Immunic at Leerink’s Conference: Strategic Moves in MS Treatment

On Wednesday, 12 March 2025, Immunic Inc. (NASDAQ: IMUX) presented at Leerink’s Global Healthcare Conference 2025. The company outlined its strategic focus on Vidofludimus calcium, a promising treatment for multiple sclerosis (MS). While the potential for significant market impact was highlighted, challenges related to funding and competition were also discussed.

Key Takeaways

• Immunic’s lead product, Vidofludimus calcium, shows promise in treating multiple sclerosis.
• Upcoming Phase 2 Caliper study results are crucial for future funding and strategy.
• The company is exploring strategic partnerships to enhance market penetration.
• Financial agreements are in place, but funding may not cover all future studies.
• Immunic is developing a second molecule with potential applications beyond MS.

Financial Results

• Immunic has secured a financing agreement for up to $240 million across three tranches.
• The first tranche was received last year, with the second contingent on the Caliper study results.
• The funds will support current studies but may not fully cover Phase 3 progressive MS trials.

Operational Updates

• The Phase 2 Caliper study in progressive MS includes 467 patients, with results expected in April 2025.
• Two Phase 3 studies for relapsing MS are underway, with over 1,000 patients each, aiming for data completion in 2026.
• Recruitment for these studies is on track, with a focus on reducing relapses and preventing disability.
• Immunic is also researching a second molecule, Anurag8 five point six, for potential use in celiac disease and weight management.

Future Outlook

• Immunic is open to partnerships to maximize Vidofludimus calcium’s market potential.
• Depending on the Caliper study outcomes, the company may pursue separate Phase 3 trials for different MS types.
• Preparations are underway for the potential launch of Vidofludimus calcium in select markets.
• Research expansion on Anurag8 five point six could lead to new therapeutic applications.

Q&A Highlights

• The Caliper study targets non-active secondary progressive MS (60%) and primary progressive MS (32%).
• Inflammatory activity was noted in 6% of secondary progressive MS patients and 16% in primary progressive MS.
• Comparisons with competitors like Ocrevus and talabrutinib were discussed, focusing on trial designs and patient populations.
• Strategic partnership timing is expected between the Phase 2 Caliper and Phase 3 readouts.

Readers are encouraged to refer to the full transcript for a detailed account of the conference call.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Good morning, everyone. Thank you for joining in the room and on the webcast. My name is Faisal Krishid. I’m one of the senior biotech analysts here at Leerink Partners. And we are here in Miami at the twenty twenty five Leerink Partners Global Healthcare Conference.

Really pleased to have this day the management team of Munich. Here with me on stage is Doctor. Daniel Witt, CEO of the company. Daniel, why don’t you start with kind of teeing up for us or introducing yourself and the company and kind of explaining what’s in store for 2025? I know we have a really exciting catalyst coming up, You know, kind of counting on the days now.

Daniel Witt, CEO, Immunic: Yeah. Thank you, myself, for it.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: And I’ll find my questions.

Daniel Witt, CEO, Immunic: For the nice introduction. And yeah, great to be here today at the conference. And, yeah, let me shortly introduce the company. So, Immunic, and I was a co founder of Immunic in 2016. Our mission is to develop safer, better drugs, and more efficient drugs for chronic inflammation autoimmune diseases, and specifically oral drugs.

Within there is a high unmet need, and that brings me directly to our lead product, BDFlimus calcium, which is the perfect example for that. So this molecule is really, on the safety tolerability side, it’s game changer for the MS field, and we progressed that molecule from phase one now into phase three studies in relapsing MS, as the first thing. And on top of that, we also have a phase two study ongoing in progressive MS, which will read out, actually, in a couple of weeks or maybe days. So April is coming, so we give guidance that we read out in April.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Okay, great. So let’s talk about that, because I think that is the new exciting thing kind of coming up. So can you just remind us quickly the design of the Caliper study?

Daniel Witt, CEO, Immunic: Yeah, as I said, the molecule is safe, but the key differentiator for the molecule is its activation of nuclear receptor one. And that gives us a molecule which has the potential to really stop progression or slow down progression in patients, and that’s a problem in relapsing MS. So as we all know, it came up last couple of years that there is this progression independent relapsed activity in RMS, but in progressive MS, it’s certainly an interesting thing because these patients just have progression, so this is their obvious key unmet medical need. And therefore, we designed a study to test which patients benefit from the drug. So this phase two study, the Canipa study, has three different patient populations.

