Josh Blacher – Chief Financial Officer Allen Baharaff – Co-Founder and Chief Executive Officer Maya Halperin – Chief Medical Officer.

Jason Kolbert – Maxim Vernon Bernardino – MLV.

Good day and welcome to the Galmed Pharmaceuticals’ Fourth Quarter 2014 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Josh Blacher, CFO. Please go ahead, sir..

Thank you, Lisa. Good morning, everyone and thank you for joining us on today’s conference call. We’re pleased to be here with you today to provide you with an update on our Clinical development programs, as well as to report to you on our financial results for the full year ended December 31, 2014.

Together in the room is CEO, Allen Baharaff and Chief Medical Officer, Dr. Maya Halperin. We’ll be happy to take any additional question that you may have at the conclusion of my prepared remarks.

Before we begin, please note that we will be making certain forward-looking statements on today’s call, including without limitations those with respect to financial results, statements and forecast regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs, as well as other statements that relates to future events.

These statements are based on our beliefs and expectations of management as of today and actual results, trends, timelines and progressions relating to our financial positions and projected development programs and pipelines could differ materially.

I urge all investors to read carefully the risks and uncertainties including without limitation the risks and uncertainties under the heading “Risk Factors” described in our registration statement on Form F-1 and Form 20-F filed with the SEC.

Galmed assumes no obligation to update any forward-looking statements or information which speaks as of the respective dates only. With that, I would now like to turn the call over to CEO, Allen Baharaff.

Allen?.

Thanks, Josh, and good morning to you all. Thanks very much for joining us. I would like to update you regarding the progress of our clinical studies. First and foremost, our Phase IIb ARREST Study NASH was sent for aramchol for the resolution of steatohepatitis was initiated last month in eight sites in these [indiscernible].

Outside of Israel, the ARREST study protocol has already been approved in several sites in Chile and Mexico. We expect that outside those countries we’ll start recruiting by the end of June or early July. Other countries in Latin America will follow too thereafter.

In Europe, clinical trial applications were submitted in a number of countries and we expect the trials in Germany, France and Italy will start recruiting early July. As you know, we also announced that we had extended our ARREST Study to include patient’s recruitment in the United States.

We do this more because we ultimately believe that U.S.-based patient recruitment will shorten the recruitment time, as well as improve the study’s breadth and relevance.

Needless to say all of our FDA requirements, to commence this study has been completed, including the chronic nine-month toxicology study, which had no toxic findings, as well as the PK study in the two new higher doses, which had no serious adverse events.

We have already identified several potential sites and we are in process of executing the necessary contracts and approvals.

We believed the side will start recruiting by December and we hope to recruit at least 60 patients in the U.S., importantly, we are pleased that Professor, Vlad Ratziu, an internationally acclaimed key opinion leader and the ARREST Study’s global principal investigator, and Professor, Rohit Loomba, is the Study’s U.S.-based principal investigator.

Now, let me take this opportunity to refresh your memory regarding the ARREST Study design. This is a very important to iterate, especially in light of sound, the recent news regarding the study results for some of our competitors.

The study population in the ARREST Study will only include subsequent insulin resistance and relatively severe NASH, which is defined as the NASH call [ph] of four or above. In consent with our Scientific Advisory Board, we selected this population because they are the most likely to benefit from the treatment.

In addition to relative severity of the NASH at baseline, we will allow for high quality of assessment of the change in the biopsy.

The ARREST study treatment period is 12 months, with two doses of aramchol, 400 milligrams and 600 milligrams relatively placebo, after one year treatment the patient will undergo a second biopsy to evaluate histological effect of aramchol. The effect would be measured by two weeks theoretical [ph] endpoint.

The resolution of NASH with how it works liver fibrosis. And second, a two point decrease in NAFLD activity score or NAS, without worsening of fibrosis. It is important to drug into more detail concerning these end points. The resolution of NASH is the result of NASH to simple steatosis by this appearance of ballooning.

Ballooning has been proved in a number of clinical studies to have the strongest correlation with liver injury and a development of fibrosis. Our primary end point in the ARREST study is a statistically significant decrease in liver fat content as measured by MRS.

