Readers are fascinated by this company struggling against great odds to develop a treatment for the very deadly glioblastoma.
DEDUCED RECKONING: Northwest Bio awaits trial results
By Joan Lappin
Nov. 12, 2020
My column last month about Northwest Biotherapeutics generated a global response from readers as distant as Northern Belfast and Japan as well as throughout Florida seeking more information. You gotta love the internet. Readers are fascinated by this company struggling against great odds to develop a treatment for the very deadly glioblastoma that took the life of President-Elect Joe Biden's son, Beau.
NWBO, which we are invested in, has spent the last 14 years working on its product DCVAX-L. The last improvement in treatment protocol was approved in 2005. Only 6% of patients survive for five years using that combination of surgical removal of the tumor, radiation therapy and Merck’s highly toxic Temovar. On average, patients survive about 18-20 months.
Because there are patients walking around cancer free many years after receiving DCVAX-L, the company persisted through constant attacks that the drug was not effective and extended the trial for a full five years after the last of 331 patients was enrolled in 2014. Over 400 other trials have failed in this interim.
This summer, the company announced that it had locked data from all global treatment sites. Due to COVID-19, it was difficult for some data to be rechecked for accuracy and groomed for analysis. On Oct. 5, NWBO announced the data was ready for submission to the independent statisticians for final calculations shortly thereafter.
In an earlier press release, NWBO suggested that “within a couple of weeks” of submission the statisticians should complete their work. “Only then will the company be unblinded to the data.”
It is now over four weeks since the data lock so shareholders have been nervously awaiting (TLD) Top Line Data detailing its ultimate effectiveness. We do know that the company, per SEC rules of material corporate developments, had four days to announce if anything had been amiss. Happily, that, has not happened.
In the 14 years since this trial was initiated, there have been many medical discoveries with regard to both genetic testing and treating glioblastoma. Remember that the mapping of the human genome was only completed in 2003. It is only recently that genetic testing has become cheap and affordable. Genetic biomarkers are now identified that help indicate which persons might most benefit from a particular personalized treatment like this one. It is now known that 40% of the population have MGMT, a DNA repair enzyme that facilitates curing glioblastoma.
In just the last few years, Dr. Linda Liau, NWBO’s lead investigator, and others researched IDH, another genetic factor, that is present in 10% of patients. Some time this year was spent to go back through detailed patient records and tumor slides to retrospectively determine the presence of both MGMT and IDH in the cohort of 331 treated patients.
The regulators in the four countries to which NWBO is applying for approval (UK, Germany, Canada, and USA) are well aware of the vast improvement in knowledge about this dread disease since the trial began. That is why the UK and the EU recently accepted revised Statistical Analysis Plans adjusting for this new information on which approval may be granted. Those announcements were a significant factor in the recent upward trajectory of the stock.
NWBO has amassed an incredibly complex set of data that is both at least five years long for each patient and broad in its depth. Therefore, it seems to be taking the statisticians longer to analyze than originally forecast. The company reserved speaking spots at various conferences this fall but not yet having been unblinded to the data, it is not yet ready for a robust presentation. Therefore, several were canceled including the SNO conference on Nov. 20. The next such 2020 opportunity I found online is at the Glioblastoma Conference on Dec. 8. Or, alternatively, the information could be first presented in a major medical journal.
This is a small company undertaking a giant task with a very small, overworked staff. Its timelines are rarely correct. It also thinks that “silence is golden” when its guidance is optimistic instead of issuing updates which investors might appreciate. Insiders and very patient long-term holders own most of the stock and are inured to this annoying reality. The price action is now determined by recently arrived retail day traders who have been attracted by the stock’s sharp gains in 2020. Many such momentum players are losing money now adding to the wild swings in price.
So, we nervously await Top Line Data from this trial which can still fail. I repeat: buy this stock only with money you are prepared to lose if the trial fails and is not approved.
Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
you would realize I had invested in this stock with a six figure USD amount back in 2016. Today I have had multiple times the shares I had in 2016 when I started posting here in the above thread due to repeated average down, particularly in the range of below $0.20. I have also mentioned I have averaged up in re(ce)nt month as well. Now with a very large paper profit sitting in about 9 accounts, nervous yet confident
While we are waiting, it is inspirational to watch patient's story on how DCVax-L saves life.
Jamil Newirth was diagnosed with Glioblastoma (GBM) brain cancer in 2012. He was told by his doctors he had about 17 months to live. He found Dr. Linda Liau, and was treated with DCVax-L. Jamil is still alive 8 years later & he founded a non-profit to help other GBM patients.