FREMONT, Calif., Nov. 12, 2015 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced
financial results for the third quarter ended September 30, 2015. The Company also today
announced that two clinical trials were initiated in October 2015: a Phase 3 clinical trial evaluating
tenapanor for the treatment of constipation-predominant irritable
bowel syndrome (IBS-C) and a clinical study evaluating the
pharmacodynamic activity of RDX022, a potassium binder for the
treatment of hyperkalemia. Additionally, the Company indicated that
it plans to initiate a Phase 2b study to evaluate tenapanor in CKD
patients with hyperphosphatemia on dialysis in December 2015.
Results from this study are currently expected in the second half
of 2016.
![Ardelyx logo Ardelyx logo](http://photos.prnewswire.com/prnvar/20140619/119451)
"We have made a tremendous amount of progress in our key
clinical programs over the last few months and are on pace to
surpass our previously announced timelines for tenapanor and
RDX022," Mike Raab, President and
CEO of Ardelyx remarked. "We are pleased to announce that we
commenced the first Phase 3 clinical study of tenapanor in IBS-C in
October and we now expect to commence the second Phase 3 clinical
study in December, rather than in the first quarter of 2016. A
pharmacodynamic study is also now underway to evaluate our novel
potassium binder, RDX022. While we previously anticipated
that we would obtain results in the first half of 2016, due to the
rapid progress of the study we can now confirm that we expect
results in January 2016. We are
pleased with the team's productivity and look forward to ending the
year with several mid to late-stage programs advancing in the
clinic."
Highlights from the Third Quarter 2015 and Recent Clinical
and Corporate Developments
- At the 2015 American College of Gastroenterology Conference,
Phase 2 clinical data showing measures of sustained response in
tenapanor-treated IBS-C patients was presented in a poster
entitled, "Tenapanor's Sustained Response in Patients With
Constipation Predominant Irritable Bowel Syndrome: Post-hoc
Analysis From a 12-Week, Double-Blind, Placebo-Controlled,
Randomized Phase 2b Trial."
- At the American Society of Nephrology Kidney Week 2015,
clinical data for tenapanor were highlighted in several posters and
in an oral presentation entitled, "Tenapanor, an NHE3 Inhibitor,
Reduces Serum Phosphate in Patients with CKD Stage 5D and
Hyperphosphatemia."
- The Company initiated the first Phase 3 clinical trial for
tenapanor in IBS-C patients and expects to initiate a second Phase
3 clinical trial in December.
- A pharmacodynamic (PD) study for RDX022, a novel potassium
binder for the treatment of hyperkalemia, was initiated in October
with results expected in January
2016. RDX022 is being developed through an accelerated
505(b)(2) pathway.
- Ardelyx strengthened its Board of Directors with the
appointment of William Bertrand, Jr.
Mr. Bertrand recently assumed the position of Executive Vice
President and General Counsel for Infinity Pharmaceuticals, Inc.,
and prior to that he served as Senior Vice President, Acting Chief
Executive Officer and General Counsel for Salix Pharmaceuticals,
where he remained as General Manager through the integration of
Salix's acquisition by Valeant Pharmaceuticals.
Third Quarter 2015 Financial Results
The net loss in the third quarter of 2015 was $18.1 million, or $0.70 per basic and diluted share, compared to a
net income of zero or $0.00 per basic
and diluted share in the third quarter of 2014.
Total revenue is comprised of licensing revenue and
collaborative development revenue, which were both related to the
Company's license agreement with AstraZeneca. Total revenues
decreased to zero in the third quarter of 2015 from $7.6 million in the third quarter of 2014 because
of the termination of the AstraZeneca agreement in June 2015.
Research and development expense in the third quarter of 2015
increased to $14.7 million from
$5.7 million in the third quarter of
2014. The change was primarily due the $7.3
million in expenses incurred for the clinical trial material
from AstraZeneca as well as an increase of $1.7 million for clinical development activities
associated with tenapanor and RDX022, and process development for
RDX022.
General and administrative expense was $3.4 million in the third quarter of 2015 as
compared to $1.8 million in the third
quarter of 2014. The increase was primarily due to an increase in
personnel expense and professional service fees.
