SAN DIEGO, CA--(Marketwire - March 25, 2013) - Vital Therapies, Inc., a development stage biotechnology company focused on developing the first bio-artificial liver for life-threatening acute liver failure, today announced an increase in the total amount of its previously announced multi-stage financing to approximately $100 million and a supplemental closing of its Senior Preferred by certain new investors. Since the initial closing in September 2012, more than $30 million has been invested under the multi-stage financing, with up to approximately $70 million remaining to be funded at future scheduled closings. The next closing is scheduled for July, which would bring the total amount invested under the multi-stage financing to more than $50 million.
The company has also announced the election of Muneer A. Satter to its Board of Directors where he will serve as Co-Chairman and Lead Director. Mr. Satter is an experienced life sciences investor who manages Satter Investment Management, a Chicago-based private investment firm, and the Satter Foundation, a private family foundation. Mr. Satter retired in 2012 after sixteen years as a partner at Goldman Sachs where he spent his career in the Merchant Banking Division. As Global Head of Goldman Sachs Mezzanine Group, Mr. Satter raised and managed more than $30 billion of investments. Mr. Satter received a B.A. from Northwestern University, and a JD/MBA from Harvard Law School and Harvard Business School. Mr. Satter is Vice Chairman of the Goldman Sachs Foundation and on the Board and Executive Committee of The Nature Conservancy.
The multi-stage financing is designed to fund three phase 3 trials of the company's investigational bio-artificial liver therapy, ELAD®, in two specific forms of acute liver failure. The three, randomized, controlled, open-label trials are expected to enroll 375 subjects in the USA, EU and Australia, making them the largest such trials done in the field. The company has been working with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of these trials and has received written guidance from both regulatory agencies.
The protocol for the first trial, in acute alcoholic hepatitis and alcohol-induced liver decompensation, is now open for enrollment at several U.S. sites. The protocols for the second and third trials, in subjects with acute alcoholic hepatitis who fail steroid therapy and subjects with fulminant hepatic failure, are complete, and clinical sites are being recruited with enrollment expected later this year. Overall, more than 40 clinical sites in USA, EU and Australia are expected to participate. The trials are expected to be complete by the end of 2015.
If results are successful and the marketing application is granted priority review and approved in the USA and EU, market launch could occur on both continents before the end of 2016. Vital Therapies retains all rights to ELAD and has no corporate partners.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a private development-stage biotechnology company based in San Diego, California. The company is developing ELAD, an investigational extracorporeal liver support system which has been studied in seven clinical trials in US, EU and Asia. Moreover, a US/EU phase 3 trial plan to support potential BLA and MAA marketing approval has received written guidance from FDA and EMA. The first protocol under this plan, for a survival trial in acute alcoholic hepatitis and alcohol-induced liver decompensation, has been allowed by FDA and is open for enrollment.
ELAD represents the first developmental stage, human allogeneic cellular therapy for life-threatening acute liver failure. The system comprises a bedside system whose central component is four cartridges containing 440 grams of immortalized human hepatoblastoma cells and 32,000 hollow fibers. The patient's plasma flows inside of the hollow fibers to allow two-way transfer of metabolites. The system has been shown to process toxins, and synthesize proteins and metabolites in ways that mimic components of normal human liver function. The ELAD cell cartridges are produced at VTI's GMP-compliant facility in San Diego, California.
ELAD is a trademark of Vital Therapies, Inc.
This press release may contain forward-looking statements, including but not limited to statements regarding anticipated future closings of the staged financing, the success of our planned phase 3 trials and ELAD's market launch. These statements relate to future events and are subject to risks, uncertainties and assumptions about Vital Therapies, Inc. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement. We do not undertake to update any forward-looking statements.