Cardiff Oncology Inc (CRDF) 2016 Q3 法說會逐字稿

Good afternoon, and welcome to the Trovagene third quarter 2016 earnings conference call.

(Operator Instructions)

Please note this event is being recorded. I would now like to turn the conference over to Beth Anderson, Vice President of Finance and Administration at Trovagene. Please go ahead.

Thank you for joining us today on our third quarter 2016 conference call. Joining me today are Bill Welch, Chief Executive Officer, and Mark Erlander, Chief Scientific Officer.

We will start the call this afternoon with Bill reviewing our Q3 results and commercial activities. Then Mark will provide an update on our clinical and technology activities and I will review our financial results.

Before I turn the call over to Bill, I must remind you of the risks inherent in our business and ask you to consider the following 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 facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities 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 the 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, I would now like to turn the call over to our Chief Executive Officer, Bill Welch. Bill?

Thank you, Beth, and hello, everyone.

I'm excited to report on our continued progress towards achieving our 2016 goals, as well as our strategy to enable broad access to our technology and liquid biopsy tests by research, clinical research laboratories, academic institutions, leading cancer centers and pharmaceutical companies.

We made significant progress in expanding awareness and value of our precision cancer monitoring technology in the third quarter through an announcement of key collaborations with the leading cancer centers and a national pancreatic cancer advocacy organization.

In addition, we're pleased that data demonstrating the clinical utility of our Trovera liquid biopsy test in lung cancer was published in peer-reviewed oncology journals. We also saw expanded access to our Trovera tests by existing and new physicians, while we gained our first Tier 1 payer contract.

I would like to focus our discussions in this call around the details from our third quarter regarding our commercial activities, publications and clinical collaborations, and growth catalysts.

As a reminder, we have by design a targeted commercial field team working to establish awareness of our Trovera technology and liquid biopsy tests with key opinion leaders, providers and payers as we further our clinical validation studies and publish our clinical data for utilization and reimbursement.

A primary focus has been to target leading oncology centers where there's a need for a highly sensitive noninvasive detection of the EGFR T790M mutation for patients with late-stage non-small cell lung cancer. I am pleased to report that of the top 30 prescribing institutions for third-generation TKIs, approximately two-thirds have clinical experience with our EGFR test.

We also increased the total number of ordering physicians by 40% and new ordering physicians by 20% in the third quarter over the second quarter. We believe that market continues to show strong interest in highly sensitive, clinically actionable diagnostics.

While our current Trovera tests are for EGFR, KRAS and BRAF, we recognize the need for a broader panel of clinically actionable genes with similar high sensitivity. A key goal for 2016 is to develop a multigene panel of clinically actionable mutations without compromising our industry-leading clinical sensitivity.

Our commercial samples provide billing and reimbursement experience with a variety of payers. We have begun receiving payments from insurers for tests processed in prior quarters. Although it's early in our rollout, we believe the payments we receive will support meaningful reimbursement.

We are working to establish reimbursement with leading national and regional payers, and are pleased that our efforts have resulted in our first Tier 1 payer contract with Blue Cross Blue Shield of Illinois. This brings our coverage to approximately 168 million lives.

Working with key opinion leaders and the Cedar Associates, a health economics firm, we completed development of our health economic model and corresponding manuscript. The economics of this independent analysis support the health outcomes and cost benefits of urine liquid biopsy as compared to tissue biopsy. We will be submitting a manuscript for publication this quarter.

In the third quarter two manuscripts on the clinical utility of our tests in non-small cell lung cancer were published in peer-reviewed journals. In addition to these publications, four additional manuscripts have been submitted for peer review. Mark will be providing more details around our publications and our clinical studies.

We also added intellectual property to further support our technology platform in the third quarter. Our patent, entitled Method for Detection of High-risk Human Papillomavirus, encompasses direct methods of detecting high-risk HPV infections by identifying a gene in urine, was issued by the US PTO.

