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lol yup a real pro
Northwest Biotherapeutics: No TLD Yet
Dec. 19, 2021 12:12 PM ETNorthwest Biotherapeutics, Inc. (NWBO)14 Comments
Summary
NWBO still has not announced toppling data, or TLD.
This situation has been ongoing for more than a year after data lock.
I will continue to hold, but will not add to my small position.
Today is exactly one year since I wrote about Northwest Biotherapeutics' (OTCQB:NWBO) impending unblinding. Given what we saw from interim data in 2018, and the pedigree of DCVax-L, and the experts vouching for the product and so on, and not to forget the 18-year long trial, nearly unheard of in biopharma - given all of these, the unblinding would have been a momentous affair. However, after more than 14 months of data lock, we still do not have unblinded data from the trial.
The thesis is simple enough. Glioblastoma patients hardly survive a few months after the disease is detected. 12-18 months is the average survival, only 25% live beyond one year, only 5% beyond 5 years. Patients from the Phase 3 trial of DCVax-L have continued living way, way longer, with median survival of more than three times the standard GBM patients. However, because the trial is still blinded, we still do not know if, by some miracle, placebo patients have survived this long. If only DCVax-L patients have shown such outstanding survival rates - which is the likelier explanation for the data - then these results are truly outstanding. However, the company's unbelievable delay in unblinding the data, and their studied silence, have wrecked the stock.
In their latest 10-Q, as before, the company has continued to blame Covid-19 for the inordinate delay:
As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.
Northwest Bio is not the only company running a trial during the pandemic. Other companies have successfully completed trials and had their drugs approved. Even the FDA, which from all indications has suffered the pandemic poorly, has continued holding PDUFAs and approving drugs. Therefore, Northwest Bio's long Covid-19 disclaimer does seem a little too defensive. The company is nearing the brink of a financial precipice, and doubt remains about their being a going concern for too long:
Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company's ability to continue as a going concern within one year from the date of this filing.
Northwest Bio managed to get $15mn financing in late November with what appears to be considerably lenient terms given the situation:
Northwest Bio…announced the closing of a $15 million financing on November 22, 2021, which brought the Company's cash reserves above $20 million.
…The financing is in the form of a 22-month loan which requires no payments for 8 months, and then provides for a subsequent 14-month amortization period. The loan has a provision for prepayment, an annualized interest rate of 8% and OID of 10%. Upon announcement of the top line data ("TLD") from the Company's Phase III clinical trial of DCVax®-L for Glioblastoma brain cancer, the lender will have a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount, and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after that post-TLD private placement.
Clearly, the lender is hoping for superb top-line data from the trial, when they can make a windfall by buying shares at a discount.
This lender has more money and more optimism than a lot of us NWBO shareholders. I took a position in NWBO three months ago, and my holdings, although small, have fallen in value by nearly 50%. I do not plan to increase my position, however I am not going to sell out either. They just announced that their UK facility has been granted a license to work with human tissues for medical products by the UK Human Tissue Authority (HTA). They also announced that the UK Medicines and Health Products Regulatory Authority ("MHRA") has inspected the facility as part of a process of granting license to manufacture products like DCVax-L. Northwest Bio will continue to make such minor announcements, and shareholders such as us will continue to hope, against all logic, that this company will one day deliver what we have been waiting for nearly two decades - TLD.
This article was written by
Avisol Capital Partners
who needs enemies such as AF if you have friends like NWBO management lol
I think NWBO once again underestimated how long the journal publication would take and then also all kinds of events happend since datalock. After they cannged their minds to publish an scientific article in coordination with TLD they could not chance their minds back again. And thus here we are waiting for the publication in a scientific journal which took months longer than the 14 months medium publication after datalock according to DI.
yes as poorman has been saying here for a long time NWBO will be acquired I agree. But remember this is NWBO and in the world of NWBO everything goes much much slower then on planet earth.
If Einstein would still be alive, he would be all over this incredible rare physics phenomenon called NWBO and probably had to rewrite his idea on time and mass.
After publication it will take many many, many months before the acquisition of Northwest will be announced. We will need formal approval by all 4 RA’s, we need uplisting etc months months
poorman IMO if the results were gray or grey than a scientific outlet would not be of much interest to an scientific outlet and NWBO would be deprived of its publication. In that case NWBO had to disclose by now that a scientific publication is not feasible or correct their still standing statement that they are working on a scientific publication. just MO
wrong on 3 accounts first "Germany" did not say anything. The EMA, which is not Germany, however bought in NWBO new endpoints. The UK follows the EMA
I don’t think any of the latest wait has anything to do with the possibility of questionable results, I instead believe it has to do with reimbursement and manufacturing capacity considerations.
it sounds like you are really disappointed?
