Earnings Labs

Insight Molecular Diagnostics Inc. (IMDX)

Q3 2018 Earnings Call· Tue, Nov 13, 2018

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Transcript

Operator

Operator

Greetings and welcome to the OncoCyte Corporation Third Quarter Conference Call. [Operator Instructions] It is now my pleasure to introduce your host Bob Yedid. Please go ahead.

Bob Yedid

Analyst

Thank you, Stacy and thank you everyone for joining this afternoon's conference call to discuss OncoCyte's third quarter 2018 financial results and recent operating highlights. If you have not seen today's financial results press releases, please visit OncoCyte's website at www.oncocyte.com. Before turning the call over to William Annett, OncoCyte's President and Chief Executive Officer, I would like to remind you that during this 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 the commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory approvals, the capacity of OncoCyte's 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 patients use of any diagnostic test the company commercializes, and our need and ability to obtain future capital and 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 Bill, President and CEO. Bill, please go ahead.

William Annett

Analyst

Thanks, Bob and welcome, everyone, to our conference call to discuss our third quarter 2018 financial results and operating highlights. Joining me on today's call are; Al Parker, Chief Operating Officer; Mitch Levine, Chief Financial Officer; and Lyndal Hesterberg, PhD, Senior Vice President of Research and Development. Al, Mitch and Lyndal will be available during the question-and-answer session. For the past year, we've been acutely focused on getting the clinical development program of DetermaVu, our lung cancer diagnostic test back on track after we encountered issues last year with the reagents for the diagnostics testing platform that we have been using. Today, I'm pleased to say that we've taken a significant step forward with the successful transition to a different platform, an industry standard Next Generation Sequencing or NGS diagnostic testing platform for targeted sequencing. Our selection of the new NGS platform follows months of rigorous testing during which we evaluated four leading clinical diagnostic testing platforms for with our DetermaVu lung cancer assay. We anticipate that the use of the widely commercialized diagnostic platform that we've chosen will increase the likelihood that DetermaVu will offer a consistent and robust result necessary for further product development and commercial success. We've now completed the transition to the new platform, including installation, training and operational qualification. We've also completed incoming quality control testing of our new custom targeted sequencing panel reagents. As anticipated, the new platform is generating consistent and reproducible data among samples tested so far. We've also observed excellent reproducibility across multiple reagent lots and believe that the precession of our new NGS platform may improve our test performance in a routine clinical testing environment. In addition, the use of the new NGS platform could allow for decentralized operations beyond OncoCyte's CLIA lab potentially enabling development of a CE marked…

Mitch Levine

Analyst

Thanks Bill, and good afternoon to everyone. At September 30 2018, we had $10.8 million of cash and cash equivalents and marketable securities valued at $830,000 for a total of $11.6 million of liquid assets. This cash balance includes the $3.3 million, net of financing expenses that we raised in July as a result of a successful at-market registered direct offering of units which are comprised of common stock and warrants. This offering was led by management and OncoCyte's Board of Directors and included an institutional investor new to our company. The financing provides us with additional resources to advance DetermaVu through the remaining development steps that must be completed prior to commercialization. The participation by management and members of the board reflects our confidence in our new diagnostic testing platform as the backbone of our ongoing DetermaVu development program as well as the company's long-term growth prospects. For the third quarter of 2018, OncoCyte reported a net loss of $3.0 million or $0.07 per share, compared to a net loss of $6.9 million or $0.22 per share for the third quarter of 2017. Operating expenses for the third quarter of 2018 were $3.0 million, as reported and $2.6 million on an as adjusted basis, which excludes certain non-cash operating expenses. 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. Cash used in operating activities was $2.5 million for the third quarter of 2018, which compares to cash used in operations of $3.5 million during the third quarter of 2017. The reduced cash used in operations in the current quarter mostly resulting from our staff reductions and executive sabbatical program we implemented last quarter. For the current third quarter, our average monthly use of cash in operations was about $833,000. During 2017, our average monthly use of cash was about $1.1 million. Cash, cash equivalents and marketable securities enable us to maintain our core capabilities and complete the development of DetermaVu as we continue to align our operating expenses with our primary goal of completing DetermaVu, essential for creating long-term value for our shareholders. Research and development expenses for the third quarter of 2018 were $1.5 million compared to $1.8 million for the same period in 2017. General and administrative expenses for the third quarter were $1.3 million compared to $4.3 million for the comparable period in 2017, which was higher than the prior period principally due to a $3.0 million non-cash expense related to the issuance of warrants to certain shareholders. We did not have any such similar charge for this quarter. That concludes my remark concerning our financial results and now, I'll turn the call back to Bill.

