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Edited Transcript of OCX earnings conference call or presentation 14-Aug-19 8:30pm GMT

Q2 2019 OncoCyte Corp Earnings Call

ALAMEDA Sep 19, 2019 (Thomson StreetEvents) -- Edited Transcript of OncoCyte Corp earnings conference call or presentation Wednesday, August 14, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Mitchell S. Levine

OncoCyte Corporation - CFO

* Ronald A. Andrews

OncoCyte Corporation - CEO, President & Director

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Conference Call Participants

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* Bruce David Jackson

The Benchmark Company, LLC, Research Division - Senior Healthcare Technology Research Analyst

* Keay Thomas Nakae

Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics

* Paul Richard Knight

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

* Thomas Flaten

Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst

* Glenn Garmont

LifeSci Advisors, LLC - MD

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Presentation

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Operator [1]

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Greetings, and welcome to the OncoCyte Corporation Second Quarter 2019 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Glenn Garmont with LifeSci Advisors. Please go ahead.

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Glenn Garmont, LifeSci Advisors, LLC - MD [2]

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Thank you, Stacy, and thank you, everyone, for joining us for this afternoon's conference call to discuss OncoCyte's second quarter 2019 financial results and recent operating highlights. If you've not seen today's financial results press release, please visit OncoCyte's website at www.oncocyte.com.

Before turning the call over to Ronnie Andrews, OncoCyte's President and Chief Executive Officer, I'd like to remind you that during today's conference call, the company will make projections and forward-looking statements regarding future events. Any statements that are not historical fact, including, but not limited to, statements that contain words such as will, believes, plans, anticipates, expects, estimates and similar expressions are forward-looking statements. We encourage you to review the company's SEC filings, including, without limitation, the company's forms 10-K and 10-Q, which identify the specific risk factors that may cause actual results or events to differ materially from those described in these forward-looking statements.

These factors may include, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory approvals, the capacity of OncoCyte third-party supply blood sample analytic system to provide consistent and precise analytic results on a commercial scale, the need to obtain third-party reimbursement for patient's use of any diagnostic test of the company commercializes, the company's need and ability to obtain future capital and the maintenance of IP rights. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. OncoCyte expressly disclaims any intent or obligation to update these forward-looking statements, except as otherwise may be required under applicable law.

With that, I'll turn the call over to Ronnie Andrews. Ronnie?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [3]

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Thanks, Bob, and welcome, everyone, to our conference call to discuss our second quarter 2019 financial results and operating highlights. Joining me today on the call are Al Parker, our Chief Operating Officer; Mitch Levine, our Chief Financial Officer; Tony Kalajian, our Chief Accounting Officer; and Lyndal Hesterberg, Chief Scientific Officer. We will all be available during the question-and-answer session at the end.

I'd like to start off today's call by taking a moment to express how truly excited I am to be here. As many of you may know, I've spent majority of my long career leading molecular diagnostic companies across all stages of development, from R&D to test commercialization for both in vitro diagnostic and lab-developed test products. These experiences over the last 30-plus years have led me to recognize the incredible opportunity of OncoCyte, first, as a board member and now as the CEO. I believe we're poised to make a tremendous impact in the continuum of care for oncology patients with DetermaVu and other complementary high-value tests.

DetermaVu is an entirely new approach to cancer detection and diagnosis. The test uses our proprietary immune system interrogation method that provides relevant biological information by detecting gene expression changes in the immune system in response to cancer. We believe DetermaVu will be a powerful clinical decision-making tool, which could help patients avoid risky lung biopsies and their associated complication and costs.

The unmet medical need and value proposition are clear. I'm convinced this is a truly unique approach with the potential for enormous commercial success in a very large and growing U.S. and global market.

