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EX-99.1 - EX-99.1 - ZS Pharma, Inc.d792847dex991.htm

 

 

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 23, 2014 (September 23, 2014)

 

 

ZS Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36489   26-3305698

(State or Other Jurisdiction

of Incorporation or Organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

508 Wrangler Drive, Suite 100

Coppell, Texas

  75019
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (877) 700-0240

 

 

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))

 

 

 


Item 7.01 Regulation FD Disclosure

On September 23, 2014, ZS Pharma, Inc. (the “Company”) issued a press release announcing positive results from HARMONIZE (ZS004), its second Phase 3 clinical trial of ZS-9 (sodium zirconium cyclosilicate), an investigational treatment for hyperkalemia. Preliminary analyses of the results showed that all three doses (5g, 10g, and 15g) of once daily ZS-9 met the primary endpoint, demonstrating that ZS-9 prevented recurrence of hyperkalemia when compared with placebo over a 28-day treatment period. This data will be presented at the American Heart Association Scientific meeting in November 2014, during the late-breaking Clinical Science Special Reports Session. A copy of the press release is furnished as Exhibit 99.1 hereto.

In accordance with General Instruction B.2 of Form 8-K, the press release is deemed to be “furnished” and shall not be deemed “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference into any filing under the Securities Act or the Securities Exchange Act of 1934, each as amended.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

EXHIBIT
NUMBER

  

DESCRIPTION

99.1    Press Release, dated September 23, 2014


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.

 

    ZS PHARMA, INC.
Date: September 23, 2014     By:  

/s/ Todd Creech

      Todd Creech
      Chief Financial Officer


INDEX TO EXHIBITS

 

EXHIBIT
NUMBER

  

DESCRIPTION

99.1    Press Release, dated September 23, 2014