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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ardelyx Inc | NASDAQ:ARDX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.84 | -9.02% | 8.47 | 8.47 | 8.49 | 9.1954 | 8.395 | 9.15 | 5,329,169 | 00:36:14 |
FREMONT, Calif., Feb. 17, 2017 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardiorenal and gastrointestinal (GI) diseases, today reported recent company progress and financial results for the fourth quarter and full year ended December 31, 2016.
"We're very proud of what we achieved in 2016 and have continued to build on that momentum in 2017, with a number of additional important milestones ahead of us," said Mike Raab, president and chief executive officer of Ardelyx. "The positive data we reported from our first Phase 3 clinical trial of tenapanor for hyperphosphatemia provides a terrific start to 2017, and we plan to begin our second Phase 3 trial for tenapanor for hyperphosphatemia by mid-year. We also plan to report Phase 3 results from our T3MPO-1 and T3MPO-2 trials of tenapanor in IBS-C by mid-year and the end of the year, respectively. These milestones are significant and, if positive, will drive us down our path of becoming an independent, fully integrated and revenue generating biotechnology company in the next several years, while bringing meaningful new medicines to the millions of patients who are underserved by current treatment options."
Recent and 2016 Highlights
Fourth Quarter and Full Year 2016 Financial Results
About Ardelyx, Inc.
Ardelyx is focused on enhancing the way patients with cardiorenal and gastrointestinal (GI) diseases are treated by using the gut as the gateway to delivering medicines that matter. The company has established unique cardiorenal and GI business units aimed at bringing new, effective medicines with distinct safety and dosing advantages to underserved patients. Ardelyx's cardiorenal portfolio includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and the Phase 3 development of RDX7675 for the treatment of people with hyperkalemia. The company's GI portfolio includes the Phase 3 development of tenapanor for the treatment of people with irritable bowel syndrome with constipation (IBS-C), and RDX8940, a TGR5 agonist approaching Phase 1 development. Leveraging the company's platform and unique gut-restriction chemistry, Ardelyx intends to build a fully integrated, revenue-generating biopharmaceutical company with leading cardiorenal and GI business units. For more information, please visit www.ardelyx.com and connect with us on Twitter @Ardelyx.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for Ardelyx's product candidates in treating the diseases and conditions for which they are being developed; Ardelyx's future development plans for its product candidates and the expected timing thereof; Ardelyx's expected timing for the receipt of results from its clinical trials evaluating its product candidates; Ardelyx's corporate goals; and the potential of Ardelyx's drug discovery and design platform. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research and the clinical development process and the uncertainties in the manufacture of clinical trial material, including process development, and scale up of manufacturing processes. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-K filed with the Securities and Exchange Commission on February 17, 2017, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc. Consolidated Condensed Balance Sheets (In thousands) | ||||
December 31, |
December 31, | |||
(Unaudited) |
(1) | |||
Assets |
||||
Cash and cash equivalents |
$ 74,598 |
$ 107,004 | ||
Short-term investments |
126,225 |
— | ||
Property and equipment, net |
8,991 |
4,711 | ||
Prepaid and other assets |
3,317 |
5,231 | ||
Total Assets |
$ 213,131 |
$ 116,946 | ||
Liabilities and stockholders' equity |
||||
Accounts payable and accrued liabilities |
$ 19,201 |
$ 7,723 | ||
Other liabilities |
779 |
322 | ||
Stockholders' equity |
193,151 |
108,901 | ||
Total liabilities and stockholders' equity |
$ 213,131 |
$ 116,946 | ||
Ardelyx, Inc. Consolidated Statements of Operations (In thousands, except share and per share amounts) |
|||||||||
Three Months Ended |
Twelve Months Ended |
||||||||
2016 |
2015 |
2016 |
2015 |
||||||
(Unaudited) |
(Unaudited) |
(Unaudited) |
(1) |
||||||
Revenues: |
|||||||||
Licensing revenue |
$ — |
$ — |
$ — |
$ 21,611 |
|||||
Collaborative development revenue |
— |
— |
— |
2,415 |
|||||
Total revenues |
— |
— |
— |
24,026 |
|||||
Operating expenses: |
|||||||||
Research and development |
26,210 |
12,783 |
94,161 |
39,885 |
|||||
General and administrative |
5,266 |
4,093 |
18,734 |
13,530 |
|||||
Total operating expenses |
31,476 |
16,876 |
112,895 |
53,415 |
|||||
Loss from operations |
(31,476) |
(16,876) |
(112,895) |
(29,389) |
|||||
Other income (expense) |
200 |
(123) |
508 |
(261) |
|||||
Provision for income taxes |
— |
(1) |
— |
29 |
|||||
Net loss |
$ (31,276) |
$ (17,000) |
$ (112,387) |
$ (29,621) |
|||||
Net loss per common share, basic & diluted |
$ (0.66) |
$ (0.65) |
$ (2.80) |
$ (1.29) |
|||||
Weighted-average shares used in computing basic net loss per share, basic and diluted |
47,303,494 |
25,958,716 |
40,118,522 |
22,892,640 |
(1) |
Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2015. |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/ardelyx-reports-clinical-progress-and-fourth-quarter-and-full-year-2016-financial-results-300409707.html
SOURCE Ardelyx
Copyright 2017 PR Newswire
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