Oncocyte Q2 2026 Earnings Report

Oncocyte EPS Results

• Actual EPS: -$0.23
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Oncocyte Revenue Results

• Actual Revenue: $0.24 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Oncocyte Announcement Details

• Quarter: Q2 2026
• Date: 8/10/2026
• Time: After Market Closes
• Conference Call Date: Monday, August 10, 2026
• Conference Call Time: 5:00PM ET

Oncocyte (NASDAQ:IMDX) (NASDAQ:IMDX) is a molecular diagnostics company that develops and commercializes tests intended to improve cancer detection, risk stratification and treatment decision-making. The company focuses on creating assays that provide clinically actionable information to physicians managing patients with suspected or confirmed malignancies, with particular emphasis on tools that can help evaluate lung nodules and other oncology-related diagnostic challenges.

Oncocyte’s product and development efforts center on blood- and tissue-based molecular assays that analyze biomarkers and genomic signals to inform clinical workflows. Its offerings are positioned to support physicians by reducing diagnostic uncertainty, guiding the need for invasive procedures, and helping to prioritize patients for additional testing or treatment. The company pursues clinical validation and regulatory review as part of its path to broader commercial adoption.

Headquartered in the United States, Oncocyte distributes its tests through clinical laboratory networks and strategic partnerships aimed at reaching physicians and healthcare systems. As a publicly listed company on the NASDAQ (IMDX), it concentrates on advancing its diagnostic pipeline, expanding commercial operations, and engaging with payors and clinical stakeholders to integrate its assays into standard oncology care pathways. Information on individual executives and recent leadership changes should be confirmed from the company’s filings and official communications for the most current details.

Oncocyte Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: FDA marketing authorization remains targeted for later this year for GraftAssureDx. The company said the FDA’s information requests appeared routine and addressable, with an SIR meeting planned to align on the response before resubmission, though timing remains outside its control.
• Positive Sentiment: Medicare’s expanded MolDX coverage, increasing potential kidney-transplant surveillance testing from eight to 14 tests in the first three years, could improve the economic case for in-house testing. Management believes this could expand its stated $2 billion TAM as testing frequency, therapy monitoring, and additional organ indications grow.
• Positive Sentiment: Head-to-head data showed clinical equivalence to leading centralized laboratory assays, driving interest from major U.S. transplant centers and reference labs. More than half of the top 10 U.S. transplant centers are engaged through the FDA program or registry, and management believes it has roughly a two-year lead in kitted product development.
• Negative Sentiment: Second-quarter cash burn was $10 million, and the company now expects approximately $8 million of quarterly cash burn in the second half of the year, above its prior $6 million estimate. Higher spending reflects regulatory completion costs, registry activities, and preparations for commercial launch, although management said it is evaluating ways to extend its runway.
• Neutral Sentiment: European regulatory progress appears favorable, with IVDR submission still targeted for the second half of the year and U.K. self-certification expected to be easier. However, broader European adoption remains dependent on reimbursement expansion and clinical catalysts such as routine approval of anti-CD38 therapies.

Presentation

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Welcome, agents. Before turning the call over to Josh Riggs, I would like to review our safe harbor. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forward-looking statements. These statements are made pursuant to and within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We encourage you to review the company's SEC filings, including the company's most recent Form 10-K and subsequent Form 10-Q, which identify risks and uncertainties that may cause future actual results or events to differ materially. Please note the forward-looking statements made during today's call speak only to the date they are made, and Insight Molecular Diagnostics undertakes no obligation to update them. With that, I would like to now turn the call over to Josh Riggs.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Thanks, Gabby. It feels great to be coming to you today with line of sight on expected FDA marketing authorization for GraftAssureDx. We have three brief but promising takeaways today in our shareholder letter. The first is that after three years of rigorous kitted product development, we believe that we are seeing the light at the end of the tunnel on having a regulated product. Back in July, we got our additional information letter from the FDA. It is a normal part of the Class II process where they ask for some additional data and clarification on intended use as part of their review. Since submitting back in March, we have about tripled the amount of samples collected in the study and feel good about addressing all their questions and comments. Prior to submitting our next data package, we are going to have an SIR meeting with the FDA.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

