Good afternoon, and welcome to the AspenBio Pharma Third Quarter Business Update Conference Call. [Operator Instructions] Please note this event is being recorded. And I would now like to turn the conference over to Joshua Drumm of Tiberend. Please go ahead.

Thank you, Emily, 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, AspenBio issued a news release that provided an overview of its current activities and upcoming milestones. We encourage everyone to read today's news release, as well as AspenBio's quarterly report on Form 10-Q, which was filed last week and is available on the company's website at www.aspenbiopharma.com. If you need a copy of the press release, please call Tiberend Strategic Advisors at (212) 827-0020, and we will email you one. Steve will open the call with an update on the current state of development for the company's in vitro diagnostic test, and he will focus primarily on the preparation activities for the pivotal clinical study, which are ongoing at major hospitals across the United States. Don will then provide an update on AspenBio's progress in preparing for launch in Europe. Steve will provide some concluding remarks, and we will then 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 the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, AspenBio Pharma 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 the company's business. These forward-looking statements are qualified by the cautionary statements contained in AspenBio's news releases and SEC filings, including its Form 10-Q for the period ended September 30, 2012, filed November 7, 2012. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, November 13, 2012. AspenBio 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'd like to turn the call to Steve Lundy, President and Chief Executive Officer of AspenBio.

Thank you, Josh, and thanks to everyone for joining us on the call today. This afternoon, we announced significant news for AspenBio, so I'll just get right to it. We are excited to tell you that we've officially begun the important hospital training phase for our pivotal U.S. clinical study for our blood-based appendicitis test. This is a major advancement for AspenBio because it sets the foundation for clinical success and brings us closer to a potential FDA clearance and commercialization of our in vitro diagnostic test in the United States. Specifically, it means that the first of our hospital sites are undergoing the formal training required to begin recruiting patients into the study. Importantly, it also means that we remain on track to meet our goal enrolling patients before year end. We are actively focused on training the participating hospital sites on the trial protocol, and this will continue over the coming weeks. We anticipate all of our hospital sites will be online and enrolling patients by early 2013. Ultimately, we expect to enroll a total of approximately 2,000 net evaluable patients at approximately 25 hospital emergency departments across the United States. Just to remind everyone, we requested and held a pre-investigational device exemption or IDE meeting with the FDA. During the meeting, FDA gave us valuable input that we incorporated into our final study plans. Our pre-IDE package, which was reviewed by the FDA prior to holding the meeting, described the data from our 500-patient pilot study completed in 2011. This study demonstrated significantly improved performance of the multi-marker test configuration over the results from the test's previous single-marker configuration, exhibiting a negative predictive value of 97%, sensitivity of 97% and specificity of 43%. As we continue our clinical development, we look forward to commencing the pivotal trial,…

Thank you, Steve. We continue to make positive progress in terms of market and business development, both in the United States and in Europe. When we set out to engage hospital sites for our upcoming pivotal U.S. clinical study, we identified and interviewed about 100 sites across the United States, establishing quality relationships with emergency department directors, abdominal surgeons and laboratory staff at these hospitals. From these, we selected our group of approximately 25 hospital sites from across the United States to recruit patients into the clinical study. Additionally, as a critical part of our market development efforts, we continue to visit and cultivate relationships with the other 75 or so sites in order to continue to validate and refine our market assumptions about the clinical utility, pricing, et cetera. Based on these constructive conversations, I can tell you anecdotally that enthusiasm for the product is very high among clinicians. We believe these efforts are a key to our success, and it's my job to make sure they continue as trial enrollment continues into 2013. It is our goal to enter the market having identified 30 to 50 potential buyers, and we believe we are well on our way to achieving that target. Relative to Europe, last week we announced that we've engaged Miguel Vernet to consult with the company as we prepare for European commercialization. Miguel is a seasoned sales and marketing veteran who is based full time in Belgium and will be advising on European business development for AspenBio. As we mentioned in our press release about Miguel's appointment, he was hired by Steve several years ago to lead the European commercial effort for genome sciences. He was very successful in helping to build that business from scratch prior to its acquisition by BD. We have full confidence…

Thanks, Don. I would like to summarize by saying we're very happy with the progress made since our last update. We've taken into account what the FDA had to say about our plans for the pivotal trial and integrated that feedback into our final trial protocol and statistical plan. We are advancing towards commencement of the pivotal trial by formally engaging and training participating hospital sites to begin enrolling patients. We've advanced our negotiations in Europe with potential distributors and are pursuing agreements in key territories. We engaged an experienced Europe-based consultant to assist us with strong commercial effort following our -- obtaining our CE Mark. We're continuing to expand our broad network of key opinion leader hospital sites in the U.S. and Europe in order to develop the market ahead of potential product launch. And lastly, we've continued to scale up manufacturing our product in order to conduct the pivotal trial and support CE Mark and commercialization in Europe. I want to point out this is an ongoing effort that will continue ahead of our anticipated U.S. commercial launch. As we look to the future, we anticipate a number of important developments. First, we look forward to updating you when we commence enrolling patients into the pivotal study. As we've said, this remains on track for occurring before the end of the year. We plan to complete the study, file for marketing clearance with the FDA, and upon receipt of such clearance, be ready to launch the product in the U.S. in late 2013. Right now, we're focused on completing protocol training for the remaining hospital sites and will do so over the coming weeks to advance the patient enrollment. We expect to file for and announce that we have obtained CE Mark for our diagnostic test before the end of the year. Market development is advancing nicely. We have met and are advancing interactions with key European Union, key opinion leader sites, and we are moving closer towards signing agreements with potential commercial distributors. Once CE Mark is obtained, we plan to be in a position to launch the product in Europe. Finally, we are pleased to announce that we will present at the 9th Lazard Capital Markets Healthcare Conference at The Pierre Hotel in New York. Our presentation is scheduled for 2:30 Eastern Time tomorrow afternoon. I look forward to meeting those of you who will be in New York for the conference. As you can see, we have numerous exciting regulatory and development initiatives ongoing as we continue our evolution into a commercial-stage in vitro diagnostics company. This is an exciting time in the company's history and we prepare -- as we prepare to commercialize our first diagnostic product. As always, we thank you for your continued support and look forward to taking your questions. Thanks, again. Operator, you may open the line for questions.

