Welcome back, everyone. We have MetaVia Inc., trades on the Nasdaq under the symbol MTVA. It's a clinical stage biotech company focused on transforming cardiometabolic diseases. It's developing the treatment for obesity and vanogliprl for the treatment of MASH. Happy to welcome the president, H.H. Kim. Welcome back to the conference today. We're very much looking forward to hearing your update. The floor is yours when you're ready.
Well, thank you for having me. Thank you for joining today's presentation. I'm H.H. Kim, CEO of MetaVia. We've been working very diligently for the past few years, focused on obesity and MASH. It's a pleasure to be presenting after a great data release last month in January on our obesity program, the DA-1726. I think it is due to give everyone and the investors and everyone out there a little bit of a story behind everything to make sure that we're in line and where we're headed with these assets. The focus of MetaVia is on cardiometabolic. We have two assets, one in obesity, one in MASH.
The obesity market, as you know, and as you see here, 650 million+ adults worldwide are clinically obese, meaning they're very big. The market is currently around $10 billion, and it's gonna go beyond that to $80 billion-$130 billion, which is an amazing speed and size compared to any other indications out there. Very fast-growing market. We have the MASH. Our Vanoglipel is focused on MASH. It's an emerging market. Right now, we have Madrigal's resmetirom that has been approved recently. It's partially approved, not fully approved yet, and it's doing great. 5%-6% of adults globally have MASH, and MASH patients typically have obesity or diabetes.
The analysts are forecasting about $20 billion-$35 billion a year in this market alone. When we look at Novo Nordisk or anyone else out there, the big pharmas, and even Madrigal, everyone is expecting this market to be a combination treatment. Everyone's looking for something to add on to THR-β, that is the resmetirom, or a GLP-1. It's gonna be a combination therapy, and we are actively seeking vanoglipol to be combined with something else. Before we go into this, to me, quite an amazing data on 1726, let me give you a quick story. Of course, we're a biotech. We've been consulting with KOLs from the start.
On the obesity drug, like 4, 5 years ago, when I started this journey, I was consulting with several KOLs, one of them was saying: "Obesity is not a disease. It's something that you eat less and exercise more, and that's how you lose weight." That was one of the KOL's opinions. After that, a year after that, Wegovy came out, Zepbound came out, and the whole market just blew into something very different, and as we see right now. For us, 1726, yes, we did start the phase I a few year, not a few years ago, a couple of years ago, and we are still in phase I.
When we had the 32 mg data last year, around April, consulted with the KOLs that we have on our website and one of the KOLs who's been involved in this obesity, especially on glucagon side, he looked at the 32 mg non-titrated four-week result, and he said that it looks great, it's working like other GLP-1, successful GLP-1s. There is too much competition out there. When you look at like, I'll show you the data. Triple G from Eli Lilly, triple agonist, retatrutide. It's doing so well that it's gonna hit 30% weight loss at one point. How is this drug gonna compete with those amazing drugs?
He was suggesting to me that, let's gather up like 20 KOLs and specialists and try to find another indication for this drug, because this is clearly working. Unlike a lot of other GLP-1s, we don't hear about, you guys don't hear about it a lot, but there are a lot of GLP-1s that doesn't work, especially GLP-1 glucagons who give up weight loss because it doesn't show that much of a weight change, and they always go to MASH. Every time he saw me, he was keep on telling me that, "Maybe you guys need to move on to a different indication." 48 mg data came, we sat down, we talked about the 48. It was truly an amazing experience where he did not at one time.
at all mentioned anything about finding a new indication, meaning the 48 mg was so good that the early indications of the efficacy, the safety data it showed without titration, it's right there with the competition, right there for a small biotech to push forward and try to get a partnering with a bigger pharmaceutical company. It's one of the best datas that's been out, coming out in recent years, and that's why the KOL never mentioned a single thing about finding another indication. It's right here, and as you see it right there on the screen, DA-1726, we're pursuing this for obesity and MASH, and it has the best-in-class profile. It is a phase I study. We had 6 active through placebo patients in it. 48 mg, we didn't do any titration.
At 8 weeks, -9.1% weight loss, -3.8 inches reduction in waist in just 8 weeks. You need to buy a new pair of pants if you have almost 4 inches of your waist down in just 8 weeks. HbA1c, yes, these were obese, otherwise healthy subjects, still lowering, and the fasted glucose, quite an amazing result. I will show you on the tables later. -23.7% liver stiffness resolution, the VCTE, and it only had mild to moderate side effects. Now, why are we running another phase I? Well-tolerated, non-titrated, 48 mg, we are going higher. I will show you the table.
