I can certainly try. If you haven't already done so, you should read the prior manufacturing contract: DCVAX-L Manufacturing Agreement

What you will see is that this agreement was intended to be used after FDA approval. It has provisions detailing minimum amounts of DCVAX-L was responsible for paying for (like a take-or-pay contract) and provisions explaining how they would go about contracting additional manufacturing capacity if demand required it. So this was already done once. I can't tell you how they modeled minimums and maximums (those amounts were granted confidential treatment), but I sure would like to know what those would be today!

My personal opinion is that they have not made much progress with Flaskworks yet. They don't even have MHRA certification yet. Further, they have extremely limited financial and employee resource limitations, and I expect that every available resource is focused on MHRA certification and the BLA right now, although I don't see any evidence to suggest that the BLA process has started.

I love the idea of Flaskworks and what it could represent if it is successfully integrated into manufacturing NWBO. Absolutely game changing technology, if it works. However, they only paid a couple million for the technology, and in my experience, that means Flaskworks is just a concept at the moment and will take many millions of dollars and multiple years to move it from concept to production...that's not even taking into account whatever regulatory slowdowns there may be.

I hope I'm wrong about Flaskworks and that it can be integrated much faster than I anticipate. My opinion is based solely on my own professional experience in acquiring small manufacturers with similar "game changing" potential (non-medical devices, so not apples to apples), so it's obviously anecdotal.

Also, I don't mean to suggest that they won't enter into a new agreement with CRL along with the release of TLD or whatever other big news they may eventually share with us. I'm just saying that the whole thing is weird and if I was drafting their disclosures, I would have included a couple sentences outlining why they chose to let the contract expire and what the plan was going forward. They disclosed the bare minimum and left all of us to try to sort it out on our own...standard for them, but unethical, in my opinion. I mean, we still really don't know what the plan is for manufacturing...some of us (the minority, I believe) assume it's all going to be done at Sawston, but why such a big pivot from prior years where there was a commitment to North American manufacturing? I'm telling you, it's impossible that Flaskworks will be ready to ramp Sawston production 5X in the next 18 months. So is it just equivalency concerns, or is it something related to whether they expect FDA approval? These are the questions that trouble me, and if NWBO was doing their job, they would lay all of this out for us as the securities rules and regulations require.

There is no such thing as a "dormant" contract. A contract is either effective (even a contingent contract is considered to be effective, just subject to the contingency), or terminated (by its terms or otherwise).



Here we go again...their SEC disclosure obligations are NOT just "financial" in nature. The whole point of a public company's disclosure obligations is to provide insight into whether a particular registrant is a good investment or not. The disclosure rules and requirement go well beyond the purely financial information. You should know that.



What "truth" are you talking about?



Maybe so...but if DCVAX-L is everything we all hope it is, why won't they be manufacturing in North America on Day 1? I sure hope demand is initially more than 500 patients per year, which is all that Sawston will be able to do initially (according to their PR). I do acknowledge that CRL maybe ready to go on manufacturing...but there is no point on hiding the existence of a manufacturing agreement. They can redact all pricing and volume stuff, so why would they keep something like that secret? I don't know, it just seems weird to me. I sure hope CRL is onboard to manufacture in the U.S. and for additional EU demand beyond 500 vaccines per year.



Here is the link from the 2020 Form 10-K for the DCVAX-D contract that you say has never been an exhibit: DCVAX-D Agreement that according to Biosectorinvestor has never been filed as an exhibit

Honestly, the Advent situation doesn't both me much and I haven't looked into whether that agreement should be filed as a material contract. Maybe it should...I'll let someone else do the analysis on that one. I mean, I think the optics of the situation are terrible (at a minimum), but it doesn't currently factor into my investment thesis.

Sigh...you are absolutely correct that the contract expired by its terms. Here is the full sentence (emphasis added):

The "later of" means the last to happen. So I was reading the provision as if termination would occur on either January 17, 2021, or some date in the future, 5 years after DCVAX-L is first sold (after any regulatory authority approves it). Since January 17, 2021 came and went, the contract would now terminate 5 years after the 1st sale. I admit that my original interpretation now seems really strange and nonsensical. The problem is, there is no trigger deadline for when a BLA should be filed, so if a BLA hadn't even been filed by January 17, 2021, should the contract now just continue indefinitely until 5 years after approval? No. You are right that once January 17, 2021 came and went, it has to make the 2nd clause null. And obviously, you are correct that a contract that expires by its terms doesn't need to be included in the Form 10-K exhibit index.

