Bob Yedid - IR Allen Baharaff - President and CEO Liat Hayardeny - Chief Scientific Officer Tali Gorfine - CMO Yohai Stenzler - CFO.

Yasmeen Rahimi - ROTH Capital Partners Ed Arce - H.C. Wainwright.

Good day and welcome to the Galmed Pharmaceuticals Fourth Quarter 2017 Earnings Call. Please note today's call is being recorded. At this time, I would like to turn the call over to Bob Yedid. Please go ahead..

Thank you Esmee and we appreciate you being with us.

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 timelines and expectations with respect to our regulatory and clinical development programs as well as other statements that may 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 related to our financial position and projected development programs and pipeline could differ materially.

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

Galmed assumes no obligation to update any forward-looking statements or information, which speak as of their respective dates only. Now it’s my pleasure to turn the call over to Allen Baharaff, President and CEO of Galmed.

Allen?.

Thank you, Bob. 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 Medical Officer, Dr.

Tali Gorfine; and our CFO, Yohai Stenzler to provide you with an update on our clinical development and lifecycle management program, as well as to report you on our financial results for the fourth quarter and full year of 2017. At the conclusion of our prepared remarks, as always, we will be happy to take your questions.

I would like to start with a recently reported results of the ARRIVE study, which did not demonstrate the typical difference between Aramchol and placebo on MRI PDFF following 12 weeks of treatment in HIV patients with lipodystrophy and nonalcoholic fatty lever disease or NAFLD.

It is important to emphasize that when a drug company had a compound with a unique mechanism of action or effect that indicates with Aramchol, the basics of drug development is to develop the compound for the magnification and in [turn] explore numerous other indications.

ARRIVE was a small investigative initiative trial in a very distinct population, whose pathogenesis is slightly different from common NASH. HIV patients have advanced liver disease, which is a major cause for morbidity and mortality.

All those pathology fatty liver is similar to common NASH, a pathogenesis involved in HIV lipodystrophy NAFLD is different and multi-factorial including the effect of the (inaudible) cell and the anti-HIV medication.

When considering the implications of these results to direct study, three points are worth keeping in mind; first, several factors have contributed to the last effect in an HIV patient with lipodystrophy and NAFLD, including the complex of both unique and common theologies, their continuous population and concomitant medication.

Second, the method introduction of Aramchol i.e. FDD-1 down regulation improved fatty acid oxidation and direct effect on fibrosis in targeting pathways invoked in common NASH. This was demonstrated in multiple relevant animal model including high fat diet, [MPB] and [EIA] and invitro model of hepatic collagen producing cell.

And thirdly, ARREST was initiated following the positive phase IIA study of Aramchol in patients with NAFLD and NASH.

While success in earlier trials does not ensure success in latter trials, as a reminder, the phase IIA demonstrated a statistically significant change in liver fat as measured by MRI spectroscopy or MRS for a 12 weeks of Aramchol 300 milligram treatment compared to placebo.

Now, lets me move to ARREST study, which is as you know is our phase IIB study for NASH certification. The ARREST study enrolled 247 common NASH patients which received Aramchol or placebo for 52 weeks. All patients had risk factors diabetic or pre-diabetic and were overweight or obese, and NASH was diagnosed with (inaudible).

As was reported, it translated to an advanced NASH population in which 60% of patient had fibrosis stage 2 or 3 at baseline. ARREST is designed to allow a thorough analysis of the potential effect of Aramchol on steatosis and NASH and fibrosis yielding both MRS and biopsies.

To-date all patients completed the treatment phase of the study and the last ongoing patient are in the follow-up phase. We look forward to the topline results which are expected during June 2018.

Before I conclude these remarks, right back to my opening comments, Galmed is continuously working on exploring numerous opportunities for Aramchol as a monotherapy as well as in combination with added compounds or NASH and other indications which are best suited to Aramchol’s unique mechanism of action.

I would like to turn the call now to Yohai Stenzler, our CFO.

Yohai?.

Thank you, Allen and good morning. This morning I will be providing you with our financial results for the period ended December 31, 2017. For more information please refer to our annual report on Form 20-F filed earlier today with the SEC, which among other things provides a summary of such financial results.

I would like to start this time with our balance sheet and cash position. During the fourth quarter, we raised net profit of $12.4 million from our ATM offering. This brings us to a year-end balance of $19 million of financial assets which includes cash, cash equivalent and marketable securities.

