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The 10-K must be filed by 5:30 EST in order for it be timely.
It's going to be really interesting to read the risk factors since they presumably are in possession of TLD. For example, last year this was one o their statements from their risk factors:
They announced TLD in December 2019. And 26 months later, the results were published in the NEJM. This is how it is usually done.
But DI would have investors believe, that NWBO is waiting on some kind of publishing commitment from a journal prior to releasing TLD.
Could you be more specific about what trials have failed?
Clinicaltrials.gov only has 3 trials for Multikine listed: 2 very small Phase I trials for HPV and the current Phase III.
I know Multikine has also done some studies on prostate cancer, HIV and HIV/HPV-induced cervical dysplasia, but those studies were back in the late 90s and didn't progress far enough to be considered failures, at least in my book. But as far as I can tell, H&N cancer has always been the main focus of Multikine. What am I missing here?
Believe me, I'm not counting on the timeline laid out by DI or whomever being accurate. I just found it interesting that this poster's prediction was accurate in the past.
Normally, I wouldn't pay any attention to this kind of prediction and reference to a direct, internal source (which I assume is DI), but then I checked your prior posts and saw that you called the Oct. 5 press release on Oct. 3.
Thanks! So add 500 to that figure from the Sawston expansion and whatever capital improvements Cognate has made since that filing and we might be in the 5,000 range? Do you think that is reasonable?
The update to the clinical trial site showing the study should be completed by April 15 doesn't mean that they will release data by this date. CVM elected to receive full data, not top line. A full data analysis usually takes a couple more months to release then TLD. I would think that sometime between April and June is when we will get a PR from CVM on their data, but that's just a guess based on when they announced data lock...and data lock could have occurred a couple weeks or even months before they announced it, so who knows?
As for when NWBO will release data, your guess is as good as mine.
I would take that kind of update. However, I wouldn't let my company give any kind of visibility on revenues from a product that hadn't launched yet, even if I had the manufacturing contract in hand.
However, regardless of what they tell us, do you have any predications on what their initial capacity might be? I hope it's at least 2,500 annually.
Marzan, less than 1% of the shares outstanding are short. And there are no more than a couple hundred thousand "naked" shorts at any given time...the daily trading volume is too small to allow more than that. This is a fact, not an opinion. I understand that in the past, the company was the subject of multiple attacks. I totally get it. But those people are gone. Now, it's the data that matters and the results of the data will dictate the future of the company.
The reason why I am skeptical of management is because of all of the missed deadlines and horrible predictions on timelines, the LP/Cognate situation, which was shady as heck, poor SEC disclosures, 37 late SEC filings, etc. I'm also skeptical because they are apparently taking an approach to releasing data that no other company has ever done, and that really bothers me, because it's just not necessary. The data is the data. It should have been out within days/weeks of the company getting it. Trying to time the release of the data with any other event is a fools errand, in my opinion. There's a reason that no other company does this.
I can tell you this though: If a reverse split is on the agenda for the upcoming ASM and they mention "uplisting," as the reason, I will increase my holdings in NWBO significantly, because then I will know that they are holding TLD until they are listed on a major exchange. I can definitely wait for that, even though I don't think that's how it should have been done.
The CEO of CVM has issued multiple letters to shareholders clearly explaining what is going on with the process, did a reddit AMA, and has been visible on social media supporting the company and telling everyone who will listen that he believes in the company and believes that the Phase III trial will be a success. I don't really love this style of communication from a CEO, personally (the social media stuff and the reddit AMA), but I appreciate what he is trying to do for his company and his shareholders.
Contrast that with NWBO, where the investor relations guy answers certain people's phone calls and tells them certain pieces of information, some of which are bold faced lies, like "they are working hard to release TLD." The release of TLD isn't something you work on for months and months...at least not the employees of the company, and certainly not him. They get the data and they compose a summary of the data in a press release. It shouldn't take more than a couple days to do this, maybe a couple weeks if they need to get feedback from KoLs on things they want to say. That's the standard way that it is done. So the big question is, why has NWBO deviated from this standard? DI is lying to everyone when he says they are working hard on anything at this point. It's not possible. They are waiting on something that is out of their hands...the question is what.
Now, I can't speak to the science about which is "better." But they can both be incredible advances in fighting cancer and both be incredibly successful commercially. What I can say for a fact is that if Multikine works, it's market is way, way bigger than DCVAX-L in the short to medium term.
I wouldn't worry about this, especially LP's gift. She was probably still blinded when she did that. As for AB's "gift," that was an estate planning transaction, so he, or his family, still have an interest in those shares, presumably. They didn't file the Form 4 correctly in a way were we could confirm that, but I think that was just more lazy/sloppy lawyering.
Also, you can't really compare gifts of stock from a clinical stage biotech to gifts of stock related to a businesses that has a long operating history. The data certainly suggests that something is going on, but I think that in most instances, it's not that the insider has specific inside info that his or her stock will go down, it's just that they know there's not a lot of upside at the current valuation. This happens, especially in cyclical businesses.
Well, I'm not telling you not to be concerned with today's valuation, because I think it's high, given the risks.
