel is doing the final data collection. We had 82 sites in four countries with three languages. In order to do the final data collection a CRA Clinical Research Associate, employed by the independent CRO, the organization who is managing the trial independently, has to physically go to the sites, sit down with the trial database and the hospital records and compare them and find any piece of data that's missing or there's a discrepancy. The way the data gets captured in a clinical trial is in what's called a case report form. A case report form can be a hundred pages long. And you're looking for any piece of data that's either missing or there's a discrepancy. At every one of these 82 sites for every one of these 331 patients. And each one where there's a piece of data missing of there's a discrepancy, generates a query. And a query has to be resolved and the resolution has to be validated. The process can involve thousands of queries. That's just normal. That's what it takes to close out a dataset. And get to the point where we have a clean, full dataset that we can go to data-lock on.
So the big things that we are working toward and which we are doing in parallel, are moving toward the statistical analysis plan getting done and approved by regulators and moving towards data-lock. I hope that my description can help you see when we say it's a multi-month process, just making the physical visits at 82 sites and then resolving the thousands of queries you can understand why that's a multi-month process. So that's what we're in the middle of and we're as anxious as you are to see the results. That's the best I can tell you of the steps and the timeline."
Question 4: Can you provide a roadmap to your marketing plan to increase stock price, who will be the focus: patients, hospitals, stock-holders, etc.? (Ike note: Turned into a question about Right-to-try)
Answer (LP): That's a very interesting question, we were so hopeful about Right-to-try because so many patients that really want to get access to the treatment and as a company as tiny as we are we try to do as much as we can in terms of compassionate use patients and Right-to-try. Unfortunately, it turned out that the legislation was passed with restrictions in it that made it unworkable. The reason I say that is because as tiny a company as we are, we don't have the resources to be able to absorb the cost and provide it for free or partially free for patients. We need the patients to pay for it. And the Right-to-try was thought to usher in a new regime where that would be possible. Unfortunately it turned out that clever lobbyists for those who were not in favor of that legislation slipped in a cross-reference and the cross-reference within the legislation said that basically it says that basically you couldn't do any charging of patients any more or different than under existing rules. Which negated the whole thing. And so, we had to give up on that, so we're not doing that, which is the answer. So what we are focused on now is getting to the finish line with the trial and everything related to the trial as vigorously as we can."
(LG): "I might just add, in terms of your bigger question, which is 'do you have a plan to get a better value in the market for what the potential is,' I think that was your question, and the answer is while the Right-to-try will be litigated, because it is actually an interpretations of some of the provisions, it's not going to help anybody who's got GBM or any other solid-tumor cancer right now, so as Linda said, that's not available to us now, some other countries have a more liberal approach. The answer is 'yes' and you are beginning to see the mosaic of some of those things, like the release we put out a week ago, I don't know if everybody's seen it, it takes the data we've already got and puts it in perspective with regard to the fact that solid-tumor cancers do not seem amenable to being dealt with at all by the Big Pharma immuno-therapies, which tend to be single-targeted. Some of the data in that release is rather stunning, talks about how many failed GBM trials there have been ever since [??] was approved. It's strengthening our internal ability with regard to outreach to investor relations, in terms of media and getting more attention as the data gets more and more serious more hospitals are talking about it. But these things don't happen right away and even with regards to the opponents we have, that spread misleading information. We do have a total campaign but one of the things we need to do is to stage it in a way, whether it's at ASCO or before or after or what have you, that the timing can come to a crescendo of sorts and not stick little pieces out there that then just get shot in again. And we've learned that lesson from the past and we're working at strengthening all those areas and getting continuing information out just like we got out a week ago yesterday. And I think you'll be seeing more and more of it and I think we're better off not laying it all out at once because then the other side will have more to attack us on. Producing those results, strengthening those capabilities of our little company, I think will be the key to eventually getting the market to pay attention."
Question 5: Can NWBO ovecome all of the forces that are aligned against them?
Answer (LG): "We're still here. Lots of people didn't think we would be."
(LP) "I can only give a couple of comments from a personal perspective. Everyone in this company is committed in a deeply personal way to this company and this technology, for whatever their respective, personal reasons are. Nobody would go through this degree of abuse for this long a period of time for a business, and certainly not to collect a salary paycheck, as is regularly suggested on the message boards. I personally think that if we could get through what we've gone through the last three years, I kind of think we can get through anything. The year 2015, we had come out . . . we had just made very strong presentations, I believe many parties were surprised, at AACR, the largest research conference in the world, and ASCO, the largest clinical conference in the world. We were hit with multiple class-action lawsuits, we were hit with the anonymous Internet report, we were hit with an attempted hostile takeover. We were hit with just incredible things. When we look back on it now, it's just amazing. In 2016 and 2017, were pretty horrific in their own way. And I've must say, this team, everything we do we do as a team. We do everything by unanimity. Management and the board, we have just kept doggedly putting one foot in front of the other. And we do say to ourselves not infrequently, 'well, we're not dead yet.' And we take satisfaction in the fact that somewhere there's a conference room with the bad guys in it who are saying to themselves, 'what does it take to kill these people?' Because what's been thrown at us, stock manipulation, you name it, is staggering. But, this team will never give up. We might be crushed like a bug but we will never give up. And at this point, with the dataset . . . I hope everyone can appreciate the year 2018. The year 2018, at least in my perspective, was really transformative for us. We came out with two sets of interim data from the clinical trial. It's not the final data, it's not unblinded. The future may look different. That's a classic forward-looking statement. But that interim data was . . . and I am only allowed to say really conservative things . . . that was encouraging. No one has ever seen that kind of survival in GBM with any agent or combination of agents. 'That doesn't mean the future will be the same as it has been.' I mean, that was transformative. The financial deal we did in December was transformative. I'm told that one of the bad guy commentators now says the only thing we've ever been good at is real estate. At least we are good at something. With that dataset and the commitment of this team, all I can tell you is I believe that if anyone can get through this, I think we have as good a chance as anybody to get through what we are up against."
