Cardiff Oncology Inc (CRDF) 2014 Q2 法說會逐字稿

Good day, everyone, and welcome to the Trovagene second-quarter 2014 financial results conference call. All participants will be in a listen-only mode. (Operator Instructions). After today's presentation, there will be an opportunity to ask questions. (Operator Instructions). Please also note today's event is being recorded.

At this time, I'd like to turn the conference call over to Mr. Stephen Zaniboni, Chief Financial Officer of Trovagene. Sir, please go ahead.

Thank you for joining us on our second-quarter 2014 conference call. Trovagene is focused on developing and commercializing our precision cancer monitoring technology, which detects DNA mutations in the urine and blood with very high sensitivity. Our technology provides oncologists with important clinical information that can guide treatment decisions by determining a patient's mutational status, response to therapy, and resistance to treatment over time.

We continue to expand the body of clinical evidence supporting our cancer mutation monitoring platform through collaborations with major cancer treatment centers and integrated healthcare networks. The benefits of our precision cancer monitoring technology are becoming apparent in terms of clinical utility and the impact on patient outcomes, with data presented at the AACR meeting and ASCO meetings earlier this year. Our intellectual property estate, protecting our technology is strong and is growing and includes methods of extracting, purifying, preparing, and detecting cell-free DNA and RNA mutations in 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 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 regulations, market acceptance, limited commercial experience, dependence on key personnel, 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 Trovagene's potential to impact the standard of care for cancer treatment. Dr. Mark Erlander, our Chief Scientific Officer, will provide an update on our product pipeline and our clinical collaborations. And finally, I will summarize our financial results and review our goals and objectives for this year. A question-and-answer session will follow the call.

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

Thank you, Steve. Expanding the mutation coverage of our platform and developing additional clinical data supporting the utility of our precision cancer monitoring technology remain high priorities for Trovagene. In the first half of this year, we have made significant progress on these objectives, and we are preparing for the commercial rollout of our cancer monitoring platform.

Before I review our recent achievements, I would like to frame the market need for our technology so our accomplishments can be put into proper context. Clinicians we speak with or work with as part of our clinical programs are highly motivated to use our technology. This is because we are enabling them for the first time to track driver mutations associated with the patient's cancer in an easy and entirely noninvasive manner throughout the course of a patient's treatment. Currently, physicians rely on imaging modalities such as MRIs, CT scans, or pet scans to gauge response to therapy and disease progression.

However, among other issues, these imaging techniques do not offer any information about a tumor's mutational status. In fact, feedback that we have received from oncologists and radiologists emphasize the need for our technology. According to these clinicians, when imaging reveals tumor growth or disease progression, the treatment regimen has likely been failing for several weeks or months already. And the higher tumor burden associated with the cancer progression makes it more difficult to treat the patient going forward.

In other words, cancer monitoring with imaging in many cases is a lagging indicator that is unable to detect mutational changes and catch disease progression early. The clinicians we are working with are confident that tracking cancer mutations over time in urine can determine tumor growth before disease progression actually appears on a patient's scan. This early warning can alert a physician that treatment is failing and that other therapy options should be considered as soon as possible to improve patient response.

Early detection of disease progression can also help patients that are failing therapy to avoid exposure to unnecessary treatment and the related side effects, and can help reduce overall healthcare expenses by cutting ineffective treatment short. Additionally, in cases where tissue biopsies are limited or not possible, detecting cancer in a liquid biopsy is the best option available to obtain the genomic information needed to precisely treat the cancer.

Given the major unmet need to monitor cancer at the molecular level, we are focused on improving the standard of care for cancer treatment by demonstrating the utility of our cancer monitoring platform in multiple clinical studies. Results from these studies are critical to drive forward adoption in the oncology community and to obtain health insurance reimbursement at attractive levels. Because our technology enables physicians to administer the right treatment to the right patient at the right time, better treatment outcomes and improved cost levels are expected. We believe that improving patient outcomes and saving healthcare systems money are key drivers of Trovagene's value proposition.