A manuscript that provides data validating the sensitivity and specificity of our high-risk HPV urine test in comparison to the Roche cobas HPV Test, will be submitted this quarter. This paper demonstrates that urine is a viable testing alternative, particularly to access women who do not participate in routine screening programs.

In the third quarter we continued our collaborations with leading cancer centers and academic institutions and also announced agreements with the University of Michigan Comprehensive Cancer Center and the University of Southern California Norris Comprehensive Cancer Center. I'm pleased to report the University of Michigan has already begun recruiting patients to their pancreatic cancer clinical studies.

To complement our work in pancreatic cancer, we announced a partnership with the Pancreatic Cancer Action Network advocacy organization and Precision Promise, the first of its kind large-scale trial designed to transform outcomes for patients with pancreatic cancer. Our Trovera test was selected for this national, multicenter initiative because of its industry-leading sensitivity, with the goal of evolving the way diagnostics are used to optimize treatment and improve patient survival. Within Precision Promise our test will be used as a dynamic tool throughout the course of treatment using experimental therapies.

And as we anticipate the fourth quarter and turn the page to 2017, we see our growth catalysts to be the following: one, develop a universal urine collection and DNA preservation kit for broad research applications and distribution; two, develop a multigene panel for detection and monitoring of clinically actionable markers in urine and blood; three, conduct testing services for pharmaceutical companies to develop drugs that need improved ctDNA tumor profiling; four, conduct testing services for third part reference laboratories; and five, initiate a program for key customers, enabling early access to our multigene panel for clinical research use.

We believe a urine and blood liquid biopsy kit for research use is a multibillion dollar market opportunity that may best be served by our low-cost DNA extraction and enrichment technology run by clinical research laboratories using their own sequencers. Initially we plan to approach academic institutions and leading cancer centers and pharmaceutical companies for utilization of our technology.

With that, I will now turn the call over to Mark Erlander.

Thank you, Bill.

In the third quarter our development and clinical activities centered around our goal of increasing the body of evidence demonstrating the robustness of our technology and the clinical utility of our liquid biopsy test. We are doing this through submission and publication of manuscripts, clinical collaborations with leading cancer centers, academic institutions and advocacy organizations, as well as presentations at key conferences.

Publication of our data across cancer types continues to be a high priority this year, with the goal of submitting nine manuscripts. The manuscript entitled A Highly Sensitive and Quantitative Test Platform for Detection of Non-Small Cell Lung Cancer EGFR Mutations in Urine and Plasma was published in the Journal of Thoracic Oncology.

The data presented is the initial results from a blinded study conducted on matched urine and plasma specimens collected from 63 patients with Stage IIID4 non-small cell lung cancer enrolled in the TIGER-X trial of rociletinib, an investigational tyrosine kinase inhibitor. The full dataset of 213 patients was presented in an oral presentation at the ASCO Conference in June, and we will be submitting a manuscript for publication this quarter.

This is the first data showing that our Trovera test successfully identifies EGFR mutations in both urine and blood with high concordance to tissue biopsy. This data is important, because approximately 60% of non-small cell lung cancer patients receiving TKI therapy develop resistance to the acquisition of the EGFR T790M mutation. The ability to use noninvasive biopsy methods to not only identify the resisting mutation but also to longitudinally monitor the response to therapy is critical to improving outcomes for patients.

A second publication entitled Noninvasive Urine Testing of EGFR-activating Mutation and T790M-Resisting Mutation in Non-Small Cell Lung Cancer was published in the Journal of Experimental Hematology and Oncology. This is a case report of a patient with late-stage non-small cell lung cancer demonstrating the clinical value of our Trovera EGFR test and the sensitivity of our technology in detecting the T790M-resistant mutation.

Prior to Trovera testing, this patient experienced a diagnostic odyssey of multiple tissue biopsies without conclusive results for determining tumor mutation status. This is, unfortunately, a very common scenario.

Our Trovera EGFR urine liquid biopsy test offered a noninvasive, real-time method that detected the T790M-resistant mutation. As a result of our testing, this patient benefited from treatment with a targeted therapy that otherwise would not have been an option.