(LG): "I only have one other thought, which I give a lot of thought to actually. In the context of your point about 'with the better our stuff gets the tougher and meaner the other guys get,' there's another word that goes with tougher and meaner and it's more brazen. And the more brazen they get, maybe they're walking into a trap. That's as far as I'm going to go, because they have been . . . we have to be conservative in what we say . . . we'll use the word 'outlandish' in how brazen they've been and the better our stuff gets, the more obvious they're going to have to get and at some point, if you have built the right things that I was talking about before, with investor relations and media and you're getting the story out there about the little engine who could, there will become a tipping point, I sincerely believe, that they'll do themselves in. And we want to be there to catch it, and that's all I'll say about it but it isn't just a one-way street where they rule the world, it gets tougher and tougher the better we get and that provides angles we can work with."
Question #6 If the forces against you are so strong, why not partner with someone?
Answer (LP): "So that's a question that's come up in each of the last several years and it's usually related to a pharma partnering. Pharma partnerings are done all across the spectrum and we've now seen the first couple of major acquisitions and partnerings with cell-therapies. Most recently, as of about two years ago, you didn't have pharma . . . dealing with a living cell product requires an entirely different manufacturing facility, an entirely different supply chain and distribution chain. And big pharma didn't have any of that. So they didn't have anything to bring to the table except a checkbook. They didn't have any operational muscle to contribute. I think that is beginning to change. And as we said last year, if we were to get the proverbial 'offer you can't refuse,' we wouldn't refuse. I asked last year and I'll ask all of you right now, at our current stock price, and our current company valuation on the one hand and with what's in the company, would you want us to do a partnering at this stage?" (Response: It depends on the deal. Not a buyout but perhaps a partnership or giving up a certain market.)
(LP) "There are various ways to slice it, one possibility for example is one could do regional partnering deals. That would be quite sensible. No reason that's not possible. One of the great things about our intellectual property and our large patent portfolio, we file them everywhere. Even in far-flung locations. And when we did that we wanted to have something that would be useful in various regional settings. So that kind of thing, I think, is a practical possibility. I'm not making any comment other than to say that it is a practical possibility."
(JJ) "Let me just add to what Linda said, I've done a lot of other mergers and acquisitions myself in other areas, you really don't want to do it unless you are on some ascendancy, you don't want to do it. And I think we are close to that point but we're not there. And you don't want to do it when the stock price is low. Your point's a good point but you have to look at it in the context of evolving further and our stock price rising. On that point, Linda, I just wanted to add to what you and Les just said. As a director, I honestly believe we are in better shape now than we've been for several years. The results that Linda mentioned are really quite unusually good. Secondly, we have now financing which we didn't have before. It's not a small thing, when you're paying a bit at a time. And I think our team has actually strengthened a little bit, particularly on the investment strategy side. I think we're going to be telling our story better in the next three-to-four months. For all of those reasons, I have to say that I am more optimistic about the company than I've been for several years."
(LP) "Let me finish the other point that I wanted to add, in agreement with all of Jerry's points, the tricky thing for us when we think about partnering is that each of our two products is a platform technology. Most of the other companies that you see that do early- or mid-stage-partnering, have a number of discrete products. And they'll partner Product A and keep Product B. For us, it's the same product. Yes, you could do a licensing deal or a partnering deal for a field of use, but in terms of being able to police that and really get the corresponding value, it's pretty tricky when it's not separate products. So that adds to our feeling of making sure we don't do something premature."
(LG) "In addition to the stock price and the timing of what to do, I think that the biggest meanest players, they have 100s of billions of dollars in their revenue stream related to the basics of chemo and radiation. If we take a step back and use conservative words, their effectiveness in terms of the response rate is much worse than ours, they cost a lot more to make if you're looking in the immuno-therapy area, and they're much harder to administer, much more toxic, I mean we're really kinda good in that area, and of the hundreds and hundreds of billions a large chunk is just the money they make from the drugs that ameliorate the effectiveness of the painful stuff. So if you take a step back, they don't mind picking up another, which is the subject of what we said a week ago yesterday, another targeted immune therapy. But we cover all solid-tumor cancers. Potentially. That's what we're working on and that's what they would be buying. But the point is, they would be eating their own revenue streams. And they have to think twice if it isn't a combo-trial where they are enhancing something, if it's a head-to-head competition that's a daunting proposition for them and they are not going to be anxious to speed up the day when their stuff is a little bit more obsolete. And that's a big consideration when you're dealing with the biggest guys."
