OncoCyte Q1 2025 Earnings Report

OncoCyte EPS Results

• Actual EPS: -$0.26
• Consensus EPS: -$0.24
• Beat/Miss: Missed by -$0.02
• One Year Ago EPS: N/A

OncoCyte Revenue Results

• Actual Revenue: $2.14 million
• Expected Revenue: $0.13 million
• Beat/Miss: Beat by +$2.01 million
• YoY Revenue Growth: N/A

OncoCyte Announcement Details

• Quarter: Q1 2025
• Date: 5/12/2025
• Time: After Market Closes
• Conference Call Date: Monday, May 12, 2025
• Conference Call Time: 5:00PM ET

OncoCyte (NASDAQ:OCX), a precision diagnostics company, focuses on development and commercialization of proprietary tests in the United States and internationally. The company is developing DetermaIO, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies; DetermaCNI, a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients; and VitaGraft, a blood-based solid organ transplantation monitoring test. It also provides testing services for biomarker discovery, assay design and development, clinical trial support, and various biomarker tests. The company has a collaboration agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) to collaborate in the development and the commercialization of research use only and in vitro diagnostics kitted transplant products using Bio-Rad's ddPCR instruments and reagents. OncoCyte Corporation was incorporated in 2009 and is based in Irvine, California.

OncoCyte Q1 2025 Earnings Call Transcript

Key Takeaways

• OncoCyte secured central IRB approval and finalized its clinical trial design, maintaining productive FDA dialogue and remaining on track to submit its transplant rejection assay data by year-end for potential H1 2026 approval.
• The company has expanded its research use only kit to 10 global sites and aims to train 20 transplant centers by year-end as part of its land-and-expand strategy to spring-load second-half 2026 revenue.
• Q1 pharma services revenue of $2.1 million surpassed expectations with a 62 percent gross margin, though Q2 services revenue is forecasted below $0.5 million due to lumpy demand.
• OncoCyte ended Q1 with $33 million in cash and achieved a free cash flow burn of $6.2 million, aligning with its targeted average quarterly cash burn of $6 million through its commercial launch.
• Its oncology pipeline, led by DetermaIO, has attracted partner interest for immunotherapy response testing, though this segment remains in earlier development relative to the transplant business.

Presentation

[Operator]

Welcome everyone and Welcome, everyone, and thank you for joining us to discuss OncoCyte's first quarter twenty twenty five results. If you have not seen today's shareholder letter, please visit OncoCyte's Investor Relations page at investors.oncoCyte.com. Today's prepared remarks build upon the information already shared in this robust letter. Joining us today are OncoCyte President and CEO, Josh Riggs Chief Science Officer, Ecky Schutz and CFO, Andrea James. We also have our analysts with us as panelists.

[Operator]

After our prepared remarks, our analysts may ask questions. Before turning the call over to Josh Riggs, I'd like to go over 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 provision of the Private Securities Litigation Reform Act of 1995.

[Operator]

We encourage you to review the company's SEC filings, including the company's most recent Form 10 ks and subsequent Forms 10 Q, which identify risks and uncertainties that may cause future actual results or events to differ materially. Please note that the forward looking statements made during today's call speak only to the date that they are made and OncoCyte undertakes no obligation to update them. And with that, I would like to now turn the call over to Josh Riggs.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Hi, everyone. Thanks for joining us today. It's great to be checking in with you about two months after we reported our annual results. We've been heads down executing on our 2025 plan. For those of you who are new to us, we're a molecular diagnostics company investing in the significant opportunity to improve transplant rejection testing.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

We are just over two years into a strategic pivot that has now brought us to the cusp of delivering a kitted molecular test kit. Our key areas of focus for 2025 are, first, finalizing our clinical assay and trial design. Second, getting through our clinical trial to submit a data package to the FDA by the end of the year. And third, spring loading back half twenty twenty six revenue by signing up transplant centers to use our research use only kit. We finalized our clinical trial design, and just a few weeks ago we got central IRB approval.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

