Substantial Progress Made in Three Clinical Programs
Company’s Interpretation of Thorough QT Study on GI Drug Candidate
Confirmed Following FDA Review
ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of
operations and provided an update on its products for the fourth quarter
and year ended December 31, 2008.
“2008 was an eventful and productive year for ARYx, as we have now
generated proof of concept for each of our three lead products. Over the
past twelve months, we completed enrollment in a Phase 2/3 clinical
trial on our anticoagulant therapy, delivered positive results on a
Phase 2b proof-of-concept study of our atrial fibrillation compound, and
moved our gastrointestinal agent to become Phase 3 enabled. Also during
this period we strengthened our resources through a strategic
financing,” said Dr. Paul Goddard, chairman and chief executive officer
of ARYx. “As further evidence of our ability to change the safety
profile of an unsafe drug, the FDA has recently communicated in writing
that they concur with our interpretation of the results of the Thorough
QT study performed on our gastrointestinal product candidate, ATI-7505.
All of these factors lead us to believe that the right partners will be
found for each of our advanced products, allowing us to continue to
build both short- and long-term value for the company and our
shareholders,” concluded Dr. Goddard.
Company Highlights
-
ARYx received written confirmation from the Food and Drug
Administration (FDA) that based on the FDA’s review of results from
ARYx’s Thorough QT (TQT) study of the company’s oral prokinetic agent,
ATI-7505, the FDA concurs that the study met the ICH E14 criteria for
the design, conduct and analysis of a Thorough QT study. Also, the FDA
concurs with the company’s interpretation of the results that the
findings were negative, meaning ATI-7505 does not significantly
increase the QT interval at the proposed therapeutic or
supratherapeutic doses. Additionally, in August, 2008, ARYx announced
successful, statistically significant results of a Phase 2b clinical
trial testing the safety and efficacy of ATI-7505 in patients with
chronic idiopathic constipation. With these data in hand, licensing
efforts for this compound are being initiated.
-
ARYx announced successful efficacy and safety data from a Phase 2b
clinical trial of its novel, oral anti-arrhythmic agent, ATI-2042
(approved USAN name budiodarone), testing the drug in the treatment of
patients with paroxysmal atrial fibrillation. ARYx has initiated
discussions with potential partners and believes that the available
efficacy and safety data should make this an attractive licensing
candidate with a compelling product profile.
-
ARYx completed patient enrollment in the ongoing Phase 2/3 clinical
trial of its novel, oral anticoagulant, ATI-5923 (approved USAN name
tecarfarin), against the leading anticoagulant agent, warfarin. The
trial remains on schedule and the company expects to be able to report
Phase 2/3 data at the end of June, as previously forecast. Based on
interactions with the FDA, ARYx believes that this Phase 2/3 trial
could be positioned as one of the required pivotal studies needed for
product registration. ARYx is actively pursuing partners for
tecarfarin based upon the data already available so that when the
current Phase 2/3 trial results become known, the company can move
rapidly towards consummating a licensing or partnering transaction.
-
ARYx completed a private placement financing with a group of existing
and new top-tier investors in November, 2008. The transaction provided
ARYx with additional net proceeds of $20.4 million that strengthened
the company’s balance sheet and provided needed capital to execute on
its planned clinical programs while enhancing ARYx’s strategic
negotiating position with potential collaboration partners.
-
ARYx received notice from the United States Adopted Names Council that
non-proprietary, generic names have been selected for two of the
company’s lead products, ATI-5923 and ATI-2042. ARYx’s novel, oral
anticoagulant, ATI-5923 is now called tecarfarin and the company’s
novel, oral anti-arrhythmic agent, ATI-2042 is now called budiodarone.
Results of Operations
For the fourth quarter of 2008, ARYx reported a net loss of $13.1
million or $0.57 per share as compared to a net loss of $8.1 million or
$0.80 cents per share in the same quarter of 2007.
For the year 2008, ARYx reported a net loss of $31.2 million or $1.65
per share as compared to a net loss of $27.6 million or $8.24 per share
in 2007. ARYx became a publicly traded company in November 2007 and, as
such, all existing Preferred Shares were converted into Common Shares.
Only Common Shares are included in the loss per share calculations.
