Immunic, Inc.
Q1 2017 Earnings Call Transcript

Published: 11 May 2017

[Operator:]

Good day ladies and gentlemen and thank you for standing by. Welcome to Vital Therapies' First Quarter 2017 Financial Results. At this time all participants are in a listen only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder this conference call is being recorded. I now like to introduce your host for today's presentation, Mr. Al Kildani. Sir, please begin.

[Al Kildani:]

Thank you, Howard. Good afternoon, my name is Al killed on the Vice President of Investor Relations and Business Development. Thank you for joining Vital Therapies' management team on our conference call to discuss the company's operations update and results for the first quarter ended March 31 2017. On today's call are several members of Vital Therapies senior management team including Dr. Terry Winters, Cochairman and Chief Executive Officer; Dr. Duane Nash, President; Mike Swanson, Executive Vice President and Chief Financial Officer; Rob Ashli, Executive Vice President and Chief Technical Officer and Dr. Jan Stange Chief Medical Officer. Before we begin we'd like to remind you that some of the statements we make today will include forward-looking statements such as statements related to the timing, conduct and enrollment of our clinical trials, future clinical trial results, the timing of certain development goals including regulatory filings and FDA approval process, possible mechanism of action of ELAD, our projected cash runway, our ability to scale up our process and to increase our manufacturing capacity to generate higher response to demand, and plans and objectives of management for future operations. Forward looking statements are subject to a number of risks and uncertainties that could cause actual events or results to differ materially, including the risk that our clinical trials program is delayed or is ultimately unsuccessful. The risks that are BLA takes longer to complete or that we need additional financing sooner than anticipated. Please note that these forward looking statements reflect our management views only as of today's date and we disclaim any obligation to update any forward looking statements except as required by law. Please refer to our SEC filings and our most recent 10-Q for a discussion of the risk factors that could cause actual events or results to differ materially. Vital Therapies Promptly makes available on its website reports that the company files with for furnishings to the SEC, corporate governance information, press releases and other posters and presentations. A replay of this call will also be available on our website later today. We encourage investors to use our Investor Relations website as a way of easily finding information about Vital Therapies. I would now like to introduce Dr. Terry Winters, Vital Therapies' Cochairman and CEO.

[Terence Winters:]

Good afternoon everyone and welcome to our first quarter 27 update call, 2017 update call. Before I start my apologies for my voice I'm recovering from a nasty cold but I assure you that it is the same old Terry. So let's begin with our usual summary of the company. And for those of you who may be new to the story. We are developing ELAD, an extracorporeal human allogeneic cellular therapy, which could improve survival in acute forms of liver failure. ELAD is at the Phase III clinical trial stage and has Orphan Drug Designation in the U.S. and EU. We are currently enrolling subjects in VTL-308, a randomized controlled trial in severe acute alcoholic hepatitis, topline data are anticipated around mid-2018. Assuming successful clinical results in the future, we plan to seek regulatory approval and to commercialize ELAD directly in most major markets of the world. The agenda for today's call is as follows

[Michael Swanson:]

Thanks Terry. We ended the first quarter with cash and cash equivalents of $86.6 million. As previously noted, this includes the proceeds of $37.8 million of underwriting discounts and commission from our March common stock offering, in which we sold a total of 10.1 million shares at $4 per share. Summarizing the results for the quarter ended March 31, 2017, the company reported a net loss of $12.6 million or a $0.39 basic and diluted loss per share. This included non-cash expenses for stock based compensation, depreciation and amortization totaling $1.6 million dollars in the first quarter of 2017, this compared to a net loss of $9.6 billion dollars or a $0.31 basic and diluted loss per share for the first quarter of 2016, which included $1.5 million for the same non-cash expenses. For more details on these financial results, please refer to our press release and our quarterly report on Form 10-Q. And with that Terry, I'll turn it back over to you.