At some point they will have to publish the article or they had to disclose they will not able to. And the not being able to publish the article deadline has come to pass long agoe thus we will see the publication given the few months delay after 14 mOS soon enough.
The reason they are refusing to release the data is because it is bad
Jan or Feb is what I think
The company has repeatedly stated they would only want to disclose TLD in coordinated with a scientific publication. DI has said publication has a usual timeframe of mOS 14 months after data lock but is now confronted with a few months delay because of Covid. So Oct 5 2020 + 14 months is Dec 5 2021 + 2 months delay is…. Exactly
If you look at the history of DCVAX L trial you will understand NWBO has a LOT of positive explaining todo pseudo progression, endpoint change, GBM definition change by WHO and thus its incredible understandable they want to coordinate TLD with a publication. IMO if they had disclosed TLD in Nov 2020 then A. Medical KOLs (and not shorts or AF) would have asked many understandable questions left unanswered and B. They had to recalculate and again disclose TLD after WHO redefined GBM
The SP decline is warrant holders that have haven exercised and selling because of profit taken after nothing had happened after SNO AND NWBO letting these warrant holders exercise. Remember NWBO did manage warrant holders NOT to exercise for almost 1 year but that cat has been left out of the out of the bag now by NWBO. Also the risc off market and biotech down does not help either. All IMO
we are in the same team Cherry I understand the tremendous potential of DCVAX platform. NWBO is therefore tremendously undervalued IMO, your opinion and many longs opinions.
Most listed companies are being valued by its future cash flow/market potential, reality however is that mr market has put NWBO for now on a first see then believe basis and does not recognize its future potential until proven otherwise. So buy opportunity!!
its a true statement and for the following reason.
It would be of a tremendous utmost extreme stupidity to lock the database without discussing with the FDA their stands on endpoints change. If the FDA advises to do some parts of the amended SAP differently than then that is very difficult to adhere to after the database has been locked already.
Second. Despite as what others (ex) may tell you. Its no big deal to change endpoints / adjust SAP with the FDA prior to datalock. The only rule the FDA will impose is the employees/staff involved in the SAP adjustment must be objective.
Go ahead and Google FDA policy towards endpoint change/ SAP adjustment prior to data lock. You will notice it is as I described.
Third. Its well known that any biotech with any meaningful clinical trial are in regular discourse with the FDA especially when it comes to SAP adjustment. If the FDA would have advised against the change IMO that is a material event ans must be disclosed
. . . so you think this is just more warrants being exercised driving the price lower?
we will need a special stock holders meeting to vote for a split. In Delaware 2/3 of votes are needed if Im correct. This is NOT going to happen without TLD
there is no evidence of anything heinous going on. The short interest is still at a very stable all time low. So until then I assume from about 1.3 till where we are now I am pretty sure its warrant holders selling and taking profit (not Thermo).
All actions in life have more ore less consequences. The partially understandable giving away of warrants at 25 / 30 cents over the last 3-4 years to get finance has resulted in converting ans selling and here we sit at the ridiculous low MC of a company introducing an effective treatment for solid cancers. NWBO could have invented a medicine for curing Alzheimer’s AND cancer it would have not made a difference.
The only rational is how incredible ridiculous undervalued NWBO is
Will buy 100k more at sub 60 cents
lol thats good to learn Thermo so am I
why on earth would any one dump, sell at best, 6,7,8 million shares 30 minutes before close? Mind boggeling dump
well said 10 well said 100% agree
So, when they should have been averaging down, they were afraid because they felt they were already losing money and didn't want to risk more
“The cert will be for the production of vaccine for the specials program."
This also puts to rest any speculation that Advent is certified for anything other than DCVAX L. Otherwise Advent will be producing any cell therapy illegally.
After approval its not specials program but regular progam
not really. If you have zero trust in LP/LG then the science can do a lapdance at the back of the moon and it would not get anywhere. The science really needs LP and LG to get ahead
I get the staying put part Im not on of those childish longs that tell others to sell if they read something the dont like.
But buy more if you have zero trust?
Anyway its going to be all just fine also for the shares you are planning to buy
This is biotech NOT for the faint of heart...
I’m not selling and plan to buy more. vs I have zero trust in LP/LG
Can you help me understand this contradistinction?
Ofcourse LP and LG have their flaws, should communicate much better and they had a hell of a lot to go through to get where we are not but ZERO trust and still buying more???
