#115: Daniel Vitt - Pioneering Patient Care: Dr. Daniel Vitt on the Future of Medicine

Is revolutionizing patient care through biotechnology an ambitious dream, or is it the future of medicine? Dr. Daniel Vitt, a leading figure in the biotech world, challenges the status quo and brings a fresh perspective to these questions.

Dr. Daniel Vitt is the CEO of Immunic Therapeutics, a company at the forefront of developing groundbreaking treatments for chronic inflammatory and autoimmune diseases. With a background in molecular biology and a passion for innovation, he is steering Immunic towards a future where patients have more effective and safer treatment options.

In this episode, we delve into:

• The visionary approach of Immunic Therapeutics in treating multiple sclerosis and leaky gut.
• The challenges and triumphs of bridging European and American biotech markets.
• The role of serendipity in scientific discovery and innovation.
• The future of Immunic: clinical trials, stock prices, and global expansion.
• Daniel’s three key lessons for anyone daring to start their own company in the biotech industry.
• Don't miss out on this insightful conversation. Subscribe to our channel and join us in exploring the future of biotech with Dr. Daniel Vitt.

💡 LINKS TO MORE CONTENT
Youtube
Christian Soschner:
Today’s speaker is Dr. Daniel Vitt:

📖 Memorable Quotes:
(00:02:23) "Every morning, when I go to work, I enjoy being part of an industry that improves patients' lives." 
(00:05:26) "Understanding the key and lock principle in biology is our path to curing diseases." 
(00:24:49) "Serendipity means you're searching for a needle in a haystack, but you find something unexpected and even more valuable." 
(01:13:23) "If you are early and have a big vision, you can succeed easily." 
(01:32:35) "Expect the unexpected and be prepared. Adaptability is key in our rapidly changing industry." 

⏰ Timestamps:
(00:01:15) Unveiling the Future of Patient Care
(00:05:26) Decoding the Key-Lock Principle in Biology
(00:11:16) The Dynamic Dance of New Technologies in Healthcare
(00:16:54) Misconceptions: Multiple Sclerosis vs. Parkinson's
(00:17:41) Exploring the Link: MS, Parkinson's, and Neurodegeneration
(00:24:15) The Power of Serendipity in Scientific Discovery
(00:35:07) Addressing Celiac Disease: A New Approach
(00:39:10) The Challenges of Multicenter Multinational Studies
(00:48:49) A Potential Game-Changer: Restoring the Gut
(00:50:38) Western Lifestyle's Impact on Gut Health
(00:52:18) The Balance of Lifestyle and Disease
(01:02:12) The True Cost of Drug Development
(01:08:31) Unveiling a Multi-Billion Opportunity: The Market Potential
(01:12:40) The Bavarian Biotech Boom: A Tale of Visionary Politics
(01:22:31) Crossing the Atlantic: European Biotech’s Path to U.S. Success
(01:23:51) Navigating the Global Biotech Landscape: Daniel Vitt's Perspective
(01:26:41) The Next Leap: Interim Analysis of a

How to Start a Podcast Guide: The Complete Guide
Learn how to plan, record, and launch your podcast with this illustrated guide.
Coaching Conversations in 2024

In 2024 we're going to be going to monthly themes and I would also encourage you to...

Listen on: Apple Podcasts   Spotify

Transcript

00:00:00:00 - 00:00:09:21

Christian Soschner

In a world racing against time where innovation is not a luxury, but a necessity. A team comes together to explore the future of medicine.

00:00:10:05 - 00:00:14:08

Dr. Daniel Vitt

It's always the same. If you're early and you have a big vision, you can succeed easily.

00:00:14:19 - 00:00:51:01

Christian Soschner

Meet Dr. Daniel Wit, the pioneering CEO of Munich Therapeutics, a company at the forefront of developing groundbreaking treatments for chronic, inflammatory and autoimmune diseases. Here are the five main points we cover in this episode. The revolutionary potential of Munich's approach to treating multiple sclerosis and leaky gut. The challenges and triumphs of bridging European and American biotech markets. Daniel's candid advice for stepping out of the comfort zone and embracing risk.

00:00:51:11 - 00:01:17:18

Christian Soschner

The Future of Munich Clinical Trials, stock Prices and Global Expansion. Daniel's Free Key Lessons for anyone daring to start their own company in the biotech industry. Are you ready to dive into the mind of a visionary? Don't miss this conversation. Watch the full episode now. Daniel, I hope I may address you with a first name.

00:01:18:17 - 00:01:19:13

Dr. Daniel Vitt

Yeah, sure, sure.

00:01:19:19 - 00:01:23:13

Christian Soschner

So then it's good to see you. How are things in Munich these days?

00:01:24:01 - 00:01:29:21

Dr. Daniel Vitt

Excellent. Great times. We've had very good years so far, and the weather is supporting that good mood as well.

00:01:29:23 - 00:01:32:01

Christian Soschner

So how is David in Munich?

00:01:32:12 - 00:01:42:17

Dr. Daniel Vitt

Oh, a very sunny, dry, perfectly perfect weather for improving mood. And also the only challenge is to focus on business in this weather.

00:01:43:23 - 00:01:48:09

Christian Soschner

What is what are your favorite activities in Munich besides business?

00:01:48:09 - 00:01:54:03

Dr. Daniel Vitt

Oh, hiking, I think. Really hiking, going outside. So nice here. Being close to the Alps.

00:01:54:16 - 00:02:07:13

Christian Soschner

Hmm. Isn't is there a part of the Alps in. In Bavaria? I guess I've always thought it's the majority in Switzerland and in Austria. I do think that's one. Batman is a famous area because that's Austrian.

00:02:08:04 - 00:02:13:02

Dr. Daniel Vitt

No, we have the Spitz in Germany. It's. But it's only only 45 minutes by car.

00:02:13:13 - 00:02:21:18

Christian Soschner

That's cool. That's cool. That's cool to go. And your business is running a biotech company. Can you tell me a little bit more about it?

00:02:22:22 - 00:02:54:13

Dr. Daniel Vitt

Yeah, I think what it's a big pleasure for me to to really be part of an industry which is which is focusing on improving lives of patients. So. And from the very beginning, when I started in that industry, I felt that I can contribute to something good. And that is always every morning, if I. If I go to work, I'm usually usually onsite, not not virtual as far as possible.

00:02:55:06 - 00:03:07:23

Dr. Daniel Vitt

I'm I enjoy being part of that industry and just with the team trying to improve patients life. And now with my career, phase three then end of the era I think for for me and the colleagues here.

00:03:08:18 - 00:03:18:24

Christian Soschner

Are you, are you back to onsite site working 100% of your time or did you also keep a little bit of remote work in your system at the Munich?

00:03:19:11 - 00:03:46:18

Dr. Daniel Vitt

No, I think for employees it's in. You need to be flexible these days. I think I like I like social interactions and I think the quality of work is also somewhat depending on social interactions. But you can't twist arms today in the office. So it's a it's a mixed setup everywhere now and also and his company. So for example, we have we allow our employees to have two days per week as flexi time.

00:03:46:18 - 00:03:52:18

Dr. Daniel Vitt

So whenever they like to to learn to eat even from the lake if they work.

00:03:54:00 - 00:03:56:15

Christian Soschner

So yeah, Monique is famous for the lakes, isn't it?

00:03:57:04 - 00:04:01:13

Dr. Daniel Vitt

Absolutely. And I think this is part of quality of life and quality of work.

00:04:03:03 - 00:04:17:09

Christian Soschner

And I couldn't agree more. I like I mean, I personally like hard work to encourage alone. It's all but communication meetings. It's better to have to meet in person if possible. There's nothing better than having a coffee or sharing a cup of coffee or tea together.

00:04:17:19 - 00:04:20:16

Dr. Daniel Vitt

Absolutely.

00:04:20:16 - 00:04:24:19

Christian Soschner

What's brought you into the life science industry? What sparked your interest?

00:04:25:08 - 00:04:59:08

Dr. Daniel Vitt

Actually, it was it was coming through computers and my fascination of modeling small molecules. So in my doing, my my master thesis, and then tea time, I focused on simulation work. So it had two components. One was quantum chemistry. So we what I did is I calculated reaction mechanisms on a computer and then I needed to visualize because you can't show big mathematical equations to people they don't understand.

00:04:59:08 - 00:05:24:21

Dr. Daniel Vitt

They're also annoying. So we we spend a lot of time on, for example, in making smart movies of, of reactions, chemical reactions. And the second part and that fascinated me even more was to simulate how a molecule fits into a binding site of a protein. And that's something which still is the core of what we do and what I do and am fascinated about.

00:05:25:23 - 00:05:55:02

Dr. Daniel Vitt

And and so it's this is a so-called key and lock principle we have in biology and chemistry for small molecules to fit into a site and the protein and then preventing an interaction or executing or starting an interaction or triggering something that's I think the way how we know more and more understand how the human body is working and how diseases are affecting proteins.

00:05:55:02 - 00:06:02:04

Dr. Daniel Vitt

And then we can use these molecules to cure or to improve the situation.

00:06:03:02 - 00:06:29:15

Christian Soschner

I'm curious now you mentioned that during your Ph.D. and muscle disease, you started simulating the interaction of proteins and also produced more movies, which I think when I look now in linked in, very often I hear the term artificial intelligence and there is a whole industry revolving around this topic to just look deep into that part, which is more or less a service industry.

00:06:30:03 - 00:06:51:08

Christian Soschner

And you're now our CEO of Munich, which is clearly a therapeutics company. So your goal is to cure diseases. What led you from this simulation aspect then to a company like Munich to say, okay, I wanted to focus on developing cannabis and not staying in the simulation area.

00:06:51:22 - 00:07:17:03

Dr. Daniel Vitt

That you mentioned that exactly what what drove me at that time is not being something where you focus. And if you start with simulation and you see a small molecule fitting into the two active side, so for example, if I have this dispute piece of fitting here it is, it is something which is bringing you to the question, okay, can I do that?

00:07:17:16 - 00:07:42:17

Dr. Daniel Vitt

Then the next step is to synthesize of molecule. And as a chemist, I'm trained as an organic chemist. So as a chemist, you you of course should think about, okay, this was on the computer, but what about action? So getting back from the virtual world to the real world. And based on that, we started I started my first company with three co-founders in 1997, starting from the computer work and then implementing that into the lab.

00:07:43:05 - 00:08:17:16

Dr. Daniel Vitt

The company is called for a scene which is still still existing, but at that time it was purely a technology company and then it'll be transformed it step by step to company and implementing the chemistry and biology, the screening, the testing then progressed further and qualified molecules for development and then in the pre-clinical development and clinical group. And so that whole thing, the whole pharmaceutical development chain was starting from the computer and now is in approval stage for this.