(NM) "The checkpoint inhibitors have been the darlings of the immune therapy space. It's very important that they been successful because prior to their success, immune therapies space was being held back by a lack of data. The checkpoint inhibitors have delivered spectacular revenue growth, and they've been pounding the table doing trials and combination trials. But what has been challenging is that big pharma companies that are behind checkpoint inhibitors are effectively working with antibodies. That's their bread and butter. So they're trying to get the antibody products to work in a way which will deliver greater revenue than their pricing commensurate with that. However, what we're starting to see with the checkpoint inhibitors, there's a number of trials going on, and the interesting thing in the UK, [] is that the checkpoint inhibitors, other than the low-response rate that we talked about, we're also starting to see that weaknesses of the checkpoint inhibitors. They're being thrown at cancers they're still single [unintelligible] and we're starting to see in some of the trials patients that are progressing rapidly rather than benefiting from checkpoint inhibitors. And I think what will happen is that the whole immune therapy space is going to start to evolve into a more balanced, into a more biological . . . "(Ike note: he got into details I didn't understand and between his accent and the distance from me, I can't tell exactly what he was saying. Summary: it is biology and not mechanism that will drive immuno-therapy and big pharma is focused on mechanism)
(LP) "I think that's an important point. Our perspective is that the field is moving in our direction. And the field is moving in our direction in several ways. We feel like the field is moving in our direction partly in what we covered in our press release last week and my presentation at Phacilitate, is starting to realize that solid tumors constitute the vast majority of the market, 80% of all cancers. And even checkpoint inhibitors are making very limited inroads on solid tumors. And the T-cells aren't anywhere yet. The concept that a silver-bullet agent and a silver-bullet target are not going to stop a highly-complex, heterogeneous solid tumor. That concept is beginning to really start to register in the field. And that's one way in which the field is moving toward us. And another way, what Navid touched on, actually you were too kind to the checkpoint inhibitors, it's not just the patients are progressing rapidly in spite of taking the checkpoint inhibitors, their beginning to discover a phenomenon called hyper-progression. In which it looks like the checkpoint inhibitors are gasoline on the fire. And they don't know right now what's causing that or which patients, what bio-markers, what profiles. So, increasingly, if you're a patient thinking about taking a check-point inhibitor, or you're a doctor, you might be helped, you might get hyper-progression, gasoline on the fire, or you might have no response. So there's this whole dawning realization that checkpoint inhibitors are definitely not the answer to everything. And indeed, with this phenomenon of hyper-progression, which, by-the-way people are having difficulty getting their papers published about this, is anyone surprised about that? Is another in which the field is moving in our direction. The further we go, the other thing that is really important, I wanted to say about our data, we've received tremendous abuse from bloggers and whatnot about taking too long with our phase III trial. But one of the ways the field is also moving in our direction, is realizing how important it is to have long-term data and get to see the far tail of the survival curve. We were subjected to excruciating pressure to go to data-lock and finish the trial. Long before the data we reported last November. That data was presented in a plenary session at the Society for Neuro-Oncology, the biggest meeting of Neuro-Oncology subjects in the world. That's a big deal. Again, it's interim data, it's going the future could be different. But just toughing it out, and getting data without the long-term tail of the curve, and I know it's been very hard for shareholders, it's been frustrating, it takes a long time, it's like having to wait on Christmas morning, I want to tear into my presents. But that was so valuable. If we had succumbed to the pressure and gone to data-lock sooner, neither we nor the rest of the world would even have known what was possible. What the capability . . . I can't attribute causation . . . but I can say that no one would have known that patients who received DC Vax would have such longevity. Some of this, we just really have to tough it out and we're so grateful for the shareholders who grit their teeth and tough it out with us."
Question #7 Have you engaged any external financial advisors to discuss valuation of the company and when do you plan to get off of the OTC?
Answer (LP): "We have informal advisors that we talk to, that Les talks to, on a regular basis. But in more of an organized effort, that's something that lies ahead of us. We are now in a position, I think, to be able to have those of discussions in a much more effective way because of the developments during 2018. With the data and the money in the bank we're able to have much more productive discussions. So that's really something that lies ahead of us based on what has just been achieved in 2018. The second question I can't answer."
Question 8: Where are the shares coming from that are use to short NWBO's stock?
Answer (LP): "Those are great questions, I'm so glad you brought that up. I'll tell you where they'ee getting the stock from, they're getting it from all of you guys. And that's something we are painfully aware of and thinking about and that's all I'll say right now. Most people, most retail investors don't know, that when you sign up for an account with a broker, they usually steer you into a margin account even though most people aren't buying and selling stocks on margin. You're not taking debt to magnify your investment. Buried in these 100-page contracts, you know when you go and click accept, we've printed them out, these 100-page contracts, and buried in the middle of them, the broker can lend out your shares, that you bought, and you own, they can lend them out and there's only one use to can lend them out for, there aren't multiple uses and we're not sure which one they're lending them out for, there's only one use for lending shares and it's to lend them to shorts. They lend them to shorts, they receive stock loan fees as revenue to the broker for lending out your shares, and they're not required to tell you they are lending it out, they're not required to tell you the money they receive, and the only usage of lending out your shares is to drive down the value of your shares. That is the state of affairs today with brokers. And it's even worse when the brokers will put you on this OBO list where you're not even, it's not even visible that you're the shareholder. The best thing is if the shares are in your name, not the street name, not the broker's name and you don't want to be on an OBO list and you don't want to have a margin account, but a lot of the brokers make it difficult or impossible or adverse to have a different type of account. [] The best thing that you guys can do to help, is spread the word far and wide on the message boards, tell everybody, have your stock in your name, do everything possible to be in an account that is not a margin account, unfortunately from what we understand, the rules are being bent, quite far, so that even when it's not supposed to be lendable it is being lent [] at least if your shares are electronic, this really matters. Because in our company estimates are that staggering amounts, in the triple-digit millions, can be involved in this and if we have about 14,400 shareholders, and if everybody would get their shares out of this situation where the brokers are lending itm out without your knowledge, and getting paid handsomely by the shorts for doing so, and keeping that revenue, and by the way, there's lawsuits between the big boys over the amount of loan fees being paid, that's how big the money flows are coming from this. And if you have your shares in an IRA, that's the most juicy target for these brokers because you're not trading. They just sit here. And the more they just sit there the easier it is for the brokers to use them and do this. So the best thing that you guys can do to help, which would be an enormous help, is spread the word and get all the fellow shareholders to get their shares out of this situation. And dry up the supply of shares for shorting Northwest's stock."
(LG) "Let me just add one thing, we're always thinking about this. As part of my answer before, there will be programs and they will involve numerous activities. But we don't roll them out one-at-a-time, it'll be part of a total package." (LP) "We can't talk about that."
(Attendee discussion with broker who claimed NWBO is not shortable because it is a penny-stock)
(LP) "Your broker either genuinely believes that and is mistaken or they're lying to you because that's factually wrong. [] Start by putting . . . having the stock in your own name and putting it in an account that's not a margin account. Those two steps, which you'll probably get hassled about putting it in a non-margin account, but those two steps, in your own name in an account that's not margin, already is a big improvement. [] Before we leave this, let me just tell you, in the process of collecting the votes for this meeting, we had large-share owners, to the tune of many, many millions, even tens of millions of shares whose shares were missing. And the broker couldn't explain it. And we spent days and days going up and down the chain, and helping the shareholder find and get their hands on their shares. As many as 10, 15 and more millions of shares at a crack. That's the scale of what's being done here."