The whole risk on market is down and has been for a while (look at the XBI) due to pending interest rates hike + little buyers on no news.
I will be buying 100k shares soon again.
Like Viking said if you have dry powder buy if you dont sit tight and wait for TLD+publication
Its NOT a loss in your account unless you sell or unless you ar a day trader
NWBO is worth
A. What the market says its worth after publication and TLD
B. What the market says its worth after approval
C. What the market says its worth after uplisting
D. What Merck, management and SSM say after Buy out
Everything before that is just noise or a buying oppertunity even if its 15 cent per share
yep its nice to know things so let me help you.
First of all you really should Google what a forward-looking statement is before you respond. A forward-looking statement predicts, projects, or uses future events as expectations or possibilities. Advent using manual production to get certified is not a project, future events as expectation, its reality. If you say otherwise then you are saying Advent is where it was 1 year or longer ago when it was just a plan and they have been sitting avround doing nothing but making plans for Advent certification. Is that what you are saying?
Second. Under the Private Securities Litigation Reform Act of 1995 it is determined that only if the listed company includes a form of a disclaimer that states that any instance of the forward-looking statement found in their material is only true at the time it was written and is under no obligation to update such written statements if conditions change or that unexpected occurrences happen to affect the statement afterwards. Such forward-looking statements, however, must be identifiable by the use of certain prescribed words.
NWBO never used such language on the subject discussed because of my first given reason. Therefore if the manual production to get Advent certified had changed, as Flipper asked, then they had to disclose this as such.
Flipper if a plan is publically disclosed by a listed company and that plan changes (for example the intention to publish a scientific article on unblinded DCVAX L trial) then that change of plan should by SEC regulation be disclosed by the company.
NWBO has stated more than once that they intent to run Advent using manual production if that plan had changed they should disclose that..
But this is NWBO so you really never know for sure
thanks Lykiri great DD and final verdict
as in leaving NWBO just before a huge run up and entering a stock that already is way ahead of itself...? bad move
the Checkmate 548 abstract is 3 weeks old and highly relevant to discuss here for obvious reasons IMO
thank you flipper verry interesting, reassuring and educational.
Essentially the Checkmate 548 TLD results are meaningless to the general public until the full demographics/stats are provided.
and they do a disservice by not making an attempt provide stats and demographics
In my opinion, they new the likely outcome before they started the trial, and tried to pad both arms so that the Opdivo arm wouldn’t look terrible. You see this phenomenon more and more in trial designs.
NWBO is taking a different approach and it’s going to try to provide as much detail as possible when results first come out.
DI confirmed via txt yesterday, that "We will let you know when we get cert."
I agree with your market cap prediction.
But please keep in mind that the 15X revenue multiple (recent ISI number) is based on actual realized revenue by NVCR over 2020 and not its prognose for 20021 or 2022 (which looks pretty grim after DCVAX L is approved).
Since DCVAX L revenue could grow as big as 3 billion, x15 would mean a MC of 30 billion in the future and at least 50% of that after or just before approval.
I believe NVCR MC has diminished because of the redefinition of GBM by WHO which should put the Helmet out of business if the FDA was any backbone they should revoke the Helmets license now IMO.
thank you for the additional explenation sentiment_stocks super appreciate it!
What we don’t know is how those methylated and unmethylated patients were divided up.
Thank you very much for answering my post. I am less stressed now I have read you answer and even more confident DCVAX L is a winner.
Methylated mgmt + idh-1 mutant are extremely long lived when combined
mr Dude first of all thank you for your warm welcome I appeciate it,
Im not Fudding and Im a serious long with a question about the Checkmate 548 publiaction and I though to ask here.
Im sorry if that question might have upset you
And on being new. Everyone was new once here right
best regards
hello fellow longs
Im new here. I have been reading this board for months and its time for me to jump in. I have been a NWBO long for 4 years now
Mr Flipper44 thank you for your wonderful posts here they have helped me through the years to keep adding to my long position with convidence.
I have a question
You post does not explain why the Methylated MGMT was previous: mOS = 21.2 months and now 32.1 in Checkmate 548's placebo survival
what was so special about the Checkmate 548's placebo survival that all over sudden it shut up to 32.1 months? Do you know that?
Also do you think this Checkmate 548 publication will delay the publication of the DCVAX L trial results article? I hope not. I mean do the KOLs no have to take into account this 2 weeks old Checkmate 548 publication?
Thank you for answering I appreciate your answer immensly
best of luck to all of you