00:08:18:00 - 00:08:39:12

Dr. Daniel Vitt

So with our most advanced molecule coming from that technology a long time ago now being tested in a Phase three registration study, I think that's a smart thing and it really can drive satisfaction as well because you see, okay, you have an idea and then transform into something which to me at the end may really help patients to be improved as a drug.

00:08:39:12 - 00:08:44:24

Dr. Daniel Vitt

And hopefully we see that approved in the next three or four years.

00:08:44:24 - 00:09:08:21

Christian Soschner

That that's a good point. Small molecules chemistry. When I started in life science in 2006, I mean, my first touchpoint was a company that was more or less focusing on chemistry. And then I learned in the industry that part of it switched to biology, biological drugs, and some also chemistry. You don't need it anymore. Where do you see the perspective of chemistry in drug development, in life science?

00:09:10:02 - 00:09:54:13

Dr. Daniel Vitt

But I think we, as we now have a steady state situation where maybe 40% of molecules which are originating as drugs are small molecules, another 40% biological molecules, antibodies, and then the remaining 20% is no cell therapy or something, fancy stuff, which is neither small molecule nor biological. And this will always be a dynamic thing, but definitely the time of small molecule is really not over, not for the next 50 years, because we just start understanding what are the targets and how can we really understand selectivity.

00:09:54:13 - 00:10:24:16

Dr. Daniel Vitt

And it's still a big challenge to find selective good molecules, either biological, osmium, work and also it's a question of what indication is that? Is an infusion an option for disease or not? This really depends on the disease. And I think what we are targeting here is chronic chronic diseases, autoimmune diseases like multiple sclerosis or other have colitis or celiac disease.

00:10:25:10 - 00:10:46:16

Dr. Daniel Vitt

So indications which are lifelong diseases where patients want to have a treatment which is improving their life, but on the other hand are not accepting side effects which may cause more trouble than the indication or the disease. And this there is still a lot of room for improvement, I think, in all of those indications.

00:10:47:10 - 00:10:53:22

Christian Soschner

And so the time for chemistry is not over and it's still playing a crucial part in the industry. Intermediate, too.

00:10:54:16 - 00:11:14:19

Dr. Daniel Vitt

And like everything in the world, there is a place for something new and there's something established. I don't think that anything can really get rid of this hype curve. So you have this overenthusiastic introduction of new technologies and they find them. They're their place, they play a role. But it's it's, it's a dynamic thing.

00:11:15:08 - 00:11:21:17

Christian Soschner

Yeah. Especially in public markets. There's always a public face. I think we see now a little bit in artificial intelligence.

00:11:22:23 - 00:11:40:20

Dr. Daniel Vitt

Well, or now we will be seeing more gene editing technologies and these things. The question is where do they and they important milestones of technology. And I think that's super helpful. But what is at the end, the practical use for treatments. And I think it's still too early to really judge.

00:11:40:20 - 00:12:05:15

Christian Soschner

When I worked with the first companies, I had the luck of bad luck or fortune. It depends on how you look at it. Of 2008 happening, it's basically one of the biggest crises, financial crisis that we had. And our companies, I will say we are all back then that had venture capitalists on board. Private companies process down to one product, one trick pony companies.

00:12:06:18 - 00:12:20:03

Christian Soschner

And we didn't really have not far aside on many pipeline companies sent in Munich these days 2020 free is definitely not a one trick pony. Can you tell me a little bit more about the pipeline that you have in your company?

00:12:20:22 - 00:12:45:19

Dr. Daniel Vitt

I think thank you for that question, because it's something I think is absolutely important for for our industry. We need to live with success and failure. We are doing big experiments which are quite costly. We do clinical trials and there is no guarantee that something we developed in the lab or under computer at the end really work out in the patient selling.

00:12:46:05 - 00:13:17:22

Dr. Daniel Vitt

And therefore a company like us needs a pipeline to balance the risk, to have multiple shots and go and, and therefore I believe we we need that diversity. But on the other hand, having too many things makes it defocus and doesn't help you to have enough enthusiasm and drive for your your key assets. So we have three product development, which I think is somehow an optimum number for a company of our size.

00:13:17:22 - 00:13:52:02

Dr. Daniel Vitt

So we have the three programs said and the most advanced molecules will flow the most calcium. It's a small molecule which is super selective and is currently in phase three clinical testing for treating motor sclerosis. Multiple sclerosis is a it's a really important and frequent disease. Lot of young patients are affected by that. It's a lifelong disease and maybe we come to that in a bit later something of have highly unmet medical need.

00:13:52:02 - 00:14:25:08

Dr. Daniel Vitt

And our focus is how can we improve the current state of technologies. So what's there of what current treatments are there? And we believe that for example, neurodegeneration or other destruction of neurons, that is still the key problem in in multiple sclerosis and slowing down disability worsening by neuroprotective effect. That's something where we want to deliver something better for the patient in the future.

00:14:25:08 - 00:14:53:07

Dr. Daniel Vitt

So that's the most advanced molecule it's said in their registration trial. So the next step after completion of this hopefully successful completion of the study, maybe only 25 to 26, we then want to submit and the A and get market approval authorization for the drug. We also run another trial of the same molecules to support scientifically this story and going a little bit beyond relapsing.

00:14:53:07 - 00:15:23:24

Dr. Daniel Vitt

And as so we test also the same molecule in progressive M.S. patients and that's a different indications are the patients don't have the relapses, but they are they are worsening on their their physical abilities over time, some very quickly, some slower. But the current drugs really don't help there. So that's an area of super high unmet medical need with quite a number of patients affected by that disease.

00:15:23:24 - 00:16:06:21

Dr. Daniel Vitt

So these are the two things for for mass. And the second molecule is I am you eight, five, six. So that's a lab code. Still, we don't have a name for that yet. It just successfully completed the first test in humans with celiac disease. I recently I was a couple of weeks ago when we published the first data and it was so good that we ourselves were quite impressed by and surprised, positively surprised by the data because it's an important piece when you, for the first time switch over from a healthy volunteer to a patient and you enter the the area of of of excitement here.

00:16:07:08 - 00:16:29:24

Dr. Daniel Vitt

Is your drug really enough exposed Does the new mode of action work what some do you have an effect already in this four week treatment. So this is there's a lot of uncertainty when you start each phase one studies and then start treating patients. But it came out so nicely that term you feel you still see my excitement about it, which the I.

00:16:30:03 - 00:16:50:04

Christian Soschner

Absolutely I think we Europeans are not I mean the Austrians are not very good with excitement. I think the US the US industry experts, all of us accelerating it are so excellent in showing excitement. We as Austrians, it's just like, okay, yeah, it's well done. How is it in how is it in Germany?

00:16:50:04 - 00:16:52:10

Dr. Daniel Vitt

We are more Austrian than American, I think.

00:16:53:16 - 00:17:07:23

Christian Soschner

Let's do a little bit with your pipeline. You mentioned multiple sclerosis. Isn't it a disease that Migratory Fox is suffering from? I think this is back in back to the future. I became famous in the eighties when I was a boy.

00:17:08:16 - 00:17:11:07

Dr. Daniel Vitt

I thought it was Parkinson's disease.

00:17:11:13 - 00:17:12:09

Christian Soschner

Yeah, yeah, yeah.

00:17:12:09 - 00:17:39:24

Dr. Daniel Vitt

But my foot. But not too far away. I think we just reported data from A and published data together with Daniela Marques group here in Munich on media footing was calcium, showing that the drug is effecting a neuroprotective molecule protein called no one, No one that said it's a nuclear receptor and this is a target which was initially discovered as a potential Parkinson's target.

00:17:40:16 - 00:18:09:04

Dr. Daniel Vitt

And and I think that therefore, IMS and Parkinson's share some of these properties leading to neurodegenerative action. And what we have shown here and published is that media freedom is calcium is an activator of no one. And with that, we believe that a drug can prevent neurons from cell death, and that should be applicable to multiple sclerosis, as we are doing right now, but should also work in Parkinson's disease.

00:18:09:04 - 00:18:16:24

Dr. Daniel Vitt

So there there is, I think, a link between both therapies may have both outcomes.

00:18:16:24 - 00:18:21:12

Christian Soschner

It how does it help to patients at the end of the day, what is the difference that you make with your truck?

00:18:22:23 - 00:18:52:14

Dr. Daniel Vitt

Yeah, I think so far, no, it gets a little more scientific, but so far, maybe until maybe two years ago, the majority of researchers and treating physicians were convinced that relapsing Ms.. So to the form of multiple sclerosis, which has these episodes of relapses and remissions, they're just that the the overall worsening of the patients was associated purely to the relapses.

00:18:52:21 - 00:19:13:10

Dr. Daniel Vitt

So meaning, okay, you have you're doing well and then you figure it out, you have a relapse. So for example, you find out that you have problems with your vision in one eye and and you go to the doctor and you find out, Oh, yeah, you're diagnosed multiple sclerosis now. And over time it goes back, but not fully back now.

00:19:13:11 - 00:19:46:14

Dr. Daniel Vitt

So you have a continuous worsening of the physical ability and walking problems and so forth, going further, maybe ending up finally in a wheelchair, and that it was believed that this is really associated to the relapses. So there's always some remaining disability from the relapse episodes. Um, one of one of the leading scientists in that space, Fred Loveland from Mount Sinai in New York published last year, nice paper where he evaluated 35,000 patient cases treated with different drugs.

00:19:48:01 - 00:20:24:04

Dr. Daniel Vitt

And the data was was thankfully provided by Novartis. And to him. And he had a closer look on what is contributing to the disability and he had all the data available and he found out that half of the disability worsening is coming from something independent of the relapses. So the whole industry, including myself, were a little bit misguided before the time point because we just focus on the inflammation, we focus on the causes for the relapses.

00:20:24:04 - 00:20:54:00

Dr. Daniel Vitt

But we didn't pay enough attention to stimulation of the neurons and the the threat there and the loss of function of neurons leading then to this underlying smoldering disease which is not linked to relapses and remissions. And this, by the way, this is called pyro, and this is not an established, established concept, luckily, and this is this is the story of of serendipity.

00:20:54:00 - 00:21:31:02

Dr. Daniel Vitt

And serendipity needs a mindful person and serendipity that we found out that beautifully misconstrue them as having both has an anti-inflammatory effect. But with this activity as an activator from the one which we published recently, we also know the drug has this effect and therefore may really improve. This is the goal here to improve time to the disability worsening for the first time, and that would really open up a completely new era of treating such patients.

00:21:31:11 - 00:21:36:17

Christian Soschner

So basically your drug can stop the progression of the disease in certain cases. Is that.