[Terence Winters:]

Thank you Mike. I would like to open up the code to your questions. In addition to Mike, joining me for this Q and A portion of our call are Duane Nash, our President; Robert Ashley Executive V.P. and Chief Technical Officer and Dr. Jan Stange, our Chief Medical Officer. So operator, can you please provide instructions and open up the call for questions?

[Operator:]

Yes sir. [Operator Instructions] Our first question or comment comes from the line of Katherine Xu from William Blair. Your line is open.

[Katherine Xu:]

Hi, good afternoon. So Terry, in your prepared remarks you said the current capacity could support $100 millions of dollars of sales at currently anticipated pricing. Can you elaborate a little bit on that pricing assumptions?

[Terence Winters:]

I think Katherine what we've said is that the pricing per treatment will be between $150,000 and $225,000 per set of cartridges. And that we intend to sell the cartridges for that for that price. And basically we will decide what to do with the --with the bedside unit which is not a major component of cost. So that's where we're at on pricing. And of course I think you know we've been working with some key people on follow issue of pricing and reimbursement.

[Michael Swanson:]

So if I could just make a quick comment. So our pricing comes from a group of expert pricing specialists. And although we ourselves have really applying where the price would be? Their recommendation was between 150 and 275 not 225.

[Katherine Xu:]

Great. And then I'm just wondering for the 308 study, so we're of curse expecting a placebo from how you read at 50 %. So I'm just wondering how confident you are in that number of course all with the observation that you have from showing , but do you have any other supporting evidence to sort of put higher covenants into or around that number?

[Terence Winters:]

Rob, can you comment on that please?

[Robert Ashley:]

Sure, hi Katherine. So yeah, of course these assumptions have critical to our statistical plan. And as you point out, 180 days survival of a 6 month survival that we saw in this subgroup from my prior study suggested that the control mortality rate would be around 50% or so or even a little more. So there is a couple of pieces of information which I think help us put some confidence around that. The first is that as we've reported towards the beginning of this study, we continue to see baseline characteristics of the subjects coming into this study which are entirely consistent with the subgroup which we analyzed at VTI-208. So we have the amounts of around 25 and average age is of around 39 or 40. So that's --that's very encouraging, if this population perform type of population. And then we've also been fortunate enough to be able to interrogate the scope of study the stuff the study was a large more than a 1000 patient study, which was carried out in the UK to look at the efficacy of steroids or Pentoxifylline and alcoholic hepatitis ultimately draw the conclusion. But whereas there was some evidence that shows steroid efficacy of 28 days, there was no evidence for any efficacy for steroids at 90 days. So these subjects remain without any treatment options. A little less than a quarter of the subjects which we've enrolled in that study have the same characteristics as VTL-308 subjects. Although the mean melt for those subjects turned out to be quite a lot less than they we're getting in outpatients, I don't know whether that's reflective of different healthcare systems and different types of populations and so on. And how many metals in are equivalent population is about 21. So the expected mortality in that group would have been about 30% to show you enough it was in the placebo group was around about 30% without main males of around 25 or so than our expected mortality would be closer to 50%. So everything that we see regarding the characteristics of a subject population are comparing with other populations which people are presenting at the meetings suggests that we're going to be in the right ball park with this mean merit and of course, enriching the population with a bilirubin have greater than 16 makes specially to coming in. So I'm as confident as I can be that the control population will behave the same way to control population behaved in our 208 steady.

[Katherine Xu:]

Great. Thank you.

[Robert Ashley:]

Welcome.

[Operator:]

Thank you. Next question or comment from the line of Jonathan Ashcroft from OPU National Capital [ph]. Your line is open

[Unidentified Analyst:]

Yes, Thank you very much guys. I was wondering you had about 9 patients per month from December to March and March to May more like 7 patients per month, certainly with no fewer clinical flights so. So I was wondering how are you reconciling that?

[Terence Winters:]

Well as we said before, Jonathan, enrollment some jumps around March-April are key months for medical meetings. But I always joke with people that patients like London buses you wait for an hour at the bus stop, none come along and then all of a sudden 4 or 5 coming together. So we are going to get bouncing up and down in terms of the monthly rate but let me ask Dr. Stange to comment.