However, the ability to treat 500 patients annually is what they will be at THIS YEAR utilizing just 4,400 square feet of an 88K square feet facility, so they have plenty of room to expand (simple math suggests up to 10,000 patents per year if all space was being used to manufacture DCVAX vaccines, although I suspect it would be more than that when Flaskworks if fully integrated). I know they state they will look to do 3rd party contract manufacturing, but I think they mean they will do that while they wait for new indications to be approved and for Flaskworks to be brought on line, etc. At least that is how I interpreted it.
If TLD suggests that DCVAX-L may work for a significant patient population in other cancers beyond GBM, then the fact that Sawston can "only" treat 500 patients per year initially won't hold the stock price down. Now, if TLD suggests that there's only 500 patients per year in Europe to treat with DCVAX-L, then that's a problem.
Also, don't forget that Cognate/CRL will be producing a significant number of vaccines as well. The market is forward looking, so you could easily justify a $10 billion plus market cap if TLD suggests application beyond GBM and it looks like the company could do over $100 million in revenue in the first year after approval.
The question is, when are we finally going to get TLD and will biomarker data somehow limit the patient population in a way that doesn't support the frothy market cap NWBO has today? To me, the biomarker data is a big risk at this point. And of course, unorthodox management (or possibly shady?). And lastly, I have concerns that the delay in TLD is due to discussions with the FDA about something, but I don't know what and I can't say whether that could end up positive (i.e., ability to submit a BLA for nGBM AND rGBM) or negative (pick your potential poison).
I would MUCH prefer to wait for the release of TLD until they were back on the Nasdaq with a 10 times smaller float. Are you kidding me??? That's a dream scenario. We aren't going to $10 or $15 or $20 or anything like that on the OTC after TLD...$6 to $8, max. NWBO needs to be listed on a national exchange for the stock price to reach it's maximum potential.
And if people who don't understand the purpose of a reverse split at this point in the game want to sell because "all reverse splits are bad," or the R/S attracts the interest of shorts because "all reverse splits are bad," even better!
There will not be any kind of partnership or buyout prior to the release of TLD. A transaction like that will happen months after the release of TLD, so think sometime in 2022.
I'm just saying, if TLD is delayed indefinitely, we might as well get uplisted while we wait.
I have also wondered about whether they could still be blinded. I don't think so, but I can't entirely rule it out.
TLD for both of these trials was announced prior to publication in a journal. Are you seriously trying to argue that TLD was delayed in both of these instances pending a journal publication??? I mean, both of these vaccinations beat the timeline for prior vaccine authorizations by 4 years. They are both remarkable achievements and underscore the ridiculous argument that NWBO would try to make regarding tying TLD to a journal publication. When you have a revolutionary treatment that will save lives, you don't wait for years to try to get it approved unless you have to. Like, because you can't get it approved until the FDA signs off on something.
You clearly don't understand what I'm saying, and that's OK.
Here's one what??? This company released TLD for their Phase III in October of 2020. The announcement of a journal article 5 months later is in line with how every other biotech except NWBO does things.
There may have been 200 million shorts (naked or otherwise) at one time, but there aren't anymore. These days, there isn't enough daily liquidity in the stock to have more than a couple hundred thousand naked shorts, at the most.
There are only about 15 million shares short out of 1.2 billion. I would say the shorts have already thrown in the towel and they won't be back in any significant number until TLD, and then they will be back, even if TLD is positive.
If they do a reverse split, it would be a minimum of 1 to 10. The market won't allow the stock price to decrease back to 1.4, but assuming the shorts were able to move the stock price down in any material way, it would be amazingly good for us because positive TLD would spike the stock price that much higher, especially without the ability to hedge via call options. The company can't issue equity until they release TLD anyway, so increased short interest is a very welcome thing at this particular point in the Company's journey, at least in my opinion.
I don't think they will have a problem with Nasdaq because of past sins. At the end of the day, Nasdaq is a for profit company and NWBO will generate money for them. In my limited experience of having to essentially ask the Nasdaq for forgiveness, they have been very accommodating and not punitive.
Why does anyone care if there is a reverse split if the reason for doing the reverse split is to help with uplisting requirements?
Please tell me what the actual harm is? And it has to be something other than perception, because that perception won't have any material impact on the stock price.
It appears you are correct. I am actually thrilled by this new-to-me revelation.
The big issue with uplisting is how to fix the stockholders' equity problem. I don't think they can fix that without issuing more equity, unless maybe positive TLD allows them to increase whatever value they have on the intangibles of DCVAX-L? Assuming that's possible, I doubt the auditors would sign off on something like that until after approval and maybe even commercialization. Would love an accountant's opinion on the stockholders' equity issue.
Of course you don't. You don't seem to have any concerns regarding your investment in NWBO. Good for you that you are so confident. I hope it works out for both of us.
My concern is that they are strait up lying about the journal nonsense, or are at least playing along with it with those that call in. And my real concern is that the delay is because they are waiting on the FDA for feedback on something very important, and that the outcome of that feedback is make or break for the company.