So where do we stand in our development of DetermaVu? In late Jun, we provided an update that our time line for the DetermaVu CLIA Validation study had shifted from our original estimates. As a reminder, the CLIA Validation study will assay 120 blood samples previously tested as part of our R&D validation study so that we can demonstrate equivalent test performance when conducted in the company's CLIA-validated laboratory with CLIA laboratory staff and include specific protocols to confirm the accuracy, reproducibility and precision of DetermaVu in a real-world clinical CLIA lab setting.

So while we had a delay in terms of timing, our belief in our approach hasn't wavered, and what I can tell you today is that the entire OncoCyte team is focused and committed to advancing DetermaVu through to a commercially available liquid biopsy product. Right now it's an all hands-on-deck operation as we work through the final steps needed to transition our workflow that was validated in our R&D setting over to a true clinical environment with all the variables and constraints associated with use in the clinical world.

I'd like to share something to put this all in perspective. In my career, I've been very fortunate to transition diagnostic tests from an R&D environment into a clinical setting over 40 different times. What I can tell you is that out of all those tech transfer events, actually only one went through as planned. Most never make it through without some technical nuance and that's what caused our development team to pause and reevaluate. This is something I've learned to expect as part of the process. And because we understand the importance of keeping our shareholders informed, I'd like to spend some extra time today updating you on exactly what happened, the current status of DetermaVu and how we're working to get back on track to move the program forward.

To provide a little background, the transition from an R&D setting to a clinical one requires ironing out all the details of workflow standardization to ensure sufficient reproducibility is in place for reporting actual patient results. The reality we face is that test components and reagents used in the R&D setting are typically research-use only, or what in our industry we call RUO. In my experience, I've consistently seen that companies need more time than they anticipate to work out the implementation of RUO components in the CLIA setting.

An important aspect to note for those new to our space is that manufacturers of RUO reagents are not required to QC these products, and thus, from time to time, we will see variability in changes in the product composition that have to be accounted for in our clinical lab setting.

I'd also like to point out this was the right moment during the development of DetermaVu to pause, step back and systematically evaluate all system components to ensure each clinical step is robust and reproducible.

Since taking on the CEO role in early July, I've personally witnessed the incredible effort of the R&D team in what they've been doing to get us back on track and can attest that we're all focused on completing our evaluation of the entire testing process.

Here are the details for exactly what we've been working on. Our Next Generation Sequencing, or NGS, as we call it, workflow consists of multiple steps, starting with the extraction of RNA from a patient blood sample. There are multiple steps in the extraction process to clean the RNA, separating it from proteins and other nucleic acids found in the blood. Purified RNA is then further prepped with multiple reagents and buffers to be ready for the sequencing system. This is a step we call the library preparation. Once complete, the RNA library is loaded onto a gene chip and the sample is placed into the Thermo Fisher gene studio for sequencing and interpretation.

While it may sound like a very complex process, NGS workflows have actually been refined and automated over the past few years to become compatible with clinical use, and we will be benefiting from that automation as we bring our tests into the CLIA setting.

So let's start off with the good news. The gene studio platform that we implemented last year is performing well. The system remains incredibly reproducible, and we remain confident that this is the best next-gen sequencing platform for use for the commercial launch of DetermaVu. Importantly, all the reagent components are manufactured under good manufacturing processes, or GMP as we call it in the industry, a requirement for FDA submission, making it ideal for reproducibility demands of our CLIA setting.

The key finding from our R&D efforts over the last 4 to 6 weeks is that we were encountering issues with lot-to-lot variability from our RNA extraction reagents. Now that we have isolated the cause, we will establish incoming QC protocols to ensure no further impact on our test reproducibility as well we'll work closely with our vendor to gain early notice of changes to these important reagents.

Extracting RNA from blood in a consistent manner is essential to the reproducibility required for CLIA validation, and we are now moving forward to rapidly reproduce the experiments necessary to keep DetermaVu advancing on the development pathway.

Also important to note is that while we're working on the extraction reagent issue, we also went back and completed a thorough review of all the workflow components. We evaluated our vendors, automation and quantitative analytical methods and now believe we are in a much better position with our development process to ensure the reproducibility that is essential for patient care.

