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): September 12, 2018  

VITAL THERAPIES, INC.
(Exact Name of Registrant as Specified in Charter)

Delaware001-3620156-2358443
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

15010 Avenue of Science, Suite 200, San Diego, CA 92128
(Address of Principal Executive Offices) (Zip Code)

(858) 673-6840
(Registrant's telephone number, including area code)


(Former name or former address, if changed since last report)

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:

 [   ]  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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ X ]

 
 

Item 8.01. Other Events.

On September 12 2018, Vital Therapies, Inc. issued a press release announcing its VTL-308 study of ELAD®, a cell-based therapy targeting the treatment of acute forms of liver failure, failed to meet either its primary endpoint of overall survival or a secondary endpoint of proportion of survivors at study day 91.  Consequently, the Company reported it will cease any further development of the ELAD System and explore strategic options.

The full text of the press release announcing results is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.       Description
99.1 Press Release dated September 12, 2018. 


SIGNATURE

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.
   
  
Date: September 12, 2018By: /s/ Michael V. Swanson        
  Michael V. Swanson
  Chief Financial Officer
  


EXHIBIT INDEX

 

Exhibit No. Description
   
99.1 Press Release dated September 12, 2018.

EdgarFiling

EXHIBIT 99.1

Vital Therapies Announces That Topline Results of VTL-308 Fail to Achieve Primary and Secondary Endpoints of Improvement in Survival

SAN DIEGO, Sept. 12, 2018 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute forms of liver failure, today announced that, while there was a numerical improvement in survival in the ELAD-treated group between three months and one year following randomization, the VTL-308 study failed to meet the primary endpoint of a significant improvement in overall survival through at least 91 days assessed using the Kaplan Meier statistical method.  The secondary endpoint of proportion of survivors at study day 91 also showed no statistically significant difference between the groups.

In light of these results, the Company does not believe the ELAD System can be approved in the United States or European Union, if ever, without additional clinical trials that would require substantial capital and time to complete.  Consequently, the Company will cease any further development of the ELAD System and explore strategic options.

“Although we did not achieve the outcome we were hoping for, we would like to thank those who made this trial possible, including our investigators and their staffs, the patients who were enrolled and their families, and all Vital Therapies employees,” said Russell J. Cox, the Company’s Chief Executive Officer.

About Vital Therapies, Inc.

Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment of acute forms of liver failure.  The Company’s ELAD System is an extracorporeal human allogeneic cellular 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.  Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-Q for the quarter ended June 30, 2018.  These forward-looking statements speak only as of the date hereof, and Vital Therapies, Inc. disclaims any obligation to update these statements except as may be required by law.

Investor Contact:

Vital Therapies, Inc. 
Investor Relations
858-673-6840
InvestorRelations@vitaltherapies.com