00:21:37:20 - 00:22:00:01

Dr. Daniel Vitt

Right? This is the ultimate goal to slow down or stop progression. And of course, I can't say the drug is doing that in a big star. We have we have we have hints for that from the office study where we have seen that maybe we treated 200 women, about one in 50 patients in the phase two study for 24 weeks, a half year timeframe.

00:22:00:18 - 00:22:36:10

Dr. Daniel Vitt

And first, this study was looking on inflammation. So we did MRI tested and looked for lesions in the brain as a primary end point, which was highly significant and very nicely worked out. But then we followed up the patients also beyond that 24 week treatment. And we looked, for example, if a patient was worsening on the disease scale for one point we looked whether this is going back to normal is a remission or it is still there.

00:22:36:10 - 00:23:10:00

Dr. Daniel Vitt

It's an ongoing loss of function basically in our disease worsening and then we looked if patients after 12 or 24 week of confirmation still have that or not and this is that this is the end for for such trials so it's it's called confirmed disability worsening and we were surprised to see that our drug had a remarkably lower that the patients on jacket had a remarkably lower disability worsening rate than the patients on a placebo.

00:23:10:06 - 00:23:37:05

Dr. Daniel Vitt

It was 3.6% of patients on placebo versus 1.6% of patients on active drug, which I think is is a pretty nice signal that a drug has actually these neuroprotective effects. But scientifically, it's difficult to say it has. This is the root cause. We just we see the drug is doing good and it's better than what others have shown so far in that respect.

00:23:37:05 - 00:23:45:06

Dr. Daniel Vitt

But that's that's not what we ultimately want to prove in the Phase three study in relapsing. Ms. And in the phase two of progressive Ms. as well.

00:23:46:08 - 00:24:11:13

Christian Soschner

Maybe we can walk through the clinical phase one, two and three trials to demonstrate how a drug that yours evolves through the clinics. I think everybody has graduated from. They've been settled in the last two years in understanding how vaccine development works and now maybe we can help people graduate with my podcast also in therapeutics. But let me ask you first another question.

00:24:11:13 - 00:24:22:20

Christian Soschner

You mentioned the very interesting sentence that kind like serendipity needs to mind from person. Can you dive a little bit deeper into that? Why do you think it needs to mind for a person?

00:24:23:04 - 00:24:45:10

Dr. Daniel Vitt

Yeah, I think I'm not sure if you know this picture. Serendipity means that you're searching for the needle in the haystack, but you find a daughter of the farmer, so need to need that. You at least need to be at the farm. Yeah. And therefore, if you're unprepared, you will never not see it and in the wrong place you will not find it.

00:24:46:02 - 00:25:10:21

Dr. Daniel Vitt

So an open minded person will see signals in a clinical trial or in research, which may hint to a totally different thing than you originally. And we're looking for these serendipity findings I think are super important. And it's not just luck. That's what I say. It's not just luck. And you will never see any effect if you're not prepared to see something like that.

00:25:12:03 - 00:25:25:18

Christian Soschner

How challenging is it? I mean, when you look at the data, is it a clear signal that you often see in the data or is it more on the weak side that you really need a lot of elaborated people to look at the data and find the needle in the haystack?

00:25:26:13 - 00:25:50:24

Dr. Daniel Vitt

I think serendipity findings usually are clear signals. That's not that in contrast to if you're searching for something, you may be too biased sometimes to look for something and and sometimes we start to ignore statistical analysis. So I do this. So I think serendipity finding are usually the stronger ones. Hmm. So Viagra is a good example for that.

00:25:50:24 - 00:25:53:19

Dr. Daniel Vitt

There was a serendipity finding and trying to.

00:25:55:22 - 00:26:21:15

Christian Soschner

That how to how do you what I'm curious about is how do you find the right people then in your scientific advisory boards or scientific boards, When you get a database, it creates a bunch of files just as PDFs, and then you show it to people what's what's your metric that you place the CEO inputting to right scientists together to come to the right conclusion, to move the project forward to the benefit of the patient.

00:26:22:16 - 00:27:02:10

Dr. Daniel Vitt

Yeah, I think you need to you need to have the right people around you, which means internal. So, so, so your team should consist of people which are scientifically driven, science driven, which are open minded and not too arrogant, self reflected. But also you need the right advisors around you. And as you mentioned, keywords. And I don't want to run or sit here and I don't want to earn some fruits of others.

00:27:03:02 - 00:27:30:00

Dr. Daniel Vitt

Actually, our our clinical team, specifically Andreas Müller, our Chief Medical officer, he's it was pretty good in, in really connecting with the key people in the world of sclerosis and also true for sort of colitis and other indications we work with or celiac disease in front of our, our medical needs and for the celiac disease program is super nicely connected to the to, to really leading fruit of of of clinical researchers in the world.

00:27:30:09 - 00:27:50:00

Dr. Daniel Vitt

And you need it because you need to you need to test the relevance of what you do and to really know I'm on the am I on the right track or do I just repeat something, Jerry, You reinvent the wheel or the TV or whatever, or is that something really new? What is the need from the coming coming from clinical practice?

00:27:50:00 - 00:27:56:18

Dr. Daniel Vitt

I think that's super important that we stop doing things which are useless at the end, even if we think it's cool.

00:27:57:21 - 00:28:01:11

Christian Soschner

That it needs a lot of leadership, I guess, to get the right people on board.

00:28:02:17 - 00:28:26:18

Dr. Daniel Vitt

Yes. And and I think it also needs it's a culture problem. So you're the company needs to somehow have that open mindset to to come to that point. I think Munich is a good example where in your team it is collected together can really do better than an established old set up where things are getting a little bit more difficult on the political side.

00:28:28:02 - 00:28:46:13

Christian Soschner

Let's move from leadership now to the to the data side, to the scientific side and to the operational side of how to move the compound forward. As an example, you're tracking multiple sclerosis. What did you track showing the Phase one study? What was the end points that you wanted to prove with that study?

00:28:46:13 - 00:29:11:07

Dr. Daniel Vitt

Yeah, Phase one is as a safety. Yeah, this is the first in human study. It is an exciting moment. You give it a new drug to patients to, to, to healthy volunteers. In this case, in cancer development, it's patients, but he is really healthy volunteers. And just you carefully look, if it's well-tolerated, you start with a low dose of the very low dose and you then increase the dose, stabilize to test.

00:29:11:22 - 00:29:44:00

Dr. Daniel Vitt

Do I see symptoms of side effects, toxicity? These are tolerability issues and then you're more or less establish a dose way of thing. It's well-tolerated. At the same time, you also measure how much exposure the volunteer has and therefore you can calculate and you can use computer modulations for some modeling or for calculating. Okay, achieve already in a range where the drug should be efficacious and and this is information you then need.

00:29:44:00 - 00:29:55:14

Dr. Daniel Vitt

Okay, it's safe and has enough exposure, then it qualifies to go further. And if not, then you need to stop there. And despite spending a couple of million, then you should stop there.

00:29:56:13 - 00:30:04:11

Christian Soschner

It also includes in the phase one setting patients already, or was it totally healthy volunteers? So without any efficacy signals.

00:30:04:23 - 00:30:33:19

Dr. Daniel Vitt

From either fully model was really healthy volunteer study or our second molecule and 856 the molecule we tested now in celiac disease patients, we did the more and not more accelerated way. So we we first started with healthy volunteers for a single dose and then 14 day continuous dose. And then as a third part in the phase one, we already included patients in this case with celiac disease, a very small amount.

00:30:33:19 - 00:30:57:03

Dr. Daniel Vitt

So this is not something where you put hundreds of patients and it's a phase one study. So we want to learn how is safety in patients? Safety and patients can be different from safety in health controls because for example, in celiac disease that the patients have an impairment goal function, the gut wall is somehow not in good shape.

00:30:57:09 - 00:31:22:00

Dr. Daniel Vitt

And for example, nutrient uptake is not optimal. And in these patients can in fact the uptake of the drug as well. So that therefore it was part of the phase one. But we also had to look on symptoms. Yeah, So we also had to look on the histology. Do we see an improvement or can we protect patients with a drug from damage of the drug of the gut?

00:31:22:00 - 00:31:56:22

Dr. Daniel Vitt

Well, we we also looked on on symptoms of disease like nausea or diarrhea. The typical lead symptoms for celiac disease also looked at biomarkers like I go to Sertraline. And the fourth dimension, which was I found the biggest surprise here was the functional readout. So we looked also for vitamin B12 uptake in the patients and we were really surprised to see that even despite this was a four week study and we even used gluten as a challenge here in the study.

00:31:56:22 - 00:32:21:03

Dr. Daniel Vitt

So we actually gave the patients the antigen and looked, can we prevent the onset? So it was tough for the patients, I think, because they needed to agree prior to the study that they are willing to accept to be punished by us by giving them gluten. But this was we needed to really make sure we can test for the drug works or not to help the patients.

00:32:21:03 - 00:32:44:10

Dr. Daniel Vitt

Maybe a later time. Point or in other for the study. So and we have seen that the drug was in both treatment groups. It was able to improve the uptake of vitamin B12 substantially. And I think therefore it is phase one is it was very helpful in giving a quicker answer whether the drug has a relevance or not.

00:32:45:23 - 00:32:52:05

Christian Soschner

I mean, how many volunteers did you have in the Phase one trial for for the setting and how many of them were patients?

00:32:53:11 - 00:33:19:02

Dr. Daniel Vitt

Yeah, all in all, I think we had around about 100 patients and 42 patients were 42 were patients with celiac disease, and they all volunteered in despite being challenged with the gluten. And and interestingly, only only five patients dropped out from the treatment associated somehow associated with the gluten challenge.

00:33:19:18 - 00:33:24:04

Christian Soschner

How many people in the Western world suffer from this disease?

00:33:25:11 - 00:33:56:10

Dr. Daniel Vitt

Yeah, if you look on the on the on what's available as information materials something like between one and 2%, maybe 1.6, 7% of our population has celiac disease. Interesting. This is a disease which is not just a Western disease. This is a global indication. It's everywhere in Asia, Africa, Europe, US. Um, so it's a pretty big thing and maybe to, to, to, to, to focus on the relevance here.

00:33:56:10 - 00:34:25:02

Dr. Daniel Vitt

Then the biggest, the biggest problem is maybe helping patients which adhere to a gluten free diet because currently that's the only way to deal with the disease is really to try to stick to a very strict gluten free diet. But something like 25 to 47% of patients of celiac disease patients have ongoing active disease disease despite the pre diet.

00:34:25:02 - 00:34:53:14

Dr. Daniel Vitt

And these are the poor guys because you have that limitation of your life quality by really being limited to gluten free food on the one hand, but on the other hand you still have symptoms. So that's that's something where they really need to have help. And also on the long run, I think having lifelong celiac disease increases risk of of cancer, increases, risk of other long term diseases.

