FREMONT, Calif., Nov. 7, 2016 /PRNewswire/ -- 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."
Recent Highlights
- Ardelyx reported today that its Phase 3 clinical trial
evaluating tenapanor for the treatment of hyperphosphatemia in
end-stage renal disease (ESRD) patients on dialysis is fully
enrolled and results are expected in the first quarter of
2017.
- In October, positive, global endpoint data from the completed
Phase 2b trial of tenapanor in patients with irritable bowel
syndrome with constipation (IBS-C) were presented at the American
College of Gastroenterology Annual Meeting. These pre-specified
analyses build off of positive efficacy findings on the study's
primary and key secondary endpoints in the same patient population,
as previously announced in October
2014, and further validate the 50 milligram, twice-daily
dose chosen for the ongoing Phase 3 trials of tenapanor in patients
with IBS-C.
- Ardelyx strengthened its management team with the appointment
of Reginald Seeto, MBBS, to the
newly created position of chief operating officer.
Upcoming Milestones
Ardelyx has multiple clinical and pipeline milestones expected
in the fourth quarter of 2016 and throughout 2017, including:
- Initiation of an onset-of-action clinical trial and a Phase 3
clinical trial with RDX227675 for the treatment of patients with
hyperkalemia expected in the fourth quarter of 2016;
- Investigational new drug application submission for RDX98940,
Ardelyx's lead TGR5 agonist, expected in the fourth quarter of
2016;
- Results from the ongoing Phase 3 clinical trial of tenapanor
for the treatment of hyperphosphatemia in ESRD patients on dialysis
expected in the first quarter 2017;
- Results from the RDX227675 onset-of-action clinical trial
expected in the first half of 2017;
- Initiation of the second Phase 3 clinical trial of tenapanor
for the treatment of hyperphosphatemia in ESRD patients on dialysis
expected during the first half of 2017;
- Results from T3MPO-1, the ongoing 12-week Phase 3 clinical
trial of tenapanor in patients with IBS-C expected in mid-2017;
and,
- Results from T3MPO-2, the ongoing 6-month Phase 3 clinical
trial of tenapanor in patients with IBS-C expected by the end of
2017.
Third Quarter 2016 Financial Results
- Net Loss: Net loss for the third quarter of 2016 was
$29.0 million, or $0.65 per basic and diluted share, compared to a
net loss of $18.1 million, or
$0.70 per basic and diluted share for
the third quarter of 2015.
- Cash Position: As of September
30, 2016, Ardelyx had cash and cash equivalents of
$160.4 million and short-term
investments of $69.7 million, for
total capital resources including cash, cash equivalents and
short-term investments of $230.1
million. Cash and cash equivalents were $160.4 million as of September 30, 2016 compared with $107.0 million as of December 31, 2015. The increase was primarily the
result of the completion of an underwritten public offering and a
private placement of common stock in January
2016, which yielded approximately $80.8 million in net proceeds and the completion
of a private placement transaction in July
2016, which yielded approximately $109.7 million in net proceeds. This was offset
by purchases of short-term investments of $69.7 million and capital equipment of
$2.1 million, as well as $65.3 million in cash required for operating and
other activities for the nine months ended September 30, 2016.
- R&D Expenses: Research and development expense for
the third quarter of 2016 increased to $24.9
million from $14.7 million for
the third quarter of 2015. The increase was primarily due to
expenses incurred for clinical development activities associated
with tenapanor, including clinical trial expenses for the two Phase
3 clinical trials in IBS-C and the Phase 3 clinical trial in
hyperphosphatemia, as well as clinical manufacturing and process
development activities associated with tenapanor, RDX227675 and
RDX98940.
- G&A Expenses: General and administrative expenses
were $4.3 million for the third
quarter of 2016 as compared to $3.4
million for the third quarter of 2015. The increase was
primarily due to an increase in professional services fees,
including fees for market research and pre-commercialization
activities, systems implementation and intellectual property
management, as well as an increase in personnel-related expenses
and facility costs.
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.
About Ardelyx, Inc.
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.
Ardelyx,
Inc. Condensed Balance Sheets (In
thousands)
|
|
|
|
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
|
|
|
|
|
|
|
|
(1)
|
Derived from the
audited financial statements included on Form 10-K for the year
ended December 31, 2015.
|
Ardelyx, Inc.
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
|
|
|
|
|
|
|
|
|
|
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SOURCE Ardelyx