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If they were eligible, they would not do a PIPE, they would just do a registered direct offering instead, like they have always done in the past. How do you not understand this?
At the end of the day, it doesn't really matter. So believe whatever you want. I found the "Next Offering" language to be an interesting statement that nobody was discussing, so I brought it up when I had the chance. I guess it's not interesting to the rest of you. No biggie.
I haven't been "told," by anyone, but I know the rules. The SEC did provide relief to companies that couldn't meet filing deadlines because of COVID, but if I recall correctly, a company had to file an 8-K stating that they were relying on the "COVID Order," or something like that. I don't recall NWBO filing such an 8-K, but I do know for a fact that they didn't list COVID as a reason for their late 2nd and 3rd quarter 10-Qs last year, thus, it is a fact that they are not eligible to use their S-3. That is why the company has to sell equity post-TLD in a PIPE, which will require a larger discount and is generally something an issuer would rather not do.
Hyperopia, you are obviously correct with respect to the 25.2 million share remaining under the authorized limit, as of June 30. You are also correct that the number is actually less than that if more debt conversions occur...I am assuming they have around 20.0 million available.
I have never said that any potential discussions with the FDA are negative. I have never even implied that. I hope that they work out in our favor and again, I think the drug will get approved. I have concerns about whether the patient population will be large enough to support the current market cap, but I believe that DCVAX-L works for some percentage of nGBM and rGBM patients...I hope it's enough to justify broad approval.
I see that you've jumped on an admission of mine that not every single biotech I follow was "unique," in the way that NWBO is. I already said that, but good for you for pointing it out and acting like I tried to compare those examples with what is going on with DCVAX-L. I award you 10 internet points and 5 more for anyone else who chimes in with a cheerleading post and jumps on this particular bandwagon. Really, you should know better.
As for the late filings, I know the count is real because I counted them all. Call it professional curiosity...maybe I'll write an article about it someday. In my world, if you file an NT 10-Q or K for any reason other than an ongoing investigation (audit committee driven or SEC), then it's late. That's how the exchanges look at it, and that's how other professionals look at, and even though the SEC may not penalize them, I'm sure they would think the same thing: that's it's horribly sloppy and embarrassing. And I can comment on the S-3 eligibility, as I did. Because it is a fact. I don't care if you believe me or not. And hey, if they don't need to issue equity anytime soon, then it doesn't really matter. They aren't seeking to increase the authorized share amount, so maybe they are going to sell themselves right after TLD. But if they DO need capital, then they've pushed themselves back at least a couple more months because now they will have to go through the S-1 process AND have a special meeting...this is CRAZY, even if they plan to sell, because until they've signed a definitive agreement, they should be ready to hit the ground running post-TLD. But this kind of self-inflicted and unnecessary delay would be par for the course for NWBO.
I agree that it is possible that the "delay" will end up not being a delay at all, as MI so graciously shared an example of yesterday. However, the journal publication stuff is nonsense, in my opinion. It doesn't further the goal of gaining regulatory approval and it doesn't further the goal of commercialization. The idea of waiting on a journal only serves the purpose of giving them a plausible explanation of the delay. I have a problem with this, because I feel like it is misleading. You are obviously free to believe what you want to believe. I see a history of statements from the company that turned out not to be true and I believe this is just another one in a long line...I just hope that the ends justify the means at the end of the day.
They ALL involved novel devices, biologics and SMDs, but you know that already, since that's what clinical stage bios are about. I guess some involved label extensions or new indications for already approved drugs. Basically all had shoe string budgets, many were global trials, etc. Not everything about NWBO's situation is unique. For sure, the length of time, the crossover issue, the FDA's recent guidance on use of historical controls and other matters relevant to NWBO, the developing science in immunotherapy, those are unique, as is the GBM target in general and attempting to become the standard of care. But all clinical stage bios have their challenges and unique issues.
I will say though, that none of the issues that you identified as unique to NWBO caused NWBO to file 37 late SEC filings (and to make poor disclosures in pretty much all of their filings) or to lose their S-3 eligibility. None of those issues caused Les Goldman to go onto the Big Biz Show and make a fool of himself. None of those issues caused the company to tell investors they would have TLD in September (before the database was even locked). Now, here we are, almost 7 months after data lock, and the company's official line is they are waiting to release TLD until they get a journal article published, or until they have a commitment to publish. I can't believe anyone believes this, frankly.
As if they would skip ASCO because they are waiting on anything having to do with a scientific journal article. Yet a bunch of seemingly very educated and intelligent people believe this statement, despite management's history of either intentionally misleading investors or gross incompetence.