[Operator Instructions] And our first question comes from Mark Massaro of Canaccord Genuity.

I wanted to start, could you describe -- are these more regional distributors in Europe or are these some larger guys that are more household names, if you will?

The distributors that we're looking at in Europe are tend to be more well-known in the country they're in, I guess, to be specific. So if -- I'll give you an example. If I'm working with a distributor in Italy, that distributor will be working specifically in Italy and not outside of those boundaries.

Okay. And could we have an update on -- I know that you have $10.2 million in cash. I know that your burn rate was running somewhere in the $1.6 million per quarter and then possibly rising to $2.8 million when the trial commences. Could you just provide an update on that? Am I pretty close on that ballpark?

Yes, Mark, you're pretty close. We are getting ready to ramp up spending a bit more now, as we have these hospitals coming on board and particularly as we enroll patients. So those estimates are very close. I will remind everybody that when we did raise the $12.2 million back in the summer, our goal was to raise somewhere in the $15 million to $17 million range. So we revised our spending estimates in order to reflect that reality, but we've absolutely not changed our plan for conducting this clinical trial in the most expeditious way possible. And we do believe we have enough cash to get through the trial and submit to the FDA and hopefully very successfully submit to the FDA.

Great. And have you made any adjustments to the trial prior to the pivotal given the last FDA meeting?

We made some changes to the actual clinical protocol itself. We added some things that the FDA recommended we add in the way of collecting certain information. We have not changed the number of patients we intend to enroll. That 2,000 number came from a very rigorous statistical analysis that we performed and that was also performed independently by another statistical analysis firm. So we feel that we've nailed both the protocol as well as the number of patients that we need to enroll and the number of hospitals we need to enroll those patients.

Great. And upon CE Mark in Europe, how should we think about timing and revenues upon launch in Europe?

Well, I think what we want to emphasize is that we are in the stage now where we're identifying key opinion leader sites. And I will say that we are a bit further behind in Europe than we are in the U.S. on this, Mark. So Don is in the process of identifying, like he said, per country, 5 to 8 hospitals, getting distributors onboard that can work with these hospitals, getting comfortable with our product. And I think in the first quarter, we'd like to see revenues start rolling in from those hospital sites. And then as we start to see the uptake, then we can start thinking about guidance for ongoing commercial activities in Europe beyond that.

That's great. And then going back to the U.S. for the clinical trial, what is the mix of hospitals among community, academic and children's hospitals?

I'd say it's a pretty good mix, but probably, I would guess half of the hospitals are community hospitals, midsized to large community hospitals. The rest are split between children's hospitals and what I would call larger academic medical centers. We tried to reflect the entire United States, but also do the recruitment so that we can efficiently conduct the study. So for example, we've got -- I know for a fact, 4 or 5 of the hospitals are in the New England area, for example. So that gives us a mix of hospitals, as well as an efficient way to have the contract research associates do the work they need to do.

Great. And what are your expectations? I know you're hoping to launch in the U.S. before the end of '13. But what are your thoughts on the timing of the trial in the U.S.?

Well, we believe that we can complete the patient enrollment in the 6- to 10-month phase, Mark. And then at that point, we should be very quick to get to a package to submit to FDA, and we'll submit to FDA as soon as we can after that. And assuming that this goes down -- what we think it will go down, which is a de novo 510(k) path, it will be hopefully a fairly fast process beyond that. Obviously, we don't have a lot of control over that part of the process, but that's kind of what we're looking at.

Great. Final question from me. Do you expect to incur sales and marketing costs for the EU launch? And can you help us frame what that amount might be?

Don, do you want to take that one?

We do expect to have some initial sales and marketing costs, Mark. But as Steve alluded to, the first quarter of 2013, those costs will be mainly derived around having what I would call a controlled launch and doing market development with 5 to 8 hospital sites in each of the 5 countries I mentioned. And clearly, the cost will be associated with finalizing the distributor agreements and also finalizing any working relationships that we have in selecting the 5 to 8 hospital sites in the first quarter. So any expenses we have will be related to those areas.

[Operator Instructions] And at this time, I'm showing no questions.

Okay. Once again, I'd like to thank everyone for joining us today, and we look forward to speaking with you again in the new year. Thank you very much.

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