FREMONT, Calif., Aug. 9, 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 announced an update of its business operations
and clinical programs, as well as reported financial results for
the second quarter ended June 30,
2017.
"At Ardelyx, we have advanced a unique, late-stage pipeline of
programs, led by our first-in-class drug candidate, tenapanor, in
Phase 3 development for both IBS-C and hyperphosphatemia, and
RDX7675, our proprietary binder for the treatment of hyperkalemia,
which is also in Phase 3 development," said Mike Raab, president and chief executive officer
of Ardelyx. "Based on the clinical data we've generated to date, we
are highly confident in both the registration and commercial
potential for tenapanor and RDX7675. In order to fully focus on the
execution of our late-stage pipeline, we have implemented a plan
designed to align our resources to deliver on these programs, while
also creating strategic optionality and reinforcing our financial
strength."
Mr. Raab continued, "As a result of a comprehensive strategic
review, we have chosen to reduce our workforce, an inherently
difficult endeavor. I am proud of everything the Ardelyx team has
accomplished over the years, and am incredibly grateful for the
hard work, dedication and innovations contributed by each person
impacted by this decision. As we look ahead, we are confident that
the changes we are making now, and the extraordinary team that
remains at Ardelyx, will best position us to efficiently execute on
our near-term milestones and to create value in the future."
Strategic Restructuring and Updated Financial
Guidance
Ardelyx completed a comprehensive strategic review of its
operations, assessing several core areas, to optimally position the
company to advance towards delivering on multiple significant
opportunities with its late-stage portfolio and execute on its
strategic objectives. This review resulted in the prioritization of
resources to focus on the upcoming milestones for the late-stage
programs, a delay in the development of a number of earlier-stage
programs and a reduction in workforce of 28 percent, resulting in a
remaining team of 76 employees.
Ardelyx believes that with this, and other cost-saving
activities, the company is positioned to extend its operating
runway to the end of 2018, excluding any revenues generated through
potential partnerships. The company expects to incur approximately
$0.8 million in one-time,
cash-related restructuring expenses, which will be recorded
predominantly in the third quarter of 2017. Ardelyx will continue
to evaluate all pathways, both internal and external, to maintain a
strong balance sheet and ensure it has the necessary resources to
fund its operations.
Clinical Progress and Prioritized Pipeline Activities
- T3MPO-1 Phase 3 Trial in IBS-C Achieves Primary Endpoint
– In May, Ardelyx reported positive, topline results from T3MPO-1,
the first of two Phase 3 trials evaluating tenapanor for the
treatment of irritable bowel syndrome with constipation (IBS-C).
T3MPO-1 achieved statistical significance for the primary endpoint,
the combined responder rate for six of 12 weeks, showing that a
greater proportion of tenapanor-treated patients compared to
patients receiving placebo had at least a 30 percent reduction in
abdominal pain and an increase of one or more complete spontaneous
bowel movements (CSBM) in the same week for at least six of the 12
weeks of the treatment period. Notably, tenapanor had a significant
impact on both constipation and abdominal pain in nine of 12 weeks
and demonstrated durable responses by maintaining the effect in
three of the last four weeks in those patients. Tenapanor continues
to demonstrate a favorable safety profile.
- T3MPO-2 Data On-Track and IBS-C Registration Program to be
Completed in 2017 – Enrollment has been completed in both
T3MPO-2, the ongoing six-month Phase 3 trial of tenapanor in
patients with IBS-C, and T3MPO-3, the long-term safety extension
study of tenapanor in patients with IBS-C. Results from T3MPO-2 are
expected early in the fourth quarter of 2017, with completion of
T3MPO-3 expected by late 2017. Based on the success of T3MPO-1 and
pending T3MPO-2 results, Ardelyx is preparing for its first New
Drug Application for tenapanor for the treatment of IBS-C, which
the company currently expects to submit in 2018.
- Second Phase 3 Trial of Tenapanor for Hyperphosphatemia
Preparing to Enroll – Ardelyx successfully completed and
achieved the primary endpoint in the first Phase 3 trial of
tenapanor as a treatment for hyperphosphatemia in patients with
end-stage renal disease (ESRD) on dialysis. Based on learnings from
the first Phase 3 trial and in an effort to optimize the potential
for clinical and regulatory success in its second Phase 3 trial,
Ardelyx has sought feedback on the study protocol from the U.S.
