OncoCyte Corporation Stock Price: Quote, Forecast, Splits & News (OCX)

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OCX

OncoCyte Corporation

OCX

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Financials

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$2.67

-$0.03

1.11%

Jun 13, 2:56:23 PM EDT

Financial information provided by Financial Modeling Prep. Options data provided by Unusual Whales. Live transcripts provided by Quartr. Reported revenue and EPS data from Earnings powered by FinChat.io. All data is provided for informational purposes only, and is not intended for trading purposes or financial, investment, tax, legal, accounting or other advice.

Market Cap: $76M
IPO Date: 12/30/15
CEO: Mr. Joshua Riggs
Fulltime Employees: 46
Sector: Healthcare
Industry: Biotechnology
Country: US
Exchange: NASDAQ Global Market

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OncoCyte Corporation Stock Price: Quote, Forecast, Splits & News (OCX)

Change

-$0.03

1.11%

Financial Profile

Prev Close

$2.70

Market Cap

$76.36M

Day Range

$2.61 - $2.70

Open

$2.61

P/E Ratio

-0.7

52W Range

$1.92 - $4.75

24H Volume

$34.27K

Dividend Yield

0.00%

EPS

-3.79

Key Issues

Earnings

Report Date

May 12, 2025

Reported Revenue

2.1M

Beat +1,586.39%

Avg 1d Change

3.36%

Report Period

Q1 2025

Reported EPS

-0.26

Miss -8.33%

Implied Move 1d

—

Transcript

6m 52s

And with that, I would like to now turn the call over to Josh Riggs. Hi, everyone.

6m 58s

For joining us today. It's it's great to be checking in with you about two months 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. 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 transplant centers to use our research use only kit. We finalized our clinical trial design, just a few weeks ago, we got central IRB approval. 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 for our final presubmission meeting ahead of locking in for the trial. The clinical trial itself, we've gone over in previous quarters, has drawn interest from several university hospitals would like to participate in both The US and Germany.

8m 19s

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. 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. 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, is the same timeline we communicated in March. Like with any FDA program, there are several work streams that must come together, 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 GraftAssure work workflow by the end of this year, which is the kickoff to our land and expand strategy.

9m 32s

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're in The US, Germany, UK, Switzerland, Austria, and South Asia. And the researchers at these universities are starting to perform real studies using donor derived cell free and discovering new applications for our test. Such as pediatric transplantation, the role of ab 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 volume needed to efficiently run an NGS platform. 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.

10m 55s

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. 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, 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. And while we do have an oncology pipeline, 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, want to spend a few minutes updating you about our oncology pipeline.

12m 12s

And where we are carefully investing to unlock future value. 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. 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.

13m 20s

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.

13m 32s

Thanks, Gabby and Josh. Hello, everyone. Just a few financial highlights this quarter.

13m 38s

First, farmer 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. And our Nashville lab team brought more order 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. As thrilled as we are to meet this customer's demand, it is situation driven, and farmer 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 graft assure customers through our funnels so that we can meet our goals 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.

14m 54s

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. 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. 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.

16m 1s

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. 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.

16m 47s

Thank you, Andrea. Alright. Analysts, your camera's on. We're gonna start the queue. Let's see here. Mark Massaro. Let's start with you. You have any questions.

17m 2s

You're on mute.

17m 5s

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

17m 45s

Yeah. Thanks, Mark. No. It's it's definitely around DetermaIO and any kitted version of that. There there's multiple flavors of of how that can work. I have in concert with an a larger NGS panel or stand alone as as a PCRS, a 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.

18m 20s

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?

18m 44s

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 swag that we've talked about a couple of times. It's eight hundred patients. Five years, two years of follow-up. So 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 know, to the study study primary investigator. We're hopeful that that comes out towards you know, the the end of this year, think. You know, San Antonio San Antonio Brest 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.

19m 43s

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? Because, presumably, these these transplant centers today probably use one of the send out tests. So just curious how we should be thinking about you know 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?

20m 32s

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 the house just makes a lot of sense for these guys. 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. 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 clinical environment before any kind of meaningful ramp up in volumes.

21m 42s

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

21m 49s

Thanks, Mark.

21m 50s

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

21m 57s

Hey, guys. Hey, miss. Think the IOTA model is set to kick off midyear. I 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 maybe just even moving forward?

