Cardiff Oncology Inc (CRDF) 2015 Q1 法說會逐字稿

Good day, and welcome to the Trovagene first quarter 2015 financial results conference call.

(Operator Instructions)

Please note this event is being recorded.

I would now like to turn the call over to Mr. Stephen Zaniboni, Chief Financial Officer of Trovagene. Please go ahead.

Thank you for joining us on our first quarter 2015 conference call.

Trovagene is focused on developing and commercializing our Precision Cancer Monitoring platform, which detects DNA mutations in urine and blood with very high sensitivity. Our liquid biopsy platform provides oncologists with important clinical information that can guide treatment decisions by determining patients' mutational status, response to therapy and resistance to treatment over time.

The body of clinical evidence supporting our cancer monitoring platform continues to grow as additional results from our clinical study collaborations with major cancer centers becomes available. These efforts will in turn support our commercialization program, which will officially launch this month and should gain momentum throughout the year.

The benefits of our PCM platform are becoming apparent, with data presentations at several major cancer meetings this year and additional manuscripts to be published in peer-reviewed journals. Our intellectual property estate protecting our technology is strong and growing, and includes methods of extracting, purifying, preparing and detecting circulating tumor DNA in both urine and blood.

Before moving on, I must remind you of the risks inherent in our business and ask you to consider the following information regarding forward-looking statements. Statements in this call about the Company's expectations, applications of its technology, markets, launch of tests and other statements that are not historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934 and are based on management's current beliefs, assumptions, estimates and projections.

Actual results may differ materially from those projected in forward-looking statements for various reasons, including risks associated with product and diagnostic test development, government regulation, market acceptance, limited commercial experience, dependence on key personnel, obtaining health insurance reimbursement, obtaining financing and other factors discussed in the Company's periodic reports filed with the SEC.

With that said, the format of this call will be as follows. First, our Chief Executive Officer, Toni Schuh, will review the Company's recent achievements and discuss the potential of our technology to change the standard of care for cancer treatment. Next, Mark Erlander, our Chief Scientific Officer, will provide updates on both our R&D and our clinical development programs.

Our Chief Commercial Officer, Matt Posard, will then make some brief comments about our commercialization program and our efforts to begin penetrating the oncology market. And, finally, I'll summarize our financial results and review our goals and objectives for 2015. A question-and-answer session will follow the call.

I'll now turn the call over to Dr. Toni Schuh, Trovagene's Chief Executive Officer.

Thank you, Steve.

We have said previously that 2015 will be our coming out year, and we are executing on this path. In February we completed an institutional equity round, raising $23 million in gross proceeds. Beyond strengthening our balance sheet, this raise significantly increased our institutional shareholder base and broadened our research analyst coverage.

We significantly expanded our commercial operations team under the leadership of Matt Posard, who joined us from Illumina in March. The commercial team is now 13 professionals strong, with 5 market development specialists in the field.

We released clinical data demonstrating clinical utilities for our Precision Cancer Monitoring solution in major cancers -- in major cancer indications at three conferences. At the European Lung Cancer Conference in mid-April our clinical collaborators from UCSD Moores Cancer Center presented strong data demonstrating that we outperform tissue biopsy in determining T790 mutational status in patients with progressing lung cancer under EGFR inhibitor treatment. We have previously shown that we outperform tissue biopsy in histiocytic disease.

At the ASCO GI meeting in January and AACR in late April we presented study results for the detection and monitoring of driver mutation in pancreatic and colorectal cancer. The data demonstrate the clinical utility of our cancer monitoring platform in these highly prevalent cancers.

We completed CLIA validation for three new EGFR mutation assays, and these assays are now available for patient testing.

We added Moores Cancer Center and City of Hope as clinical sites to our lung cancer study program, which plans to enroll 700 patients in the aggregate.

Our strong clinical performance leverages three key advantages of our proprietary platform. First, our assays are extremely sensitive and optimized for highly degraded target DNA. Second, urine as a specimen enables the collection of very large amounts of circulating tumor DNA. As such, in urine we simply have a better chance to capture oncogene mutations that occur in low abundance. Third, we can obtain patient samples quite frequently. Our impressive ability to observe efficacy signals within days of delivering a new treatment leverages this advantage.

Let me say a few words on the importance of sample volume and DNA quantity. The clinical community has recognized the promise of liquid biopsies, and in particular circulating tumor DNA, for better cancer monitoring.