So with all that said, here's where we stand today. Our updated timeline is built in the time to retest the original R&D samples in our updated workflow. We have the samples ready to go and have identified possible solutions to expedite and move the process along as efficiently as possible. Once completed, we will then reinitiate the CLIA validation process. These additional steps mean we're pushing out the original timeline by approximately 6 to 9 months. Because of this change in timing from the original plan, many of you have asked us to be more transparent about the process. So to honor that request, here are some specific milestones we will work towards.

Over the next few weeks, we anticipate completing our work with the new lot of extraction reagents, which have been validated by our newly implemented QC process. This effort will allow us to establish the robustness of our full test system on the selected lots. Once that's completed, we'll begin to test the full system on clinical samples from our archived sample set to validate reproducibility.

When our R&D team is fully confident we've met the requirements for establishing the robustness and accuracy of our testing methods, we will then begin the full CLIA Validation study, and we will establish our lockdown performance parameters. Based on the work we've done to date, we believe we can complete this process within 6 to 8 weeks, which will move us into Q4.

Upon completion of these steps and CLIA validation, we will begin our final clinical validation.

As previously communicated in this phase, we will analyze approximately 440 blinded prospectively collected patient blood samples, and this will be the final confirmation prior to making DetermaVu commercially available. Notably, the good news is that we have collected all of the patient blood samples that we need to complete the study and stand ready to expedite this final step.

It's probably most important to highlight that while we have encountered a modest delay in our commercial availability time line, this hasn't shifted the time line in working toward our final goal of securing broad reimbursement for DetermaVu. The real target we're aiming for is the Centers for Medicare & Medicaid Services, or CMS, review of our reimbursement dossier. As mentioned in our press release today, we're very fortunate to recruit Padma Sundar, an expert in marketing and market access in molecular diagnostics, and she has been actively working toward this goal in parallel with advancing our CLIA Validation and Clinical Validation studies. As of today, we believe we have an assured approach to what is ultimately our most important milestone.

For those of you who are not familiar with the CMS process, there are a number of important steps that must be completed before submitting a dossier for CMS review. First and foremost is a reproducible test, which as we discussed already, we're working diligently to deliver. Another component is a peer review publication. And I can share that we're already making progress towards the manuscript template that details the underlying science and results of our DetermaVu studies. We've also started the planning for the clinical utility study we will need for final CMS acceptance and are poised to start site recruitment immediately after we complete clinical validation.

The good news here is that we have a number of key opinion leaders who are enthusiastically ready to participate with us. Moreover, I'd like to remind you that we've already had enthusiastic responses for 10 public and commercial health plans, which represent 77 million covered lives. They can see the potential of DetermaVu to improve patient outcomes and improve their health care economics. These stable opinions, plus our extensive work to prepare for CMS review, are encouraging, and lead us to believe that we can still execute an aggressive time line for reimbursement, which is the most important milestone for revenue generation from our diagnostic test.

So thank you for allowing me the time to share the development process in such detail. I hope it was helpful information.

Next, I'd like to address our quest for high-impact talent. I have a personal philosophy that great people are the key to achieving great things. And while I'm very impressed with our current team at OncoCyte, there are some critical skill sets and experience we needed to add to complement our team and fully execute our tactical plan.

I shared on the last call part of these efforts have been focused on building a world-class commercial team to support the launch of DetermaVu. As mentioned during the June call, we successfully recruited Padma Sundar to serve as Senior Vice President of Marketing and Market Access. Having Padma on the team experience and her experience from Guardant and Affymetrix is a great step forward as we advance our plans to market DetermaVu to the broadest possible patient population. Her experience as a marketing executive preparing and developing markets for molecular diagnostic tests with a focus in the liquid biopsy space will be invaluable to our efforts and is already paying dividends.