00:34:53:14 - 00:35:21:01

Dr. Daniel Vitt

So it also has a negative impact on your life expectation at the end. And therefore it's a real disease with a lot of patients affected. So in Europe and in the US you find about 2 million each and there's no treatment is despite gluten free diet so far. So we think that that need to be changed and therefore we will use the also celiac disease as the first proof of concept indication for I'm your age, five or six.

00:35:21:19 - 00:35:35:15

Christian Soschner

So it's eat of eating lifestyle or taking a direct and at the end of the day to enjoy the European versions of cakes and bread and rolls and all these options that we have everywhere.

00:35:35:15 - 00:35:43:23

Dr. Daniel Vitt

Basically it's mainly it's bread and these things. So it's we just I think the main source of gluten.

00:35:44:12 - 00:35:46:05

Christian Soschner

Is supporting in Vienna.

00:35:47:07 - 00:36:13:08

Dr. Daniel Vitt

That's definitely something you have problems with. And gluten free Saturday, maybe it's not the nicest thing to eat, but it's maybe better than nothing. So yes, and, and, but this treatment should really gets goes beyond that diet. Yeah. I think patients with celiac disease will need to adhere to the free diet for the whole life. No way out there.

00:36:13:21 - 00:36:46:19

Dr. Daniel Vitt

Okay but there we may at offer a first option to then be in out of symptoms free of symptoms of diarrhea, nausea and so forth, and malnutrition. I think malnutrition is a big problem and might be 12 is one thing that there's something like iron metabolism. So anemia has a side effect there. So there's a lot which really doesn't make the life of of severe serious patients lives.

00:36:47:05 - 00:36:56:13

Christian Soschner

Yeah, sounds like good. And when we move forward then with with your track interface to setting what's the what's the goal that you want to prove.

00:36:56:24 - 00:37:19:11

Dr. Daniel Vitt

So if we if we just limit phase one to the at safety and tolerability and peak, then in phase two we are testing activity. Do we see a therapeutic effect and therefore not interface to our current plans which are not final, but our current plans are to use exactly that population of ongoing active celiac disease patients by trajectory diet.

00:37:20:02 - 00:37:50:01

Dr. Daniel Vitt

So we want to include such patients in the Phase two study and treat them for at least three months and then look whether we can improve their histology, their symptoms, nutrition uptake and biomarkers. So then things we have seen in phase one in the patient portion, no, in a bigger test set of patients. And here really what you want to achieve is just a distinct significant improvement, meaning that your treatment group should behave better than the placebo controlled group in the phase two.

00:37:50:22 - 00:37:56:21

Christian Soschner

How many patients do you need to think to understand it? 1200 wasn't the first one first study and.

00:37:57:08 - 00:38:20:19

Dr. Daniel Vitt

It was three studies basically. Now, in the phase two, usually this has something like 200 to 250 patients could differ early, but this is all based on statistical simulations and my team, but round about 200 to 300 patients. Maybe it's the right scale for a typical Phase two study. There are differences, but this is in the autumn. You usually the size of the Phase two study.

00:38:21:13 - 00:38:26:21

Christian Soschner

And for a multiple sclerosis drug. What this study says, which was the study says in phase two.

00:38:27:18 - 00:38:32:19

Dr. Daniel Vitt

In phase two was 215. And now in phase three, it's a 1000.

00:38:33:03 - 00:38:33:21

Christian Soschner

1000.

00:38:34:03 - 00:38:35:21

Dr. Daniel Vitt

A study. Now, how many.

00:38:35:21 - 00:38:36:11

Christian Soschner

Sites.

00:38:37:22 - 00:38:45:24

Dr. Daniel Vitt

Are we currently? 150 sites for two or two studies aiming to recruit 2000 patients into altogether? Yes.

00:38:47:02 - 00:38:49:08

Christian Soschner

In Europe and the United States, I guess.

00:38:49:20 - 00:38:51:21

Dr. Daniel Vitt

All its all over the world number.

00:38:52:14 - 00:38:55:11

Christian Soschner

Oh, this must be a nice piece of work.

00:38:56:02 - 00:38:58:13

Dr. Daniel Vitt

It is. It's it's tough work.

00:38:59:01 - 00:39:05:13

Christian Soschner

Yeah. But what are the main challenges, in your opinion, in doing a multicenter Martinez Schnell Global study?

00:39:06:09 - 00:39:15:11

Dr. Daniel Vitt

I think not. Maybe not surprising these days. Distribution chains are a problem. Our data are.

00:39:15:16 - 00:39:16:08

Christian Soschner

Still a problem.

00:39:16:18 - 00:39:49:06

Dr. Daniel Vitt

Yes, because if you have a blood sample, I want to bring that from a lab in India to a testing site in Belgium. And you have only 48 hours to do that. That's a challenge. So logistics is still it was always and is still a challenge. But of course, at the end recruitment, you need to really quickly have enough patients available which fall into the criteria of treatment and quality qualified to be included in the study.

00:39:50:13 - 00:40:28:14

Dr. Daniel Vitt

And I think that the team is really doing a great job here in talking to the local doctors around the world. So they're traveling a lot and it's important to speak with investigators on the site to tell them about neuroprotective effects, to tell them by the experience and in clinical sides of the Phase two study. We're really excited about what they have seen here as a therapeutic benefit for our patients so that they they know about the potential of the drug and can educate the patients about the benefits of entering such a trial.

00:40:28:14 - 00:40:39:03

Christian Soschner

It's a lot of leadership again. So it's I think it's not only that the patients at the door can just say you have to join the study. It's need probably also a lot of convincing to try something new.

00:40:39:16 - 00:41:10:18

Dr. Daniel Vitt

It's a very human thing. You can't rely on machines and computers. So I mean, it's a personal thing. You need to establish a relationship between the management of the company and the employees, the treating physicians and the patients and even the the press or social media like we doing today to make people aware that there is a medical need and people are suffering.

00:41:11:08 - 00:41:31:11

Dr. Daniel Vitt

And we need to come up with answers. And to do that, we need to do clinical trials as there seven there will be no new medicaments in the future and somehow this is forgotten. And the public awareness that if we if we talk only about pricing of drugs, we forget about the need of new drugs for unsolved problems.

00:41:32:03 - 00:41:42:03

Dr. Daniel Vitt

And therefore this is a quality of the discussion. We also want to continue to make sure that we get people aware about these unmet medical needs.

00:41:43:07 - 00:41:51:15

Christian Soschner

Now, that's that's absolutely true. That's absolutely true. And I think social media is a good place to start, is to help spread information and reach out to people.

00:41:52:08 - 00:42:07:24

Dr. Daniel Vitt

And therefore, you're doing a good job on this. And to really make sure you get a broader understanding of these more complex things where we usually, as researchers, tend to stay at home and work rather than talking about it.

00:42:08:22 - 00:42:28:05

Christian Soschner

The end for retail investors and institutional investors, it helps sometimes to simplify, simplify the decisions to a point that they can digest it very quickly. And I think it helps moving things forward, which is really challenging sometimes in science. How do you see challenges of scientific communication in your company?

00:42:29:09 - 00:42:55:23

Dr. Daniel Vitt

Yeah, I think the challenge of the company, I think the company is is is good on this end and we have a good team in trying to translate it into into messages and to get awareness there that it's more a legal issue, obstructive illiteracy or somehow bound to a legal environment which is really preventing advertisement for drugs which are not yet approved, all of these things.

00:42:55:23 - 00:43:09:02

Dr. Daniel Vitt

So somehow to be over careful on these things, talking to investors is not a problem, but talking to the public. Maybe misinterpreted as advertising for a drug which we don't do there.

00:43:09:09 - 00:43:23:16

Christian Soschner

We need to talk to raise awareness on one hand. So yeah, I think we need to do that when we look at your pipeline again. So your compound Amul eight, five, six and celiac disease is in phase two. If I understood it right.

00:43:23:21 - 00:43:29:21

Dr. Daniel Vitt

It completed phase one with patients. So it's a bit between phase one and phase two.

00:43:30:15 - 00:43:31:07

Christian Soschner

Limbo stage.

00:43:31:07 - 00:43:46:02

Dr. Daniel Vitt

And preparing a phase to study, meaning just 250 patients thing where you really test for a dose dependent effect of the drug. So we want to find out what is the right dose strengths of the drug for treating celiac disease as a next point.

00:43:46:19 - 00:43:58:23

Christian Soschner

But the data of the Phase one trials were solid so that your scientific board recommended to move forward in the Phase two study and you are currently in preparation stage of the study?

00:43:59:10 - 00:44:21:11

Dr. Daniel Vitt

Yes, it was overwhelmingly good. So it was really, you know, last year we had a failure. We had a failure of one of our drugs where at the first two doses tested, it didn't work out. That's also part of our life. This was the bad day. If you if you if you find out that something is not working as you calculated, you projected and you thought it is here, it was different.

00:44:21:11 - 00:44:43:01

Dr. Daniel Vitt

Yeah, we we we tested that in this very small amount of patients, but every, every data point was moving in the right direction. And the holistic view is really this is a new treatment options, a new mode of action. And we didn't speak about it, but this is for severe disease. It will be a new kind of treatment because what the drug is doing it is helping the gut want to renew.

00:44:43:07 - 00:45:13:02

Dr. Daniel Vitt

So it's more targeting than natural function of gut renewal and therefore is reestablishing the proper barrier function in the gut wall. So the antigen can can't cross the gut more so than the gluten related peptide and not quite crossing the gut one on the one hand. But also we impair the function of the gods and therefore indirectly repair and the onset of the disease.

00:45:13:21 - 00:45:16:22

Christian Soschner

So we are talking basically about leaky gut syndrome. Oh.

00:45:17:12 - 00:45:49:14

Dr. Daniel Vitt

Oh, that's exactly what we might be embarking on. It's more fixing a leaky gut. Yes. And this is done without immunosuppression. And that is new. I think it's a it's a different way to solve the problem compared to what's really believed to be the right way to do it. And given that leaky gut or so-called leaky gut is, I think, a problem not only in celiac disease, but also in patients with positive colitis or Crohn's disease and and other stuff like that.

00:45:50:04 - 00:45:59:14

Christian Soschner

And and sort of interrupt you out of curiosity and your track candidate has the potential to restore the gut. What did adhere to tried.

00:46:00:15 - 00:46:20:12

Dr. Daniel Vitt

Without immunosuppression so it this really it's an epigenetic regulator of 36 protein and and it stabilizes it's binds very tightly binds to 36 and stabilizes the protein and it's a high expression of that. So the structural effect of of the protein is therefore improved.