However, as of today, most clinical data generated involve late-stage cancer patients with relatively abundant circulating tumor DNA in their blood. As patients respond to effective therapies, the mutational signal is often reduced to very faint traces. And, of course, eventually we want to use this technology in earlier disease stages, with much weaker mutational signals in the patient circulation.

Experts in the field agree that input DNA limitations are posing a real challenge here. Urine as a specimen addresses this limitation very effectively, and in our view will become the specimen of choice for this reason alone.

To use a metaphor, detecting driver mutations in circulating tumor DNA from a blood sample can be compared to searching for a needle in a haystack. Compared to a 10-ml blood sample, the 100-ml urine sample represents a 10 times larger haystack, and as such a 10 times better chance to have a needle or a few needles in there. The same holds for oncogene mutations.

Our proprietary enrichment technology takes this now a step further. In keeping with the haystack metaphor, our enrichment process essentially removes most of the hay and multiplies or amplifies the few needles in the haystack. At this point the needles become easily visible. They become obvious.

For our Precision Cancer Monitoring process, the combined advantage of large circulating tumor DNA input and targeted enrichment translates into very high clinical sensitivity when it comes to detecting and quantifying a driver mutation of interest in a patient sample. Our urine-based assays simply have a better chance of detecting and tracking mutations with low abundance.

Now, a key component of our coming out plan is the launch of our field force and the marketing launch of our Precision Cancer Monitoring solution. Let me make a few comments about the commercial operations team in place to execute on this.

As stated before, our team has been expanded to a head count of 13 professionals. We are excited that we have been able to attract top talent to develop the market for urine-based cancer monitoring solutions. Matt Posard is a highly accomplished leader with deep experience in commercializing clinically innovative diagnostics at Biosite and a game-changing DNA analysis platform at Illumina. We have also appointed Rob Kelley as VP of Marketing and Nick Nelson as Head of Market Development. Both joined from Illumina, as well.

As we speak, our market development specialists have completed their training and are starting to reach out to hospitals and physicians. Matt will provide more information on his team's immediate plans later in the call.

Cancer monitoring using causative or driver mutations as biomarkers to measure tumor dynamics in near real time has the potential to significantly improve patient care. We remain focused on establishing our Precision Cancer Monitoring platform as the leading disease management solution in the field.

As stated before, we are expanding demonstrated clinical utility from histiocytic disease, our introductory model indication, to highly prevalent cancers such as lung, colorectal, pancreatic and skin cancer. We anticipate offering a full range of mutation assays for clinically validated and actionable driver mutations in these cancers within this year.

Now I will turn the call over to Mark Erlander, who will provide an update on our research and development activities and our clinical programs.

Thank you, Toni.

The primary objective of our clinical development program is to demonstrate utility for noninvasive, near real-time detection and monitoring of oncogene mutations for any tumor type with our platform. To that end, we have ongoing programs with 15 top-tier cancer treatment centers, which will result in multiple opportunities for data presentations later this year as well as throughout 2016.

In June we have four accepted abstracts for presentation at ASCO and one abstract accepted for the AACR Precision Medicine meeting of Integrating Clinical Genomics in Cancer Therapy. In addition, in the fall of 2015 we expect to have data presentations at the World Conference on Lung Cancer, the European Society for Medical Oncology meeting, and the AACR-NCI-EORTC International Conference on Molecular Targets in Cancer Therapeutics. In terms of manuscript publications, our plan is to have three submitted to major cancer journals by the third quarter of 2015.

As Toni mentioned earlier, we have presented several meaningful data sets from clinical studies so far this year at the ASCO GI Cancer Symposium in January and in April at both the European Lung Cancer Conference and AACR. Results from all of these studies demonstrate that our proprietary assays enable physicians to determine mutational status and monitor treatment response in lung, colorectal and pancreatic cancers. From all of these presentations I want to highlight results from two studies which generated significant interest.

In lung cancer we reported in an oral presentation that our urine-based T790M assay detected the mutation in more patients relative to tissue biopsy, which could inform clinicians on which patients are candidates to receive therapy with next-generation EGFR inhibitors. Additionally, longitudinal monitoring with our assay demonstrated that detection of the T790M-resistant mutation was possible up to three months prior to progression observed with imaging. Most intriguing, we demonstrated that daily monitoring of patient urine samples enabled the detection of significant tumor cell death within days of the patient receiving targeted therapy.