We are engaging in dialog with companies that develop and market third-generation TKIs regarding the importance of testing for the EGFR mutations and T790M-resisting mutations. Through these interactions, there is increasing interest in our technology and the opportunity to test for the T790M-resistant mutation in patients progressing on a first or second-generation TKI.

This further supports ensuring that patients who are at greatest risk and in most need will have access to the appropriate target therapy. As our technology continues to evolve, we believe there's an opportunity for our tests to be included in additional clinical utility and drug development collaborations.

In the third quarter we expanded our clinical collaborations and began working with the University of Southern California Norris Comprehensive Cancer Center to establish a standardized framework for the use of our Trovera urine liquid biopsy testing to define practical considerations and best practices for liquid biopsy testing from urine.

This collaboration will also explore the development and clinical treatment algorithms through investigational studies to solidify how and when liquid biopsy testing can be employed. We believe this pioneering work will facilitate new standards in patient care and pave the way for new cancer treatment guidelines.

Importantly, we also entered into two collaborations focused in pancreatic cancer. To put this into perspective, pancreatic cancer is now the third-leading cause of cancer-related death in the United States, with a five-year survival rate of only 8%.

In 2016 more than 53,000 people in the United States will be diagnosed with pancreatic cancer, and nearly 42,000 will die from the disease. Most importantly, 71% of patients die within the first year of diagnosis.

Previous studies indicate that at least 90% of patients with pancreatic cancer are positive for the KRAS mutation, which is considered to be the predominant driver mutation for the development of pancreatic cancer. The high sensitivity of our KRAS liquid biopsy test identifies the presence of a tumor with 93% detection, thus making our test a highly sensitive biomarker for not only detecting the driver mutation but also monitoring responsiveness to experimental therapies.

With the University of Michigan Comprehensive Cancer Center, our collaboration is a multiphase research program. Our Trovera urine and blood tests are being utilized as noninvasive diagnostic tools that enable clinical investigators to quickly assess the efficacy of a given therapy and then either continue with this therapy or pivot to another therapy to determine which one will be most effective in treating an individual patient's tumor.

In the future, and as this initiative progresses, there are plans for our Trovera test to be used to detect pancreatic cancer in earlier stages of the disease, which we believe will provide a tremendous benefit to patients by enabling surgery which would otherwise not be possible, with the goal of increasing overall survival.

We are expanding upon the work we are doing in pancreatic cancer to a partnership with the Pancreatic Cancer Action Network national advocacy organization. This clinical trial initiative will investigate multiple treatment options under one clinical trial design utilizing an individualized treatment approach based on the molecular profile of a patient and their tumor.

There are 12 initial clinical trial sites participating in Precision Promise, including many of the leading cancer centers in the country, such as Cedars-Sinai, Dana Farber, Fred Hutchinson, Memorial Sloan Kettering and University of Southern California and UC San Diego, among others. The number of clinical trial sites is expected to increase, providing the opportunity for our Trovera KRAS test to be used broadly and for large datasets to be generated, further validating its clinical utility and quickly assessing response to therapy.

Presentation of data at key molecular diagnostic and oncology conferences is critical to increasing awareness of our growing body of evidence. In September we presented at the Third Precision Medicine Congress in London. A presentation entitled Clinical Utility for Detection and Monitoring Circulating Tumor DNA from Urine and Plasma highlighted the proven clinical utility of our noninvasive urine and blood test as a viable alternative to a tissue biopsy.

We also shared data on promising emerging applications of urine- and blood-based liquid biopsies, including early response biomarkers for drug efficacy and patient response to therapy as well as monitoring for cancer recurrence and early detection of cancer.

Complementing our data in the non-small cell lung cancer, four abstracts have been accepted for presentation at the 17th Annual World Lung Conference that will take place in Vienna in early December. Three of the four presentations will focus on the work we have done in detection and longitudinal monitoring of the EGFR T790M-resistant mutation in non-small cell lung cancer.

The fourth presentation, also in non-small cell lung cancer, is data on health outcomes and total cost of care analysis. This data demonstrates improved patient experience and cost savings that are associated with a urine liquid biopsy test when it is compared to a tissue biopsy.

