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Apologies if this has already been posted. The overwhelming deluge of posts precludes me from checking.
This is an article from Cohen Milstein's website co-authored by NWBO attorney Laura Posner titled Protecting Market Participants from Manipulative Trading.
https://www.cohenmilstein.com/protecting-market-participants-from-manipulative-trading/
NPR this morning announced a story about Recurring Glioblastoma at 645. I assume they mean 6:45pm Central Time. That's all that was said.
Thank you everyone for the encouraging notes.
The following is from the 2023 goals section of today's press release:
expansion of the operation in Sawston following completion of the Phase 1B buildout;
continued development of the Flaskworks system, including choice of the system version to take forward;
I read this as a statement that Flaskworks is still under development and thus it is likely not part of the commercial manufacturing application under consideration. While some will no doubt be disappointed, we could take comfort in knowing that the company is taking what I would think is a more incremental approach, basically taking the same manufacturing process that passed the "specials" hurdle over the higher commercial hurdle. Presumably, this will lead to a higher probability of success.
For insight on the cost of manufacturing I think it's safe to assume that Advent has enough staff in place to support the previously announced capacity of 500 patients/year. This is very rough but that works out to about 1 employee/month per patient. Of course, probably most of those employees are "fixed" (leadership/support functions) and only a portion would be "variable" which would mean the labor cost per patient is possibly substantially lower than the 1:1 ratio would imply.
A final note regarding my assertion that $.70 is a great buying opportunity for NWBO is to take into account the meltdown in the larger biotech sector, especially small companies. XBI, an often quoted biotech ETF was down 26% in 2021 and over 40% from the ~February 1st peak. Also, a newsletter I read reported that its recommended portfolio of small biotech stocks was down over 40% last year. These headwinds impact all companies even though biotechs have their own unique milestones.
I lied. Here's another note. I was asked about BioNTech's news. I know very little about their program beyond what I've read on this board but we do know any approved treatment will take years to commercialize and of course it may not (probably is not from what I've read) be as effective as DCVax-L. All this aside, we should welcome big pharma companies promoting immunotherapy. Remember how big CAR-T was a few years ago and how Kite and Juno were such big news and both were bought out in a big pharma feeding frenzy? Maybe it'll happen again. This time NWBO would be the belle of the ball. The only difference would be the numbers would likely be bigger this time.
I rarely post but have been an avid follower of this board for several years and a follower of NWBO for a decade.
I haven’t posted much because I lack specialized expertise that would be truly informative for you all but I do have a deep generalized knowledge of the company from following it for so long and a perspective that might help. For example, I attended the ASM meetiing last week as well as the 2018 meeting. I enjoyed the meetings and want to thank all the people who talked to me. Both times I was one of the last people to leave (5 hours after the start of the meeting last Friday). Note to everyone: The best part of the ASM is after they stop recording. Linda Powers is an extremely careful person who acts like Adam Feuerstein is hearing every word she says (as she should), but if you are attentive, there are also a lot of subleties you’ll pick up. After Ms. Powers stopped answering questions, there were conversations with fellow investors. Too bad more of you weren’t there. I can only imagine how great it would be to talk to DocLogic, iwasadiver, hyperopia (nice note today), flipper, thermo, lyriki, Sentiment, and many others.
I’m writing because I do think we have a buying opportunity right now and I want to encourage present holders of the stock to stay the course.
At the end of 2021 the stock price was about $.70 which is also where it is now. In 2022 the fully-diluted share count of NWBO increased from 1.478b shares to 1.523b shares, an increase of about 3% (after a less than 1% increase in 2021). Yes, there’s more dilution coming, and the numbers were greatly aided these past couple of years by funds from the exercise of previously granted warrants. This was good work by Linda Powers and Les Goldman which should be acknowledged. Also don’t forget the Sawston real estate deal that netted the company ~$50m at a very difficult time. I think that deal saved the company, or at least saved us retail shareholders.
So, in addition to the minimal dilution we also had a lot of progress with the data release, journal article, and the lawsuit - Linda Powers’ top 3 accomplishments. I’d also add the Pazdur article on external controls and Linda Liau’s statement that the FDA required the crossover in the Phase 3 trial. Those two points address the two most cited areas of vulnerability in the study results. Altogether major steps forward as well as major steps in improving our odds with regulators.