The $11.0 million loan tells me that neither TLD nor the journal article are coming in March, and probably not in April either...it's peculiar to me that they knew in late February/early March (when the terms of the loan would have been first discussed) that they wouldn't be able to release TLD in March or April if they are just waiting on a journal.
I certainly hope that the delay has to do with ATLinsider's theory regarding NWBO submitting BLAs to various regulatory authorities, but while I acknowledge it is possible, I don't think it is likely.
This is a boiler plate statement that DI is now apparently using to justify the delay. You appear to be an experienced biotech investor. Wouldn't you agree that companies approaching the release of Phase III data all say something similar, with the only variation being "release of TLD and presentation at a future medical conference." Yet, I cannot find even one example of a company releasing TLD through a journal article. Not one. And you know why? Because top line data is a summary of the full data, and the journal article will contain an analysis of the full data. So it's just nonsense to think that NWBO is going to wait to release data through a journal. Not only would it be the first time this ever happened, but it doesn't make any sense and serves no purpose. Even though the management team collectively has no experience with this phase of drug development, they can't be so naive, or just plain stupid, to think that there is any benefit in their purported strategy to withhold TLD in favor of a journal article. It certainly won't help with regulatory authorities. The FDA's BLA process isn't going to be impacted in the least by a journal article. And any benefit to the stock price will be temporary, because the data is the data and ultimately, if it's clean enough to anticipate FDA approval, the stock price will go up, but if it's murky enough that it will be a close call, then the stock price will be vulnerable to attack. The good news is that at least we are past the point of worrying about a total failure.
I agree with you on the uselessness of calling IR. However, it's interesting in this case the DI is apparently willing to tell certain investors things that, if true, should be in a PR. Like, "we were going to release TLD, but one of our advisors told us to wait for journal publication." At least they can't hide behind the Oct. 5 press release forever...maybe another couple months though.
Is it deceitful for DI to mislead investors by either stating they are waiting for a journal article before releasing TLD or letting investors think that is what the company is doing? I would say so. Regardless, it's certainly poor form to say these types of things to certain investors over the phone and not via a PR to everyone, wouldn't you agree?
As I noted in an earlier post, the agreement has to be filed as an exhibit in the first quarter Form 10-Q.
Regulation S-K, Item 601
However, it is best practices to include the agreement as an exhibit to the Form 8-K. In fact, it's far beyond just being "best practices," it's just how everyone does it.
Any other questions, DB?
Toxic financier or not, if the loan is unsecured and not convertible, the loan itself is not toxic in this particular situation. Obviously, we need to see the actual loan agreement to confirm the terms, but it would be even beyond NWBO's disdain for securities laws not to include those terms in the 8-K if the loan isn't unsecured/not convertible.
Now whatever the delay is that is preventing the release of TLD until some undetermined time after March 31, that could definitely be toxic.
Yeah, I'm with you on what seems like an absurdly high number of people that are likely walking around with material non-public info at this point. It's a very weird situation.
Well, I don't know that the lender isn't shorting. But I also don't care if they are. I would love for the short interest to rise significantly and for someone to borrow my shares and pay me interest while we wait for TLD.
I personally don't see the logic in making a loan and then selling shares short. And if they have material non-public info, they can't short the stock. I don't know if they have seen the actual TLD...I doubt it. But I can almost guaranty they have material non-public info of some sort that suggests they will be repaid.
Good to know. Providing an $11.0 million unsecured note to NWBO certainly suggests that they are privy to something we aren't.
Do you know if they have an equity position in NWBO? I would assume so, but curious if you know for sure.
Actually, we have no idea whether it's convertible or secured because they didn't file the agreement as an exhibit to the 8-K, which is what every other public company does so that there are no questions about stuff like this. These guys have a long history of horrendous SEC disclosures so I would not them to provide all of the material terms of the loan agreement as they are required to do.
They are required to file the agreement with the 10-K...actually, they SHOULD file it with the 10-K, but they aren't required to file it until the 10-Q for the first quarter. Maybe we'll have TLD by the time they file the 10-Q in May...or perhaps June or July if they have a 38th late filing.
NWBO would not get an $11.0 million loan now if the release of TLD was imminent. $11.0 million is only enough to keep the lights on for a quarter or so at the current burn rate. This is just a bridge to hopefully being able to issue equity at a higher price after TLD.
This means for sure no TLD in March, otherwise they would use their S-3 and raise more capital. I would say the best we can hope for now from a timing perspective is TLD sometime in the 2nd quarter.
Yes, I understand. But I personally think it's a pretty frothy market cap going into the Phase III data readout. I'm just saying that in my opinion, based on other biotech's market caps waiting for a Phase III data readout (not just CVM, it was just the easiest for me to compare it to off the cuff), it's not cheap. I certainly hope that the stock price today ends up being EXTREMELY cheap in retrospect, but today I don't view it that way, given the risks.
My point is that most investors holding today are doing so because of the platform potential of the stock, not because of GBM, and that the idea that DCVAX-L is a potential platform technology is well known amongst biotech investors. I mean, most biotech investors today don't believe that DCVAX-L will be successful, but I would imagine that those same investors know that if it IS successful, then it is likely to be a platform technology. And so if we get positive TLD, then biotech funds will be buying hand over fist.