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
- Earlier this week, Ardelyx reported positive results from its
Phase 3 trial evaluating tenapanor for the treatment of
hyperphosphatemia in patients with end-stage renal disease (ESRD)
who are on dialysis. The trial met its primary endpoint,
demonstrating a statistically significant difference in change in
serum phosphorus between the pooled tenapanor-treated patients and
placebo-treated patients from the end of the eight-week treatment
period to the end of the four-week randomized withdrawal period, in
the responder population. Additionally, the responder population
had a substantial mean reduction in serum phosphorus from baseline
to the end of the eight-week treatment period. Notably, patients
treated with tenapanor experienced a favorable safety and GI
tolerability profile.
- In December 2016, Ardelyx
initiated both a Phase 3 clinical trial and an onset-of-action
clinical trial with RDX7675 for the treatment of patients with
hyperkalemia. Data announced in January
2016 demonstrating clinically relevant fecal potassium
binding in a pharmacodynamic study in healthy volunteers supported
the initiation of the Phase 3 study. The company also announced in
August 2016 that the United States
Patent and Trademark Office issued a Notice of Allowance for its
composition of matter patent for RDX7675. This patent has now
issued, providing key intellectual property protection through
2035.
- Ardelyx strengthened its leadership team in 2016 with the
appointments of Reg Seeto, MDDS, to
chief operating officer, and Paul
Korner, M.D., MBA to chief medical officer.
Fourth Quarter and Full Year 2016 Financial Results
- Cash Position: As of December 31,
2016, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $200.8 million compared to total capital
resources including cash, cash equivalents of $107.0 million as of December 31, 2015.
- R&D Expenses: Research and development expense for
the year ended December 31, 2016
increased to $94.2 million from
$39.9 million for the year ended
December 31, 2015. The increase of
$54.3 million was primarily due to
the advancement of our late stage clinical product candidates
including an increase in personnel, facility and other costs,
primarily related to increased research and development headcount,
along with the following preclinical, clinical and manufacturing
activities:
- Gastrointestinal portfolio: increased activities
associated with tenapanor in our GI portfolio, including the
commencement of T3MPO-1, T3MPO-2 and T3MPO-3 to evaluate tenapanor
to treat IBS-C, as well as clinical manufacturing and process
development activities associated with tenapanor and RDX8940;
- Cardiorenal portfolio: increased activities related to
tenapanor in our cardiorenal portfolio, including the Phase 3
clinical trial to evaluate tenapanor for hyperphosphatemia in ESRD
patients on dialysis, as well as clinical manufacturing activities
associated with RDX7675.
- G&A Expenses: General and administrative expense was
$18.7 million for the year ended
December 31, 2016 compared to
$13.5 million for the year ended
December 31, 2015. The increase was
primarily due to an increase in personnel, professional fees and
market research and pre-commercialization activities.
- Net Loss: Net loss for the year ended December 31, 2016 was $112.4 million compared to a net loss of
$29.6 million for the year ended
December 31, 2015.
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,
2016
|
|
December 31,
2015
|
|
|
(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 December
31,
|
Twelve Months
Ended December
31,
|
|
|
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