Q1 2025 OncoCyte Corp Earnings Call
Speaker Change: You have joined the meeting as an attendee and will be muted throughout the meeting.
Speaker Change: First quarter of 2025.
Speaker Change: If you have not seen today's shareholder letter fees.
Speaker Change: <unk> Investor Relations page at investors Dot dot.
Speaker Change: Dot com.
Speaker Change: Today's prepared remarks built upon the information already shared English robust letter.
Speaker Change: Joining us today, our Oncotype, President and CEO, Josh Riggs, Chief Science Officer.
Andrew hygiene: And CFO Andrew hygiene.
Andrew hygiene: We also have our analysts analysts with that Pamela.
Andrew hygiene: After our prepared remarks, our analysts may ask questions.
Andrew hygiene: Before turning the call over to Josh ranks I'd like to go over our safe harbored the.
Andrew hygiene: The company will make projections and forward looking statements regarding future events.
Andrew hygiene: Any statements that are not historical facts are forward looking statements.
Andrew hygiene: These statements are made pursuant to and within the meaning of the safe Harbor provision of the private Securities Litigation Reform Act of 1985.
Andrew hygiene: We encourage you to review the company's SEC filings, including the company's most recent Form 10-K, and subsequent forms 10-Q, which identify risks and uncertainties that may cause future actual results or events to differ materially.
Andrew hygiene: Please note that the forward looking statements made during today's call speak only to the date that they are made and Oncotype takes oncotype undertakes no obligation to update them.
Speaker Change: And with that I would like to now turn the call over to Josh rates.
Josh Rates: Hi, everyone. Thanks for joining us today.
Josh Rates: 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.
Josh Rates: For those of you are new to us, we're a molecular diagnostics company investing and the significant opportunity to improve transplant rejection testing. We are just over two years into our strategic pivot that has now brought us to the cost of delivering a kitted molecular test kit.
Josh Rates: Our key areas of focus for 2025, our 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 2026 revenue by signing a transplant centers to use our research use only kit.
Josh Rates: We finalized our clinical trial design and 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.
Josh Rates: We continue 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.
Josh Rates: The clinical trial itself, which we've gone over previous quarters is drawn interest from several university hospitals that we'd like to participate in both the U S and Germany.
Josh Rates: We expect to welcome at least three of the top 10 transplant centers in the United States is clinical trial participants.
Josh Rates: And if we look at all of the U S transplant hospitals actively engaged in supporting our trial, we see nearly 10% of U S transplant volumes represented.
In the near future, we are going to be up on clinical trials dot Gov and on our way to first patient in.
Josh Rates: But I'm really looking forward to sharing that milestone.
Josh Rates: We'll follow that with an introduction to 101 or more of our sites principal investigators and Kols call.
Josh Rates: We believe the strong interest we are seeing for the trial will translate well to future demand for our IBD assay.
Josh Rates: 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.
Josh Rates: Like with any FDA program. There are several work streams that must come together and from what we can see we're on pace.
Josh Rates: So we continue to target FDA approval in the first half of 2026.
Josh Rates: Continuing on we are on track to have 20 sites trained on our graph to show workflow by the end of this year, which is the kickoff to our land and expand strategy to land hospitals with or are you old product and then expand to selling our clinical kitted product post FDA clearance.
Josh Rates: We now have 10 sites running or are you OSA. They are in the U S, Germany, U K, Switzerland, Austria and Southeast Asia.
Josh Rates: And the researchers at these universities are starting to perform real studies using donor derived cell free DNA in discovering new applications for our tests, such as pediatric transplantation, the role of absolute quantification and long term kidney transplant management and ultra sensitive detection of microcom rhythm for bone marrow transplants.
Josh Rates: We are thrilled that researchers are exploring new ways that our technology can potentially help future patients.
Josh Rates: Youll see in the shareholder letter that we are starting to prove out the value of digital PCR as a technology differentiator.
Josh Rates: Simpler, it's faster and it offers better sample economics that engie asset low volumes, most transplant centers don't have the sample volumes needed to efficiently run and NDS platform.
Josh Rates: These machines require a processing chip the costs well north of a $1000 per run that.
That math just doesn't work when you only have a couple of samples a day.
Josh Rates: With PCR testing, even running a single sample as an affordable option given that the batch size does not meaningfully alter the cost per result.
Josh Rates: With only a few pipe heading steps and a simple readout labs don't need sophisticated hands to get the work out.
We see a great future for PCR technology to bring testing closer to the patient.
Speaker Change: <unk> has been investing in improving and simplifying digital PCR workflows for years and our assay benefits from these ease of use improvements.
Speaker Change: 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.
Speaker Change: Speaking of that pivot you may have noticed that our company name Unco site doesn't really fit our strategic direction, which has broadened considerably.
Speaker Change: The first market in which we are commercializing his transplant.
Speaker Change: And while we do have an oncology pipeline, which I will get to in a minute the name uncle <unk> no longer makes sense.
