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Immunic, Inc. (IMUX)

Q3 2015 Earnings Call· Thu, Nov 5, 2015

$10.55

+5.66%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Vital Therapies’ Third Quarter 2015 Financial Results Call. At this time, all participants on the phone lines have been placed on mute. Later we will conduct a question-and-answer session. [Operator Instructions] Please do note, today’s program is being recorded. I would like now introduce your host Al Kildani, Vice President of Investor Relations and Business Development. Please go ahead.

Al Kildani

Analyst

Thank you, [Rowan]. Good afternoon. My name is Al Kildani, 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 earnings for the third quarter ended September 30, 2015. On today's call are several members of Vital Therapies' senior management team, including Dr. Terry Winters, Co-Chairman and Chief Executive Officer; Mike Swanson, Chief Financial Officer; Dr. Duane Nash, Executive Vice President and Chief Business Officer; Rob Ashley, 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 and conduct of our clinical trial programs, future clinical trial results, the timing of certain development goals, including regulatory filing, our projected cash runway 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 ultimately unsuccessful. Please note that these forward-looking statements reflect our management's views only as of today's date and we disclaim any obligations, update any forward-looking statements expect as required by law. Please refer to our SEC filings for a more detailed discussion of the risk factors that could cause actual events or results to differ materially. Vital Therapies property makes available on its website reports that the Company files or furnishes with the SEC, corporate governance information, press releases and other posters and presentations. A replay of this call will be available on our website later today. I would now like to introduce Dr. Terry Winters, Vital Therapies' Co-Chairman and CEO.

Terence Winters

Analyst

Thank you, Al. Good afternoon everyone and welcome to our third quarter 2015 update call. First, a brief summary of the company for those of you who may be new to our story. We're developing ELAD, an extracorporeal, human allogeneic cellular therapy which could improve survival in liver failure. ELAD is a phase three clinical trial stage and has orphan drug designation in the United States and the EU. Assuming successful clinical results in the future, we plan to seek regulatory approval and commercialize ELAD directly in most major markets of the world. The agenda for today's call will be to review key developments, including; number one, actions taken since the announcement of results from VTI-208 Phase III clinical trial and alcohol-induced liver decomposition or AILD subjects. Two, our plans to move forward with the purpose new Phase III trial [to be named] VTL-308, including a regulatory update and anticipated milestones. Three our upcoming late break of presentation of the VTI-208 results at the American Association for the Study of Liver Disease or ASSLD meeting later this month as well as a poster presentation expanding on our work regarding ELAD’s potential mechanism of action. Four measures taken to strengthen our financial condition including the recent financing and finally the summary of our financial results for the third quarter ended September 30, 2015. After this, we will open up the call for Q&A. I would like to begin with the summary of our activities since August 21 announcement of the topline results of our VTI-208 Phase III clinical trial, which failed to achieve its primary or secondary endpoints. Since then we have conducted an extensive review of the VTI-208 data and it appears that reduced ELAD tolerability in subjects with high Model of End-Stage Liver Disease, or MELD, scores, exacerbated in…

Michael Swanson

Analyst

Thanks Terry, and good afternoon. We ended September 30, 2015 with cash and cash equivalents of $59.8 million and as Terry just mentioned we received $32.4 million and net proceeds from our follow-on offering in late October. Our average monthly cash usage for operations and capital expenditures during the first nine months of the year was approximately $4.7 million. Assuming we limit our focus principally to the VTL-308 clinical trial, we expect to be able to get our average monthly cash usage to drop by over third as a result of the workforce reduction and the discontinuance of our VTI-210 and VTI-212 clinical trials. Our use of cash will change based primarily on the timing and enrollment of the VTL-308 trial. Summarizing our results for the quarter ended September 30, 2015, the company reported a net loss of $12.3 million including approximately $900,000 in severance charges related to the workforce reduction. Non-cash expenses for stock-based compensation, depreciation and amortization totaled $1.5 million in the third quarter of 2015, this compared to a net loss of $12.8 million for the corresponding period in 2014 including non-cash expenses of $1 million for stock-based compensation, depreciation and amortization. For more details on these financial results please refer to our press release issued earlier today. With that I’d like to turn it back to Terry.

Terence Winters

Analyst

Thank you, Mike. Before we take your questions I would like to summarize our key upcoming milestones. Firstly our presentation of the VTI-208 data at the late breaking session of the AASLD meeting on November 16, together with a poster presentation on the further findings regarding ELAD's mechanism of action at another session on November 17. Second FDA feedback on our briefing document including the proposed trial protocol for VTL-308 anticipated by year-end. Third the first subject enrolled in VTL-308 anticipated in the first half of 2016. Finally, additional presentations on ELAD's mechanism of action including analysis of samples from the VTI-208 should be at medical meetings in 2016. So now I would like to open up the call to your questions. In addition to Mike Swanson joining me for the Q&A portion of our call are Dr. Duane Nash, Executive Vice President and Chief Business Officer, Rob Ashley, Executive Vice President and Chief Technical Officer and Dr. Jan Stange our Chief Medical Officer. Operator can you please provide instructions and open up the call for questions.

Operator

Operator

Of course. [Operator Instructions] Our first question comes from the line of Matt Keller from Credit Suisse. Your line is open. Your question please.

Matthew Keller

Analyst

Hey guys thanks for taking the question. I guess is first getting back to your comments on the FDA potentially having comments on trial design and statistical plan is there anything specific you think the FDA might want to change or is that more of just a general restatement that put in there?

Terence Winters

Analyst

No, Matt it’s really a general risk statement so just can’t ever predict what will come out the FDA as I am sure you know.

Matthew Keller

Analyst

Got and I know you submitted fairly recently but is there been how is the dialogue been thus far on this FDA given you anything at all?

Terence Winters

Analyst

No, not a present

Matthew Keller

Analyst

Okay perfect and then just lastly when will you start enrolling in Europe and is there expectation that this 308 trial gets you approval in Europe?

Terence Winters

Analyst

So when was start enrolling in Europe I hope is going to early in 2016, but I think you know that it's some a lot of bureaucracy both in Europe and the U.S. to get these trials to the enrollment stage and touch your second question yes we would expect the trial to send a good chance of getting us approval in Europe.

Matthew Keller

Analyst

Great thanks for taking my questions.

Terence Winters

Analyst

Thank you, Matt.

Operator

Operator

Thank you. [Operator Instructions] I am showing no further questions. I would like to turn the call back over to management for any additional remarks.

Terence Winters

Analyst

Well, thank you, thanks to everybody for listening we look forward to end of the call and the New Year. Thank you everybody. Bye.

Operator

Operator

Ladies and gentlemen, thank you very much for your participation. This does conclude the program. You may now disconnect.