Normal. Those who hoped to make quick bucks on the basis of a negative news (a no brainer for them) by shorting got burned while those who thought they could sell and buy back cheap regretted too.
Exacerbated on the fact that some funds which still have a stake would sell as the rules of their funds dictate.
As a result, share price initially went significantly low, down around 35% after market and down further to around 40%, then up some as selling dried out and buying started getting in in the next day trading until the news released in the afternoon. At the end of day, the price had been up about 70% from the low.
The market having been so used to negative news, which are honestly more than abundant, saw some light at the end of tunnel from the news released the next day, which is significant as it is the first time the company has directly addressed the trial.
All in all, this is not a normal stock. It has been and will continually go extremes. It is a major battleground stock, but ultimately it will all depend on the trial results.
Well since my last couple of posts in reply to two readers which even received no acknowledgement, obviously not much interests here in CFC, I have felt disheartening and lost interests to post anymore. Well, a lot have happened since then. Below just a quick recap for my own record:
the company voluntarily moved to OTC from NASDAQ for being able to finance continual operations
it raised about 11 million
Remember Kat, the beautiful and young British lady? Her recent scan showed her cancer has not come back. Great for her!
Finally, FDA has listed partial clinical hold placed on the company, and the company has reached its targeted 248 PFS events for primary endpoint readout, and has yet to reach 233 targeted OS events. See link below:
Personally I think the lifting of the hold is big in and of itself. The trajectory from here should be steady climb, though not in a straight line fashion and the comany may still need one last round of financing to get topline data readout.
Too many things have happened and the share price has kept falling as the company awaits for 233 OS events to be reached, which is expected to be in June or July this year.
Financing has always been an issue for this company, many potential investors have withheld due to concerns about further toxic financing, thus probably huge dilution.
All in all, it will all come to one's level of confidence on whether the trial can bear a FDA approval fruit. I have bought more shares as my confidence has not changed as finally we now see some insider activities.
Time to hash out a strong buy thesis again on this first day of 2018:
Those who have constantly instilled fear, uncertainty and doubt (FUD) now have a clear and loud answer:
-- the company has secured enough financial resources, not a month or weeks worthy of operating funds, but the resources which are enough to see the data of DCVax-L trial. So gone are the constant suggestions of bankruptcy, imminent default, reverse slit, and further dilution;
-- the company has come all the way into 2018: it passed planned PFS, OS analyses and entered a new phase. By doing so, it ushers in a triple insurance for the success of DCVax-L trial. So gone are the wishes of those who want the company to fail at PFS analysis dreaming pseudoprogression would not only wreak a havoc but deal a fatal blow to the the trial, those who want the company to fail at OS analysis hoping the confound effect of crossover (arm) would not only wreak a havoc but deal a final blow to the trial due to undistinguished difference between arms or a weak p value, those who have desperately wanted the company to stop the trial when the planned PFS and OS events had been reached. Instead, the trial is ongoing into a new territory just as FDA has also ushered in a new era with more favorable, flexible, caring and discrete policies toward cancer treatment developments;
-- the science behind DCVax-L is strong with numerous live examples of its wonder in treating GBM patients, and its mechanism of action (MOA) is concrete with a delicate balance no other treatments can ever never dream off as it is to be acted on human's complex brain to fight off the most heterogeneous malignant GBM tumors. So gone are the persistent nuances as if DCVax-L were designed and had been tested to be a perfect solution to the dread disease GBM (so shorts have constantly picked some imaginable bones from inside the egg's shell in order to instill FUD). Instead, in our stride to ultimately conquer the deadly GBM, DCVax-L will be proved to be the first stride in the right direction to a solution of completely defeating the ugly GBM. We know there are still some uncertainties and that is why the ongoing test, and we have endured hardships, and a long journey until today: now we know that journey will be a pause with the first successful stride in sight!
Now we hope, anticipate with new found confidence: we will achieve that first stride by meeting 1) the designed PFS requirement, and the designed OS requirement and/or 2) either the designed PFS requirement, or the designed OS requirement and/or 3) strongly favorable long-tail OS at the times of 2, 3, 4 and 5 years.
So goodbye to those who want the company to bankrupt, those who want the science to be another victim, those who have placed the short bets dreaming of making utterly excessive personal gains at the cost of delaying human's efforts to defeat cancers, whoever who have been and will be beneficial in seeing our endeavors, hardships, tears, and passions go in vain.
