Good day, and welcome to the Galmed Conference Call to discuss financial results for the third quarter of 2020. Today's conference is being recorded.

Before we begin, please note that we will be making certain forward-looking statements on today's call, including those regarding financial results, statements and forecasts regarding anticipated time lines and expectations with respect to our regulatory and clinical development programs as well as other statements that relate to future events.

These statements are based on beliefs and expectations of management as of today, and actual results, trends, time lines and projections relating to our financial position and projected development programs and pipeline could differ materially.

In particular, there is a significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on Galmed's business and operations.

We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitations, the risks under the heading, Risk Factors, described in our annual report on Form 20-F filed with the SEC and the risks and uncertainties included in the Form 6-K filed with the SEC earlier today.

Galmed assumes no obligations to update any forward-looking statements or information, which speaks as of their respective dates only..

Thank you, Christine. Good morning, and thank you for joining us on today's conference call. I'm pleased to be here today with our Chief Scientific Officer Dr. Liat Hayardeny. Our Chief Financial Officer, Yohai Stenzler.

To provide you with an update on our clinical development programs as well as report to you our financial results for the third quarter of 2020. As always, we will be happy to take any questions you may have at the conclusion of our prepared remarks.

I'd also like to say that I hope that you and your family are safe and well as we work to overcome the COVID-19 outbreak. The news in the past week regarding the progress on the Pfizer vaccine has been particularly encouraging and we look forward to putting this all behind us. Our business report this quarter is going to be relatively short.

However, they're expecting to be able to report next month first in human PK data from our Aramchol meglumine program.

Earlier this quarter, we announced that we entered into a research agreement with Gannex Pharma, a wholly owned company of Ascletis Pharma and the developing combination therapy of ASC41 is an oral thyroid hormone receptor beta agonist and Aramchol.

By combining the ASC41 with its rapid reduction of liver fat and improves blood lipid profile with Aramchol that showed improvement in glycemic index and fibrosis. We believe physician will have a both solid additional tools in there toolbox.

Earlier this week, we announced collaboration with MyBiotics an Israeli based company that develops microbiome based products and is restoring microbiome equilibrium for the therapeutics and food markets.

This collaboration is part of our overall plan to maximize Aramchol clinical efficacy is built on our work to date, which includes doses optimizations, 300 milligrams BID resulted in higher exposure of Aramchol by 53%.

Product optimization, development of Aramchol meglumine with higher scalability and lower variability and treatment duration optimization. Microbiome is known to be a major driver of NASH and fibrosis and offer great promise as new approach to treat this challenging disease.

The growing interest following the recent positive top line data from the SER-109 Phase 3 suggests that microbiome is a novel drug mortality, both as a monotherapy and in combination with Aramchol. The collaboration also aims to identify specific microbial biomarkers for Aramchol. Based on microbiome data collected from Galmed clinical studies.

It could serve as a biomarker for Aramchol at an early stage of treatment. .

Thank you, Alan and good morning, everyone. This morning I will be providing with our financial results for the third quarter ended September 30, 2020. For more information, please refer to our report on Form 6-K filed earlier today with the SEC, which, among other things, provide the summary of such financial results.

For the third quarter of 2020 our net loss totaled $6.9 million or $0.32 per share, compared with a net loss of $4.5 million or $0.21 per share for the corresponding quarter in 2019. Research and Development expenses totaled $6.5 million for the third quarter of 2020 is compared with $4.1 million for the third quarter in 2019.

The increases resulted primarily from an increase in the clinical trial expenses in connection with our ongoing ARMOR trials. Turning now to G&A. Our general and administrative expenses for the quarter totaled $1.5 million compared with $1 million for the corresponding period in 2019.

The increase resulted primarily from an increase in the cost of our DMO insurance policy premium. During the three months ended September 30, 2020. We've had a net financial income of $0.7 million or $0.5 million in the third quarter of 2019. The increase primarily relates to the realization of unrealized gains from prior periods. .

Our first question comes from line of Steve Seedhouse with Raymond James. Please proceed with your question..

Great, thanks very much. I was hoping that you could just elaborate on the Gannex TR beta that you've licensed.

