OncoCyte Corporation (OCX) Q1 2019 Earnings Call Transcript
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OncoCyte Corporation (NYSEMKT: OCX)
Q1 2019 Earnings Call
May 14, 2019, 1:30 p.m. ET
Contents:
Prepared Remarks
Questions and Answers
Call Participants
Prepared Remarks:
Operator
Good day and welcome to the OncoCyte conference call to discuss the first quarter 2019 financial results and operating highlights. Today's call is being recorded. At this time, I'd like to turn the call over to Bob Yedid of LifeSci Advisors. Please go ahead.
Bob Yedid -- Investor Relations, LifeSci Advisors
Thank you, Operator and thanks to 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 release, 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.
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Any statements that are not historical fact, including but not limited to statements that contain words such as will, believe, plan, anticipate, expect, estimate, 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 specific risks that may cause actual results or events to differ materially from those described in these forward-looking statements.
These factors may include without limitations 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 analytics results on a commercial scale, the need to obtain third-party reimbursement for patient use of any diagnostic test the company commercializes or need and ability to obtain future capital and maintenance of IT rights.
Therefore, actual outcomes 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 -- Chief Executive Officer
Thanks, Bob. 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, PhD, Chief Scientific 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 study of DetermaVu, our liquid biopsy lung cancer diagnostic test. With the subsequent progress we have made toward 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 rate of $37 million of net proceeds, strengthening our balance sheet and leaving us well-positioned to complete development and immense commercialization of DetermaVu, while also beginning the development of an expanded R&D program to leverage our unique immune system interrogation approach in other cancer indications. Today, we'll provide a brief recap of our recent accomplishments, an update on the remaining steps on the path toward commercialization, and finish with a brief review of our financials.
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 in patients with a suspicious lung nodule. In short, DetermaVu's value proposition is to reduce the number of expenses, risky lung biopsies of benign nodules.
Late last year, we announced our successful transition to the Thermo Fisher Ion Torrent Gene Studio S5 next generation sequencing platform to ensure consistent, robust, and reproducible results. In 2019, we quickly followed with positive results from our R&D validation study. That study demonstrated sensitivity of 90% with a 95% confidence interval of 82% to 95% and specificity of 75% with a 95% confidence interval of 68% to 81%.
The R&D validation study analyzed 250 blinded patient blood samples utilizing the optimized mRNA biomarkers and algorithms previously determined by the company's algorithm development site. These study results solidified that DetermaVu is a best-in-class commercially viable test with the potential to fundamentally change the way lung cancer is diagnosed.
As a reminder, sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of the nine nodules correctly identified. A 95% confidence interval or CI suggests that there is a 95% chance that final test performance will be within the stated range.
We will be presenting these results as a late-breaking poster presentation at the American Thoracic Society 2019 International Conference. One of the largest and most well-regarded multi-disciplinary medical conferences. It is being held May 17th to May 22nd in Dallas. The abstract, entitled Blinded Prospective Validation Study of a whole blood gene expression classifier or the diagnosis of benign versus malignant pulmonary nodules will be our first formal presentation of these data and we look forward to sharing these results with the broader scientific and medical community.
Just last month, we announced the successful completion of the analytical validation study, the next key development milestone. Analytical validation established the performance characteristics of the DetermaVu assay system utilizing the Thermo Fisher next generation sequencing platform in OncoCyte's CLIA laboratory.
The studies required for analytical validation are established in the clinical laboratory standards institute guidelines and cover testing for minutes of quantitation, precision, reproducibility, and interfering substances. We have now completed all of these studies successfully and are encouraged to report that the analytical validation data supports the robust performance previously seen in the R&D validation study.
After completion of the analytical validation study, we quickly initiated our CLIA laboratory validation study, which is one of the remaining two studies necessary prior to commercialization. In the CLIA laboratory validation study, we are assaying approximately 120 blood samples previously tested as part of our R&D validation study. This study aims to demonstrate equivalent test performance when conducted in the company's CLIA-validated laboratory with CLIA laboratory staff and includes specific protocols to confirm the accuracy, reproducibility and precision of DetermaVu in a real world clinical CLIA lab setting. We look forward to reporting results from the study.
