I rarely post but have been an avid follower of this board for several years and a follower of NWBO for a decade.
I haven’t posted much because I lack specialized expertise that would be truly informative for you all but I do have a deep generalized knowledge of the company from following it for so long and a perspective that might help. For example, I attended the ASM meetiing last week as well as the 2018 meeting. I enjoyed the meetings and want to thank all the people who talked to me. Both times I was one of the last people to leave (5 hours after the start of the meeting last Friday). Note to everyone: The best part of the ASM is after they stop recording. Linda Powers is an extremely careful person who acts like Adam Feuerstein is hearing every word she says (as she should), but if you are attentive, there are also a lot of subleties you’ll pick up. After Ms. Powers stopped answering questions, there were conversations with fellow investors. Too bad more of you weren’t there. I can only imagine how great it would be to talk to DocLogic, iwasadiver, hyperopia (nice note today), flipper, thermo, lyriki, Sentiment, and many others.
I’m writing because I do think we have a buying opportunity right now and I want to encourage present holders of the stock to stay the course.
At the end of 2021 the stock price was about $.70 which is also where it is now. In 2022 the fully-diluted share count of NWBO increased from 1.478b shares to 1.523b shares, an increase of about 3% (after a less than 1% increase in 2021). Yes, there’s more dilution coming, and the numbers were greatly aided these past couple of years by funds from the exercise of previously granted warrants. This was good work by Linda Powers and Les Goldman which should be acknowledged. Also don’t forget the Sawston real estate deal that netted the company ~$50m at a very difficult time. I think that deal saved the company, or at least saved us retail shareholders.
So, in addition to the minimal dilution we also had a lot of progress with the data release, journal article, and the lawsuit - Linda Powers’ top 3 accomplishments. I’d also add the Pazdur article on external controls and Linda Liau’s statement that the FDA required the crossover in the Phase 3 trial. Those two points address the two most cited areas of vulnerability in the study results. Altogether major steps forward as well as major steps in improving our odds with regulators.
Looking forward, with manufacturing approval coming soon (hopefully Q1 2023) and submission of applications for final approval likely in several jurisdictions this year (my unexpert view: First half in UK and second half in US with second half UK approval?) we have potential catalysts. Personally, I think growing revenue from the specials program (others have previously reported that Linda Powers said interest has increased since the journal article) will get harder and harder to keep under wraps and this could become a significant catalyst for the stock price. Note, I asked Ms. Powers point blank why the company doesn’t announce/report specials revenue or patients and she said the regulator would be extremely upset if the company used words like sales or revenue in regard to the program and it was clear to me she doesn’t intend to touch that with a ten foot pole (my analogy).
I also think the blinded combination study interim results recently presented by Linda Liau will be critically important this year. Personally, I think a publication based on the five year data would be ideal, but even without it presumably the FDA will be aware of the data (experts please weigh in). It’s one thing for reasonable people to debate over external controls and crossover in the P3 study for the DCVax-L 2.9 month increase in OS, but when you are talking about a 10x increase in five year survival from 5% to 50%, then issues like external controls and crossover are reduced to petty hair-splitting because even though it’s preliminary data, the almost total lack of side effects takes away the downside. I think that logic is a train that the FDA wouldn’t want to stand in front of, especially since the UK will almost certainly have already made its (positive?) decision.
I hope that 2023 will prove to be “the year” for NWBO, but we shouldn't draw lines in the sand. Instead, think of NWBO as a tortoise. It’s slow but it will eventually get where it is going.