This is a key milestone where an external committee has reviewed and approved the safety and ethics of our trial. We've continued to have productive dialogue with the FDA and are now preparing our for our final pre submission meeting ahead of locking in for the trial. The clinical trial itself, which we've gone over in previous quarters, has drawn interest from several university hospitals that would like to participate in both The US and Germany. We expect to welcome at least three of the top 10 transplant centers in The United States as clinical trial participants. And if we look at all of The US Transplant hospitals actively engaged in supporting our trial, we see nearly ten percent of US Transplant volumes represented.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

In the near future, we are going to be up on clinicaltrials.gov and on our way to first patient in, and I'm really looking forward to sharing that milestone. We'll follow that with an introduction to one of one or more of our site principal investigators in a KOL call. We believe the strong interest we are seeing for the trial will translate well to future demand for our IVD assay. We believe we are on track to submit to the FDA by the end of this year, which is the same timeline we communicated in March. Like with any FDA program, there are several work streams that must come together.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

And from what we can see, we're on pace. So we continue to target FDA approval in the first half of twenty twenty six. Continuing on, we are on track to have 20 sites trained on our graft to share workflow by the end of this year, which is the kickoff to our land and expand strategy to land hospitals with our RUO product and then expand to selling our clinical kitted product post FDA clearance. We now have 10 sites running our RUO assay. They are in The US, Germany, UK, Switzerland, Austria, and Southeast Asia.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

And the researchers at these universities are starting to perform real studies using donor derived cell free DNA and discovering new applications for our tests, such as pediatric transplantation, the role of absolute quantification in long term kidney transplant management, and ultrasensitive detection of microchimerism for bone marrow transplants. We are thrilled that researchers are exploring new ways that our technology could potentially help future patients. You'll see in the shareholder letter that we are starting to prove out the value of digital PCR as a technology differentiator. It's simpler, it's faster, and it offers better sample economics than NGS at low volumes. Most transplant centers don't have the sample volumes needed to efficiently run an NGS platform.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

These machines require a processing chip that costs well north of a thousand dollars per run. That math just doesn't work when you only have a couple samples a day. With PCR testing, even running a single sample is an affordable option given that the batch size does not meaningfully alter the cost per result. With only a few pipetting steps and a simple readout, labs don't need sophisticated hands to get the workout. We see a great future for PCR technology to bring testing closer to the patient.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Bio Rad has been investing in improving and simplifying digital PCR workflows for years, and our assay benefits from these ease of use improvements. The net takeaway is that transplant is doing really well. And just a few years after our strategic pivot, we are closer than ever to building a rapidly growing sustainable business. Speaking of that pivot, you may have noticed that our company name, OncoCyte, doesn't really fit our strategic direction, which has broadened considerably. The first market in which we are commercializing is transplant.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

And while we do have an oncology pipeline, which I will get to in a minute, the name OncoCyte no longer makes sense. In the coming weeks, we plan to unveil our new name. Also, our CFO has asked me to inform you that this rename is being done on a very tight budget so we can strategically allocate our capital toward the things that we believe will create real shareholder value. Onto oncology. Because our main focus on transplant is going well, I want to spend a few minutes updating you about our oncology pipeline and where we are carefully investing to unlock future value.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

DetermaIO is showing real promise in the drug rescue category. We are really good at finding patients who respond to immunotherapy for certain types of cancer. Enriching for responders is a great way to get a drug with marginal benefit across the finish line. We were out there talking with strategic partners about DetermaIO. One of those potential partners told us, never in my wildest dreams did I think the results would look this good on the work that you are doing.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

So with all the caveats that our oncology pipeline is still earlier than transplant, we do see future markets for potential long term revenue growth where we where we will be able to invest in r and d after our transplant business is healthy and self sustaining. Before I turn it over to Andrea, I'll conclude with the fact that from where I sit, I feel good about how far we've come and where we are going. Not only are we successfully building a market for our transplant product, but also we are seeing increased interest from potential corporate partners who see the value in our technology in both transplant and oncology. This type of external validation supports our confidence that we are on the right path, making the right investments and have the right people to build a valuable business. Let me turn it over to Andrea.