This meeting is a lot like the Q-sub process, where you get direct and written feedback on your planned approach. It is an opportunity for both parties to make sure there is clear understanding on what is needed to get through to authorization and clear up any potential misunderstandings. Once we have the green light from them, the next steps are pretty straightforward. We package it all up, hit submit, and wait for their response. Since March, we have been pleased with the timeliness of FDA's engagement. We continue to target receipt of FDA marketing authorization later this year, with the caveat that the timing of government agency review is not completely within our control. The second takeaway is that we can see that the market landscape is likely improving for transplant rejection tests like GraftAssureDx.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

We believe that Medicare's recently expanded reimbursement guidelines for these tests even better primes GraftAssureDx for commercial success. We know our analysts are well familiar with the recent MolDX LCD, which boosts surveillance from eight to 14 tests in the first three years post-kidney transplant. This higher testing frequency is potentially great for our customers. It strengthens the economic case for bringing dd-cfDNA testing in-house. The market landscape is also improving on a competitive front. We believe that we are about two years ahead with regard to kitted product development among competitors. Third, and finally, we have seen strong head-to-head data that favorably compares our assay to other leading assays on the market, driving increased interest from potential future customers. That includes top transplant centers and reference labs here in the U.S.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

It feels like half the country is in a three-point stance waiting for the opportunity to bring dd-cfDNA testing in-house. From an expense standpoint, Andrea will take you through some of that in a minute, we believe that we are fully staffed to support material revenue growth. So far, we have invested ahead of revenue generation, preparing for commercialization. Future investments will be tied to our expectation of revenue growth. Given where we are with the FDA, which we believe is likely in the latter stages of the review process, we are looking at all areas of the organization to make sure that we are well-aligned for success. I expect that we will have opportunities to strengthen commercial and operations ahead of launch as the momentum we've built attracts more and more industry attention.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Market demand for dd-cfDNA testing stretches into the hundreds of millions annually, and we are building the team that can get us there. The investments we have made have opened many doors. Over half of the top 10 transplant centers in the U.S. are working with us, either through our FDA program or through our registry. Going forward, we will be focusing on closing business and driving a top line and margin profile that brings us to break even and, beyond that, strong profitability. One last note before I hand the call over to Andrea. So much of our energy right now is pointed towards getting things done at the FDA, but I'd be remiss to fail and mention the progress we are making on the science side.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

The head-to-head data that has come out has been fantastic, showing clinical equivalence to leading tests that are performed at central laboratories. We continue to demonstrate leadership in showing how dd-cfDNA can help manage patients on therapy for antibody-mediated rejection. We are starting to see a future where dd-cfDNA can do much more than just rule out for biopsy. This progress on the science side supports growth in our total addressable market, which Andrea will cover. Now, let me turn the call over to our CFO, Andrea James, to provide a review of our financial results for the first quarter. Should be second quarter there. Andrea.

[Andrea James, CFO at Insight Molecular Diagnostics]

Yeah. Hi. Thanks, Josh. Hi, everyone. First, as Gabby said, I hope you've had a chance to read our shareholder letter, and if you haven't, please do go check it out. It is considerably more thorough than a typical earnings press release, and accordingly, it allows us to keep our prepared remarks relatively brief and allow more time for Q&A. This is the ninth quarterly shareholder letter we've published since I joined the company two years ago, and we're thrilled to be updating you about our planned transition from a product development stage company into a revenue-generating, profitable business. In the second quarter, core spending came down further from its Q4 2025 peak. You see this in the GAAP OPEX figures, as well as in the sequential narrowing of our Adjusted EBITDA loss to $7.8 million.

[Andrea James, CFO at Insight Molecular Diagnostics]

Our peak spend in Q4 2025 was tied to activity regarding our FDA submission. This and other working capital items drove cash burn of $10 million in the second quarter, which we expect to be the high watermark on cash burn for the foreseeable future. We now expect to burn approximately $8 million per quarter in the second half of this year. This is above our prior expectation of roughly $6 million per quarter, primarily reflecting the timing of cost to complete the regulatory review process, along with registry activities ahead of associated GraftAssure CORE revenue and investments to prepare for commercial launch of GraftAssureDx. We continue to expect modest revenue in the second half across laboratory services, research use only kit sales, and GraftAssure CORE. Remember, GraftAssure CORE is our lab-developed test.