Maybe just comment on the selectivity and potency of that molecule for TR beta and also selectivity for deliver if you could just to compare and contrast it with the other clinical stage TR betas?.

Thank you, Steve. So force, we are not at liberty to disclose any information from ongoing studies by Gannex as it is a public company, but I will let Liat maybe talk a little bit about the specificity and I guess what you also would like to know is the differentiation from Madrigal steroid based. So Liat please go ahead. .

Thank you, Steve. So, we do know and we saw the pharmacokinetic data and the binding essays of ASC41. It is more specific.

And to be an actually can be given in a much lower dose, which shows much higher specificity, we are currently checking the effects of these compounds standalone together with an ample standalone and the combination in order to compare an in-vivo study. The rationale, the scientific rationale for the combination is quite clear.

We do know that this compound can reduce liver fat quite fast, I would say and should have a massive effect on liver fat. And we are talking about one to 10 dose of Madrigal MTL-3196, so we're talking about much more specific. We know that they have a very good liver steatosis data.

And we do know that Aramchol will have a very good liver fibrosis data, the natural solution and fibrosis improvement. So that being said, together, it will give us that much better natural solution and fibrosis improvement..

And it has a very good safety profile. As far as we've seen so far. .

Yeah, well, it has a very good safety since it's, as I said, it can be given as one to 10 dose of Madrigal compound, so we will have less safety issues, very good efficacy and places where Aramchol is going to be combined with..

Okay, thank you. And then the other question I just had was Allen you mentioned that there's a lot of moving parts, obviously, geographically in the ARMOR study. And a lot still left to play out with the pandemic.

But I was hoping, I think heading into the study, you had some idea of how the enrollment would split between US, Europe, I think South America and Israel at least.

And I was wondering if you already sort of had some sense of if that geographic distribution of enrollment that you had originally anticipated will in fact, play out differently, or if it's kind of still too early to tell, given all the moving parts..

So, it is -- it is unfortunately too early to say we are still, this is a reminder, we were talking about between 40% to 50% of patients coming from the US. 35% coming from Europe, and 10% coming from the Middle East, and the rest coming from Latin America and the rest of the world, Korea and the rest of the world, Asia, Australia, etcetera.

Unfortunately, the two main agents of the study, which is the US and Europe have slowed down significantly over the last quarter, I was hoping we've seen June, July was a pickup but then with the second wave, it kind of slowed down again.

So this is why I've asked the both our internal clinical team and together with our CRO to sit talk to the investigators one by one, understand what is the capacity what have changed in the hospitals, in the clinics, in the countries. There is some countries like Australia, which are doing very well because there is no, COVID is quite contained.

Korea is doing well. But all in all those countries are kept. I need the two big engines to act and unfortunately, they are slowing down; so we need to see how we compensate. We have good news coming from Brazil. They weren't expecting Brazil to come into play so early in the game.

And what I've been hearing from our regulatory people is that we may be able to start and recruit patients already in January in Brazil. This is good news because studies, I can tell you that.

As far as I know, only the Tobira study, the elegant study was recruiting in Brazil, Genfit and Intercept were not getting recruit because of regulatory issues, we've passed these hurdles. And I hope that they can contribute many patients to the trial.

But again, we all have to bear in mind, at the end of the day 85% of the patients' needs to come from Europe and the U.S..

Got it. Thanks for the question..

And just as you know to head up, I mean, we are using as you know, this is not a time which is lost, because at the end of the day, we are planning to switch patients to Aramchol meglumine.

And we are using this time to advance and this is why, if you recall, from our previous guidance, we were not expecting to have clinical data from meglumine as early as this year. So we pushed the timelines of Aramchol meglumine. And I hope that that would bring good news.

And we will certainly have also an impact on our own , on the physicist conductivity study..

Our next question comes from a line of Kristen Kluska of Cantor Fitzgerald. Please proceed with your question. .

Hi, everyone, thanks for taking my questions and hope you're all doing well. I wanted to ask about your recently announced collaboration with MyBiotics. So maybe I could first take a step back here and ask you, to describe your view on the role of the microbiome as it relates to NASH.

You know, I know we've seen a lot of evidence so far in 2020, about the potential of these medicines and biomarker work in general. And then also, as you look at the NASH base say five to 10 years down the line from now when, we might potentially have some therapies on the market.