[Andrea James, Chief Financial Officer at OncoCyte]

Thanks, Gabby and Josh. Hello, everyone. Just a few financial highlights this quarter. First, pharma services revenue of $2,100,000 exceeded our expectations, particularly with a large order that came in late in the quarter that we processed quickly and efficiently. This enabled us to invoice $1,400,000 with just a few days left in the quarter.

[Andrea James, Chief Financial Officer at OncoCyte]

And our Nashville lab team brought more automation this quarter, which drove gross margins of 62%. This revenue is great for us. It extends our cash runway, and it deepens our relationship with our customers. In q one, the vast majority of the revenue came from a single corporate customer that was impressed with our lab team's work, and they had asked us to help them meet some some of their own deadlines. This customer also is now seeking partnering opportunities on one of our oncology assays, which Josh alluded to in his pre prepared remarks.

[Andrea James, Chief Financial Officer at OncoCyte]

As thrilled as we are to meet this customer's demand, it is situation driven, and pharma services revenue, as I had said last quarter, will continue to naturally vary as we balance it with our own strategic priorities. This is particularly true because our sales team doesn't focus it on it. We want our sales team out there moving potential GraftAssure customers through our funnel so that we can meet our goal to have 20 transplant centers by the end of this year, and therefore spring load our commercial launch and our back half twenty twenty six revenue. To put it simply, we want our sales team focusing on the land and expand strategy that you just heard Josh talk about. At this time, we expect q two pharma services revenue to be less than $500,000, and we did not invoice for any services in the month of April, which really speaks to its lumpiness.

[Andrea James, Chief Financial Officer at OncoCyte]

We concluded the first quarter with nearly $33,000,000 in cash, and that includes restricted cash, which we'll we'll begin having access to later this year. Our free cash flow was negative 6,200,000.0 in the quarter, which is right in line with our target average quarterly cash burn of 6,000,000. For free cash flow, we're simply calculating cash flow from operations less purchases of property and equipment. Finally, we also collected $1,400,000 in receivables in the April. As we noted last quarter, we will have a couple of quarters this year where cash burn ticks up a bit, but not a lot before coming back down.

[Andrea James, Chief Financial Officer at OncoCyte]

The biggest knee needle mover here is our clinical trial and the instruments that we much must purchase to support that trial at our partner sites, albeit at a discount. Also, r and d will continue to reflect the added cost of FDA compliant software development for our IVD program. We continue to target an average of about $6,000,000 per quarter of cash burn until our commercial launch next year. Finally, Josh talked about our corporate rename. I'm really excited about this.

[Andrea James, Chief Financial Officer at OncoCyte]

Along with the rename, we will also announce a new corresponding Nasdaq ticker. We really took a resource conscious approach to the rename. We take capital stewardship seriously, and we want to keep the spotlight and our investments where they belong, which is on advancing research, on serving our customer community so they can, in turn, better serve their patients, and on investing in the commercialization of our transplant assay, which we expect to translate to real shareholder value creation. Okay? With that, Gabby, let's come up into gallery view and start taking questions.

[Operator]

Thank you, Andrea. Alright. Analysts, your camera's on. We're gonna start the queue. Let's see here.

[Operator]

Mark Massaro, let's start with you. Do you have any questions?

[Andrea James, Chief Financial Officer at OncoCyte]

You're on mute.

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

Okay. Can you hear me okay? Great. Alright, guys. Thank you for the time today.

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

So I am intrigued by the larger revenue generating pharma customer that seems to be asking about, like, oncology. And so I was wondering if you could expand on that a little bit. To what extent, can you, share if this partner is interested in potential oncology kits in the future, or is this more of a function of just perhaps generating revenue that can fund, the base transplant business?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. Thanks, Mark. No. It's it's definitely around DetermaIO and and a kitted version of that. There there's multiple flavors of of how that can work either in concert with an a larger NGS panel or standalone as as a PCR assay.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

I think, you know, the data that keeps coming out there is is seen as differentiating and and stands well against kind of like MSI and and TMB, particularly in the tougher cancers like colon cancer. I think we we have some some unique advantage there.

