Earnings Labs

Insight Molecular Diagnostics Inc. (IMDX)

Q1 2019 Earnings Call· Tue, May 14, 2019

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Transcript

Operator

Operator

Good day and welcome to the OncoCyte Conference Call to discuss First Quarter 2019 Financial Results and Operating Highlights. Today's call is being recorded. At this time, I would like to turn the call over to Bob Yedid of LifeSci Advisors. Please go ahead.

Bob Yedid

Management

Thank you, operator and thanks everyone for joining us for this afternoon's conference call to discuss OncoCyte's first quarter 2019 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 facts, 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 to the risk 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, uncertainties in the results of clinical trials or regulatory approvals, the capacity of OncoCyte's third party supply blood sample analytical 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, 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 now turn the call over to Bill Annett. Bill?

William Annett

Management

Thanks, Bob. And welcome everyone to our conference call to discuss our first quarter 2019 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 Ph.D, Chief Scientific Senior Officer. We will all be available during the question-and-answer session. 2019 has been a transformative year for OncoCyte. We started 2019 with the successful completion of our R&D validation studies DetermaVu, our liquid biopsy lung cancer diagnostic test. With the subsequent progress we have made towards completing product development, we remain on track for commercial availability of DetermaVu in the second half of this year. In addition, in mid-February, we completed a successful equity raise of $37 million of net proceeds, strengthening our balance sheet and leaving us well positioned to complete development and commence commercialization of DetermaVu. We'll also beginning the development of an expanded R&D program to leverage our unique immune system interrogation approach and other cancer indications. Today we'll provide a brief recap of our recent accomplishments and update for the remaining steps on the path towards commercialization and finish with a brief review of our financial. As a reminder, DetermaVu is our confirmatory non-invasive liquid biopsy test that we are developing to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is designed for use following a low dose CT scan and before determining, whether a tissue biopsy is necessary to patient with a suspicious lung nodule. In short, DetermaVu value proposition is to reduce the number of expensive, risky lung biopsies of benign nodules. Late last year, we announced our successful transition to the Thermo Fisher Ion Torrent GeneStudio S5 next-generation platform to ensure consistent, robust and reproducible results. In 2019, we quickly followed with positive results from our R&D validation study.…

Mitch Levine

Management

Thanks Bill, good afternoon everybody. At March 31, 2019, we had cash and cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. As we mentioned earlier, our balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering. For the first quarter ended March 31, 2019, we incurred a net loss of $3.9 million or $0.08 per share as compared to $3.8 million or $0.12 per share for the three months ended March 31, 2018. Our operating expenses for the three months ended March 31, 2019 were $4 million and $3.2 million on an as adjusted basis as compared to $3.9 million or $3.4 million on an adjusted basis for the same period in 2018. We have provided a reconciliation between GAAP and non-GAAP operating expenses in the financial tables included with our earnings release which we believe is helpful in understanding our ongoing operating expenses. Research and development expenses for the quarter ended March 31, 2019 were $1.3 million as compared to $1.5 million for the same period in 2018 relatively unchanged quarter over quarter as we continue to focus resources on the development of DetermaVu. General and administrative expenses for the quarter were $2.4 million as compared to $1.7 million for the same period in 2018, an increase of $700,000. This increase was primarily due to $400,000 in personnel and related expenses, and $300,000 in stock based compensation expense due to increased grants of equity awards to our employees. Sales and marketing expenses for the three months ended March 31 2019 were $200,000 as compared to about $700,000 for the same period in 2018, a decrease of $500,000 as we reduced our marketing activities and personnel after Q1 2018 and concentrated our resources on the development of DetermaVu. Cash used in operations was $6.7 million in the first quarter. Typically we use more cash in the first quarter because of timing of payments of merit salary increases and personnel related costs. We also had some significant nonrecurring cash outlays this quarter, including a $2.1 million payment to BioTime in February for shared services from prior years. That concludes my remarks concerning our financial highlights.

Operator

Operator

Great, thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] And our first question here is from Bill Quirk from Piper Jaffray. Please go ahead.

Bill Quirk

Analyst

Great. Thanks and good afternoon, everybody. First off, Bill, recognizing that you're obviously focusing on DetermaVu for lung cancer. You did comment several times and applying the technology and other areas of oncology. And so I guess which one should we be thinking about and if it's not too much to ask when we see some initial data? Thank you.

William Annett

Management

Thanks Bill. Yes, we are -- as we mentioned before, we do believe that the underlying mechanisms in our immunological approach may be very applicable across multiple cancer types, particularly solid tumors. We are in the process right now of looking at different opportunities and deciding and prioritizing on research projects in other cancer types. And we haven't finished that exercise yet, but when we do, we will be talking in further calls about what our R&D strategy and plan going forward will be.

Bill Quirk

Analyst

Okay. Understood. And then just staying on that subject rather, excuse me, on DetermaVu for a moment. Based on the ATS comments you made concerning the clinical relevance of DetermaVu. Help us think about your strategy or potential for guidelines inclusion there?

William Annett

Management

Sure. Well, certainly at this point in time, there are no guidelines for a test such as ours, because it's a brand new space, there really aren't any alternatives right now to the use of clinical data. We would very much like to see in the future guidelines developed and we'd like to be included in those guidelines. And that's what we, we'll be moving forward with the various studies which we have talked about, particularly the clinical utility study post commercialization. We hope to be able to give data, which would be helpful for the bodies that develop guidelines.

Bill Quirk

Analyst

Okay, got it. And then last one for me, one for Mitch, you've talked about this in the past. Any change your initial thoughts concerning the sales force build around the brand initial commercialization. I'm assuming, you're going to continue to have that be relatively small, I mean until you get to reimbursement. But can you just remind us what you're thinking there?