More recently, we were fortunate to bolster our team with the appointment of Dr. Kim Dickinson as Vice President of Clinical Operations. Kim, as a respected leader in clinical operations and pathology, brings the experience that will be essential to advance our R&D programs and clinical studies. We believe that adding Kim to the team will allow us to fully exploit the potential inherent in our immune system interrogation approach. She will be key to delivering access to patients, to samples and to trial sites as we enter the clinical phase of our development and as we broaden our efforts into other areas of unmet clinical need in lung cancer management.

So let's talk a bit about the future. I'm very confident in OncoCyte's ability to provide relevant information to physicians along the patient journey. Today, despite a significant investment in research over the last 10 years, the cure for lung cancer continues to evade the medical community. Importantly, the industry's increasing research and focus has lead us to a better understanding of the disease continuum and uncovered several critical decision points that today remain underserved by current liquid biopsy landscape.

The decision point today that has created the most shareholder value has been centered around answering what targeted therapy is best suited for this patient. While this is an important decision point and one best suited for the cell-free DNA and circulating tumor DNA companies like Guardant and Foundation Medicine, there are several other important critical questions earlier in the clinical decision continuum that remain unanswered today, leaving significant room in the market for the OncoCyte approach.

The market opportunities for these unmet needs along the patient journey are substantially larger than the ones currently served by the ct and cfDNA players. Our strategy team has identified critical decision points along the lung cancer continuum, where we can bring incredible value to patients, stakeholders and ultimately to our shareholders. We have a line of sight on several potential opportunities to complement DetermaVu and bring forward the time line for potential revenues for OncoCyte.

I look forward to the following investor conference season to share more of these strategic insights and to share how OncoCyte aspires to continually improve the management of lung cancer patients while increasing our value to stakeholders and shareholders. While these initiatives are in their early stages, I want our shareholders to understand that we believe DetermaVu is just the beginning. Our vision is bold and compelling and we believe achievable both technically and financially. Right now though, I hope it's clear that our top R&D priority is executing on DetermaVu and completing the work that remains to deliver a commercial product with widespread adoption and reimbursement.

It's been incredibly exciting to be a part of the evolution of molecular diagnostics over the past 20 years. I've been very fortunate to have led some amazing teams through transformative shifts in clinical decision-making and in patient care, and I believe there's much more to come. And that's why I'm so pleased to be here at OncoCyte. Our team has done pioneering science that is just on the cusp of being translated into widespread clinical benefit. I am committed to getting DetermaVu across the finish line and I hope after this call you, too, are confident that we're on our way.

At this point, I'd like to turn the call over to Mitch Levine for a review of our financials. Mitch?

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Mitchell S. Levine, OncoCyte Corporation - CFO [4]

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Yes, thanks, Ronnie. First, I'd like to introduce a new member of the finance team, Tony Kalajian, who joins us as Chief Accounting Officer. Tony has consulted for OncoCyte for many years and brings over 20 years of experience in domestic and international financial reporting, auditing and accounting. Welcome, Tony.

Now to our results. At June 30, 2019, we had cash, cash equivalents and marketable securities of $36.3 million as compared to $8.4 million at December 31, 2018. Through the second quarter ended June 30, 2019, we incurred a net loss of $5.4 million or $0.10 a share as compared to $4.5 million or $0.12 per share for the 3 months ended June 30, 2018. Our operating expenses for the 3 months ended June 30, 2019, were $5.5 million and $4.3 million on an as-adjusted basis as compared to $4.2 million or $3 million on an as-adjusted basis for the same period in 2018.

We have provided a reconciliation between GAAP and non-GAAP operating expenses in the financial tables, including with our earnings release, which we believe is helpful in understanding our ongoing operating expenses.

Research and development expenses for the current quarter were $1.5 million as compared to $2.3 million for the same period in 2018, a decrease of about $800,000. This decrease was primarily due to amortization expense of intangible assets reflecting a noncash impairment charge we recorded as of June 30, 2018. These related to intangible assets for therapeutic uses that we no longer plan to develop or commercialize. There was no amortization expense for intangible assets recorded during the current quarter.