[Andrea James, CFO at Insight Molecular Diagnostics]

We are prudently exploring all options to extend our runway while still properly investing to meet market demand, and we will continue to enforce cost discipline across the business. Future investments will be tied to our expectation of material revenue growth. We remain very excited about the size of the market and our disruptive approach. We believe that Medicare's higher reimbursed testing frequency is favorable to our previously stated $2 billion total addressable market for kitted transplanted-organ testing. You can think of our TAM as growing in concentric circles. The core TAM, which takes total kidney transplants per year and living kidney transplant recipients multiplied by a baseline and conservative two tests per year at our ASP, approaches $2 billion. Higher surveillance testing frequency grows this beyond $2 billion. Adding in therapy monitoring, which Josh just mentioned, grows the TAM again.

[Andrea James, CFO at Insight Molecular Diagnostics]

Expanded organ indications grows the TAM yet again. Remember that Dr. Ekkehard Schütz and his team designed the GraftAssure platform to be organ agnostic, and we've talked about how we're not stopping at kidney, but we are also investing in heart. To that end, we have a KOL call planned for August 17th to talk about heart transplant testing. It will feature Dr. Max Jacob Liebo of Loyola University Medical Center, as well as our VP of Medical Affairs, Dr. Nick Ioannou, and our CEO, Josh Riggs. They will explore how in-house dd-cfDNA testing may be used for heart transplant rejection monitoring. So stay tuned for a press release with registration details. Okay, Gabby, we can now take questions, and Eric, if you could please bring us up into gallery view, that would be awesome. Thank you. Everybody's got their hands up. Yay.

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Thank you so much, Josh and Andrea. Let's Mason Carrico from Stephens.

[Mason Carrico, Research Analyst at Stephens]

Hey, guys. Appreciate you taking the questions here. You called out the SIR meeting with the FDA. Could you just expand on that meeting a bit? What was the reason the meeting was set? What is it focused on specifically, and did you call out a date for that meeting?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

We did not call out a date. I'd say anytime you get questions, there's some interpretation that's possible there on the best way to respond to them. I think the SIR meeting is just an opportunity for us to make sure that we're 100% aligned with the FDA before we package up this additional data and hit the submit button.

[Mason Carrico, Research Analyst at Stephens]

Got it. I guess if authorization were to slip into, let's say, the first half of 2027, could you walk us through the changes, the levers that you could pull from an operations standpoint to extend the cash runway if need be?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah, I'd say they're the usual ones, but the investment that we're making in the registry, I think, is probably the most significant lever. I think accelerating the enrollment there provides a revenue offset that we don't have right now going into the second half just because of some delays in getting that started.

[Andrea James, CFO at Insight Molecular Diagnostics]

Remember that we have a test that we can run out of our Nashville lab that's reimbursable at $2,753 per result. Not only is it registry revenue, but we think we can attach some GraftAssure CORE revenue to that along with those registry participants.

[Mason Carrico, Research Analyst at Stephens]

Got it. I'll stop there. Thanks, guys.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Thanks, Mason.

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Mark Massaro from BTIG.

[Mark Massaro, Analyst at BTIG]

Hey, guys. Thank you for taking the questions. I am curious about, I recognize it is still early days, but I am curious about some of the research use only kit revenue you sold. I think it was $21,000 in the quarter. Can you give us a sense for what these kits were for? Actually, I will just leave it there. Can you explain why these were ordered and for what use?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Sure. It is ex-U.S. usage right now, so there are some areas of the world that have trouble accessing testing here in the United States from where they are at. So they brought it in and validated it for clinical purposes there. I would say that is what is driving that demand.

[Mark Massaro, Analyst at BTIG]

Okay. That is helpful. What is the latest thinking around the commercial opportunity with Bio-Rad? Is there any potential expansion of that agreement? Assuming you get FDA approval, what gives you confidence in the current strategy versus potentially seeking some alternate strategies?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. Bio-Rad has been such a great partner for us throughout this process. They have supported us on every phase of the FDA engagement. We have an opportunity to negotiate with them both ahead of authorization, and then there is a 90-day period after authorization. I think we are encouraged by the support that we feel. We got to sit down with them while we were at ADLM a week and a half ago. I think everybody looks at the list of centers that we are engaged with here in the U.S. and in Europe and can see how that is a real opportunity, especially for instruments that maybe do not have a natural home in the central labs or the core labs there, or even in the HLA labs. That kind of adoption menu and placement is very attractive for platform manufacturers and the ability to build additional content.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

I would say we are both motivated to figure out a great way to work together in the future and drive this high-value molecular content closer to the patient.