The problem with the burn rate is that they are not spending enough. I do not believe they have the internal expertise, experience or capacity to get through the BLA process on their own. Same with commercialization.

So for me, the scary part of the delay on the release of TLD is that I see no evidence they have done anything substantial to prepare for submitting a BLA. I believe that if they were doing anything substantial to advance DCVAX-L towards regulatory approval and commercialization, it would be reflected in their financials by a jump in spending. As for what they are doing if they aren't working on the BLA? Other than working on the Sawston facility, I have no earthly idea.

I certainly don't know for a fact that the burn rate is too low, but I know that spending typically ramps the closer a biotech (with no approved product) gets to approval.

Perhaps MI Dendreon can share some insight on whether the burn rate tells him something about where the company may be with respect to the BLA process and preparing for commercialization.

You are wrong. Material contracts that are still effective must be included in the Form 10-K exhibit index every year. Once again, I will repost the link to the securities regulation that provides the requirement. Regulation Requiring "Republishing" of Material Contracts Every Year

You can refuse to read the link, and talk about how you don't need to read it...whatever. Personally, I find that to be very intellectually dishonest. The regulation is right there in Item 601(b)(10). Moreover, it is a fundamental concept of disclosure principals that nobody in the industry questions at all. There is zero debate about whether material contracts that are still effective need to be "republished" every year in the Form 10-K exhibit index. Your position is ludicrous and has zero support whatsoever. It's entirely made up by you. I have no idea why you continue to dig your heels in on this topic. If you really do have a law degree, you have an ethical obligation not to mislead people on the law. You have over 100 followers on this website and over 16,000 posts, most of which I assume are on the NWBO board. It is wrong for you to misstate the law, repeatedly, and refuse to even read the rule that explains why you are wrong. My "trying to hard," is aimed at what I consider to be very inappropriate behavior. Even though you are not providing legal advice, you have people that trust what you say partly based on your alleged professional background that you refer to fairly often ("Trust me, I'm a lawyer!"). I will not watch while you lead people astray on this topic. I may not be able to keep up with all your posts...but I'm going to continue to call you out because you are wrong and it is an important topic.



The first sentence is an outright lie as it relates to securities rules and regulations. You have no experience as a securities attorney. As evidenced by your continuous statements that material contracts don't have to be "republished" every year AND another of your statements that a public company can choose to file every single contract that they enter into as a material contract. No person with any basic understanding of securities rules and regulations could even dream up such nonsense. However, I do think I've figured out your legal background...you are either a procurement contract attorney or you work for one in a contracts administrator role. As for your statement that you should leave this subject to people that know what they are talking about...perhaps it is time to take your own advice?

The Cognate contract termination provision said the contract would terminate on the later of January 17, 2021 or 5 years after the first commercial sale of DCVAX-L pursuant to a BLA or market authorization. Here's the contract, previously filed as an exhibit to the 2020 Form 10-K (and every other Form 10-K since 2011): DCVAX-L Manufacturing and Services Agreement

Again, there are 3 options for what has happened: (i) the contract is still effective, but the company no longer considers it material; (ii) the contract is still effective, but the company failed to include the contract on its exhibit list as required by securities rules and regulations; (iii) either the company or Cognate/CRL terminated the contract and the company failed to disclose the termination, as required by Form 8-K.

That's it. Those are the options. Again, someone should call DI and ask him what the status of the contract is. It should take him 2 seconds to answer.

Thanks for sharing. Did you ask directly whether Cognate would be used as a contract manufacturer? I assume you did, but wanted to confirm.

Doc, I do not know whether there is a "hidden contract." If there is not currently a manufacturing agreement in place with Cognate/CRL, then I sure do hope they have a framework for a new agreement. Seriously. This is critical.

