Northwest Bio: Biopharma’s Promising Delinquent (OTCMKTS:NWBO)

Cozy Window Nook with Open Journal And Coffee

Elle Mundus

I covered Northwest Biotherapeutics (OTCQB:NWBO) in 2018 for the first time. Then in 2020, when their so-called trial was locked, I began covering it more often. I was hoping that like any normal company, NWBO will unblind their trial, publish their data, and get on with the regulatory process. So I covered the company 9 times so far, out of which 3 times I said Buy. Prices at publication for these 3 articles were $1.36, $1.24 and $.71, respectively, and the dates were Dec 20, 2020, Oct 13, 2021, and May 21, 2022, respectively.

While these calls would have made money for intrepid investors who sold out at the slightest profit, generally, NWBO stock has been a disaster. Indeed, it is not so much the stock but the company that has been the disaster. If I want to list the reasons for this, here’s how it will look:

Unbelievable delay: DCVax-L’s GBM trial is among the longest running industry sponsored trials. Here’s a list of some of the longest running trials. Note that all of them seem to be non-industry. I can see how that may work; a trial just gets bogged down in governmental inertia. But for a profit-motivated company to run a clinical trial for twenty years is unheard of, unthinkable, obnoxious, ugly.

Lack of communication: It is not that NWBO doesn’t release press releases – it does. However, they do not “interact” with people. They release these PRs from a lofty platform, talking about the Sawston facility and a financing plan and so on, when investors are dying to get answers to their questions about the GBM trial. Moreover, since ASCO 2019, they haven’t been to any major conference anywhere, barring this [The Industry Expert Theater is not an official event of the ASCO Annual Meeting]. These are foras where people can ask questions, interact. NWBO behaves like government; there are announcements, but there are no interactions.

Lack of clarity: There are tons of issues which bears have used to malign the company. Pseudoprogression, changing of endpoints, changing of protocols, switching speakers at the May 2022 data announcement; however NWBO never defends itself. You will never see a whitepaper or even a tweet anywhere from them clarifying issues. While normal companies do not do that usually, NWBO is not a normal company. Investors deserve that the company defends itself – and them – against relentless attacks. Again, normal companies don’t need to do that, because their data speaks for itself. But NWBO is not a normal company. Its data doesn’t “speak” for two decades. Meanwhile, shareholders are decimated.

So what now for Northwest Bio after their May 10 data announcement? Admittedly, the data was outstanding. I have discussed it all before. But now, after 5 more months of stunning silence, investors want to know – when are they filing for approval? Are they actually filing for approval?

Next steps

NWBO announced results from their GBM trial at the NYAS in May. Actually, that’s not exactly right. NWBO did not announce results. Results were announced by a third party – Dr. Paul Mulholland, MBBS, MSc, PhD, FRCP, University College Hospital. In the acknowledgements section, there was no mention of Northwest Bio. Investors are confused. This does not look like TLD – topline data – which are supposed to be way more exhaustive, include much more information, like demographics, baseline characteristics, extensive/complete safety and AE data, and so on. This looks more like a summary, and from the acknowledgement, it seems orchestrated by Dr. Linda Liau and other academics. There is no publication yet in a peer-reviewed journal or in a forum of peers, like a major conference. Like the company said about the NYAS presentation:

Additionally, the slides used in the presentation will be posted online concurrently with or promptly following the presentation at Virtualtrials.org/Dcvax. The slides will not be posted on the Company’s website. [emphasis mine]

I think that should be the next steps here for NWBO to make. Instead of making noise about their Sawston facility, they need to announce a major publication first.

After that, they should file for approval.

Do they have the cash to do all that?

NWBO has a market cap of $700+mn and a cash reserve of only around $7mn as of June. This does not take into consideration their $15mn debt facility, which will be triggered once they announce TLD. Was the May data drop TLD? I said yes earlier, but now I have my doubts. How does a company get so complicated a guy cannot figure out if the data they announced is TLD or not?!

Anyway, they don’t have much cash, right now, but if they get to TLD, they will have a $15mn lifeline. That should be enough to see them through. Or the CEO can come out with a major loan, like she did a couple years ago – for major share/warrant considerations.

Bottomline: should you buy, sell, or hold NWBO?

At risk of sounding funny, I want to say “neither” to all three questions. Does that make sense? It does, to me – what I mean is, if this company did things the normal way, then this data would make for a superb investment. But they don’t do anything in the normal way, so I don’t know. I can interpret the data, I can understand that the people behind the data have excellent pedigree. I cannot for the life of me interpret what NWBO is going to do. And that, my friends, remains the problem.

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