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

Fantastic. I wanted to ask about just what the next milestones are on DetermaIO. Apologies if I missed it. Can you just share any additional readouts we should be looking for and when we think that might represent a a more maybe tangible opportunity for the company as far as revenue generation occurs?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Absolutely. So I think, if you if you stretch the way back machine, we we submitted to Moldex back in December of twenty twenty two, for reimbursement. And so we've been kind of in a holding pattern with them, since that time. I think the the data that came out at the end of last year helps kind of push things forward. But I think the biggest thing we're looking forward to is the is the SWOG study that we've talked about a couple of times.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

It's 800 patients, five years, two years of follow-up. So it started in 2016. We have all of those samples in house now and are are starting to to process those. I don't control when that data gets reported out. You know, so that'll go up to the, you know, to the study, study primary investigator.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

And we're hopeful that that comes out towards, you know, the the end of this year, I think. San Antonio San Antonio breast is a natural place, for a triple negative breast cancer study to to read out. But that's that's me kind of reading some tea leaves there, Mark.

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

Yep. Maybe one more question for me, and then I'll hop in the queue. I would love to hear any potentially, you know, recent feedback in the last two months, in particular, from some of the larger US Transplant centers. I think you talked about three of the largest 10 that plan to, be trial participants. Just what are you hearing in terms of their, enthusiasm for the study?

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

Because presumably, these these transplant centers today probably use one of the SendOut tests. So just curious how we should be thinking about, you know, per it's probably a little early for this. But after securing FDA approval, do you have a sense for what percentage of tests they might move, you know, perhaps within the first year or two?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

I would say enthusiastic is probably the best word I have to describe their relationship with us. I think you were feeling a lot of pull through from these centers. They they want access to the technology. There's a lot of questions that they want to ask that are really hard to do when when there's only a send out option available. So having something that they can run-in house just makes a lot of sense for these guys.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

I mean, these are the top academic research institutions. They've got big questions they wanna answer. So I think we're feeling kind of this partnership approach is is is creating a lot of friends. I it's hard for me to tell how quickly they'll switch. I mean, your transplant centers are generally risk averse, I think, like most major academic centers.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

It's nice that they'll get to interact with it. It's nice that they'll be a part of creating the data that goes to the FDA. So maybe they'll be the quickest, to switch, but I can't really hang a number on how quickly they'll they'll they'll flip, those centers. I think we estimate at a minimum six months of them kind of introducing it to their clinical environment before any kind of meaningful, ramp up in volumes.

[Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG]

Alright. Got it. I look forward to the learning the name change, but I will, hop back in the queue. Thanks, guys. Thanks, Mark.

[Operator]

Thank you, Mark. Mason Caracao, you're up next.

[Mason Carrico, Research Analyst at Stephens Inc]

Hey, guys.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Hey, Mason.

[Mason Carrico, Research Analyst at Stephens Inc]

I think the IOTA model is set to kick off midyear. Was curious what you're hearing from the field around how much of an impact that could have, on market growth in the back half or or maybe just even moving forward.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. We consider it one of the wins in the sales. You know, donor derived cell free DNA in general. You know, I think there there was a lot of choice words when the program was announced, by by some of our partners. They're not very excited about it.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Think, you know, change is met with skepticism here in an environment that is increasingly full of change. So I I think it's going to be I I think demand increasing in general. It's the one thing that we've pointed to for about the past year that, you know, the if you use more marginal kidneys or you use more marginal organs, you're going to have more adverse events. And and I think that leads to more testing and more demand for tools to help manage those patients. I think we're very hopeful that the anti c d thirty eight drugs get to market quickly because I think they'll help offset some of the the worst effects of of using the marginal organs.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

But I am not a physician, so, like, that's that's my best guess on how it's gonna play out.