Mitch Levine

Management

Hey, Bill. Yes, you're exactly right. We are not making any changes in the development of our sales force. We expect to ramp modestly and slowly, as we develop milestones, such as peer reviewed papers that get published will bring in some more sales people at that point. But I think in the early going mostly through medical science liaison and possibly a couple of outside sales people, ultimately at full ramp when we have reimbursement, we expect to have approximately 40 outside sales people at peak.

Bill Quirk

Analyst

Okay, perfect. And then just last one for me. I asked last quarter about getting New York CLIA certifications, is this still the plan, guys. In other words, you are going to pursue that following the commercial release?

William Annett

Management

Yeah. Lyndal, do you want to answer that?

Lyndal Hesterberg

Analyst

Sure. Glad to. New York is absolutely in our plans, as you may have realized it has a cue that because of takes time for the state to have their inspectors come through all the various CLIA Labs. So we are looking forward to that as soon as they can get things done, post our commercialization that the ball's sort of in their court at this point.

Bill Quirk

Analyst

Got it. Thank you.

William Annett

Management

Thanks, Bill.

Lyndal Hesterberg

Analyst

Thanks, Bill.

Operator

Operator

Your next question is from Bruce Jackson from The Benchmark Company. Please go ahead.

Bruce Jackson

Analyst

Hi, thanks for taking my question. In terms of getting to the 40 reps post launch, how long do you think that would take?

William Annett

Management

Our suspicion is that we will have reimbursement within about two years plus or minus. And at that point, we'll have our 40 reps. I think that as we see milestones along the way, as I point out, perhaps it's peer reviewed papers that are published, et cetera, that would make openings into the physicians' office easier. That will be very helpful to us and we'll ramp up at that time, but we expect it to be modest in the foreseeable future.

Bruce Jackson

Analyst

Okay. And then with the R&D expenses and the operating expenses generally, do you think that didn't kind of stay in this current range, or might they drift up a little bit as we get towards the end of the year?

William Annett

Management

Yeah, I think that you'll see them grow very modestly, Bruce, as we bring in some more professionals and we begin to commercialize DetermaVu will have a modest ramp up, but it shouldn't be more dramatic than what you've seen in the past.

Bruce Jackson

Analyst

Okay. And then last question the R&D strategy here, you had a breast cancer test in the pipeline at one point in time also a pretty good bladder cancer test. Would you start there with the tests that you have and then to perform a process similar to DetermaVu where you ran the test through the samples with some new candidates and then came up with a new test or would you just start from scratch and just use the DetermaVu platform as a discovery vehicle and then and then prioritize the test? And that's it for me. Thank you.

William Annett

Management

Yeah, good question, Bruce. Lyndal, do you want to answer that?

Lyndal Hesterberg

Analyst

Sure. And just to clarify, as Bill said, we're still in the planning process and evaluating all the opportunities first. But second, we know there's areas that we want to explore based on just the biology and the biology of the immune system interrogation. And so, first and foremost, we need to expand and protect our DetermaVu, product in that line. And then pass that is where we want to look at other opportunities, both within lung cancer and potentially other solid tumors. But that's still at this point in the planning stage.

Bruce Jackson

Analyst

Okay. Thank you.

William Annett

Management

Thanks Bruce.

Operator

Operator

[Operator Instructions] Next question here is from Casey Woodring from Janney Montgomery Scott. Please go ahead.

Casey Woodring

Analyst

Hi, guys, this is Casey on for Paul. Lot of my questions have been answered here, but maybe one that you guys could speak to as maybe what sort of opportunity will the presentation that you guys had at the American Thoracic Society Conference be, would it simply just be your first chance to present, the details of the R&D validation study? Will you be able to go out and market yourselves to pulmonologist and attendants there maybe talk to payers and any color you can give there. Thanks?

William Annett

Management

Yeah. So, you know, the American Thoracic Society Conference is largely a scientific conference. So it is not so much a conference for payers and others. Perhaps Lyndal, you could talk a little bit about the -- what we would be representing, mindful that we're under embargo until that point in time.

Lyndal Hesterberg

Analyst

Sure. Glad to. So in general sense we will be sharing not just the top line results, which we've already reported, but also the details underneath in terms of the patient population, the characteristics that were there, what we've used, in this such that -- we -- my hope is that the physicians that are looking at us will see that we've done a good job in our clinical study collection itself and getting a cross sectional representation of these patients at risk for lung cancer. The other piece that we will be disclosing there is the performance against clinical factors along which doctors already have and they use today in their best efforts to try to identify patients who are at higher risk of cancer as a guidance for themselves as to which ones to carry the biopsy. The trouble is the clinical factors alone, while they're helpful are not sufficient, and are not, in my opinion, good enough. And that's where the biology and our biomarkers, we believe will perform those clinical factors significantly. And we'll be sharing some of that new information at the ATS presentation.

Casey Woodring

Analyst

Okay. Thank you.

William Annett

Management

Thanks, Lyndal. And as a reminder, that presentation is next Tuesday, May 21, at ATS. So we will be making the poster and the information available after that point.

Casey Woodring

Analyst

Great. Thank you.

Operator

Operator

This concludes the question-and-answer session. I'd like to turn the floor back to Mr. Annett for any closing comments.

William Annett

Management

Thank you. And thanks everyone for joining our call this afternoon. So we did hope that you are all as excited as we are about OncoCyte's progress and our upcoming milestones. We're well funded. We're well positioned to develop an exciting potential pipeline of liquid biopsy tests. And of course, we continue to rapidly advance the development of DetermaVu and expect in just a few months to have a commercially available product and potentially multi-billion dollar lung cancer diagnostic test market. We look forward to providing you with further updates in the upcoming months.

Operator

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.