Question 9: Is the deal with Huawei strictly a real estate deal or is there possible future collaboration? Concern about IP theft.
Answer (LP): "Right now the Huawei deal is just the Huawei deal, it's just real estate. I don't have any reason at this moment to think it's going to be more or different than that. In terms of the physical setup we sold most of the site. We retained 17 acres, of ownership, we also retained the very large, roughly 90,000 sqft, facility, which is ginormous, for a clean-room manufacturing facility of cellular products. Retained that. And a very large amount of space around it, I think the lease is filed with our SEC documents so I'm OK to say this, things like 600 surface parking spots, surface parking spots, specified. You can't put us in a multi-story car park. Large amount of [space?] for plant and equipment, the plant and equipment of air handling and wire handling is ginormous. It's physically separated, there's physical berms, there's chainlink fence with barbed wire on the top that surrounds it. It looks a bit like a prison but it's OK. Huawei is not allowed to set foot in our facility, they don't under the lease they don't even have the usual landlord rights to enter into the premises, it's highly restricted, and the only time that they can come in is if they have signed a confidentiality agreement and they're escorted. And even then, it's further restricted that they only see what's in compliance in our determination with our regulatory requirements and that includes controlled access to the building. There's a lot of things built in that I think give us pretty much everything that you can humanly have for protection. We are physically separated, they can't enter our space and so forth. I think it's not impossible that if Huawei doesn't collapse from everything that's going on, would we ever consider a regional partnering in China? No reason not to consider it. But there's nothing contemplated right now."
(LG) "To give you further confidence, the documents themselves, have very clear language that says we will not be competing with them, i.e. we're not going into the telecommunications business, and they won't be competing with us, they're not going to be in the medicine business."
Question #10: Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?
Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don't talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can't comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that's Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved."
Question #11: Does new infusion of capital help speed the process?
Answer (LP): "Working with the huge team of experts that we're working with, we have several of each, it's like Noah's ark, we have several statisticians, we have several radiologists, we're kind of maxed out, we're not limiting the SAP process by funds, by money, at the moment. We've got top experts, by the way who are completely independent, they had no involvement in the trial, they weren't involved in signing it or executing it, or reviewing it or anything. There isn't more that we can throw money at that will make it bigger or go faster. We're already 'pedal to the metal.'
Final comments (JJ): "If you look at the numbers on the votes associated with what we handled today, you're really staggered by the extent to which there's a lot of shareholder support for the company, for the directors, for Linda, etc. And I know that that extends in large measure to many of the people around the table and I just wanted to personally thank those of you [] for coming for the meeting and we will try to do better and better about responding but we really value our shareholder base. It turns out that Northwest Bio has lasted this long in addition to Linda and Les's leadership, because of the support of retail shareholders. And that's you and I want to thank you personally."
(AB) "The only thing I would add, is we have been at this, I have for 25 years and we will never give up until this is available to all brain cancer patients, and that will happen."
Meeting closed @ ~14:40.
IkeEsq Sunday, 02/03/19 01:24:29 PM
Re: None
0
Post # of 212343
NWBO 2018 Annual Shareholders Meeting
February 2, 2019 at 13:30 EST
1050 Connecticut Ave, NW, Washington D.C.
In the room: Linda Powers (LP), Cofer Black (CB), Les Goldman (LG), Jerry Jasinowski (JJ), Marnix Bosch (MB), and Dr. Navid Malik (NM)
On the phone: Alan Boynton (AB) and Lisa Porter (Computer Share the transfer agent)
Approximately 30 share-holders in attendance
Total shares outstanding: 519,729,780
Total shares represented: 460,778,896 (Ike note: someone coughed during the 800 which could be off the rest of the numbers are good)
88.6% of shares are present, meaning there is a quorum
Three proposals, no shareholder nominated Directors, all three proposals passed
13:45: Formal Meeting adjourned, informal Q&A begins
(Ike note: Questions are paraphrased, answers in quotes are verbatim quotes, speaker initials in parenthesis)
Question 1: One of the attendees asked why there was no response to her letter to the company in reference to increasing the share price sent in January 2018?
Answer (LP): Unaware of letter, copy presented, LG/LP will respond. (Ike note: It appears based on the conversation that the letter was an offer to provide expertise in raising the stock price based on the attendee’s previous experience as a VP in charge of raising the stock price for a Fortune 500 company) “We would love to have dedicated people and when we get bigger we will certainly look forward to having that.”
Question 2: What is the status of combination trials?
Answer (LP): “I can talk about what we’ve said publicly.. . . What we’ve said publicly is a couple of things. First off, we feel that our technology is very well suited for a lot of combinations. Combinations with checkpoint inhibitors, combinations with targeted agents, it’s really well suited for combinations because of the mechanism of action of how our technology works and because the safety profile is so utterly benign. You know, if you’ve seen other combination trials for example of two checkpoint inhibitors together, the toxicity of that is so high that there’s a 40% dropout rate from the patients just because of the side effects, right? So we are very much looking forward to doing combination trails. There has been public disclosure about two combination trials that we would like to do with DC Vax-L for example. One that we announced publicly was a . . . and its still there on the table for us to go forward with when we are ready . . . it’s a combination trail with DC Vax-L and Keytruda, the checkpoint inhibitor drug of Merck. That trial, which we did announce publicly and has been approved by Merck, and those agreements were signed and all that, but as small as we are we haven’t yet been able to launch that trial in parallel with everything else. But that should be a very interesting trials when we do it. Colo-rectal cancer is the number two cancer, second only to lung cancer. And if you’ve noticed in a lot of the publicity about immune-therapies, there’s been surprisingly little attention to colon cancer. If you also notice in the literature, checkpoint inhibitors, which are the big darlings of the pharma industry right now, have had no effect, none at all, in any patients with colo-rectal cancer except patients who have what’s called MSI, microsatellite instability a particular version of colon cancer, which only 5% of colon patients have. So we think that’s going to be a very interesting combination trial and we are looking forward to the day when we have enough resources and we can go forward with it. The other combination trial that we have said publicly, and actually it wasn’t us that really said it publicly, it was UCLA that said it publicly, is a combination trial together with BMS’s checkpoint inhibitor in brain cancer, and that would be for recurrent brain cancer. Gioblastoma. Our current trial, as you probably remember, phase III trial is for newly diagnosed Gioblastoma. Just to finish on that, that’s the beauty of, in our view, of the DC Vax-L and DC Vax-Direct technologies, they’re platform technologies. We believe, forward-looking statement, will be applicable to any type of solid-tumor cancer. So those are probably the two most tangible ones, those are the ones we talked about publicly. For us it’s a resource and bandwidth issue. Both of them are there to proceed when we have the resources and bandwidth to be able to proceed.”