I wanted to ask if you think that this is successful weather tools like this could be used for precision medicine to try to identify potential responders from the very early stages..

Kristen, yes, of course. Liat, please take that. Thank you, Kristen..

Okay. So thank you, Kristen, for doing this. I just want to say that to put everything in kind of a perspective, we there were multiple activities around Aramchol in order to actually maximize its ability to treat NASH patients. So as an overall plan, we elevated the exposure to Aramchol.

We have a better product now with Aramchol meglumine and we use the combination that I previously discussed with the thyroid hormone receptor agonist, as well as the combination that we are planning with MyBiotics.

Now, that the science around the involvement of microbiome and the etiology all the way back to 2015 and onwards, it is now an emerging scientific evidence that it may be the cause.

Or at least I have to say a company called to enhance this disease and patients that has different microbe biota is more prone to develop enough of the end-NASH , and more advanced publications are showing this specific microbiome profile for fibrosis.

And, I would say that the scientific eyes around this or the attention around this is really ongoing and growing. We will actually are looking for three main outcomes of this combination and collaboration.

So the first one is going to be collaboration to induce and to enhance the efficacy to Aramchol, to take into consideration for example, that we have responses to Aramchol that we will be able to identify and see how the microbiome of the responders different from the non-responders, and then see to change the microbiome, of the non-responders to the responders one and by that enhance the efficacy of Aramchol.

As a standalone therapy, microbiome change and the right flow can be a standalone potential therapy. And of course we have Galmed looking for this combination of that standalone together with Aramchol efficacy to create a better treatment to NASH patients..

And we have already incorporated Kristen in our ongoing clinical studies, microbiome samples, we are collecting samples, were collecting samples of healthy volunteers of NASH patients of Aramchol treated patients, there is a lot of data that now we can provide and work together with MyBiotics, which is a leading company in the space to exert everything Liat just eluded.

.

I have to say we are going to the multiple dosing of Aramchol meglumine, the dose is on the way almost finalized. The multiple dose will start as early as mid-December. And the microbiome samples is already implemented in multiple dosing of Aramchol meglumine as well. So it's going to be in all our studies onwards..

Okay, great. And then, just the second part of that question is; as the evidence of the microbiome role in general is emerging.

And if you find in your experience that it is helping identify those patients and the combinations work, do you think that down the line, we can look at NASH as something where precision medicine can come to play to really see which therapies might have the most potential just from the get go rather than starting patients on treatment X, and it doesn't work and moving them on to treatment Y?.

Definitely, and it's also will, cause for personalized medicine as well. I believe that in a time we will hopefully have multiple medicines in the market or so in the NASH space. Yes, definitely this is going to be accompanied therapy for end also biomarker for efficacy; so we look definitely accessorized medicine as well..

Great, thanks so much..

Thank you, Kristen..

Our next question comes from line of Ed Arce with H.C. Wainwright. Please proceed with your question..

Hi, good morning, everyone. Thanks for taking my questions. And thanks for the additional details are more and other aspects. So I recognize as you said in your prepared remarks, Alan, that there is a new recruitment plan underway. As you look at the various types and across the globe and the different recruitment rates of those.

My question is, and perhaps this is just too early to say that, but you have current guidance for full enrollment by the end of next year.

Is there a chance that that could be updated or revised when you get back to us, perhaps next month sometime on more details around the plan?.

So thank you, Ed. Actually we are moving right away from this call for your conference. So if all the listeners, Liat will be presenting or will be with you on a fetch, I think in 30 minutes or so for your Israeli conference. So thank you for inviting us. There's too many bode in the era, I mean, then this is where we have to decide.

On the one hand, we want to push and we are pushing as much as possible on recruitment and timelines for ARMOR, and specifically in countries which are less affected by COVID-19, which is easier. But as I repeat and said before, US and Europe are key countries, and recruitment have slowed down significantly in these places.

I can tell you that places like France, UK, Spain, Belgium, probably I missing another one or two European countries, we have not randomized the patient now for the last two months. So there is a very serious COVID-19 second wave in these countries. And I don't have to tell you what's going on in the US. So yes, we are adding more and more patients.

