Bob Yedid – Investor Relations Allen Baharaff – President and Chief Executive Officer Yohai Stenzler – Chief Financial Officer Liat Hayardeny – Chief Scientific Officer Tali Gorfine – Chief Medical Officer.
Jason Kolbert - Maxim Group Yasmeen Rahimi - Ross Capital Partners Ed Arce - H.C. Wainwright.
Good day and welcome to the Galmed Pharmaceuticals Third Quarter 2017 Earnings Call. Today's call is being recorded. I will now turn the call over to Bob Yedid. Please go ahead..
Hello and welcome to Galmed's third quarter 2017 conference 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 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 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 and risk and uncertainties included in the Form 6-K filed which was 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. With those remarks now completed, it's my pleasure to turn the call over to Allen Baharaff, 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 reporting on our financial results for the third quarter of 2017. At the conclusion of our prepared remarks, as always, we will be happy to take your questions.
Our primary focus at Galmed is on advancing Aramchol, our first-in-class orally active liver-targeted SCD1 modulator which is in clinic in NASH and in HIV-associated lipodystrophy and NAFLD. Our ARREST study in NASH is progressing as planned.
As a reminder, ARREST is a 12-month Phase IIb double-blind, randomized trial to evaluate the efficacy and safety of two Aramchol doses versus placebo in 248 patients with NASH. To-date, 154 of the ARREST patient have being completed 52-weeks of treatment. As previously reported, top-line data of the ARREST are expected in second quarter of 2018.
Our ARRIVE clinical study for HIV-associated lipodystrophy and NAFLD and investigator initiated proof-of-concepts Phase IIa being conducted by Professor Rohit Loomba at the NAFLD Research Center, at the University of California San Diego is also progressing as planned.
As a reminder, the study's primary endpoint is a three month effect ton liver fat measured by MRI which will correlate to ARREST primary end point. As of beginning of November, all 50 patients have been randomized, accordingly top-line data from the study is expected to be available in the next quarter.
Our goal is to present the data at the International Liver Congress EASL 2018 in April next year being held in Paris. In addition to these clinical trials, we were pleased to announce the publication of data on Aramchol mechanism of action in the peer-reviewed journal Hepatology Communications in early October.
The paper imparts that role of Aramchol is that of steatosis and fibrosis in mice, summarizes the work conducted by collaboration of key international basic and clinical finding on Aramchol's mechanism of action. The publication provides further confirmation on Aramchol's dual effect on both steatosis and fibrosis.
Finally, on October 26, we hosted a key opinion leader meeting with investor community in New York. Professor Scott Friedman, MD of the Icahn School of Medicine at Mount Sinai has cut the current treatment landscape and unmet medical need for patient with NASH.
During the meeting, we provided and overview of the scientific personnel and ongoing clinical development programs of Aramchol. We were pleased to see the high interest and attendance by buy side investors, equity research analyst, other industry participants both in the room and on the webcast.
Highlights of our clinical development of Aramchol as a monotherapy, we are closing reviewing the pre-clinical safety and efficacy of other molecules currently under development. We are conducting pre-clinical studies to further explore the potential of complementary mechanism to Aramchol effect on NASH.
I would like to turn the call now over 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 quarter ended September 30, 2017. For more information, please refer to our quarterly results on Form 6-K filed earlier today with the SEC, which among other things provides a summary of such financial results.
For the third quarter of 2017, our net loss totaled $2.8 million, or $0.23 per share, compared with a net loss of $3.8 million, or $0.34 per share, for the corresponding quarter in 2016. We recognized $0.3 million of revenue for the three months ended September 30, 2017, the same as the corresponding period.
The revenue relates to the amortization of the up-front payments under our license agreement with Samil Pharm. Research and development expenses totaled $2.3 million for the third quarter of 2017. This compared with $3.3 million for the first quarter of 2016.
The decrease during the first quarter of 2017 primarily relates to the decrease in expenses related to ARREST trial. Turning now to G&A, our general and administrative expenses for the third quarter totaled $0.7 million, the same as for the corresponding period in 2016.
During August, we completed a registered direct offering and a private placement to existing shareholders and directors with aggregate net proceeds of $2.7 million to the Company.
Our cash balance as of September 30, 2017 which includes cash, cash equivalents and marketable securities totaled $9 million, just slightly below the $9.2 million we reported at the end of last quarter.
We believe that our existing cash balance including the fund raised during the third quarter will be sufficient to maintain our current core operations through 2018. With the completion of our prepared remarks, Allen, Tali, and myself are available to answer the questions.
Operator, please provide instructions for the Q&A portion of our call?.
I just want to take a few minutes and really understand in detail how you are going to get the cash balance to work as long as you are going to – as long as you are projecting? And I wondered if we could just take – sorry, I came into the call a little bit late.
Can we take a little bit of time and just review what you see as a catalyst unfolding over the next 12 months? Thanks..
Thank you, Jason. Thank you for the good two questions. The first let me answer you about the cash balance. As both studies are going to basically end around February 2018, you will see significant decrease in expense – in our expenses.
And hence we – accordingly the $9 million which are – which we have as cash delivery for this will be sufficient through 2018. We are not projecting any other expenses on new clinical trials, which is the most significant expense of a biotechnology company of our size. I hope this clarify this point..
Yes. Of course, I understand, but at some point just link with me kind of the runway and the associated catalyst, because at some point, right you are going to need more capital in order to bring Aramchol all the way to the marketplace. So, help me understand kind of how you see as the CEO the next 12 to 24 months unfolding.
That would be very helpful..