Looking forward, with manufacturing approval coming soon (hopefully Q1 2023) and submission of applications for final approval likely in several jurisdictions this year (my unexpert view: First half in UK and second half in US with second half UK approval?) we have potential catalysts. Personally, I think growing revenue from the specials program (others have previously reported that Linda Powers said interest has increased since the journal article) will get harder and harder to keep under wraps and this could become a significant catalyst for the stock price. Note, I asked Ms. Powers point blank why the company doesn’t announce/report specials revenue or patients and she said the regulator would be extremely upset if the company used words like sales or revenue in regard to the program and it was clear to me she doesn’t intend to touch that with a ten foot pole (my analogy).
I also think the blinded combination study interim results recently presented by Linda Liau will be critically important this year. Personally, I think a publication based on the five year data would be ideal, but even without it presumably the FDA will be aware of the data (experts please weigh in). It’s one thing for reasonable people to debate over external controls and crossover in the P3 study for the DCVax-L 2.9 month increase in OS, but when you are talking about a 10x increase in five year survival from 5% to 50%, then issues like external controls and crossover are reduced to petty hair-splitting because even though it’s preliminary data, the almost total lack of side effects takes away the downside. I think that logic is a train that the FDA wouldn’t want to stand in front of, especially since the UK will almost certainly have already made its (positive?) decision.
I hope that 2023 will prove to be “the year” for NWBO, but we shouldn't draw lines in the sand. Instead, think of NWBO as a tortoise. It’s slow but it will eventually get where it is going.
A couple of thoughts on the lawsuit.
From what I understand about the law firm NWBO is using, they work primarily on contingency (that's good because NWBO doesn't really want to use its very cheap shares to fund the lawsuit) and they work on very big cases that typically settle but usually take many years to resolve. The good news is that the firm must A. expect to win and B. expect to win a very large settlement.
So, the next steps in the spoofing lawsuit process are just part of a long process. I think we should stick this lawsuit in our collective sock drawer and just forget about it. Sure, a big pot of several hundred million dollars of non-dilutive capital would be a great thing, but acting like it's going to happen soon (I mean 2023) is just setting everyone up for disappointment, or in other words, just feeding ammo to the stock manipulators.
I'm not a lawyer but think about this from Citadel's point of view. Why should they settle for let's say $200m right now vs. say $500m 5 years from now? But, wouldn't a settlement turbocharge NWBO's stock price and trigger substantial losses on Citadel's (presumed massive) naked short position. To me, they should want to drag things out as long as possible to give them more time to destroy NWBO, more time to cash out their position, or at a minimum simply to defer their day of reckoning.
On the question of whether Flaskworks will be part of the expected upcoming commercial manufacturing approval I have a small contribution.
Linda Powers did say that they have the manual and the Flaskworks processes are operating "side-by-side" at Sawston.
I take that to mean that testing is still ongoing and thus I don't expect it to be part of the initial commercial manufacturing approval that is expected to come any day now. I suppose if the commercial approval takes longer than expected the odds of Flaskworks being included in that would increase. That's just a logical leap from an uninformed person (me) and not based on actual knowledge about the approval process.
IDH Mutation Question
I am a long-time long on the stock but post rarely. My question relates to the change in definition of glioblastoma to exclude IDH positive patients.
NWBO has stated that it has had to reach back and test patient samples from the P3 study to determine their IDH mutation status because the significance of the IDH mutation wasn't known in the early years of the study.
Assuming I have all of this correct, does the change in definition of glioblastoma make it difficult to compare historical control data in past trials, which presumably lack IDH mutation data, against our upcoming trial data?
Also to GGB. I share your frustration but.....
First, we all know NWBO doesn't make timelines and that employees of the company frequently make misleading statements. But, to a large degree, that is why we are all here in the first place. At $.16/share NWBO was incredibly undervalued if you believed the published clinical data. It's a little bit of a chicken/egg thing as to whether the company's inability to do what/when it says led to the short-seller attack or vice-versa, but regardless, that is how we got to NWBO having a fully-diluted market cap below $300m while advancing a late Phase III trial with very good blinded data in a multi-billion dollar application.
Despite the years and years of history (I lost a lot of money on NWBO 5+ years ago) I believe the risk/reward for NWBO is very, very favorable and when the stock was trading sub $.20 I'd expand my position 1-2% every week to the point that eventually NWBO accounted for more than 2/3 of my stock portfolio (maybe 20% of my net worth).
When NWBO hit $.75 - $1.20 I started selling and sold almost 20% of my position, recovering my entire cost basis for NWBO. I sold because I was massively overweighted in NWBO and the risk/reward had changed incrementally. Note: After all this appreciation, NWBO is now 80% of my portfolio and more than 50% of my net worth.
