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Immunic, Inc. (IMUX)

Q1 2018 Earnings Call· Tue, May 8, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Vital Therapies' First Quarter 2018 Financial Results. [Operator Instructions] I would now like to introduce our host for today's conference, Mr. Al Kildani. Please go ahead sir.

Al Kildani

Analyst

Thank you, George. Good afternoon my name is Al Kildani, Vice President of Investor Relations and Business Development with Vital Therapies. 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, 2018. On today's call are several members of the Vital Therapies senior management team, including Russell Cox, Chief Executive Officer; Dr. Duane Nash, President; Rob Ashley, Executive Vice President and Chief Technical Officer; Dr. Jan Stange, Chief Medical Officer; and Mike Swanson, Executive Vice President and Chief Financial 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 and conduct of our clinical trials, event rates, which may vary from projections; future clinical trial results, and whether such results will support any regulatory submission or approval; our plans for and the timing of certain development goals including regulatory submissions and approval strategies; our projected cash runway; potential product indications and market sizes; and plans and objectives of management for future clinical and market 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 risks that our clinical trials program is delayed or is ultimately unsuccessful; the risk that our biologics license application or BLA takes longer or is more expensive to complete; or that we need additional financing sooner than anticipated. Please note that these forward-looking statements reflect our management's 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 filed earlier today 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 or furnishes 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 Russell Cox, Vital Therapies' Chief Executive Officer.

Russell Cox

Analyst

Good afternoon, everyone, and welcome to our first quarter 2018 update call. On today's call, I'll begin with some introductory comments, provide an update on the status of the VTL-308 trial, discuss some of the recent activities on the publications front and then I'll ask Mike to review our first quarter financial results. And finally, we’ll open up the call for Q&A. I'm pleased to update you on the significant progress we're making here at Vital Therapies. This is my second call as CEO and with four months now under my belt I cannot be more excited about my decision to join Vital. In case, you are new to the Vital Therapies story, we are a late stage biotechnology company developing ELAD, a cell-based therapy with the potential to save lives of people suffering from acute forms of liver failure. With cell therapies emerging at the forefront of the biopharmaceutical innovation, we have a unique and exciting opportunity to put our stamp on this space. We believe, we're in the right place, at the right time and I'm thrilled to lead this Company as we enter what we hope is the homestretch of the clinical development. I will now turn to status of our 308 Phase 3 clinical trial. We're pleased to announce that we completed enrollment at the end of March, with a total of 151 subjects. This included 78 subjects in the ELAD treated arm and 73 in the control arm. As a reminder, the study was designed to achieve a targeted overall blended total of approximately 55 deaths at time of data lock. And the ability to enroll additional subjects if necessary. As we stated in our last call, independent statistical experts evaluated the blended event rate in 308 based on data available through December 31, 2017…

Mike Swanson

Analyst

Thank you Russ. We ended the first quarter with cash and cash equivalents of $43.6 million. Our average monthly cash usage for operations and capital expenditures during the first quarter was approximately $4.4 million. The increase in average monthly cash usage as compared to prior periods is due to the payment of incentive compensation in the first quarter. Our use of cash will continue to vary primarily on the timing of expenditures related to our VTL-308 clinical trial and on the timing of expenditures in anticipation of a future BLA for ELAD. Based on our current level of operations limited BLA and commercial related expenditures our quarter-end cash balance would fund our operations through the first quarter of 2019. Summarizing our results for the quarter ended March 31, 2018, the Company reported a net loss of $14.4 million or a $0.34 basic and diluted loss per share. This included non-cash expenditures for stock-based compensation, depreciation and amortization totaling $1.9 million. This compared to a net loss of $12.6 million or a $0.39 basic and diluted loss per share for the first quarter of 2017, which included $1.6 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. With that I’ll turn it back over to you Russ.

Russell Cox

Analyst

Thank you. Mike. Although 308 enrollment has completed, we have much to look forward to between now and the release of our top line results. On May 24, we will hold an Analyst R&D Day, that should be a great opportunity for those interested in a more detailed understanding of SAH, and how we believe the mechanism of action of ELAD may impact the pathophysiology of the disease. We are transitioning, our preparations for submitting the BLA for ELAD, which we hope to do sometime in 2019 assuming positive trial results. We’re also beginning to lay the groundwork for a successful commercial launch in the event of positive data and regulatory approval by leveraging our learnings from the conduct of the 308 clinical trial. And of course, sometime in the third quarter probably September, we expect to announce top line results from 308. I'd like to open up the call for questions. In addition to Mike joining me for the Q&A portion of our call are Dr. Duane Nash, President; Rob Ashley, Executive Vice President and Chief Technical Officer; Dr. Jan Stange, Chief Medical Officer. Operator can you please provide instructions and open up the call for questions.