All in all, four sixty seven patients, and sixty percent of the patients have secondary progressive MS, and this is the non active secondary progressive MS. So these patients don’t have inflammation, they don’t have relapses. Then thirty percent of the patients, or thirty two percent of the patients, suffering from primary proof of SFMS in the study. And it’s also a, I forgot to say, in SMS there’s no drug approved right now. So this is a totally white space.

So that’s the sixty percent. That’s the sixty percent.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yes. And that’s the talagrutinin. That’s what you’re talagrutinin. We’ll get to it. We’ll get to it.

Daniel Witt, CEO, Immunic: It’s important difference here, because I think we really focus on these non inflammatory patients only, which are the right definition of SPMS. Yes. And in PPMS, I think there’s also high AMENITY. There’s Ocrevus approved for that, so ocrelizumab, Antecid-twenty therapy, and two in a year infusion. And that is mainly available for younger patients, because of the B cell depletion, I think.

It always needs to be decided by the doctors what’s the right time to prescribe it and to use it, because as we all know, it can lead to increased infections and therefore somehow also has some limitations. And I think we want to address the whole space of progressive MS, and we are testing here what’s up indication is the most promising.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. Yes. So that’s helpful on the patient segments. So you recently disclosed some of the baseline characteristics of the population you enrolled. Can you tell us what are the biggest highlights of what you disclosed from the baseline characteristics?

And in particular, how is this population different from some of the studies that have read out, like the talabrutinib in non active SPMS and the OCREVA study in primary progressive? Right.

Daniel Witt, CEO, Immunic: The most important thing is that if you have an anti inflammatory drug and it has some neuroprotective effects, as we have and others also believe they have, then I think you have these two different effects you can have in a patient, And if a patient you include in the study still has active inflammation, they benefit from the anti inflammatory treatment as well. So this gives a little bit of a challenge on reading out the clinical signal in such trials. And what we know is that in, for example, tolebotulinid’s study, we know the exact details because Sanofi so far didn’t publish the details there, but we know that they included patients with non relapsing segment progressive MS, meaning these patients may still have more inflammatory lesions at baseline. We recently published our baseline numbers, and we really, in this population, we have just a six percent six percent patients with inflammatory activity. So I think it can be newer at the end, this is more really the pure SBMS population at the end.

And it’s important also, from a scientific point of view, to separate these two signals, and these patients and our patient cohort allow us to separate that. Which brings me to one important point, what’s the purpose of the study? The purpose is really to demonstrate the drug is near protective. So really focusing on, can we reduce the rate of disability? So you had only six percent

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: of your patient population had inflammatory Any non active

Daniel Witt, CEO, Immunic: secondary sixty percent non active secondary progressive population. In the PPMS, it’s a bit more challenging because they don’t have relapses from the very beginning, so here, I think usually, activity is a little bit higher. We have sixteen percent, something like that, in that population. And compare that with OCREVUS, they have twenty four percent, twenty five percent. Yeah.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: And so for the talibutan study in the non active, SPMS, what percentage did they have of that inflammatory lesion activity?

Daniel Witt, CEO, Immunic: They didn’t tell us. So that’s not public. Interesting. And Something we maybe said no if we will publish later. Yeah.

And so but

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: they did disclose that they had sixteen percent of the patients had, like, prior relapse activity in the last few years. Is is that a is that a comparable number?

Daniel Witt, CEO, Immunic: Actually, they they disclosed for the whole study something like twenty six percent inflammatory activity, if I’m going to write this one. I don’t know the exact numbers, but yeah. Got it.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Okay. So what defines success for you in this phase, two, Rita?

Daniel Witt, CEO, Immunic: I think if patients are doing well, that’s the first thing, and on a quantitative level, I think reduction of disability. So we know that the biggest issue of patients is to keep their individual independence as long as possible, and really progression, disability worsening, that’s the issue, so we want to slow down that whole process. So a meaningful medical effect here on reducing that, that’s our goal of this study.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Got it. What number does that translate to?

Daniel Witt, CEO, Immunic: There are maybe two answers to that question. The first is, so we asked our advisors to keep people at KUVA’s in the MS world, what do you think is a success here? What is really good? And I think the answer is efficacy, after a little bit of a discussion, was believed to be something like fifteen percent reduction, so a hazard ratio of 0.85 would be a medical relevant signal. I personally believe that we should be able to show something like 20 improvement, and every percent point more is better.

