Ardelyx Reports Third Quarter 2017 Operating Results and Clinical Progress
"2017 has been a landmark year for
Clinical Program Updates
Tenapanor for IBS-C
- T3MPO-2 Phase 3 Trial in IBS-C Hits Statistical Significance for All Primary and Secondary Endpoints - In October,
Ardelyx announced positive results from the company's second Phase 3 registration study of tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements. Tenapanor was well-tolerated in the study, consistent with previous studies. - T3MPO-1 Phase 3 Data Highlighted in Oral Presentation at ACG Annual Meeting: At the
American College of Gastroenterology (ACG) Annual Meeting in October,Bill Chey , M.D., a principal investigator in the T3MPO clinical program, presented detailed data fromArdelyx's first positive Phase 3 registration study, T3MPO-1, evaluating tenapanor for the treatment of people with IBS-C, which were originally announced inMay 2017 . - T3MPO-3 Long-term Safety Study Fully Enrolled; Preparing for NDA:
Ardelyx's long-term safety study of tenapanor for IBS-C, T3MPO-3, is fully enrolled and on track to conclude by the end of 2017. With the completion of T3MPO-3,Ardelyx expects to have all data necessary to file a New Drug Application (NDA) with theU.S. Food and Drug Administration (FDA ) in the second half of 2018, seeking marketing authorization for tenapanor in IBS-C. - Tenapanor Pain Mechanism Spotlighted at ACG Annual Meeting: Also at the ACG meeting,
Ardelyx and collaborators fromJohns Hopkins University School of Medicine reported preclinical data showing that tenapanor works to reduce abdominal pain caused by IBS-C through the inhibition of TRPV-1 dependent signaling.
Tenapanor for Hyperphosphatemia
- Second Phase 3 Study of Tenapanor for Hyperphosphatemia: In an effort to optimize the potential for clinical and regulatory success in its second Phase 3 trial, and based on learnings from the first successful Phase 3 study,
Ardelyx sought feedback on the study protocol from theFDA .Ardelyx is awaiting feedback fromFDA , and pending the agency's response is ready to begin enrollment in this Phase 3 clinical trial. - Data from First Phase 3 Study Highlighted at ASN Annual Meeting: Last week,
Ardelyx presented detailed positive efficacy and safety data from the company's first Phase 3 study of tenapanor for the treatment of hyperphosphatemia at theAmerican Society of Nephrology (ASN) Annual Meeting. The data were originally announced inFebruary 2017 .
RDX7675 for Hyperkalemia
- Onset-of-Action Study:
Ardelyx anticipates providing an update from its onset-of-action study for RDX7675 for the treatment of hyperkalemia by the end of 2017.
Third Quarter 2017 Financial Results
- Cash Position: As of
September 30, 2017 ,Ardelyx had total capital resources including cash, cash equivalents and short-term investments of$129.3 million compared to total capital resources including cash, cash equivalents and short-term investments of$200.8 million as ofDecember 31, 2016 . - R&D Expenses: Research and development expenses were
$15.4 million for the three months endedSeptember 30, 2017 , a decrease of$9.5 million , or 38 percent, compared to$24.9 million for the three months endedSeptember 30, 2016 . The decrease consisted of a net$10.2 million decrease in external program costs, primarily due to a decrease in expenses incurred for clinical development activities related to the completion of some of the company's Phase 3 clinical trials for tenapanor, as well as a decrease in clinical and process development activities. This was offset by an increase of$0.7 million in internal program costs, primarily due to increases in salaries and stock-based compensation costs prior to a corporate restructuring announced inAugust 2017 , as well as severance costs associated with the corporate restructuring. - G&A Expenses: General and administrative expenses were
$5.8 million for the three months endedSeptember 30, 2017 , an increase of$1.5 million , or 35 percent, compared to$4.3 million for the three months endedSeptember 30, 2016 . The increase was primarily due to increases in salaries and related costs, including stock-based compensation and facilities costs, due to an increase in headcount and an expansion of facilities in the second half of 2016, increased legal fees, principally related to patent applications, and severance costs. - Net Loss: Net loss for the quarter ended
September 30, 2017 , was$20.7 million compared to a net loss of$29.0 million for the quarter endedSeptember 30, 2016 .
About
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Ardelyx, Inc. |
||||
Condensed Consolidated Balance Sheets |
||||
(In thousands) |
||||
September 30, |
December 31, |
|||
(Unaudited) |
(1) |
|||
Assets |
||||
Cash and cash equivalents |
$ 59,454 |
$ 74,598 |
||
Short-term investments |
69,834 |
126,225 |
||
Property and equipment, net |
8,622 |
8,991 |
||
Prepaid and other assets |
5,195 |
3,317 |
||
Total Assets |
$ 143,105 |
$ 213,131 |
||
Liabilities and stockholders' equity |
||||
Accounts payable and other current liabilities |
$ 15,727 |
$ 19,201 |
||
Long-term liabilities |
741 |
779 |
||
Stockholders' equity |
126,637 |
193,151 |
||
Total liabilities and stockholders' equity |
$ 143,105 |
$ 213,131 |
||
(1) |
Derived from the audited consolidated financial statements included on Form 10-K for the year ended December 31, 2016. |
Ardelyx, Inc. |
|||||||||
Condensed Consolidated Statements of Operations |
|||||||||
(In thousands, except share and per share amounts) |
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||
2017 |
2016 |
2017 |
2016 |
||||||
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Unaudited) |
||||||
Operating expenses: |
|||||||||
Research and development |
$ 15,365 |
$ 24,863 |
$ 58,325 |
$ 67,951 |
|||||
General and administrative |
5,860 |
4,337 |
17,752 |
13,469 |
|||||
Total operating expenses |
21,225 |
29,200 |
76,077 |
81,420 |
|||||
Loss from operations |
(21,225) |
(29,200) |
(76,077) |
(81,420) |
|||||
Other income |
501 |
169 |
1,624 |
307 |
|||||
Provision for income taxes |
— |
— |
— |
— |
|||||
Net loss |
$ (20,724) |
$ (29,031) |
$ (74,453) |
$ (81,113) |
|||||
Net loss per common share, basic & diluted |
$ (0.44) |
$ (0.65) |
$ (1.57) |
$ (2.15) |
|||||
Shares used in computing net loss per share, basic and diluted |
47,464,310 |
44,935,126 |
47,404,039 |
37,706,045 |
|||||
View original content with multimedia:http://www.prnewswire.com/news-releases/ardelyx-reports-third-quarter-2017-operating-results-and-clinical-progress-300550656.html
SOURCE
Monique Allaire, THRUST IR, 781-631-0759, monique@thrustir.com OR Alicia Davis, THRUST IR, 910-620-3302, alicia@thrustir.com