Full Press Release Details
Ardelyx Reports Third Quarter 2016 Financial Results and Recent Progress
Enrollment Completed in Phase 3 Trial of Tenapanor for Hyperphosphatemia in Patients with ESRD on Dialysis
Conference call to be held today at 4:05 p.m. ET
FREMONT, Calif., November 07, 2016 Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on
gastrointestinal and cardio-renal diseases, today reported an update on recent progress and financial results for the third quarter ended September 30, 2016.
We have made substantial progress throughout 2016, both as a company and through the advancement of our clinical programs, said Mike Raab,
president and chief executive officer of Ardelyx. We have advanced our three ongoing Phase 3 clinical trials for tenapanor, are on-track to initiate Phase 3 development for our second product candidate, RDX227675, in patients with hyperkalemia
before the end of the year and have further progressed our earlier-stage pipeline of novel therapies. As we look ahead, 2017 is set to be a transformational year for Ardelyx, with results from our Phase 3 clinical trial of tenapanor in patients with
hyperphosphatemia expected in the first quarter and results from our T3MPO-1 and T3MPO-2 Phase 3 clinical trials of tenapanor in patients with IBS-C expected mid-year and at the end of the year, respectively.
Ardelyx has multiple clinical and
pipeline milestones expected in the fourth quarter of 2016 and throughout 2017, including:
Third Quarter 2016 Financial Results
Conference Call Information
Ardelyx will host a conference call and audio webcast today at 4:05 p.m. Eastern Time to provide a business update and discuss third quarter 2016 financial
results. To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 11901928. The webcast can be accessed under Events and Presentations in the
Investor Center section of the company s website at www.ardelyx.com.
Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, minimally-systemic, small
molecule therapeutics that work exclusively in the gastrointestinal (GI) tract to treat GI and cardio-renal diseases. Ardelyx has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to
discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and designed tenapanor, which it is evaluating for the treatment of irritable bowel syndrome with constipation (IBS-C) and for the treatment of
hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. In addition to tenapanor, Ardelyx is developing RDX227675, a non-absorbed polymer for the treatment of hyperkalemia, or high potassium, a problem prevalent in patients
with kidney and heart disease. Ardelyx is also advancing several research programs focused in GI and cardio-renal diseases. Ardelyx is located in Fremont, Calif. For more information, please visit Ardelyx s website at www.ardelyx.com.
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 of tenapanor in the treatment of IBS-C, the expected timing for the receipt of the results from Ardelyx s two on-going Phase 3 clinical trials evaluating tenapanor for the treatment of IBS-C, the
potential for tenapanor in treating hyperphosphatemia in ESRD patients on dialysis, the expected timing of the results of the ongoing Phase 3 clinical trial evaluating tenapanor for the treatment of hyperphosphatemia in ESRD patients on dialysis,
the expected timing of the initiation of the second Phase 3 clinical trial evaluating tenapanor for the treatment of hyperphosphatemia, the potential for RDX227675 in treating hyperkalemia, the expected timing of the initiation of the
onset-of-action and Phase 3 clinical trials evaluating RDX227675 in treating hyperkalemia and the expected timing of the results of the onset-of-action clinical trial, the expected timing for the filing of an investigational new drug (IND)
application for RDX98940 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 tenapanor, RDX227675, RDX98940 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. 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 November 7, 2016, and its future current and periodic
reports to be filed with the Securities and Exchange Commission.
| Investor Contact: | Media Contact: | |
| Monique Allaire | Alicia Davis | |
| President & Executive Leader | Director, Corporate Communications | |
| THRUST IR | THRUST IR | |
| 781-631-0759 monique@thrustir.com | 910-620-3302 alicia@thrustir.com |
SOURCE Ardelyx, Inc.
| September 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 160,360 | $ | 107,004 | ||||
| Short-term investments | 69,726 | |||||||
| Property and equipment, net | 6,969 | 4,711 | ||||||
| Prepaid and other assets | 4,262 | 5,231 | ||||||
| Total Assets | $ | 241,317 | $ | 116,946 | ||||
| Liabilities and stockholders equity | ||||||||
| Accounts payable and accrued liabilities | $ | 17,635 | $ | 7,723 | ||||
| Other liabilities | 789 | 322 | ||||||
| Stockholders equity | 222,893 | 108,901 | ||||||
| Total liabilities and stockholders equity | $ | 241,317 | $ | 116,946 |
Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenue: | ||||||||||||||||
| Licensing revenue | $ | $ | $ | $ | 21,611 | |||||||||||
| Collaborative development revenue | 2,415 | |||||||||||||||
| 24,026 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 24,863 | 14,705 | 67,951 | 27,101 | ||||||||||||
| General and administrative | 4,337 | 3,374 | 13,469 | 9,438 | ||||||||||||
| Total operating expenses | 29,200 | 18,079 | 81,420 | 36,539 | ||||||||||||
| Loss from operations | (29,200 | ) | (18,079 | ) | (81,420 | ) | (12,513 | ) | ||||||||
| Other income (expense) | 169 | (77 | ) | 307 | (138 | ) | ||||||||||
| Provision for income taxes | 30 | 30 | ||||||||||||||
| Net loss | $ | (29,031 | ) | $ | (18,126 | ) | $ | (81,113 | ) | $ | (12,621 | ) | ||||
| Net loss per common share, basic & diluted | $ | (0.65 | ) | $ | (0.70 | ) | $ | (2.15 | ) | $ | (0.58 | ) | ||||
| Shares used in computing basic net loss per share, basic and diluted | 44,935,126 | 25,930,928 | 37,706,045 | 21,859,383 |