Yeah. Got it. So that’s there. And looking on other data, like, the only data point we really have is the previous data, which was some kind of twenty four percent for the total population. And if you discount the inflammatory subfraction, it’s a nineteen percent signal.

So that’s maybe the best thing today.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. You mean when you take that subgroup of just that pure Yeah, which

Daniel Witt, CEO, Immunic: we have in our study, so I think that would be the right comparative for

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: the PPMS. Got it. So the correct or previous compared to the query is that subgroup that had 0.81 on the hazard ratio? Yes.

Daniel Witt, CEO, Immunic: SPEAKER one: Okay. Makes sense.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: And then, so how do you think about the talabrutinib benchmark on disability? Because that was a bit better. It was 0.69.

Daniel Witt, CEO, Immunic: They didn’t disclose what the subpopulations are, so we can’t do that.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: And you have a safer problem.

Daniel Witt, CEO, Immunic: It was a good signal, honestly. It was a good signal if we just look on disability in any patients. The question is, well, what is the origin of that? If it’s really the anti inflammatory effect, then the real numbers are lower. Right.

I can’t comment on things that I don’t know, and it’s not public. So we will see how the FDA will handle that. I think honestly, I think it patients deserve maybe the choice of maybe one or two treatments. At the end, I also I think the biggest problem of BTK inhibitors are still the liver tox issues. Yeah.

Totally. All of the developments and clinical hold from the FDA is an issue somehow. We will see how that goes further.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. And there’s I mean, this is a disease area where there’s plenty of precedent for, you know, safer products being used. Better sales, clearly, yes. Yeah, totally.

Daniel Witt, CEO, Immunic: Especially when it comes to some fatal outcomes, I think. That changes the view of patients and of doctors as well.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. So in the progressive MS subtypes, there’s not a lot of precedent for properly run phase two studies before phase three. Like, a lot of the large pharma development has gone straight into phase three in progressive based on relapsing phase two’s. So how should investors think about the kind of phase two to phase three translatability? Like, what I mean is if you achieve this 0.8 hazard ratio in the setting of a phase two, what do you expect when you go to phase three?

Should that signal strengthen, weaken, or stay the same?

Daniel Witt, CEO, Immunic: Actually, it should stay the same. This study is big enough. It’s big enough to give a solid signal.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Got it.

Daniel Witt, CEO, Immunic: There are, of course, event rates at the end are decisive of the stability and the noise in the data set, but I think this study will tell us how to design a successful phase three study. And you’re right. This is the first industry sponsored phase two study in progressive MS at all. So I think that’s the right way to do it, because we want to know what the signal is and then to decide what is the right population. For example, it could be that specifically primary progressive are benefiting more or secondary progressive are benefiting more.

We don’t know that yet. I think we will know that in a couple of weeks from now. SPEAKER one: Yeah.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: That’s my next question. So you have these two major subgroups, right, the non active secondary progressive, the primary progressive. How are you going to decide which one to push into phase three? Is it even an either or? Or how are you thinking about that?

Daniel Witt, CEO, Immunic: The FDA still believes they are separate indications. So if we want to get approval, I think we need to run a study. Depending on the data a little bit, we may use the data from the Calabrio study to convince people that it’s approvable, but it was not designed as a pivotal study. So we will have end of phase two meeting and discussing the data. There’s another thing which is also important to to mention.

We have the phase threes ongoing, the big phase three studies, so 1,000 patients each and the insured studies. And so the holistic view of data may also be a good reason to talk again to the regulators to maybe get an expedited way towards approval. So that’s something which at the end depends on the data, but there’s a way forward. In a classical way, I think with the data we’re generating here, it will be very clear and easy to define the right straight strategy for phase three for each of those indications for primary progressive and for secondary progressive.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: SPEAKER one: Got it. Makes sense. And then can you just remind us so the disability outcome in the CALOPR study is a phase two, because in a phase two you can’t actually power that as the primary, then you have a phase three. Can you remind us the statistical considerations around it? Like when we’re talking about these benchmarks of 0.85 or 0.8 on the hazard ratio, Is there like, could that be statistically significant, or is the powering not there to No, it’s not there.

Daniel Witt, CEO, Immunic: I think this study can’t be powered for statistical benefit on that clinical outbound. This is the phase three endpoint. If we would have powered it for that, it would be a phase three study. And it would be much larger. So therefore, this study is really an exploratory study to educate us what is the effect size and to plan a proper phase three study.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: SPEAKER one: Got it. Makes sense. And then can you remind us so you had an interim analysis that looked at the NFL biomarker. Could you explain how and why that gives you confidence on what we’re going to see in days, two weeks on the full study readout? Yeah.

