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Q4 2012 Earnings Call
March 26, 2013 4:30 pm ET
Stephen T. Lundy - Chief Executive Officer, President and Director
Donald R. Hurd - Chief Commercial Officer and Senior Vice President
Jeffrey Frelick - Canaccord Genuity, Research Division
Yi Chen - Aegis Capital Corporation, Research Division
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Thank you, Yosef, and thank you, all, for joining us this afternoon. With me on today's call are Steve Lundy, President and Chief Executive Officer; Jeff McGonegal, Chief Financial Officer; and Don Hurd, Senior Vice President and Chief Commercial Officer. This afternoon, Venaxis issued a news release that provided an overview of its current activities and upcoming milestones. Additionally, Venaxis' annual report on Form 10-K was filed this afternoon and is available on the company's website at www.venaxis.com. We encourage everyone to read today's news release, as well as the annual report. If you need a copy of the press release, please call Tiberend Strategic Advisors at (212) 375-2686 and we will email it to you.
Steve will give an update on recent milestones and the ongoing pivotal study of APPY1. Don will then provide an update on Venaxis' progress in preparing for full-scale commercialization of APPY1 in Europe. Steve will provide some concluding remarks and we will open the call for a question-and-answer session, where Steve, Jeff and Don will be available to take your questions.
Please note that certain of the information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Venaxis management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with this company's business. These forward-looking statements are qualified by the cautionary statements contained in Venaxis' news releases and SEC filings, including its 10-K for the year ended December 31, 2012, filed today, March 26, 2013. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, March 26, 2013. Venaxis undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date of this conference call.
Now I would like to turn the call to Steve Lundy, President and Chief Executive Officer of Venaxis.
Stephen T. Lundy
Thank you, Josh, and thanks to everyone for joining us on the call today. I want to start by highlighting some of our major accomplishments over the last few months, many of which have transformed the company and positioned us for success in the future. Most importantly, we made good on a number of important promises, the most significant of which is the initiation of our pivotal clinical study for APPY1 in the United States. But before I talk about the study, I want to quickly highlight that this is our first conference call as Venaxis Inc., having completed our corporate name change in the fourth quarter last year. We view this corporate rebranding as an important part of our future as a pure play, commercial stage in vitro diagnostic company. And we are very pleased to be addressing our shareholders for the first time under our new corporate identity.
Now on to the clinical trial update. We announced toward the end of the year that we'd been -- begun training hospital sites. And shortly thereafter, we announced that the first patients had been enrolled. As of now, enrollment into the APPY1 pivotal U.S. clinical study is expected to continue across the 28 participating hospital sites through much of 2013. Based on current projections, we anticipate completing the study and potentially filing with the FDA for clinical regulatory clearance of APPY1 by the end of the year.
As we've mentioned on previous calls, we plan to enroll a total of 2,000 net evaluable patients. It took a lot of hard work to get to this point, and we appreciate the commitment from our product development team, which made significant contributions to improving the performance of the test, also our manufacturing team and our regulatory affairs team. We also appreciate our meetings with FDA, who, just to remind you, provided valuable guidance and insight into the design of the pivotal study, both at our pre-IDE meeting and in subsequent follow-up.
Today, APPY1 utilizes a multi-marker -- multi-biomarker test configuration with improved performance that has been validated in more than 500 patients through successful pilot study. We did not want to go to FDA until we had the right product to meet the current needs of emergency physicians to treat abdominal pain, and we believe we have that product in APPY1. Now that we've advanced to our pivotal study, our primary focus is on completing efficiently and expeditiously, ensuring the highest quality data, which we intend to submit for FDA clearance of the test in late 2013.
Another major focus continues to be on market development, which we believe will be critical to the success of APPY1, both in the U.S. and overseas. In the U.S., we're continuing to cultivate relationships by growing network at hospital sites, many more than are participating in our pivotal study. Our goal is to amass significant market insight and other key intelligence in order to maximize potential uptake of APPY1 when we launch the test following regulatory clearance. I want to reiterate from our last call, it is our goal to enter the market having identified 35 to 50 potential hospital site buyers in the U.S. Thanks to our continued investment in commercial market development, we're moving ever closer to achieving that target.