Assuming successful completion of the CLIA validation study, we will begin the final remaining step prior to commercialization, clinical validation. In the clinical validation study, we will analyze about 440 blinded prospectively collected patient blood samples with the final confirmation of test sensitivity and specificity in our CLIA lab setting.
Importantly, we already have all of the patient blood samples that we need in our freezers and can rapidly proceed through this final step. Between our two blinded studies, the R&D validation and clinical validation study, we will have run about 700 blinded prospectively collected samples. These studies are intended to produce the error bar for DetermaVu's sensitivity and specificity performance to about plus or minus 5%, which we believe is the range of accuracy needed for physician confidence and adoption. We'll touch upon this in greater detail later in the call.
We remain on track to complete these two remaining studies by mid-2019. Assuming a successful completion, we plan on making DetermaVu commercially available in the second half of this year. We are proud of our recent progress and are grateful to the entire OncoCyte team for the rapid and efficient execution of the studies required to bring DetermaVu to market.
While we've been excited by our remarkable progress thus far, we're also equally excited by the significance of these results from a scientific perspective. That said, I'd now like to provide a brief reminder about DetermaVu's unique approach, which harnesses the immune system's exquisite sensitivity to the presence of cancer.
At OncoCyte, we believe that our results represent a true scientific breakthrough in the field of liquid biopsy or early cancer diagnosis. Our approach, which we call immune system interrogation detects gene expression changes in the immune system in response to cancer, all from a simple blood sample. We have shown in a blinded study that it can reliably and reproducibly diagnose early stage lung cancer.
We believe that our approach was the first to succeed as an early stage lung cancer diagnosis. Other companies are applying alternative methodologies to detect lung cancer, such as direct detection of cell-free DNA, tumor DNA or circulating tumor cells in the blood. While some types of this type may be successful in late-stage cancer, they remain unsuccessful in early stage cancer, likely because at the earliest stages, there just aren't enough of these components in the blood for reliable detection and diagnosis.
So, instead of trying to directly detect and small and very difficult-to-find traces of cancer, instead we are detecting an amplified, highly sensitive response to the cancer by the body's immune system. This unique approach is what has allowed us to succeed where many of our competitors have failed. Our results back this up. All of the samples from our study are with patients with lung nodules no larger than 30 millimeters, which are generally indicative of very early stage cancer.
We're also increasingly excited by the potential of our immune system interrogation approach to be broadly applied across solid tumors, particularly for early stage malignancy. While we remain focused on rapidly completing the remaining steps for the commercialization of DetermaVu for lung cancer, we are also actively developing our plans to expand our technology more broadly. We look forward to providing future updates about our plans, next steps, or our R&D activity as we determine our next areas of focus based on both patient need and commercial opportunity for OncoCyte.
Before we move to commercialization and reimbursement, I'd like to provide a brief reminder of how DetermaVu has the potential to address the significant challenges and lung cancer diagnostic paced by patients, doctors, and payers. Lung cancer remains the leading cause of cancer death, both in the US and worldwide, generally because most patients are not diagnosed until they have late-stage disease.
Detecting lung cancer early will allow for earlier treatment with a better chance of saving or prolonging life. However, it's important to note that current methods of detection rely on low-dose CT scans or X-rays, followed by tissue biopsies. This is where the main problem lies. Lung biopsies are risky, with high rates of complications, such as collapsed lung and intensive care unit stays, and in 1% of cases, results in death.
In fact, this high complication rate was recently highlighted by a major study published in the Journal of the American Medical Association, JAMA, which examined outcomes of over 340,000 patients that underwent lung biopsies and found a complication rate of 24% in Medicare patients and 22% in patients under 65 years old. This rate of complications is higher than previous estimates and emphasizes that for most patients, the probability of serious complications associated with biopsies is greater than the likelihood of confirming lung cancer.