Q - Laura Chico

Analyst

Thanks, very much for taking the question and good afternoon. I guess, Russell as you mentioned, you're transitioning the focus towards the BLA. I'm wondering if you could elaborate a little bit in terms of what are some of the activities that you are considering the highest priority at this point. And then as a quick follow up, I'm just curious, are you keeping sites open at this point or is there any potential for you to have any expanded access to ELAD at this stage.

Russell Cox

Analyst

Thanks Laura for the question. So in terms of what are the priorities on the BLA, I think the first thing for us to make sure that we had a great handle around was exactly what are those things that we can do in parallel path and what is on critical path. So, we have probably three or four things that we would identify as being on critical path that are getting the largest focus at this point in time. As you can imagine those a lot of those are sort of on the manufacturing front, but having said that there's nothing in the BLA, that is unique or different that would allow us to – have to look at this different than any other BLA filing. And then in terms of keeping sites open, we obviously are doing data clean-up and spending time in the sites doing that. But we are – obvious closed for enrollment. And then in terms of expanded access, I think that as we look at all the different things that we would like to do in terms of preparing for commercialization, there is some consideration to whether that might be something that we could do down the road but nothing that we're willing to commit to at this time.

Laura Chico

Analyst

Okay, understood, and I guess one quick follow-up, you mentioned the investor event that, you'll be hosting in a couple weeks. What are the key focus there? It sounded like there would be a little bit more detail around perhaps the disease state itself but also towards the mechanistic application of ELAD. Just curious, if there's anything else in terms of highlights that we should be expecting.

Russell Cox

Analyst

Yes, I think you called it correctly. I mean clear emphasis on the science around what we have learned from MOA perspective and I think you’ll find that very interesting. In addition you're going to get a chance to hear from clinicians who are in the field and who are actually familiar with ELAD and can kind of give a flavor for severe alcoholic hepatitis and what that actually looks like. So, I think that will be a good learning.

Laura Chico

Analyst

Thanks very much.

Russell Cox

Analyst

You bet.

Operator

Operator

And our next question comes from Jonathan Aschoff [National Securities] Your line is now open.

Jonathan Aschoff

Analyst

Thanks, hello guys. I was just curious, were the patients assessed for how well they fit the entry criteria, that was at the clinical trial site or at the doctor site where they originally presented.

Russell Cox

Analyst

Yes. So let me let me turn that question over to Rob. He can probably give you a little bit more granularity on exactly how we did that.

Rob Ashley

Analyst

So the specific characteristics of the patient that enabled them to be enrolled were assessed at the site where the treatment was being planned to take place. However, there was clearly a review and a discussion which took place between the investigator and the referring site as to the likelihood that somebody would be eligible once referred but the final determination of eligibility was carried out at the treatment site immediately prior to randomization. Jan, I don’t know whether you have something to add to that.

Jan Stange

Analyst

Yes. So the final determination actually did happen at the trial site. And then the team of Chief Medical Officer, who would review the charts and make sure all the criteria are met, there was no waiving or anything.

Jonathan Aschoff

Analyst

Okay, thanks. I was just making sure that was the answer. So it didn't really matter how long it took them to go from the site of original presentation to the treatment site, which I mean, clearly sounds like that didn't matter because you assessed them at the site right before treatment.

Russell Cox

Analyst

Yes, usually that would happen in a quite short time so they didn’t stay around for one or two months at the referring site, if they were meeting the criteria, they were pretty fast at the trial site.

Jonathan Aschoff

Analyst

Okay, just because that time lapse was a problem, was one of the 208 problems. But thank you very much guys.

Russell Cox

Analyst

Hey, thanks Jonathan. Maybe Duane can add something to that as well.

Duane Nash

Analyst

Yes, Jonathan. So to clarify, the baseline characteristics that are listed in the press release, those were as of time of randomization. And so at that point, they're already in the trial site at the hospital enrolled and they had to actually meet the criteria at time of randomization. So you can imagine them referring hospital at that point, they will look like alcoholic hepatitis but the time we actually or the time the site actually pulls the trigger is when they have to meet all the criteria. They have to meet them all at the same time and that’s those are the numbers that we publish as baseline characteristics. Does that make sense?

Jonathan Aschoff

Analyst

Absolutely. Thanks guys. I’ll see you in a couple weeks.

Russell Cox

Analyst

Sounds good.

Operator

Operator

I am showing no further questions at this time. I would like to turn the call back over to Mr. Kildani for closing remarks.