One thing people haven't mentioned on this board which is the primary reason for my post is this. We need to think in terms of marginal utility. If NWBO goes to $8, how much money will you make? What is the incremental benefit to you if it goes to $9? For me, the incremental utility of the $1 gain in NWBO stock price from $8 to $9 is not that high while the incremental utility on what NWBO stock has achieved so far is very high.
So, if you have a large (relative to your financial situation) position in NWBO, yes, you should absolutely take some chips off the table. If it's a small portion of your net worth, then don't worry about it and swing for the fences. There are exceptions like tryn who is trying to change the arc if his retirement. That makes sense.
So, to conclude, GGB, you've been watching NWBO for many years. You follow this message board and have developed a level of trust in some of the experts who post here. You know what NWBO is and is not. You know what can be known about DCVax-L and Direct. Presumably, you understand your financial situation and have performed the type of analysis I suggest above. If yes, then you should disengage to some extent. Turn off your computer and read a book or fly a kite. Try not to think about NWBO. Try not to let your emotions overcome your judgement and your years of due diligence.
I think the rude remarks, such as this one, to MI Dendream are out of line.
I'm very long NWBO but am also frustrated by the company's very poor track record when it comes to forward-looking statements. It is entirely legitimate to judge the company on this basis, particularly as we look forward to the post-TLD period when the level of scrutiny is going to be exponentially higher.
It is also appropriate to acknowledge that this poor track record has contributed in a major way to the very low stock price of recent years which has created tremendous upside potential for risk-tolerant investors. I guess this sword has two edges.
Nothing in the NYT on Ivermectin and COVID-19 and Washington Post only had a blurb related to the Bolivian program.
https://www.washingtonpost.com/world/2020/05/22/trump-is-not-only-leader-pushing-unproven-coronavirus-cures/
Gary: You are probably right. I was trying to be optimistic.
Also, my assuming we suddenly revert to "normal" valuations when we've been in a long-term pattern of abnormal valuations should raise eyebrows.
After all, the positive blinded data released several years ago could rightly have been seen as a catalyst to snap us back to "normal" valuations but it didn't work out that way in actuality. Friday's wild ride up was nice (probably my personal best one day gain) but it took place on relatively limited volume (roughly 1% of shares outstanding) and without significant news. Is that the signal that NWBO is out of the woods and going forward will be traded as a "normal" biotech stock?
I sure hope the rally continues over the coming weeks and months but paranoia is almost always a synonym for wisdom when it comes to NWBO.
I post only rarely, and have no medical expertise whatsoever, but I have been investing in biotech stocks for about a decade and have been in and out of NWBO over the past six years.
A lot of people are posting messages about what they expect the stock price to do over the coming weeks and months remaining in 2020. While I'm very, very long on NWBO I think a lot of people are getting ahead of themselves and I think we should be careful.
First, we have about 1.2 billion fully diluted shares outstanding. There is absolutely no reason when talking about upside to start a projection by assuming anything less. In fact, when talking about upside, we should probably be talking about 1.5 billion shares because additional equity will be issued to raise money for the FDA filing and launch preparations.
Next, if we go with Larry Smith's estimate of the GBM market globally as $10b/annually, then I think we might assume 20% of that as a reasonable target to achieve in the next 5-6 years or so. If we assume this business will be high margin and have some additional growth opportunity, then say a six multiple of revenue could apply. So, that's $12b in market value or $8 per fully diluted share five years from now.
In my view, I could see NWBO having a $1b+ valuation after the study is locked but before results are announced. To me, that looks like a share price in the $.80 to $1.00 range with maybe a little bit more upside for the Direct product which although it is being minimally valued by the market now, is leveraged to DCVax-L since they are similar products. Positive results would seem to get us a doubling from there which after a big raise would likely leave us with a $3b market cap going into the PDUFA in the middle of 2021. That's a pretty darn good number in my view given that you can NEVER count on the FDA. Every follower of NWBO should be well aware of this.
So, to the point of my note. If we do see a significant short squeeze in the next couple of months and the share price gets to $2 or $3 before news, that'd be a gift for long suffering longs that should be taken advantage of to at least cover one's cost basis. Every shareholder should be making plans based on their own situation. Also, do realize that the attack on the stock likely will not end even with wildly positive results in July. I have little doubt that even with very positive results that the stock will come under repeated attack over the next year and even beyond a positive FDA approval. I'm sure in 2021 we'll be flabbergasted as we are now as to why the stock price is relatively low despite the vastly improved position of the company.
