Expert Financial Analysis and Reporting

There has been frenetic trading in Northwest Biotherapeutics stock as investors await the release of topline data from the DCVax-L phase 3 trial followed by the release of the full data set. There was speculation that the data could be presented at the Society for Immunotherapy of Cancer (SITC) in a poster session on either November 11 or 13. There was also speculation that the data could be presented in poster session on November 20 at the Society on Neuro-Oncology. Evidently, the company submitted titles of the abstracts some time ago as placeholders in the event that the full data set was available for discussion. This hasn’t yet happened so the company will not present either poster.

It made no sense to me in the first place that the company would present the results of a 14 year clinical trial costing over $400 million in a 15 minute poster session. The thinking probably was that the presentation could be shifted as a late breaker oral presentation if the full data set was available and positive. There was also speculation that the full data set would be released at the Brain Tumor Immunology and Immunotherapy conference. Linda Liau is scheduled to deliver an address at 4:00 PM on November 6th at the conference. However, this is not the case. Dr. Liau is a prominent neuro-oncologist who frequently gives lectures. Again this is not a venue where one would expect the trial results to be released.

The data lock was announced on October 5, 2020. It is probably the case that the top line data and some of the detailed results are known to a few investigators, but not necessarily management. So when might the data be released and what can we read out from the longer than anticipated (by many investors) time for releasing the data? There are two extreme outcomes for the trial.

• The first is that the trial failed to reach its primary endpoints and was a failure. I think that we can probably dismiss this as it would be a material event that would have to be immediately released.
• The other extreme is that the trial reached its primary endpoints and was a success. In this event the Company might not have to release results immediately. It would be a colossal mistake to release the data in a press release. It should be released in a peer reviewed journal or a medical conference. It could be the case that the Company is in discussions with one or more journals or conferences to release the full data set. If so, the Company must walk a tight line on what it can put out in a press release. Prestigious conferences and journals will not present or publish results of a trial if the key findings of the trial have been previously released. I am hoping this is the case.
• There are also possible in-between scenarios where the results are not clear cut.

Like many investors, I thought that we might have topline data by now, but we were probably not being realistic on how long it takes to do this. If the trial is successful, I think we could see a press release similar in form to one just put out by Pfizer announcing positive results from a Phase 3 investigational study evaluating the safety and efficacy of tofacitinib in adults with active ankylosing spondylitis that stated:  “The study met its primary and key secondary endpoint. The data will be presented for the first time during a late-breaking virtual oral presentation on Monday, November 9 at 12:45 p.m. ET at the American College of Rheumatology”. I think this is representative of the first press release that we might see from Northwest. We would have to wait for a conference presentation or journal publication to see the full data set.

In conclusion, I am reasonably certain that the trial did not fail outright. I am hopeful that the trial was a clear clinical success, but I can’t rule out the possibility for some equivocation in the results. We will just have to be patient and await the press release. In the meantime, the volatility of the stock is just noise. The extreme downside on the stock is zero and the upside can range from moderate to explosive. I am just sitting tight with my fingers crossed.