00:46:22:00 - 00:46:54:02

Christian Soschner

But isn't it sort of neurotic? And isn't that opening the door to huge potential for your drug benefit as far as disease? Thanks for effort, business background, but out of curiosity, I mean, looking at this, the root cause of many problems basically. So it means that the gut ward not only allows nutrients to pass into the body, but also toxic material to the qualities way then it ends up in the liver, destroys the liver damage is delivered and it goes up into the brain, destroys the brain and all other organs, basically at one point in time will fail.

00:46:54:06 - 00:47:08:07

Christian Soschner

And when you close the door, I mean, if I understand you, right, so you shut the door and say, okay, now toxic that C toxic substances, your time is over. You go, you're flushed out and you can't enter the body. Is that the right picture of your track of the potential?

00:47:08:20 - 00:47:34:18

Dr. Daniel Vitt

Exactly. So really, this is the plan is the concept. And this is, as I said, this is not using immunosuppressants, for example, which is normally the way to deal with that. Stop the reaction to the toxins or the antigens here. What we do is we really try to establish the natural situation, which means, okay, the gut one is healed and to heal gut the world will not let toxins or antigens pass through.

00:47:35:01 - 00:48:00:12

Dr. Daniel Vitt

On the one hand, but also ensure the proper uptake of nutrients. Because the problem with leaky gut is not that you just have too many toxins, you also lose the ability of the gut. What should take up an active way? Things like vitamin B12, which is needed by the body and therefore it needs to malnutrition symptoms if you don't have that And as I said, it goes beyond I said initially celiac disease, use additive colitis or Crohn's disease.

00:48:00:21 - 00:48:31:07

Dr. Daniel Vitt

But you're right, it even would include something like Parkinson's disease where you all believe that decapitated bacteria are causing Parkinson's reactions and and by stopping that, it's so-called gut brain axis. Yeah. If you if you stop that, you may even to this may even help Parkinson's patients. We don't test that right now. And this is something where I think let's see how that evolves over time.

00:48:31:23 - 00:48:41:07

Dr. Daniel Vitt

And we were the first focus on GI indications. So I think in gastrointestinal tract should be looked at first. But the concept, I think, can clearly be expanded beyond that.

00:48:42:19 - 00:48:45:10

Christian Soschner

It would be really great.

00:48:45:10 - 00:48:47:01

Dr. Daniel Vitt

Yeah. Yeah I absolutely.

00:48:47:01 - 00:48:54:13

Christian Soschner

Agree. It's also and and you mentioned it. I said it's good enough and you said, no, it's a lot better. States are actually made of semantic, but this would be really game changer.

00:48:54:13 - 00:48:56:12

Dr. Daniel Vitt

Changer would be game changer, yes.

00:48:57:05 - 00:49:18:16

Christian Soschner

How long do you think does your team need until proving interface free setting, which is then coming after the phase two that's in a significant big patient population. You really can restore the got word, and let's put it bluntly, heal it and restore the natural state.

00:49:19:05 - 00:49:41:07

Dr. Daniel Vitt

I think that should be feasible in the Phase two already because phase two testing of patients for statistical readout and histology. So the healing will be part of the all the readout. So I think this such a study may take one and a half to two years and by end of this year, beginning of next year. So not too far.

00:49:41:07 - 00:50:08:07

Dr. Daniel Vitt

I think it's usually just a question of resources and includes money to to find finance that and there's always an alternative also can think of by partnering and therefore with such a unique new concept. And we are a first in class. Yes. So this is the first molecule which is acting as imaginative, said six in a clinical trial.

00:50:08:07 - 00:50:26:24

Dr. Daniel Vitt

We think that it should also be exciting to the big pharma companies already at this stage because we have such wonderful efficacy data from the Phase one patient cohorts. Good safety is a good production process in place. So I think it's a once in a lifetime opportunity. I think from my novel.

00:50:27:09 - 00:50:49:15

Christian Soschner

When I remember a conversation I had with a professor at UCLA a couple of years ago, I was in 20 1516 when he said there was that you solve the problem by finding toxins in the gut and flushed them out basically. So you leave the category as it is. But his opinion was that, if I recall it right, that basically Western lifestyle destroys the gut more.

00:50:49:15 - 00:51:10:15

Christian Soschner

So you can't do anything about it if someone doesn't get you to this super, super clean diet, No alcohol, no farm, no cakes, no sugar and just leaves and a skeptic lifestyle up on a mountain, then probably this person safe. But usually the gods were during life. At some point in time becomes leaky. Your tracting has really solved the problem.

00:51:10:15 - 00:51:14:05

Christian Soschner

It's not just treating the symptoms, it's social and the problem.

00:51:15:18 - 00:51:38:06

Dr. Daniel Vitt

And I think this lifestyle discussions always go in the wrong direction. I think the diseases are diseases because there's something wrong in the body, which is not wrong behavior of patients. It's a genetic. So we should not put celiac disease patients in the and and they're not saying you they saying that, but just referring some of these literature things.

00:51:38:18 - 00:52:08:07

Dr. Daniel Vitt

This is a really disease which has an organic reason that it's there. But you're right, associated problems that are associated to western diets. And somehow because we eat a lot of gluten containing food and because it's convenient and it tastes as well. So and in in Austria, I think all these music plays and stuff is really something which is everything.

00:52:08:07 - 00:52:09:24

Dr. Daniel Vitt

It contains a lot of gluten there.

00:52:10:16 - 00:52:12:12

Christian Soschner

Don't want to miss it.

00:52:12:12 - 00:52:13:17

Dr. Daniel Vitt

That's great stuff.

00:52:13:17 - 00:52:16:05

Christian Soschner

So we also need some fun in life.

00:52:16:19 - 00:52:24:18

Dr. Daniel Vitt

Yeah, absolutely. And luckily, I think I'm not I'm not celiac disease patient and I am.

00:52:24:18 - 00:52:42:09

Christian Soschner

But but can you can can you drug to more so it's 1111 part of one part is helping select disease patients. But then you also have this other part is huge lifestyle discussion that's ongoing. Can you attract and also restore regard for in adults not a settings.

00:52:42:22 - 00:53:12:03

Dr. Daniel Vitt

Yeah. If it's disease, yes I think we we we as a as a biotech and medical company you can't really develop just lifestyle drugs because at the end we need to really use the money for solving medical problems. And I feel ethically that bond to that because you can you can spend the money only once but there's so many things we we need to solve.

00:53:12:03 - 00:53:40:02

Dr. Daniel Vitt

And I mentioned additive colitis, for example. There are patients right now only have immunosuppressive therapies available which then lead to a higher risk of infections, for example, by nature and and so side effects of these treatments are always there. They're intrinsic basically. And there's this concept would be different. So this concept would mean, okay, we we don't need to really switch off their whole immune system.

00:53:40:02 - 00:53:51:06

Dr. Daniel Vitt

We could we can keep it up and running and maybe just prevent or heal the control independently and therefore stop symptoms as well. It's just a different way to solving the problem.

00:53:52:02 - 00:53:55:02

Christian Soschner

So huge potential. Huge potential.

00:53:55:17 - 00:53:58:13

Dr. Daniel Vitt

I agree. It's a multibillion opportunity at the end, of course.

00:53:59:01 - 00:54:10:11

Christian Soschner

How much how much money does such a project consume until you get it to the regulatory authorities for final approval market access approval.

00:54:11:05 - 00:54:35:06

Dr. Daniel Vitt

I think this depends really on the indication and and if how big the trials are and if you calculate all the money you put into things which didn't work out in the end because I think at the end it's not about the money you put in the successful, but the portfolio you're working on now. So I think my, my, my rule of thumb, this would be half a billion right now for a molecule of that precision.

00:54:36:00 - 00:54:41:24

Dr. Daniel Vitt

And the most expensive part is definitely phase three. When you have 4000 patients that what's up?

00:54:41:24 - 00:54:47:22

Christian Soschner

What what are your goals with your I am your 856 drug candidate.

00:54:48:24 - 00:55:16:07

Dr. Daniel Vitt

I think I want to see that approved on the market and be part of the success there and can and can say to myself I contributed to to a reasonable improvement here. I think that that's my ultimate goal. That's why I'm doing that. And eight, five, six is such a big pleasure because it is a game changing molecule, new mode of action.

00:55:16:07 - 00:55:21:20

Dr. Daniel Vitt

It's scientifically interesting and medically interesting. So the quite unique combination, I think.

00:55:22:14 - 00:55:53:16

Christian Soschner

It's good for you. I mean, for the for the plans and the strategies for what I learned in my life. You mentioned also on one hand, partner English. If I'm industrially out license, it helped them scientifically to move it forward. But basically if they how to work to them or on the other hand so asking investors for capital to move the compound forward either by a spin out or in the company or doing a mixture of those, what's your ideal plan for that compound?

00:55:53:16 - 00:56:03:23

Christian Soschner

Do you want to take it to phase three and market access in your company or are you currently looking for partnering options? Investors?

00:56:03:23 - 00:56:25:17

Dr. Daniel Vitt

I think now what we are welcome to this normal worldwide, not a new world, meaning it's a question of availability of financing and I think you mentioned 2008 for a lot of company was forced to to to to drilled down to a single product company level. This is not good because. You have a bias in what you do there.

00:56:25:18 - 00:56:48:22

Dr. Daniel Vitt

So I think we need a portfolio of things to do to to work on phase three. As I said, it's very expensive and luckily we are listed on Nasdaq and we have access to capital. And the company raised more than 300 million in the last five years and having access to NASDAQ and therefore we are in a luxury position that we have the ability to run a phase three clinical trial right now in multiple sclerosis.

00:56:49:12 - 00:57:11:06

Dr. Daniel Vitt

But I think I doubt that we can run multiple Phase three studies in big indications because this was just been too expensive and therefore this is difficult to finance or impossible to finance, or at least it doesn't make sense because you need to like to dilute a lot at an early time point, which of course really is a problem then for for the investor returns.

00:57:11:16 - 00:57:33:12

Dr. Daniel Vitt

And with investors, the whole thing doesn't work. So we we need these investors. They are good. They know what they do, but they need to trust that the business concept here is really active and it and I see it working. So therefore I believe we need to to really work on both and we need to make sure we have proper finance and access to capital.

00:57:34:04 - 00:58:01:20

Dr. Daniel Vitt

And secondly, that we established a trust for relationship with other companies because at the end we need an established sales force to really market the drugs. They are good examples of of biotech companies which managed to really get through phase three and on the market even in them. As recently there was two G Therapeutics who got their first molecule approved for treating Imagine this and anticipated 20 antibody which is in a swimming in the same pool as queries from Roche.

