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
- In February, 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. Notably, tenapanor demonstrated a positive safety
profile, with GI tolerability in patients treated.
- In April, the company presented a poster titled "Effect of
tenapanor on serum fibroblast growth factor 23 levels" at the
National Kidney Foundation Spring Clinical Meetings in Orlando.
- On May 2, a poster titled
"RDX7675 reduces intestinal potassium absorption to a greater
extent than patiromer or sodium polystyrene sulfonate in mice" was
presented at the European Society of Cardiology Heart Failure World
Congress in Paris.
Upcoming Milestones
- Presentation of a poster titled "Minimally-systemic TGR5
agonist RDX8940 improves hepatic steatosis and insulin sensitivity
in Western-diet-fed mice" at Digestive Disease Week in Chicago on May
9;
- Results from T3MPO-1, the ongoing 12-week Phase 3 clinical
trial of tenapanor in patients with IBS-C, are expected in the
second quarter of 2017. The company plans to hold a conference call
in conjunction with the data announcement;
- Initiation of the second Phase 3 clinical trial of tenapanor
for the treatment of hyperphosphatemia in ESRD patients on dialysis
is expected in mid-2017;
- Results from the RDX7675 onset-of-action clinical trial are
expected in the third quarter of 2017;
- Results from T3MPO-2, the ongoing six-month Phase 3 clinical
trial of tenapanor in patients with IBS-C, are expected in the
second half of 2017; and
- Completion of T3MPO-3, the long-term safety extension study of
tenapanor in patients with IBS-C, is expected by late 2017.
First Quarter 2017 Financial Results
- Cash Position: As of March 31,
2017, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $173.4 million compared to total capital
resources including cash, cash equivalents and short-term
investments of $200.8 million as of
December 31, 2016.
- R&D Expenses: Research and development expenses were
$22.4 million for the three months
ended March 31, 2017, an increase of
$3.1 million, or 16 percent, compared
to $19.3 million for the three months
ended March 31, 2016. The increase
consisted of a $3.4 million increase
in our internal program costs primarily related to costs associated
with research and development headcount to support the growth of
our research and development activities. This was offset by a net
decrease of $0.3 million in our
external program costs, primarily due to a reduction of clinical
activities related to tenapanor offset by increased costs
associated with product development activities related to RDX7675
and RDX8940.
- G&A Expenses: General and administrative expenses
were $6.0 million for the three
months ended March 31, 2017, an
increase of $1.7 million, or 40
percent, compared to $4.3 million for
the three months ended March 31,
2016. The increase was primarily due to increases of
$1.2 million in personnel and other
costs including share-based compensation, as a result of an
increase in headcount and $0.5
million in professional fees.
- Net Loss: Net loss for the quarter ended March 31, 2017 was $28.0
million compared to a net loss of $23.5 million for the quarter ended March 31, 2016.
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,
2016
|
|
|
(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
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ardelyx-reports-first-quarter-2017-operating-results-and-highlights-recent-progress-300452088.html
SOURCE Ardelyx