Finally, two abstracts have been accepted for presentation at the HPV 2017 31st International Papillomavirus Conference. The first demonstrates clinical performance in a general screening population in China and illustrates comparable clinical sensitivity and specificity observed between urine and cervical samples.

These results support the utility of urine testing for cervical cancer screening, especially among women who do not participate in routine screening. The second abstract describes the analytical performance of the Trovagene HPV high-risk urine tests.

As a component of our evolving technology we are continuing to -- we are developing a multigene panel with seven clinically actionable oncogenes encompassing more than 200 insertions, deletions and mutations areas. Additionally, we are completing work on a second-generation urine collection kit that will be ready for research use in early 2017. This new DNA collection and preservation kit may enable applications for both genomic and genetic testing.

In summary, we continue to expand the body of evidence supporting the value and the clinical utility of our technology and Trovera test as an important disease management tool for the detection and monitoring of driver and resisting mutations across a number of common cancers.

I will now turn the call over to Beth to review financial highlights from the third quarter. Beth?

Thank you, Mark.

Financial results for the three months ended September 30, 2016 are as follows. Trovagene reported a net loss of $10.2 million, or $0.34 per diluted share, during the third quarter of 2016, compared to a net loss of $2.7 million, or $0.23 per diluted share, for the same period in 2015.

Total operating expenses were approximately $10 million in the third quarter, slightly down from $10.1 million in the prior quarter and an increase from $6.5 million in the third quarter of last year. This year-over-year increase in operating costs can be attributed to the expansion of our research and development, clinical and commercial activities.

R&D expenses increased as we approached completion of the development of our second-generation urine collection and DNA preservation kit and continued to invest in the development of our multigene panels. We believe the next-generation urine collection and DNA preservation kit and multigene panels will result in global distribution, broader adoption and application of our tests.

Expenses related to clinical activities were associated with ongoing current clinical studies as well as with development of new studies, including the addition of bioinformatics personnel to streamline the analysis of data from the testing of urine and blood samples.

During the year, sales and marketing expenses increased from 2015 because of our deployment of a targeted commercial team to create awareness of our technology and testing platform.

The net cash used in operating activities in the third quarter of 2016 was $7 million, as compared to $8.1 million in the second quarter of 2016. During the third quarter of 2016 the Company received $2.3 million in net proceeds from the sale of approximately 422,000 shares of common stock under a controlled equity offering. The weighted average number of shares of common stock outstanding used to calculate per share results was $30.3 million.

As of the end of the quarter Trovagene had cash, cash equivalents and short-term investments of approximately $47 million.

I will now turn the call back over to Bill.

Thanks, Beth.

I look forward to sharing our continued progress, and thank you for participating on this call.

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

(Operator Instructions)

Bryan Brokmeier, Cantor Fitzgerald.

Hi, good afternoon. Bill, could you elaborate a bit more on the multigene panel that you're developing? What genes and cancers are you targeting?

What's the timeline for launching it? And what's the timeline for releasing data, analytical validation data, clinical validation and clinical utility data?

Sure, Bryan. I'll have Mark walk through that. Mark?

Yes, absolutely. Hi, Bryan. So, first of all, the seven genes basically are clinically actionable genes in lung cancer, colorectal cancer, pancreatic, melanoma, and just they basically are the EGFRs, the KRASes, the NRASes, the BRAFs, as well as PIK3CA and also c-kit. So they are -- they've really -- we are really focused --- our focus is on those that are clinically actionable with treatment decisions today and also that the panel would be able to offer the full solution for these cancers.

The timeline that we're looking at is analytical validation would be completed by the end of -- do you want me to -- fourth quarter, with clinical validation coming right behind that in the first month of -- first quarter of next year. And I'm trying to remember if there was anything else that you were asking besides that. We obviously plan to -- a whole publication strategy is around the panels as we develop them through 2017.

Yes, just to give a little more flavor on that, that's our goal, as Mark said. We have a lot of details working hard. Obviously there's no guarantee, but we have a pretty good fix on what the profile of this product should look like.