William Annett

Analyst

Thanks Mitch. Before opening the call up to your questions, we thought it would be useful to reiterate the timeline of upcoming development activities. By the end of this year or early 2019, we will report results from our R&D validation study. Again, this will gauge the test's accuracy to about plus or minus eight percentage points and where there are several additional development steps to complete prior to filling to commercialization. The results of the R&D validation study will indicate whether we likely have a commercially viable test. This is a very important data and a significant milestone for our company that we expect within the next few months. If it is successful, this will be followed in the first half of 2019 by analytical and CLIA validation studies. Our path to commercialization concludes with a clinical validation study to confirm product performs claims in an independent blinded data set. Following commercialization, we plan to conduct a post launch clinical utility study designed to demonstrate improved outcomes at a reduced cost to the healthcare system, a key step in securing payer reimbursement. We're excited about the progress that we're making in developing DetermaVu and look forward to the completion of the near term studies underway, which should provide visibility into the accuracy of our test by about the end of the year. If these studies and the studies we plan for the first half of 2019 are successful, we plan to make DetermaVu commercially available in the second half of 2019. That completes our formal remarks. We are now open for questions.

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Paul Knight with Janney. Please go ahead.

Paul Knight

Analyst

Hi, Bill that was a very well prepared commentary and congratulations on the NGS platform. As you talk to the - I think you're talking about the - when you're talking about the $4.2 billion or $4.7 billion market, I think that's Lung-RADS 3 and 4, is that assuming that all of these patients who're eligible and then kind of really what I'm getting at is what portion of these Lung-RADS 3 and 4 are getting biopsies? So are you thinking the whole market addressable or are you thinking just the biopsy market is addressable?

William Annett

Analyst

Great, thanks Paul. Yeah, that's a great question and it really is fundamental to understanding the market opportunity here. So to look at the total addressable market, what we're talking about is the total potential of all tests if everyone in the categories got screened and had follow-on procedures. So you're also correct Paul, that we're talking Lung-RADS 3 and 4 and Lung-RADS is a radiological classifications system which is used by radiologists and pulmonologists to classify the risk of lung nodules and basically Lung-RADS 4 includes everyone who has a lung nodule of above 8 millimeters or larger and Lung-RADS 3 is everyone who has lung nodules of about 5 millimeters to 8 millimeters. So today the standard of care is for people in the Lung-RADS 4 category, the larger nodules, the vast majority of those people are going to go to the biopsy. In Lung-RADS 3, the 5 millimeters to 8 millimeters nodules, there is a mix depending on the individual physician, some physicians will send people on to biopsies in this category, others will have watch and wait, they will have more frequent screening of low dose CT scans. And again the numbers are - there's approximately 400,000 to 600,000 people in the US in Lung-RADS 4 with the 8 millimeter and larger and there is another 800,000 or so in Lung-RADS 3, so in total about 1.4 million in Lung-RADS 3 and 4. In order to get the total addressable market, we basically multiply that number by the assumed pricing of that of the - the test which is in the $3000 to $4000 range. So that's the total addressable market. When I think, Paul, your question is really about what portions would be getting biopsies? That number of 1.4 million assumes that everybody in the US, they all - 10 million to 15 million Americans at high risk would go and get their annual lung screen and that is certainly the standard of care, that's what is recommended today, but we are in a situation where not all of those people are getting their screens. There are various campaigns underway that we are trying to get more screen and we do anticipate as to those the rest of the medical industry that that the screens will increase very significantly over the coming years, but that - so that large number is basically aspirational. We think ultimately that are pretty high percentage of those people will get their screens and nodules will be discovered and then they would be eligible for our test. Hopefully that answers your question.

Paul Knight

Analyst

Yes, very good. And then lastly, what was to this population is Medicare. It seems like it probably is a big portion and therefore we don't have to go through the arduous process of commercial payer like maybe the other tests?

William Annett

Analyst

Right, a great - another great point. Lung disease or lung cancer or lung nodules tend to be predominantly in an elderly population generally over the age of 55 or 60, so Medicare will be a very high percentage, we believe that it will be in the vicinity probably of 55% to 60% of our revenue perhaps more.

Paul Knight

Analyst

Okay. Thank you.

Operator

Operator

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

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

Hi, congratulations on the progress and continue on the potential market discussion. What percentage of the people who are eligible to be screened today are actually being screened?

William Annett

Analyst · The Benchmark Company. Please go ahead.

So, we've been trying to get that information and it is difficult to combine and it is still probably fairly low. We've seen some estimates in the 15% to 20% range currently. We've also seen estimates that say that by the early 2020 has been over in the next four or five years but that percentage could get up into the 60% or more. What we do know is that talking to key opinion leaders they are saying that the number of screens is increasing very dramatically. Remember that this screening for this population is fairly new, it's only three years ago that it became efficiently part of the standard of care and about just over three years ago that Medicare started paying for. So there is general consensus in the - among the profession pulmonologist and radiologist and so on that the number of screens is increasing very quickly.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

Okay. And then looking at the Canadian marker, so the original grip of markers they get from the Wistar Institute, those are - I think those are all RNA markers, right, 560 ARNA markers?

William Annett

Analyst · The Benchmark Company. Please go ahead.

Yes, that's right.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

And then you've got the new markers that you recently patented and are those also RNA markers, how would they include other types of targets?

William Annett

Analyst · The Benchmark Company. Please go ahead.