[Jan Stange:]

The only thing that I would like to add is that April was better than March. And we have the variation of enrollment per month in the last study 2-8 [ph], sometimes 5 patients per month sometimes 16 patients per month sometimes 3 a day. There is just not parametric statistics. This is very nonparametric and I would not see a trend towards this enrollment. No.

[Unidentified Analyst:]

OK. I'm wondering, are you truly getting those early enough stage patients that fits well within the entry parameter thresholds or are you having to enroll patients that sort of fit the entry criteria very often let's say towards the very inevitably acceptable ranges of those different parameters?

[Robert Ashley:]

Let me jump in before Jan jumps in. As you all know Jan is from East Germany and I regard him as my East German policeman on the enrollment. And the answer is very strong, we do not accept patients into the trial that do not fit the enrollment criteria, but comment, but let me make the statement. I don't have anything to do with the East German police. But the answer is absolutely yes. I mean that is the reason why for enrollment we have to do a lot of activities to maintain our target. And the reason for that really is that we are 100% sticking to our entry criteria which are based on our data that we learn 208. And we don't see that they end up in one spectrum more it's all over the place, but they are clearly and comfortably within our new specified criteria.

[Jan Stange:]

Yeah. And I think we can say we have never enrolled a patient that is outside of the criteria. No.

[Unidentified Analyst:]

Yeah go ahead --.

[Jan Stange:]

As I mentioned earlier there is the mean melody is 25, which is absolutely what on we had in the prior study. And that means that --also is around about 25 makes the deciliter. So it's not like we're enrolling patients to a '16 or '17 makes the deciliter. We're right some of them, where we hope to be with this patient population which is really a testament to everybody's efforts.

[Unidentified Analyst:]

Okay, yeah. I mean in terms of those who refer to you, roughly how many, what percent as there are 67 enrolled is what percent of how many were overall referred to by people who called these patients fit your criteria?

[Terence Winters:]

Are you referred to the prescreen I would say and again this is also very noisy. We have some sites that screen 30 patients 40 patients a month and find 1. And then we are sites that prescreen 10 and find 3. So it's very noisy. But in general, I would say we look at 10 to identify 1, that's the all over statistics as of now. However if we continue to educate our trial sites and also they are referring network outside the trial sites with very generous what kind of subjects they should consider for prescreen. So there we learned that some of the refereeing sites in the past who even put patients on the prescreen that had liver cancer or active Hepatitis B as a reason for jaundice to put that on the prescreen and we are educating them that we don't need to know. What we need to know is alcoholic hepatitis, yes or no and what are the criteria there. Jon to answer your question, as of now the statistics are approximately 600 plus prescreen and we are 67. That might change over time since we are in an active education process.

[Unidentified Analyst:]

Okay thanks. And then the last quick one I think is, what's going to be the R&D trend at least if you will from the 1Q spend over the rest of the year?

[Terence Winters:]

The spend expense right?

[Unidentified Analyst:]

Yes right.

[Terence Winters:]

My initial reaction would be that it would be identical. Is that reasonable Mike?

[Michael Swanson:]

Yes. Really now I think that moves around the R&D spend significantly is the timing of patient enrollment. As we've just been discussing there are going to be fluctuations from month-to-month and quarter-to-quarter. And that's the biggest driver of our costs right now.

[Unidentified Analyst:]

Okay great. Thank you very much for all the answers.

[Terence Winters:]

Thank you Jonathan.

[Operator:]

Thank you. [Operator Instructions] I'm showing no additional audio questions at this time. I'd like to turn the conference back over to management for any closing remarks.

[Al Kildani:]

I'd just like to thank everybody for attending the conference call today. And we'll do it again for the second quarter results I believe in early August. Is that right? Yes. Thanks everybody. Bye.

[Operator:]

Ladies and gentlemen thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone have a wonderful day.