Food and Drug Administration. The company expects to begin patient
enrollment by October of 2017. The study is expected to be
comprised of a 26-week randomized treatment period followed by an
up to 12-week, double-blind, placebo-controlled, randomized
withdrawal (RW) period with an open-label extension.
- Onset-of-Action Data for RDX7675 for Hyperkalemia to
Follow T3MPO-2 Results – Earlier this year, Ardelyx announced
the initiation of an onset-of-action study, as well as a single
Phase 3 trial designed to support the registration of RDX7675 for
the treatment of hyperkalemia. Consistent with its efforts to
ensure the on-time delivery of T3MPO-2 results, completion of
T3MPO-3 and enrollment in the second hyperphosphatemia Phase 3
study, Ardelyx has adjusted the timing for the RDX7675
onset-of-action study results and currently expects to report data
following the T3MPO-2 results in the fourth quarter of 2017.
Second Quarter 2017 Financial Results
- Cash Position: As of June 30,
2017, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $148.7 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
$20.6 million for the three months
ended June 30, 2017, a decrease of
$3.3 million, or 14 percent, compared
to $23.8 million for the three months
ended June 30, 2016. The decrease
consisted of a net $5.8 million
decrease in our external program costs, primarily due to a
reduction of clinical activities related to tenapanor as well as
product development activities related to RDX8940, offset by
increased costs associated with product development activities
related to RDX7675. This was offset by an increase of $2.5 million 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.
- G&A Expenses: General and administrative expenses
were $5.8 million for the three
months ended June 30, 2017, an
increase of $1.0 million, or 20
percent, compared to $4.9 million for
the three months ended June 30, 2016.
The increase was primarily due to an increase of $1.0 million in personnel and other costs
including share-based compensation, as a result of an increase in
headcount.
- Net Loss: Net loss for the quarter ended June 30, 2017 was $25.7
million compared to a net loss of $28.6 million for the quarter ended June 30, 2016.
Conference Call Information
The company will host a conference call today, August 9, 2017 at 8:00
a.m. ET to discuss the company's strategic review and second
quarter financial results. To participate in the conference call,
please dial (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and
reference call ID number 47784045. A webcast of the call, and
reference slides, can also be accessed by visiting the Investor
page of the company's website www.ardelyx.com, and will be
available on the website for 60 days following the call.
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, the company's TGR5 agonist.
For more information, please visit http://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 tenapanor and its other 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; the potential of Ardelyx's drug
discovery and design platform; Ardelyx's ability to generate
revenues in the future; and Ardelyx's expectations regarding the
exhaustion of its current capital resources. 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, and the
uncertainties in the manufacture of clinical trial material,
including process development and the 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 August 9,
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)
|
|
|
|
June 30,
2017
|
|
December
31, 2016
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
63,636
|
|
$
74,598
|
Short-term
investments
|
|
85,088
|
|
126,225
|
Property and
equipment, net
|
|
9,335
|
|
8,991
|
Prepaid and other
assets
|
|
6,063
|
|
3,317
|
Total
Assets
|
|
$
164,122
|
|
$
213,131
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
18,388
|
|
$
19,201
|
Other
liabilities
|
|
756
|
|
779
|
Stockholders'
equity
|
|
144,978
|
|
193,151
|
Total liabilities and
stockholders' equity
|
|
$
164,122
|
|
$
213,131
|
|
|
|
|
|
(1)
|
Derived from the
audited financial statements included on Form 10-K for the year
ended December 31, 2016.
|
Ardelyx,
Inc.
|
Consolidated
Condensed Statements of Operations
|
(In thousands, except
share and per share amounts)
|
|
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
20,572
|
|
$
23,838
|
|
$
42,960
|
|
$
43,091
|
|
General and
administrative
|
5,846
|
|
4,852
|
|
11,892
|
|
9,130
|
|
Total operating
expenses
|
26,418
|
|
28,690
|
|
54,852
|
|
52,221
|
|
Loss from
operations
|
(26,418)
|
|
(28,690)
|
|
(54,852)
|
|
(52,221)
|
|
Other
income
|
697
|
|
77
|
|
1,123
|
|
139
|
|
Provision for income
taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
Net
loss
|
$
(25,721)
|
|
$
(28,613)
|
|
$
(53,729)
|
|
$
(52,082)
|
|
Net loss per
common share, basic & diluted
|
$
(0.54)
|
|
$
(0.83)
|
|
$
(1.13)
|
|
$
(1.53)
|
|
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
47,403,243
|
|
34,636,559
|
|
47,373,404
|
|
34,051,785
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Ardelyx