Beyond the risk to patients, biopsies are also expensive. According to a study of Medicare data by an independent health economics firm, they have an average cost of nearly $15,000.00. This means that increased screening for early detection without DetermaVu would likely also lead to a greater number of patients having lung nodules detected and undergoing unnecessary biopsy procedures at considerable risk to the patient and cost to the healthcare system.
This is why DetermaVu is attractive to physicians and patients. It's a simple blood test that can help clinicians determine which patients are least likely to have a malignancy and should not have a biopsy. This means that DetermaVu has the potential to eliminate unnecessary biopsy, avoiding complications and saving lives, while also leading to significant cost savings to the healthcare system.
While the benefits to patients are clear, I'd like to spend a little time explaining why DetermaVu is extremely valuable to clinicians. It's important to note that DetermaVu is differentiated from other diagnostics as the reported sensitivity and specificity are achieved without the use of clinical data in the algorithm.
This will have a real world impact for physicians, as DetermaVu will provide an independent biological assessment of the risk of cancer incremental to the risk of information from clinical data alone, such as lung nodule characteristics like size and margins and the patient's smoking and health history, which the doctors already have. This resonates with doctors, as it provides a new tool for risk stratification and decision making beyond available clinical data.
I've been asked by investors and the public recently what we think the results of our final clinical validation study will be. I don't want to speculate and of course, we haven't even begun testing the sample yet, so, we can't know. But I would like to remind everyone about the significance of the 95% confidence interval we announced for the R&D validation study.
The confidence interval suggests that there is a 95% probability that our final results will be within the stated range. As you will recall, a confidence interval for sensitivity was 82% to 95% and for specificity, 68% to 81%. So, what does this mean for doctors?
We previously highlighted that our reported R&D validation sensitivity and specificity significantly exceed the parameters we believe are required for a successful commercial product in the lung cancer diagnostics market, based on our market survey of chest physicians. Today, I'd like to expand on this by highlighting an official policy statement of the American Thoracic Society entitled "Evaluating Molecule Biomarkers for the Early Detection of Lung Cancer: When is a Biomarker Ready for Clinical Use?"
This published policy statement, which comes from a committee of key opinion leaders in lung cancer detection provides guidance for the level of evidence required to support the clinical use of a biomarker for early lung cancer detection.
The policy states that for a molecular diagnostic to be clinically useful, the lower range of sensitivity would need to be at least 80% and the lower range of specificity would need to be at least 40%.
We're very excited that these numbers both substantiate our prior market research and independently confirm that at the 95% confidence interval, the levels of sensitivity and specificity reported for DetermaVu thus far are within the boundaries of clinical usefulness as determined by the American Thoracic Society. Consequently, we believe that DetermaVu will provide doctors with a highly sensitive and specific test, allowing them to confidently determine which patients will need biopsy.
Now, to briefly touch upon the commercial opportunity for DetermaVu -- we believe that there is an estimated total addressable market of $2 billion to $4.7 billion in the US alone depending on the scope of physician utilization, reimbursement rate, and market penetration. These figures emphasize the large number of patients with lung nodules that would benefit from DetermaVu.
As a note on the potential scope of utilization of DetermaVu, many physicians who follow the Lung-RADS guidelines, biopsy lung nodules 8 mm or larger in size, because those nodules are statistically more likely to be malignant than smaller nodules, but we see an opportunity for DetermaVu in testing patients in the 5 mm to 7 mm range as well based on the incidence of physicians now electing to biopsy those nodules.
One of our goals for DetermaVu is to see it adopted for use as a confirmatory test of guidance and making patient care recommendations regardless of the size of the nodules detected by a low dose CT or other scan. Our plan remains to launch DetermaVu independently in the US and in preparation of making it commercially available, we have begun to build a small and targeted commercial team to effectively promote DetermaVu among the approximately 6,000 pulmonologists in the US.
We are in the early stages of building a talented team of medical science liaison professionals, sales reps, marketing professionals, and patient support staff. We will provide updates for our commercial plans as they are finalized in the near future. Of course, after commercialization, a major focus of the company will move toward securing broad reimbursement for Medicare and private payers, an essential step for a commercially successful diagnostic test.