22m 12s

Yeah. We consider it one of the wins in the sales. We have 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. 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, I 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. 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. But I am not a physician, so like, I'll I'll that's that's my best guess on on how it's gonna play out. Okay.

23m 13s

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?

23m 52s

Yeah. I I would say there's very few centers that we've come across that take a 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 to the institution. 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 that it will it'll stand up to any kind of comparative analysis.

24m 40s

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 kind of already had, what's derisked if that's the right word versus, you know, what what will be the focus here?

24m 58s

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 don't 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 q sub that we've got coming up and, you know, what you see is kind of the the big topics there. Yeah. I mean, we are on track with submitting this week. The the QSAP to the FDA. We had as Josh said, we had the first pre meeting. I I talked about that in the last call, what the outcome was, which was kind of a little bit in favor to us. We had this information on meetings and send you to understand what digital PCR is and what are the specifics. 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.

26m 11s

We want to see this. We want to see that. We want to see this. That was actually very, very good. So we took the opportunity and baked more or less every what they were asking for into our QSAT now And, you know that the Q sub 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 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. We I don't not sure, Josh, if you said it, but, we we have received [indiscernible] central, IRB, already. There was a approved. 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 doc 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.

27m 43s

Got it. You. That's helpful. Appreciate it, guys. Yeah. Thanks, Mace.

27m 48s

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

27m 53s

Hey, guys. Appreciate you taking the questions.

27m 57s

Josh, just following on 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?

28m 10s

No. It's all, I 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 work that's done, at our lab in Nashville. That's a big lift. 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.

28m 33s

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 here 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?

28m 49s

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

28m 54s

Got it. And then, Andrew, 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 2026 activity? Should we anticipate anything at towards the tail end of this year?

29m 9s

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 submission, we're gonna 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 that we don't have to go out and hire a big sales force. You know, there's just handful, maybe a hundred call points in The US. 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.

29m 56s

Awesome. I appreciate it.

29m 57s

Thank you.

30m

Thank you, Thomas. Mike Matson? [indiscernible] Hey, Mike. Yeah.

30m 6s

Thanks.

30m 7s

So just a few on some of the know, the transplant centers that'll be in the the study. So you have three US centers right now using graft GraphSureIQ.

30m 18s

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

30m 27s

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.

30m 34s

Okay.

30m 35s

And then for the for the new ones that that come online that are be involved in the trial, do any do they need is there any kind of learning curve that they need so they could some experience with GraphSure IQ, before they move on to actual trial.

30m 49s

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.

31m 3s

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 send out tests over there as I understand it. Right? So maybe there's just of even more of an appetite not to see that they're isn't an appetite here, but, you know, can you maybe comment on that?

31m 29s

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

31m 50s

Okay.

31m 51s

Got it. Thank you.

31m 55s

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

32m 1s

Alright, guys. Thank you for taking our questions. Maybe, Josh, can you remind us within the current standard of care, how many how many tasks 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 is the compliance rate for those tests right now?

32m 26s

Yeah. You know, so we're not out commercializing a ton right now. So so most of my information here is gonna be secondhand. I mean, there 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 size.

32m 55s

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

33m 2s

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

33m 5s

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 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?

33m 31s

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

33m 46s

Yeah. It's a thank you for the question. So we we could show last year that using our test 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. 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 AVMR, 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 a ABMR, especially chronic long last ABMR is the major cause of graft loss. So it it was always a very bad prognosis when when you have to tell a patient oh, you you have antibody mediated rejection. That's not going away.

35m 28s

And most probably you're going to lose your your graft over the next three, four years. And that has completely changed. So and there are additional drugs up coming 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, like like the the German speaking countries. Where we are testing another c d 38 antibody, is called daratumumab. The beauty of this drug is that it's is already approved. In The US. It's, just not for ABMR, but it's drug that you can give off off label. And I think the the other positive event was that the FDA gave felsatomide 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. No drug has no side effects, and, it's clear that that you don't want to give a drug forever. So that's usually given for about half a year, and then you stop.

37m 17s

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 SAFI DNA is is rising again.

37m 35s

So that's really a 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 we're at going to go over the next year. And especially in this case, I think donor derived cell free DNA plays really a pivotal role for these patients.

38m 5s

Yep.

38m 6s

That that's very helpful.

38m 10s

You're welcome.