Question 3: Will NWBO unblind data prior to ASCO?
Answer (LP): "ASCO is certainly a great venue and it's been great for us when the timing has worked out, to be able to, as we did last year we had just announced the first interim data from our phase III trial, three days before ASCO, that just happened to work out beautifully on the timing. And a few years before that we had unveiled our initial DC Vax-Direct data. So we agree with you that it's great when that works. I can't answer your specific question about what is going to be the exact timing of unblinding. What I can tell you is what we said in our press release on November 19th, which was right after the SNO conference and right after that we had announced the updated data from the clinical trial. And we said, here are the steps we have to go through in order to get to unblinding and then what we would do with the unblinded data. And you can look at what those stages are and you can read what we said that each of those stages is a multi-month process. And so you can figure the arithmetic. The first stage, as we said, we have to get the Statistical Analysis Plan developed and then submit it to regulators, and approved by regulators. That doesn't sound like much but it is a ginormous exercise. We are working with teams of experts. Neurosurgeons, neuro-oncologists, radiologists, regulatory advisors, statisticians. All of these advisors in a big team, which is the right way to do it, and there's a lot of complexity, to say the least, about the statistical analysis plan and the statistics that you put in. There's no one way to do it. If you read all the literature, and there's no single cookie-cutter 'this is how you analyze a dataset from a phase III trial, bum, bum, bum.' There's a lot of decisions and choices to be made and stitched together into a coherent plan. You can perhaps understand from the description I just gave you, which I don't think rises to material by itself, description of what goes into the process, why we say that each stages is a multi-month process. Because you go through that process with two-dozen experts, and then you go through the process again in regulatory approval of that statistical analysis plan. And remember, we're in four separate countries with four separate regulators. Which, yes, it is more complex and takes longer, but also means we have multiple chances to win. So it's worth, and we believe very strongly it's worth the extra effort and expense and time and so forth. So I know it's really frustrating.
In parallel, and yes, people ask us all the time, 'are you at least doing things in parallel when you can?' Yes, we are. That thought has occurred to us. What we're doing in parallel is doing the final data collection. We had 82 sites in four countries with three languages. In order to do the final data collection a CRA Clinical Research Associate, employed by the independent CRO, the organization who is managing the trial independently, has to physically go to the sites, sit down with the trial database and the hospital records and compare them and find any piece of data that's missing or there's a discrepancy. The way the data gets captured in a clinical trial is in what's called a case report form. A case report form can be a hundred pages long. And you're looking for any piece of data that's either missing or there's a discrepancy. At every one of these 82 sites for every one of these 331 patients. And each one where there's a piece of data missing of there's a discrepancy, generates a query. And a query has to be resolved and the resolution has to be validated. The process can involve thousands of queries. That's just normal. That's what it takes to close out a dataset. And get to the point where we have a clean, full dataset that we can go to data-lock on.
So the big things that we are working toward and which we are doing in parallel, are moving toward the statistical analysis plan getting done and approved by regulators and moving towards data-lock. I hope that my description can help you see when we say it's a multi-month process, just making the physical visits at 82 sites and then resolving the thousands of queries you can understand why that's a multi-month process. So that's what we're in the middle of and we're as anxious as you are to see the results. That's the best I can tell you of the steps and the timeline."
Question 4: Can you provide a roadmap to your marketing plan to increase stock price, who will be the focus: patients, hospitals, stock-holders, etc.? (Ike note: Turned into a question about Right-to-try)
Answer (LP): That's a very interesting question, we were so hopeful about Right-to-try because so many patients that really want to get access to the treatment and as a company as tiny as we are we try to do as much as we can in terms of compassionate use patients and Right-to-try. Unfortunately, it turned out that the legislation was passed with restrictions in it that made it unworkable. The reason I say that is because as tiny a company as we are, we don't have the resources to be able to absorb the cost and provide it for free or partially free for patients. We need the patients to pay for it. And the Right-to-try was thought to usher in a new regime where that would be possible. Unfortunately it turned out that clever lobbyists for those who were not in favor of that legislation slipped in a cross-reference and the cross-reference within the legislation said that basically it says that basically you couldn't do any charging of patients any more or different than under existing rules. Which negated the whole thing. And so, we had to give up on that, so we're not doing that, which is the answer. So what we are focused on now is getting to the finish line with the trial and everything related to the trial as vigorously as we can."
(LG): "I might just add, in terms of your bigger question, which is 'do you have a plan to get a better value in the market for what the potential is,' I think that was your question, and the answer is while the Right-to-try will be litigated, because it is actually an interpretations of some of the provisions, it's not going to help anybody who's got GBM or any other solid-tumor cancer right now, so as Linda said, that's not available to us now, some other countries have a more liberal approach. The answer is 'yes' and you are beginning to see the mosaic of some of those things, like the release we put out a week ago, I don't know if everybody's seen it, it takes the data we've already got and puts it in perspective with regard to the fact that solid-tumor cancers do not seem amenable to being dealt with at all by the Big Pharma immuno-therapies, which tend to be single-targeted. Some of the data in that release is rather stunning, talks about how many failed GBM trials there have been ever since [??] was approved. It's strengthening our internal ability with regard to outreach to investor relations, in terms of media and getting more attention as the data gets more and more serious more hospitals are talking about it. But these things don't happen right away and even with regards to the opponents we have, that spread misleading information. We do have a total campaign but one of the things we need to do is to stage it in a way, whether it's at ASCO or before or after or what have you, that the timing can come to a crescendo of sorts and not stick little pieces out there that then just get shot in again. And we've learned that lesson from the past and we're working at strengthening all those areas and getting continuing information out just like we got out a week ago yesterday. And I think you'll be seeing more and more of it and I think we're better off not laying it all out at once because then the other side will have more to attack us on. Producing those results, strengthening those capabilities of our little company, I think will be the key to eventually getting the market to pay attention."