At AACR we presented technical data regarding our PCM platform which indicated that urine samples from a population of cancer patients contains 10 times more DNA than was observed in plasma. We are currently leveraging greater numbers or greater amounts of DNA in urine to demonstrate increased sensitivity using urine as the liquid biopsy sample. In addition, we demonstrated single-copy detection for our assays with linearity, thereby both enabling high sensitivity for detection plus quantitation for our patient monitoring.

On the platform development front, we recently advanced three new assays into our clinical lab to detect and monitor EGFR mutations, which are common drivers of lung cancer and treatment resistance. We currently have five urine-based oncogene mutation tests available in our clinical lab, including those that detect BRAF V600E, the KRAS oncogene mutations, as well. We have additional active oncogene mutation assay candidates in our pipeline, each of which is planned to be transferred into our clinical laboratory and become available to clinicians during 2015.

We've had a strong start to the year, and we are beginning to build momentum in the medical oncology community. We remain focused on expanding the assay menu for our PCM platform and continuing to build the clinical evidence to support our platform and drive adoption by oncologists.

Thanks for your attention. Toni, I'll hand it back to you.

Thank you, Mark.

Before we move to Steve and the financial review, I would like to introduce Matt Posard, who joined Trovagene as our Chief Commercial Officer in mid-March. Matt has over 20 years of experience identifying, directing and successfully commercializing innovative technologies in the molecular diagnostics and the life science fields. Most recently he led the new and emerging market opportunities business at Illumina. Welcome, Matt.

Thank you, Toni. I'm very excited to be here.

I've always been motivated by the application of great technology to help clinicians address unmet medical needs, and I truly believe our technology can do just that with the management of cancer patients. Since I joined about a month ago we've made a lot of progress. We've already added new key leaders on the commercial team, including heads of marketing and market development. Our inaugural clinical field team completed their training about a week ago and are now in the field.

We've fine-tuned our strategic and operating plans and have already created new branding and sales tools, a scalable CRM tool and a new website. I am highly confident that our PCM platform and the clinical data we've generated thus far will allow our team to quickly begin executing on our commercial goals. I will now outline some details for our go-to-market strategy and plans.

Clinical awareness of liquid biopsies using circulating tumor DNA is currently very high, and we intend to leverage this by focusing on two primary strategic objectives. First, we will establish Trovagene as a credible liquid biopsy provider in the oncology market and distinguish ourselves through our commitment to demonstrating value through compelling clinical evidence. Second, we will ensure that the market understands that urine is not only a viable sample type for measuring mutant DNA but is the optimum sample type, for reasons outlined earlier by Toni.

We believe that our PCM platform will emerge as a standard of care one day, but it will require smart market development and responsible go-to-market plans. As Mark just outlined, our first step was to partner with major academic institutions and leading cancer centers to produce compelling clinical data. As we enter our initial commercial phase, we will also begin working with influential early adopters who need to gain clinical experience with their patients using our PCM platform.

We also have plans to work with payers and to provide them with evidence of the clinical and economic benefits associated with the use of our products and services. And, lastly, we are addressing the short, medium and long-term regulatory requirements both within the United States and abroad.

Our immediate priority is for our market development team to establish product evaluations among carefully selected clinicians who are influential at both the local and national levels. These include a balance between clinicians practicing at prominent comprehensive cancer centers as well as those in local community oncology practices. As we go forward and implement this strategy I plan to provide metrics on future calls so that our commercial progress can be appropriately benchmarked.

Thank you for your attention. I'll now turn the call over to Steve Zaniboni to present the financial results for the recent period.

Thanks, Matt.

Financial results for the first three months of 2015 are as follows. For the first quarter, ended March 31, 2015, Trovagene reported a net loss of $7.2 million, or $0.33 per share, as compared to a net loss of $3.2 million, or $0.17 per share, for the three months ended March 31, 2014. The increase in net loss is primarily due to increased operating expenses and changes in the fair value of derivative instruments.

Operating expenses were approximately $5 million for the first quarter, as compared to $3.4 million for the same period in 2014. Operating costs include noncash expenses related to stock-based compensation of approximately $712,000 and $560,000 in the respective periods.

