FREMONT, Calif., May 9, 2016 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced
financial results for the first quarter ended March 31, 2016.
![Ardelyx logo Ardelyx logo](http://photos.prnewswire.com/prnvar/20140619/119451)
"We are very pleased with the progress we have made thus far in
2016," said Mike Raab, President and
Chief Executive Officer of Ardelyx. "The remainder of the year
looks to be an exciting period for Ardelyx, as we expect to execute
on multiple upcoming milestones. We expect results from the second
Phase 2b clinical trial evaluating tenapanor for the treatment of
hyperphosphatemia in ESRD patients in the second half of 2016. We
look forward to building upon the positive results from our
clinical trial evaluating the pharmacodynamic activity of the lead
product candidate from our RDX022 program in healthy volunteers,
which we announced in January, and we plan to initiate a Phase 3
clinical trial in patients with hyperkalemia during the fourth
quarter 2016. In the fourth quarter, we also expect to submit
an IND for RDX98940, the lead development candidate from our RDX009
program."
Highlights from the First Quarter 2016 and Upcoming Clinical
Milestones
- Completed an underwritten follow-on public offering of common
stock in January 2016, with net
proceeds totaling approximately $80.8
million;
- Reported positive results from the pharmacodynamic (PD)
clinical trial evaluating the activity of RDX227675, the lead
product candidate from our RDX022 program, in 60 healthy adult
volunteers in January 2016. RDX227675
successfully demonstrated the ability to bind potassium in the
gastrointestinal tract and was generally well-tolerated at all
doses administered up to 27.5 g/day;
- Ardelyx plans to proceed with a Phase 3 clinical trial for
RDX227675, which it currently intends to initiate in the fourth
quarter 2016. Ardelyx expects to pursue FDA approval for
RDX227675 using the 505(b)(2) regulatory pathway;
- Results from the second Phase 2b clinical trial evaluating
tenapanor for the treatment of hyperphosphatemia in end-stage renal
disease (ESRD) patients are expected in the second half of
2016;
- Ardelyx currently expects to file an IND in the fourth quarter
of 2016 for RDX98940, Ardelyx's lead development candidate in its
RDX009 program; RDX98940 is a minimally-systemic TGR5 agonist that
stimulates local secretion of GLP-1 and GLP-2 in the
gastrointestinal tract; and
- Results from T3MPO-1 and T3MPO-2, two ongoing Phase 3 clinical
trials evaluating tenapanor for the treatment of IBS-C, are
expected in 2017.
First Quarter Ended March 31,
2016 Financial Results
Net loss for the first quarter
of 2016 was $23.5 million, or
$0.70 per basic and diluted share,
compared to a net loss of $3.5
million, or $0.19 per basic
and diluted share for the first quarter of 2015.
Total revenue is comprised of licensing revenue and
collaborative development revenue. Licensing revenue for the first
quarter of 2016 decreased to zero from $3.9
million for the first quarter of 2015. Licensing revenue for
the three months ended March 31, 2015
related to the recognition of revenue from upfront and milestone
payments received from AstraZeneca. As our collaboration agreement
with AstraZeneca was terminated in June
2015, there was no further recognition of revenue related to
the upfront and milestone payments after the six-month period ended
June 30, 2015.
Collaborative development revenue is comprised of development
expenses that were reimbursable to Ardelyx by AstraZeneca.
Collaborative development revenue for the first quarter of 2016
decreased to zero from $2.0 million
for the first quarter of 2015. The decrease was attributable to the
termination of the AstraZeneca agreement in June 2015 and related cessation of reimbursement
of research and development expenses.
Research and development expense for the first quarter of 2016
increased to $19.3 million from
$6.2 million for the first quarter of
2015. The increase was due to expenses incurred primarily for
clinical development activities as well as clinical manufacturing
and process development activities associated with tenapanor and
RDX227675.
General and administrative expense was $4.3 million for the first quarter of 2016 as
compared to $3.2 million for first
quarter of 2015. The increase was primarily due to an increase in
professional services fees, personnel and public company costs.