General and administrative expenses for the second quarter of 2019 were $3.6 million as compared to $1.3 million for the same period in 2018, an increase of $2.3 million. This increase is primarily attributable to investment banking-related expenses, personnel and related expenses, including management transition costs accrued as of June 30, 2019; legal, recruiting, accounting, auditing and tax services expenses; and stock-based compensation expense due to additional equity grants, including new hires.

Sales and marketing expenses for the 3 months ended June 30, 2019, were $300,000 as compared to $600,000 for the same period in 2018.

As Ronnie mentioned earlier, in late May, we made a key hire in marketing, and we expect that our sales and marketing expenses will increase modestly as we continue to build the sales and marketing team at the appropriate time for our planned commercialization.

Cash used in operations was $2.8 million for this quarter as compared to the approximately $4 million during the second quarter of 2018, in line with our expectation for the current quarter's cash burn of around $1 million a month.

That concludes my remarks concerning our financial highlights. Operator, we are now ready to open the call for Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Paul Knight with Janney Montgomery Scott.

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Paul Richard Knight, Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst [2]

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Ronnie, you've said 6 to 9 months additional on the time line. Is this all linked to the CLIA validation process? Or are you adding in additional time for paper publishing, et cetera?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [3]

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No, the 6 to 9 months is really focused on the CLIA validation process. Obviously, we want to get this right and we don't want to short-change it. And there's really 6 major buckets of effort there. One is we want to validate RNA extraction components that we talked about and our ability to do RNA cleanup, then the library prep and then obviously the sequencing test performance once it's in the instrument. And then we have the whole software component, a [variant call], and then ultimately, we want to validate the actual algorithm for final results reporting.

And so we've established that time frame. We do believe that the CLIA validation process, if we get the right -- if we get lucky and we get the right opportunity with the instruments and potentially the ability to bring in a few extra instruments from Thermo, that we might be able to compress that. But right now, we're still sticking with the 6 to 9 month until we can see those efforts that we're working on to expedite it and move up.

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Paul Richard Knight, Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst [4]

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And well, you -- we had the next question regarding your $1 million per month burn. Is that for this year? Is it for the next 12 months? Where are you at in terms of ramp? And I guess, following on to that would be, I guess we should now expect early commercialization sales somewhere in, what, Q4 next year?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [5]

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Yes, I think we will know more as we get into Q3 and we get through the CLIA validation to report that back to you. Our plan, obviously, is to work diligently and try to do -- be as effective and efficient as we can once we get the CLIA validation to begin to prepare these other components that have to be in place for CMS submission. And I think that's a good target for us.

I think we've said, at least, I know I mentioned I have talked to Tony about it, I think we said externally that our ramp-up of our commercialization is going to be very methodical. I think the beauty of the learnings that have come from the team that we're bringing in, the years of experience that they've had, is really it's a more targeted approach to commercialization.

We have 10 states that make up close to 50% of the patient population that we need to go after. And so obviously, we will use overwhelming force in those states to begin to generate revenues. Some of those states have private payers who have shown more aggressive approach to funding these types of tests. As well as in those states, the private -- the self-employed or self-insured companies, where we can go in and work with the larger patient populations and show healthy economic benefit. Those are the things we'll do to try to accelerate the revenues, but certainly, it will allow us to work methodically at building a sales force on the revenues that we generate from this targeted approach.

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Operator [6]

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Our next question comes from Thomas Flaten with Lake Street Capital Markets.

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Thomas Flaten, Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst [7]

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Just a follow-up on the timing question. So what would be a reasonable expectation for a CMS dossier submission? I know we had talked about kind of mid-2020. What would you say that current guidance would be?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [8]

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I'd say right now I don't want to speculate. I think if I look back at the last 7, 8 months, the thing that got us where we are today is we anticipated the best possible timeline. And I think right now, while next summer is plausible, I don't think I'm in a position to really commit with a lot of confidence as to what that -- that we could make that date. I think we will know more as we get into October and November as we get the CLIA validation and we get teed up to go to clinical validation.

