FREMONT, Calif., Nov. 7, 2018 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), today reported business highlights and financial
results for the third quarter ended September 30, 2018.
"During our first Renal Day event, we heard strong feedback from
physician, dietician and policy experts on the need for greater
awareness of the health risks of hyperphosphatemia and for new
treatments that are both effective and convenient for patients on
dialysis. Our panelists shared enthusiasm for tenapanor, making us
even more energized about its potential to become the first and
only non-binder treatment for this severe and highly prevalent
disorder in patients on dialysis," said Mike Raab, president and chief executive officer
of Ardelyx.
"Tenapanor has a completely new mechanism for treating
hyperphosphatemia and is easy to take, with just two small pills
daily. In our first Phase 3 trial, tenapanor demonstrated efficacy
in reducing serum phosphorus and a favorable safety profile.
Additionally, preclinical data presented recently at ASN show
encouraging synergy between tenapanor and sevelamer. We look
forward to beginning a clinical trial soon to evaluate tenapanor in
combination with either sevelamer or another approved phosphate
binder, and to further advancing our second Phase 3 registration
trial of tenapanor as a monotherapy for the treatment of
hyperphosphatemia, with data anticipated in 2019. Positive data
from these studies would affirm our belief that tenapanor has the
potential to be used both as a monotherapy and combination agent
with existing phosphate binders," added Mr. Raab.
Business and Pipeline Updates
- Preclinical Data Demonstrate Synergy of Tenapanor and
Sevelamer Combination: At the American Society of
Nephrology (ASN) annual meeting in October
2018, preclinical data were reported from animal models in
which sevelamer, a phosphate binder and today's standard-of-care
for the treatment of hyperphosphatemia, was administered at three
dose levels with either tenapanor or placebo added twice daily for
11 days. Two additional groups received either tenapanor or placebo
alone. Results from this preclinical study showed that the
combination of tenapanor and sevelamer resulted in greater
reductions in intestinal phosphate absorption than when either
agent was administered alone, with a synergistic effect between the
two treatments. These data support Ardelyx's plans to evaluate
tenapanor in combination with phosphate binders in a planned Phase
2/3 clinical trial.
- Company Hosted "Renal Day" Focused on Treatment Landscape of
Renal Disorders: In October 2018,
Ardelyx hosted an investor event called "Renal Day," the first of
an anticipated annual series of events. Panelists included Dr.
Geoff Block, director of clinical
research at Colorado Kidney Care; Dr. Glenn
Chertow professor of medicine (nephrology) at Stanford University School of Medicine;
Rory Pace, renal dietician, director
of nutrition services at Satellite Healthcare; and Lauren Randall Buckley, group vice president,
health policy & reimbursement strategy at Jeffrey J. Kimbell
& Associates. The panelists discussed the significant need to
improve hyperphosphatemia management in patients on dialysis,
challenges with today's treatments, which are limited to binders,
and the current market access landscape. Panelists also spoke to
the important role tenapanor could play in treating
hyperphosphatemia patients in the future, if approved. A replay of
the event is available on the Events and Presentations page under
the investor relations section of Ardelyx's website at
www.ardelyx.com.
- Tenapanor's Unique Mechanism of Action Inhibiting
Paracellular Phosphate Absorption Detailed in Science
Translational Medicine: The novel mechanism of action for
tenapanor for the treatment of hyperphosphatemia was published in
the peer-reviewed journal Science Translational Medicine. In
the paper, titled "Inhibition of sodium/hydrogen exchanger 3 in the
gastrointestinal tract by tenapanor reduces paracellular phosphate
permeability," Ardelyx concluded that phosphate absorption in
humans occurs primarily through a dynamically regulated
paracellular pathway, rather than the transcellular transport
pathway. This pathway of phosphate flux is inhibited by tenapanor
in a manner that appears largely specific for phosphate, whereas
the overall absorption of other ions and large molecules studied,
other than sodium, appears not to be affected.
- New Drug Application for U.S. Marketing Authorization of
Tenapanor for IBS-C Submitted to U.S. Food and Drug
Administration: Ardelyx submitted its New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) in
September 2018 requesting U.S.
marketing authorization for tenapanor for the treatment of patients
with irritable bowel syndrome with constipation (IBS-C). Based on
standard FDA review timelines, Ardelyx expects to receive
notification of acceptance of the filing for substantive review
before the end of the year.
- Data from T3MPO-3 Long-Term Safety Trial of Tenapanor for
IBS-C Showcased in Presidential Poster at ACG 2018 Annual
Meeting: In October 2018, new data from the company's
long-term safety trial of tenapanor for IBS-C, the T3MPO-3 trial,
were presented at the American College of Gastroenterology (ACG)
2018 Annual Meeting. Results from T3MPO-3 showed a mean compliance
rate with tenapanor of approximately 98 percent. Overall, tenapanor
was well-tolerated, with the most common adverse event being
diarrhea (9.2%). There were limited discontinuations (2.1%), with
only 1.7 percent of patients discontinuing due to diarrhea.
Third Quarter 2018 Financial Results
- Cash Position: As of September
30, 2018, Ardelyx had total capital resources including
cash, cash equivalents and short-term investments of $186.4 million compared to total capital
resources including cash, cash equivalents and short-term
investments of $134.0 million as of
December 31, 2017.