My concern is what happened to the "old" manufacturing agreements and does the Company's statement that they plan to use Sawston to manufacture DCVAX-L for the UK and "other regions" include North America or not? Because if it includes North America, and they can "only" manufacture 500 vaccines per year, my valuation doesn't work.

I believe CRL is the perfect contract manufacturer for DCVAX. I believe it's possible that some small portion of CRL's valuation of Cognate might have included anticipated demand for DCVAX-L. I get the story. What I don't get is why all of a sudden the Company stopped talking about Cognate/CRL and manufacturing in North America. I don't understand this and the more I think about it, the more it bothers me, honestly. I'm looking for an answer. I don't claim to have the answer.

This post is nonsense as it relates to my concerns about what happened to the Cognate/CRL manufacturing agreement between the 2019 Form 10-K and the 2020 Form 10-K.

I said someone should call DI and ask whether there is a manufacturing agreement with Cognate today. Not whether there is some super secret framework for manufacturing later. I swear, you talk out of both sides of your mouth and the back of your head.

Literally nobody is presuming this. Terrible straw man, even for you.



The law does allow for confidentiality when parties enter into a material definitive agreement. All you have to do is redact the portions of the agreement that you believe qualify for confidential treatment from the exhibit before filing and put some magic language at the top of the exhibit. Read here for more details: Confidential Treatment Requests. There is nothing in the securities laws that allows you not to disclose an agreement that is considered material.



What in the wide wide world of sports are you trying to say here???

I cannot believe anyone is still talking about whether the Cognate/CRL contract is still effective.

Here's the deal, again (not for you Ex, but for anyone else that is reading this): Either the Cognate/CRL agreement was terminated or NWBO is not in compliance with securities laws and obligations because it was not disclosed on the Form 10-K exhibit index. Actually, if it was terminated for any reason than the term expiring, they should have filed a Form 8-K disclosing that event...but I digress.

The only way that the contract could still be valid and not have to be included in the Form 10-K exhibit index is if the company determined that the contract was no longer material. That's not possible under our facts, unless the company has no intention of having DCVAX-L manufactured in North America in the near future (which the risk factors do suggest--see the last quote below).

There are also the Company's own words that some people around here just don't want to accept. From the 2020 Form 10-K:

Now look at what the Company said about manufacturing in the same risk factor provision, but from the 2019 Form 10-K:



Someone should call DI and ask him about the status of the Cognate/CRL agreement. He should be able to answer that question. The ability to manufacture in North America is critically important, and yet, there is apparently no existing agreement. I mean, does anyone here who has any real life business experience really think that CRL is spending a substantial amount of money ramping up for DCVAX-L production without a signed agreement? What would be the purpose of not disclosing the signed agreement, or keeping it in LOI format or something that might not technically trigger an 8-K filing event? Why in the world would they do that? What is the benefit to anyone in keeping this stuff secret? And why wasn't it a secret in 2019, but now it is? The existence of a manufacturing agreement doesn't have anything to do with the release of TLD, a journal article, the FDA or anything else. But it would allow investors to see that they actually have a way to produce DCVAX-L in North America. Right now, we don't even know that they INTEND to manufacture in North America. From the 2020 Form 10-K:



From the Company's own disclosures, they only mention North America and Europe as places they intend to seek regulatory approval. It seems like they are telling us that there will be no manufacturing in the US, at least initially. I sure hope this was sloppy drafting, but with the removal of the Cognate agreements from the 2020 Form 10-K exhibit index and the substantial changes in the disclosures surrounding manufacturing between the 2019 and 2020 Form 10-Ks, I am not so sure it's just sloppy drafting. I honestly don't know what to make of the situation.

Haven't you wondered why that fast track language is in all the 10-Ks and not in the 10-Qs? It's pretty easy to figure out...here's a hint, go look at what section in the 10-K your language comes from and then go see if that same section is included in all of the 10-Qs. And by included, I mean, see if all of the other items disclosed under that item in the 2020 Form 10-K are also in the 10-Qs.

Actually, I didn't ask how long it takes to uplist...but thank you for clarifying what you meant by having their ducks in a row. I'm not sure the person that asked the question understood that it's a multi-month process regardless of whether the stock price jumps.