And overall we want to make sure that it has a similar type sensitivity that we currently have. And the product can also work in urine and blood, which we think is significant.

And we've offered this in our CLIA laboratory, and as we look to kind of cement some of our technology we'd look to -- look for a sister kind of, alpha kind of academic locations that may also want to perform this technology. And we'd focus that sometime early next year.

Okay. And right now part of the -- you're starting to see some increasing traction on the reimbursement side. Have you started to benefit? Have you started to get paid by Blue Cross Blue Shield of Illinois, or have you not yet started to see that come through the income statement?

So we are getting paid by a variety of payers, Bryan. I would say our volumes are low by design. We have a very targeted field force. And the areas they're focused on are those that are most at need where clinical data has been published and is working well in third-generation TKIs.

And part of the overall package is to get some papers published, then to present that for Medicare for trying to establish a kind of a Tier 1 kind of process for our technology, for reimbursements on both individual and maybe collected panels. But in between that, yes, we are getting paid on a per kind of test basis, and it varies across the board. As you might imagine, we have a variety of payers.

And since the distribution is so broad we really don't feel good commenting other than we think that the outliers in both the upper, which are pretty high, and the lowers is to just get an overall reimbursement we think is good for ourselves going forward. And I feel pretty good about that, actually.

Okay. And, lastly, you talked a bit about the HPV assay. You received the new patent on that. How should we be thinking about you monetizing the HPV assay, and are you working toward selling that asset or a partnership, or what's the strategy around HPV?

You know, the HPV asset is really interesting, Bryan. We have broad, we believe, freedom of operating technology in urine for identification of a screening test for HPV. And these are folks, so I guess Mark could probably talk more, but these are folks that wouldn't normally follow through and do the HPV Pap smear-type test.

And there's, we think, both in the US and overseas culturally and age-based there's a large percent of young women or women who just choose not to get screened because of the current system. So we think a urine-based test, frankly, could be significant.

The challenge in the US is how we bring that forward. We're not going to build a huge lab and do that. We probably would look to some partners in potentially the US and certainly overseas. There are certain locations that are very interested in. The place we just did some studies most recently has been in Asia, and it seems like that resonates over there.

So we'll look to monetize that. It could be a variety of sources or systems. And since I don't have that to be announced today, I think I'd keep it pretty open in terms of how we might do that.

Okay. Thanks a lot.

Jason Kolbert, Maxim Group. Hello, Jason, is your phone on mute? I'm sorry, we're not able to hear you. We'll move on to the next question.

Bill Quirk, Piper Jaffray.

Great, thanks, and good afternoon. Can you hear me?

Yes, Bill. How are you?

Very well, thank you. So I guess kind of building off of Bryan's last question, does this -- I guess two-part question on HPV. One, Bill, does this accelerate this in terms of a priority for Trovagene? I noticed that it kind of wasn't in the -- in kind of the five drivers that you highlighted relatively early in the call.

And then secondly, and please correct me if I'm wrong here, but I think this is the first time we've heard you talk about this potentially in the domestic setting. And maybe you can just elaborate a little bit on that. It strikes me that the product profile is very attractive to the kind of developing world. I hadn't really been thinking about this from a developed world standpoint.

Yes, Bill. So, the reason we don't mention it on a day-to-day or strategic basis is because mainstream what we're doing is ctDNA preservation, getting it out of urine and then analysis. Our urine collection kit may have opportunities we talked about for doing DNA stability in urine that could go out not just for ctDNA but potentially research for germ lines or transplant or other locations. So those are the two that are -- occupied most of internal mindshare and execution.

But we have a number of broad patents, and we've continued to kind of work on the side on HPV, because the market is very big, and we're going at it opportunistically with our technology. It can be stabilized with our urine preservation-type kits. We think the ex-US market might be easier both from an IP and the clinical studies for folks to go forward with.