Also impacting the net loss was a noncash change in the fair value of derivative instruments. The first quarter of 2015 included a change that resulted in a loss of $1.9 million, as compared to a gain of $33,000 for the same period last year.

As our stock price rises, the accounting liability from certain derivative instruments rises, as well, causing a noncash drag on our net earnings under generally accepted accounting principles. Without the derivative liability impact in the period our net loss would have been $0.24 per share.

The net cash used in the first quarter was $5 million, consistent with our internal expectations.

Shares of common stock outstanding used to calculate per share results increased to 24.3 million shares from 18.9 million shares in the prior-year period due to our common stock offering of approximately 5 million shares that was completed in February 2015.

On March 31, 2015, Trovagene had cash and cash equivalents of approximately $44 million, compared to $27 million on December 31, 2014. In February 2015 the Company raised approximately $23 million in gross proceeds through a common stock offering. We believe that our current cash position is sufficient to fund operations well into 2016.

Now turning to our goals for 2015, we plan to introduce and gain adoption of our PCM platform among strategically selected clinicians and institutions, complete and conduct additional clinical studies at major oncology centers and through collaborations with integrated healthcare networks, present and publish clinical results for studies using Trovagene's PCM platform as they become available, complete CLIA development and release additional urine-based assays to expand Trovagene's liquid biopsy platform for the detection and monitoring of multiple clinically actionable oncogene mutations, and enter into additional R&D and commercial collaborations with pharmaceutical companies.

In conclusion, Trovagene is well positioned to leverage its investment in its intellectual property, clinical study programs and its collaborations to build a better clinical pathway for cancer monitoring. We believe that upcoming data presentations at medical conferences and publications in peer-reviewed journals should begin to drive early adoption of our technology later this year.

This concludes our prepared remarks. Operator, we are now ready for the question-and-answer session.

(Operator Instructions)

Paul Knight, Janney Capital Markets.

This is actually Bryan Kipp on behalf of Paul. Congrats on all the publications, all the data, etc., very impressive. In light of that, Toni, what was -- have you guys seen any incremental calls, discussions with customers, clinicians, etc., in light of your AACR data? There was a lot of buzz around that. Just want to hear about any pacing or post-follow-up discussions that you guys had.

So maybe as an introductory comment on that, I was personally not at the conference, but Mark Erlander and Rob Kelley, our VP of Marketing, they were there. And maybe, Mark, you want to describe how the clinicians responded to the data that were shown and how they responded to the fact that you can actually do this at this quality level from urine as a sample.

Yes, I mean, we presented back to back at the European Lung Cancer Conference in Geneva, then came right to AACR in Philadelphia and presented data there, as well. I think that what I would say a general reaction which has followed since then is a -- I would say a pleasant surprise and an excitement by physicians and KOLs that really urine is a very viable specimen, and beyond being viable, particularly in the study that we showed where we could monitor daily to show efficacy of these third-generation TKIs in non-small cell lung cancer.

I think overall there's really a -- there's an excitement. We are -- for the use of urine because of its noninvasive nature and also the large amount of DNA that you can get from that sample and the ease of frequency of testing. That's the general comment.

That's the general comment. And specific for us, this was, of course, from a timing perspective very important that we could show at the European Lung Conference once again that we are actually outperforming biopsy in terms of determining mutational status, that they cannot serve response very fast, and at the AACR meeting, where we could show compelling data specifying that we get an order of magnitude more DNA from a patient.

These two data sets are, if you want, so actually enabling for our initial field force to go out and get meetings. And, although it's still early, they're getting their meetings. Let's put it this way.

Appreciate it. I guess my one follow-up is Matt coming online from Illumina and has the extensive background here, just general commentary, I'd love to hear and see what's under the hood and did his due diligence. What really -- obviously you guys have a very novel platform, but just his personal anecdote on as he looked under the hood why he came in and why he was really, really intrigued by the opportunity would be very interesting.

Yes, sure. I said this in my remarks, and I think I've been consistent with this even behind the scenes. I've been pleasantly, pleasantly -- well, frankly, surprised. You tend to see things once you come onboard that you didn't get to uncover in the due diligence. And honestly what I'm seeing behind the scenes is the data we've got generated publicly is extremely consistent with the data that we haven't published yet.