Accordingly, the ARREST study would be considered to be successful is aramchol will show a statistically significant effect relative to the placebo in reduction of liver fat concentration, as well as the resolution of NASH in biopsy findings.

Combining with imaging any theoretical findings will reduce the inherent variability of the measurements independently and will provide a more comprehensive assessment of aramchol or NASH.

Turning now to our proof-of-concept study in cholesterol gallstones, as we reported the study was initiated last December, recruitment has unfortunately occurred more slowly than anticipated. We’ve recruited only eight patients so far to the study.

We have therefore decided to open three additional centers and close the initial under performing center. And we are still in the process of revising our recruiting strategy and side profile [ph], we are not quite in a position to provide update on [indiscernible] completion of the study, but we do so as soon as possible.

I’m turning now to financial; I’ll turn the line over to CFO, Josh Blacher.

Josh?.

Thanks, Allen and thanks once again for joining the call. This morning I will be providing you with our financial results for the year-ended December 31, 2014. For more information please refer to our Annual Report on Form 20-F filed earlier today with the SEC, which among other things provide to summary of such financial results.

We’ve reported cash and cash equivalents and other liquid current assets totaling $32.2 million by December 31, 2014, which compares to $35.4 million at September 30, 2014. This change is consistent with the previous guidance we have stated regarding our annual burn rate of roughly $12 million.

You’ll note that during the quarter we began deploying the cash management strategy with the leading international bank. Since the end of 2014, we completed executing the strategy.

Our marketable securities or investment grade with an average credit rating of Aa3/AA- an option adjusted duration of 0.9 years and effective market yield of 0.6%, roughly 67% of the portfolio is invested in corporate bonds and 22% in municipal bonds.

This cash management strategy is expected to provide interest incomes of a couple of $100,000 on an annual basis. We continue to believe that our existing cash balance will be sufficient to fund our current operations into 2017, including the completion of our ARREST Study.

Of course either our burn rate or our plans can change in the future, so there is no assurance of these funds will last until 2017 as anticipated.

For the full year-ended December 31, 2014, on a GAAP basis, our net loss totaled $9.1 million or $0.88 per share, compared to a net loss of $17.5 million or $3.45 per share for the year-ended December 31, 2013.

The 2014 net loss included $0.6 million of non-cash, stock-based compensation expense, versus $10.9 million of non-cash stock-based compensation expense in 2013. Our largest expense remains R&D, which totaled $6.7 million for the year-ended December 31, 2014. This compares to $7.2 million for the year-ended December 31, 2013.

Please note that 2013’s R&D expense including a non-cash stock-based compensation expense of $4.3 million. During 2014, chemistry and formulation studies increased by $1.8 million and clinical studies increased by $1.0 million.

The change in these two line items account for more than three quarters of the annual data and reflect a larger scale production of aramchol for our clinical tasks, as well – cost of the studies and sales. Turning to G&A, our general and administrative expense for 2014 totaled $2.5 million versus $7.4 million for the year ended December 31, 2013.

The decrease in 2014 primarily resulted from higher stock-based compensation in 2013 of $6.6 million versus $0.6 million in 2014, excluding this non-cash line item total G&A expenses increased by $1.1 million, which reflect significant increase in salaries and benefits, rent and office maintenance fees and investor relation and business development expenses, as a result of our successful IPO in the hiring of a number of officers and employees to help us achieve our goals.

We are contended with our financial results during the first year’s – during our first year as a public company and the prudent management of our financial resources remains as utmost important.

Finally, I have had the chance to meet many of you during the last six months, but I would like to reiterate that I’d remain very accessible by e-mail or phone as appears on today’s press release. Please feel free to contact me at any time. I look forward to working closely with you in the future.

Allen?.

In closing, we are very pleased with our progress and the status of clinical development program to date and look forward to continuing to execute our plans. With that said, Lisa, please provide instruction for the Q&A portion of the call. Thank you..

Yes, sir. Thank you. [Operator Instructions] And we will take our first question from Jason Kolbert from Maxim..