To accomplish this, we have developed a comprehensive reimbursement strategy. It includes conducting a post-commercialization clinical utility study, which will follow actual patients for one to two years measuring in the real world how the use of DetermaVu improves health outcomes for patients and lowers cost for the healthcare system.
Thus far, we are highly encouraged by the results from ten public and commercial health plans. They all view DetermaVu favorably and recognize the large unmet need we are working to address. However, as I said before, as with other diagnostic companies and given the reality of reimbursement in the diagnostic space, we believe that it would be one to two years before we generate significant revenues from DetermaVu.
So, as I said at the start of this call, this is a transformational time for OncoCyte. We believe we are only months away from our first commercial product and are beginning to explore how our unique apporoach can be leveraged for a pipeline of revolutionary liquid biopsy tests for early stage cancer diagnosis. We are convinced that DetermaVu can fundamentally change the paradigm of lung cancer diagnosis and treatment, leading to meaningful improvements for patients, physicians, and payers.
At this point, I'd like to turn the call over to Mitch Lavine for a review of the financials. Mitch?
Mitch Levine -- Chief Financial Officer
Thanks, Bill. Good afternoon, everybody. At March 31, 2019, we had cash, cash equivalents, and marketable securities of $39.9 million as compared to $8.4 million at December 31st, 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 31st, 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 31st, 2018. Our operating expenses for the three months ended March 31st, 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 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 included with our earnings release, which believe is helpful in understanding our ongoing operating expenses.
Research and development expenses for the quarter ended March 31st, 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 31st, 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 non-recurring 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.
Questions and Answers:
Operator
Thank you. At this time, we will be conducting a question and answer session. If you'd like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. One moment please while we poll for questions.
Our first question is from Bill Quirk from Piper Jaffray. Please go ahead.
Bill Quirk -- Piper Jaffray -- Analyst
Thanks, good afternoon, everybody. First off, Bill, recognizing that you're obviously focusing on DetermaVu for lung cancer, you did comment several times on applying the technology in other areas of oncology. Which ones should we be thinking about if it's not too much to ask, when might we see some initial data?
William Annett -- Chief Executive Officer
Thanks, Bill. Yes, 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. 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 -- Piper Jaffray -- Analyst
Okay. Understood. Staying on DetermaVu for a moment, based on the ATS comments that you made concerning the clinical relevance of DetermaVu, help us think about your strategy or potential for guideline inclusion there.
William Annett -- Chief Executive Officer
Sure. Certainly, at this point in time, there are no guidelines for tests 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'd very much like to see in the future guidelines developed and we'd like to be included in those guidelines. That's what we'll be moving forward with the various studies we've 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 -- Piper Jaffray -- Analyst
Got it. Last one for me, one for Mitch -- you've talked about this in the past -- any change to your initial thoughts concerning the salesforce build around the initial commercialization? I'm assuming you're going to continue to have that be relatively small until you get to the reimbursement, but could you just remind us what you're thinking there?
Mitch Levine -- Chief Financial Officer
Hey, Bill. You're exactly right. We are not making any changes in the development of our salesforce. We expect to ramp modestly and slowly as we develop milestones such as peer-reviewed papers that get published. We'll bring in some more salespeople at that point, but I think in the early going, mostly through medical science liaison and possibly a couple of outside salespeople. Ultimately, at full ramp when we have reimbursement, we expect to have approximately 40 outside salespeople at peak.
Bill Quirk -- Piper Jaffray -- Analyst
Okay. Perfect. Last one from me -- I asked last quarter about getting New York CLIA certification. Is that still the plan, guys? Are you guys going to pursue that following the commercial release?
William Annett -- Chief Executive Officer
Lyndal, do you want to answer that?
Lyndal Hesterberg -- Senior Vice President of Research and Development
Sure, I'd be glad to. New York is absolutely in our plans. As you may realize, it has a queue. It takes time 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. The ball is sort of in their court at this point.
Bill Quirk -- Piper Jaffray -- Analyst
Got it. Thank you.