You will clearly see why we're pulling this up. I would like to make sure that everyone understands, we're not running another phase I because we failed in the lower doses. We succeeded, we excelled, but we're running another phase I because we have room to go up and we have room to catch up with the Triple G. That is the reason why we're doing another phase I. Yes, it does break my heart that we have to run another phase I, because, yes, time is essential to a biotech, but still, we have room to go up, and we have a chance to catch up with the Triple G. That is the reason we're doing another phase I. Part III-A, it's just one-step titration, 16 mg for four weeks, then we're going up to 8mg for 12 weeks.
This is trying to make sure that we do not have any of the moderate side effects. Let's get rid of that, then we have a completely clean set of safety profile. Part III-B, 2-step titration, 16 mg for four weeks, 32 for four weeks, then 64 for eight weeks. We're doubling it up every time we're going up on the titration. Just two steps, 64 mg. Up to now, every time we up-dosed it had very dose-dependent weight loss. Very excited to see how the 64 mg will perform. This data will be out by end of the year, 2026. Vanoglipel, DA-1241. This is a small molecule, orally available, once-daily pill. Phase IIA, presumed MASH subjects. We met the primary endpoints and even showed direct hepatic effects.
Significant HbA1c reduction is something that's very different than resmetirom, the approved medicinal drug, and other MASH-focused drugs. With all that, we will be releasing more data on vanoglipol throughout the whole year on the major medical conferences, and we are actively seeking for a combination partner or a licensing partner with this drug. If you ask me, 1726, 1241, vanoglipol, what is more exciting for this year? 1726, great titration. We'll be looking at 64 mg, but I actually am very excited to do a data release on vanoglipol in the middle of this year at one of the major medical conferences on the combination effect. It's gonna be. I believe it could be a game changer, and it's gonna be an eye-opener for everyone.
Very much looking forward to that data release. Now, we are a small company, we're a small biotech, but especially since we are reliant on the science coming from our strategic partner, Dongwha, in South Korea, we are very slim in the U.S. The reason for that is the non-executive management, you can see Mi-Kyoung Kim, Chief Scientific Officer, she is still working for Dongwha in Korea as the research center head, and she's the one who came up with these two assets from scratch. They made it in their research center, no licenses attached to it. Who are the most experts in these two drugs? It's them over in Korea. That's why we are relying on the research center to bring about the science and give us the support.
They have about 400 PhDs over there, I'll be honest with you, they're much cheaper than the U.S. scientists. They work day and night and make sure that they give us what we need. That is the reason why it's a little bit slimmer over on our side in the U.S., the MetaVia side, which actually helps with our cash flow. CEO, myself, why is a lawyer running the company here? Why am I the CEO? I came up with this idea. I was the one who came up with the idea of moving two cardiometabolic assets from Korea to the U.S., since U.S. market is the biggest for cardiometabolic. Who's the best suited to push this through when you get to the end goal?
The person who came up with the idea. Here I am. I resigned from Dong-A as the General Counsel, came over to the U.S. I am the person who's pushing these. I just love these two assets. Great potential. I hope everyone out there believes in it like I do. We have Marshall, the CFO, who has 35 + years in finance. Mi-Kyoung Kim , the PhD, the head of research center in Korea. I call her the mother of the assets, maybe I shouldn't. We have Chris Feng, Dr. Chris Feng, consulting CMO. The last position he held was at Eli Lilly on global obesity clinical trials. Robert Homolka, SVP of Clinical Operations, 35+ years in clinical, and he's the man, he's running the clinical trials.
Multiple near-term catalysts. 2025, we ran the 48 mg non-titrated. We are running the titration schedules in phase I, Part III. We're hoping to start the study within the first quarter or early part of second quarter. First patient in probably around end of March to April, and it's a 16-week, 4-month trial. We'll be able to have the data released by end of this year. Vanoglipel, we're trying a lot of different combination therapies in animal models as we speak, and once that's concrete, we're going to meet up with the FDA and see how we can design the phase II. DA-1726, it's an Oxyntomodulin analog, mimics natural gut hormone released after your meal. Unique ratio of 3 to 1.