Given that background, the key milestones we achieved in the first half of this year include expansion of our platform's oncogene coverage with our KRAS multiplex assay, which runs using next-generation sequencing technology. Data presentations demonstrating validity and clinical utility of our cancer monitoring platform at both the AACR meeting in April and the ASCO meeting in June. The reference to our cancer monitoring platform in international clinical treatment guidelines for histiocytic disease such as Erdheim-Chester disease and Langerhans cell histiocytosis. And, so far this year, we have announced clinical collaborations with four major cancer treatment centers and integrated healthcare networks, including US Oncology, Catholic Health Initiatives, Northwestern University, and Dana-Farber Cancer Institute. These organizations complement our ongoing collaborations with M.D. Anderson, Memorial Sloan-Kettering, and the Norris cancer center at USC. With eight of the world's top cancer centers as our con collaborators and more than 30 clinical programs in progress, we look forward to presenting additional study results later this year, including the potential for two more manuscripts published in peer-reviewed journals. Given our robust clinical development programs, we expect that 2015 will be a year of significant clinical data presentations and publications that support the clinical utility of our precision cancer monitoring platform.

In addition to the advancement of our clinical programs, we recently strengthened our balance sheet, ending the second quarter with approximately $35 million in cash. Our strong financial precision will enable us to begin executing on our sales and marketing strategy in the fourth quarter of this year, which we believe will drive adoption of our technology and put us on the path to generating meaningful revenue.

Generally, there are three key phases for companies developing diagnostic tests that provide novel clinical utility, and we expect Trovagene follow the same path. The first phase is to validate that our technology actually can detect oncogene mutations in urine with high sensitivity in a clinical setting. We have achieved this milestone.

Next, clinical utility needs to be demonstrated. We have presented the results of our clinical study program at major medical conferences such as AACR and ASCO and expect to continue to do so as the result of additional clinical studies become available.

And finally, we need to convert the clinical utility demonstrated in our studies in diagnostic revenues, which we will begin to do later this year with the rollout of our marketing and sales program.

I'm proud of the accomplishments we have achieved so far and believe that Trovagene's molecular diagnostic platform is positioned to lead the industry in cancer monitoring by tracking DNA mutations in a liquid biopsy. We remain focused on the execution of our business plan and are dedicated to helping oncologists improving cancer care.

With that, I'll turn the call over to Dr. Erlander.

Thanks, Toni. We continue to advance our developmental programs at Trovagene in both the R&D lab and in our clinical studies. With regard to new essay development, we have made significant progress with our proprietary sample preparation and enrichment technologies, improving the limit of detection of our cancer monitoring platform, and achieving industry-leading levels of analytical sensitivity.

We have improved our assay designs as well, which we believe will result in superb clinical performance. We expect to expand the mutation coverage of our platform and transfer new essays into our CLIA lab later this year and throughout next year. By the end of 2015, we expect that our precision cancer monitoring program will cover the most relevant actionable genomic alterations in all clinically validated oncogenes such as BRAF, KRAS, EGFR, ALK, PIK3CA, HER2, and NRAS. These well-validated genomic alterations consist of multiple mutations, insertions, deletions that when tracked accurately and quantitatively can provide critical information to oncologists to help direct therapy.

On the clinical development front, as Toni has mentioned, we are now collaborating with eight top cancer centers and integrated healthcare networks, and those programs are expected to yield steady results throughout 2015 in important treatment areas such as metastatic colorectal cancer, pancreatic cancer, melanoma, and finally lung cancer. Additionally, we expect to expand our list of internationally recognized collaborators in the near future.

In the second quarter, we released three data sets at the AACR meeting and ASCO meeting demonstrating that our precision cancer monitoring technology was not only able to detect oncogene mutations in urine but was also useful for quantifying and tracking oncogene mutation levels over time. The first data set announced at ASCO demonstrated that mutational load, observed with our assay technology, correlated to treatment response. This correlation was highly significant. Importantly, patients in this study had various types of advanced cancers and were undergoing a variety of treatment regimens.

Clinical utility was demonstrated in this study for our technology, as the results showed that reduced BRAF V600E mutational load over time correlated to a statistically significant increase in the patient's time to tumor progression. With our cancer monitoring program or platform, oncologists are able to detect and monitor a patient's disease and treatment response in near real time using a non-invasive sample from the patient.

