Immunic, Inc. Common Stock R&D Day 2026

as development program with preclinical, clinical, and commercial positioning insights on the potential of how vidofludimus calcium's differentiated approach could reshape the treatment for patients with relapsing MS. Dr. Spoor and Dr. Krieger will provide expert perspectives on the MS patient journey, current treatment paradigms, and unmet medical needs. Now, I would like to turn the call over to our CEO, Erik Lundgren, to kick the presentation off.

Erik? Great. Thank you, Jessica, and thank you everyone for joining us.

Good morning. I am Erik Lundgren, the CEO of Immunic, and I am thrilled to be with all of you here today. Thank you so much for your interest in our story. Jessica, if you could just push onto the next slide. I will be very quick so we can get into the exciting science here this morning. Just to set the stage, we are at an incredibly exciting and important pivot point in the company's history, where we are really moving towards developing a fully integrated MS-focused company.

As you will hear throughout the session, we are right on the precipice of unblinding two pivotal phase III studies that we hope will create a path for us to advance our lead asset, vidofludimus calcium, into relapsing MS, so that we can address some significant remaining unmet needs in the MS community, and needs that are faced by people living with MS on a daily basis. As I sort of frame the conversation to follow, we are going to really focus in on that near term inflection and catalyst point in relapsing MS. Keep in the back of your minds, we are not going to spend much time at all today on this, but another huge part of the value proposition for Immunic and for vidofludimus calcium sits in a potential progressive MS population with data to come.

In fact, I will tease at the end of this a little bit of opportunities where we are going to have to share that story in a more fulsome way with this community in a few weeks. The other pieces I would love to just stress here is this pivot point of the company itself. We are really poised to build an MS-focused company full of executives and team members who have been in the field, who care deeply about and deeply understand the plight of people living with this disease, and are really committed and passionate about transforming care in MS. That is really where we are focused, and we think we have got the right asset to do it, we have got the right capital structure to support it, and we have got the right momentum in our hiring practices to build that organization to take us into this new era for the company.

Finally, you are going to hear a red thread throughout all of these conversations that our principal posture right now, in addition to driving our programs, is listening. Really focusing on listening to the people who treat MS every day, and the people who live with MS every day, so that we are understanding what it is that needs to be developed so that we can take on the remaining unmet needs, which are significant. Next slide, please, Jessica. You can see highlighted in green where we are going to focus a lot of our conversation today. That is on the relapsing program, really anchored by our 2 phase III studies, the ENSURE-1 and the ENSURE-2 studies. As you will hear throughout, these are fully enrolled, and we are tracking towards reading these out by the end of this year. Well on track there. Much more detail to come.

Worth popping down to see the phase II EMPhASIS study as well, which Dr. Panzara will go through some of the highlights of that study to sort of set the stage for what we can hope to see towards the end of the year. Next slide, please, Jessica. Finally, just before we get into the science, just a few words on the market itself. Headline here is that MS is a large and growing market with significant remaining unmet need. From a market perspective, it is large. Globally, it is a $30 billion market, or nearly a $30 billion market. In the U.S., it is about a $17 billion market today, growing at about 7% annually. It is a market that recognizes and rewards innovation, and you can see that in the fact that there has been over 11 blockbuster therapies developed in MS over the last 25 years.

Maybe the most important piece to highlight here is it is a large and heterogeneous patient population dealing with a chronic disease. What patients need at various points along their journey changes. What that results in is the need for diverse sets of therapeutic options, unique mechanisms of action, and the potential to address a wide range of needs over time. This is not a winner-take-all market. It is a market where we want to really tap into the needs of people living with MS, be aggressive in our development posture so that we are meeting and exceeding those needs. If we do so, it is a market that will value the innovation that we can deliver. Ultimately, we will see that rewarded in how the company can grow from that.

With that, it is my immense pleasure to turn the stage over to the first of our guest speakers. It is Dr. Amit Bar-Or. Amit holds the Melissa and Paul Anderson President's Distinguished Chair at the University of Pennsylvania. There, he directs the Center for Neuroinflammation and Experimental Therapeutics, and serves as the chief of the division for MS and related disorders. Dr. Bar-Or's research focuses on neuroimmune health and central nervous system inflammatory diseases. He runs a cellular and molecular neuroimmunology lab, directed at understanding general principles of immune regulation and immune neural interactions and their contributions to inflammation, injury, and repair of the human central nervous system. Following an undergraduate degree at McMaster University, Amit earned his medical degree at McGill University in Montreal. Dr. Bar-Or has published over 400 peer-reviewed publications and has led multiple national and international collaborative research initiatives.

Thank you, Amit, for joining us, and I'll turn over to you.

Thanks, Erik. First, let me just confirm that you can both see the screen with the presentation and hear me.

We can. Yes, we can.

Perfect. Thanks for the kind introduction, Eric. Hello, everybody. Pleasure to be here and follow on Eric's background presentation to tell you about targeting novel mechanisms to address the unmet needs in terms of the clinical context. This is really going to end up leading to the biological basis by which we think vidofludimus calcium may offer some very unique advantages in relapsing MS with a focus here, but as Eric had already alluded to, in the context of protection and repair throughout the spectrum of MS. To do that, I am going to start by presenting a very simplified model of MS immune pathophysiology.

I will try to avoid jargon and really only highlight the key points, so it is not about too much immunology jargon to contend with, but use that as a basis for commenting about some evolution in our concepts of the clinical spectrum of MS. You will hear more about this from Dr. Krieger, but I will introduce these terms of RAW, relapse associated worsening, and PIRA, progression independent of relapse activity, and try to talk about some of the biological underpinnings as a way of then providing the framework for thinking about the mechanism of action of vidofludimus calcium. The unmet needs and the novel promising targets is what we are really going to be segueing into to then deal with the biology, in particular of the Nurr1 pathway, with a focus on trying to protect and support repair from ongoing injury throughout the MS process.