[Mason Carrico, Research Analyst at Stephens Inc]

And as we kind of think about your tests rolling out in the clinical market, is there any risk of friction between the transplant centers themselves and the physicians who work there in terms of the tests they order, I guess? The way I kind of think about it, is there a scenario where centers may prefer in house testing because they can participate in the economics, but physicians may tend to continue leaning towards LDTs because that's what they're used to or that's where there's more clinical evidence. And and if that is a scenario, I mean, how do incentives align? How how does that all shake out exactly?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. I would say there's very few centers that we've come across that take a heavy handed approach by, like, saying you have to use this, you have to use that. There are some that take that approach, but I think in most cases, it's up to the doctor to choose what test is right for the their patients. Obviously, we won't be you know, have a we won't have a role in deciding. That'll be up to the institution.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

But, I think there's gonna be a lot of show me, in in the in the market once we get out there. They're gonna wanna see that it performs as well as what they've been using. You know, one of the hardest things to change in the world is physician behavior. But I think, you know, we're we're we're comfortable that that our technology performs and that it will it'll stand up to any kind of comparative analysis.

[Mason Carrico, Research Analyst at Stephens Inc]

Got it okay. And last one for me, and I'll hop back in the queue. Could you just walk us through how you're thinking about the final Qsub meeting? What do you expect to be the focus there? And given the discussions you've you've kind of already had, what's derisked, if that's the right word versus, you know, what what will be the focus here?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. I'd like to invite Ecky to respond on this one because I know he's been doing a lot of prep work, and he just had a call with them teaching the FDA about a donor not donor derived, the digital droplet PCR. But, yeah, I'd say we've we've we've slimmed down the assay, made it more user friendly, and, you know, developed a trial design that's, you know, really, really simple. But I know, Ecky, I mean, maybe you can talk a little bit about sort of the the last Qsub that we've got coming up and, you know, what you see is kind of the the big topics there.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

Yeah. I mean, we are on track with submitting this week the the Qsub to the FDA. We had as Josh said, we had the first pre meeting. I I talked about that on the last call, what the outcome was, which was kind of a little bit in favor to us. We had this informational meeting since they needed to understand what digital PCR is and what are the specifics.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

I think that went very well, and, we also, had the opportunity, to to ask about certain things. And the FDA was very very forthcoming and told us, okay. We want to see this. We want to see that. We want to see this.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

That was actually very, very good. So we took the opportunity and baked more or less everything what they were asking for into our Qsub now. And, you know, that the Qsub is more kind of a question and and and answer game. So we have, five questions that we wanna ask that I think will give us a lot of comfort if we we get to an agreement with the FDA that our final submission is going to be accepted and is is more or less answering, everything that that they could think of. And, so that's, still on track, as Josh said, by year's end.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

We, I I don't not sure, Josh, if you said it, but, we we have received a so called central, IRB, already that was approved. And and the good news is that our largest center is one of the centers that are using a central IRB. So that means, as soon as we have, our documentation, our accompanying documentation ready, which we think is next week. And we got the kits, produced, which might take another two weeks, that we, can collect the first samples for the clinical trial.

[Mason Carrico, Research Analyst at Stephens Inc]

Got it. Thank you. That's helpful. Appreciate it, guys.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. Thanks, Pace.

[Operator]

Thank you, Mason. Thomas Flaten, you're up next.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Hey, guys. Appreciate you taking the questions. Josh, just following on from from the prior questions. Aside from the study, is there anything else that you guys need to do from an FDA submission perspective to to complete that that that document or filing?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

No. It's all I mean, it's all about the data generation at this point. There's a lot of work that we do in house. So there's a lot of the verification validation work that's done, at our lab in Nashville. That's a big lift.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

There's a software development, that you heard us talk about. All of that's kind of proceeding on pace, but the the biggest piece is getting these these clinical samples collected and and accrued and and and ready to run.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Got it. And then of the 20 centers that you're hoping to have by year end, and I saw the three of the 10 you have already are in The US. Would it be proportional when we get to the end of the year? Will six of the 20 be in The US, or are you trying to skew that more US oriented ahead of launch?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

I think we'll see see more in The US ahead of launch.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Got it. And then, Andrea, just a quick one for you. With respect to sales and marketing spend, how are you thinking about ramping that ahead of launch? Is that more of a 2026 activity? Should we anticipate anything at towards the tail end of this year?