I don't pretend to know what the delay is about with respect to the release of TLD. As I've said many times now, my best guess is that it has something to do with some kind of ongoing discussion with the FDA. Hopefully the timing has worked out so they can get an LBA presented at ASCO.
LOL. I was hoping you would share exactly what you provided, a real world example that supports that it is at least possible that NWBO's delay in releasing data doesn't necessarily mean that it will delay regulatory approval, which ultimately is my biggest issue with the current delay. Similarly with your example, I've said over and over that I think the delay has something to do with ongoing discussions/negotiations with the FDA, not waiting for publication (or a commitment to publish) of a journal article, as is the company line around here. Interesting to see a real world example of a "delay" like that ending up not being a delay at all and being very positive.
I have concerns that NWBO doesn't have the resources or expertise to run multiple paths at the same time like your company did, but at least you have demonstrated that it is possible.
If you don't have the time to read my posts, maybe you shouldn't form conclusions as to what I have and haven't said? And then call me out publicly and attempt to make fun of me?
Also, I have read all of your posts and I don't think I mischaracterized a single thing. Feel free to explain when you have more time.
You should read my posts closer. I've said multiple times what I think the delay might be about. Key word being "might." Also, my anecdotal information about how other clinical stage bios release TLD is based on way more than 2 situations. Probably 50 or 60 over the last 15 years? Just a guess, and like I said, it's anecdotal, so whatever. All I know for sure is that NWBO is in completely unchartered territory with respect to its delay on releasing TLD AND it's purported reason for such delay, and I am curious about why that is. Since I'm not going to know for sure until TLD is released, I continuously think about whether to sell and move on with a modest gain or hold and wait for data (hero or zero). I understand that many people here are committed to holding until data no matter what, but I am not one of them. And it's OK for investors to have different strategies or convictions.
And if the criteria to post on this message board was the industry experience that MI has, then none of us would be posting. By the way, I find his or her posts incredibly valuable and am grateful that he or she shares them with us. As for why I post here, I don't know...I guess it's just because sometimes I feel like it. You are certainly welcome to block me or not pay attention, or even to call me out or make fun of me. Whatever.
However, speaking of contributions to the board, all I see from your prior posts is general cheerleading and congratulating and thanking other people for sharing views that agree with your own. What is the point of that? I mean, I don't care what you do, and those types of posts make up 90% of the daily posts on this message board, so you are certainly not alone, but continuously cheerleading on a message board seems like a huge waste of time to me. As does attacking people who don't 100% toe the ride or die bull line. I mean, you've accomplished literally nothing except for maybe winning some internet points from other NWBO cheerleaders.
I can't recall any other data lock PRs other than NWBO and CVM. What I should have said is that TLD is usually released within 3 months of the public knowing about the end of a trial (in my anecdotal experience). This is just for clinical stage bios, where the results of all trial are material and are generally disclosed on a prompt basis. I know that NWBO's situation was very different since the end of the trial occurred in 2018 and they waited approximately 2 years to get the revised endpoints approved (at least by the UK and EU) prior to data base lock, so their data lock PR makes sense to me.
You are clearly the expert in this area and I defer to you on your experiences. My observations are very anecdotal, but I agree that a clear failure is usually PR'd right away.
I don't know anything about congresses or penalties associated with violating their rules. I just know that they company told investors they would release TLD in September, prior to even the database being locked. And I believe they had TLD at least by the middle of November. So this delay is surprising to me and I personally don't think it is because they are waiting on a journal article or ASCO. Plenty of other biotechs release TLD promptly, present the data later at an industry congress, and then publish the results later in a journal article. I'm not aware of a single clinical stage biotech waiting to release TLD for months and months while waiting on an industry congress abstract to be released or for results to be published in a journal. Do you know of any companies that have ever done it this way?
You may not see a difference, but I do. CVM told investors in the summer that they were waiting for a full analysis.
CVM is NOT "following LP's playbook." Not even close.
CVM made the decision prior to data lock to forego receiving TLD and to wait for the full data analysis. Full analysis usually takes 4 to 6 months. The data lock announcement was in early December. I'll start worrying about CVM if June passes without the results from their trial.
I do think it was a strange decision to wait for the full data analysis, but I can live with his explanation for doing it that way. It's nice when a company actually communicates with its investors.
I cannot recall a time that TLD took more than 3 months, although I'm sure there are some. It seems like the longer the delay on the release of TLD, the more likely it is that the trial failed to meet its primary endpoints and the company is data mining for subgroups that may have responded well.