Cash and cash equivalents were $171.7
million as of March 31, 2016
compared with $107.0 million as of
December 31, 2015 primarily because
of an underwritten public offering completed in January 2016 that yielded approximately
$80.8 million in net proceeds, offset
by $16.1 million in cash required for
operating and other activities.
Conference Call & Webcast Information
Ardelyx
management will host a live conference call and webcast today at
4:30 p.m. ET to discuss the financial results for the first
quarter ended March 31, 2016. The
live webcast and a replay may be accessed by visiting the investor
relations section of the Ardelyx website at ir.ardelyx.com.
Please connect to the Company's website at least 15 minutes
prior to the live webcast to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively,
please call 1-855-296-9612 (US) or 920-663-6277 (International) to
listen to the live conference call. The conference ID number for
the live call is 1292888. Please dial in approximately 10 minutes
prior to the call. An archived webcast replay will be available on
the Company's website until May 23,
2016.
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 tract to
treat gastrointestinal 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 constipation-predominant irritable bowel syndrome, or
IBS-C, and management of hyperphosphatemia in patients with
end-stage renal disease. In addition to tenapanor, Ardelyx is
developing RDX227675, a non-absorbed polymer for the treatment of
hyperkalemia, or high potassium, in kidney and heart disease
patients. Ardelyx is also advancing several research programs
focused in gastrointestinal and cardio-renal diseases. Ardelyx is
located in Fremont, California.
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 for
tenapanor in treating IBS-C and hyperphosphatemia in end-stage
renal disease patients, Ardelyx's future development plans for
tenapanor and the timing thereof, the expected timing for the
receipt of results from T3MPO-1 and T3MPO-2, the two ongoing Phase
3 clinical trials evaluating tenapanor for the treatment of IBS-C,
the expected timing for the receipt of the results for the Phase 2b
hyperphosphatemia clinical trial, the potential for RDX227675 in
treating hyperkalemia in kidney and heart disease patients,
Ardelyx's future development plans for RDX227675 and the timing
thereof, the expected timing for the initiation of the Phase 3
clinical trial for RDX227675, the expected timing for the filing of
an IND 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, 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, scale up and tech transfer 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-Q
filed with the Securities and Exchange Commission on May 9, 2016, and its future current and periodic
reports to be filed with the Securities and Exchange
Commission.
Ardelyx,
Inc.
|
Condensed Balance
Sheets
|
(In
thousands)
|
|
|
March
31,
2016
|
|
December
31,
2015
|
Assets
|
|
(Unaudited)
|
|
(1)
|
Cash and cash
equivalents
|
|
$ 171,678
|
|
$ 107,004
|
Property and
equipment, net
|
|
4,597
|
|
4,711
|
Prepaid and other
assets
|
|
4,223
|
|
5,231
|
Total
Assets
|
|
$ 180,498
|
|
$ 116,946
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$ 12,458
|
|
$
7,723
|
Other
liabilities
|
|
292
|
|
322
|
Stockholders'
equity
|
|
167,748
|
|
108,901
|
Total liabilities and
stockholders' equity
|
|
$ 180,498
|
|
$ 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 and Comprehensive Loss
|
(In thousands, except
share and per share amounts)
|
|
|
Three Months
Ended
|
|
March
31,
|
|
2016
|
|
2015
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenues
|
|
|
|
Licensing
revenue
|
$ --
|
|
$ 3,884
|
Collaborative
development revenue
|
--
|
|
1,999
|
Total
revenue
|
--
|
|
5,883
|
Operating
expenses
|
|
|
|
Research and
development
|
19,250
|
|
6,198
|
General and
administrative
|
4,279
|
|
3,175
|
Total operating expenses
|
23,529
|
|
9,373
|
Loss from
operations
|
$ (23,529)
|
|
$ (3,490)
|
Other income
(expense), net
|
62
|
|
(12)
|
Provision for from
income taxes
|
—
|
|
—
|
Net loss and
comprehensive loss
|
$ (23,467)
|
|
$ (3,502)
|
|
|
|
|
Basic and diluted
net loss per share
|
$ (0.70)
|
|
$ (0.19)
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
33,466,955
|
|
18,606,760
|
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SOURCE Ardelyx