So the ability for us to detect circulating tumor DNA in urine for me was counterintuitive, Bryan, that there would actually be more DNA in urine from a collected sample than there would be in blood, and that the quality from the short reads that we're detecting in these DNA fragments actually adds to the sensitivity and our ability to quantify it. So I feel like the team has the right tools right now for us to get the initial adoption outlined in our goals, and very confident that the publications and the additional data that's planned this year is going to just give us more tools to sell from.

Appreciate it very much.

Bill Quirk, Piper Jaffray.

I guess just a question for me about how we should think about the pacing of additional data here over the coming months and kind of over the end of the year. And I guess I'm specifically thinking about some of the clinical utility and maybe some of the economic utility that Matt referenced. Thanks.

Mark, do you want to speak to the timing?

Yes, I would say that the timing is that we are going to be presenting much larger data sets in the fall of this year. We are -- we also are presenting or just about ready to present our first study in looking at the health economics within lung cancer.

And so we're -- really we're driving -- we're spending a lot of our time and energy focusing on the lung cancer paradigm and really demonstrating the health economics and the upside of using a urine sample to detect and monitor the T790M mutation. So that's kind of where we're -- Bill, that's where we're really going right now and really driving and spending a lot of our resources.

Got it. And then I guess just thinking, too, about the 21 new NGS codes that were released, obviously we're coming up, supposedly, anyway, on the initial pricing of those here at the end of the month, recognizing that that's slipped, but nevertheless we're going to get some data points here soon. How should we think about this whole process in conjunction with your longer term panel strategy? And do you see any risk to where reimbursement numbers are currently? Thanks.

So maybe I start this, Bill. So we of course are, if you want, so in a hybrid situation. The NGS panel codes, they apply to us, if you want, so somewhat, because in the essence we are using NGS today as a detector, not really as a -- in the way this was originally designed for as a sequencing platform. We use it as detector, and we leverage the enormous specificity that we get out of that detector, and we have PCR in the sample prep.

So our objective is really to move as fast as we can towards a not otherwise classified status and from there to negotiate towards our own CPT codes that we believe are supported by clinical utilities that is very hard to demonstrate for our competition. I mean, for example, I do not believe that so far any other player in the circulating tumor DNA space has been able to consistently show that you outperform biopsy when determining mutational status.

I also do believe that no other party has been able to show that we can observe treatment-related changes in tumor dynamics that are indicative of response within days of changing a treatment. So we really believe that we are carrying the banner here in terms of demonstrating clinical performance and offering novel utilities, and we want to very aggressively move towards our own code.

At this point in time we have limited experience with billing. I mean, we have sent our first set of bills out, and the reaction of the payers runs the gamut from paying what we asked for to not paying anything, as you would expect. And that's the process that we expected and, frankly, the process that we want to see. We want to have a good reason to argue with payers.

Understood. Very good, guys. Thanks a lot. Appreciate it.

(Operator Instructions)

Bryan Brokmeier, Maxim Group.

Toni or Matt, Toni, you were just talking about your -- the little bit of interaction that you've had so far with payers. With only a few tests you did recognize the first product revenues this quarter. Were the payers actively engaged by you, or was payment made without direct interaction required by you?

When you're that early in the process there's no direct interaction, right. You send your bill out and you sometimes succeed and you sometimes don't. I think it would be an over-interpretation to assume that at this point in time somebody dug deep into the science and made the decision on that basis.

So have you -- particularly on those ones where you were not paid, have you reached out and gotten in front of the appropriate people at those payers in order to discuss the data that you have and the reasons why they should consider reimbursing?

Given how close to the real-time events you are, correct formulation will be certainly we will reach out and are reaching out to every single payer who didn't pay our full bill. That is something that we had anticipated, and I'm saying it again, that's essentially the discourse you want to have to open up the negotiations.

Okay. A question that I continuously get and something that I still need to better understand is given the increasing number of companies that are trying to get into the space -- granted, none of them that I know of have technology that allows them to test the urine, they're fully focused on blood -- but you mentioned your strong and growing IP protection.

I'm not a patent attorney, but there are a lot of different types of patents, some of them more defensible than others. Could you provide some of the details on what the key attributes of your IP are that gives it such a strong position compared to other patents that you may also have?

So let's start with our weakest patent asset. We know since the Supreme Court rulings around Prometheus and around Myriad Genetics that traditional older patents that are very close to covering a law of nature, that these patents are not necessarily very strong. I do believe that our very first transrenal DNA patent may be -- may be in proximity of this.

