John Vandermosten: Alright, thank you and hello, Andy and Eric. Can you just give us a sense of any other checklist items that need to be completed besides the FDA clearance on the BT-600 trial before you can start your first administration?
Adi Mohanty: Yes, hi, John. So like I said, what we’re doing is going through that checklist of everything that we control. And so making enough material; getting all the supply ready; getting the site ready; getting our partners, the CROs ready; getting the protocols ready; getting the IRB ready. We’re doing all of those, and they’re well on track and we would be ready with all of those any day that we get the clearance from the FDA. What we’re not controlling is the review with the FDA. So we’re working closely with them, and we’re hoping that we get that done in November. And so tentatively, we’re planning that all the stuff we have to get ready on that checklist really is done, and that in December, as soon as we get the clearance, we go activate the sites, do what we need to do — and I think like somebody else mentioned, we can then share when we have started the trial in December.
John Vandermosten: Okay. Very good. It sounds like you could start very shortly after you get the clearance. And then moving onto on to BioJet, when do you think you have serious discussions with the BioJet partners on going to the next step, which would be in the clinic? And would you — might include potential and milestones and things like that. When do you achieve or reach that stage?
Adi Mohanty: That’s an interesting question. So the way I would hope we’re being clear people to understand. What we have now are research collaborations. These are great. These are ways where large companies work with innovative technologies, like ours, because they find that there is a potential that they could use that. They’re interested in it, but they’d like to learn how our technology and their molecules kind of work, and this is a way where we can get some cost-sharing, but the main idea here is to learn how to work together. Progressing through those is what leads to the next stage of conversations, which then is about what I would call the partnerships. So I’m qualifying these relationships, which we have, which are very much like partners, but they really are research collaborations.
And progressing those into partnerships, which then look like what many people might be used to seeing, whether it’s a licensing or some other sort of partnership that comes with an upfront payment, a plan, milestones — that’s when you get into discussions about what kind of molecule, what kind of kind of indications, what maybe a clinical plan might look like. There might be some situations where the company, like ours, helps them with those. There might be some where we allow them to run with it and they come up with their own plans. So I think what needs to be more near-term focus is that we are seeing tremendous progress with these collaborations. Over the last several months, we have gotten way better at execution, right? We’ve made the BioJet 2 which is our next-gen device.
We’ve done the animal studies to make sure that the device works. We then showed it to our collaborators who agree that the device works to a point where they want to include their molecules. We run their molecules in our device, and we’ve gotten that initial first one’s data. We’re expecting the second one’s data. In a month or two, we’ll get the third one’s data. Those data are what enable us to then have the conversation of, okay, given that this combination works, how do you see this relationship? So those could be near term, pretty interesting inflections, and they lay out certainly what the development path is. But for a small company, they could mean significant things in terms of how investors might view our relationships with, at that point, partners.
