(Source: Business Wire)

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided an update on its products for the first quarter ended March 31, 2009.
"During the first quarter, we remained on track with all of our lead programs in order to meet our existing clinical and corporate goals. We are close to completing the Phase 2/3 study of our novel, oral anticoagulant tecarfarin (formerly ATI-5923), and are confident that we will have data from that trial by the end of June," said Dr. Paul Goddard, chairman and chief executive officer of ARYx. "Additionally, we are in ongoing, detailed discussions with a number of potential partners for the development and commercialization of our novel, oral anti-arrhythmic agent, budiodarone (formerly ATI-2042), as well as for tecarfarin. 2009 is off to a good start and we expect the rest of the year to be an exciting and newsworthy period, with progress across all stages of our portfolio."
Company Highlights
ARYx neared completion of the Phase 2/3 clinical trial of its novel, oral anticoagulant, tecarfarin, against the leading anticoagulant agent, warfarin. This week all patients have completed the required treatment period and the company has begun the process of finalizing the database and preparing for the analysis of the results from this study. The company expects to report data from this study at the end of June, as previously forecast. The company also intends, based on the successful outcome of this study, to complete a partnering agreement for tecarfarin by the end of the year.
ARYx announced successful efficacy and safety data from a Phase 2b clinical trial of its novel, oral anti-arrhythmic agent, budiodarone, testing the drug in the treatment of patients with paroxysmal atrial fibrillation. ARYx believes that the available efficacy and safety data makes this an attractive licensing candidate with a compelling product profile. The Company is in active partnering discussions with a number of potential partners and anticipates a licensing agreement in the near-term.
In March, ARYx received written confirmation from the Food and Drug Administration (FDA) of its review of results from ARYx's Thorough QT (TQT) study of the company's oral prokinetic agent, ATI-7505. The FDA indicated that they concur with the company's position that the study was valid in meeting the ICH E14 criteria for the design, conduct and analysis of a TQT study. Also, the FDA concurred that the study met the primary endpoint, meaning that ATI-7505 does not significantly increase the QT interval at the proposed therapeutic or supratherapeutic doses. With these data in hand, along with the clinical and safety results in over 1000 people, ARYx has actively begun licensing efforts with potential partners to complete the development and potential commercialization of this compound.
Data representing the development to date of tecarfarin and budiodarone are being presented at a number of clinical and scientific meetings. A presentation discussing the previously disclosed results of the Phase 2b budiodarone clinical trial will occur tomorrow, May 15, 2009, at the Heart Rhythm Society meeting in Boston. An abstract on the previously disclosed results of the completed Phase 2 studies on tecarfarin was presented at the AC Forum in San Diego on May 10, 2009. Submissions to other major meetings and publications are pending.
Financial Results
As of March 31, 2009, ARYx had cash, cash equivalents and marketable securities totaling approximately $33.0 million which is in line with previous cash flow projections.
For the quarter, ARYx reported a net loss of $9.8 million or $0.36 per share, compared to a net loss of $9.5 million or $0.54 cents per share in the same quarter of 2008.
ARYx had no revenue in the first quarter of 2009 compared to revenue of $1.0 million for the first quarter of 2008. 2008 revenues were earned under the company's former agreement with Procter & Gamble Pharmaceuticals. That agreement was terminated during 2008 with all payments to ARYx fully earned by the third quarter of 2008.
Research and development expenses for the first quarter of 2009 were $6.8 million, compared to $7.6 million during the same period of 2008. The decrease in 2009 is primarily due to the completion of the Phase 2b clinical trial of budiodarone in December, partially offset by higher expenses in support of the company's ongoing Phase 2/3 clinical trial of tecarfarin. With the expected completion of the tecarfarin study in the second quarter of 2009, ARYx's clinical spend on that program will be substantially complete in the company's effort to ready the program for partnering.
ARYx's general and administrative expenses during the first quarter of 2009 were $2.6million compared with $2.9million for the same period last year. The decrease in expense for 2009 is primarily due to lower Sarbanes-Oxley compliance costs, a reduction in general legal fees and lower executive bonus expense.
Conference Call and Webcast Information
ARYx will host a conference call and simultaneous Webcast on Thursday, March 14, 2009 at 8:00 a.m. Pacific Time to review the results for first quarter 2009 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 877-741-4241 Participants outside of the U.S. should dial 719-325-4760. The passcode for the call is 1974909.
Replays of the call will be available through June 30, 2009 at ARYx's Website.
About ARYx Therapeutics, Inc.