Good morning guys, congratulations on all the progress, a couple of questions.

Maya I know you were recently in New York and in Boston at the labor meeting and you were talking to me a little bit about all of the news while it occurred in the space, can you help understand how the competitive landscape has changed a little bit and how aramchol has positioned within that landscape, particularly in terms of understanding what the end points might be for NASH trial?.

Okay, thanks for the question Jason and good morning everybody. There have been two studies published lately, one is by Conatus, and this is a small proof-of-concept study in the NAFLD and NASH.

We have already partial data, but we understand that study was in small proof-of-concept in 38 patients treated for one month with emricasan placebo and the primary end point was reduction in liver enzymes ALT. And apparently the end points were reached.

We just want to repeat that this is a proof-of-concept aramchol passed proof-of-concept almost a few years for now. We had 60 patients treated for three months the endpoint was much the pre-treat towards imaging FRET [ph] reduction by an MRI.

The other end studies that have been completed and communicated lately is a golden study, Genfit’s GFT505 study. We again has very few data they are going to communicate the data at the coming European Congress for Liver Disease. And therefore I don’t think I should be commenting on that data.

What I would like to underline is how our clinical – how the ARREST Study differs from the golden study. The primary endpoint in ARREST study is this appearance of active steatohepatitis with no worsening in fibrosis.

Now, we have to be, as Allen mentioned, very careful in defining those endpoints in order to make sure that we achieve them, refer to on these appearance of active steatohepatitis has been defined in two seminal articles.

One appeared in 2014 and the other one already in 1999, and in those articles, this appearance of active steatohepatitis has been defined and these appearance of ballooning. I must understate again – underline again that ballooning, which is a sign of cell base is for early NASH, while fibrosis is for late NASH.

So this appearance of ballooning made differed between steatohepatitis, which is an active form of NASH to – steatohepatitis and this is what we have as a primary endpoint. As a histological endpoint, as I listed to the primary endpoint is faced by NMRI’s and close two endpoints or complementary.

When you I mean now you increase in fibrosis we mean no increase whatsoever in fibrosis score as opposed to other studies which allow for some advance in the fibrosis score. So our ARREST Study to some would be this disappearance of active steatohepatitis with no increasing fibrosis score..

Excellent one, there Maya, thanks. Can you just opine with me a little bit to about what was involved in opening up the current trial to include U.S.

sites? What’s the significant of that and in terms of hiring additional people, particularly on the clinical front, have you made any progress?.

Okay, so thanks for the question. Having U.S. side, its very relevant for us, as it allowed for quicker recruitment type, these are countries where the biopsies are lest well understood than in the UK, in the U.S., sorry. We have among our sites, I think, six academic sites and may be two commercial.

Those academic sites are affiliated with the centers have participated also in the NASH research group. And those are very well versed in MRI and in biopsies with high quality, we had high quality data. Also, we hope that by recruiting around quarter of 35% of patients in the U.S. we’ll have FDA regard this as a U.S.

study and we will not have, again we hope we cannot be sure because we did not discuss yet with the FDA, that this would mean that we will not have to repeat Phase IIb in the U.S., providing our data. And this may be actually shortening the development plan.

Of course, having aramchol the and known by the Americans opinion leader [indiscernible] treatment will be a big asset to the company will help us in future studies and in penetrating the market.

And also we hire, I learned, in the last part of your question, we hired a very efficient, experience and energetic VP for clinical which will communicate in a separate communication to be in a press release soon when she will start working probably by tomorrow..

We will take our next question now from Vernon Bernardino from MLV..

Hi, good morning everyone, can you hear me very well?.

Hi, thank you Bernardino and good morning..

Good morning.

I just have a few questions and I was just wondering that now that you’ve completed the TOX and PK studies, the doses that you have tested and also as to how they relate to the doses you might bring forward, let’s say in a Phase III trial?.

Okay, we recently completed a PK study on 66 subjects, both single and repeated dosage for ten days with no know serious adverse events, we have fixed it escalation doses from 200 mg up to 600 mg.