00:58:02:12 - 00:58:36:12

Dr. Daniel Vitt

And it's a nice, nice example that companies can do this today, but it's a tough way and you really need a lot of support from every angle to succeed in that. And therefore I think for us it is more attractive to balance things also in partnerships, maybe not everything. Yeah, so I would keep that open. My, my, usually my, my, my professional business position here is clearly the more options you have, the better your business decision is at the end.

00:58:37:06 - 00:58:54:10

Christian Soschner

Mm hmm. That's. That's good. Good, good philosophy for business. So maximize the number of options. I'm a good friend of the Biontech for, for example, finding a strong partner who has an established salesforce already. I mean, building Salesforce. This is science by itself.

00:58:55:02 - 00:59:03:06

Dr. Daniel Vitt

Absolutely. I think without Pfizer, they would have really struggled. And in the speed of and distribution, there's also a distribution problem there.

00:59:03:06 - 00:59:26:07

Christian Soschner

And I think Moderna did it themselves didn't do so they themselves. So you have both possibilities on the market before we move before we move to the investment focused questions, I have a few because your address is on. The Nasdaq, you mentioned didn't miss something in running for your portfolio. Is there a question open that you would like me to ask?

00:59:27:03 - 00:59:30:24

Dr. Daniel Vitt

No, I think there's there's a third program, three and one which is new.

00:59:30:24 - 00:59:33:09

Christian Soschner

If the free fall one. We didn't talk about the first one yet.

00:59:33:21 - 01:00:00:03

Dr. Daniel Vitt

Yeah it's pretty new and preclinical. I don't talk about what it is focusing on. It's using our learnings from the phase, from our clinical studies and we didn't speak about a success we recently had in lots of related clinical trials. We did this one year treatment maintenance study of leukemias, calcium in lots of colitis patients and it came out so great that I thought, okay, we need to do something there.

01:00:00:14 - 01:00:37:00

Dr. Daniel Vitt

And based on the learnings there in the knowledge, we said, okay, we have also a new molecule with a similar action but different properties and therefore we said, okay, let's let's focus one of those assets to gastrointestinal diseases. And following a little bit the philosophy of the fruity. Ms. And therefore we started that program as, as a third pillar, we're Standing Rock, but that's not relevant for the current business, for the current finance discussions because it's really early and therefore it doesn't play a role today.

01:00:37:11 - 01:00:58:08

Dr. Daniel Vitt

But we need to be prepared for tomorrow if we do a deal or we we we get immediate funding was approved, then the question of what's next year and why, why losing time there and not using or leveraging the the scientific excellence we have established here in this area. And come up with something new. So that's all I can tell you today.

01:00:58:08 - 01:01:04:02

Dr. Daniel Vitt

About 381. What is important piece of the future of the company now?

01:01:04:04 - 01:01:21:03

Christian Soschner

Definitely. I mean, it's always a problem in the industry when a company acquires expertise or definitive expertise, then license to lead, compound, and then the team just falls apart because there is nothing, no work to do. And it's obviously a loss for the industry when this happens.

01:01:21:03 - 01:01:23:16

Dr. Daniel Vitt

Yeah, it's a such a loss of value at the end. Yeah.

01:01:23:24 - 01:02:04:23

Christian Soschner

Yeah, yeah, yeah, yeah. I think there's a lot of value that's not tangible. That's hard assets like buildings, but people working together, setting things together in the life science industry, in the biotech industry, especially in the clinical setting, in preclinical setting, a proficient team that knows how to take attract candidates, a potential candidate from the lack bench, move it forward into patients, and then structure the right scientists and the right clinical companies, heroes who help moving that forward to future phase one face to face resetting, springing to the market.

01:02:06:00 - 01:02:07:05

Christian Soschner

This is not easy to build.

01:02:07:19 - 01:02:15:15

Dr. Daniel Vitt

No, absolutely not. No. Sometimes I forgot how complex that was in the past. So in medical and we have established like now.

01:02:15:24 - 01:02:39:22

Christian Soschner

Oh yeah, Oh yeah. I mean, this is the discussions that we had with patients, for example, during the pandemic where some politicians mentioned that let's just make the patents available and we solve our problems. And I always thought that's not a real problem, that we have a mean licensing deals. Does this daily business, they are possible. The problem is they know how to transfer.

01:02:40:17 - 01:03:08:24

Dr. Daniel Vitt

Good, good point that you bring this up. This is something which really makes me upset because it's just honesty and sorry for that burning stupid thinking of some politicians and it's an opportunistic bullshitting basically because you would eliminate the industry if you do this. If people totally underestimate that we can only finance these half a billion budget for getting new drugs.

01:03:08:24 - 01:03:39:06

Dr. Daniel Vitt

There are a lot if we have investors interested in getting getting returns and if we don't have patents in place, we will lose it completely. Lose the attractiveness for any investor to get in. And there are some countries in the world where the governments have decided to to force companies for free licenses. And in these countries there's is no longer drug development and the availability of drugs really goes down and.

01:03:39:06 - 01:04:03:22

Dr. Daniel Vitt

And if you do this in Europe or in the US, you would kill the industry. And it's really that tough and it will be all or nothing if this goes beyond just an urgent pandemic exemption rules, because there's always away from the public health systems to solve the problems in a way which doesn't touch the patent world at all.

01:04:04:09 - 01:04:12:00

Dr. Daniel Vitt

There's enough pressure on the industry right now about that. What would you go beyond the point where we go out of business now?

01:04:12:00 - 01:04:37:15

Christian Soschner

Rich Masters in a previous podcast addressed the topic as well, and he said that it was a huge point and gives you a smiling Boston to talk about it. Rich Masters is the chief marketing and public affairs officer at Bio, a biotechnology innovation organization. Now I have it and in the podcast, I mean the figures that I have in mind is that when you bring one to bring in number track to the market.

01:04:37:15 - 01:04:43:23

Christian Soschner

So just about by expressing it in one figure, it's these days $4 billion that someone needs to.

01:04:44:08 - 01:05:11:07

Dr. Daniel Vitt

Put on to calculate the field trials. Yes, it's $4 billion. And this is nothing you can finance just with a little bit of public money or so. We need the whole finance industry to support it as it doesn't work. And yet, look, I think maybe the big pharma company can deal with that because they have revenue streams, But you would immediately eliminate the whole biotech industry, which is just R&D focused.

01:05:11:17 - 01:05:20:13

Dr. Daniel Vitt

So but therefore, I think that that should be something where it's not in the interest of the public to do something like that.

01:05:21:11 - 01:05:29:02

Christian Soschner

From my business perspective, Big pharma is in the right place to bridge the gap between science and products. It's just the structures are too big.

01:05:29:20 - 01:05:34:00

Dr. Daniel Vitt

For well and to be careful, they're my potential partners, so.

01:05:34:18 - 01:05:59:04

Christian Soschner

I know it's big pharma. The strengths, in my opinion are when you look at the development chain, market access, bring products to the patient and take it up in a phase three settings. So there have to be structures. When I look down at the business, for example, I would think is doing also if you're preclinical program, you need to have a quick, flexible teams to search for the needle in the haystack.

01:05:59:04 - 01:06:05:22

Christian Soschner

And from from my corporate experience, I think the structures of big corporations are not set up for that.

01:06:06:22 - 01:06:16:24

Dr. Daniel Vitt

No, you're right. But I need to be careful. You know, if you listen to this podcast from sitting on the other side of the table, the negotiation side.

01:06:18:15 - 01:06:47:06

Christian Soschner

That's true. That's true. So you have free programs in the development and preclinical one at the beginning of close to phase two and the first one is in is in phase three. That's a good sign, I think, for investors, but also retail investors who might be interested in supporting your work. But buying your shares is a very good risk profile.

01:06:47:19 - 01:07:16:20

Dr. Daniel Vitt

I agree. And I think the beauty is really that the Phase three program is really a low risk program compared to other things. Phase two was perfect with just repeating more or less in the phase three would be done in phase two. But I am out of patience and therefore there's this there's light at the end of the tunnel of development already there, which which I think is just for somebody who is not, but a day trader.

01:07:17:02 - 01:07:37:09

Dr. Daniel Vitt

I think this is I mean, it makes sense to have a look at of course there's the risk associated because any study can fail for whatever reason. And then I was talking about the celiac disease program. I think really this barrier function stuff or they could got, as you said, I think this is, as I said, already a once in a lifetime opportunity.

01:07:37:09 - 01:08:00:15

Dr. Daniel Vitt

And I see huge potential in that. Also, there is no guarantee that it will at the end reach the market because it's part of our industry risk. But so far it looks as good as can be at that stage of development. So that's why I really like the balance. The portfolio we have right now.

01:08:01:15 - 01:08:17:08

Christian Soschner

If, if this time you have six program, let's put it this way, let's assume it's an ideal world and everything works 100% fine. How big when you must express to market in a number of people. Market B.

01:08:17:20 - 01:08:18:11

Dr. Daniel Vitt

It's a much.

01:08:18:11 - 01:08:19:06

Christian Soschner

Imperfect world.

01:08:19:14 - 01:08:27:08

Dr. Daniel Vitt

It's a multi billion opportunity, definitely maybe 5 to 10 billion that's causing it's a quarter.

01:08:28:07 - 01:08:30:18

Christian Soschner

And how much of the market do you think you can capture?

01:08:32:04 - 01:09:01:18

Dr. Daniel Vitt

And that's something you really can't answer. I think this it really depends on what else is ongoing there. I think so far this is to my best of my knowledge, the only drug which has that mode of action and it will supplement really what's there right now would perfectly fit into the portfolio of a lot of companies which have for antibodies for 23 and 17 integrin antibodies.

01:09:01:18 - 01:09:36:09

Dr. Daniel Vitt

So it's it's a world where there's this established therapies work in some patients, but there's still a major portion of patients don't respond initially on these treatments and combinations could be an interesting could be interesting add on here because since we don't lower the immune system, it's something which should be good for combining with immunosuppressive drug maybe at a later time point, but that could then open up the market access to a huge number of patients which are currently just treated in monotherapy with these kind of molecules.

01:09:37:13 - 01:09:45:07

Christian Soschner

That's that's a very good pipeline. It's impressive. What's your field with your team in the last years? How old is in Munich? How does your company.

01:09:45:07 - 01:09:50:10

Dr. Daniel Vitt

Yeah we we started officially beginning of 17. The company.

01:09:51:03 - 01:09:53:07

Christian Soschner

Was 76 years on due.

01:09:54:08 - 01:10:19:10

Dr. Daniel Vitt

To the 16 it was legally founded and the of it back to my my personal history so the initially the first two products came from my old company for I see in license those two molecules and I'm very glad that we did it and I think also it was good for for us yet that time because they they were focusing on oncology pivotal trial and more focusing on getting some money for doing that.

