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Insight Molecular Diagnostics Inc. (IMDX)

Q3 2017 Earnings Call· Tue, Nov 14, 2017

$4.21

+9.64%

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Transcript

Operator

Operator

Good day and welcome to Third Quarter 2017 Financial Results Conference Call for OncoCyte Corporation. Today’s conference is being recorded. At this time, I would like to turn the call over to Mr. Michael Polyviou. Please go ahead sir.

Michael Polyviou

Management

Thank you, operator. We appreciate everyone joining us on this afternoon's conference call and webcast to review OncoCyte's financial results for the third quarter of 2017, product development update and anticipated near-term milestones. If you have not seen this afternoon's press release, please visit www.oncocyte.com. Before turning the call over to Bill Annett, OncoCyte's President and Chief Executive Officer, I would like to remind you that during the course of this conference call the company will make projections and forward-looking statements regarding future events. We encourage you to review the company’s filings with the SEC including without limitation the company’s forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in this these forward-looking statements. These factors may include without limitation, risks inherent in the development or the commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory certifications, uncertainty in timing of the training reimbursement authorization from third party payers, need and ability to obtain future capital and maintenance of intellectual property 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 by applicable law. With that, I would like to turn the call over to Bill Annett, please go ahead. Bill?

Bill Annett

Management

Thank you Michael and welcome everyone to our conference call to discuss our operating and financial results for the third quarter ended September 30, 2017. Joining me on today's call are Lyndal Hesterberg, our Senior Vice President Research and Development, Kristine Mechem, our Vice President of Marketing and Russell Skibsted, our Chief Financial Officer. Kristine and Russell will be available during the question and answer session. Before I move on to the quarterly update, I'm pleased to let you know that we have just hired a full-time Chief Financial Officer, Mitch Levine. Mitch is a very experienced financial executive with a tremendous healthcare track record and I'm confident that he will be a great addition to our senior leadership team. His addition demonstrates our commitment to strengthening our senior management team to execute our long-term growth strategy based on the development and commercial commercialization of novel liquid biopsy diagnostic tests for the early diagnosis of long and other cancers. We'll be announcing Mitch’s appointment in a press release tomorrow morning. Mitch is also on the call with us today. So with respect to the third quarter, during this period we made significant progress. As we successfully completed the analytical validation study of DetermaVu, our liquid biopsy lung cancer diagnostic test and received certification and licensure of our CLIA laboratory. These were the primary goals of the quarter and we achieved both on budget and in a timely manner. The analytical validation study data were presented by OncoCyte at the International Association for the Study of Lung Cancer or IASLC in Chicago in September. The studies required for analytical validation have been established in the Clinical Lab Standards Institute guidelines. These guidelines cover the testing for such matters as limits of quantization, precision, reproducibility and interfering substances. OncoCyte completed all of…

Operator

Operator

[Operator Instructions] And we will take our first question from Bruce Jackson with Lake Street Capital Markets.

Bruce Jackson

Analyst

If we could dive into the delay in the commercialization with the consumables, consumables covers a pretty wide area of inputs for the testing and we're talking something it's as simple as like buffer or is it more complicated than that. And then what's your best guess as to the launch date. Would it be sometime in Q1 or early 2018? So that’s the first question.

Bill Annett

Management

Thanks, Bruce. So the consumables in question are cartridges which contain the reagents that are used in the processing system that analyzes the blood samples. So that is what we have ordered a new launch. In terms of the launch date, we're not giving a projection at this point in time. We're waiting for the next lot of consumables and when we get them, when we get the next lot of these cartridges, then we will begin clinical validation. And so as I say, at this point, we're thinking the completion of clinical validation will be in -- will be moving into 2018.

Bruce Jackson

Analyst

And then looking at the other development programs, you talked about the breast cancer tests, is the idea there that you're going to launch that one about one year after the lung cancer test, is that still kind of the timeline?

Bill Annett

Management

So we are going to talk more about the test of course at the San Antonio Breast Cancer Symposium. And we haven't given a final date yet for the launch date of breast cancer, but again, yes, it will be sometime after we launch our lung cancer test, at least a year.

Bruce Jackson

Analyst

Last question, the bladder cancer tests, that one is a good candidate for partnering type of setup. Any news on the bladder cancer tests?

Bill Annett

Management

Yeah. We haven't been actively pursuing out-licensing that at this time. It's been lower on our priority list than the lung cancer and breast cancer. So no new developments on bladder.

Operator

Operator

[Operator Instructions] And we will move next to Carolina Ibanez-Ventoso with Janney Montgomery.

Carolina Ibanez-Ventoso

Analyst

Regarding the issues you had with consumables, were you able to save part of the samples to analyze them again or will you have to collect new patient samples?

Bill Annett

Management

Hi, Carolina. So we have all of the samples we need. We only use a small amount of the samples when we run them. So we have reserves. So we don't have to collect more samples. We have all of the 300 samples that we require for the study on site in our freezers and they’re ready to use.

Carolina Ibanez-Ventoso

Analyst

And then regarding the data that you already have collected, what are your plans on publications, publishing this data?

Bill Annett

Management

Well, the presentations which have been given on the analytical validation study at IASLC and the 300-patient study we presented at American Thoracic Society and most recently at Chest, we're not planning on publishing any of those at this point in time, but we hope to publish results of future studies as we finish clinical validation.

Operator

Operator

[Operator Instructions] And we will take our next question from [indiscernible].

Unidentified Analyst

Analyst

Bill, so with respect to the early analysis of the samples, can you tell us how the fact that you have these inconsistent results, how does that affect the overall reporting of the performance characteristics that you will publish at the end of the study.

Bill Annett

Management

So it shouldn't impact at all. So in effect, we haven't begun the clinical validation study yet and because we ran into these anomalous results, so once, as I mentioned once, we get the new lots of cartridges and consumables and then we will start clinical validation. And so we have no results at all at this point time in turn on the clinical validation study. Once we get the consumables, launch the study and complete it, then we’ll know what the results are.

Unidentified Analyst

Analyst

So maybe just for clarity, as you were preparing to analyze the results, as you were trying to dial in the control side, is that when you noticed the problems and therefore you hadn't yet run any of the samples you had received.

Bill Annett

Management

Yeah. So we started running samples, which we had received. We ran a relatively small number of them and in the QC process, our team noticed that there were anomalous results in these housekeeping or control markers. And as I mentioned earlier, basically, these are synthetic controls. They're highly stable, chemical compounds and they're quantitative in their numbers, the level of them shouldn't change at all between different tests, but in fact, we saw there were significant variations and that was -- that's what the controls are for of course is to show you when something is off. So we were able to see fairly quickly that there was some sort of problem and our technical team was able to do the analysis, investigate the causes and find that it was, we believe, a problem of the consumables.

Unidentified Analyst

Analyst

So because you didn't have the control set up, you never ran and actually, never ran the test to an actual result for any of the samples.

Bill Annett

Management

We ran for some of the samples first, a relatively small number of them, but the results were not valid because of the problems with the consumables. So we're going to -- we have to, in essence, we have not started the clinical validation study yet, although we have run a relatively small number of samples.

Operator

Operator

[Operator Instructions] And it does appear there are no further telephone questions at this time. I would like to turn the conference back over to Mr. Bill Annett for any additional or closing remarks.

Bill Annett

Management

Thank you. Thanks to everyone for attending our conference call today. I look forward to updating you on our continued progress towards the achievement of our stated goals, including the planned launch date of DetermaVu. Thank you very much.

Operator

Operator

This concludes today’s conference. Thank you for your participation. You may now disconnect.