Had a conversation with DI recently.
I'll start this by saying that he is incredibly calculated and as such, he predictably did not reveal any information that I would consider new or wildly interesting.
I took notes but did not record the conversation so I am not going to include any quotes in here. We scheduled a call and had discussions lasting about 30 minutes regarding some questions I had submitted to him, mostly around communication and how it was being handled with regards to aspects of business operations not including the PIII trial.
We opened with discussions focused on data release which was actually not my interest in calling, though it took up a good portion of our time. He reviewed the process they are undergoing to get them to data release, which was very much just a rehashing of the Oct 5 release and the ASM comments. He was passionate when discussing this, not quite defensive but close to it; he’d definitely had this discussion with numerous other parties in the past, ha. His main deliverable was that progress is being made, but they simply cannot report on it without unnecessary risk. Try as I might, I could not glean much information from him with regards to where they might actually be. Some things I picked up on that may have been slip of the tongue or could possibly have more meaning:
- He mentioned that they can’t just call these scientists and doctors and ask them to rush or give updates/timelines because their investors would like to know. This makes me think the authoring of the paper is complete and it is in review/approval stages. Now I’m not terribly familiar with medical journal publication processes, so I’m not sure if this would imply these revisions/iterations are being done pre or post submittal.
- He made reference to CVM rushing to release TLD without a supporting paper and getting beaten down even though they have some data and results that are actually, potentially, positive; said now they are stuck in a quiet period until scientific publication just like NWBO, but their quiet period is marred by a muddy TLD release. He stressed that the goal is approval, not getting TLD to market, and that rushing to release TLD does not get them to approval any faster. I know what you’re thinking and no, I did not take this as DI equivocating muddy CVM data to muddy NWBO data. I think it has more to do with how they are analyzing the data, which leads me to:
- They are obviously predicting criticism for going to historical controls, and believe a fully peer reviewed paper immediately available is critical to their timeline. He cited the recent trial design that the FDA approved the use of historical comps in.
- He continued to reference TLD and the journal publication as different items. Not sure how this translates to a data release timeline; I assume TLD released the week a journal is scheduled to publish.
- Absolutely no mention of a conference in the entire discussion; as I predicted prior, I do not think data release correlates with a conference anymore. If they line up it will be purely coincidental.
After this, we discussed Sawston in some depth. He confirmed that they are not in a quiet period with regards to operations unrelated to the PIII trial, but also stressed that they really don’t have much going on outside of getting trial results to the public. He said that material events at Sawston (MHRA application, results, etc) will absolutely be released as available. He said that any timelines involving site visits, travel, etc should be subject to Covid delays. He said that process is now entirely in MHRA’s hands to move forward. He outlined the procedure, saying they’ve got to work with MHRA to schedule a time when everyone can be on site, complete the audit, wait for their report and approval or findings which, if any, will need to be addressed. There was a moment where he mentioned that they had already been contacted to schedule the inspection; however he doubled back and corrected himself to future tense later so not sure whether that was a slip or a mistake. Either way, if they were delayed I think they are past that now and the inspection is either scheduled or already completed. I could not get any update from him on the Flaskworks prototyping and setup.
I questioned him with regards to financing moving forward, particularly their ability to remain solvent into ’22 when calculating their free cash and burn rate. He commented that their ability to raise capital in creative and non-dilutive ways has been very good. It sounds like they have almost full control over the warrants and are exercising as needed to cover any other deficits. They have no concerns for funding or needing offerings in the near term. It was mentioned that if the share price were in the $5-10 range it would be much easier to execute an offering that is amenable to all stakeholders. And don't read into that, it was not a sly way of saying they are planning on doing an offering once the share price hits $5+.
In all, as I said, not much new information to glean from this. I will say that he was speaking very freely; it truly did not come off as practiced, CYA, legal speak that he was reading from a form letter. I grilled him on shareholder accountability and the lack of updates on non-DCVAXL issues. He was understanding of the sentiment, but said multiple times that they just don’t have anything to update on outside of the trial. He said they could absolutely push a pump piece, but refused to do so. They are going to release material information, and that is it. On the whole, the conversation really didn’t change my outlook especially with regard to the trial. Perhaps alleviated a bit of my concern with management strategy; at least pushed my impatience out til October. Confirmed a lot of assumptions. DI’s accessibility, openness, and willingness to have discussions was certainly settling. Hopefully I wasn’t just getting team speak, it certainly didn’t come across that way and I’ve been in many investor meetings.
If you have questions on things I didn’t comment on let me know and if it was mentioned I’ll comment as best I can.