Question 5: Can NWBO ovecome all of the forces that are aligned against them?
Answer (LG): "We're still here. Lots of people didn't think we would be."
(LP) "I can only give a couple of comments from a personal perspective. Everyone in this company is committed in a deeply personal way to this company and this technology, for whatever their respective, personal reasons are. Nobody would go through this degree of abuse for this long a period of time for a business, and certainly not to collect a salary paycheck, as is regularly suggested on the message boards. I personally think that if we could get through what we've gone through the last three years, I kind of think we can get through anything. The year 2015, we had come out . . . we had just made very strong presentations, I believe many parties were surprised, at AACR, the largest research conference in the world, and ASCO, the largest clinical conference in the world. We were hit with multiple class-action lawsuits, we were hit with the anonymous Internet report, we were hit with an attempted hostile takeover. We were hit with just incredible things. When we look back on it now, it's just amazing. In 2016 and 2017, were pretty horrific in their own way. And I've must say, this team, everything we do we do as a team. We do everything by unanimity. Management and the board, we have just kept doggedly putting one foot in front of the other. And we do say to ourselves not infrequently, 'well, we're not dead yet.' And we take satisfaction in the fact that somewhere there's a conference room with the bad guys in it who are saying to themselves, 'what does it take to kill these people?' Because what's been thrown at us, stock manipulation, you name it, is staggering. But, this team will never give up. We might be crushed like a bug but we will never give up. And at this point, with the dataset . . . I hope everyone can appreciate the year 2018. The year 2018, at least in my perspective, was really transformative for us. We came out with two sets of interim data from the clinical trial. It's not the final data, it's not unblinded. The future may look different. That's a classic forward-looking statement. But that interim data was . . . and I am only allowed to say really conservative things . . . that was encouraging. No one has ever seen that kind of survival in GBM with any agent or combination of agents. 'That doesn't mean the future will be the same as it has been.' I mean, that was transformative. The financial deal we did in December was transformative. I'm told that one of the bad guy commentators now says the only thing we've ever been good at is real estate. At least we are good at something. With that dataset and the commitment of this team, all I can tell you is I believe that if anyone can get through this, I think we have as good a chance as anybody to get through what we are up against."
(LG): "I only have one other thought, which I give a lot of thought to actually. In the context of your point about 'with the better our stuff gets the tougher and meaner the other guys get,' there's another word that goes with tougher and meaner and it's more brazen. And the more brazen they get, maybe they're walking into a trap. That's as far as I'm going to go, because they have been . . . we have to be conservative in what we say . . . we'll use the word 'outlandish' in how brazen they've been and the better our stuff gets, the more obvious they're going to have to get and at some point, if you have built the right things that I was talking about before, with investor relations and media and you're getting the story out there about the little engine who could, there will become a tipping point, I sincerely believe, that they'll do themselves in. And we want to be there to catch it, and that's all I'll say about it but it isn't just a one-way street where they rule the world, it gets tougher and tougher the better we get and that provides angles we can work with."
Question #6 If the forces against you are so strong, why not partner with someone?
Answer (LP): "So that's a question that's come up in each of the last several years and it's usually related to a pharma partnering. Pharma partnerings are done all across the spectrum and we've now seen the first couple of major acquisitions and partnerings with cell-therapies. Most recently, as of about two years ago, you didn't have pharma . . . dealing with a living cell product requires an entirely different manufacturing facility, an entirely different supply chain and distribution chain. And big pharma didn't have any of that. So they didn't have anything to bring to the table except a checkbook. They didn't have any operational muscle to contribute. I think that is beginning to change. And as we said last year, if we were to get the proverbial 'offer you can't refuse,' we wouldn't refuse. I asked last year and I'll ask all of you right now, at our current stock price, and our current company valuation on the one hand and with what's in the company, would you want us to do a partnering at this stage?" (Response: It depends on the deal. Not a buyout but perhaps a partnership or giving up a certain market.)
(LP) "There are various ways to slice it, one possibility for example is one could do regional partnering deals. That would be quite sensible. No reason that's not possible. One of the great things about our intellectual property and our large patent portfolio, we file them everywhere. Even in far-flung locations. And when we did that we wanted to have something that would be useful in various regional settings. So that kind of thing, I think, is a practical possibility. I'm not making any comment other than to say that it is a practical possibility."
(JJ) "Let me just add to what Linda said, I've done a lot of other mergers and acquisitions myself in other areas, you really don't want to do it unless you are on some ascendancy, you don't want to do it. And I think we are close to that point but we're not there. And you don't want to do it when the stock price is low. Your point's a good point but you have to look at it in the context of evolving further and our stock price rising. On that point, Linda, I just wanted to add to what you and Les just said. As a director, I honestly believe we are in better shape now than we've been for several years. The results that Linda mentioned are really quite unusually good. Secondly, we have now financing which we didn't have before. It's not a small thing, when you're paying a bit at a time. And I think our team has actually strengthened a little bit, particularly on the investment strategy side. I think we're going to be telling our story better in the next three-to-four months. For all of those reasons, I have to say that I am more optimistic about the company than I've been for several years."