For NWBO, the delay on releasing TLD is unprecedented, so I don't know what to make of it. It's such a long delay that it seems impossible for them to have missed on the revised primary endpoints or for them to be data mining. There must be some issue with the FDA on the revised primary endpoints or the framework for using historical controls. Hopefully it gets resolved soon and resolved in our favor.
My point is that it is unlikely that NWBO has had any kind of a deal, tentative or otherwise, with Merck for years, and that they should not accept an offer without shopping around. I was just giving an example of one of the main reasons a public company would enter into an agreement to sell itself without shopping around. There are certainly other reasons.
It wouldn't shock me if Merck ends up buying NWBO, but it would shock me if a sale was announced with any BP within weeks (or even months) of the release of TLD. I would love for it to happen though.
I appreciate this sentiment and while I agree that it would be a mistake to go it alone, I don't evaluate my investments by the assumption that there will be a buyout. There are a whole lot of things that go into a buyout beyond the data that we have no visibility on, or at least, I don't (strength of the IP portfolio, for example, from the perspective of BP IP attorneys).
I don't think that a third party has looked at the data yet. And I cannot imagine that there has been some tentative deal with Merck for years...that is just not how public company M&A is done. You need more than 1 interested party to maximize value for shareholders...when you see a transaction that is done without a bidding process of some sort (formal or informal), it's usually in a distressed asset where management is looking to keep their jobs going forward. Maybe that's the case here, but I don't think so.
I'm fully on board with your general point that TLD cannot be clearly negative. And it is with this idea in mind that I believe that the downside in NWBO's stock price from here is minimal, or least minimal in comparison to a biotech like CVM, for example, which will lose 90% of it's value (at least) if the Phase III results don't support potential FDA approval.
My general point in my postings today is to suggest that there's a lot of room for the data to be something between bad (regulatory approvals clearly unlikely) and stellar (regulatory approvals all but guaranteed and support for other indications evident).
My hope is obviously for stellar data, but I have some doubts about this based on the company's actions and statements (and the lack thereof as well). I'm still holding, at least through ASCO. And of course, I would like to see $8 to $10 per share (or more) post-TLD like everyone else.
This is what the PR says:
You are certainly free to interpret the PR as you wish. I'm just saying that in my opinion, it's going to take years for them to ramp production at Sawston, based on what the PR says. And years before Flaskworks is ready to be used in the production of DCVAX-L, based on the PR (and the 10-K risk factors, which really drive this point home). That is what the PR is saying.
That doesn't mean that Sawston won't ultimately operate at full capacity and produce 15,000 vaccines a year. And it doesn't mean that they won't build a plant in North America that can produce another 15,000 vaccines per year. It just means that it's going to take years for them to do so, assuming that TLD is positive and supports approval for all GBM patients and potentially other indications.
I can't remember which poster it was that recently said that DI told him back in October that he thought the stock price had gotten ahead of itself when it was trading above $2.00...well this is the kind of thing that he was talking about, in my opinion. It's going to take time to support something like a $10 billion market cap if the company is actually planning to go it alone.
I hear you Gandalf. But my question to you is this: if they really think they have a universal cure for cancer, why did they tell us a couple weeks ago that they only have the capacity to treat up to 500 patients per year and that they were planning to use their additional space for 3rd party contract manufacturing? They had TLD when they issued that press release, and yet, as positive as it is that they are close to being ready to apply to the U.K for certification of the facility, it doesn't support a conclusion that DCVAX-L is about to be rolled out for all GBM patients, much less other indications. In my opinion, that press release was largely an effort to set some expectations about valuation going forward. I don't see the point of the detail they gave about the potential for annual supply and how they are going to use the extra capacity otherwise.
In biotech land, you raise money when you can. Outside of the IPO, there's no better time for a clinical stage biotech to raise money than after positive TLD (whether Phase II or Phase III).
To get DCVAX-L approved and ready for commercialization today with the current manufacturing in place, it would probably cost somewhere in the neighborhood of $10.0 to $20.0 million.
However, NWBO isn't going to just get stick with an approval for GBM and operate within its cash flow for a couple years (or if they do, there's no upside for us as investors). They have to immediately start other DCVAX-L trials for other indications, in addition to getting DCVAX Direct back in the clinic. Plus, they will need to build out manufacturing, and if they don't sell themselves soon, I think they may be considering building their own plant in North America. This is why they need to raise a bunch of capital shortly after TLD if they plan to make a run at "going it alone." Really, to hit the ground running with other trials, they would need more than $50.0 million.
$50 million is a WAG roughly based on what I assume would be a major push to increase manufacturing capacity, pursue regulatory approvals and hire a bunch of people to run the company. It's also roughly in line with what other similarly situated biotechs go out and raise (less than most, actually).