ARYx had no revenue in the fourth quarter and $19.7 million of revenue
for the full year 2008, compared to $1.0 million and $4.2 million for
the same periods in 2007. These differences, particularly the
significant increase in the 2008 full year revenue, are specifically
related to an acceleration of the revenue recognition of the original
$25 million nonrefundable upfront license fee received from Proctor &
Gamble Pharmaceuticals, Inc. (P&G) as a result of P&G’s termination of
their collaboration agreement with ARYx covering our prokinetic agent,
ATI-7505.
Research and development expenses for the fourth quarter and full year
2008 were $10.7 million and $40.1 million, respectively, as compared to
$7.4 million and $25 million during the same periods of 2007. The
increase in 2008 is primarily due to ARYx’s continued investment in the
ongoing Phase 2/3 clinical trial for tecarfarin, and the Phase 2
clinical trial of budiodarone. Additional expense was also incurred
during the year 2008 due to the initiation of Phase 1 clinical
development of ATI-9242.
General and administrative (G&A) expenses during the fourth quarter and
full year 2008 were $1.8 million and $9.8 million respectively. For the
same periods of 2007, G&A expenses totaled approximately $2.2 million
and $7.7 million, respectively. The decrease in expense during the
fourth quarter of 2008 as compared to the same period in 2007 was
primarily due to lower stock compensation expense and the decision in
early 2009 to eliminate 2008 officer bonuses. The increase in expenses
for the full year 2008 as compared to 2007 was primarily due to higher
stock compensation expense, increased personnel costs and other
administrative expenses associated with ARYx operating as a public
company, including the cost of compliance with the Sarbanes-Oxley Act of
2002. G&A expense for the full year 2008 includes approximately $1.2
million of non-cash stock compensation expense.
As of December 31, 2008, ARYx had cash, cash equivalents and marketable
securities totaling approximately $44.6 million. This amount includes
net proceeds of approximately $20.4 million raised through a private
placement transaction that was completed in November 2008.
Conference Call and Webcast Information
ARYx will host a conference call and simultaneous Webcast on Thursday,
March 26, 2009 at 8:00 a.m. Pacific Time to review the results for
fourth quarter and full year 2008 and to provide a general business
update on the company. The Webcast will be available live via the
Internet by accessing the ARYx Website at www.aryx.com.
Alternatively, the call can be accessed by dialing 877-874-1589.
Participants outside of the U.S. should dial 719-325-4805. The passcode
for the call is 6454631.
Replays of the call will be available through May 1, 2009 at ARYx's
Website.
About ARYx Therapeutics, Inc.
ARYx Therapeutics is a biopharmaceutical company focused on developing a
portfolio of internally discovered products designed to eliminate known
safety issues associated with well-established, commercially successful
drugs. ARYx uses its RetroMetabolic Drug Design technology to design
structurally unique molecules that retain the efficacy of these original
drugs but are metabolized through a potentially safer pathway to avoid
specific adverse side effects associated with these compounds. ARYx
currently has four products in clinical trials: an oral anticoagulant
agent for patients at risk for the formation of dangerous blood clots,
tecarfarin (previously named ATI-5923); an oral anti-arrhythmic agent
for the treatment of atrial fibrillation, budiodarone (previously named
ATI-2042); a prokinetic agent for the treatment of various
gastrointestinal disorders, ATI-7505; and, an agent for the treatment of
schizophrenia and other psychiatric disorders, ATI-9242. Please visit
our web site at www.aryx.com
for additional information.
Forward-looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to the timing and availability of
our clinical results, the potential safety and efficacy and commercial
potential of our product candidates, the initiation of new clinical
trials, the completion of preclinical work, the ability of preclinical
packages to lead to further clinical trials and the ability to find
partners to help advance our product candidates through clinical
development. Words such as "believe," "anticipate," "will," and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon ARYx's current expectations.
Forward-looking statements involve risks and uncertainties. ARYx's
actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
these risks and uncertainties, which include, without limitation, the
risk that we will need substantial additional funding and may be unable
to raise additional capital when needed which would force us to limit or
cease our operations and related product development programs, the risk
that collaborative arrangements will likely place the development of our
product candidates outside of our control, the risk that we depend on
collaborative arrangements to complete the development and
commercialization of each of our product candidates and we may have to
alter our development and commercialization plans if collaborative
relationships are not established for ATI-5923, ATI-2042 and ATI-7505,
the risk that our product candidates may not demonstrate safety and
efficacy or lead to regulatory approval, the risk that any failure or
delay in commencing or completing clinical trials for our product
candidates could severely harm our business, and the risk that third
party manufacturers could delay or prevent the clinical development of
our product candidates. These and other risk factors are discussed under
"Risk Factors" and elsewhere in ARYx's Annual Report on Form 10-K for
the year ended December 31, 2008, its Quarterly Report on Form 10-Q for
the quarter ended September 30, 2008 and other filings with the
Securities and Exchange Commission. ARYx expressly disclaims any
obligation or undertaking to release publicly any updates or revisions
to any forward-looking statements contained herein.