Daniel Witt, CEO, Immunic: I think NFL is an important achievement of the industry and research globally in the neurology space. It is a protein that’s I think it’s one of the proteins which is disseminating from impaired neurons or dying neurons, and of course, there can be different sources in an individual, so their contributions can come from the brain, can come from the CSF, also from the periphery. So if you want to use a biomarker, you need to ask yourself, so what is it telling me? And is it proven? And luckily, there was a very nice publication from Roche on their successful phase three study or phase three study or Oratorio, and what they did is they re baseline the patients after one year of a previous treatment.

So what that led to is the stop of any remaining focal inflammation, so more or less, you force your patients to be really just a progressive population, and then they looked on to what extent is baseline NFL predicting future disability outcome, and the clear answer to that, and there was actually was nine year data in that paper. They have shown that with a pretty good hazard ratio of zero point six five, something like that, over the time, there was a very clear separation. Lower baseline NFL predicts lower future disability risk. Yeah. So that was a great study, and it was also a big study.

So I think we can conclude from that, and NFL is, in this situation, a good predictor. It is maybe not if you have still lesions. So in a total population where you have lesions, because they can’t go, so there’s a relapse remitting profile of the lesion, and it also leads to NFL fluctuation. If you have that, then I think you need to be careful on that data. That’s why a lot of old publications come to wrong conclusions on on use of NFL in MS.

For example, it could in relapsing MS, it may be used as a diagnostic marker, because you can easily measure these values and see if it’s an elevated level of NFL.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: So that’s a nice way to think about it. So basically, in your study, because of the type of patients you enrolled, anything you see on NFL, it’s not relapse related NFL release. It’s it’s actually related to kind of the disease progression in your view. Exactly.

Daniel Witt, CEO, Immunic: So we we think then with the numbers we have seen, and it was even statistically significant when we read out 50% of the patients after the first twenty four weeks. And remember, this is a one hundred and twenty week study. It’s a huge thing. This was quite impressive. We were really partying around NFL data, so I think it’s, for me, it’s really the reason why I believe in a positive outcome of the whole clinical data.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. Yeah. So I want to shift gears a little bit. You mentioned you have the phase three insurer program going on and relapsing MS data next year. You guys have pulled off a feat of running a phase three relapsing MS program as a small company.

Can you remind us, so you recently had a, no, I say that because, like, investors It’s a challenge. Investors who don’t know, they hear this. They’re like, oh, this company did a 1,000 plus patient study.

Daniel Witt, CEO, Immunic: A 1,000 plus.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yes. Yes. Yeah. So I want to talk about you had the interim analysis in December. Can you describe what happened at the interim analysis and how that gives you yeah, what level of confidence that gives you into the data next year?

Daniel Witt, CEO, Immunic: First of all, climate conferences don’t do that, so they don’t need to do that because they don’t care. They just do the study and read out that thing. For us, it’s a big thing. It’s a big study. It costs a lot of money, and I think the very simple idea behind the Insure studies was we confirm, we want to confirm in a highly statistically significant way, what we have seen in phase two study, the emphasis RMS phase two study.

And so we had two goals of that study. The first goal is to get an approval of the data package, and very easy, therefore, the endpoint need to be relapse reduction, and so we powered that study to deliver this. It’s the most conservative approach you can take, and I think the reason why we did it in a way is we didn’t want to gamble, and we want to make sure we don’t run into unsure waters on shortcutting, changing inclusion criteria, and endpoints, ambitious endpoints, which you maybe just don’t achieve because you don’t know the whole picture, so that was the more conservative part of the planning, and the second thing is that, well, we know we have a drug which can be better, and this is really based on disability prevention, so therefore, we have established a design where we can pull the data from the two phase three studies, at the readout point, on reading out confirmed disability worsening. Yeah. And this should make a difference for the patients, for the doctors.

So statistics for the regulators and the clinical benefit shown in confirmed disability worsening and these other endpoints for doctors and patients, and also the safety for everybody, for the regulators and for the patients. I think we also want to confirm that outstanding safety and tolerability profile of the drug, which has none of the known issues current drugs have.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: SPEAKER one: Got it. And that data will be next year?