Okay. Great. So, the catalyst, I mean the first catalyst will come in the next quarter with the publication of the ARRIVE study data. As you know, and as I mentioned before, the primary endpoint of this study is almost the same primary endpoint of the ARREST study, i.e. regarding of liver fat content measure by MRI.
Now, with the result of this study, as of course we are as you know, we are a biotechnology company and we evaluate all the time, our need, our financing need and opportunities and we believe that if the market conditions will the right conditions, we will evaluate again the profitability of raising additional funds according to the different conditions.
So, first catalyst is –in the first quarter of 2018 that is the ARRIVE study. The second catalyst is in the second quarter of 2018, the ARREST study, and in between or after this we will have additional publications and additional presentations at the conferences. We are presenting at the end of this year, we are presenting at HEP DART, Dr.
Carol Brosgart, a member of our board will be presenting Galmed at HEP DART conference in Hawaii and next week Dr. Liat Hayardeny our CSO and myself are going to present at the Stifel conference and we are preparing presentations also for EASL and AASLD with the data of the study..
I know that you've been making tremendous effort in business development opportunities and you've been looking at kind of regional partnerships.
Can you talk a little bit about how that effort is going and, with data coming you are going to have a lot of exciting things to talk about with possible partners? What's does the interest level look like? How much are you traveling? Tell us what countries you are travelling to?.
I'm afraid I can neither confirm nor deny any contact or any discussions that we are holding at this stage. One thing that is evident is that transactions are being made based on data. So, whether they come before or after, of course I cannot disclose.
But when we look at the possibilities and we always said so, we are looking both geographical items and global items simultaneously. So, we started with Korea, where we already licensed Aramchol and there may be other transaction before or after data..
And we will move to our next question Yasmeen Rahimi from Ross Capital Partners. Your line is open..
Congratulations on staying on track and a tremendous amount of progress, so we're very excited to see the data. So, a number of questions, the first two are directed to Liat. So can you share with us what the differences are in the ideology between NAFLD that is associated with HIV-associated lipodystrophy.
Where does this NAFLD that actually sits on in typically NASH patients. And then the second question is, you know upon positive data that we anticipate in the first quarter, what do you have next plan be for development? And then the third question is, what do you expect in terms of fat content.
Do you anticipate that baseline levels between the ARRIVE and ARREST study would be different? And then I have one follow-up question, if time permits. Thanks you..
I think it's fair off of me to refer these very good questions to Dr. Tali Gorfine, our CMO..
Okay. So, with respect to NASH in HIV patients, I'm not familiar with histologic differences between the populations.
While the mechanisms and the reasons why HIV patients have a lot of NASH can be related both to the drugs that they are receiving, the viruses that they have been infected with, and the diabetic syndrome that I have which is very difficult to manage. Ultimately NASH is a – has one definition in terms of histology.
Now please bear in mind that this is the first time such a study is being conducted, which looks at PD effect in these patients and looks for it over time. I cannot give you baseline characteristics feeds as the Professor Loomba hand, and they will be reviewed once the study is being completed.
I think it truly interesting and I'm proud that we have been investing time and effort in this specific calculation..
Can you repeat the second question Yasmeen?.
Yes.
The second question was assuming positive data, what would be your development path for this niche indication to go forward? Are you able to comment on that at this point?.
This is a very, very important question. We are now discussing with Professor Loomba and with Carol Brosgart and we have a few ideas that I cannot disclose at this time..
Great. And then one last question, I may.
You have beautifully shown in your last – in the paper that was published in October a mechanistic map for Aramchol which really we have not seen with any other molecules in development, on pathways that is so well defined and showing how Aramchol's anti-oxidative pathways has a tremendous effect of anti-fibrosis.
So, can you maybe talk to us a little bit about the rough pathway in NAFLD associated and the HIV-associated lipodystrophy?.
Yasmeen, you are asking about same mechanism. The mechanisms that is describing NAFLD and NASH for HIV patients and regular population non-HIV patients, the mechanism are exactly the same.
So, Gorfine just alluded the cause for NAFLD or NASH in HIV patients is sometimes different – relation, but once the definition is NASH positive or NAFLD positive, then it's actually the same and the disease is [indiscernible] as the NASH in patients which are non-HIV starts of the [indiscernible], the ballooning to fibrosis and therefore we expect that regulation of SCD1 which has previously described for us atrial fibrillations or steady acid oxidation will be exactly the same and we will see the down regulation in fatty acid in the liver the same as in normal population and the same as we showed in the Phase IIa.
I guess we will know at the end of next quarter..
And our next question comes from Ed Arce from H.C. Wainwright. Your line is open..
Let me add my congratulations on the progress especially, the paper, [indiscernible] long call that was recently published from data back in the spring. My only question really was if you could elaborate perhaps a bit further on the data that you expect to present next spring at EEASL? Thanks you..
We are going to present the data on ARRIVE that will – we will have the data next quarter as we said. And it will be presented – we will submit it for the late break news for EEASL. So, we're going to have the data baseline characteristics and results of the three months for treatment of 600 milligram per patient with the placebo.
We are submitting another abstract on the role of Aramchol on fibrosis direct if that's on fibrosis. We have new emerging data on the proliferation and collagen reduction from hepatic store cells which bring forth our direct effect on fibrosis. This is not – this is going to submit as planned deadline for EEASL November 15..
[Operator Instructions] I would now like to turn the conference call back over Allen Baharaff for any closing remarks..
So thank you all for joining the call today. As always, we are very open and if you have any questions, please do not hesitate to contact us at all times.
We'll be presenting at EEASL next week, so we'll be very happy to meet if you would like to come to the conference or meet outside the conference, be very happy to do so, and looking forward, for the next point, the next quarter..
That concludes today's conference. Thank you for your participation. You may now disconnect..