Operator
Our next question is from Bruce Jackson from The Benchmark Company. Please go ahead.
Bruce Jackson -- The Benchmark Company -- Analyst
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 -- Chief Executive Officer
Our suspicion is that we'll 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, etc. that would make openings into the physician's office easier. That will be very helpful to us and we will ramp up at that time. We expect it to be modest in the foreseeable future.
Bruce Jackson -- The Benchmark Company -- Analyst
Okay. Then with the R&D expense and the operating expenses generally, do you think they're going to stay in this current range or might they drift up a little bit as we get toward the energy of the year?
William Annett -- Chief Executive Officer
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 -- The Benchmark Company -- Analyst
Okay. Last question on the R&D strategy here -- you had a breast cancer test in the pipeline at one point in time and also a pretty good bladder cancer test. Would you start there with the test that you have and perform process somewhere to DetermaVu where you ran the test through the samples with some new candidates and then came up with the new test or would you just start from scratch and just use the DetermaVu platform as a discovery vehicle and then prioritize? That's it for me. Thank you.
William Annett -- Chief Executive Officer
Good question, Bruce. Lyndal, do you want to answer that?
Lyndal Hesterberg -- Senior Vice President of Research and Development
Sure. Just to clarify -- as Bill said, we're still in the planning process and evaluating all of the opportunities first. Second, we know there are areas we want to explore based on the biology of the immune system interrogation. So, first and foremost, we need to expand and protect our DetermaVu product and then past that is where we want to look at other opportunities, both within lung cancer and potentially other solid tumors. That's still at this point in the planning stage.
Operator
Once again, as a reminder, it is *1 to ask a question. The next question is from Casey Woodring from Janney Montgomery Scott. Please go ahead.
Casey Woodring -- Janney Montgomery Scott -- Analyst
Hi, guys. This is Casey on for Paul. A lot of my questions have been answered here, but maybe one you guys could speak to is what sort of opportunity will the presentation that you guys had at the American Thoracic Society Conference be? Will it simply be your first chance to present the details of the R&D validation study or will you be able to market yourselves to pulmonologists in attendance or maybe talk to payers, any color you can give there. Thanks.
William Annett -- Chief Executive Officer
Sure. 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 what we'll be presenting, mindful that we're under embargo until that point in time.
Lyndal Hesterberg -- Senior Vice President of Research and Development
Sure. I'd be glad to. In a general sense, we'll be sharing not just the topline 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 my hope is that the physicians that are looking at this will see that we've done a good job in our clinical study collection itself in 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 alone, which doctors already have and they use today in their best efforts to try to identify patients who had higher risk of cancer as a guidance to themselves as to which ones to carry the biopsy. The trouble is that clinical factors alone, while they're helpful, are not sufficient and aren't, in my opinion, good enough. That's where the biology and our biomarkers will outperform those clinical factors significantly and we'll be sharing some of that new information at the ATS presentation.
William Annett -- Chief Executive Officer
As a reminder, the presentation is next Tuesday, May 21st at ATS. So, we will be making the poster and the information available after that point.
Operator
Thank you. This concludes the question and answer session. I'd like to turn the floor back to Mr. Annett for any closing comments.
William Annett -- Chief Executive Officer
Thank you. Thanks to everyone for joining our call this afternoon. We do hope you are all as excited about 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. Of course, we continue to rapidly advance the development of DetermaVu and expect in just a few months to have a commercially available product in the potentially multi-billion-dollar lung cancer diagnostic test market.
We look forward to providing you with further updates in the upcoming months.
Operator
This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.
Duration: 38 minutes
Call participants:
Bob Yedid -- Investor Relations, LifeSci Advisors
William Annett -- Chief Executive Officer
Mitch Levine -- Chief Financial Officer
Lyndal Hesterberg -- Senior Vice President of Research and Development
Bill Quirk -- Piper Jaffray -- Analyst
Bruce Jackson -- The Benchmark Company -- Analyst
Casey Woodring -- Janney Montgomery Scott -- Analyst
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