Daniel Witt, CEO, Immunic: That data so the study completion is projected for next year. And what I can confirm here is our recruitment is on track. SPEAKER one:

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Okay, great. Look forward to details on that. So I want to we’re about ten minutes left. I want to talk a little bit about the strategic vision path forward for the company. You founded this and have steered this forward.

As you think about the opportunity set available for the drug, obviously, MS is a large indication. How do you think about the strategic partnerships for the asset and what that looks like going forward, especially as you’re kind of on the doorstep of a phase three readout next year?

Daniel Witt, CEO, Immunic: Yeah, this is the number one question for us as a company, of course how to handle this value in the context of a challenging capital market, where in a normal market, maybe our market cap should be something like a 700,000,000, 1 billion ish place, but so how do we handle that? So if you look if you drill it down to the value of the asset, and we just do a classical NPV evaluation of what we have, and look on the competitive space cleaned up, a lot of competitors gotten out of studies didn’t work out. So we have a very interesting unique asset which is developed in all of the MS indications. It is currently just based on RMS, basically, and or previous in PPM, and it’s a $23,000,000,000 market in the seven major markets. There are companies with a huge need for next drugs to fulfill the pipelines.

We have a high unmet medical need for stopping disability, so we think the value of the asset is much higher than our market cap, substantially higher. So how to handle that in this world? So we, I think, we still take a double approach. On one hand, we convinced Jason Talio last year to join us as chief opening officer with his commercial background in the MS space, so that we have the ability to also prepare a potential launch of the drug in either one or more territories, so that’s still something we think is feasible, but also looking on, as I said, on the value, and value development and cash needed for commercial launch and so forth, we think it could also benefit from a partnership, so based on where we are in the data coming out now in April, we started, I think, actually, end of last year and during JP Morgan Week, a lot of BD discussions with players in the space, and we know that most companies have an eye on it right now, so I’m pretty optimistic if we continue that we will find a good partner to work with us on leveraging the whole commercial potential of the drug.

And then I think that this would clearly enable us to strengthen the pipeline. We have that wonderful second molecule, Anurag8 five point six, where we recently imported some surprising data on the gut repair and the associated in routine change, which was a little bit unexpected thing. So we think we want to continue that in maybe celiac disease, and maybe also have an eye on weight management there. And we have more things in the pipeline on your protection and so at earlier stage. So there’s a lot we can do to establish the company on the next level based on the success of Vida Flamingos Galcio.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. So I guess as you’re starting to engage in partnership discussions, what’s kind of interesting and unique here is that the timing between the two programs, right? So a potential partner would have to be kind of like on board with a nearer term commercial launch, but then also on the development side, you know, embarking on a phase three in progressive MS. How does that kind of play in to the discussions in terms of that kind of dual remit across the two indications?

Daniel Witt, CEO, Immunic: Everybody loves it. It’s the thing you want to have. You have a rock solid base, for a start, and a new job site from a multibillion opportunity from Progressive MS. That’s perfect. I think people love it.

And also, considering PMS as a single phase three study, so not two studies needed, the size of the study is maybe not larger than a single RMS study, so it’s feasible. And also, in progressiveness, I think such a study will be easier to recruit. Given the unmet need is so high, it’s obviously easy to recruit.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. And there’s a precedent of how these studies are run as well.

Daniel Witt, CEO, Immunic: If you own the drug and you bring it to the market, you really can change the world how we treat MS. So it is the potential of a real breakthrough. Yeah. It depends, of course, on the data at the end, but I think it has the potential to really change the way we treat MS.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. And as you think about the sequencing of the potential value inflection points in the company. So you kind of have the phase two caliper readout coming up next month. And then it’s going to be roughly a year and a half, give or take, to the phase three readout, right? So that’s another

Daniel Witt, CEO, Immunic: Yeah, we got completion of the phase three studies next year, the first of those in the second quarter and in the second one, the second half of next year. It is still open how the readout goes. So I’m careful on saying the readout will be at that time frame, because it depends on the full recruitment of both studies and also whether we do it sequentially or together. There’s an open discussion on how we handle that.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Got it. Yeah, but I guess just to put it broadly, so you have the next year, phase three, which will obviously be that’s a phase three, or that’s a potentially big value inflection point. As you’re thinking about strategic path forward, how do you think about timing of that, given that you have these two major de risking events with a gap in between?

