Immunic 3rd Annual Guggenheim Healthcare Innovation Conference

Yeah, for sure. Thanks for having us, first of all. I think it is a really exciting time for us. We have two pivotal trials reading out in December, so we are right around the corner, right on the threshold of that data. These are two studies called ENSURE-1 and ENSURE-2, and they would, if they are positive, result in an NDA filing and approval in relapsing multiple sclerosis. So, I would say our priorities really are preparing for that readout, building the commercial launch apparatus and infrastructure to support it. Then we just announced last week, progressive MS study, a third pivotal trial in progressive MS called the ProTEct-MS study, that we are initiating right now, expecting the first patient in the first half of next year.

Yeah. I mean, I think I joined in June. I joined following 19 years at Genentech Roche. The reason I'm probably here is I was a part of launching ocrelizumab, which is the most prescribed MS medicine in the world today, and it was quite an experience to transform the MS market with the introduction of anti-CD20s. That was a decade ago, though, and I think I came because the unmet needs today are extremely clear in MS. They're as clear today as they were then, and I think the market is ripe for disruption again, and that's where I think this is allowing us to sort of lean in. As you said, I mean, I'm not the only new person. Our board, not only our board chair, multiple board members have turned over.

We've had the ability to bring in a bunch of executive and team level talents, which is really a reflection of this pivot from a development stage to a pre-commercial stage company. I'd say that's and then with the board changes, the remit strategically has also become crisper, which is about, this is an MS company focused on commercializing our lead asset.

Yeah. That's where we are.

From a commercial perspective, we're actively preparing. Once we have successful data in December, it will be an accelerated effort to scale and ramp the company. We're not waiting for that. We've put a lot of work in place to validate our initial strategic assumptions around go-to-market strategy. We've begun to hire key leadership roles on the commercial side of the business, a VP of marketing. Today, we just had a new vice president of patient advocacy start at the company. We've built out the medical affairs organization and begun to deploy a series of medical science liaisons that are out there educating the market. We're doing a lot of work now, and of course, if we have successful data in December, we'll accelerate those efforts.

KOLs are quite excited about the Nurr1 activation side of our story. To sort of back up, though, vidofludimus calcium is a once-daily oral tablet, and it really has two underlying mechanisms, as you said, Yatin. There is DHODH inhibition, which is a proven pathway in relapsing MS, more on the neuroinflammatory side. But there is really nothing approved today that is neuroprotective.