How are you arriving at the conclusion that they can uplist in a month? I think the only way NWBO can qualify for uplisting in the near future is if the stock trades above $4.00 for more than 90 consecutive days.

My assumption is that the money will be used to hire regulatory consultants to begin the BLA process. Maybe they will also use some of the proceeds to start hiring the many people they will need to hire if they intend to bring DCVAX-L to market themselves, including hiring a Chief Regulatory Officer and/or Chief Marketing Officer.

Well, if TLD was coming out in the next 2 months, they wouldn't have done a loan with these terms. I don't know when it is coming, but it isn't imminent. That is my point.

You realize this isn't the first convertible debt financing they've done, right? Further, everyone should understand that they most likely haven't started on the BLA, much less begun thinking about commercialization. They haven't spent enough money this year to have done much, if anything, on the BLA. Not to mention the lack of any disclosure supporting the fact that they are working on the BLA. The point being that they are still years away from commercialization.

The only way that a private placement doesn't occur within a few days of the release of TLD is if they haven't been working on the private placement in advance because they haven't shared TLD with their prospective private placement purchasers. A normal company wouldn't share TLD privately with investors, even under an NDA. But this is NWBO, and we are already in unchartered territory, so who knows.

I believe that the only way that the stock price goes up significantly (like, $4+) after the release of positive TLD is if they do the private placement in connection with the release of TLD and set a floor. Even better if they have a heavy hitter take a stake (or BP).

The point is, the lender has access to info we don't. Whether it's Sawston info or something else.

Let's not get carried away here...

On the positive side, they now appear to have the cash to get started on the BLA process and start to at least think about commercialization. On the negative side, this PR confirmed we have many months left before TLD is released.

You are wrong about this. It's certainly possible someone loaned them $15 million without looking at TLD, but they know more than we do, assuming it's an unsecured loan.

If you wanted to gamble on the company, you would be better off just buying the common stock on the open market because you have unlimited upside and can cut your losses and sell at anytime. Instead, they made an unsecured loan (presumably), which they can convert into shares, but they would only do that if the stock price increased significantly.

They have to do a private placement because they don't have a current S-3 registration statement they can use. They could file an S-1, but that would require TLD to be released and then probably 2 months or so for the SEC to bless it.

It's going to be really interesting to see how they price a private placement, assuming they ever release TLD. They should have about 25 million shares they can sell.

Here it is: Short Swing Profit Allegations

Note that this appears to have been related to Cognate, not any of NWBO's executives. I just skimmed the document so maybe there's something more there.

Post of the year right here. Very well said.

I am well aware of who is in control and I have a big problem with her strategy, even if she thinks what she is doing is for the benefit of shareholders. Again, what she is doing has never been done before by a public biotech. There are multiple reasons that public biotechs release TLD pretty much as soon as they receive it. One of those reasons is that it is hard to satisfy the requirements of the securities laws and regulations if you decide to withhold material information that directly affects the future of your company for more than a year.

As for the SEC...they don't actively monitor every public company. They will review a company's disclosures every couple years and issue a comment letter that will ask for explanations of various things, but unless they receive a complaint or a disclosure triggers something they are monitoring for all public companies, then they won't know what is happening. If someone really made a complaint in this case, then depending on who the person is and how the complaint was communicated (and what information was provided), the SEC will definitely take it seriously and will start looking into it quickly, especially if the complaint made it clear that the company is directing the exercise of "in the money" warrants as they sit on the results of their Phase III trial.

I am definitely not buying any more shares.

Believe me, I hope you are right. Hopefully the ends justifies the means...

I don't doubt this...I was giving them until this last 10-Q to update their risk factors and other provisions of their disclosures that cannot be accurate today if they are in possession of TLD, not to mention what they know about manufacturing and various regulatory issues. I still might make the complaint.