Another study, which we presented at ASCO, demonstrated that our cancer monitoring platform provided significant clinical utility for the diagnosis and treatment of histiocytic diseases including Erdheim-Chester disease and Langerhans cell histiocytosis. These diseases can be associated with the BRAF V600E mutation, and successfully obtaining a conclusive biopsy in many affected patients is not always possible. Physicians at Memorial Sloan-Kettering and M.D. Anderson demonstrated that our urinary cell-free DNA technology definitively detected BRAF V600E mutations in histiocytic patients particularly when biopsy could not. Importantly, properly determining the BRAF status of a patient with histiocytic disease can represent clinical -- or critical information with regard to treatment selection.

We believe that a clinical utility shown in this study is a model case for our platform, and these results drove the recent referencing of our cancer monitoring technology in published guidelines for the treatment of histiocytic diseases.

In addition to superior BRAF V600E detection in this difficult-to-biopsy patient population, results were also presented which demonstrated our technology's ability to monitor treatment response in histiocytic patients over time.

We continue to implement a clinical study strategy based on our collaborations with key opinion leaders, integrated healthcare networks, and leading pharmaceutical and biotechnology companies. With these collaborations, we seek to further demonstrate concordance of mutational status between our urine-based diagnostics and tissue biopsy as well as responsiveness and resistance to therapy by monitoring cancer patients over time.

We expect to submit three manuscripts to peer-reviewed oncology and molecular diagnostic journals in the near term, with publications of these study results potentially later this year or in the first quarter of 2015. In total, we are tracking to submit eight manuscripts to medical journals over the next 12 months for our clinical programs. We believe that these publications will demonstrate compelling clinical utility with our precision cancer monitoring platform, and should help drive awareness and uptake of our oncogene mutation monitoring solutions as part of our marketing and sales program.

At Trovagene, we are developing our diagnostic platform to improve the standard of care of cancer patients by enabling physicians to track the underlying genomic drivers of disease. The current standard of care for monitoring patients relies on cancer imaging, which can be a lagging indicator and does not provide specific information regarding tumor mutational status.

The excitement of our collaborating physicians and their colleagues continues to be a strong indicator to me that we are creating something very important for patients and for the field of cancer therapy.

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

Thanks, Mark. Trovagene financial results for the second quarter are as follows. For the three months ended June 30, 2014, Trovagene reported a net loss of $1.1 million, or $0.06 per share, as compared to a net loss of $5.3 million, or $0.34 per share, for the three months ended June 30, 2013.

Operating expenses were $3.3 million for 2014 second quarter as compared to $2.4 million for the same period in 2013. Operating costs include non-cash expenses related to stock-based compensation of approximately $419,000 and $347,000 in their respective periods. Also impacting the net loss was a non-cash change in the fair value of the derivative instruments. For the three months ended June 30, 2014, this change resulted in a gain of $2.2 million as compared to a loss of $2.9 million for the same period in 2013. The net cash used in the second quarter of 2014 was $2.7 million.

Trovagene's financial results for the first quarter of 2014 are as follows. For the six months ended June 30, 2014, Trovagene reported a net loss of $4.3 million, or $0.23 per share, as compared to a net loss of $6.4 million, or $0.41 per share, for the six months ended June 30, 2013.

Operating expenses were $6.7 million for 2014's first half as compared to $4.9 million for the same period in 2013. Operating costs include non-cash expenses related to stock-based compensation of approximately $979,000 and $887,000 in their respective periods.

Also impacting the net loss was a non-cash change in the fair value of the derivative instruments. For the six months ended June 30, 2014, this change resulted in a gain of $2.2 million as compared to a loss of $1.6 million for the same period in 2013. The net cash used for the first half of 2014 was $5.6 million.

Shares of common stock outstanding used to calculate per-share results increased to 18.9 million shares from 15.5 million shares on June 30, 2013.

On June 30, 2014, Trovagene had cash and cash equivalent of approximately $34.7 million compared to $25.8 million at December 31, 2013. Our cash balance includes the $15 million debt financing that we completed at the end of the second quarter of 2014. We estimate that our current cash position will be sufficient to fund our operation well into 2016.