(LP) "Let me finish the other point that I wanted to add, in agreement with all of Jerry's points, the tricky thing for us when we think about partnering is that each of our two products is a platform technology. Most of the other companies that you see that do early- or mid-stage-partnering, have a number of discrete products. And they'll partner Product A and keep Product B. For us, it's the same product. Yes, you could do a licensing deal or a partnering deal for a field of use, but in terms of being able to police that and really get the corresponding value, it's pretty tricky when it's not separate products. So that adds to our feeling of making sure we don't do something premature."
(LG) "In addition to the stock price and the timing of what to do, I think that the biggest meanest players, they have 100s of billions of dollars in their revenue stream related to the basics of chemo and radiation. If we take a step back and use conservative words, their effectiveness in terms of the response rate is much worse than ours, they cost a lot more to make if you're looking in the immuno-therapy area, and they're much harder to administer, much more toxic, I mean we're really kinda good in that area, and of the hundreds and hundreds of billions a large chunk is just the money they make from the drugs that ameliorate the effectiveness of the painful stuff. So if you take a step back, they don't mind picking up another, which is the subject of what we said a week ago yesterday, another targeted immune therapy. But we cover all solid-tumor cancers. Potentially. That's what we're working on and that's what they would be buying. But the point is, they would be eating their own revenue streams. And they have to think twice if it isn't a combo-trial where they are enhancing something, if it's a head-to-head competition that's a daunting proposition for them and they are not going to be anxious to speed up the day when their stuff is a little bit more obsolete. And that's a big consideration when you're dealing with the biggest guys."
(NM) "The checkpoint inhibitors have been the darlings of the immune therapy space. It's very important that they been successful because prior to their success, immune therapies space was being held back by a lack of data. The checkpoint inhibitors have delivered spectacular revenue growth, and they've been pounding the table doing trials and combination trials. But what has been challenging is that big pharma companies that are behind checkpoint inhibitors are effectively working with antibodies. That's their bread and butter. So they're trying to get the antibody products to work in a way which will deliver greater revenue than their pricing commensurate with that. However, what we're starting to see with the checkpoint inhibitors, there's a number of trials going on, and the interesting thing in the UK, [] is that the checkpoint inhibitors, other than the low-response rate that we talked about, we're also starting to see that weaknesses of the checkpoint inhibitors. They're being thrown at cancers they're still single [unintelligible] and we're starting to see in some of the trials patients that are progressing rapidly rather than benefiting from checkpoint inhibitors. And I think what will happen is that the whole immune therapy space is going to start to evolve into a more balanced, into a more biological . . . "(Ike note: he got into details I didn't understand and between his accent and the distance from me, I can't tell exactly what he was saying. Summary: it is biology and not mechanism that will drive immuno-therapy and big pharma is focused on mechanism)
(LP) "I think that's an important point. Our perspective is that the field is moving in our direction. And the field is moving in our direction in several ways. We feel like the field is moving in our direction partly in what we covered in our press release last week and my presentation at Phacilitate, is starting to realize that solid tumors constitute the vast majority of the market, 80% of all cancers. And even checkpoint inhibitors are making very limited inroads on solid tumors. And the T-cells aren't anywhere yet. The concept that a silver-bullet agent and a silver-bullet target are not going to stop a highly-complex, heterogeneous solid tumor. That concept is beginning to really start to register in the field. And that's one way in which the field is moving toward us. And another way, what Navid touched on, actually you were too kind to the checkpoint inhibitors, it's not just the patients are progressing rapidly in spite of taking the checkpoint inhibitors, their beginning to discover a phenomenon called hyper-progression. In which it looks like the checkpoint inhibitors are gasoline on the fire. And they don't know right now what's causing that or which patients, what bio-markers, what profiles. So, increasingly, if you're a patient thinking about taking a check-point inhibitor, or you're a doctor, you might be helped, you might get hyper-progression, gasoline on the fire, or you might have no response. So there's this whole dawning realization that checkpoint inhibitors are definitely not the answer to everything. And indeed, with this phenomenon of hyper-progression, which, by-the-way people are having difficulty getting their papers published about this, is anyone surprised about that? Is another in which the field is moving in our direction. The further we go, the other thing that is really important, I wanted to say about our data, we've received tremendous abuse from bloggers and whatnot about taking too long with our phase III trial. But one of the ways the field is also moving in our direction, is realizing how important it is to have long-term data and get to see the far tail of the survival curve. We were subjected to excruciating pressure to go to data-lock and finish the trial. Long before the data we reported last November. That data was presented in a plenary session at the Society for Neuro-Oncology, the biggest meeting of Neuro-Oncology subjects in the world. That's a big deal. Again, it's interim data, it's going the future could be different. But just toughing it out, and getting data without the long-term tail of the curve, and I know it's been very hard for shareholders, it's been frustrating, it takes a long time, it's like having to wait on Christmas morning, I want to tear into my presents. But that was so valuable. If we had succumbed to the pressure and gone to data-lock sooner, neither we nor the rest of the world would even have known what was possible. What the capability . . . I can't attribute causation . . . but I can say that no one would have known that patients who received DC Vax would have such longevity. Some of this, we just really have to tough it out and we're so grateful for the shareholders who grit their teeth and tough it out with us."
Question #7 Have you engaged any external financial advisors to discuss valuation of the company and when do you plan to get off of the OTC?
Answer (LP): "We have informal advisors that we talk to, that Les talks to, on a regular basis. But in more of an organized effort, that's something that lies ahead of us. We are now in a position, I think, to be able to have those of discussions in a much more effective way because of the developments during 2018. With the data and the money in the bank we're able to have much more productive discussions. So that's really something that lies ahead of us based on what has just been achieved in 2018. The second question I can't answer."
Question 8: Where are the shares coming from that are use to short NWBO's stock?