In the US it's unclear. We're probably not going to take it forward ourselves in terms of how to monetize it in our own laboratories, but because the sales calling is actually pretty big, it's a primary care call sales force, and it may be that someone might want to do an FDA-like study or do an LDG study.

From our standpoint, we've queued it up for publication and execution showing sensitivity and specificity, and we're looking to find the right home for that, broadly scoped, keeping our options option. And we've had interest in that asset. And so we're just going to play it as it comes forward and get the best value for the Company.

Okay, got it. No, thank you, very helpful, and appreciate you going into detail there. Second question is around the pancreatic KRAS Trovera product.

And I certainly understand the potential benefit from the multigene panel, but just to play devil's advocate here, and maybe you'll throw this question to Mark, if we have a patient population that has 90%, or I should say 90% of the patient population has mutation to KRAS, can you help talk a little bit about the value proposition of the single-gene test, where 9 out of 10 patients are likely positive?

Again, I certainly understand the value prop on the multigene panel. Just struggling a little bit on the single genes. Thanks.

Yes, that's a great question, Bill. I'll take this one. So in pancreatic cancer you've absolutely nailed it, it's unusual in the sense that pretty much all pancreatic cancer patients have KRAS.

And so here the biomarker or the test, the KRAS assay, obviously today we offer it as a single assay hotspot. It has great, very great sensitivity, 0.001%.

And it's really not being used in the same way. It's being used as a -- in Stage IV, or advanced Stage III and Stage IV as a biomarker for determining not only prognosis but also responsiveness to therapy. So the big deal in Stage IV disease is to move quickly if a patient is not responding.

And so the KRAS there is really being utilized, and what you'll see in publications soon, is really being used to monitor the tumor -- the patient's response or the tumor response to a therapy, and then within a couple of weeks being able to pivot to another therapy if basically the KRAS remains elevated. So that's where we're using it there.

The other place, as you move up the food chain in pancreatic cancer, another really big area of clinical utility is to determine which patients would be able to have a successful resectable pancreatic cancer. And so 20% to 30% of patients that basically have resectable and have this Whipple procedure will already develop metastasis immediately after surgery.

So we believe that since this once again could be used as a biomarker for pancreatic cancer, we can determine very effectively whether or not the patient is responding to surgery, there's no KRAS left, or in fact there is still metastatic cancer postsurgery. There is also a part of that is also being able to predict these patients that usually go through a neoadjuvant chemotherapy prior to surgery, and we think that this tool could be used, i.e. KRAS, to determine the success of shrinking the tumor enough for there to be a successful surgery.

This area is actually a really big area, and this is actually part of the hottest area currently today where this biomarker could be used. And we are actively working at MD Anderson and University of Michigan in studies looking at this.

So that's really kind of where we are today with it. Clearly it can move up even further in basically identifying whether cysts that are in the pancreas are actually cancerous. But I will veer off of that right now until we have more data that support that.

I think the beauty, though, are the pancreatic organizations looked at our assay being the most sensitive, knowing this is a driving mutation, looking at both late and potentially early-stage intervention to understand (inaudible).

Yes, the big deal is that basically this KRAS is being used as a biomarker for response to therapy, and because we really are the only ones out there that have such a high sensitivity, reported sensitivities of more in a 25% to 70% range, ballpark, so with us being able to pretty much detect every single pancreatic cancer patient, and we know that KRAS is coming from the tumor, this is the great way to determine and assess responsiveness early on for therapies.

Got it. Thank you.

Sorry, that was a little longwinded.

Sun Ji Nam, Avondale Partners.

Hi. Thanks for taking the questions. Maybe starting off with a clarification, is T790M mutation test the biggest portion of the Trovera tests ordered today?

I think, Sun Ji, the two probably larger tests are the EGFR and our KRAS test. Those two are the ones that get the most orders.

And I think our focus coming out of ASCO has been on EGFR and T790M, because, gee, we had an oral presentation. It's the place where we're trying to establish credibility in with the various key opinion leaders. And we've been able to get access to a number of medical oncologists.