From our continually updated DDs, I see no hope for those fellas and their short positions in 2018 and beyond. We may see an increased trading activities with slowly steady appreciation of price.
Happy New Year, good fortune to patients, investors and anyone who cares!
I am expecting a manuscript discussing blinded data from the 331 patient phase 3 trial of DCVax-L in newly diagnosed glioblastoma will be published in a peer reviewed journal in the immediate future. This paper has been co-authored by most of the investigators in the trial.
The design of the trial allowed for patients started on SOC to receive DCVax-L if their cancer progressed. As a result, I estimate that: (1) about 221 patients were started on DCVax-L, (2) about 110 patients were started on SOC and roughly 76 of these patients were given DCVax-L when their cancer progressed, and (3) only around 34 patients received just SOC.
This trial is essentially a one armed study of DCVax-L. The results for mOS as shown in the expected manuscript should be an excellent proxy for what mOS will be when the phase 3 results are unblinded at some future point.
There is great deal of historical data that shows that mOS for SOC is about 16.5 months. As discussed in this paper, if the mOS for the blinded 331 patients shows a 2.5 month improvement in mOS (19.0 months versus 16.5 months), there is a strong chance for approval. The last drug approved in newly diagnosed glioblastoma was temozolomide in 2005. It showed a 2.5 month improvement over what was then SOC. Subsequently temozolomide was included as part of SOC and given to almost all GBM patients
Key opinion leaders consider an improvement of 4.0 month in mOS in an aggressive cancer like newly diagnosed GBM to be a major advance.
An 8.0 month or longer improvement in mOS would be a home run.
This data should also give an idea as to whether there is a survival tail. If roughly 25% of patients are alive at three years in this trial, this would compare to 15% expected with SOC. In other words 10 more out of 100 treated with DCVax-L would be alive at three years than would be the case if they received just SOC.
Why is that important? It is because the checkpoint inhibitors like Opdivo and Keytruda had survival tails like this in metastatic non-small cell lung cancer and metastatic melanoma which are aggressive tumors like newly diagnosed glioblastoma.
It is the survival tail of Opdivo and Keytruda (keeping 10 more patients alive at three years) that excited key opinion leaders and has led to these and other checkpoint inhibitors as a group reaching $9 billion of sales following their introduction in late 2014.
The mechanism of action of DCVax-L is such that it is reasonable to think that it might show efficacy in most (all) solid tumors-lung, breast, colon, etc. Newly diagnosed glioblastoma might only be the first indication.
A savage social media attack on the Company combined with extremely aggressive naked shorting has resulted in the stock selling at $0.25 per share. It is priced in the expectation that the trial will almost certainly fail. If DCVax-L is eventually approved as seems possible, this might well be the most amazing story ever told in biotechnology. Let's hope so.
I don't know why I am still interested in posting anything more? Apparently, people in Ottawa are more interested in buying a second house, the third, the fourth, and now are focused on preventing a specific party to get into the rein of the provincial power. Anyhow JFYI, below is a publication of some blinded, blended interim trial data on DCVax-L:
Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) to standard therapy for newly diagnosed glioblastoma.
After surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS).
For the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone.
Addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival.
It is now known that the purchaser of company's UK property is Huawai, unbelievable. It seems there is more behind this very generous deal from Huawei -- Huawei may be expanding its shares in biotech sector thereby diversifying its business -- I believe there is more news to come, not simply just this seemingly land purchase deal -- one thing is that it will help nwbo to automate future vaccine preparation to lower the cost.
From 8-k today https://www.otcmarkets.com/filing/html?id=13119000&guid=X2_8U619PyC6M3h "On December 14, 2018, Northwest Biotherapeutics, Inc. (the “Company”) completed the transactions with Huawei Technologies Research & Development (UK) Limited, an unrelated third party, involving the Company’s UK property: the sale of most of the property for approximately $47.3 million in gross proceeds, the retention of the Company’s ownership of 17 acres of the property, which the Company believes will have substantial additional value in the future, and the lease-back of the 87,000 square foot manufacturing facility which the Company has been developing on the property, together with adjacent areas, for up to 40 years (in two 20-year terms) on favorable terms."
With this fund, the company has at least had enough funds to complete its phase III DCVax--L trial. It will be a fascinating story unfolding shortly after.