With the warrant holders being permitted to exercise their shares slowly over the course of the last year while they are "in the money," LP and LG are looking at jail time if TLD isn't good enough to support the share price...because they will have known that this would be the case since last fall when they changed course all of a sudden. That actually gives me some comfort, since I don't think they want to go to jail, and they have to know how bad the optics are of allowing warrant holders to cash in (and provide financing for the company) while they know that the trial results aren't going to support regulatory approval, or even if they might not support regulatory approval. Are they unethical, yes? As attorneys, they have to know that their current disclosures are not in compliance with SEC rules and regulations. Are they criminals? That remains to be seen.

Yep. It's got to be something like that. Or they are waiting on the FDA for something.

Like you, I hope I'm wrong. Or I hope that whatever is going on is resolved in a way that is favorable to patients (and us investors).

I hear you Sir Pumpernickel. I am well aware that DCVAX-L as a monotherapy won't work for everyone.

I will pray for your mother and I wish your mother and your family the best. Unfortunately, I know the personal pain of having a parent pass away.

One of the news reports I read said that the tumor that was removed in 2015 was benign. It also said she received "immunotherapy," though it didn't say what kind...seems strange that it would have been something other than DCVAX-L though, right? Assuming the news reports were all correct and that the GBM wasn't diagnosed until 2018?

But, maybe Flipper was right and the type of GBM she was diagnosed with in 2018 isn't considered GBM anymore (and was known to be unresponsive to DCVAX-L...or she did actually receive it for compassionate use and it didn't work).

Anyway, whatever happened, her passing is tragic and sad, as it is for all cancer patients.

So now you are an expert on how to launch a drug too? You realize the person that you are responding to is an actual subject matter expert, right? And yet you authoritatively insist that he is wrong and you are right regarding a subject you know nothing about?

Presenting at a conference does NOT preclude the publication of the full trial results in a medical journal. There are THOUSANDS of examples of published articles that include information that was previously presented at a conference. If DCVAX-L is going to be the new SOC for GBM...journals will be lining up to publish the full trial results, regardless of whether some of that information was presented at a medical conference. You know this, right? This is literally how every other publicly traded biotech in the United States does this.

Again, this is the first time in history that a biotech has withheld TLD in anticipation of publishing the full trial results in a journal. THE VERY FIRST TIME!!! So how can you know whether it is a better way, or the best way, to release TLD?

And I will also say this again...I believe the company is lying to us when they say the delay in TLD is because they are waiting on publishing, for all of the reasons set forth above. There is something else going on.

Thanks flipper44.

What exactly are you correcting? My point is that NWBO lacks the internal expertise to prepare for and file a BLA. Are you saying that the members of the SAB are collectively filling the role of a CRO and working on this on behalf of NWBO?

I had to look up Susan Bayh and was surprised to see that she was diagnosed with GBM in 2018, 2 years after she was appointed to the NWBO board and disappointed to see she passed away earlier this year. Does anyone know if she received DCVAX-L? I assume she must have. She only served for 1 year as a director; that is unusual.

Yep. It is a huge, huge deal that nobody working for the company has any experience with the BLA process. It is possible that the company has hired a consultant to act as the CRO, but if they have, they have not complied with their duties under the securities laws to tell us that.

From their current cash burn rate, it is obvious that they are not doing any substantial work to get a BLA ready for filing, nor are they doing anything substantial to address commercialization, which I guess makes sense since they must be at least 2 or 3 years away from commercialization. If they released TLD tomorrow, it would take them well over a year to get the BLA filed, and that is assuming they hired a consultant to help them with that process.

Let me get this straight...you still believe that the Company has a manufacturing agreement with Cognate/CRL to produce DCVAXL? Despite the fact that the Company told everyone in the last Form 10-K that it doesn't have an agreement with Cognate/CRL and they dropped these agreements from their exhibit index of material contracts?

Please explain.

Could you please tell the board why you considered this a very interesting and excellent post, considering that this exact statement has been in the last five Form 10-Qs and it has been substantially the same statement since 2018 at least?

Inquiring minds want to know.

They are cutting and pasting old disclosures...you have to know this, right? Otherwise, please explain to me the burn rate and how they could possibly be spending money on US manufacturing and also spending money getting a BLA ready and other expenses necessary for commercialization.

Are you kidding me? Seriously. For whatever you may know about science, you don't understand a thing about SEC rules and reporting requirements. You must be related to biosectorinvestor.