Cash and cash equivalents were $129.0
million as of September 30,
2015 as compared to $107.3
million as of December 31,
2014. The increase in cash and cash equivalents compared to
December 31, 2014 was primarily due
to $74.3 million in net proceeds,
after all costs, from the issuance of common stock and warrants to
purchase common stock offset by changes in working capital, cash
paid for purchases of property and equipment, the $15 million up-front payment to AstraZeneca in
connection with the termination agreement, and the $10 million payment to AstraZeneca for
reimbursement of certain research and development expenses incurred
by AstraZeneca under the collaboration agreement during 2015.
Conference Call & Webcast Information
Ardelyx management will host a live conference call and
webcast today at 8:30 a.m. Eastern Time to discuss the third
quarter financial results. The live webcast and a replay can be
accessed by visiting Ardelyx's website on the investor
page of the Company's website at http://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 62864853. Please dial in approximately 10 minutes
prior to the call. Following the webcast, an archived version of
the call will be available until November 20, 2015.
About Ardelyx
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 (IBS-C) and for
the control of hyperphosphatemia in CKD patients on dialysis. In
addition to tenapanor, Ardelyx is developing RDX022, 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 CKD
patients on dialysis, Ardelyx's future development plans for
tenapanor and the timing thereof, the expected timing for the
receipt of the results for the Phase 2b hyperphosphatemia clinical
trial, the potential for RDX022 in treating hyperkalemia in kidney
and heart disease patients, Ardelyx's future development plans for
RDX022 and the timing thereof, the expected timing for the receipt
of the results for the RDX022 pharmacodynamic clinical trial 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,
RDX022, 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 August 12,
2015, the Form 10-Q expected to be filed on November 12, 2015 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,
2015
|
|
December
31,
2014
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
129,047
|
|
$
107,286
|
Accounts
receivable
|
--
|
|
2,584
|
Property and
equipment, net
|
4,391
|
|
2,131
|
Prepaid and other
assets
|
4,628
|
|
1,413
|
Total
Assets
|
$
138,066
|
|
$
113,414
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts payable and
accrued liabilities
|
$
12,584
|
|
$
5,557
|
Deferred
license revenue
|
--
|
|
47,053
|
Other
liabilities
|
352
|
|
122
|
Stockholders'
equity
|
125,130
|
|
60,682
|
Total liabilities and
stockholders' equity
|
$
138,066
|
|
$
113,414
|
|
(1) Derived from the audited
financial statements included on Form 10-K for the year ended
December 31, 2014.
|
ARDELYX,
INC. CONDENSED STATEMENTS OF OPERATIONS (in
thousands, except share and per share
amounts)
|
|
|
Three Months Ended
Sept. 30,
|
|
Nine Months Ended
Sept. 30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
--
|
|
$
4,767
|
|
$
21,611
|
|
$
14,509
|
Collaborative
development revenue
|
--
|
|
2,831
|
|
2,415
|
|
10,755
|
Total
revenues
|
--
|
|
7,598
|
|
24,026
|
|
25,284
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expense
|
14,705
|
|
5,694
|
|
27,101
|
|
18,514
|
General and
administrative expense
|
3,374
|
|
1,823
|
|
9,438
|
|
4,401
|
Total operating
expenses
|
18,079
|
|
7,517
|
|
36,539
|
|
22,915
|
(Loss) income from
operations
|
(18,079)
|
|
81
|
|
(12,513)
|
|
2,369
|
Other
expense
|
(77)
|
|
(7)
|
|
(138)
|
|
(19)
|
Change in fair value
of pref. stock warrant liability
|
--
|
|
--
|
|
--
|
|
(1,593)
|
Benefit from income
taxes
|
30
|
|
--
|
|
30
|
|
-
|
Net (loss) income and
comprehensive (loss) income
|
$ (18,126)
|
|
$
74
|
|
$
(12,621)
|
|
$
757
|
|
|
|
|
|
|
|
|
Basic net (loss)
income per share
|
$
(0.70)
|
|
$
--
|
|
$
(0.58)
|
|
$
--
|
Diluted net (loss)
income per share
|
$
(0.70)
|
|
$
--
|
|
$
(0.58)
|
|
$
--
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net (loss) income per share
|
25,930,928
|
|
18,374,277
|
|
21,859,383
|
|
7,476,642
|
Shares used in
computing diluted net (loss) income per share
|
25,930,928
|
|
19,133,217
|
|
21,859,383
|
|
7,476,642
|
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SOURCE Ardelyx