- R&D Expenses: Research and development expenses were
$17.9 million for the three months
ended September 30, 2018, an increase
of $2.5 million, or 17%, compared to
$15.4 million for the three months
ended September 30, 2017. The
increase was primarily related to our second tenapanor
hyperphosphatemia Phase 3 clinical trial that was offset by a
decrease related to discontinuation of the RDX7675 program,
reduction of activities associated with the RDX8940 program and
personnel costs, including stock-based compensation costs as a
result of a reduction in force during the third quarter of
2017.
- G&A Expenses: General and administrative expenses
were $6.0 million for the three
months ended September 30, 2018, an
increase of $0.1 million, or 2%,
compared to $5.9 million for the
three months ended September 30,
2017. The increase was primarily due to an increase in
professional services partially offset by a reduction in personnel
costs due to reduction in force during the third quarter of
2017.
- Net Loss: Net loss for the quarter ended September 30, 2018, was $24.1 million compared to a net loss of
$20.7 million for the quarter ended
September 30, 2017.
Financial Guidance
Ardelyx maintains its expectation that its cash, cash
equivalents and short-term investments will be sufficient to fund
the company's operations until at least mid-2020 based on its
current operating plans.
About Ardelyx, Inc.
Ardelyx is focused on enhancing
the way people with cardiorenal diseases are treated by developing
first-in-class medicines. Ardelyx's cardiorenal pipeline includes
the Phase 3 development of tenapanor for the treatment of
hyperphosphatemia in people with end-stage renal disease (ESRD) who
are on dialysis and RDX013, a potassium secretagogue program for
the potential treatment of high potassium, or hyperkalemia, a
problem among certain patients with kidney and/or heart disease. In
addition, Ardelyx has completed Phase 3 development of tenapanor
for the treatment of irritable bowel syndrome with constipation
(IBS-C) and submitted a New Drug Application to the U.S. Food and
Drug Administration seeking U.S. marketing approval for this
indication. To efficiently bring its treatments to market, Ardelyx
is pursuing strategic collaborations for tenapanor for IBS-C and
hyperphosphatemia in certain territories. Ardelyx has established
agreements with Kyowa Hakko Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. 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, the potential for
the use of tenapanor as monotherapy and in combination with
phosphate binders as adjunctive therapy for the treatment of
hyperphosphatemia, Ardelyx's expected timing for receipt of data
from its ongoing Phase 3 clinical trial of tenapanor for the
treatment of hyperphosphatemia in ESRD patients, Ardelyx's expected
timing of receipt of notification from the FDA of acceptance for
filing for substantive review of Ardelyx's NDA for the treatment of
IBS-C, and Ardelyx's expectations regarding the sufficiency 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 the clinical development process, including the
regulatory approval 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 November 7, 2018, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
Ardelyx,
Inc.
|
Consolidated
Condensed Balance Sheets
|
(In
thousands)
|
|
|
|
September
30, 2018
|
|
December 31,
2017
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
75,015
|
|
$
75,383
|
Short-term
investments
|
|
111,391
|
|
58,593
|
Accounts
receivable
|
|
167
|
|
10,796
|
Unbilled license
revenue
|
|
5,000
|
|
—
|
Property and
equipment, net
|
|
5,996
|
|
8,032
|
Prepaid and other
assets
|
|
9,099
|
|
5,099
|
Total
Assets
|
|
$
206,668
|
|
$
157,903
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
other current liabilities
|
|
$
14,549
|
|
$
17,871
|
Uncharged license
fees
|
|
1,000
|
|
—
|
Loan payable, long
term
|
|
49,020
|
|
—
|
Other long-term
liabilities
|
|
651
|
|
720
|
Stockholders'
equity
|
|
141,448
|
|
139,312
|
Total liabilities and
stockholders' equity
|
|
$
206,668
|
|
$
157,903
|
|
|
|
|
|
(1)
|
Derived from the
audited financial statements included on Form 10-K for the year
ended December 31, 2017.
|
Ardelyx,
Inc.
|
Consolidated
Condensed Statements of Operations
|
(In thousands,
except share and per share amounts)
|
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
—
|
|
$
—
|
|
$
2,320
|
|
$
—
|
|
Other
revenue
|
172
|
|
—
|
|
202
|
|
—
|
|
Total revenues
|
172
|
|
—
|
|
2,522
|
|
—
|
|
Cost of
revenue
|
2
|
|
—
|
|
466
|
|
—
|
|
Gross Profit
|
170
|
|
—
|
|
2,056
|
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
17,941
|
|
$
15,365
|
|
$
47,337
|
|
$
58,325
|
|
General and
administrative
|
5,961
|
|
5,860
|
|
18,290
|
|
17,752
|
|
Total operating
expenses
|
23,902
|
|
21,225
|
|
65,627
|
|
76,077
|
|
Loss from
operations
|
(23,732)
|
|
(21,225)
|
|
(63,571)
|
|
(76,077)
|
|
Other (expense)
income
|
(394)
|
|
501
|
|
141
|
|
1,624
|
|
Provision for income
taxes
|
—
|
|
—
|
|
(6)
|
|
—
|
|
Net
loss
|
$
(24,126)
|
|
$
(20,724)
|
|
$
(63,436)
|
|
$
(74,453)
|
|
Net loss per
common share, basic & diluted
|
$
(0.39)
|
|
$
(0.44)
|
|
$
(1.17)
|
|
$
(1.57)
|
|
Shares used in
computing net loss per share, basic and diluted
|
62,071,397
|
|
47,464,310
|
|
54,204,907
|
|
47,404,039
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Ardelyx