Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, Peter Silva, Glenn Rossman, Kevin Jackson, Michael Jannery

News Feed Item

Vital Therapies Announces First Quarter 2014 Financial Results and Provides Operational Update

SAN DIEGO, CA -- (Marketwired) -- 05/28/14 -- Vital Therapies, Inc. (NASDAQ: VTL), a biotherapeutic company developing a cell-based therapy targeting the treatment of acute liver failure, today announced financial results for the quarter ended March 31, 2014, and provided an update on recent operations.

"In 2014, we have made significant progress in two key areas," said Terry Winters, Ph.D., Chief Executive Officer and Co-Chairman of Vital Therapies. "We not only completed our initial public offering, but we also surpassed the mid-point in planned enrollment of our VTI-208 Phase 3 clinical trial."

Recent Highlights

  • Completed an initial public offering, or IPO, raising aggregate gross proceeds of $62.1 million, before deducting underwriting discounts and other offering expenses.
  • Enrolled 111 subjects as of May 27, 2014 in VTI-208, a phase 3 randomized, controlled trial, evaluating the ELAD® System, the company's experimental bio-artificial liver, in 200 subjects with alcohol-induced liver decompensation.
  • Opened four sites for enrollment as of May 27, 2014 in VTI-210, a Phase 3 randomized, controlled clinical trial for subjects with severe acute alcoholic hepatitis.

First Quarter 2014 Financial Results

Vital Therapies reported a net loss for the quarter ended March 31, 2014 of $10.7 million and, after the accretion of redemption value and deemed dividends on our preferred stock, a net loss attributable to our common stockholders of $13.8 million. This compares to a net loss of $9.4 million and a net loss attributable to common stockholders of $10.3 million for the quarter ended March 31, 2013. This resulted in a net loss attributable to common stockholders of $24.49 per share for the three months ended March 31, 2014, as compared to a net loss of $22.11 per share for the corresponding period in 2013, on both a basic and fully diluted basis. These per share figures are based on weighted-average common shares outstanding of 564,186 shares and 467,167 shares, respectively. These weighted averages do not reflect the preferred stock that was converted into common stock in conjunction with the IPO or the common stock issued in the IPO. As of May 27, 2014, the company had 21,790,745 shares of common stock outstanding.

Total operating expenses for the first three months of 2014 were $11.9 million compared to $4.9 million for the comparable period of 2013. Research and development expenses were $9.2 million for the first three months of 2014, as compared to $3.4 million for the same period of 2013. The increase in research and development costs is primarily related to increased Phase 3 trial activity in our VTI-208 clinical trial and related preparations for our VTI-210 and VTI-212 clinical trials. General and administrative expenses were $2.7 million for the first three months of 2014 compared to $1.5 million for the comparable period of 2013 as costs for salaries, stock-based compensation and consulting and professional services increased in 2014.

Cash and cash equivalents at March 31, 2014, totaled $46.0 million compared to $38.2 million at December 31, 2013. In April 2014, the Company raised an additional $54.0 million of gross proceeds from selling 4,500,000 shares at $12.00 per share in our IPO, and an additional $8.1 million in May 2014 from the sale of 675,000 shares at $12.00 share on the full exercise of the underwriters' overallotment. In total, we received net proceeds of $52.4 million after deducting underwriting discounts and other offering expenses.

Operational Update

As of May 27, 2014, the company had enrolled 111 subjects in VTI-208, a Phase 3 randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. There are 50 clinical sites in the United States, Europe and Australia currently open for enrollment. The company continues to anticipate the release of preliminary data from VTI-208 in the first half of 2015.

Additionally, as of May 27, 2014, the company had four sites open for enrollment in VTI-210, a Phase 3 randomized, controlled clinical trial in 120 subjects with severe acute alcoholic hepatitis. The company also expects to initiate enrollment in the second half of 2014 for VTI-212, a Phase 2/3 clinical program in subjects with either fulminant hepatic failure or surgery-induced liver failure. Preliminary data for VTI-210 and VTI-212 are anticipated to be released in 2015 or 2016.

About Vital Therapies, Inc.

Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting treatment of acute liver failure. The company's lead product candidate, the ELAD System, is an extracorporeal bio-artificial liver therapy currently in Phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies® and ELAD® are trademarks of Vital Therapies, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning our future financial performance, our ability to undertake certain development activities such as clinical trial enrollment, the conduct of our clinical trials and the timing of data release and accomplishment of certain development goals. Forward-looking statements are based on management's current, preliminary expectations and are subject to various risks and uncertainties. These forward-looking statements do not constitute guarantees of future performance. Risks and uncertainties with respect to our clinical trials include but are not limited to the successful opening and the continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, unexpected adverse events or safety issues and the sufficiency of funding. These and other risks regarding our financial position and research and development programs are described in detail in our SEC filings, including the Registration Statement on Form S-1 which was declared effective on April 16, 2014. Vital Therapies, Inc. does not undertake to update any forward-looking statements.


