PR Newswire
FREMONT, Calif., May 5, 2017
FREMONT, Calif., May 5, 2017 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a late-stage clinical company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, today reported an update on recent progress and financial results for the first quarter ended March 31, 2017.
"We've had a very active start to the year with the reporting of our first Phase 3 data evaluating tenapanor in patients with hyperphosphatemia from our cardiorenal portfolio, and have a lot more to look forward to in 2017," said Mike Raab, president and chief executive officer of Ardelyx. "We expect to complete our T3MPO program, which is evaluating tenapanor for the treatment of patients with IBS-C, by the end of this year. If successful, this program will be instrumental to our GI portfolio, and continue our progress towards becoming a commercial organization. These milestones bring us several steps closer to realizing our goal of becoming a fully integrated, revenue-generating biotech company that enhances the lives of people with cardiorenal and GI diseases."
Recent Highlights
Upcoming Milestones
First Quarter 2017 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 portfolios 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 portfolios. 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 expectations regarding the timing of its initiation of, and receipt of results from its clinical trials evaluating its product candidates and for the completion of its T3MPO program; Ardelyx's corporate goals; and the potential of Ardelyx's drug discovery and design platform; Ardelyx's ability to commercialize its product candidates; and Ardelyx's ability to generate revenues in the future. 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, including the regulatory approval process, the uncertainties in the manufacture of clinical trial material, including process development, and scale up of manufacturing processes, and uncertainties in the drug commercialization process. 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-Q filed with the Securities and Exchange Commission on May 5, 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) | ||||
| | | | |
| | March 31, 2017 | | December 31, |
| | (Unaudited) | | (1) |
Assets | | | | |
Cash and cash equivalents | | $ 71,213 | | $ 74,598 |
Short-term investments | | 102,210 | | 126,225 |
Property and equipment, net | | 8,915 | | 8,991 |
Prepaid and other assets | | 5,427 | | 3,317 |
Total Assets | | $ 187,765 | | $ 213,131 |
| | | | |
Liabilities and stockholders' equity | | | | |
Accounts payable and accrued liabilities | | $ 19,314 | | $ 19,201 |
Other liabilities | | 767 | | 779 |
Stockholders' equity | | 167,684 | | 193,151 |
Total liabilities and stockholders' equity | | $ 187,765 | | $ 213,131 |
| | | | |
(1) | Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2016. |
Ardelyx, Inc. | |||||
Consolidated Statements of Operations | |||||
(In thousands, except share and per share amounts) | |||||
| | | |||
| Three Months Ended March 31, | | |||
| 2017 | | 2016 | | |
| (Unaudited) | | (Unaudited) | | |
Operating expenses: | | | | | |
Research and development | $ 22,387 | | $ 19,250 | | |
General and administrative | 6,047 | | 4,279 | | |
Total operating expenses | 28,434 | | 23,529 | | |
Loss from operations | (28,434) | | (23,539) | | |
Other income (expense) | 426 | | 62 | | |
Provision for income taxes | - | | - | | |
Net loss | $ (28,008) | | $ (23,467) | | |
Net loss per common share, basic & diluted | $ (0.59) | | $ (0.70) | | |
Weighted-average shares used in computing net loss per share, basic and diluted | 47,343,234 | | 33,466,955 | | |
| | | | | |
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SOURCE Ardelyx
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