Form 8-K ZS Pharma, Inc. For: Sep 10
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 10, 2015 (September 10, 2015)
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.) |
| 1100 Park Place, Suite 300 San Mateo, California |
94063 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (650) 458-4100
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 8.01 | Other Events. |
On September 10, 2015, ZS Pharma, Inc. (the “Company”) issued a press release announcing that the Company confirmed that it has participated in preliminary discussions with Actelion Ltd. (OTC: ALIOF) regarding a potential strategic transaction. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| EXHIBIT |
DESCRIPTION | |
| 99.1 | Press Release, dated September 10, 2015 | |
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 10, 2015 | By: | /s/ Jeffrey Farrow | ||||
| Jeffrey Farrow | ||||||
| Chief Financial Officer | ||||||
INDEX TO EXHIBITS
| EXHIBIT |
DESCRIPTION | |
| 99.1 | Press Release, dated September 10, 2015 | |
Exhibit 99.1
ZS Pharma Corporate Statement
SAN MATEO, Calif., September 10, 2015 (GLOBE NEWSWIRE) — ZS Pharma, Inc. (Nasdaq: ZSPH), today confirmed that it has participated in preliminary discussions with Actelion Ltd. (OTC: ALIOF) regarding a potential strategic transaction. ZS Pharma regularly and routinely explores opportunities with various strategic partners and will continue to do so. These discussions may or may not lead to any transaction. ZS Pharma does not intend to comment further on market speculation or disclose any developments unless and until it otherwise deems further disclosure is appropriate or required.
About ZS Pharma
ZS Pharma is a publicly-traded (Nasdaq: ZSPH), biopharmaceutical company with offices in Redwood City, California and Coppell, Texas. ZS Pharma’s lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), is an investigational treatment for hyperkalemia that has been submitted to the FDA for potential approval for the treatment of hyperkalemia. The ZS-9 Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 26, 2016.
ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology for the treatment of kidney and liver diseases. Additional information about ZS Pharma is available at www.zspharma.com.
Forward-Looking Statements
ZS Pharma cautions you that this press release contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: our expectations regarding the timing of the review of an NDA by the FDA, submitting an MAA to the EMA, the likelihood of regulatory approval of ZS-9, our expectations regarding our ability to successfully commercialize ZS-9, if approved, estimates of our expenses, future revenue, capital requirements and needs for additional financing, our ability to produce ZS-9 in commercial quantities in higher capacity reactors, the
initiation, timing, progress and results of future nonclinical studies, clinical trials and research and development programs, and our financial performance. Any forward looking statements in this press release are based on management’s current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this press release may turn out to be inaccurate. Factors that may cause actual results to differ materially from expectations include, among other things, those listed under Part I, Item 1A. Risk Factors in ZS Pharma’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission August 6, 2015 and its other reports, which are available from the SEC’s website (http://www.sec.gov) and on ZS Pharma’s website (http://www.zspharma.com) under the heading “Investors”. All forward-looking statements are qualified in their entirety by this cautionary statement and speak only as of the date of this press release. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks described in the reports we will file from time to time with the SEC after the date of this press release.
| ZS Pharma Contacts | ||
| Jeffrey Farrow (Investors) | Denise Powell (Media) | |
| ZS Pharma | Red House Consulting | |
| 650.458.4100 | 510.703.9491 | |
| [email protected] | [email protected] | |
| Source: ZS Pharma | ||