[Mark Massaro, Analyst at BTIG]

Awesome. Last one for me, and then I will hop back in the queue. Obviously, the final LCD for MolDX, I thought was very favorable. Certainly for CareDx and Natera. I am just curious if you have had conversations, presumably what is good for the send-out is probably good for the kitted, right? Can you just give us a sense for any conversations you have had about your confidence around utilization of kits on a repeat surveillance basis?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. It was funny; we were talking to MolDX the day before they put the LCD out, and we were talking to them about surveillance, and we got a lot of "Well, under the current LCD." It was a very interesting conversation to be a part of. I think what we are going to see is exactly what the Starzl group described back in January, which is these centers need to have the test in their hands so that they can really build the protocols that make the most sense for them, and they want to work together as a group. This is international as well, where they want to really figure out what is the optimum schedule. It is hard for me to gauge if the centers themselves are going to follow exactly what is in the LCD, if they are going to go beyond that.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

I think the medical necessity here is still being evaluated. We are very happy to see that MolDX sees the value in early and often intervention, particularly as we see the impact that these anti-CD38 drugs are having on patients. We just published another paper a couple of weeks ago that shows that early intervention matters. Doctors are not going to want to wait until you have had a long development of AMR before they intervene. I think the flexibility that MolDX has given clinicians here is great to actually be aggressive in the management of patients, aggressive in the management of AMR. I think we are building a great tool for that. I think it is all good for both, I think, for the send-out labs and for those centers that choose to bring this in-house.

[Mark Massaro, Analyst at BTIG]

Awesome. Thank you very much.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. Thanks, Mark.

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Thank you. Thomas Flaten from Lake Street.

[Thomas Flaten, Analyst at Lake Street]

Yeah, great. Thanks for taking the questions. Josh, anything you can comment on the nature of the questions that FDA sent back to you regarding the review and approval?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah, I think we're going to keep the exact questions confidential, but I would say we didn't see anything terribly surprising in there. The questions all felt fairly routine and addressable with the data that we have in-house.

[Thomas Flaten, Analyst at Lake Street]

Got it. You didn't mention, I don't think, in your prepared comments anything about the self-certification process or the IVDR submission. I was curious if you had an update on that.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. I'd like to hand that one to Dr. Schütz. I know he's working closely with his team on getting through the final audits here so that we can hit that submit button. So maybe, Ecki, you could talk just a little bit about the work that we're doing to get ready for Europe. You're on mute there, just in case, before you dive in.

[Ekkehard Schütz, Chief Science Officer at Insight Molecular Diagnostics]

So what we had meanwhile was an informational meeting with our notified body, where we more or less got very good guidance. I think the way that the IVDR process is going to go is a little bit more flexible and easier than what we are seeing with the FDA. We are still really planning to get this done in the second half of this year, and I think there's a very realistic chance that we can do it. We are not anticipating that we need to provide large clinical studies or anything that would really put a big burden on my team. It looks really, to my mind, way easier than I initially thought.

[Ekkehard Schütz, Chief Science Officer at Insight Molecular Diagnostics]

Of course, there are going to be a couple of hurdles that we have to address, but I'm very positive about the IVDR process, and the self-certification with this IVD, which only applies to the U.K., as you might think, is even easier.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. Thank you, Ecki. It certainly helps to be able to tap into the network of researchers that we have there and the long history of publications that we have in Europe. Heidelberg has been a wonderful supporter of the regulatory process. We're happy to bring those samples along as well. I think we are seeing, just on the market access side in Europe, Switzerland has figured out a way to pay for some of this testing, which is great. I think they're one of the first countries to be pushing this forward. We're starting to see tenders in Italy and some of the other countries, but it still feels very early days in Europe. I think the biggest catalyst will be the approval of an anti-CD38 for routine use.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

I think the data is showing that there's clear clinical utility for using donor-derived cell-free DNA to manage the application of those therapeutics, and we've had robust conversations with the pharma that are engaged in that and trying to pull that forward. We remain hopeful that that drives market access and demand and reimbursement across Europe, which we see as largely the gating factor for them adopting the technology broadly.

[Thomas Flaten, Analyst at Lake Street]

And then just one quick one. How many of the FDA study sites do you anticipate being registry sites as well? I am trying to figure out how many of the study sites will be early adopters on the commercial side versus opting for the registry.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Sure. I mean Ecki, maybe you can comment real quick. I think the overlap is about 50% of the FDA sites are coming into the registry, but I do not know if you would modify that. You are on mute there, brother.

[Ekkehard Schütz, Chief Science Officer at Insight Molecular Diagnostics]

Of course. No, I agree. I think we have a couple of candidates that I would say that they are going to be 100% in, and we have half of that where we actually have no real visibility of whether they would do it or not.