And the two doses that we will take forward for the ARREST Study that 400 milligram and 600 milligram have shown to be of no adverse events and a very good PK – shown a very good PK profile..

On Phase 3 [indiscernible]….

Based really of course of Phase 3 we’ll repeat it, I mean we are – as you remember Vernon, we also have an interim analysis after six months, after 120 patients, complete six months of treatment.

In that time, we will also look at the PK profile, and if we will see that there is no difference between the 600 mg and the 400 mg, of course we will revert to a single dose of 400 milligrams. But most importantly, this would also establish a safety profile, in safety profile as aramchol as they were demonstrated so far..

And regarding the doses tested, I know eventually and I am not sure if you’ve achieved this yet, have you now attained the maximum tolerated dose, so that don’t need to be done?.

No, we have no treats, in our chronic of toxicology studies the nine months chronic toxicology study, we have no treats and maximum tolerated dose, MTD. And hence when consulting the regulated FDA, we were administrated the animal with the maximum feasible administered dose which was found to be 1500 mg/kg per day.

These are equivalent to about 50 times, 50 fifty times therapeutic dose and still we have not observed serious adverse event. So there is no MTD, but the data. Maya I would like you to address that point..

Your formulated the question, is still to be done, we cannot continue giving more than that in order to reach an MTD, because this is impossible to administrate, as Allen said its maximum administrable volume wise.

So this completes the requirements of the FDA and we have updated the IND and we hope to not to hear from them in the next week, which means that we can go forward, but we have no further toxicology studies to do as far as we know..

Terrific, that means at the very least you have further confirm the safety of aramchol.

One question that I have and relates to topic that Jason looked into, and that is what the golden results anticipated for GFT505, they were inconsistency as far as these clinical sites were concerned regarding how they were treating these patients, as well as the kind of test that they were capable of doing.

I assume you’ve learned from their mistakes and the sites that are now part of ARREST and will be part of ARREST in the U.S., you are going to be able to control for those, because that seemed to be a very big factor and the inconsistency of the results..

Well, we – I don’t know maybe you know more details than we do, I think I’m not sure that the result should be influenced by the number of centers, but may be I don’t know exactly what were the mistakes done between the size, what we can say is that we have a very close relationship with the sites and even in choosing the sites was very much involved – all involved in Latin America….

And head – I just returned this week in fact from spending a week with Professor Ratziu, traveling to Mexico and Chile visiting our key investigators and the key size that we participated in the study.

And we had a very good surprise from the level of the quality of the both the investigators and the clinics themselves, most of them are private clinics and with very extremely experienced in clinical studies.

So we tend to do that I mean, I’m going to do that Maya and we have an internal auditor that will also make regular audit to ensure the quality of the size as we are hopping that there should be..

Yes, and I’m glad you mentioned Dr. Vlad Ratziu, because he, as you know, was a part of the golden study and with the concerns that I had just mentioned, as far as the inconsistency across the capabilities of the clinical trial sites that he would know the mistakes and how to avoid them in the ARREST Study for Galmed.

So thank you very much for taking my question..

Yes. After the – and then we should also asking for the benefit, we should also remember that the golden study was designed number of years ago. And then may be border line NASH was filed acceptable and which is clearly following the September 2013 workshop.

Already it was made clear to everyone that the right population is only severe NASH as we have in our study, not for and above.

And this is unfortunate; this is when we said that we had a privilege that in some of the ways it paid for us by some of our other competitors that is correctly what happened, we have the benefit of starting late learning from other mistakes..

Yes, I think so and good luck. I’m looking forward to the next update..

Thank you I look forward to you..

[Operator Instructions] And it appears at this time we have no additional telephone questions. I would like to turn the conference back over to Mr. Allen Baharaff for any additional closing remarks or comments..

I just would like to say thank you all again for your continued support over the last year. And as Josh mentioned earlier, we are always available for you for any questions, Josh, myself and Maya, any question you may have, clarifications, we try to come as often as possible to the U.S. and in available in all other means.

Thank you again for joining us today..

And ladies and gentlemen, this does conclude today’s conference. And we do thank you for your participation..