|By Marketwired .||
|May 28, 2014 04:50 PM EDT||
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."
- 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.
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.
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 ============= =============
Co-Chairman & Chief Executive Officer
Chief Business Officer
Vital Therapies, Inc.
DevOps approaches within “Unicorns” vary significantly from the reality of DevOps in the enterprise. Most enterprises manage portfolios of heterogeneous applications that are increasingly interconnected, delivered by global teams, at various stages of technology maturity, and are often encumbered by additional compliance and governance obligations. In his session at DevOps Summit, Dalibor Siroky, Director and co-founder at Plutora, will discuss the emerging and evolving experiences of Agile, Co...
May. 6, 2015 07:00 PM EDT Reads: 220
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
May. 6, 2015 06:30 PM EDT Reads: 921
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
May. 6, 2015 06:15 PM EDT Reads: 2,728
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developmen...
May. 6, 2015 05:00 PM EDT Reads: 1,058
While Docker continues to be the darling of startups, enterprises and IT innovators around the world, networking continues to be a real mess. Indeed, managing the interaction between Docker containers and networks has always been fraught with complications. Without automation in networking, the vision of running Docker at scale and letting IT run the same apps unchanged on the laptop and in the data center or for any cloud cannot be realized.
May. 6, 2015 05:00 PM EDT Reads: 1,013
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises a...
May. 6, 2015 04:45 PM EDT Reads: 813
Why does developer experience matters, what makes for a great developer experience and what is the relationship between developer experience and the broader field of user experience? Software developers are gaining more influence over the purchase decisions of technologies with which they must build on and with which they must integrate. For example, the success of Amazon Web Services, Heroku and MongoDB has been driven primarily by individual software developers choosing to use these tools, ra...
May. 6, 2015 04:45 PM EDT Reads: 635
Enterprise IoT is an exciting and chaotic space with a lot of potential to transform how the enterprise resources are managed. In his session at @ThingsExpo, Hari Srinivasan, Sr Product Manager at Cisco, will describe the challenges in enabling mass adoption of IoT, and share perspectives and insights on architectures/standards/protocols that are necessary to build a healthy ecosystem and lay the foundation to for a wide variety of exciting IoT use cases in the years to come.
May. 6, 2015 04:30 PM EDT Reads: 1,287
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
May. 6, 2015 03:00 PM EDT Reads: 946
Zerto has announced the general availability of Zerto Virtual Replication 4.0 (ZVR 4.0). The company’s enterprise-class business continuity/disaster recovery (BC/DR) software is the first to protect, replicate, and migrate data between VMware vSphere and Microsoft Hyper-V hypervisors, as well as across private, hybrid and public cloud environments including Amazon Web Services (AWS). ZVR 4.0 also allows channel partners and cloud service providers to expand their offerings to grow revenues by pr...
May. 6, 2015 02:46 PM EDT Reads: 580
Avnet, Inc. has announced that it ranked No. 4 on the InformationWeek Elite 100 – a list of the top business technology innovators in the U.S. Avnet was recognized for the development of an innovative cloud-based training system that serves as the foundation for Avnet Academy – the company’s education and training organization focused on technical training around top IT vendor technologies. The development of this system allowed Avnet to quickly expand its IT-related training capabilities around...
May. 6, 2015 02:45 PM EDT Reads: 1,054
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
May. 6, 2015 02:15 PM EDT Reads: 5,380
This talk focuses on the application of DevOps fundamentals to include network infrastructure. It draws from real deployment case studies on the extension of today's paradigms to address the challenges of the network infrastructures' ability to seamlessly and cohesively integrate into agile workflows. In this session at DevOps Summit, Arista Networks will focus on configuration management using automation with a nod to future work necessary to include telemetry and ephemeral state information....
May. 6, 2015 01:30 PM EDT Reads: 1,264
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
May. 6, 2015 12:15 PM EDT Reads: 5,882
SYS-CON Events announced today that B2Cloud, a provider of enterprise resource planning software, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. B2cloud develops the software you need. They have the ideal tools to help you work with your clients. B2Cloud’s main solutions include AGIS – ERP, CLOHC, AGIS – Invoice, and IZUM
May. 6, 2015 12:00 PM EDT Reads: 4,533