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Thomas Flaten, Lake Street Capital Markets, LLC, Research Division - Senior Research Analyst [9]

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Great. And then with respect to the strategic initiatives that you will be, I guess, announcing in more detail come the fall, with the current cash position that you have, is that sufficient to fund some of those initiatives? Or will you need to -- or are those of the size that we should anticipate some, I guess, different level of funding required to undertake those initiatives?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [10]

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Yes -- the -- right now, the strategic team has looked at a number of opportunities. Some are small tuck-ins that are incremental to what we're doing that don't require a lot of cash. There are some bigger aspirations long term, but I think right now, our focus is to get DetermaVu back on track. And if a couple of these smaller opportunities come along, we might take those shots on goal. But right now, the goal is to use the capital we have to get us to where we need to be.

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Operator [11]

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Our next question comes from Bruce Jackson with The Benchmark Company.

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Bruce David Jackson, The Benchmark Company, LLC, Research Division - Senior Healthcare Technology Research Analyst [12]

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So if we can take a look at the 6 buckets of -- looking at the workflow on the validation and just specifically look at the RNA extraction, are you still considering automating that process? And are there any [great] limiting factors in fully addressing that process? So for example, the ability to order and get the equipment in a timely fashion?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [13]

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Great question, Bruce. We sat back and really took a long, hard look at this as while we pause, should we go ahead and try institute automation? And the team, after thinking about it, we clearly realized that the best thing we can do right now is to get the manual process stabilized and ready for market. It's much easier to automate a stable process than it would be to try to add one more variable. So while we will be focused -- we have our tiger team focused on getting the current manual extraction process validated, we obviously will have concurrent opportunities to look at some of this automation and begin to see its impact, both on our operational efficiency, but certainly on performance. But we do not plan to do the CLIA validation with the automation at this time. But we will obviously layer in that automation once we're CLIA validated and we're on the market. We'll begin to come back. And then as we ramp up and scale our volumes, we'll add in the automation.

My experience has been that automating a process that's not reproducible doesn't help the reproducibility necessarily, although we do know that automating RNA extraction will improve the yield and more than likely will improve the reproducibility because that system will have reagents manufactured under good manufacturing practices versus RUO reagents. So there will be well-established outgoing QC parameters that we will get along with the reagent shipments. But for now, we're going to stick with the workflow we got. We're going to stick with the manual process. We believe we've got it nailed down now, and we don't want to be changing that midstream.

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Bruce David Jackson, The Benchmark Company, LLC, Research Division - Senior Healthcare Technology Research Analyst [14]

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Okay. Okay. And then just broadly, it is interesting you discussed that you took a look at the entire workflow. So taking just broadly -- with the clinical path in getting to 6 to 9 months, is most of the activity focused on the extraction side of it? Or are there any other areas we should be paying attention to? What's the biggest swing factor in terms of the timing?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [15]

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Yes, right now it's to take the lots of the extraction reagent that we've vetted and we believe will work well for us and to rapidly put those through their paces as we bring up each component of the workflow and make sure that we eliminate any other variables. We've got those samples. If we keep our heads down and stay focused, that's probably a 2- to 3-week process. And then once we get to that point, we should be able to enter the CLIA validation phase with some confidence and the lots that we have and the ability to move forward.

Once we do that, obviously we have developed already our own incoming QC protocols to once we find the perfect lot for us, that will be the composition that we're going to ask the manufacturer to either sequester for us or to continue to make to that specification. So they have been helpful, and we are working with them, and we do believe we'll have a viable process going forward to ensure consistent supply of that product.