So, incorporate that into your plan as well and be disciplined about sticking with your plan especially if all goes well.
Volume is rather low considering the importance of the news. I think we'll see a pickup in volume (and price) this afternoon and especially tomorrow. That's my anecdotal recall of how things work with this type of stock and good but non-definitive news. I've been a buyer this morning with the intent to flip them over the next few days (I'm already way overweight in NWBO shares).
Early July, so round that to 3 months.
Despite the spin from the naysayers, shorts, or whatever you want to call them, the most important question was answered. Expect a short attack on Monday so don't be surprised if the stock ends the day down. However, three months is not a long time, and typically, you can expect the stock price of a small single product company to go up steadily over that period of time. Any stock price weakness over this period is a gift for buyers. I'll go out on a limb and assuming there is zero other news (including financings) that the stock price will be in the $.50 - $.75 range going into July 4th.
Last year, management took a good number of questions, and afterwards stayed around and spoke with small groups of shareholders informally for quite some time. After the rest of the management team left, Les Goldman stayed around and continued answering questions. That was great for me and made the flight to D.C. very worthwhile.
So, the contrast between these meetings is particularly stark for me. By answering only the most important question and answering it very clearly, Linda Powers did a very good thing. While there are many other questions that would have been nice to have answered, she provided nothing for people to criticize or second guess and nothing to distract from the overriding issue.
Additionally, the company will have the option to provide that information in the coming weeks or months. Presumably they will wait until top line data is released. However, assuming the data is positive, I think we'll see a very steady drumbeat of news after that.
This is very similar to last year. The only difference is that the Q&A at 30 minutes seems short.
Good article which provides quite a bit of detail on coronavirus risk vs. different kinds of exposure.
https://www.newyorker.com/news/news-desk/keeping-the-coronavirus-from-infecting-health-care-workers
Endpoints on the Opdivo failure. Of course, Carroll doesn't acknowledge NWBO.
https://endpts.com/strike-three-bristol-myers-third-i-o-shot-at-glioblastoma-misses-as-opdivo-flops-yet-again-on-key-endpoint/
Strike three: Bristol-Myers’ third I/O shot at glioblastoma misses as Opdivo flops yet again on key endpoint
Glioblastoma continues to defy about everything thrown at it.
Bristol-Myers Squibb put out word Thursday morning that its third Phase III assault on brain cancer using its star PD-1 Opdivo failed the first endpoint, with no significant improvement in progression-free survival for patients who face grim odds.
CheckMate-548 appears headed for a complete collapse, though overall survival is still being studied. Researchers had tried to see if the checkpoint therapy could outdo the standard of care by adding it to the standard — temozolomide and radiation therapy.
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They already tried — and failed — earlier this year with CheckMate-498, a Phase III that combined Opdivo and radiation against temozolomide. That trial failed the mark on OS in May.
Two years ago the company was forced to concede defeat on Checkmate-143, the first use of a PD-1 against glioblastoma.
Bristol-Myers has had a string of setbacks in the clinic with Opdivo, though the pharma giant still enjoys blockbuster revenue even as Merck’s Keytruda continues its clinical blitz that put them on top of the market.
In this case, though, the Bristol-Myers team joins a long list of failures in fighting brain cancer, which remains one of the toughest targets in oncology. AbbVie had its own bitter setback to report in May when their antibody-drug conjugate depatuxizumab mafodotin (or depatux-m; previously known as ABT-414) also failed in improving survival times for brain cancer victims.
Several years ago AbbVie showed up at ASCO with ABT-414 and Rova-T to tout their potential. Rova-T failed completely for the R&D team, forcing a complete write-off of a drug they bought for $5.8 billion upfront.
Robert Prins UCLA
A complete failure here won’t extinguish all hope that a PD-1 could yet play a role in glioblastoma. Robert Prins at the UCLA Jonsson Comprehensive Cancer Center reported evidence earlier this year from a tiny exploratory trial that a checkpoint may help patients when used ahead of surgery. But it’s a long shot.
One of the few remaining Phase III studies for glioblastoma likely to read out soon belongs to Tocagen $TOCA which is making the difficult assault with Toca 511/FC. Researchers announced several months ago that they would continue to the final readout, dashing any hopes for an early success. There isn’t much confidence in this drug, though, with the stock falling from a high north of $15 last fall to just above $3 a share this morning. The market cap is holding at a micro-level $72 million.
These failures won’t encourage others to make a try.
AUTHOR
John Carroll
EDITOR & FOUNDER