GLP-1 reduces appetite, decreases food intake, and controls the glucose. Glucagon increases energy expenditure, boosts calorie burning, and it actually browns the white adipose tissues, the fat. In combination, we are looking at superior weight loss potential and have direct hepatic effects through the glucagon. Let's look at this competitive landscape. The table has the GLP-1 glucagon plus anything with glucagon, which is retatrutide, the Triple G. 1726, currently in phase I. Yes, this is not apples to apples. Phase I is smaller in sample size, still, it's a very good indication of early efficacy signals and safety. 1726, 3 to 1 unique balance, once-weekly injectable. We haven't done any titration. In 8 weeks, no titration, 9.1% weight loss.
Fasting glucose, this is important because GLP-1 lowers glucose, while glucagon actually increases it, so the balancing act is very important in glycemic control. Ours, -12.3 mg per deciliter in eight weeks. Quite amazing. Waist circumferences, eight weeks, -9.8 cms, that's almost four inches in just eight weeks. Let's look at pemvidutide. It's Altimmune's GLP-1 glucagon with a unique 1-to-1 perfect balance. They haven't done the titration in their phase I, currently going into phase III. Weight loss, phase IA, 12 weeks, no titration, 10.3% at their lower dose, while 9% at their higher dose. We're right there, with only eight weeks. Fasting glucose, -0.8 mg per deciliter at 12 weeks. Not much of a glycemic control. That's why pemvidutide can't be used in type 2 diabetes patient pool.
Waist circumferences, - 10.2 cm, whoa, 24 weeks. Mazdutide, Eli Lilly licensed it in from Innovent phase II in the U.S. They just finished, released the data recently, in the last year. Once-weekly injectable, while they have not disclose the balance between the GLP-1 glucagon. Our research center sees it as 6 to 1. They're doing 5-step titration. Body weight loss in their phase II, 48 weeks, - 22.3%. Quite amazing. This is right up there with tirzepatide. How do they do in week 8? Less than 5%. When did they hit somewhere around 9%-10%? Week 16. Fasting glucose, 48 weeks, - 12.3 mg/dL at 48 weeks. That's exactly where we are at 8 weeks. Waist circumferences, 48 weeks, - 16.6 cm.
Week 8, it was less than 5 cm. survodutide, Boehringer Ingelheim's drug, being licensed in from Zealand, 8 to 1 balance, once weekly injectable, 7-step titration. I believe they're working on this titration scheme to make it less than 7 steps. Body weight loss, 46 weeks, -1 6.7%. Not that great, right? With the current competition. Week 8, less than - 6%. Fasting glucose, their phase I, six week result did not show any treatment effect. Max of - 8.7 mg/dL at around week 16. You have the waist circumferences from survodutide, up to - 16 cm at 46 weeks.
When you look at the GLP-1 glucagon, no matter the balance, although it is an early signal coming from our DA-1726, you can clearly see that we have a potential to be better than any other GLP-1 glucagons out there. That's why we're saying potential for best-in-class. Let's expand the map a little bit. Let's go into triple G with the retatrutide. Eli Lilly, currently in phase III, very heavily biased on GIP, once-weekly injectable, three-step titration. 48 weeks, whopping -24.2% weight loss. Where were they at week eight? Between 9 and 10. Remember, this is 48 mg that we hit 9.1%. We're going up to 64. We have a chance to be following right there with GG G. Fasting glucose, 48 weeks, obese, healthy patients, -10.6 mg/dL. Waist circumferences, amazing.
48 weeks, almost 20 cm. Where were they at week 8? Less than 9 cm. That is the reason why, although it's heartbreaking for me and everyone in MetaVia, we're running another phase I, because we have a chance, not that far off chance, to chase the Triple G, that I do believe personally will hit - 30% weight loss. We have a chance to follow that. Let's look at the adverse events. DA-1726, before we go into this, we can clearly see that anything that has glucagon in it has pretty bad safety profile. Ours, no titration. Yes, we did have moderate vomiting. 83.3% had mild to moderate vomiting, 50% mild nausea with no constipation, 16.7% mild diarrhea, no discontinuations. Yes, we did have a lot, moderate vomiting. What is vomiting?
I've been going down there every single week to see how the subjects were reacting to our drug. It was heartbreaking to see if the subject felt like he had to go to the bathroom and spit, not like what we say, vomiting, right? Pumping out food or anything. Every single time they had to go to the bathroom because they felt something and spit out, we counted it as vomiting. We took the very conservative approach to this. That's how we counted. If the moderate vomiting is counted when a subject went into the bathroom to spit twice in 2 to 3 hours. Although we took it a very conservative approach in counting the AEs, we believe it's very important to make sure that we are conservative on this side.