It's early stage. In fact, I think we might've touched about 10% of the overall medical oncologists in terms of sales qualified, so to get experience. It's those two markers. Now, as we move forward with more publications and more markers with our credibility now I think the market can get bigger, obviously.

Okay, that's helpful. And then maybe could you talk about with kind of the early adopter here how they are using the test, the Trovera test. Are you seeing kind of similar patterns in terms of frequency of how the physicians are ordering?

Are you seeing a lot of repeat customers, and things like that? I would love to kind of get any color in terms of the usage from the early adopters.

I think we have a number -- quite a few repeats. I would say when you go out to third-generation TKIs, these are somewhat rare, high-value, really need the right test at the right time type of thing.

So an oncologist might have a patient, and they might not have another patient similar to that weeks or otherwise. So I think the most important here is to get in front, to see that both urine and blood with our technology gets the kind of things that they're looking for for those patients that don't have tissue availability.

And the KRAS I think we'll probably get the most uptake and the market will probably come up more I think in the colorectal cancer-type markers, where it's a driver-dominant mutation, colorectal cancer. But the pancreatic has been a great research area that as we get more data we might be able to identify potentially earlier opportunities for use.

But I think KRAS is primarily clinically used right now in CRC. Is that correct, Mark?

Yes, I mean, it's used in CRC, and we obviously are looking forward to our multiflex panel there, because there we can cover even more KRASes and BRAF and also NRASes. So we think that we already have uptake of KRAS in colorectal cancer right now, looking at monitoring patients who are -- and looking for the emergence of resistant mutations. But, yes, I don't know if I really could add much more than that.

And then, finally, from the -- Bill, maybe could you remind us what the go-to-market strategy is for your urine collection device? I know you talked about research. It's only early on, obviously, but curious as to given that the customer phase might not be overlapping with your current target customers.

Yes, thanks, Sun Ji. You know, we've developed this research [chit] for our own use for ctDNA preservation in urine. No one has one, so we had to make our own. And we put a lot of effort in this from a consumer friendly and patents and our stabilization agent and the like.

And it strikes us that, while we -- as we (inaudible) hoping by the end of this year, that's our goal to get that available, and then we'll start to get it in the distribution, like, but that we can have a use for it in our laboratories. And it would be good for ctDNA preservation, but it may have -- the question, we may have opportunities for other types of DNA preservation in urine.

And that's -- we're going to go test that with a variety of different laboratories and researchers to see do they see a use for things like germ line or potentially like transplant where you're looking for DNA measurements, or other opportunities outside of potentially ctDNA. So it's certainly designed with one in mind, but we think it could have broader opportunities both domestically and internationally.

Great. Thank you.

Jason Kolbert, Maxim Group.

Hi. Sorry. Earlier my volume wasn't working. This is Lauren Chung calling for Jason Kolbert. Thanks for taking the call.

I have a question on the clinical research service revenue and your clinical collaboration. How should I see that going forward? Do you expect to increase -- add more clinical collaborations? Just if you can give me more color on how I should see that revenue going forward.

Sure, we see essentially three different revenue buckets. One is testing we perform in our laboratories, so your clinical services, and we do that for other laboratories from our doctors who send us samples, reporting back to them.

And we can also as we look forward, we've done some -- before we've put out some data on the third-generation TKI for a pharmaceutical study we did for someone, and we'd look to do more pharmaceutical-like CRO-type testing in our laboratory. So you would see that where we're just getting reimbursed for tests we perform ourselves.

And another area that we think could be dynamic is helping to set up other laboratories performing our tests on a research basis for clinical use that they validate themselves. And that would come in the form of we'd have kits, research kits, and collection devices that they could use to run both in blood and urine.

And we see that's something as first we need to get our panel done by the end of this year and see about the markers, and work with some research groups next year if they want to bring that up. But I see another valuable revenue stream coming from our call it technology transfers or chit, our research-based kit market.

Thank you.

There are no additional questions at this time. This concludes our question-and-answer session. I would like to turn the conference back over to Bill Welch for any closing remarks.

Well, just thank you all for participating in the call today and the interest in Trovagene, and we look forward to future communications. Thank you.

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