But even if it was $25 million, I don't think they could do an offering without raising the authorized share amount, even if they technically had a little bit of room.
I'm not disagreeing with you that it looks like the company doesn't plan to be around for much longer. They certainly could be planning to sell or enter into some kind of partnership agreement. At this point, I don't have any conviction one way or another about what I think is going to happen, other than I think DCVAX-L will eventually get approved.
The thing is, DCVAX-L can get approved, be incredibly beneficial to certain patients and be a tremendous accomplishment from a science and technology perspective without the stock price going up significantly in the near term. I think a lot of people on this message board don't understand this. Of course, I hope I'm wrong and that the market immediately reflects other indications like it has for NVCR...it certainly could, maybe even should. But we have a market cap today of $1.2 billion (not including over 500 million of outstanding derivative securities). The company told us they can produce 500 vaccines a year and then said they plan to utilize the rest of the Sawston space for 3rd party contract manufacturing in the near term. So if the company's revenues are expected to be around $100 million per year for the next couple years, are we going to see $6 per share anytime soon? I don't think so, but I hope I'm wrong. Actually, I hope for a buyout because that would be in societies best interest.
I was an advocate of a R/S because it would solve both the authorized share and uplisting issues. 2 birds, 1 stone. However, the company didn't feel the need to address either of these issues at this year's ASM. So the issue is moot at the moment.
Here's the problem: If TLD is positive, they need to raise a significant amount of money in anticipation of pursuing regulatory approvals and commercialization (around $50 million?). But I don't see how they can do that without either increasing the amount of shares that are authorized for further issuance or doing a reverse split to bring the number under the current authorization.
Right now, they are authorized to issue up to 1.2 billion shares of common stock. As of Dec. 31, 2020, they were 829.6 million shares issued and outstanding, 331.7 million warrants outstanding and 308.0 million options outstanding. That is 1.47 billion securities outstanding, or 269.0 million securities over what they are allowed to issue.
I know that the employees are agreeing to suspend their ability to exercise warrants and options, but even with these friendly agreements, they don't have the cushion to issue equity in an underwritten public offering. So what is the plan? We have to assume they have TLD by now. They should have a good idea of how the market will react to the news.
In my opinion, these are the 3 most likely scenarios: (i) they are planning to sell the company shortly after the release of TLD, which will require a special meeting, at which point, they can add the increase in authorized shares as a proposal; (ii) they are going to enter into a licensing agreement with BP that will provide the cash they need to get through the next year and all of the employees are fine to wait another year before they exercise their warrants/options; (iii) they are still months away from releasing TLD and they plan to run on fumes from warrant exercises until then.
I do not believe in the Merck/Duffy fantasy. The idea that Merck has been "calling the shots" for the last couple years is ridiculous. But, we have to be getting close to some kind of resolution. The timing works out for ASCO. Let's hope that the misguided delay in releasing TLD is because their advisors told them to wait until ASCO to make the big reveal, and that TLD will be worth the wait.
No proposals to deal with the authorized share amount issue. Very interesting. Let's hope it's because they plan to call a special meeting in the near future to sell the company (and deal with the authorized shares issue then as well).
So you would have the company buy back shares instead of either (i) authorizing additional shares or (ii) authorizing a R/S to get the total number of shares (and derivative securities) under the currently authorized amount?
Are you sure you understand what the issue is here? Assuming they have positive TLD, they will access the capital market by issuing shares. They currently have authorization to issue up to 1.2 billion shares and they are over 1.1 billion with just common stock and in the money warrants, and not including issued and outstanding stock options. Still think a stock buy back is feasible?
I won't even address the absurdity of a pre-revenue biotech even thinking about adopting a stock repurchase plan.
If they don't R/S to fix the authorized share issue AND get them on the track to uplisting, then they are complete fools with absolutely no ability to think critically. So I would say there is a 10% chance they include a R/S proposal in the proxy.
There is not a single member of management or the board who has any experience running a drug trial. They didn't fully understand the process. That's the only explanation that I have other than some kind of fraud.
Maybe their inexperience (and incompetence) is why their "advisors" told them they couldn't announce TLD until they had a commitment from a journal to publish the full data analysis. That actually would make sense. I could see LL saying, "I'm not going to sign off on any TLD press release statement until my paper is published because I know you people will mess it up like you have every other communication you've ever released."
That will certainly happen, but only if TLD is "negative," meaning the data suggest that DCVAX-L isn't approvable, will need further trials for approval, or the patient population is too small to support the market cap. I would bet that there are criminal charges that could be brought as well if it comes out that they've been sitting on negative info for months and failed to disclose that in their most recent 10-K.
