COPPELL, Texas, Aug. 14, 2014 (GLOBE NEWSWIRE) -- ZS Pharma, Inc. (Nasdaq:ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today reported financial results for the second quarter ended June 30, 2014.
"Our first quarter reporting as a public company has been both eventful and productive. We completed patient enrollment in ZS004, our second Phase 3 trial for ZS-9, and began enrollment in ZS005, a long-term, Phase 3 safety study," stated Robert Alexander, Ph.D., chief executive officer of ZS Pharma. "Additionally, we remain on track to file our NDA in the first half of 2015 and are well-positioned to fund our operations into 2016."
Second Quarter 2014 Financial Highlights
- A net loss attributable to common stockholders of $16.4 million, or $4.72 per share, basic and diluted, was reported, which compared with a net loss attributable to common stockholders for the second quarter of 2013 of $7.5 million, or $4.81 per share, basic and diluted.
- Cash and cash equivalents were $130.0 million at June 30, 2014, compared to $9.2 million at December 31, 2013. In June 2014, the company issued 6.84 million shares of common stock at a price to the public of $18.00 per share in an underwritten public offering. Net proceeds from the offering were approximately $112.2 million, after deducting underwriting discounts and commissions and estimated offering expenses. Shares outstanding as of June 30, 2014 were 20,818,771.
- Research and development expenses for the second quarter of 2014 were $9.98 million, compared to $6.34 million for the comparable period in 2013. This increase was primarily due to costs associated with the enrollment of ZS004, the initiation of ZS005 and our manufacturing scale-up costs.
- General and administrative expenses for the second quarter of 2014 were $4.55 million, compared to $0.97 million for the comparable period in 2013. This increase was primarily due to an increase in compensation, professional fees and other expenses to support ZS Pharma's expanding operations and the increased complexities of operating as a public company.
About ZS Pharma
ZS Pharma is a publicly-traded, specialty pharmaceutical company based in Coppell, Texas. ZS Pharma's lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), is an investigational treatment for hyperkalemia that is being evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels. 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 is available at www.zspharma.com.
ZS Pharma cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "should," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the timing of potential regulatory submission and approval of the NDA and/or MAA for ZS-9. Inclusion of forward‐looking statements should not be regarded as a representation by ZS Pharma that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the ZS Pharma business, including, without limitation: the potential for clinical data to not meet pre-specified statistical endpoints, regulatory authorities to not approve an application for ZS-9; analysis of ongoing or future potential clinical trials, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with clinical results achieved to date; the therapeutic and commercial value of ZS-9; and other risks described in ZS Pharma's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ZS Pharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ZS Pharma's Prospectus on Form 424B4 filed with the Securities and Exchange Commission June 18, 2014, which is available from the SEC's website (www.sec.gov) and on ZS Pharma's website (www.zspharma.com) under the heading "Investors". All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
|ZS Pharma, Inc.|
|Condensed Statements of Operations|
|(In Thousands, Except for Share and per Share Amounts)|
|Three Months||Three Months||Six Months||Six Months|
|June 30||June 30||June 30||June 30|
|Research and development||$9,976||$6,335||$15,235||$10,744|
|General and administrative||4,554||972||8,571||1,687|
|Total Operating Expenses||14,530||7,307||23,806||12,431|
|Loss from operations||(14,530)||(7,307)||(23,806)||(12,431)|
|Other (income) expense:|
|Interest income, net of interest expense||(5)||(4)||(8)||(11)|
|Expense to mark warrants to market||1,774||12||3,071||121|
|Preferred stock accretion||(129)||(172)||(310)||(342)|
|Net loss attributable to common shareholders||$ (16,428)||$ (7,487)||$ (27,176)||$ (12,883)|
|Net loss per share attributable to common shareholders, basic and diluted||$ (4.72)||$ (4.81)||$ (10.61)||$ (8.27)|
|Weighted-average common shares used to compute net loss per share attributable to common shareholders, basic and diluted||3,482,340||1,557,643||2,560,778||1,557,643|
|ZS Pharma, Inc.|
|Condensed Balance Sheet Data|
|June 30||December 31|
|Cash and cash equivalents||$130,002||$9,170|
|Accumulated deficit||$ (77,100)||$ (50,234)|
|Total shareholders' equity (deficit)||$128,993||$ (45,182)|