Good day. Welcome to the Galmed Conference Call to discuss Financial Results for the First Quarter 2021. Today's conference is being recorded.

Before we begin, please note that we'll be making certain forward-looking statements on today's call, including those regarding financial results, statements and forecasts regarding anticipated timelines 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 the beliefs and expectations of management as of today and actual results, trends, timelines, and projections relating to our financial position and projected development programs and pipeline could differ materially..

Thank you Dona. 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; and our Chief Financial Officer, Yohai Stenzler, to provide you with an update on our clinical development programs as well as we report to you on our financial results for the first quarter of 2021. As always, we would be happy to take any questions you may have at a conclusion of our prepared remarks.

As we have had our invested year end KOL only few weeks ago, my report used this time would be very short.

Starting with Globe, with our Global Phase 3, registrational ARMOR study and as previously reported the additional, the open label part was approved in the U.S., Canada, Australia, UK, France, Belgium, Spain, Israel, Chile and Turkey and is expected to be approved in the coming weeks in Korea and Mexico.

Based on our plans and the rapid regulatory approvals, I can confirm that the results from the approximately one-third of the study population, about 50 subjects, that has completed the post-baseline liver biopsy are expected to be available in Q4 2021 as planned.

That being said in Q4, we expect to have results on the efficacy of Aramchol with higher exposure on fibrosis and liver that's confirmed by liver biopsy. Also reported earlier this month, Aramchol received an IND approval in China.

We give the approval of ARMOR study in China as a significant milestone in the development of Aramchol for NASH & fibrosis, which may accelerate the pace of randomization of patients with the double-blind placebo part of the ARMOR study and also position Aramchol as one of the Foremost Therapeutic Candidates for National Fibrosis in this large and emerging market.

We look forward to rapidly initiating enrollment in China. As soon as practical. It's previously reported, ARMOR double-blind placebo control registration of the part is expected to initiate by the end of Q1 2022. And is expected to be based on Aramchol meglumine, which is a short-form of Aramchol free acid with an improve target product profile..

Thank you, Allen. Good morning and textbook learning. Joining today this morning, I will be providing you with our financial results for the quarter ended March 31st, 2021. For more information please take yourself on Form 6-K primarily with the SEC, which among other things provides a summary of such financial results..

Thank you. The floor is now open for questions. our first question is coming from Steve Seedhouse of Raymond James, please go ahead..

Great. Thank you. Can you just talk about what you're seeing in the single ascending dose study for the Amilo-5MER? I mean, you're doubling the highest dose obviously that you tested in the initial escalation. Just curious if that's based on PK alone, or if that's based on some of the inflammatory biomarker data that you indicated you're collecting..

Thank you, Steve. No PK and safety into the ability You have to that line of action of Amilo-5MER is Serum regulation of Serum Amyloid A, obligation and full utilisation. It only happens on times of inflammation, that healthy volunteers do not have hyper and production and polymerization and aggregation of Serum Amyloid A.

So there's no use in looking into a downregulation of Serum Amyloid A, which is not elevated in volunteers..

Got it. Perfect. And then just regarding Aramchol meglumine, can you just clarify if you've had a type C meeting with FDA and the feedback you're expecting is subsequent to that, or are you still planning on having a type C meeting or are you just awaiting a written feedback in third quarter? Thank you..

We are waiting for a written bond. We submitted the request for me. I mean, due to co-pays, we obviously cannot travel to Washington now. So we applied for a meeting and the old so sense the package.

And we expect the, in June 2021 to have a written response from the FDA on our fully plan, they also got all of their bio-equivalence studies results that we had together with co-lead methylamine as compared to.

But the FDA has confirmed the DC's done under meeting time table which is mandatory timetable for a response. .

Sorry. Our next question is coming from Ed Arce of H.C. Wainwright, please go ahead..

This is Thomas you've asked me a couple of questions for congrats on other progress made this quarter.

Just wondering off the histology data from patients 2021, how many patients will be how what's the percentage of patients that have been treated for 24 weeks or 48 weeks or 72?.

Okay, thank you. So, so the majority, if not all patients are going to be F2, H3; these are patients which have transitioned from the double-blind placebo.

And as you know, we have one recruited F2, F3 patients for this double-blind placebo part, on top of my head, we're talking about 25 patients are going to be on the 48 and 72 weeks on biopsy front and about 25 would go for 24 week..

Okay, thanks for the additional amount for the study.

And then for the new China we'll get started with the new Aramchol meglumine formulation?.

