Good morning, and welcome to the Venaxis second quarter 2013 business update conference call. [Operator Instructions] Please note this event is being recorded. Now I'd now like turn the conference over to Joshua Drumm at Tiberend Strategic Advisors. Please go ahead.

Thank you, Emily, and thank you all for joining us this morning. 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. Yesterday morning, Venaxis issued a news release that provided an overview of its current activities and upcoming milestones. Additionally, Venaxis' prospectus filed May 24 is available on the company's website at www.venaxis.com. We encourage everyone to read yesterday's news release. 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 provide an update on recent milestones and give an update on the ongoing pivotal study of APPY1. Don will then provide an update on Venaxis' progress in preparing for full-scale commercialization of the APPY1 Test in Europe. Steve will provide some concluding remarks, and we'll open the call for 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 the 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 prospectus filed May 24, 2013. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, July 16, 2013. Venaxis undertakes no obligation to revise or update any forward-looking statements 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.

Thank you, Josh. And thanks to everyone for joining us on the call today. First and foremost, we will provide an update on our ongoing pivotal study for APPY1, then I'll hand it over to Don, who is joining us on the call today from Europe to provide an update on our market development activities in Europe. I'll start with the clinical update. Yesterday, we announced that the ongoing U.S. pivotal study passed the first of 2 scheduled interim futility analyses under the protocol. The assessment was performed by an external Data and Safety Monitoring Board on the first 579 patients to complete the study, including the required patient follow-up period. The analysis involved an independent review of the validity, integrity and clinical and scientific relevance of the ongoing study, and, following this analysis, the external Data Safety and Monitoring Board recommended that the pivotal trial continue. While the test performance of the study remain blinded to Venaxis, this is an important milestone in the trial and allows us to continue to focus on enrolling the rest of the planned 2,000 evaluable patients as quickly and efficiently as possible. At this point, we have approximately 830 patients who have either completed or currently enrolled in this study, awaiting the required 2-week follow-up, following the release from the hospital with initial diagnosis of negative for appendicitis. We're very pleased to say that the rate of patient enrollment continues to accelerate. The study is now enrolling patients from all of our participating hospital sites, and patient recruitment continues to improve on a month-by-month basis as we continuously work with the sites to further enhance the enrollment process. Based on our experience enrolling the previous 500-patient study of APPY1, which was conducted in 2011, we had estimated the completion of the clinical study…

Thanks, Steve. European market development for our CE Marked APPY1 Test remains an active and an ongoing process for Venaxis. We continue to execute on our milestones and are on track for a full-scale European launch for APPY1 beginning in the fourth quarter of this year. To remind everyone, our market development plan, which we initiated in late 2012 in anticipation of CE marking of APPY1, first involved hiring a highly qualified consultant to be our feet on the ground in Europe with the right commercial skill set and capabilities to connect us with the highest quality partners and leading hospitals. With Miguel Vernet in place, we began aligning ourselves with distributors in key territories that we determined to account for 75% of the in vitro diagnostic market in Europe. We then began establishing strategic market development agreements with these top distributors. In these agreements, we outlined clear milestones that included validating the size of the market opportunity in each territory, identifying and engaging the top 5 to 8 key opinion leader hospital sites as candidates for conducting clinical and economic outcome studies, as well as vetting and establishing relationships with additional hospitals as high-priority sales targets. The goal is twofold. First and foremost, it is to fully understand the impact of the APPY1 Test on the clinical workflows and economic outcomes in each territory and to generate a robust and objective body of evidence that fully demonstrates the value of the APPY1 Test for all types of hospitals. These include university, community, children's or general-type hospitals. Second, by engaging target hospitals in each territory, we expect to build customer demand for APPY1 ahead of the full launch, which will allow us to hit the ground running in terms of selling APPY1 through specialized distribution partners. These targeted hospitals identified…

Thanks, Don. I'll conclude by reiterating our commitment to gaining U.S. regulatory clearance and developing a market for APPY1, which we believe has potential to improve the way emergency physicians manage their patients who present with abdominal pain. Despite the time needed initially to bring our hospital sites up to speed, our pivotal study is going very well and is enrolling patients at an accelerating rate. We are also continuing to meet our commercial milestones in Europe, as Don mentioned, and the positive feedback and enthusiasm we're seeing from our partners and potential customers has been very encouraging and continues to amplify as we're able to further develop the market. In closing, I'll reiterate that we have the capital to achieve major regulatory and commercial milestones we have set for ourselves. Through a prudent use of this cash, we believe we have the financial resources to execute on our plan. With that said, we look forward to taking your questions. You may go ahead, operator. Thank you.

[Operator Instructions] Our first question will come from Jeff Frelick of Canaccord.

Steve, maybe first question on enrollment. Can you give us a sense how many patients you're enrolling currently per month? And you had mentioned some acceleration. Do you -- can -- expect that acceleration to kind of continue as we get through the summer and into the fall?