[Andrea James, Chief Financial Officer at OncoCyte]

There will be some incremental spend tied to unlocking the RUO sites, which is already baked into the 6,000,000 cash burn. So we've got some incremental sites associated with the FDA program. And as we get closer to submission, we're going to divert those dollars to sales and marketing at the end of the year. So we should be okay. I mean, the good thing about this is the the customer market is very concentrated, and so part of the value prop is that we don't have to go out and hire a big sales force.

[Andrea James, Chief Financial Officer at OncoCyte]

You know, there's just a handful, maybe a hundred call points in The US Yeah. And similarly in Europe. And so, you know, the sales team, they're doing a really great job with the resources that they have. And as we are able to divert some, of the investment, from the clinical trial tour to the RUO site unlock, we'll be able to just divert some of those dollars over there.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC]

Awesome. I appreciate it. Thank you.

[Operator]

Thank you, Thomas. Mike Matson? Up next.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Hey, Mike. Yeah. Thanks. So just a few on some of the, you know, the transplant centers that will be in the the study. So you have three US centers right now using graft Grapture IQ.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Are any of those that you and you're expecting three more in the study. So are those three for the study gonna be different than the three you have right now?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. There's gonna be a mix of incremental and some some that are current users, but it it's gonna be much more than three.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Okay. And then for the for the new ones that that come online that are gonna be involved in the trial, do they need is there any kind of learning curve that they need to, like, get some experience with, GrabSureIQ, before they, you know, move on to the actual trial?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

No. It's a good question. I think it's, fortunately, it's PCR, so it's it's pretty easy for these guys, you know, to come up on the workflow. We will there'll be an instrument drop. There'll be about a week and a half of training, and then they're they're ready to go.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Okay. Alright. And then just the current mix of centers, you know, you've got six in Europe and three in The US. So, I mean, does that is that reflective of at all of the relative kind of interest in demand? I mean, I don't think they have you know, they don't have the SendOut test over there as I understand it.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Right? So maybe there's just more of even more of an appetite, not to say that there isn't an appetite here, but, you know, can you maybe comment on that?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. No. Absolutely. So what happened is we did feel an initial pull from Europe that was much stronger than The United States. But what what we did is we kind of poached our funnel for our favorite sites in The United States and held them off for the for the FDA program.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

And so you're gonna see a lot more pop up in The US just by by virtue of that.

[Mike Matson, Senior Equity Research Analyst at Needham & Company]

Okay. Got it. Thank you.

[Operator]

Thank you, Mike. And last, we have Yuan Sai.

[Yuan Zhi, Managing Director at B.Riley Securities]

Alright. Thank you for taking our questions. Maybe, Josh, can you remind us within the current standard of care, how many how many tests do you need to run to detect the transplant rejection in the first year of, kidney transplant, and what would that look like beyond one year? A follow-up question will be, what's is the compliance rate for those tests right now?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. You know, so we're we're not out commercializing a ton right now. So so most of my information here is gonna be secondhand. I mean, there are there are publications that recommend, you know, four or more tests in the first year, and then, you know, maybe quarterly to biannually after that. I would say, in general, the the average is somewhere around 2.3 to 2.5 tests per patient under management, and that gives you kind of an average to think through as you're as you're looking at market sizes.

[Yuan Zhi, Managing Director at B.Riley Securities]

And in your current trial, how how frequently do patients receive

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

So it's it's single time point in our study.

[Yuan Zhi, Managing Director at B.Riley Securities]

Got it. So for you once the benefit of your test is you will be able to detect some of these subclinical rejections. So if those are detected, what does it mean actually to the patients and doctors? What kind of treatment would they start after that? And in other words, what is the additional benefit to detect such, you know, subclinical rejections?