38m 11s

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

38m 44s

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. Mason Kerraco at Stevens. Thank you for your question. Thomas Flatten at Lake Street. Thank you. Mike Matson at Needham. Thank you. And Jan Yuan Zhi at B Riley Securities. We appreciate you guys being here. We wanna get your firm names into the transcript.

39m 14s

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.

39m 24s

Thank you. See you next quarter. Bye, everyone. [indiscernible]

Key Insights

OCX is progressing on its 2025 plan, focusing on finalizing clinical assay and trial design, completing a clinical trial for FDA submission by year-end, and preparing for a commercial launch in the back half of 2026 by signing transplant centers to use its research use only (RUO) kit.
The company has received central IRB approval for its clinical trial, expects participation from at least three of the top 10 US transplant centers, and aims to have 20 sites trained on its GraftAssure workflow by year-end; currently, 10 sites are running the RUO assay across the US, Europe, and South Asia.
OCX highlights the advantages of digital PCR over NGS for transplant testing, citing lower costs and simpler workflows, and notes growing interest in new applications such as pediatric transplantation and bone marrow transplants.
Pharma services revenue for the quarter was $2.1 million, exceeding expectations due to a large late-quarter order; however, this revenue stream is expected to be lumpy, with Q2 pharma services revenue projected to be less than $500,000.
The company ended Q1 with nearly $33 million in cash (including restricted cash), reported a quarterly cash burn of $6.2 million (in line with targets), and continues to target an average quarterly cash burn of about $6 million until commercial launch next year; FDA approval for the transplant assay is targeted for the first half of 2026.

Recent Transcripts

Transplant assay clinical trial on track for FDA submission by year-end; strong pharma revenue exceeded expectations.

OncoCyte advances kidney transplant assay, targets FDA submission in 2024, and secures strong funding.

Earnings

Report Date

May 12, 2025

Reported Revenue

2.1M

Beat +1,586.39%

Avg 1d Change

3.36%

Report Period

Q1 2025

Reported EPS

-0.26

Miss -8.33%

Implied Move 1d

—

Transcript

6m 52s

And with that, I would like to now turn the call over to Josh Riggs. Hi, everyone.

6m 58s

8m 19s

9m 32s

10m 55s

12m 12s

13m 20s

13m 32s

Thanks, Gabby and Josh. Hello, everyone. Just a few financial highlights this quarter.

13m 38s

14m 54s

16m 1s

16m 47s

Thank you, Andrea. Alright. Analysts, your camera's on. We're gonna start the queue. Let's see here. Mark Massaro. Let's start with you. You have any questions.

17m 2s

You're on mute.

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

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Thanks, Mark.

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

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Got it. You. That's helpful. Appreciate it, guys. Yeah. Thanks, Mace.

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

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Hey, guys. Appreciate you taking the questions.

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

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Awesome. I appreciate it.

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Thank you.

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Thank you, Thomas. Mike Matson? [indiscernible] Hey, Mike. Yeah.

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Thanks.

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So just a few on some of the know, the transplant centers that'll be in the the study. So you have three US centers right now using graft GraphSureIQ.

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

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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.

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Okay.

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Okay.

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Got it. Thank you.

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

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

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

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Yep.

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That that's very helpful.

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You're welcome.

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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.

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Thank you. See you next quarter. Bye, everyone. [indiscernible]

Key Insights

OCX is progressing on its 2025 plan, focusing on finalizing clinical assay and trial design, completing a clinical trial for FDA submission by year-end, and preparing for a commercial launch in the back half of 2026 by signing transplant centers to use its research use only (RUO) kit.
The company has received central IRB approval for its clinical trial, expects participation from at least three of the top 10 US transplant centers, and aims to have 20 sites trained on its GraftAssure workflow by year-end; currently, 10 sites are running the RUO assay across the US, Europe, and South Asia.
OCX highlights the advantages of digital PCR over NGS for transplant testing, citing lower costs and simpler workflows, and notes growing interest in new applications such as pediatric transplantation and bone marrow transplants.
Pharma services revenue for the quarter was $2.1 million, exceeding expectations due to a large late-quarter order; however, this revenue stream is expected to be lumpy, with Q2 pharma services revenue projected to be less than $500,000.
The company ended Q1 with nearly $33 million in cash (including restricted cash), reported a quarterly cash burn of $6.2 million (in line with targets), and continues to target an average quarterly cash burn of about $6 million until commercial launch next year; FDA approval for the transplant assay is targeted for the first half of 2026.