But at the same time, we have to take into consideration the switch to Aramchol meglumine which we want to make a very efficient switch. And we know that Aramchol meglumine is a better drug product at the end of the day. And we would like more and more of our patients to be able to enjoy Aramchol meglumine for a longer period.

So we are really, it's kind of two conflicting roles in one hand push as much as possible and recruitment, on the other hand, see the benefits for the patients. And we try to balance between the two.

And we have a meeting with a regulator with FDA and the European regulators to discuss this program and decide what is the best way in order to make that happen. I hope that by December when we come with the data with meglumine and the new recruitment plan, all of that will be revealed.

And you will have a very clear diagnosis, guidance of timelines of executions and catalysts. In our mind, everything is crystal clear. Unfortunately, it's not yet public information. So we cannot disclose that at this phase, in this stage..

Right, that's fair enough. Thank you very much for that. And that's a great segue, actually, to my next question. As you mentioned right at the beginning, your first in human PK data is expected for meglumine next month, as you mentioned. So I'm wondering, given this is key to your overall plan to move forward with the bioequivalence.

From the salt to meglumine, will you be identifying the equivalent dose next month to the 300 milligram BID of the salt is that part of what you're expecting to announce next month?.

So, Liat will take that..

So that just on the single dose, of course the design will be in need next month, the next middle December, we will know the single dose exposure. Usually, let's put it this way the regulator sees bioequivalence single dose in fast patient and this is good enough.

Because Aramchol has a long half-life, we are waiting for two days and then start immediately selecting to those for the multiple dosing which will end by the end we will have data hopefully by the end of January already, we will know the multiple dosing and then we will have to go I mean, we go directly to the regulator to present the single dose, just in between I can definitely tell you that while the analyzing the Aramchol meglumine we keep on with the food effects only to be on the safe side, there's not going to be anything that the regulators will ask for and we will not have to present.

So we will actually send the package with the single dose, multiple dose and at that time the single will have to provide us with some data that usually for the regulator is good enough.

If the regulator is asking for 80% to 125% exposure data, so it's going to be good enough for us because of the long half-life we will give them already the multiple dosing So we will have a clue with regards to are we going to be able to go back to the single dose or not? With Aramchol meglumine, we definitely know that we will be able to reach higher exposure to lower those will anyway be needed, if it's going to be placed daily.

Or if it's going to be once daily, then we will need a higher dose but once daily homogeneity among patients will be much better. So we see much better productivity. So in the mid-December we'll publish the results of the single dose.

With the bioequivalence, we took two doses to first in human of Aramchol meglumine and we compared it to the 300 milligrams, the tablets that the patients are actually receiving in our Mo, and we'll publish the results..

Great. Thanks, Liat. That's helpful. One final question then for me if I may, around this MyBiotics collaboration and combination that you announced on Monday, you mentioned earlier, one of the objectives with these patients with this regulated MyBiotics is to enhance the efficacy specifically of those non-responders.

And I would imagine that the way that you do that is that exactly the biomarker that they've developed.

And so I'm wondering if you could give us a bit more detail around how exactly the company is able to identify potential responders or help you enhance the advocacy?.

So imagine is that we are talking about, the best way to characterize. You have a patient, you characterize his response, a natural solution and fibrosis improvement. These are the regulatory endpoints to the clinical trials.

And you see that all the patients that you have, that responds well to Aramchol has a very pattern, which is completely different from the non-responders with microbiome or microbiota.

And you know exactly what kind of microbiome change is a company Aramchol response, what you are going to do is either change the microbiota off the non-responders to fit to the Aramchol responder's one. And by that you push the response to Aramchol even better to what it is..

Got it. That's helpful. Thanks, again..

Thank you. We have no further questions at this time. Mr. Baharaff. I would now like to turn the floor back over to you for closing comments..

So, thank you all for joining our call today. And I do hope that you will follow our press releases on during December. I think that there is a lot of exciting news that we are hopefully, that we will start and releasing by December and January, coming from both the Aramchol meglumine.

But also, I would like to remind you that Amilo-5MER our pipeline products is also entering first in human study early Q1. So hopefully by the Analyst Day of the 26th of January, we'll be able to communicate some data from this study as well. Keep safe and thank you all for joining the call..

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day..