This statement has been substantially the same in all of the 10-Qs going back at least 1 year.

As usual, you are wrong. Companies that engage consultants to "think about future issues" routinely file those agreements as material contracts. There are hundreds, if not thousands of examples of these filings. This is especially true when the "future issues" relate to what path a company is going to take forward (i.e., put itself up for sale or restructure). It is also true when a company like NWBO hires a consultant who is essentially filing the role of a Chief Regulatory Officer. The only possible argument against these agreements being material contracts is that they were entered into in the ordinary course of business. Most pre-revenue biotechs don't ever make it to the point where a BLA is filed and so by that standard, it wouldn't be ordinary course. The pre-revenue biotechs that do make it to the BLA stage likely have employees that have been through the process before, so if they have a consultant, it won't be the person who will do the heaving lifting, but more just bodies to help assemble the filing, and that kind of consulting agreement would definitely be ordinary course. But for NWBO, I think their consultants must be doing substantially all of the BLA work and acting as a Chief Regulatory Officer. If so, you are basically outsourcing a CRO and that is definitely NOT ordinary course and would need to be disclosed in a Form 8-K. I have a lot of respect for Dr. Bosch, but his resume doesn't suggest to me that he has any experience with the BLA process...maybe MI Dendream can chime in on this subject.

But regardless, you are missing the point (again): The Company told us that it was negotiating these agreements in a section of the 10-Q that is the equivalent of a Form 8-K. If they thought the mere negotiation of these agreements was material, doesn't the fact that one or more of these agreements was actually entered into have to be material for 8-K purposes? They could have said anywhere in the MD&A section of the 10-Q that they were negotiating consulting agreements with people that would help them with regulatory issues, but they chose to do it under Item 5, so that means they thought they were required to disclose the fact that they were negotiating these agreements. I know you cannot follow this logic and I am wasting my time typing this...but maybe it will benefit someone else.

Look, unless I see the actual contracts, I cannot know for sure whether the agreements are material. But the company clearly thought that they were, or would be. Or, the company incorrectly used Item 5 to make this disclosure, which is entirely possible since they bungle basically every filing that they make.

That statement was made in both the 2Q and 3Q 2020 (which was actually filed in Jan. 2021) Form 10-Qs.

Item 5 of Form 10-Q allows a reporting company to use this item to disclose things that are otherwise disclosable on Form 8-K. So...if the company thought that the fact that they were negotiating agreements with key consultants needed to be disclosed on Form 8-K, any actual agreements entered into would definitely need to be disclosed as material contracts and filed as exhibits. This has bugged me since they make these disclosures, but, I figured they hadn't actually entered into these agreements since they weren't disclosed.

Your post got me curious again so I went back through the 2Q Form 10-Q and saw that since January 1, 2021, they have issued 910,000 options at an average weighted price of $0.92 with an average remaining time period of 9.1 years. Obviously, this disclosure cannot be correct because the stock has not closed below $1.00 (yet) and only 6 months had passed at that time...so these options must have actually been granted sometime in the fall of 2020, and they likely went to the "key consultants," which raised ANOTHER disclosure issue, since these agreements cannot credibly be argued to not be material. Their own Item 5 Form 10-Q disclosures tell us they know they are material.

So, the good news is that they probably have retained some key consultants who might currently be helping prepare for potential applications. The bad news is, we really can't say for sure because the company has been so sketchy/misleading with its disclosures.

Today's volume probably won't even add up to $2.0 million in total shares traded. That is significantly less than 1% or the company's market cap on a fully diluted basis (it's approximately 0.17%).

Everyone should let that sink in when discussing the stock price or what's on the bid, etc. I realize there's not much else to talk about, but still.

All that matters is TLD. Not even Sawston news matters. I mean, the stock price may go up on the news, but it's still just MMs playing games, as nobody is going to start buying the stock in any material way because of Sawston's approval, which is a given.

Whatever that blog thing is, it's discussing the delisting and relisting of stocks in INDIA. It is not relevant to NWBO.

The NASDAQ and NYSE both explain what is required for uplisting and it's been discussed on this board ad nauseum.