Allen Baharaff – President and Chief Executive Officer Yohai Stenzler – Chief Financial Officer.
Jason Kolbert – Maxim Ed Arce – H.C. Wainwright & Company Mike Guo – SunTrust.
Good morning and welcome to the Galmed Pharmaceuticals Second Quarter 2017 Earnings Call.
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 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.
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 on March 23, 2017 and the risks 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. Please note today’s call is being recorded. At this time, I’d like to turn the call over to Mr. Allen Baharaff, President and CEO. Please go ahead, sir..
Thank you, Odro. Good morning and thank you for joining us on today’s conference call. I’m pleased to be here today with our CSO, Dr. Liat Hayardeny; and our CFO, Yohai Stenzler to provide you with an update on our scientific and clinical development program and to report you on the financial results for the second quarter of 2017.
As always, we will be happy to take any questions you may have at the conclusion of our prepared remarks. Our ARREST Study progressed as planned. The DMC for the ARREST Study made during July 2017 to review the accumulated safety data of our ongoing clinical trials.
Following review of the data, the DMC issued a positive recommendation for the continuation of the ARREST trial with no changes to protocol. To date more than half of the ARREST station completed 52-weeks of treatment as previously reported two blind data of the ARREST is expected in the second quarter of 2018.
Our investigator-initiated ARRIVE Study for HIV-associated lipodystrophy conducted as UCSD is also progressing as planned. As a reminder, the aim of this study is to examine the efficacy of three months treatment of Aramchol versus placebo in reducing liver fat in patients with HIV-associated NAFLD.
The study primary endpoint is measured non-invasively by MRI PDFF and secondary endpoints included change of liver stiffness measured by MRE and changes in pericardial effect. We are aiming to present the data at International Liver Congress, EASL, on April 28th in Paris. Let me turn now to our scientific work.
We’re continue investigating significant effort into better understanding the mechanism by which Aramchol done regulatory to steatosis and fibrosis. Results showed direct and non-direct anti-fibrotic effect in multiple NASH and fibrosis models.
The data is consistent across all in-vitro and in-vivo models tested indicating down regulation of collagen production and fibrosis. ARREST is designed to demonstrate and translate those anti-fibrotic effects in human data.
Now, I note our investors express concerns on the company’s limited cash position which has previously reported the sufficient to maintain our current operations through data and through the first half of 2018.
I would like to reassure all our investors that we continue to diligently manage our expenses and valued our financing alternatives in a strategic manner with a view towards maximizing value of our shareholders. I would like to turn the call over to Yohai Stenzler, our CFO.
Yohai?.
Thanks, Allen. Good morning and thank you for joining us today. This morning, I will be providing with our financial results for the quarter ended June 30, 2017.
For more information, please refer to our Quarterly Report on Form 6-K filed earlier today with the SEC, which, among other things, include our unaudited consolidated financial statement of the three and six months ended June 30, 2017.
For the second quarter of 2017, our net loss totaled $2.7 million, or $0.22 per share, compared with a net loss of $4.3 million, or $0.39 per share, for the corresponding quarter in 2016. We recognized $0.3 million of revenue for the three months ended June 30, 2017 compared to no revenue for the same period in 2016.
The revenue relates to the amortization of the up-front payments under our license agreement with Samil pharm. Research and development totaled $2.3 million for the second quarter of 2017, this compared to $3.4 million for the corresponding period in 2016.
The decrease during the second quarter of 2017, primarily related to the expected decrease in the ARREST trial related expenses. Turning now to G&A, our general and administrative expenses for the second quarter totaled $0.6 million versus $0.9 million for the second quarter of 2016.
The decrease primarily resulted from a decrease in professional fees and salaries and benefits. Looking now at our balance sheet at June 30, 2017 current assets, which includes mostly cash, cash equivalents and marketable securities totaled $9.4 million, which are $2.6 million less than the $11.7 million reported at March 31, 2017.
We continue to believe that our existing cash balance will be sufficient to maintain our current operations through the first half of 2018 and allow us to complete the ARREST study as scheduled. With that said, operator, please provide instructions for the Q&A portion of our call..