Turning to our goals for the remainder of 2014, we plan to 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 precision cancer monitoring platform as they become available. Complete CLIA development and release additional urine-based solutions for the detection and monitoring of multiple clinically actionable oncogene mutations in parallel. Enter into additional R&D collaborations with pharmaceutical companies, and expand and enter into new partnerships with strategic diagnostic and life science companies.

In conclusion, Trovagene is well positioned to leverage its investment and its intellectual property, scientific research, and collaborations to build a better clinical pathway for cancer monitoring. We believe that the 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). Sung Ji Nam, Cantor.

Toni, I was wondering, or Mark or anybody -- was wondering if you guys could give us more color in terms of your market go-to-market strategy later this year. Is it kind of more of what you have been doing in terms of developing partnerships and more clinical trials, or are you trying to do something slightly different?

So, I mean, I think it is clear that as you enter into a set of clinical studies to validate your technology in clinical institutions, these clinical institutions familiarize themselves with your technology and they become aware of what you can do and how powerful this tool is. And then what you simply see, and I would say this is part of our commercial strategy, that then early adopters recognize that these assays that they are learning about in clinical studies are useful in other real patient settings that they are facing.

And I think this combined momentum of individual experience in a larger -- individual clinical experience in a larger number of hospitals plus published data, that generates the momentum that we believe is sufficient to start in the fourth quarter of this year a marketing rollout that initially targets early adopters, targets opinion-leading clinicians. And then through the year of 2015, we will inch by inch, if you want, expand our reach to the clinical oncology community.

And then you guys have pretty compelling data with respect to histiocytic diseases. And including guidelines that were published. I was wondering are you starting to see traction or early demand or testing within that population, or do you think this also requires additional sales and marketing effort on your part?

So what I described in general terms is something that we are already seeing for histiocytic disease. When histiocytic disease is for us essentially a model case for potentially BRAF-positive malignancies with sometimes struggles, or in many cases actually struggle to obtain biopsy material. That's the situation that you see in many other cancers that are more frequent as well, like lung cancer, metastatic melanoma depending on where the metastases sit, and so on. But it's a first defined clinical case; and we see this momentum that I described in general terms, they are happening already.

Okay. And then one last one from me and I'll get back into queue. You guys saw the FDA notifying Congress with their intent to publish draft guidelines to potentially regulate LDPs. It seems like they are interested in at least regulating the high-risk type of testing. And was wondering kind of what your thoughts are on that and what your strategy might be, how you guys are -- obviously it's early, but as you kind of look at that, as that evolves, what your strategy might be in order to address that.

So first of all, I do not think that anybody who is in the space of molecular diagnostics that really offer novel clinical utilities, and everybody who is in the companion diagnostic space and the oncology space is really surprised by the release of these draft guidelines of the FDA. That's a discussion that is going on for many, many years and have been several different attempts to regulate these.

And so it should not come to anybody's surprise, at it also doesn't come to a surprise for us, what we have done in setting up our Company so far is simply that our CLIA lab is operating to what we believe are the highest QSR standards, quality system regulation standards. We are actually using ISO guidelines, the ISO guidelines, to set up our lab operations. And then we validate our assays to very high standards. And we are conducting controlled clinical studies, blinded clinical studies; we are generating the type of evidence that the FDA has stated they would like to see before assays are used with patients.

So we feel actually calm and comfortable about this right now. And because we believe that we are analytically performance leaders and that this analytical performance leadership position combines with our ability to look at any cell-free DNA regardless of where it comes from, particularly if it's a urine sample, that these two features together will make us into a clinical performance leader. And as such, we actually have an interest that there is regulation that differentiates between better and worse. And so, to quite a degree, we appreciate increased regulation there because, yes, if you're confident that you are doing your stuff well, you're confident that you can be successful within more sophisticated regulations.

Great. Thank you.

(Operator Instructions). Bryan Brokmeier, Maxim Group.

You have eight collaborations and continue to pursue other opportunities with cancer centers, integrated health networks, and biopharma companies. Is the medical community reading your publications and seeing you at conferences and hearing about you through some of their peers and reaching out to you to create new collaborations for you? Or are you sort of developing these relationships through pre-existing relationships and cultivating them into new potential collaborators after they become more comfortable and want to move forward with you?