Answer (LP): "Those are great questions, I'm so glad you brought that up. I'll tell you where they'ee getting the stock from, they're getting it from all of you guys. And that's something we are painfully aware of and thinking about and that's all I'll say right now. Most people, most retail investors don't know, that when you sign up for an account with a broker, they usually steer you into a margin account even though most people aren't buying and selling stocks on margin. You're not taking debt to magnify your investment. Buried in these 100-page contracts, you know when you go and click accept, we've printed them out, these 100-page contracts, and buried in the middle of them, the broker can lend out your shares, that you bought, and you own, they can lend them out and there's only one use to can lend them out for, there aren't multiple uses and we're not sure which one they're lending them out for, there's only one use for lending shares and it's to lend them to shorts. They lend them to shorts, they receive stock loan fees as revenue to the broker for lending out your shares, and they're not required to tell you they are lending it out, they're not required to tell you the money they receive, and the only usage of lending out your shares is to drive down the value of your shares. That is the state of affairs today with brokers. And it's even worse when the brokers will put you on this OBO list where you're not even, it's not even visible that you're the shareholder. The best thing is if the shares are in your name, not the street name, not the broker's name and you don't want to be on an OBO list and you don't want to have a margin account, but a lot of the brokers make it difficult or impossible or adverse to have a different type of account. [] The best thing that you guys can do to help, is spread the word far and wide on the message boards, tell everybody, have your stock in your name, do everything possible to be in an account that is not a margin account, unfortunately from what we understand, the rules are being bent, quite far, so that even when it's not supposed to be lendable it is being lent [] at least if your shares are electronic, this really matters. Because in our company estimates are that staggering amounts, in the triple-digit millions, can be involved in this and if we have about 14,400 shareholders, and if everybody would get their shares out of this situation where the brokers are lending itm out without your knowledge, and getting paid handsomely by the shorts for doing so, and keeping that revenue, and by the way, there's lawsuits between the big boys over the amount of loan fees being paid, that's how big the money flows are coming from this. And if you have your shares in an IRA, that's the most juicy target for these brokers because you're not trading. They just sit here. And the more they just sit there the easier it is for the brokers to use them and do this. So the best thing that you guys can do to help, which would be an enormous help, is spread the word and get all the fellow shareholders to get their shares out of this situation. And dry up the supply of shares for shorting Northwest's stock."
(LG) "Let me just add one thing, we're always thinking about this. As part of my answer before, there will be programs and they will involve numerous activities. But we don't roll them out one-at-a-time, it'll be part of a total package." (LP) "We can't talk about that."
(Attendee discussion with broker who claimed NWBO is not shortable because it is a penny-stock)
(LP) "Your broker either genuinely believes that and is mistaken or they're lying to you because that's factually wrong. [] Start by putting . . . having the stock in your own name and putting it in an account that's not a margin account. Those two steps, which you'll probably get hassled about putting it in a non-margin account, but those two steps, in your own name in an account that's not margin, already is a big improvement. [] Before we leave this, let me just tell you, in the process of collecting the votes for this meeting, we had large-share owners, to the tune of many, many millions, even tens of millions of shares whose shares were missing. And the broker couldn't explain it. And we spent days and days going up and down the chain, and helping the shareholder find and get their hands on their shares. As many as 10, 15 and more millions of shares at a crack. That's the scale of what's being done here."
Question 9: Is the deal with Huawei strictly a real estate deal or is there possible future collaboration? Concern about IP theft.
Answer (LP): "Right now the Huawei deal is just the Huawei deal, it's just real estate. I don't have any reason at this moment to think it's going to be more or different than that. In terms of the physical setup we sold most of the site. We retained 17 acres, of ownership, we also retained the very large, roughly 90,000 sqft, facility, which is ginormous, for a clean-room manufacturing facility of cellular products. Retained that. And a very large amount of space around it, I think the lease is filed with our SEC documents so I'm OK to say this, things like 600 surface parking spots, surface parking spots, specified. You can't put us in a multi-story car park. Large amount of [space?] for plant and equipment, the plant and equipment of air handling and wire handling is ginormous. It's physically separated, there's physical berms, there's chainlink fence with barbed wire on the top that surrounds it. It looks a bit like a prison but it's OK. Huawei is not allowed to set foot in our facility, they don't under the lease they don't even have the usual landlord rights to enter into the premises, it's highly restricted, and the only time that they can come in is if they have signed a confidentiality agreement and they're escorted. And even then, it's further restricted that they only see what's in compliance in our determination with our regulatory requirements and that includes controlled access to the building. There's a lot of things built in that I think give us pretty much everything that you can humanly have for protection. We are physically separated, they can't enter our space and so forth. I think it's not impossible that if Huawei doesn't collapse from everything that's going on, would we ever consider a regional partnering in China? No reason not to consider it. But there's nothing contemplated right now."
(LG) "To give you further confidence, the documents themselves, have very clear language that says we will not be competing with them, i.e. we're not going into the telecommunications business, and they won't be competing with us, they're not going to be in the medicine business."
Question #10: Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?
Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don't talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can't comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that's Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved."
Question #11: Does new infusion of capital help speed the process?
Answer (LP): "Working with the huge team of experts that we're working with, we have several of each, it's like Noah's ark, we have several statisticians, we have several radiologists, we're kind of maxed out, we're not limiting the SAP process by funds, by money, at the moment. We've got top experts, by the way who are completely independent, they had no involvement in the trial, they weren't involved in signing it or executing it, or reviewing it or anything. There isn't more that we can throw money at that will make it bigger or go faster. We're already 'pedal to the metal.'
Final comments (JJ): "If you look at the numbers on the votes associated with what we handled today, you're really staggered by the extent to which there's a lot of shareholder support for the company, for the directors, for Linda, etc. And I know that that extends in large measure to many of the people around the table and I just wanted to personally thank those of you [] for coming for the meeting and we will try to do better and better about responding but we really value our shareholder base. It turns out that Northwest Bio has lasted this long in addition to Linda and Les's leadership, because of the support of retail shareholders. And that's you and I want to thank you personally."
(AB) "The only thing I would add, is we have been at this, I have for 25 years and we will never give up until this is available to all brain cancer patients, and that will happen."
Meeting closed @ ~14:40.
IkeEsq Sunday, 02/03/19 01:24:29 PM
Re: None
Post # of 212343