|
ARYx Therapeutics, Inc.
|
|
Condensed Consolidated Balance Sheets
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
2008
|
|
2007
|
|
|
|
|
(note A)
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ 35,999
|
|
$ 55,476
|
|
|
Marketable securities
|
|
8,588
|
|
7,640
|
|
|
Other current assets
|
|
1,263
|
|
1,783
|
|
Total current assets
|
|
45,850
|
|
64,899
|
|
Property and equipment, net
|
|
3,198
|
|
3,655
|
|
Other assets
|
|
2,100
|
|
1,071
|
|
Total assets
|
|
$ 51,148
|
|
$ 69,625
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Current liabilities
|
|
$ 7,616
|
|
$ 6,008
|
|
|
Current portion of long-term borrowings
|
|
3,403
|
|
3,536
|
|
|
Current portion of deferred revenue
|
|
—
|
|
3,913
|
|
Total current liabilities
|
|
11,019
|
|
13,457
|
|
Long-term borrowings
|
|
11,278
|
|
3,444
|
|
Deferred revenue
|
|
—
|
|
15,584
|
|
Other non-current liabilities
|
|
1,436
|
|
1,793
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
Common stock
|
|
27
|
|
18
|
|
|
Additional paid-in capital and other
|
|
181,285
|
|
158,053
|
|
|
Accumulated deficit
|
|
(153,897)
|
|
(122,724)
|
|
Total stockholders’ equity
|
|
27,415
|
|
35,347
|
|
Total liabilities and stockholders’ equity
|
|
$ 51,148
|
|
$ 69,625
|
|
|
Note A: The balance sheet has been derived from the audited financial
statements at that date but does not include all of the information and
footnotes required by U.S. generally accepted accounting principles for
complete financial statement presentation.
|
ARYx Therapeutics, Inc.
|
|
Condensed Consolidated Statements of Operations
|
|
(in thousands, except per share amount)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Collaboration services
|
|
$
|
—
|
|
|
$
|
10
|
|
|
$
|
232
|
|
|
$
|
262
|
|
|
Technology license fees
|
|
|
—
|
|
|
|
974
|
|
|
|
19,492
|
|
|
|
3,896
|
|
|
Total revenue
|
|
|
—
|
|
|
|
984
|
|
|
|
19,724
|
|
|
|
4,158
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
Cost of collaboration service revenue
|
|
|
—
|
|
|
|
10
|
|
|
|
232
|
|
|
|
262
|
|
|
Research and development
|
|
|
10,743
|
|
|
|
7,392
|
|
|
|
40,145
|
|
|
|
24,994
|
|
|
Selling, general and administrative
|
|
|
1,794
|
|
|
|
2,176
|
|
|
|
9,764
|
|
|
|
7,702
|
|
|
Total costs and expenses
|
|
|
12,537
|
|
|
|
9,578
|
|
|
|
50,141
|
|
|
|
32,958
|
|
|
Loss from operations
|
|
|
(12,537
|
)
|
|
|
(8,594
|
)
|
|
|
(30,417
|
)
|
|
|
(28,800
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income, net
|
|
|
(22
|
)
|
|
|
907
|
|
|
|
1,127
|
|
|
|
2,591
|
|
|
Interest expense
|
|
|
(491
|
)
|
|
|
(417
|
)
|
|
|
(1,928
|
)
|
|
|
(1,352
|
)
|
|
Net loss
|
|
$
|
(13,050
|
)
|
|
$
|
(8,104
|
)
|
|
$
|
(31,218
|
)
|
|
$
|
(27,561
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.57
|
)
|
|
$
|
(0.80
|
)
|
|
$
|
(1.65
|
)
|
|
$
|
(8.24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to compute basic and diluted net loss
per share
|
|
|
22,917
|
|
|
|
10,094
|
|
|
|
18,964
|
|
|
|
3,346
|
|
ARYx Therapeutics, Inc.
David Nagler, 510-585-2200 ext. 211
Vice
President Corporate Affairs