Let me answer this high level, and I think then Mark can give more color to this. But there are two data points in this regard. First of all, I believe that we -- roughly for every clinical study that we commit to, we turn another three to four requests down. Not because we don't have the lab capacity to do this, but every one of these studies requires pretty sophisticated clinical and scientific input. You can't just run a study for the sake of running a study; it has to be a meaningful objective. So the interest that the clinical community has in performing studies with us is, frankly, somewhat overwhelming.

And from the studies that we perform, there's another parameter that one should follow, and that is the number of samples that we process in our lab in these clinical evaluations. And we are now in early August 2014. So since July 2013, I believe we have processed around 1500 samples already from clinical studies. And now you need to consider these are not samples from archived sample collections, where somebody opens up their fridge and sends us 100 vials or 100 slides. Every single sample is collected under an IRB-approved controlled clinical trial and is from an actual patient.

And in my experience -- I'm in this industry for quite a while -- I have never experienced such a push flow of clinical samples during the development phase of these tests. Everybody who develops molecular diagnostic tests will tell you consistently that the hardest part of our job is to get clinical samples. And that's, frankly, surprising to me how that is not the case in Trovagene. And Mark, you may --

Well, and I think to answer your question -- for example, in the Erdheim-Chester, the histiocytic program that we are doing, we did start out first at M.D. Anderson and did some initial work there. And it was our collaborator there thought it was -- so he was really excited about it, and he called his colleagues at Sloan-Kettering who he has worked with before and then said we need to do even a bigger study.

And so it does grow that way, through peer-to-peer conversations or -- and that's actually the best way of identifying another collaborator. We do have, as Toni said, have a lot of interest, unsolicited to us.

I think the key thing that we always keep in mind here at Trovagene is that -- and to Toni's point earlier, we simply don't just do clinical studies. We have to really identify where the use of cell-free DNA diagnostics has true clinical utility. For example, in our model system with a histiocytics, we identified the reason we went after that so fast and so hard was that 50% to 60% of those patients, they cannot get a biopsy. And we now also know that if they do have a BRAF mutation, they have an amazing response to BRAF inhibitors.

And so here you have a population where half of them will have the mutation necessary to have a response; however, 50% to 60% these patients, you can't get a biopsy. And the only way to get a biopsy is through a cell-free, in this case, urine or plasma. And we demonstrated with urine, it has great -- you basically get a mutation status on every single patient. And so that was their -- then that issue there, that was clinical utility. That is to say that simply here is a reason to use cell-free.

So, not to go on too long here, I think that what we are doing is we are really handpicking the ones -- the collaborations that really drive utility, which will drive adoption, which will then of course drive to reimbursement as well.

Thanks, Mark and Toni. And also, I don't want you to get into too much detail on this, but based on some of the studies that you and your partners have conducted to date, and those that you have seen from other companies that are developing CTC or circulating free tumor DNA biomarkers, can you maybe provide a little bit of some of your thoughts on how your assays compare to those of those other companies?

Maybe I'll answer that first because Mark is usually very modest about his assay. So I think first of all, in this space I think everybody who is involved in cancer monitoring would agree that over the past 18 to 24 months, cell-free DNA has emerged as the diagnostic specimen of choice with a vengeance. It's really -- the performance of cell-free DNA as a diagnostic specimen is superb. I do believe that it's fair to say that in the same way how cell-free DNA has left circulating fetal cells behind in the minimal invasive prenatal market, cell-free DNA will be the dominating clinical specimen in cancer monitoring.

And then you are left with a question: well, how do you best get it? If you have a blood sample, that's fine. But what if the prevalence of cell-free DNA, if your blood sample is not enough? What if it's a light sample? Then you need to get a bigger sample. That's easy with urine, difficult with blood. What if you need to get samples very often because you're monitoring dynamic behavior on shorter timelines? That's easy with urine; that's difficult with blood. What is with home care settings? Their urine is better than blood. And so we are very confident with urine.

But our assays work with cell-free DNA from blood and from urine; they work with both. And we feel that we have achieved industry-leading analytical sensitivity. I think we are comfortable to claim single-molecule sensitivity with inputs of up to 100,000 genomes or more. And I think that's pretty good.

And we have also shown very nice quantitative performance over essentially that entire dynamic range, over that dynamic range of five logs, and we believe you need that. I think we believe you need that type of analytical performance.