We believe once we do titration, these will go away because up to 32 mg, it was very clean. Pemvidutide, 1 to 1, a balance phase I MASH study, 12 weeks, 73% mild to moderate vomiting, with 91% mild to moderate nausea, almost 20% constipation, 18% diarrhea. They didn't have any discontinuations on their phase I MASH study, but in their 48-week study, almost 20% discontinuation. Mazdutide, Eli Lilly's drug, 5-step titration, they had almost 92% subjects had at least one treatment-related adverse events in their 48-week study. Survodutide, 7-step titration, phase II, 91% of their subjects had treatment-related AEs. Both of their discontinuations were almost 20%, and tirzepatide almost 25%. Retatrutide, the Triple G, yes, it has glucagon in it.
16% discontinuations, Triple G, the most important is the AE, the special interest. As you can see, no one else has that. Anything above 10% needs to be reported. 13% hypersensitivity, anti-drug antibody reactions of 18%, and cardiac arrhythmia for 11%. Overall, these are the issues with the Triple G. They have other issues than just GI side effects, and if we can control our drug, DA-1726, with titration and get rid of the moderate while chasing the weight loss, the fast, the waist circumferences with the Triple G, we have a very competitive drug. Since we're running out of time, I'll just go into Vanoglipel. GPR119 activation, we can find that in liver and immune cells, acts directly into the liver.
That showed great hepatic effects in our phase IIA trial, and even showed glycemic control. Liver function improved, ALT reduced by 22.8 UL, inflammation, fibrosis markers all improved, and very well tolerated. It's important that there was no treatment-related discontinuations while we ran almost a 100-patient trial. That is the reason why it's gonna be safe in combination therapies, and that is the reason why we're pursuing for a combo as well. On the financials, in September 30th, the end of third quarter, cash of $14.3 million. We did raise about a little over $9 million in January, and the shareholding is a little different. We'll be disclosing all this with our 10-K by end of next month.
Overall, everything, we have enough cash to run through the titration study and going into 2027. Strong cash position. Just to wrap up quickly, DA-1726, best-in-class pro profile. Please remember, we're running another phase I. Yes, yes, it hurts me, but we're not doing it because it didn't work. We're doing it because it's working so great. We're going up to 64 milligrams, dose-dependent weight loss happening. If we can go with this titration, remove the moderate side effects, and hit something closer to the Triple G, we're gonna be a very different drug, very different company by then. Vanoglipel combination, yes, we'll be releasing those data within this year, and I'm super excited about that one. Let me wrap up for questions.
Perfect, H.H. Kim, thank you so much for that. We do have lots of questions. Let's start with 1726. How does it compare to other obesity drugs on the market and those in the late-stage clinical trial?
As I showed you that table, GLP-1 glucagon. Let's think of this. There's a lot of new therapies coming out, not even in the late stage, early stage. It's a very crowded space. What is the trend right now is that whatever you do with obesity, it's gonna have a GLP-1 backbone. Amylin, you have to use it with GLP-1 because that's the only way to show glycemic control and weight loss, more weight loss. Amylin is based on a backbone of GLP-1. You have siRNAs coming up. What do you do with that? You have to add it up with a GLP-1. GLP-1 is the backbone of the obesity therapy as we speak.
We have glucagon added to it, showing you in the table early indications of this, early signals of our efficacy, but still very, very promising than any other drugs out there.
How should investors interpret preliminary versus final top-line metrics in terms of real-world impact and likelihood of success?
In phase I, it's a small study. We had six actives, three plus placebo. Does that translate well into a larger phase II or phase III? I believe so. We've been witnessing a lot of studies throughout with GLP-1s, and we are following that trend, so I do believe these will. Our drug will show these trends into a bigger study.
Well, H.H., I wanna give you a second to tell our viewers some closing remarks. We'll send the rest of these questions to you, so you can answer on your own.
Okay. Well, thank you for having me, and thank you for listening for 30 minutes on what we've been doing and what we are trying to do for the for this year, 2026. Just please remember, it breaks my heart to run another phase I, but we're doing it because the drug is showing such a great early signals on efficacy. That's the only reason we're doing it again. We are actively talking to bigger, the big pharmas, for both of their assets, and I truly believe this can be something very special by end of this year.
Perfect.
Thank you!
Well, thank you. Thank you so much. We'll see you again real soon, and everyone, we'll be right back with our next presenter.