[Thomas Flaten, Analyst at Lake Street]

Got it. Thanks, guys.

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Thanks, Thomas. Mike Matson from Needham.

[Mike Matson, Analyst at Needham]

Yeah, thanks. I just want to ask one. It was good to hear about the interest of the large reference labs in the test. I am wondering about the economics of selling to them versus the transplant centers, which would probably be buying lower volumes. I am thinking maybe these reference labs would have a volume discount, but then maybe you would not have to pay a sales commission or something if they are just putting in big orders.

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Yeah. Gosh, I love the question, and we have spent a lot of time, as you might imagine, debating pricing power here at the company, and we are not going to publish the list price, but I think you give discounts based off of volume and threat of substitutes. Right now there are not a ton of substitutes out there, if any. I think we expect early on that we are going to have significant pricing power. That may change over time, but to me, I think Andrea has thought a lot about this.

[Andrea James, CFO at Insight Molecular Diagnostics]

Yeah

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

Let me let her jump in on this one.

[Andrea James, CFO at Insight Molecular Diagnostics]

I just wanted to say, too, and we build some of these thoughts into when we're building out our TAM and what our go-forward models look like, but remember that our pricing power is tied to our reimbursement, and that remains true of whoever's running the test.

[Andrea James, CFO at Insight Molecular Diagnostics]

The pricing power largely holds up. Would there be some volume discounts for guarantees, and in return you get some visibility and predictability, which we all love? Sure. But remember, the reimbursement doesn't change, and so as we seek to port the reimbursement for GraftAssureCore over to GraftAssureDx, that's going to port over to all of our customers as their revenue and their reimburse. As reimbursement grows, as you get more private payer coverage, that also helps your pricing power. So there are some things that are within our control so we can maintain our pricing power. You can also grow the utility of the test, right? As testing frequency grows, there's more of an economic incentive to adopt in-house testing, and so all of those things we think are favorable.

[Mike Matson, Analyst at Needham]

Okay, got it. Then I had a follow-up just on the TAM. So you mentioned $2 billion, but obviously we have this Medicare coverage, or I guess Medicare reimbursement policy about covering more frequent tests. You called out some other things, so I guess what I was wondering is, the $2 billion number—is that number going up? I guess, can you give us an estimate of what the size is, taking all those things that you listed into account, or does it already do that?

[Andrea James, CFO at Insight Molecular Diagnostics]

Yeah. No, it is growing, and we think we have opportunities to grow the TAM over time, even as we develop new products in the future. Right now we are published at a $2 billion TAM, and we talked about the things that grow that. But that $2 billion TAM, and this is why it is really, really important, why we love talking about testing frequency, that is based on two tests per year per patient in kidney.

[Mike Matson, Analyst at Needham]

Yeah.

[Andrea James, CFO at Insight Molecular Diagnostics]

So it is this really, really simple thing. So once you start adding, you can read the MolDX LCD. As you start growing the testing frequency and the reasons why you test per year, that two becomes 2.3, then it becomes 2.5, then it becomes three. As that grows, it grows the TAM accordingly. Does that make sense?

[Mike Matson, Analyst at Needham]

Yeah, it does. Thank you. That is all I had.

[Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics]

Thank you. Are there any additional questions, Josh?

[Josh Riggs, President and CEO at Insight Molecular Diagnostics]

All right. Thanks everybody for taking time to join us today. I'd like to thank our dedicated employees for their hard work. I also want to thank our clinician partners who have helped us with the development of the assay. Finally, I'd like to thank our shareholders for giving us a chance to make managing kidney transplants easier and more accessible. We are excited about the progress we are making and look forward to sharing additional progress with you guys in the coming months and quarters. We will see you all on our KOL call on Monday, August 17th. I hope you guys have a good day. Thank you.

Participants

Analysts

• Gabrielle Woody, Executive Assistant and Human Resources Coordinator at Insight Molecular Diagnostics
• Josh Riggs, President and CEO at Insight Molecular Diagnostics
• Andrea James, CFO at Insight Molecular Diagnostics
• Mason Carrico, Research Analyst at Stephens
• Mark Massaro, Analyst at BTIG
• Thomas Flaten, Analyst at Lake Street
• Ekkehard Schütz, Chief Science Officer at Insight Molecular Diagnostics
• Mike Matson, Analyst at Needham