Thank you. [Operator Instructions] We will go first to Jason Kolbert at Maxim..
Hey guys, thank you very much. Really appreciate the update.
Can you just talk a little bit as we work towards data in the second quarter of 2018, what other events other than the presentation of data at EASL we should be thinking about and what data you might be announcing over the coming year?.
So first thank you very much, Jason. First we are preserving presentations for the AASLD. We have submitted a number of presentations which would be accepted either as oral or poster and we are also working at late-breaking news which will include additional data from ongoing pre-clinical studies, which we are now conducting.
So it should be quite a lot of news flow around October, November at AASLD and of course we are going to participate in a number of business conferences during the year. We also have submitted the paper on the direct effect of Aramchol on fibrosis.
We should also, publish we are now – under review now by the publication and it should republish the – I believe before the year-end..
Okay, Allen, thank you very much. And just talking a little bit about the cash balance to down to $9 million, is it just going to be using an ATM and doing what you can to preserve capital on the balance sheet as you move towards second quarter 2018.
Is that the strategy?.
Okay. As previously said we are not – we are continuously evaluating our alternatives, as you will see so far we have not used ATM. The last time we used ATM was in September 2016, we have not used it still, and we do that on a regular basis.
As you can imagine interest is growing and you can see that from the recent activity in the share over the last couple of weeks..
Last question now and I know you have been very involved and focused in Asia, can we expect the continued progression of talks maybe even a deal coming and when we talk about Asia are we really talking about China?.
Okay, thank you. First, of course, I can neither confirm nor deny discussions on any deals, but of course we repeatedly said and you’re opted to rise and we – we came – this was I think Q3 or Q4 increased already also with – at a Maxim Inauguration Conference in China.
And we were recently – we strongly believe in this region and Asia, I’m referring to China. And we, just to remind again, we have full data, PK data on Chinese population before we enroll Chinese patients to ARREST study, we conducted a full Phase I data on Chinese first-generation that was done in the U.S. under the FDA protocol.
So we already do advance discussions with the FDA with Chinese FDA. And China is going to hub a large number of NASH and NAFLD patients. And is certainly for us is a very important place to concentrate any addition of course to the global licensing being in U.S. and Europe..
Thanks for the update Alan. I appreciate it..
Okay, thank you Mark. Thanks Jason..
[Operator Instructions] We’ll go next to Ed Arce at H.C. Wainwright & Company..
Hi, Allen good morning. Thanks for the update. There were just one of the focus on I guess probably the same couple of issues.
With data now especially in quarter of 2018, just wanted to ask about how you expect to manage the cash between now and then, given that cash burn year-to-date averages about $3.2 million a quarter, that wouldn’t quite get you to the end of the first quarter of next year.
So clearly there needs to be something else, unless the actual burn is off, is expected to come down considerably. Perhaps you could just discuss little more detail around how you think about that..
Okay, thank you Ed. First of all Ed you notice our cash burn rate is going down. We’re going down to $2.6 million in this quarter. And as we publically stated and as Yohai earlier reported, management believes we have sufficient cash to data and through the first half of 2018.
Nonetheless, repeating what I’ve said earlier, we continuously of course will look very, very carefully and you’ll notice that our G&A expenses have gone down, and we monitor our expenses very, very carefully and we will continue on, literally on a daily basis monitor our financing opportunities and will act accordingly to the best benefit of our shareholders..
Okay, in terms of the data release for ARREST, is there anyway you could share with us perhaps any more specific of a timeline in the second quarter, perhaps closer to April than June..
In between I think, it’s closer to May, it’s very much depend, but last patient in were somewhere in February. So if you take three months follow-up period, which gives us also the time to collect all the data and prepare all the analysis, so somewhere around May between 1 and 30 of May, we should have the data out.
I can tell you that our statistician with extremely experienced, and assured me that it will take you no more than three working days to prepare the data for me on my desk. So we do not want the data. It would be somewhere in May, but the company would actually win..
Okay..