So, so what the IMD that was approved was the existing protocol IE protocol 3 of the ARMOR study, which is the twice daily, the DID RM coated with the enhanced exposure, the 50% higher exposure. This is the data that we will see also from the open label study. We have the protocol 4, the open label study and this is now in process.

We are now in discussion or to approve these amendment protocol; amendment, and protocol 5 is going to be meglumine which has to be first approved of course, by the FDA. And then we will amend the globally, including China.

So we are starting with Aramchol acid but hopefully moving swiftly to our meglumine when allowed all over, not only for China, but all over the world..

Okay. So sounds good.

Perhaps one final question from Amyloid Phase 1b study, can you think over it rational of going ahead with but the thing is our phase 1b?.

Yeah, definitely. We are developing Amilo-5MER in two formulations. One of the formulation is going to be well a directed to ulcerative colitis. That means that it's going to be opened in a certain pH Parallel we do want to see an exposure of subcutaneous use. So we go with a both formulation into Phase 1b..

Okay, sounds good..

That's kind of development will allow us to go through multiple indications because indication as RA for instance require the applied injectable administration where others require local oral, like alluded for the GI tract. So we are working in parallel with two formulation to allow us to expand the development program to other indications.

Once we start to fix one disease, the one that we described of course, for IBD for ulcerative colitis..

Yeah. So, so yeah, that's for the additional indication. Thank you so much. And we look forward.

You, our next question is coming from Kristen Kluska - Cantor Fitzgerald. Please go ahead..

Hi team. This is Rick on for Kristen today. Congrats on the quarter. And I just wanted to ask a couple of questions. In light of the ongoing pandemic, I wanted to ask about the team's confidence in being able to have a comprehensive data set for this first 50 patients in histology results to Aramchol.

You believe these results could tailor your inclusion-exclusion criteria for reinitiating study by the end of first quarter 22?.

So as our VP of clinical affairs Shai Feinsod just returned from a treatment in the U S visiting our US sites -- Some of our us sites, as you may recall, we've carefully selected out of the 215 sites, which are active in the ARMOR study about 55 sites, which were less affected by COVID-19.

Israel, fortunately, I mean, in terms of working here from Israel we are almost back to normal. We have other problems, but nothing to do with COVID-19. But Europe, we see some delays but we are not many patients coming from Europe at that time. And in our forecast, the majority of patients would come from the U.S.

and we've selected areas in the U S sites, which were less affected by COVID-19 and meeting with the CIS just recently we confirmed the timelines and this all is going well. Expand for the re-initiation of the double-blind spot of Aramchol by Q1 2022..

Understood, thank you.

Maybe just one more given the complexity of the IBD markets I know you kind of maybe alluded to this earlier but it's there there's certainly a large and diverse patient population to serve as far as knowing the best segment of the market to target with the Amilo-5MER, what specific signals are you looking for? A proof of concept data in order to better inform, you know, what kind of patient populations subset of the market you would really target the trials?.

Thanks for that. We are targeting colitis patients, mild, moderate the tasty and deliverability and secrecy of Amilo-5MER would be superior as we see it now in animal models, TK.

So the ability in healthy volunteers to all the other idol, crime reducers that are currently in the market, you have to understand that all the time is very, very compound in the market. They are extremely efficacious, so that ability is not so easy. And the immune system is exercise, not the same.

And if these other compounds are I would say harming the ability of the patients to form a good immune response and or to Mount a grid in your response. I mean, Amilo-5MER, which is very safe, very focused.

And the mechanism of action is very specific upstream to all the site of pain, a produced in highly inflammatory is going to be the best benefit risk ratio for the long term, a disease views. And the safety margin is going to be extremely better..

One of the things that COVID-19, if he's one of the additional lessons is that there isn't room for immune system modulators and immune system suppressor. And we see that many of the patients which have been treated on the biologics and all those very effective drugs unfortunately were exposed to COVID-19.

And we believe that the reasonable in the lessons learned from COVID-19 for drugs that such it with a profile such as Amilo-5MER, and we are looking forward to demonstrate all these superior safety and tolerability and efficacy data in our Phase 1 and Phase 2 8 study. Thank you for that...

Thank you. At this time, I would like to turn the floor back over to Mr. Baharaff for closing comments..

So thank you all for joining our call as always, you are very welcome to contact us and within the next 40 in the quarter before our next quarterly call, and we are looking forward to finally see you in person.

I hope that with easel coming very soon and certainly for traveling with travel restrictions will be lifted, and we'll be able to come and visit you very soon. Both in the U S and Europe. Thank you all for joining the call,.

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time and have a wonderful day..