It's kind of why I think that there must be something positive going on behind the scenes, because it's all so weird and horribly unprofessional that it can't be fraud.
Also, the insiders haven't sold and won't be able to until TLD is announced, so there are no issues there.
They do not have to have a shareholders' meeting within 13 months of the prior years' meeting. However, if they don't, then a shareholder can call a meeting . I can't remember what all of the rules are for that, I think a shareholder has to file a petition with the Delaware Court of Chancery. But it would be pretty entertaining if someone wants to take charge of shaking things up a bit. Who here wants to volunteer if they can't have a meeting by May 18 :).
Also, if the company doesn't have its ASM within 30 days of the prior years' ASM, shareholders don't have to comply with the prior deadline to submit shareholder proposals for inclusion in the proxy. Anyone want to submit a proposal to separate the Chairman of the Board and CEO position? It sure would be nice to have an independent chairman that actually has experience with successfully commercializing a drug or selling a biotech company. Or frankly, it would be nice to have ANYONE on the Board or in executive management that has ever had any experience getting a drug or therapy approved by a regulatory agency.
CVM asked their CRO for a full data analysis, not TLD, so they will never see TLD (well, the full data analysis will have a summary, but you get the point). Compare this to NWBO, who apparently asked their CRO for TLD first. So CVM's data release time period and NWBOs time period can't be viewed the same, or at least I can't view them the same.
As for whether NWBO is still blinded, that seems impossible to me, but who knows.
The issue I have with NWBO's approach is that they continue to refer to "TLD," when what they are actually doing, assuming they are really waiting for an article to be published, or for a commitment to publish, is releasing the full data analysis.
NWBO's approach is also troubling because they SAW the TLD and THEN decided to hold back TLD until the release of the full data analysis via a journal article. There's all kinds of potential problems with this, but it appears that the biggest problem, that the results would leak, isn't going to happen. So good for them on that point. But, it certainly suggests that the results are not spectacular if they felt like they need to wait on full data. Please note that when I say "not spectacular," I mean from a commercial perspective. I feel pretty confident at this point that DCVAX-L will get approved, at least in the UK/Europe, and that it will be a huge deal from a science perspective. My concern is that the patient population that will benefit from DCVAX-L is too small to support the current market cap.
Are you suggesting that the FDA pays attention to the cabal/sleaze media/shorts and that they influence the outcome of the FDA's regulatory decisions?
They have been planning to apply for "fast track" status since 2013. Literally nothing in that portion of the risk factors has changed in 8 years.
It's an aspirational statement, because they hope to be successful. It's NOT a statement implying that, based on the unblinded data, they are in the process of applying for fast track status.
I certainly hope the data is fantastic and that they apply for and receive "fast track" designation, but the language from the 10-K risk factors about fast track is not a clue of any kind about the data or trial results.
That's pretty much it. The Flaskworks risk factor is also interesting and confirms that its impact is years away, assuming it works.
There was also this one:
There is no GAAP treatment for risk factors. The risk factors are ultimately approved by the Board, which in this case, is really just whatever LP wants to do since it's a friendly board...I doubt the other board members even read them.
What they "can" do and "should" do are different. The risk factors need to be accurate on the day they are filed, so they can't just say, "well, this isn't a risk anymore, but it was on Dec. 31, so we'll just include it." If they have TLD and can tell whether or not that the results of the trial are "encouraging," or "positive," then they should have updated that risk factor and since they didn't, that strongly suggests that they don't currently have TLD. If in fact that they DO have TLD, then not updating this risk factor could result in an SEC enforcement action. Let me be clear: it almost certainly will NOT result in one, but it could. See Mylan
If you haven't already done so, I encourage everyone to compare the current risk factors against last year's because there are some interesting changes.
The risk factors aren't something that the auditors are involved in.
Or it means they just decided not to update it to avoid any confirmation one way or the other. Your risk factors should be true as of the filing date, not as of the end of the period presented. When you are speaking only to a specific time, you reference that time period; you can see they did that for a couple of their other risk factors.
This quote was also in the last 10-K and might have been in prior years as well (I would guess that it was).
I can't begin to explain how easy it is for a company to meet their filing deadlines. You have to try hard not to, by just not caring at all, which they have done at least 37 times before. Will they make it 38 today?
Yes, they won't reveal the results, but if they have TLD, that statement needs to be updated. So any change in that paragraph at all should confirm that they are in possession of TLD...I know most people assume they are, but every now and then I wonder, since the delay is so unfathomable to me.