Now ARRIVE data is – before it’s going to come before and it is very important I think that ARRIVE data will also in addition to the effect on for the specific indication we also look at full body fat and other organs, I mean the ability of Aramchol to reduce liver, sorry fat content from other organ and in specifically we look at pericardial effect.
This is extremely important because it will open avenues to a number of very interesting new indications for Aramchol, which we will take forward once we complete the ARREST..
I’m sorry, did you say looking at cardiovascular effects?.
Epicardial – epicardial and pericardial effect..
Okay, all right.
And then just to confirm you said the ARRIVE data is expected to be released at EASL next April?.
Before – it should be before we have a date – as we little before 37 out of the 50 patients have been randomized, this is of course not in our hand, because its an investigator-initiated study, managed and run by Professor Loomba.
But I have good reasons to believe that the later it would be in Q1 2018 data from this study should be at Q1 2018, this is a three-month study. So it should be too difficult to complete and publish the results….
Okay. Great. Thank you very much Allen..
Thank you, Ed..
No we’ll move next to Edward Nash at SunTrust..
Hi, thanks for taking the questions. This is Mike on for Edward.
So just a two quick question, the first one is about the data releasing second quarter of next year, just want to know what’s the format of the data is that going to be a press release or are you going to present a data at some medical conference?.
Very much depends on the timing, we will be able to do some analysis, I mean this is about in the later in May and I think May I not sure when EASL is in 2018 but normally its in April so we might be too late even for the next breaking news for EASL.
But if we would try and do something before, its not it will be a press release of course and we were looking at the right venue to publish the results..
Okay..
Of course, at AASLD – I mean full data of course will be presented at AASLD 2018..
Okay, and also the extent of the data you are going to present for the top line, you’re not going to be like a plain vanilla, just to say whether it’s a mid-term or mid of the permanent endpoints or are you going to have some kind of a detailed analysis of the primary and also the secondary endpoints which are balancedly [ph] based?.
We will do, of course we will do our best that the data will present in a best possible way, the data from the study. So whether it will be just the primary as we did on our Phase 2a, just the effect, the liver fat content through primary and if we grow this of course the secondary – the primary and secondary effect on fibrosis.
As you remember our statistical analysis plan, it’s designed in a way that the effect of fibrosis, the effect of 600 mg of fibrosis is the primary secondary. So these are the two key data that we should present the effect on liver fat and fibrosis..
Got it. Maybe just one last question. In the technical aspect, I understand that sir your primary endpoints of measuring liver fat is through MRS. I guess that some of other Phase 2 trial presented at EASL using MRI.
Could you, if that is possible, can remind us the difference between MRS and MRI in term of the measuring liver fat?.
Okay. So MRS was today by the way it has been shown that in recent publications that there is quite a parallel – I mean, it’s almost the same results are getting through MRI and MRS. MRS is measuring the fat content against water.
It’s Magnetic Resonance Spectroscopy, and its fat has very [Audio Dip] signature, it can measure very accurately peaks of fat against water, and it gives you the data in a percentage very clearly, but it’s more complex to – you need to see, I mean, sides have to trained, it is not an analysis which is done regularly in hospital.
And we had to train all the sides and of course everything is centrally read. MRI which seems really – I mean, this was parallel, it’s the same – it’s a different software for the same machine. So it – we’re using the same MRI, say, 3 Tesla MRI, but we’re using a software which is a spectroscopy software.
The MRI software is more prevalent in many more hospital. And now the industry is turning as – you can see the number of Phase 2a studies which are done by large pharma including Gilead, DMI, et cetera, which are the using the same endpoint, the MRI three months or four months of liver fat content.
So the measurement end result is the same, the technology slightly different depends on the software, whether it’s an MRS or a MRI..
Got it. Thanks so much, Allen..
And there are no further questions at this time. I’ll turn the conference back over to management for any closing remarks..
So thank you very much. I’ve just wanted to inform you that Galmed is going to be – I mean, management is going to be in September in New York. I would be very happy to meet face to face with any investors. And we’re – as always, I mean, please feel free to contact us for any question you have and we’re very happy to respond.
Have a nice and quite summer..
Thank you. And that does conclude today’s conference. Thank you for your participation..