But when you go beyond this, the way how you extract DNA from urine, you are after the very short DNA fragments. That's counterintuitive for traditional DNA analysis. Traditional DNA analysis desired long fragments. So the methods that we have developed to selectively obtain the small DNA fragments where we have reason to believe that they stem from the systemic circulation, these are very strong method patents. We believe we own that.

The methods that we have developed to purify these DNA samples, to get rid of all the other components that you would find in urine that interfere with your ability to detect the sequence effectively, we own that.

And then as you go towards enrichment, the enrichment primers that you design immediately adjacent to a mutation of interest has virtually very -- in many cases not one degree of freedom to be changed, because you are on such a small lot of real estate that you simply can't move these primers up and down the sequence and modify them. So these primers that all have a synthetic tail to them, so they are not naturally occurring sequences, provide you with strong proposition of matter IP.

And then as you learn about what changes in tumor DNA, in circulating tumor DNA, really mean clinically, which of course requires that you are able to measure that reliably, you will develop proprietary methods to determine how to clinically interpret an observation.

And so I do believe we have down this whole analytical and diagnostic process a range of strong method and actually even composition of matter IP that protects us.

Yes, I mean, Bryan, I would only add that we are aggressive in this area, and we do believe through our patent counsel that not only the patents that have been issued but the ones that are pending currently, in essence, what Toni said, we cover from the start of the urine sample to the monitoring of the cancer patient. From urine through methods and composition of matter patents and patent applications we believe that we have a very strong fortress in this area.

And maybe as a side note to that, Bryan, I'm sure you are observing that, and we are observing this now, as well, as circulating tumor DNA moves towards the center of attention -- I mean, Eric Topol here in San Diego has referred to cell-free DNA in oncology to the stethoscope of the next 200 years. So I think there can be no question that circulating tumor DNA will become as important in oncology as circulating fetal DNA has become in noninvasive prenatal testing.

However, as that emerges we now start to see the controversial discussion developing amongst the different groups that are participating in that field, and we feel kind of vindicated by what people point out to. In the essence, what you hear from leading players in the cancer genomic field, in the cancer sequencing field, you could summarize that as there are sensitivity issues with next-gen sequencing by itself and there are sample issues with circulating tumor DNA derived from blood.

And we have for years now stated you need to try the analytical sensitivity higher, hence enrichment. And we have for years now stated you need to optimize the amount of input DNA so that you can leverage the higher sensitivity of analytical readout, hence urine as a sample. So we are actually quite pleased to see how this field moves in general and how the participants in the market, through their discussions and through their controversies, are validating our approach.

Thanks. And just quickly back to reimbursement, you -- do you have any claims, is anybody working on reimbursement on any claims readjudication companies that you've engaged in order to further drive reimbursement?

Yes. So we have a third-party billing company, XIFIN, who's very experienced in the diagnostic field. So I would say XIFIN is doing the interface with the payers, which they have an excellent system set up to do that.

Internally we have to develop all of the materials that support our health economic argument, and we provide that to the payers and also to XIFIN as they're communicating and interacting, and that will ultimately lead to these face-to-face discussions and sessions with the top payers.

And as we begin now to move into larger cancer indications like lung cancer we have actually already a year ago begun, we have commissioned a study to a leading health economic consulting firm in the country, Health Advances, and their findings that relate to our health economic performance in lung cancer will actually be presented in Washington tomorrow.

So this was pretty extensive work that shows that relative to tissue biopsy in lung cancer, the economic benefit of the Trovagene assay, which, I have to repeat myself, does not require you to compromise for quality, right, when you go from the biopsy to the cell-free DNA, we're actually better than biopsy, so, but at the same time we can serve -- we can save the healthcare system more than $10,000 per avoided biopsy procedure, because we also -- not only do we avoid the direct cost, we avoid the very significant comorbidity that comes with these biopsy procedures -- prolapsing lungs, infections, pain and so on.

Okay. Thanks a lot. Appreciate it.

(Operator Instructions)

Showing no further questions, this concludes our question-and-answer session. I'd like to turn the conference back over to Dr. Toni Schuh for any closing remarks.

Well, thank you all for your interest in Trovagene. We are having a lot of fun here this year, and keep watching us. Keep watching us. Thanks.

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