Yes, I think we do, Jeff. I mean, right now, the rate that we've seen over the last month has been about -- has been 200 patients or so per month, give or take. And what we've done is we've -- as you, I think, know, we enrolled initially 28 hospitals in the study, and we did an evaluation after the first few months. So several of these hospitals were not enrolling at the rates we had hoped, and we are actively replacing them with other hospitals that we think will accelerate -- that have a huge potential to accelerate enrollments. So that's -- I think that's one factor. The other factor is just getting the hospitals up to speed, as I mentioned. There were several things that we identified early in terms of getting these hospitals to enroll at the max level. For example, a lot of these hospitals are university hospitals, and one of the enrollment criteria is that there be no imaging performed or actually received -- the results received before a patient is enrolled. And many of these hospitals being academic hospitals, they're starting with an ultrasound, and one of the things we had to do was counsel them on how to enroll the patients prior to the physicians getting the ultrasound results. And that's just an example of something that really did kind of hold back enrollment as we started. So that's just one example. So between those 2, additional hospitals being recruited into the study and just really helping the hospitals with the enrollment criteria, we think we'll accelerate quite significantly beyond where that 200 or so a month is today.

So if it's sub-28, can you share how many hospitals are contributing to the study right now?

Well, all of the hospitals are contributing, Jeff. It's just that some of them were contributing at levels below our expectations. For us to really -- for it to be a feasible hospital -- I mean, remember that we have contract research associates that are going out to these hospitals on a regular basis and collecting their data, auditing their databases and so forth. They need to be contributing 3 to 4 patients a week, and some of these were contributing let's say 1 to 2 a week. And that's just wasn't acceptable, so we elected to, in some cases, close down a couple of hospitals and enroll new ones.

And can you just maybe elaborate a little further on the changes to the enrollment criteria that you cited in your opening comments from FDA?

Yes, the main one, Jeff, was we wanted to exclude the very high-risk patients. And so those were the patients that, if you remember our CP-11 [ph] study, that would have gone directly to a surgical consult anyway. We -- the FDA felt that there -- and we agree that those patients probably aren't the best candidates for the test. So as we've seen from the prevalence data from the study, the prevalence has gone from a 29% rate of appendicitis in CP-11 [ph] to about a 23% in the study. So that was something we had to get our arms around as well. That actually was -- we are quite happy with that. 23% is, we think, right on target, and that's something we really wanted to monitor very closely to make sure we're on track. So that was the biggest difference.

And that's fairly close to real world, right,Steve?

Yes, yes. We -- when we did our statistical analysis plan, Jeff, we anticipated somewhere between 20% and 25% prevalence, and we're right in the target. So that's really good news actually.

Okay. And then just 2 quick questions for Don on Europe. So how many -- Don, can you maybe share how many hospitals you currently have signed up for the short clinical studies?

Presently, we have 5 hospitals identified, and all 5 are in different processes, steps of signing on the dotted line, Jeff. And let me clarify that. It's -- I mean, I'm here just to make sure that we do finish that and we start the study imminently [ph] in a majority of them. So none have signed on the dotted line yet, but I expect imminently that they will move very quickly in that direction. It's a process.

Okay. And then you talked about 3Q starting to see publications come out of these studies. So is this -- will this be kind of a rolling publications, maybe one appears in late September and then subsequent months we'll see some additional studies come out?

I would think that would be a logical approach to it because there -- obviously these hospitals, I mean, they have different -- just to give you a flavor, and I think you know this as well, I mean, Ethical Committee have to meet and approve the study, right? And emergency people, lab people are ready to sign off, but they need to have the Ethical Committee review. So not all hospitals have that review at the same time. So that means that some will start different times and finish different times, so your explanation is pretty accurate.

So when do you expect -- now that you have 4 distribution partners covering multiple countries throughout Europe, when do you expect to have a study basically arming each distributor partner? When will that occur? Early '14?

No, I would hope in the fourth quarter. I have a study going in each of those territories.

Our next question comes from Yi Chen of Aegis Capital.

My first question is based on the current enrollment speed. Is it likely that we will see the result from the second futility testing early fourth quarter this year?

Well, if you look at -- just to give you a -- Just to go back, we got, as I mentioned, about 830 patients that are enrolled now. So we've got approximately 400 to go. And at a rate of -- accelerate above the 200 a month we're doing today and look at a follow-up of, say, 3 weeks after that to get all the database closed, so that's probably -- we're looking at 2 months from now or so.

Second question is, could you give us some color on the pricing for testing the EU area?

We haven't established pricing yet in the EU. I think we've guided in general that we're probably targeting somewhere in the $75 to $80 range. Now the pricing in EU will be probably about 25% to 30% less of that because we'll be transferring the -- the distributor will be buying the product at a discount and selling it after that. So you see, we've modeled ASPs in Europe somewhere in the $40 to $50 range. We have not finalized a pricing yet either in the U.S. or in Europe. I think that's one of the reasons why these studies that Don refers to are very important. And we are going to be conducting a study -- similar study in the U.S. as well. So -- but we -- I think those prices probably will fall into that range.

Okay. My final question is what's your current estimate for cash runway?

Well, we've got, as mentioned at the end of the second quarter, about -- some $20 million in cash, and I think you can estimate approximate burn going forward about $1 million a month. So that kind of gives you our runway, which is approximately 1.5 years or so. That assumes -- that's without any revenue. So to the extent that we can mitigate that burn through rising revenue, which we do believe will be -- starting to take place in the fourth quarter and accelerating in 2014, obviously that burn would be mitigated to some degree.

Okay. When you plan to file the 10-Q?

It will be approximately August 8 or 9.

[Operator Instructions] And this concludes our question-and-answer session. I'd like to turn the conference back over to Steve Lundy for any closing remarks.

Thanks for everybody -- to everybody for joining the call today. We certainly look forward to updating you next quarter and when we have our next futility analysis. So thanks again. Have a great day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.