                           Vital Therapies, Inc.
                       Selected Financial Information
              Condensed Consolidated Statements of Operations
                         (unaudited, in thousands)

                                                       Three Months
                                                      Ended March 31,
                                               ----------------------------
                                                    2014           2013
                                               -------------  -------------
Operating expenses:
  Research and development                     $       9,219  $       3,432
  General and administrative                           2,657          1,494
                                               -------------  -------------
Total operating expenses                              11,876          4,926
                                               -------------  -------------
Loss from operations                                 (11,876)        (4,926)
Revaluation of future purchase rights
 liabilities and other income (expense), net           1,128         (4,432)
                                               -------------  -------------
Net loss                                             (10,748)        (9,358)
Accretion to redemption value and deemed
 dividend on preferred stock                          (3,070)          (973)
                                               -------------  -------------
Net loss attributable to common stockholders   $     (13,818) $     (10,331)
                                               =============  =============

Net loss per share attributable to common
 stockholders, basic and diluted               $      (24.49) $      (22.11)
                                               =============  =============
Weighted-average common shares outstanding,
 basic and diluted                                   564,186        467,167
                                               =============  =============



                           Vital Therapies, Inc.
                       Selected Financial Information
                   Condensed Consolidated Balance Sheets
                         (unaudited, in thousands)

                                                 March 31,     December 31,
                                                    2014           2013
                                               -------------  -------------

Cash and cash equivalents                      $      46,041  $      38,186
Other current assets                                   6,223          5,669
Property and equipment, net                            3,081          2,467
Other assets                                             263            263
                                               -------------  -------------
  Total assets                                 $      55,608  $      46,585
                                               =============  =============

Accounts payable, accrued expenses and other
 current liabilities                           $       7,161  $       4,846
Future purchase rights liabilities                     1,472          2,600
Long-term liabilities                                    279            321
Convertible preferred stock                          104,712         83,475
Stockholders' deficit                                (58,016)       (44,657)
                                               -------------  -------------
  Total liabilities and stockholders' deficit  $      55,608  $      46,585
                                               =============  =============

Contact:
Terry Winters
Co-Chairman & Chief Executive Officer
Duane Nash
Chief Business Officer
Vital Therapies, Inc.
858-673-6840

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing ...
Platform-as-a-Service (PaaS) is a technology designed to make DevOps easier and allow developers to focus on application development. The PaaS takes care of provisioning, scaling, HA, and other cloud management aspects. Apache Stratos is a PaaS codebase developed in Apache and designed to create a highly productive developer environment while also supporting powerful deployment options. Integration with the Docker platform, CoreOS Linux distribution, and Kubernetes container management system ...
As organizations shift toward IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection &E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 16th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships, will disc...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, will analyze a range of cloud offerings (IaaS, PaaS, SaaS) and discuss the benefits/challenges of migrating to each of...
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance...
VictorOps is making on-call suck less with the only collaborative alert management platform on the market. With easy on-call scheduling management, a real-time incident timeline that gives you contextual relevance around your alerts and powerful reporting features that make post-mortems more effective, VictorOps helps your IT/DevOps team solve problems faster.
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch ...
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, will discuss why containers should be paired with new architectural practices such as microservices ra...
Roberto Medrano, Executive Vice President at SOA Software, had reached 30,000 page views on his home page - http://RobertoMedrano.SYS-CON.com/ - on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, and SOA World Magazine. He is a recognized executive in the information technology fields of SOA, internet security, governance, and compliance. He has extensive experience with both start-ups and large companies, having been ...
HP and Aruba Networks on Monday announced a definitive agreement for HP to acquire Aruba, a provider of next-generation network access solutions for the mobile enterprise, for $24.67 per share in cash. The equity value of the transaction is approximately $3.0 billion, and net of cash and debt approximately $2.7 billion. Both companies' boards of directors have approved the deal. "Enterprises are facing a mobile-first world and are looking for solutions that help them transition legacy investme...
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focu...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes ...
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, it is now feasible to create a rich desktop and tuned mobile experience with a single codebase, without compromising performance or usability.
Application metrics, logs, and business KPIs are a goldmine. It’s easy to get started with the ELK stack (Elasticsearch, Logstash and Kibana) – you can see lots of people coming up with impressive dashboards, in less than a day, with no previous experience. Going from proof-of-concept to production tends to be a bit more difficult, unfortunately, and it tends to gobble up our attention, time, and money. In his session at DevOps Summit, Otis Gospodnetić, co-author of Lucene in Action and founder...