Slightly outdated but still a good read:
Northwest Bio, Wow!
Oct. 9, 2020 4:12 PM ET
|
22 comments
|
About:
Northwest Biotherapeutics, Inc. (NWBO)
Bohsie Research
Long Only, Deep Value, Special Situations, Biotech
(176 followers)
Summary
With Data Lock just announced, Top Line Date is imminent.
Numerous statistical and mathematical markers from available data shine a positive light on potential trial results.
The company may have a lucrative option even if median Overall Survival does not meet the secondary endpoints.
I have written about DCVax-L and Northwest Biotherapeutics in the past, crunching numbers, and statistically analyzing blinded data, and more so now I believe that even with the jump in share price, this undervalued stock has huge upside potential even in the worst scenario. With the blinded data we already have, and the last patient enrollment in November 2015, there is enough information already to show DCVax-L is a good investment. Here are my reasons:
1) We know that over 25% of the patients treated are showing a PFS greater than 15 months (and more likely 17 months +) (see
my article) with the last enrollment occurring in November 2015, and the 248th PFS event occurring sometime between end of December 2016 and February 2017 (
Article). With pseudo progressions being removed, even more so 15 months is unheard of, and no other trial has shown median PFS results over than 10 months. The Achilles heel of this trial is by no means the PFS Endpoint (mPFS), but rather the original secondary OS outcome (mOS) due mainly to the crossover.
2) This takes us to Overall Survivability. With the crossover, and with an effective vaccine, DCVax-L could actually ultimately hurt the trial itself by not meeting the 2 month increase in median Overall Survival. However, we know that the blinded mOS results are nearly two months greater than the blinded median OS results from the Optune trial, and over seven months greater than the SOC. And that is the blinded results. For the secondary outcomes to fail, the entire intent to treat population would need to show similar results to the treated Optune population. Additionally, there are shorts that try to add skepticism to these blinded results stating that all the intent to treat population used Optune treatments, resulting in the increased overall survival, however, as a statistician, this is statistically improbable, and secondly, the DCVax-L trial has been operating well before the Optune trial, years in fact. However, as I mentioned, if the vaccine is truly effective, then there is a chance that the two month increase will not be met, however, if that is the case, NWBO management will have a very strong case to compare these results to SOC populations, as recently approved by the FDA. I also wouldn't be surprised that NWBO rolled this comparison into their trial design when they recently received approval for their SAP (Statistical Analysis Plan). One area we do know that they are analyzing is with Methylated MGMY patients.
3) And that comes to my third point, Methylated and unMethylated MGMT patient data from blinded results show drastic increases in overall survival with increases of seven and nearly 10 months from blinded Optune results (see
Statistically Significant article). If even one of these sub-population show drastic increases, these in itself will provide ample justification for approval of a vaccine that shows little if any side effects.
4) During the writing of this article, it was determined that not only was the
SAP redefined in the EU, the primary endpoints of the study are now OS compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed gliobastoma. We already know that the blinded data shows much better results than control patients in every trial done to date, so this in itself is a huge positive assertion that there is a very good chance that the results will be positive. Additionally, a secondary endpoint is overall survival compared to contemporaneous clinical trials, in patients with recurrent GBM. I would even bet that this is similar to the SAP here in the U.S.
So after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily provide Linda Powers and her board ample bargaining power to sell NWBO's proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range, providing a share price of between $14 and $28 per share. Even if Big Pharma kept their wallets tight, a buyout of $5 billion would readily attract one company that feels like they are trailing the immunotherapy curve.
Of course, as is the issue with all stocks, risk plays a significant role, and this should always be taken into account when investing. However, as I have said many times, this stock has significant upside potential, even after the stock recent surge near the $1 range, it has the potential to skyrocket ten to twenty fold or more with positive results. I liken this stock to buying a lottery ticket with much better odds then one would ever get. However, one does not buy a lottery ticket without the understanding that it is not a given, and money may be lost, but the upside may be huge. At a share price hovering under $1, and the top line data expected any week, or even day now, this is readily an investment worth the risk, as the payoff may have you saying, Northwest Bio, WOW!
Disclosure: I am/we are long NWBO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: As with all stocks, there are risks associated with this recommendation, so understanding these risks and doing your own due diligence is necessary prior to investing.
