MetaVia Inc. (NASDAQ: MTVA)

[00:00:09]Welcome back everyone. We have an update from Metavie Inc. Trades on the NASDAQ under the symbol MTV A. It's a clinical stage biotech company focused on transforming cardio metabolic diseases.

[00:00:21]Happy to welcome President CEO HH Kim and the CFO Marshall Woodward. Welcome gentlemen, we're looking forward to hearing your update today.

[00:00:30]>> Thank you Anna.

[00:00:31]Uh thanks everyone for joining.

[00:00:34]Uh we have 10 minutes to give you a brief update on what we have been doing.

[00:00:40]Uh so we have been attending uh two major uh medical conferences recently. Uh one being EASL, the European liver uh meeting.

[00:00:52]And in that conference uh we did we did one poster presentation on our DA 1726.

[00:01:01]It's the GLP-1 glucagon dual agonist uh with the unique balance of 321.

[00:01:07]And the new data released on that poster was on uh the QTCF, the heart rate. Now uh to in the past, there are data showing that glucagon may increase heart rates and it was a pretty important uh safety uh data that we collected during our uh uh phase one. And we have not seen any abnormalities in the heart rates, which is a very good sign.

[00:01:36]Now after that, uh we attended uh the ADA, American Diabetes Association uh conference over in New Orleans.

[00:01:44]And we had three posters there.

[00:01:48]On DA 1726, the obesity drug, um we the new data on the poster was on the PK.

[00:01:57]and uh it a textbook like PK profile very dose dependent. That was great and just on 1726 we are currently running a phase one part three which focuses on titration and plus higher dose level of 64 mg.

[00:02:21]We had the first patient in in April and we are very smoothly going through the titration and uh hopefully we will be able to have the data of the 16 weeks study out before end of this year.

[00:02:39]Now I would like to take a little more time on the ADA posters on our oral asset which is vanalcopal the GPR 119 small molecule oral drug that we finished a phase two A in mash patients. We met the primary end points but we did have two posters on vanalcopal all of them are non clinical but it was on the combination potential of this drug.

[00:03:16]Now the mash indication itself with amazing job by Madrigal the resmetirom drug is selling very well and it's really pioneering the mash market. And the competition is getting higher and higher semaglutide the GLP-1 from Novo Nordisk got approval to be prescribed on mash as well and there are multiple other injectables out there such as GLP-1 GIP GLP-1 glucagon and uh FGF21s are going into the mash field. Uh and it's getting highly competitive. Uh that's the reason why we we were are still actively searching for a combination of this drug to move into the mash indication and potentially other indications as well.

[00:04:14]You can find these posters on our website. Uh it has a lot more detail than this. This is just a highlight for this 10-minute session.

[00:04:22]But, I'll start with the poster 3043LB.

[00:04:26]This is a vanalgliptin plus resmetirom, the approved conditionally approved drug in mash.

[00:04:33]Now, the highlight of this study uh on mice was that when you look at the middle part, it's the weight.

[00:04:44]So, mono arm of vanalgliptin, mono arm of resmetirom, control, everything through time in the study gained weight.

[00:04:54]But, the combination uh lost weight. How much? By 23.6% compared to control. Now, this and resmetirom. This is uh very different than what we have seen in clinic.

[00:05:09]Uh vanalgliptin did not have significant weight loss effect as and resmetirom didn't have weight loss effect as well.

[00:05:17]So, in combination, we have seen something very different.

[00:05:22]When you look under the the at the left-hand corner, fat mass, lean mass, lean mass hasn't changed. But, fat mass went down by minus 43.5%.

[00:05:34]But, more importantly is the right-hand corner.

[00:05:38]This is the food intake. As you know, uh the GLP-1's out there, all of them, the weight loss is coming from appetite control.

[00:05:48]Now, look at this. Food intake combination actually ate more food than the control or the vanalapril arm and still had significant weight loss.

[00:06:03]Why is this?

[00:06:04]We are thinking that resmetirom, the THR beta agonist, does show energy expenditure.

[00:06:12]Uh we believe that vanalapril enhances that feature of resmetirom, which results in a significant uh weight loss.

[00:06:29]Just to go a little bit more into the MASH results, uh you can clearly see that the NAS improvement in the combination is better. Plus, when you look at the mono arms, they even had no change group groups, but the combo didn't even have that, which is quite amazing. Then the liver steatosis as well, the combination had a lot better results uh compared to the mono arms of vano and resmetirom.

[00:06:55]Uh this is quite significant results coming out from a combination and we will be exploring a little more into this potential combo uh as we speak.

[00:07:07]Now, another poster was on 2856 LB on a metformin combination and you can see that um the monotherapy didn't lose weight, while combination lost minus 16.3% of the weight, and the fat mass reduction is quite significant.

[00:07:29]This is the We believe this is due to increase in GLP-1 production and the plasma the peptide YY. Uh peptide YY is known to have an effect on appetite control.

[00:07:43]And of course, as you know, GLP-1 has that as well. So, this combo is a little different than resmetirom combo because resmetirom combo had uh the appetite control was non-existent while losing weight. While this metformin combination actually had uh lowered food intake which resulted in uh weight loss.

[00:08:07]Now, fasting glucose, of course, metformin, as you know, is a type 2 diabetes agent. So, in combination with vanaglipol, uh the fasting glucose levels were all better than uh the mono arms.

[00:08:24]Now, with these posters, we believe we have shown something uh for vanaglipol to move forward as a combination uh potential. And uh we are looking into different angles, different agents out there to uh see how vanaglipol works with uh other type 2 diabetes approved drugs or even in mash. And uh once we have that uh concluded and we have a a path forward, uh we will meet with the FDA and push uh vanaglipol into another phase two in combination therapy.

[00:09:05]Marshall, could you give a brief update on uh our finances?

[00:09:12]>> Sure. Thanks, H. H. Uh we have guided that we have cash into Q4 of this year.

[00:09:20]Uh that guidance has not changed, but I think the more uh compelling way to think about how much cash we have is we have cash on hand to get us through the uh phase 1.3 the ongoing phase 1.3 uh clinical trials for DA 1726, which is our obesity drug.

[00:09:43]H H >> Thank Thank you, Michael.

[00:09:47]We are cruising through uh smoothly with the titrations that's in our part three for the obesity drug DA 1726, and we are looking for new uh strategies for valaglucose, and please look at the posters on our website. It is very different than uh at what we have seen in other combination with resmetirom uh and metformin.

[00:10:18]Thank you for your time.

[00:10:21]>> All right, thank you, gentlemen. We appreciate your time and presentation on this matter. Great to learn more about Metavie. Thank you for the update. Uh we have lots of questions for you, but we'll send them to you so you can answer on your own, and we certainly hope that you'll come back again real soon.

[00:10:35]>> Real good. Thank you.

[00:10:37]>> Thank you.

[00:10:38]>> All right, everyone stay with us. We'll be right back.