We believe our existing cash balance will be sufficient to maintain our current operations through the end of 2019.

Turning now to our statement of operation; our net loss for the three and 12 months ended December 31, 2017 totaled 3.6 million and 12.3 million respectively, compared with a net loss of 4.8 million and 17 million for the corresponding period in 2016.

As a result, our loss per share for the three and 12 months ended December 31, 2017 was $0.27 per share and $0.98 per share as compared to $0.40 and $1.49 for the same period in 2016. Our revenue for the three and 12 months ended December 31, 2017 was 0.3 million and 1.1 million respectively, compared to 0.3 million and 0.5 million during 2016.

The revenue related to the amortization of the up-front payment under the license agreement with Samil Pharm. Research and development expenses for the three and 12 months ended December 31, 2017 was 2.2 million and 9.7 million. This compares with 4.2 million and 14.3 million for the corresponding period in 2016.

Turning now G&A, our general and administrative expenses for the three and 12 months ended December 31, 2017 totaled 1.7 million and 3.8 million respectively versus 0.8 million and 3.1 million during 2016. With that said, operator, please provide instruction for the Q&A portion of our call. .

[Operator Instructions] And we’ll take our first question from Yasmeen Rahimi with ROTH Capital Partners..

I just wanted to ask a number of questions around the timeline.

Question one is, should we be expecting just topline you know meaning just MRI PDFF data in June, and when would we be getting a glimpse of any of this histological end points in June as well or would that be actually be provide more in detail probably later and therefore maybe in the April, I apologize for the (inaudible).

And then the second question is around more additional color that we should be seeing on the ARRIVE study.

When should we be seeing more details from that study?.

The first question was about rest I’m assuming?.

Yes..

Of rest of June, right?.

Correct, whether we will see histology data as well or just MRI PDFF..

So it’s both, you will be able to see both MRI and MRS and the biopsy of course, the biopsy results. .

Fantastic, and in terms of the ARRIVE study, I know you guys supported topline inside, but should we be seeing, are we going to see any additional color around it before June?.

So as you know, this was an investigator initiative study, and we are eagerly waiting for Professor Loomba, he’s working on further analysis. So as soon as we get the data, I promise that as we did with the primary data, we will release that as soon as we get it. .

And we’ll take our next question from Ed Arce with H.C. Wainwright. .

First, what about on the read-out that you’re expecting in June along with the components of NASH from the biopsy data, the histology data, did you report in any terms results in fibrosis as well? Second question is, just wanted to confirm the 247 patients that completed the trial, I believe you said.

And then the last question was, if you could repeat for me the cash runway. .

The first is that yes, biopsy data include fibrosis. So this is our as you know our primary and secondary and we are at Aramchol we get unique mechanism of action and we hope to be posted on steatosis and fibrosis.

Secondly, the last question is on cash balance, as we reported our cash balance for the end of the year is $19 million and this should keep us through the end of 2019. So you had a question - for the original question. I am sorry Tali, may be Tali would like to take the question..

Yes, just about 247 patients were randomized to the study, of course not everybody completed 52 weeks of treatment. But all the patients have completed, all the ongoing patients have completed with 52.

That means they completed the treatment period and we have some patients ongoing in the follow-up period, which is what we are waiting for them to finish and then lots of dataset analyzing and report as we get it. .

And actually one other one occurred to me, could you go over again the [powering] of the study were?.

The powering of the study was based on the phase IIA study with use of lipodystrophy after three months. So the primary appointed power for MR spectroscopy, as we do have a large sample size to allow booking and assessing biopsy based end points including fibrosis, reduction in NASH score, two points reduction in NASH score and NASH resolution. .

[Operator Instructions] It appears there are no further questions at this time. Mr. Allen Baharaff, CEO, I’d like to turn the conference back to you for any additional or closing remarks. .

Thank you so much.

By the way, by coincidence we noticed that today is our fourth anniversary the company went public on 13th of March 2014, and I am looking forward, all of us here is Galmed are looking forward to continue and serve all our shareholders for a very successful future for all of us and looking forward to talk in June for our [other] study results.

Thank you. Operator, you can conclude the call. .

And that concludes today’s conference. Thank you very much for your participation. You may now disconnect..