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. I'd like to hand this one to Ecky because, you know, he was a part of that that groundbreaking research that came out last year. You know, if you could Ecky, if you could talk just a little bit about, you know, why catching AMR matters now, especially with, you know, sort of the anti CD 30 eights that are coming out.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

Yeah. It's a thank you for the question. So, we we could show last year that, using our test, in patients that are at high risk for antibody mediated rejection, which are those patients, who have certain types of antibody, called donor specific antibodies. And it it it was up also up to the same time that you could say it doesn't matter because there's no treatment. But, in parallel to that, we were evaluating a new treatment, that should really work very well on anti anything that is antibody related.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

And, so that that is, a drug called feldsartan, which is a CD38 antibody. And so shortly after we have shown that that we can shorten the time to diagnose ABMR, we could show that there's a very effective treatment for ABMR, which, actually really changed the complete perspective, on testing for for an ABMR because now we are, able, as soon as we catch it, to treat the patient. And ABMR, especially chronic long lasting ABMR, is the major cause of graft loss. So it it was always a very bad prognosis when you have to tell a patient, oh, you have antibody mediated rejection. It's not going away.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

And most probably, you're going to lose your graft over the next three, four years. And that has completely changed. So and there are additional drugs upcoming that are targeted to antibody mediated rejection. We are participating in one phase two trial, as the measuring partner for donor derived cell free DNA. And we are also having investigator initiated study that is happening in Germany, Austria, and the German speaking countries, where we are testing another CD38 antibody, which is called daratumumab.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

The beauty of this drug is that it is already approved in The US. It's just not for ABMR, but it's a drug that you can give off off label. And I think the the other positive, event was that the FDA gave fezadimod a breakthrough, device approval. So in The US, now fasinumab can be used for ABMR. And what what we have really shown in in the studies is that it's it's really, very beneficial if you are also monitoring while you are, giving this drug.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

No drug has no side effects, and, it's clear that you don't want to give a drug forever. So that's usually given for about half a year and then you stop. And what we have seen already in the study that was published in New England Journal is that once the disease, the ABMR, is going into a recurrence, then the donor derived cell free DNA is, is rising again. So that's really a good tool that you can say, okay, at this point, the patient who was, pretty much cured from his ABMR needs the next cycle of the drug. So that's, I think, where it's going to go, over the next year.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

Especially in this case, I think donor derived cell free DNA plays really a pivotal role for these patients.

[Yuan Zhi, Managing Director at B.Riley Securities]

Yep. That that's very helpful.

[Ekkehard Schütz, Chief Science Officer at OncoCyte]

You're welcome.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Yeah. No. Thanks. And I think, you know, we're excited. We've got some more data coming out this year on those on the recurrence monitoring.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

We're excited about that. All this ties to the claims expansion that we got last fall, you know, where we were looking at the de novo DSA positive patients, where we basically got a a screening claim there. You need to test those patients six times at the first sign of de novo DSA. So we're we're excited. I mean, there we feel like the market is growing, in general for testing.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

So the pie is getting bigger for everybody, and I think that that feels really good.

[Andrea James, Chief Financial Officer at OncoCyte]

Really quickly, I wanna do a housekeeping before we do another round to see if anyone has any follow ups. I just wanna get, our wonderful analysts joining us. I wanna get your firm names into the the transcript. So we have Mark Massaro at BTIG. Thank you for your question.

[Andrea James, Chief Financial Officer at OncoCyte]

Mason Carrico at Stevens. Thank you for your question. Thomas Flatten at Lake Street. Thank you. Mike Matson at Needham.

[Andrea James, Chief Financial Officer at OncoCyte]

Thank you. And Yuan Yuan Zhi at B Riley Securities. We appreciate you guys being here. We wanna get your firm names into the transcript.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

Alright. And if there are no follow-up questions, we will say thank you and look forward to catching up with you guys on the follow ups.

[Operator]

Thank you. See you next quarter. Carry on.

[Josh Riggs, President & Chief Executive Officer at OncoCyte]

See you guys.

Participants

Executives

• Josh Riggs, President & Chief Executive Officer
• Andrea James, Chief Financial Officer
• Ekkehard Schütz, Chief Science Officer

Analysts

• Mark Massaro, Managing Director - Senior Equity Research Analyst at BTIG
• Mason Carrico, Research Analyst at Stephens Inc
• Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, LLC
• Mike Matson, Senior Equity Research Analyst at Needham & Company
• Yuan Zhi, Managing Director at B.Riley Securities