01:10:19:10 - 01:10:53:01

Dr. Daniel Vitt

And we we leveraged the two assets which were outside of oncology there, and I think that was good for everybody. And also we had the chance to really focus on accelerated development for beautiful HMOs and for the at that time, I mean, 9 to 5 as a second molecule with very dedicated development program. And yeah, of course, if it's a second company, we learned a lot about the do's and don'ts.

01:10:53:01 - 01:10:57:05

Dr. Daniel Vitt

And also access to capital is much easier if you have a track record.

01:11:00:01 - 01:11:02:16

Christian Soschner

As So you think you are co-founder basically of in Munich?

01:11:02:22 - 01:11:05:22

Dr. Daniel Vitt

Yes, I'm in Munich and there was also co-founder, of course.

01:11:05:22 - 01:11:32:22

Christian Soschner

And so it's a good track record. And I'm curious, you mentioned that immunity. You founded the company in Munich, in Bavaria, in Germany, which is a, I think one of the biggest and best ecosystems in biotech and life science we have in Europe. It's impressive what comes out of this environment. How many companies evolved out of Ferrari and Munich in the last two decades?

01:11:33:06 - 01:11:39:02

Christian Soschner

I think the every time I look at the ecosystem, it's growing, growing and growing and growing.

01:11:39:02 - 01:12:13:14

Dr. Daniel Vitt

And and we were we were lucky part of that because when we started Forest, yet at the time it was really due to the Bavarian government support for funding and of course he was was build there was very very good terms and conditions in the market to finance and new startup in Bavaria and we we decided to to to to relocate we we started in Spokane in middle of Germany and then moved over to to Martin Street because there was a hotspot and still is the hotspot of biotech.

01:12:13:14 - 01:12:36:14

Dr. Daniel Vitt

And if you then look back, basically this is really all due to the decision of the at that time of the government to sell their their stock of intercom and to use the money for investing it in science. And we as in Munich are still earning the fruits of that time of pretty smart political litical decisions which are maybe not they were not mainstream.

01:12:36:14 - 01:12:51:03

Dr. Daniel Vitt

I think this was really something where we had politicians at that time had more visions than maybe today to say it, but along a long lasting effort, which I personally benefited from.

01:12:51:04 - 01:12:52:15

Christian Soschner

When when was the decision?

01:12:53:22 - 01:13:07:14

Dr. Daniel Vitt

It was 1990 when we started and was based on the the first startup phase in Mountain Street in 1995 96, where that high tech initiative started.

01:13:08:13 - 01:13:12:15

Christian Soschner

And I think the I mean, in Vienna, it was almost empty back in the nineties.

01:13:13:06 - 01:13:21:18

Dr. Daniel Vitt

And we had be and was just later and therefore it was it's always the same issue early and you have a big vision. You can succeed easily.

01:13:22:14 - 01:13:36:14

Christian Soschner

That's true. It's true. And I have a collaboration with the Austrian stock market and I frequently get the question why are biotechs not interested list getting listed in Europe? So what's the reason?

01:13:37:14 - 01:14:15:04

Dr. Daniel Vitt

I have a very clear answer to that, because the legal environment is preventing biotechs from raising enough money in really European law. And I went to to look for is he was is the public company on the Frankfurt Stock exchange and I think the company would have been in the very what may have been a multibillion company. And if if if if we would listed the company would have listed the company next thing, then the problem is really that if you need money for growth and you want to fuel development of the next product, you need to have enough money.

01:14:15:04 - 01:14:34:01

Dr. Daniel Vitt

You need to be able to raise more than ten 20% of your market cap. This is the problem. And then in Germany or in everybody in Europe, you need to write a prospectus and it may take three months. If you have an investor want to put in 20 million next morning, you need to you need to take the money.

01:14:34:01 - 01:14:59:18

Dr. Daniel Vitt

You need to be legally able to take the money. And in the US environment, it's different. You can do that. You have access to the market. It all depends on how good you are and do people believe that it's a good investment at that time point and you're free to negotiate? You can. You can have a stock already prepared to give given out based on the prospectus.

01:14:59:24 - 01:15:07:19

Dr. Daniel Vitt

I don't see any disadvantage for investors on the US system here. It's really a disadvantage to companies because it really blocking capital race.

01:15:08:15 - 01:15:23:14

Christian Soschner

I think investors in the US market need to qualify first before they are to to enter the bigger number scheme and in Europe is it's difficult to track from what you said it's the other way around. The companies are forced to do this basically checks.

01:15:24:11 - 01:15:45:05

Dr. Daniel Vitt

Yeah and it's so simple it put maybe everybody can do that exercise let's just look on which company raised, what amount of money and in what context. And I went through both experiences and I am pretty glad that I'm listed on that. Honestly, it's more it's a tough world. I think it's the easy, but it gives the company access to what the company needs.

01:15:45:14 - 01:15:51:00

Christian Soschner

So you you went public in on the European market and on the Nasdaq.

01:15:51:00 - 01:15:51:10

Dr. Daniel Vitt

Yes.

01:15:51:23 - 01:15:53:16

Christian Soschner

With Munich obviously first company.

01:15:54:17 - 01:16:22:11

Dr. Daniel Vitt

And unique with in Frankfurt with the first company was Percy there was in 2005 it was the only life science IPO in 2005. Congratulations and the tough time in the market. But I think only the tough ones survive. And and then with Munich, we did it. We took a different road because as a European company, the normal IPO track is more challenging.

01:16:23:13 - 01:16:57:04

Dr. Daniel Vitt

So we did a so-called reverse merger. So we we did we, we did a bid or an offer for a company which was looking for a new future after a phase three failure. It was based in San Diego and called Vital therapies. And there was a competitive process. So they they received something on 70 so seven zero offers and is supposed to be acquired formally and after quite competitive process.

01:16:57:05 - 01:17:37:06

Dr. Daniel Vitt

We we succeeded getting that through. So we they accepted the offer of a takeover and, and then they acquired in Munich, Germany. We took over 80% of the ownership renamed the company US company into Munich, Inc. And since then, legally we are a U.S. company and we took over the Nasdaq listing of the company. Oh, okay. Okay. And then but it's it's it's smart, but it's also hard because at that time point we needed to have commitments of our current shareholders are putting in more money because you can't go to Nasdaq with empty pockets.

01:17:37:06 - 01:17:38:20

Dr. Daniel Vitt

You will be two weeks.

01:17:38:23 - 01:17:45:15

Christian Soschner

So I always say availability of capital in the US. For biotech companies, it's such a huge difference to Europe.

01:17:46:06 - 01:17:54:16

Dr. Daniel Vitt

Yeah, it just can't be bigger. Honestly, I think it's like 100 to 1.

01:17:54:16 - 01:17:55:02

Christian Soschner

Okay.

01:17:55:23 - 01:18:06:01

Dr. Daniel Vitt

So I really think that and if you look around, the most successful companies in Europe are really listed in US tech over there.

01:18:06:03 - 01:18:24:19

Christian Soschner

Almost all I think are Biontech Biontech is listed on the Nasdaq was 19 or something. The only listing that I'm aware of was in Brazil, I think also 2005 on, but then was acquired by a French company. Then we are our tech heritage listed also on the Nasdaq.

01:18:24:19 - 01:19:03:07

Dr. Daniel Vitt

Both two listings. Yeah. And even Morphosys was was listed now after the merger is also and that's right so it's more or less unavoidable to do that. And as I said, this is on the one hand being exposed to investors there and the and because this is the right target audience as well, but also just the legal environment and this is what people usually over oversee and judging because this is not just talking about attractiveness of of of trading platforms.

01:19:03:07 - 01:19:05:04

Dr. Daniel Vitt

So it's the legal environment which.

01:19:06:21 - 01:19:35:09

Christian Soschner

I heard very often that the US investors like to invest in companies that have a US story. And since you have profound experience in getting a company listed in Europe, in the United States, I would like to verify this, how I put the storytelling on the US market. How challenging is it as a European company to convince investors to put their money in your company and not some other options that they have on their own market?

01:19:36:12 - 01:20:04:03

Dr. Daniel Vitt

I think it's today. It's a global world. We have. I don't see any difference between being European or U.S. more your story, your knowledge, your reputation. Yeah, I think, of course if you're new to the market, you don't know everybody. You know, you don't know anybody there. So you need to knock on every door. Of course, it's a tough time, but the end is you need to build credibility.

01:20:04:03 - 01:20:28:23

Dr. Daniel Vitt

And I think Americans don't care about where people come from. It's really more about the content and maybe the way you build your relationship. I think we have an advantage of being being in German, but also be true for Austrian or Swiss or whatever in that you we don't have the tendency to oversell too much, which helps us a little bit on credibility.

01:20:32:01 - 01:20:34:17

Christian Soschner

Of getting it there. Original story out of Europe is pretty small.

01:20:35:22 - 01:21:00:05

Dr. Daniel Vitt

That's maybe true, but on the other hand, I think are treated fair. And if if we if something and if you do something negative about us the same effect as if American companies do something negative, if we are successful at the end, we will be at the end of market books and we will get what we would be deserve.

01:21:00:05 - 01:21:05:11

Dr. Daniel Vitt

And therefore, even if our market cap is not where it should be from my point of view right now.

01:21:06:05 - 01:21:10:04

Christian Soschner

And but it is basically good for investors. I mean, this opportunity then.

01:21:10:04 - 01:21:26:10

Dr. Daniel Vitt

To I don't care the current market cap if a for the place money on that level and at the end it's a binary thing biotechs if they succeed it's a big, big win for everybody involved and that's what we're working for. I think at the end.

01:21:26:23 - 01:21:50:22

Christian Soschner

I mean, you have this same story, I think for for the uptake like in video showed a couple of weeks ago. So they will place basically play a key role in artificial intelligence and then you have this uptake. So it's a a long linear curve. Usually on the stock market, you have this and you have a push for when you present your data and it works, it plays for you and it works.

01:21:50:22 - 01:21:55:10

Christian Soschner

In phase two. You probably have done this development of the office stock price.

01:21:55:24 - 01:22:26:07

Dr. Daniel Vitt

Exactly. And that's what we're working for. And at the end, of course, most of the successful biotech companies at the end, acquired by one of the bigger companies, everybody by the multiples today just heard the biceps, which one of our peers in the information space was acquired early. So this is a Nemec world. And and there you at the end you want to get the fair price for what you have should be of what it's currently the market cap.

01:22:26:21 - 01:22:57:02

Christian Soschner

So what I'm interested in when when Europeans position just orient the US market. I mean when you look at my US context, they're always very good in telling their story they issue said tend more to oversell compared to the Europeans. What's your advice to companies would for started in Europe then want to expand to the US market wants to get to know investors wants to get US investor support list on the Nasdaq.