And now to make a fine point here: what if your entire sample contains only 1000 cell-free genomes? Then you might need five orders of magnitude of dynamic range. And your analytical assay could embrace or could manage five orders of dynamic range, but your sample has only three. Then essentially the clinical sensitivity of your assay is not limited by your assay technology, it's limited by your specimen. It's essentially only a portion of the haystack; while you're looking for the needle, and you want to look at the entire haystack.

So the reason why I am so evasive about this is whenever you talk about analytical sensitivity, you need to realize that when it's hard to get a diagnostic specimen, very often the limiting factor of your sensitivity is not your assay, it's your sample. And that's what urine overcomes. Mark?

I can only echo Toni's comments with regard to that. I do think that the issue of analytical sensitivity is sometimes used as a way to compare technologies in this space, when in fact the reality is that not only do you have to have analytical sensitivity of single-molecule detection, but you do have to have a specimen that has enough genomes to be able to see, like a for example 1 in 100,000. If you only -- so I think that there is really the specimen -- the biological specimen or the liquid biopsy that you obtain becomes very important depending on the different clinical questions that you are asking. And I think that -- as Toni said, because we came from the urine-based approach and developed assays that were with very short footprints, that allows us and enables us to move into other biological specimens such as plasma as well. But -- or other biopsies or tissue biopsies, for that matter.

But I think the key critical question is what is the clinical question that you're trying to address, and what is the best specimen for that? And many times what it is is it's urine because of the fact that you have a lot more DNA and you also can do high -- frequency of testing is not relegated to an office or hospital or -- to have your blood drawn. So this is really -- these advantages become critically important in the practicalities of optimizing therapy for a cancer patient.

Okay. Thanks. And you mentioned in your prepared remarks all the different biomarkers -- all the different mutations that you are targeting, and you plan on introducing assays for all of these by the end of 2015. So what are the near-term assays that you are targeting? What are the next mutations, and when do you see those becoming available, particularly those before the end of 2014?

Bryan, Mark will answer that, but let me give you two sentences of explanation before he answers this. So as we developed our analytical procedure, our first objective was to show that we can achieve desired analytical performance.

Second objective was to say, well, can we move to next-generation sequencing, because then we have very high specificity in the detector. We have -- the universal detector is very high specificity. And now, while it is understandable that from the outside you might think, okay, now we're going to add one assay after the other. What we are really doing internally is we are automating the assay development process because we ultimately want to be in a position that we say, you tell us the mutation. And I don't want to pin Mark now on the time, but in a very short period of time we are able to crank out an assay to track that mutation.

So, yes, we do have a near-term plan about what the next oncogenes are that we want to cover. Some have one mutation, some have many. But keep that in mind, that the true objective is to really automate this assay rollout now. So you go from the one-off digital PCR to a highly multiplexed detector next-gen sequencing to developing the design parameters for primers and so on that is fully automated.

As Toni said, we transitioned earlier this year to a next-generation sequencing platform because of the scalability. We've talked about this in prior calls: the scalability and the ability to run many more samples. And also the ability to have a much higher, tighter quantification of mutational status over time or longitudinally per patient.

We have -- we are converting the BRAF assays that we initially worked on on a digital drop into an NGS quantitative. That will be completed. Our KRAS we offer right now qualitative will be quantitative and prior -- these are all things that will happen before the end of the year. We also are targeting the obvious EGFR T790M mutations as well.

And we have in the pipeline -- the ones that I mentioned, those are all coming. And quite frankly, we are going -- we are churning as fast as we can. But we are building what I would consider to be a formulaic approach, which is what Toni was talking about, and building the pillars of the foundation for that. And so that also is a parallel process to what we're doing now in delivering these assays that I mentioned.

Okay. Thanks a lot.

Is that helpful?

Yes. Yes, very much. Thanks.

(Operator Instructions). Everyone, at this time I'm showing it no additional questions. I'd like to turn the conference back over for any additional or closing remarks.

Thank you very much for your interest in the Company. We appreciate it. And if you have any further questions, contact us by email or phone. You know where we are. And talk to you all soon.

Ladies and gentlemen, the conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your telephone lines.