Daniel Witt, CEO, Immunic: I think I don’t perceive it as a gap. It is close. Yeah. And given the size of what we’re talking about, this is a blockbuster indication and a molecule, I think it deserves the attention we give it to that. So there may be more data coming from our other programs, but it has never the same relevance as these two

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: important results. Yeah, what I mean

Daniel Witt, CEO, Immunic: by that Partnership could be the other thing. So if we enter a partnership, this could also change a little bit the view. From our point, our shareholders and investors on the one hand, but also of the market, the patients, the doctors, So there’s a lot. I can imagine that there are a lot of things which could happen in the next couple of months.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah. Yeah, but I guess what I mean is if you’re in a situation where you’re talking about partnerships, but you know you have another big value inflection point coming up, are you kind of compelled to wait then because you know you have a phase three readout kind of on the horizon? Depends

Daniel Witt, CEO, Immunic: a little bit on the funding situation and the market situation. Yeah.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: And I know I’m bugging you on the hypotheticals. Yeah. So Yes.

Daniel Witt, CEO, Immunic: I think in a perfect world, I would go to the very end and launch it. Yeah. Yeah. But there are also reasons to maybe join forces with somebody who has an established marketing organization for the indication. So yeah, I think I need to be just flexible and open minded.

And it’s always my credo expect the unexpected, so let’s see how that goes further.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah, that makes sense. Yeah, and sorry, I know I’m bugging you on all these hypothetical things. Yeah.

Daniel Witt, CEO, Immunic: And we have the same discussion internally. So Glenn and I, we usually talk about it every week. So what’s

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Of course, yeah.

Daniel Witt, CEO, Immunic: How do we handle that? Because he managed to cash it and how we structured that, and then but what’s the price of the money? Today, it’s also

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: a discussion Yeah, totally.

Daniel Witt, CEO, Immunic: If you raise money from equity side, it’s also not cheap.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yeah, so let’s talk about that, because you have an interesting kind of financing agreement in place. Can you remind the folks listening, how does that work? And then what does that fund?

Daniel Witt, CEO, Immunic: First of all, I want to thank BBF for taking the lead last year and supported by Leerink at that time to do this big pipe investment in last January. So we signed this three tranche deal with up to $240,000,000 supporting the company. Of course, for the price of dilution, that’s unavoidable, but I think it was was very good for the company and secured the financing, and we got the first tranche last year, the second tranche could be invested after the decalable data comes out, And the third tranche is a bit linked to the second tranche execution, so we will see. We will see how that goes forward. We published the deal and the terms, and so on.

Yeah. So that’s one of the things which I think it brings the company in a good situation, but also, clearly, we want to grow, so we want to grow the company. Also, I think we should also give eight fifty six, our second molecule in celiac disease and maybe also obesity, an opportunity to show its strength and to generate more data. So that’s another aspect of what’s kind of not covered by the funds we have.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: So you’ll get that 80 or hopefully, you’ll get that 80. Can you remind us, like, does that that takes you to the phase three readout? Does that also cover any, like, kind of starting up of the phase three in progressive?

Daniel Witt, CEO, Immunic: No. So this is not covering. So phase three in progressive. Look, I don’t want to overpromise here things, but I don’t think that’s a problem. If you have good data on progressive MS, we have good problems to solve because everybody want to have it.

So that’s something where that’s not a problem from my point of view. We will find some money to work together with us on that.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Right. I admire the confidence.

Daniel Witt, CEO, Immunic: Given by the disability data because this is, as I said, important for PMS, but also supporting the RMS development.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Yep. Cool. So we’re right at time. There’s just one question that I always like to wrap this up with. Just to close this out, what do you think investors misunderstand most about the Amunix story?

Daniel Witt, CEO, Immunic: I think they don’t get the market size we’re working in and how nicely that molecule is positioned as maybe the best development option right now in MS at all. And that’s maybe because people are mixing up RMS and PMS and really don’t understand the real unmet medical need, which is progression, which is fifty percent of progression is not related to relapses. So you have 15 molecules approved in The US making 23,000,000,000 of sales and solving half of the problem. So that’s maybe, in simple words, how I see the world, and that gives us and maybe others in the future an opportunity to add something medically meaningful on top of that, which could really make it a multibillion opportunity. So if you don’t understand that, then you may not get the story.

Yes.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: Great. Sounds good. Well, thank you so much, Daniel, for joining us here. Thank you, folks in the room, who dialed in. And we look forward to hearing from you in, I guess, a few weeks.

Daniel Witt, CEO, Immunic: Yeah. And thank you for having us here. It’s always a pleasure to be here in the conference.

Faisal Krishid, Senior Biotech Analyst, Leerink Partners: All right. Thank you.

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