Yes, those are all mRNA or messenger RNA markers as well. And again these are - what we are seeing is the body's immunological response is what we are trying to capture with these markers.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

And then are you testing off of those markers in your 700 sample algorithm development study?

William Annett

Analyst · The Benchmark Company. Please go ahead.

So, why don't I let Lyndal Hesterberg to answer that question, Lyndal?

Lyndal Hesterberg

Analyst · The Benchmark Company. Please go ahead.

Sure. The quick answer is no, we are not testing all of those markers, we have evaluated in our prior smaller studies that we and disclosed that a number of the markers were are providing much higher value. And so we are training or testing on the 700 sample study, the markers that are demonstrating the most value.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

Okay. So it's a subset of the 800 roughly markers that you had before, okay.

Lyndal Hesterberg

Analyst · The Benchmark Company. Please go ahead.

Yes, that's correct.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

And last question on the algorithm development, are you going to be looking at any physiological markers like nodule size for inclusion and the algorithm?

William Annett

Analyst · The Benchmark Company. Please go ahead.

So we did say in our press release in July about the 155 patient study that we although limited number of patients 155. We did see results which were equal to or better than it seem in the reported results in 2017 and where the 2017 results did include the module size as a clinical factor. The 2018 study did not include the clinical data, which is important. However, as we said on our July release, we need to do a much larger sample size than 155 and that's why we are doing the larger studies now. Lyndal, do you have other thoughts about that?

Lyndal Hesterberg

Analyst · The Benchmark Company. Please go ahead.

No, I think you covered it well there, though.

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

Hi, well, that's it for me. Thank you very much.

Operator

Operator

[Operator Instructions] Our next question comes from Keay Nakae with Chardan. Please go ahead.

Keay Nakae

Analyst · Chardan. Please go ahead.

Hi, maybe a question for Lyndal, but is there anything about the major characteristics of the 700 patient samples in the R&D study that make particularly good robust sample that will help you tease out the performance of the test?

William Annett

Analyst · Chardan. Please go ahead.

Yeah, Lyndal?

Lyndal Hesterberg

Analyst · Chardan. Please go ahead.

Yes, in fact, there is a number of features about the 700 patient sample that I think do make it particularly robust. To be specific, as you may recall, the clinical sample collections and studies that we've been doing and now over 60 sites around the US were potentially [ph] designed to capture the US demographic of lung cancer patient and the screening patients. So this is in age, gender, ethnicity as well as geographic diversity. And so we have put together what I believe to be a very representative and also robust sample study for the US testing population and from that certain we had consultants and others independently for me at least in the development team independently select what they thought were the most appropriate samples to include in the training with the full intention of the deem as robust as we possibly can make it.

Keay Nakae

Analyst · Chardan. Please go ahead.

Okay. And just a second question, once you have the results, is your plan to simply talk about the kind of the overall performance relative to prior test or how specifically will you be with the performance characteristics knowing that you often like to present that detail at scientific conferences?

William Annett

Analyst · Chardan. Please go ahead.

Yeah, good question. We definitely - as you know, often the - some of the specifics are embargoed if you wanted to present at medical conferences and although you can usually say at a high level when you talk about the success or failure. Lyndal, any thoughts about R&D validation study results and what we can say?

Lyndal Hesterberg

Analyst · Chardan. Please go ahead.

I thought - no, your point is quite - [ph] I think very accurate. Unfortunately or fortunately [indiscernible] take a look at it, but we do have to be careful and embargo specific information. I would expect though that we should be able to give general performance levels once we've seen the R&D validation results so that all of us can feel comfortable with the test performance.

Keay Nakae

Analyst · Chardan. Please go ahead.

So would that include being specific about sensitivity, specificity and AUC?

William Annett

Analyst · Chardan. Please go ahead.

I'm not sure about that yet. That isn't something that we have discussed at this point and until we get the actual results. So we'll certainly consider that very carefully when we give the results of that study.

Keay Nakae

Analyst · Chardan. Please go ahead.

Okay, were good. I mean, I appreciate why you would want to withhold some of that to be able to present at the conference, but obviously yeah, knowing that this is how much better it possibly is in the prior is certainly an important data point as well.

William Annett

Analyst · Chardan. Please go ahead.

Yes. Yeah, definitely.

Keay Nakae

Analyst · Chardan. Please go ahead.

Okay, thanks.

William Annett

Analyst · Chardan. Please go ahead.

Thank you, Keay.

Lyndal Hesterberg

Analyst · Chardan. Please go ahead.

Thanks Keay.

Operator

Operator

There are no further questions. I would like to turn the floor over to Bill Annett for closing comments.

William Annett

Analyst

Alright, well, thank you again everyone for joining our call this afternoon. As I hope you can appreciate based on our prepared remarks today. This is a very exciting time at OncoCyte. We've moved well past the platform issues that we encountered last year and we're now moving forward with significant momentum in the development of our DetermaVu lung cancer diagnostic test for a potential multibillion dollar market. We look forward to providing you further updates on our next quarterly call.

Operator

Operator

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