01:22:57:02 - 01:23:14:16

Christian Soschner

How should they prepare their storytelling, in your opinion, should stay, stay European and hope that everybody accepts the European way? Or should they amend their storytelling to fit the expectations of US investors or to cut really to to really push for the noise.

01:23:14:16 - 01:23:47:01

Dr. Daniel Vitt

I'm not sure if I'm if I'm European or U.S.. I think what we do is more international storytelling. Tell people the story. What's it about doing it down to the to the to the core. So I am struck is positioned to change way we treat a multiple sclerosis. That's the story. It's very clear Celiac disease program can really be a game changer in the way we treat leaky gut in the future.

01:23:47:01 - 01:24:10:09

Dr. Daniel Vitt

That be a multibillion opportunity. We need to somehow make sure that the investors and the market get the message and I don't think there is a difference between European and American companies. There are good and bad everywhere. I know that's true. My my advice would just be give it a try. Because at the end, just just being sitting in the comfort zone is the wrong thing.

01:24:11:09 - 01:24:23:22

Dr. Daniel Vitt

It is no comfort zone. If you do this business, it's tough. And and if good, we will succeed and so my advice would be to just try it. Yeah. Yeah.

01:24:24:06 - 01:24:26:13

Christian Soschner

And so you are in dedicated, right, San Diego.

01:24:27:18 - 01:24:51:24

Dr. Daniel Vitt

Now, legally, we are not? We are. We are We are based in New York City. Have an office in New York which is also a hub for So I'm flying again flying a lot right now because we are turning to, to see investors in person on a regular basis. And most of the money is sitting still in New York or in Boston.

01:24:52:12 - 01:24:53:04

Dr. Daniel Vitt

Mm hmm.

01:24:54:18 - 01:24:58:22

Christian Soschner

What what are your future plans for the company?

01:24:58:22 - 01:25:27:09

Dr. Daniel Vitt

Well, I think I need to focus on the value generation side. I think my biggest issue right now is the market cap and the stock price. So But having said that, we are quite successful right now in the clinical trials that we read out recently. I'm feel very optimistic and committed to to develop the value story. And second thing is just to keep getting more options is great.

01:25:27:15 - 01:25:52:07

Dr. Daniel Vitt

Yeah. So therefore business development is super important right now for the company. So we have been at bio conference as well as most people in our industry. It was super, it was a very such a nice experience to see open minded people on the other side of the table. Good discussions. It was such a fun, fun for me because I'm doing that for, for for two days later.

01:25:52:17 - 01:25:57:06

Dr. Daniel Vitt

I attended First Buy in 1999 and it was very small.

01:25:58:17 - 01:26:00:03

Christian Soschner

I'll be how big was it back then?

01:26:00:15 - 01:26:34:12

Dr. Daniel Vitt

And it was in the it was in downtown Boston, downtown in center, and not sure thousand people there. So yeah, there was 18,000. So that was different, that experience. Yeah. And now I feel that what we are doing is the right thing at the right time and, and, and we need to believe in what we do and continue in execution here and getting more options on the table and then when that.

01:26:34:13 - 01:26:36:06

Christian Soschner

But now your next data points coming in.

01:26:37:08 - 01:27:00:15

Dr. Daniel Vitt

So the next the next really important data point is the interim analysis of progressive and this Phase two study. This study, and that's expected in the second half of this year and the second half of this year starts in two weeks. So let's say the data comes out in two weeks to the very first day of the second half.

01:27:00:15 - 01:27:04:06

Dr. Daniel Vitt

But somewhere in the in the middle of the second half, we expect to have.

01:27:04:13 - 01:27:08:22

Christian Soschner

An and I'm you at five six on Saturday still data.

01:27:09:21 - 01:27:40:17

Dr. Daniel Vitt

This is the progressive a mess of three months data in 4856. I think we are not preparing the way to be studying and we will submit an anti for the to the FDA. We are planning this international study exploring how big it is or should be. We have we have a good draft for the protocol in place which was discussed with global crowds really on making sure we're doing the right things.

01:27:40:17 - 01:27:48:04

Dr. Daniel Vitt

We're measuring endpoints to establish the the right dose for phase three and it.

01:27:49:06 - 01:27:56:20

Christian Soschner

Sounds like a good opportunity currently on the table. No investment advice, no medical advice. But basically there is some upside.

01:27:56:20 - 01:28:02:10

Dr. Daniel Vitt

There's upside. And yeah, and you see anyhow, the team here is very committed. Well, also, I mean.

01:28:02:19 - 01:28:18:05

Christian Soschner

Since you are listed on the Nasdaq, everybody can buy stocks of shares any time. But I also looking for raising capital. Are you also looking for investors who will increase your cash position in the near term?

01:28:18:18 - 01:28:50:19

Dr. Daniel Vitt

Yeah, that's a that's a that's a was a difficult question because it means dilution and it means that pay a price, you accept something for this year, There's no free lunch in this world. But yes, I think clearly what we would be interested in having considering something like a raise which may pave the way for full return on the face Rhys-Davies study by did something I can throw over the counter here today.

01:28:50:19 - 01:29:05:08

Dr. Daniel Vitt

It's something we should be prepared. So we are not actively raising money in that respect. But we are talking to investors to build up the trust for a relationship to be prepared. If the timing is good for doing a capital increase, what.

01:29:05:10 - 01:29:07:12

Christian Soschner

Want to be open for discussion.

01:29:07:12 - 01:29:11:23

Dr. Daniel Vitt

If some audiences yeah for good investors which have a bit share our vision.

01:29:12:06 - 01:29:21:09

Christian Soschner

They see something that sounds like a great opportunity. See opportunity. How can how can investors reach you?

01:29:21:09 - 01:29:35:18

Dr. Daniel Vitt

Or they can just reach us to the home page. We have this section on the homepage and just Jessica, our head of Investor Relations, is taking care of all of these interactions. And we are pretty responsive that people are asking.

01:29:35:18 - 01:29:45:18

Christian Soschner

I'm almost at the end of my of my questions. I would like first to ask you, did I miss anything in this recording? Is there any points that you would like to address before we you.

01:29:47:01 - 01:30:16:08

Dr. Daniel Vitt

Know, I think we covered most of the things and and I think you're you're really down to the point. It's an exciting thing. It sounds like it has some ethical value but also has some financial value to to do that. What we do because I think bringing something from idea to an approved médicament, which is a multi-billion sales opportunity, that's a that's a economic interesting thing.

01:30:16:08 - 01:30:41:03

Dr. Daniel Vitt

And therefore the good thing is today that our market is stable enough and evolved enough that everybody can be part of that. If people like, you know, it's a it's a it's an interesting industry. And Khurana showed us that the life science industry is helpful for the world to survive, and everybody can be part of that.

01:30:42:09 - 01:31:05:00

Christian Soschner

Now, I couldn't agree more. I think our life expectations in the West and also in the rest of the world is increasing. And I think one crucial part of this development is basically the fundamental life science industry. If I did, the industry would probably still have to expect to not grow that in 30 to 35 years or so.

01:31:05:00 - 01:31:29:07

Christian Soschner

So it's a very fantastic industry. Let me ask him a final question. I mean, when I look back and you look back at your journey, 50 Munich and you had over two decades experience in the industry, what are the three key lessons that you learned along the way that you would share as an advice to someone who wants to start their first company now?

01:31:29:07 - 01:32:01:06

Dr. Daniel Vitt

Yeah, I think maybe three things. First of all, just do it. Yeah, it's an execution focused thing. You need to be prepared to to to execute and to do something and to try. And this is a trial and error thing. You need to learn from the failure and you need to learn from their successes of yourselves to build up your own, your own world of experience and your own coordinate system to to succeed there.

01:32:02:03 - 01:32:30:24

Dr. Daniel Vitt

The second thing is, and that's maybe the tough thing to expect, the unexpected to be prepared. And we talked about serendipity, but I believe Darwinism in our industry means you need to adapt to the changes because technology changes can be very quick and and good companies can adapt to that very quickly. And you mentioned Biontech as the best example after the IPO.

01:32:30:24 - 01:33:03:06

Dr. Daniel Vitt

It was challenging for them. But then with Corona, they very quickly adapted to the new environment and made the best out of that. It's a quite impressive how were who was doing that and therefore we really think this was one of the best examples of cricket that changed to new environment. And the third piece is the don't, don't get isolated, be part of the global ecosystem, talk to people, talk to other companies, investors everywhere.

01:33:03:06 - 01:33:22:23

Dr. Daniel Vitt

You can learn so much that there's no limit. You can just give it a call or whatever you do talk because more or less, if you're if you start somewhere in Europe or in the U.S. or whatever, it doesn't matter if you are open minded and you believe that you're part of a global ecosystem, then it.

01:33:22:23 - 01:33:36:21

Christian Soschner

Thank you very much for this fantastic conversation. I enjoyed every single minute and learned a lot of new things from you and I liked the idea of eight, five, six, three. It sounds like a great opportunity.

01:33:38:08 - 01:34:00:13

Dr. Daniel Vitt

Yeah. Yeah. Also, thank you for that wonderful interview. It's really good to have also enough time to talk. Usually it's always very short and here I think it's it's a lot where I can even learn in this discussion here, and I hope that I can contribute a little bit to the to the education and learning for of others about what we are doing and what the industry is doing.

01:34:01:06 - 01:34:10:07

Christian Soschner

Thank you very much for sharing your story and I wish you and your team all the best for the future and your drugs to the market and help the patients.

01:34:11:15 - 01:34:12:06

Dr. Daniel Vitt

Thanks a lot.

01:34:13:06 - 01:34:14:04

Christian Soschner

Have a great stay.

01:34:14:05 - 01:34:15:07

Dr. Daniel Vitt

Bye bye.

01:34:16:05 - 01:34:50:21

Christian Soschner

What a journey that was with Dr. Daniel Witt. Today we learned that being early and having a different vision isn't just an advantage. It's a strategy for success. Navigating international markets is a wild but necessary ride for global impact and comfort zones. They Are the silent killers of innovation break free and the world becomes your laboratory? If this conversation sparked something in your We need your help to keep this fire burning.

01:34:51:05 - 01:35:16:13

Christian Soschner

Hits that like Patton drop a comment with your thoughts. And if you haven't already, subscribe to the channel. It's a small click for you, but a giant leap for this podcast. And don't keep this conversation to yourself. Share this episode with your friends, your family, or anyone you think needs to hear it. Your engagement doesn't just make my day.

01:35:16:14 - 01:35:32:14

Christian Soschner

It helps more incredible speakers like Danielle, which means more ground breaking content for you. Thank you for being part of this journey. Until next time, keep questioning, Keep learning and keep growing.