0001193125-14-215112.txt : 20140528 0001193125-14-215112.hdr.sgml : 20140528 20140528161712 ACCESSION NUMBER: 0001193125-14-215112 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140528 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140528 DATE AS OF CHANGE: 20140528 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VITAL THERAPIES INC CENTRAL INDEX KEY: 0001280776 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36201 FILM NUMBER: 14872999 BUSINESS ADDRESS: STREET 1: 15222 AVENUE OF SCIENCE, SUITE B CITY: SAN DIEGO STATE: CA ZIP: 92128 BUSINESS PHONE: 858-673-6840 MAIL ADDRESS: STREET 1: 15222 AVENUE OF SCIENCE, SUITE B CITY: SAN DIEGO STATE: CA ZIP: 92128 8-K 1 d733751d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

May 28, 2014

 

 

VITAL THERAPIES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36201   56-2358443

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

  (IRS Employer
Identification No.)

15010 Avenue of Science, Suite 200

San Diego, CA 92128

(Address of principal executive offices, including zip code)

(858) 673-6840

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On May 28, 2014, the registrant issued a press release announcing its financial results for the quarter ended March 31, 2014. A copy of the press release and accompanying information is attached as Exhibit 99.1 to this current report.

The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this current report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any such filing, unless the registrant expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press Release dated May 28, 2014, of the registrant.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VITAL THERAPIES, INC.
By:  

/s/ Michael V. Swanson

 

Michael V. Swanson

Chief Financial Officer

Date: May 28, 2014


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press Release dated May 28, 2014, of the registrant.
EX-99.1 2 d733751dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

VITAL THERAPIES ANNOUNCES FIRST QUARTER 2014 FINANCIAL RESULTS

AND PROVIDES OPERATIONAL UPDATE

San Diego, Calif. — May 28, 2014 — 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.

Contact:

Terry Winters

Co-Chairman & Chief Executive Officer

Duane Nash

Chief Business Officer

Vital Therapies, Inc.

858-673-6840

 

2


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,
2014
    December 31,
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   
  

 

 

   

 

 

 
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