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Operator [16]

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(Operator Instructions) Our next question comes from Keay Nakae with Chardan Capital Markets.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [17]

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Yes. My question is focused really on working with the supplier of the RUO. So it sounds like, and correct me if I'm wrong, you have enough product maybe from different lots that's consistent enough to go ahead and complete the CLIA validation, but there's still then some work to do with the vendor in order for them to provide you the preferred formula in a consistent manner?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [18]

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Yes, Keay, thanks. Great question. I'm glad you asked that because I probably wasn't as clear as I needed to be. We already have the lots and the composition of those lots. We've already looked at a number of lots that we know work. And so what we want to do now is to look at the best of those and get those lined up for future use.

Once we get going on that, we'll then obviously work with them and make sure they know that, that is the performance expectations that we have going forward. We would -- more than likely, we'll sequester a very large amount of that, which we hope will lasts us a 1 year, 1.5 years, it has a very long shelf life. And so the goal would be to, once we get that, to sequester that lot, we don't think that will impair our P&L at all because typically, these companies will sequester the lot and hold it for you, and yet you'll only be charged for it as they ship it to you and invoice you for it. So we are, again, working with them, and they've been -- all of our vendors have been very helpful in this process with us and we're appreciative of that.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [19]

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And again, assuming you have the preferred version of the reagent, what's the risk of the timing involved for the supplier to be able to do what they need to do on their end to be able to provide you that on a consistent lot-to-lot basis?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [20]

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Yes, Keay, they -- like I said, we will, in the next few weeks, hopefully pick one that we like the best, and we will sequester hopefully 18 months of that now. And so it will be manufactured in bulk and we'll be able to -- they will be able to kit it and send it to us as we need it. So our goal is to pick one and move forward with that one and eliminate the risk of this happening in the future.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [21]

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Okay. And then just on the Clinical Validation study, within the time frame you gave us, are you also expanding the time to complete that? And if so, why, given that you have the necessary samples to do that study?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [22]

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Yes, we're not expanding the time frame for the Clinical Validation study. We have those samples. The limitation to speed is the single sequencer we have today. And by the time we get there, we will have added multiple instruments to our workflow so that we will have multiple workflow lines that will be available so that we can increase our turnaround time capacity. So we do believe that once we get through CLIA validation, that the time frame we had originally allowed for Clinical Validation will still be the appropriate time frame.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [23]

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Okay. And then just -- thanks for that answer, but I guess in saying you'll have multiple systems, is there then some additional work required -- granted they all should work the same, but do you need to guarantee that that's the case?

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [24]

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Yes, that's a great question. So Keay, what we'll end up doing is -- the latest works in our world is we'll have a team that will be focused on the actual clinical workflow that's live and validated, and we'll have another work line or work flow or 2 with these instruments. And we will be validating these instruments alongside the one that's clinically active, and that's how we'll bring these up concurrently to make sure that they all are correlated.

One thing I note from my years on the manufacturing side of these systems is that they do, they are very, very consistent across the systems when you know the targets you're looking for. The challenges that next-gen sequencing and next-gen sequencers have is when you don't know what you're looking for. If you're doing a full exome, the whole genome, transcriptome, sometimes you get variability between these instruments. But when we're using a custom [ample seek] kit with known targets that we're amplifying, the chip is extremely accurate and reproducible.

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Operator [25]

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There are no further questions. I would like to turn the call over to Ronnie Andrews for closing comments.

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Ronald A. Andrews, OncoCyte Corporation - CEO, President & Director [26]

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Thank you all again for joining our call. I know it was a little long, but I hoped the details we shared today hit the mark in the transparency we committed to bring to you guys. We believe we've made great progress in ensuring that DetermaVu is going to meet our high-quality clinical standards. And I can promise you we're going to continue to drive each other here to ensure that we do everything in our power to deliver the assay for the patients we aim to serve and for the shareholders who put their trust in us.

So in closing, I'd like to make it clear that we're committed to providing as much information as possible to keep you fully informed of our progress and plans, and I look forward to future updates. Thanks, everyone.

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Operator [27]

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This concludes today's conference. Thank you for your participation.