Speaker Change: In the coming weeks, we plan to unveil our new name also our CFO has asked me to inform you that this renamed as being done on a very tight budget. So we can strategically allocate our capital towards the things that we believe will create real shareholder value.
Speaker Change: On to oncology.
Speaker Change: 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.
Speaker Change: The term of Io 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 and.
Speaker Change: Enriching for responders is a great way to get a drug with marginal benefit across the finish line.
Speaker Change: We were out there talking with strategic partners about the term of Io.
Speaker Change: One of those potential partners told us never in my Wildest Dreams that I think the results would look this good on the work that you're doing.
Speaker Change: 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&D. After our transplant business is healthy and self sustaining.
Speaker Change: Before I turn it over to Andrea I'll conclude with the fact that from where I sit I.
Speaker Change: Feel good about how far we've come and where we're going.
Speaker Change: 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.
Speaker Change: 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.
Andrea: Let me turn it over to Andrea.
Andrea: Thanks, Kathy and Josh Hello, everyone, just a few financial highlights this quarter.
Andrea: First farmer services revenue of $2 1 million exceeded our expectations, particularly with a large order that came in late in the quarter that we process quickly and efficiently. This enabled us to invoice one $4 million with just a few days left in the quarter and our.
Andrea: Nashville Lab team brought more automation this quarter, which drove gross margins of 62%. This revenue is great for us extend our cash runway and it deepens our relationship with our customers in Q1. The vast majority of the revenue came from a single corporate customer that was impressed with our lab teams work and you had asked us to help them meet.
Andrea: Some of their own deadlines.
Speaker Change: This customer also is now seeking partnering opportunities and one of our oncology assays, which Josh alluded to in his prepared remarks.
Speaker Change: I'm thrilled to see our to meet this customer's demand. It is situation driven and pharma services revenue as I had said last quarter. We will continue to naturally vary as we balance it with their own strategic priorities. This is particularly true because our sales team doesn't focus on it.
Speaker Change: We want our sales team out there moving potential gratis, where customers through our funnels 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 2026 revenue to put it simply we want our sales team focusing on the land and expand strategy, but you just heard Josh talk about.
Speaker Change: At this time, we expect Q2 pharma services revenue to be less than $500000.
Speaker Change: We did not invoice for any services in the month of April which really speaks to its lumpiness.
Speaker Change: We concluded the first quarter with nearly $33 million in cash and that includes restricted cash, which we will begin having access to later this year, our free cash flow was negative $6 2 million in the quarter, which is right in line with our target average quarterly cash burn of $6 million for free cash flow, we're simply calculating cash flow from operations less purchases of <unk>.
Speaker Change: Property and equipment.
Speaker Change: Finally, we also collected $1 $4 million in receivables in the first week of April.
Speaker Change: As we noted last quarter, we will have a couple of quarters this year, where cash burn picks up a bit but not a lot before coming back down the biggest needle mover here is our clinical trial and the instruments that we must must purchase to support that trial at our partner site, albeit at a discount.
Speaker Change: So R&D will continue to reflect the added cost of FDA compliance software development for IBD program. We continue to target an average of about $6 million per quarter of cash burn until our commercial launch next year.
Speaker Change: 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 on our investments where they belong which is on advancing research.
Speaker Change: 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.
Speaker Change: Thank you Andrea.
Speaker Change: Okay.
Speaker Change: Alright analysts Aragon, who are going to start the queue.
Speaker Change: Let's see here Mark Massaro start with you do you have any questions.
Speaker Change: Year on year.
Speaker Change: Okay can you hear me okay.
Speaker Change: Great Alright, guys. Thank you for the time today, so I am intrigued by the larger <unk>.
Speaker Change: Revenue generating.
Speaker Change: Pharma customer that seems to be asking about.
Oncology and so I was wondering if you could expand on that a little bit to.
Speaker Change: To what extent.
Speaker Change: Can you share if this partners 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.
Mark Massaro: Yes, Thanks, Mark no, it's definitely around determine Io and in a kitted version of that.
Mark Massaro: There is multiple flavors of how that can work either in concert with a larger NGF panel.
Or stand alone as a PCR assay.
Mark Massaro: Think the data that keeps coming out there.
Mark Massaro: As seen as differentiating and stands well against.
Mark Massaro: Like MSI and <unk>, particularly in the tougher cancers like colon cancer.
Mark Massaro: I think we have some some unique advantage there.
Mark Massaro: Fantastic.
Speaker Change: I wanted to ask about just.
Speaker Change: What the next milestones are on determined Io.
Speaker Change: Apologies if I missed it can you just share any additional readouts, we should be looking for and when we think that might be.
Speaker Change: Represents a more maybe tangible opportunity for the company as far as revenue generation occurs.
Speaker Change: Absolutely. So I think if you if you stretch the way back machine, we submitted to <unk> back in December of 2022 for reimbursement and so we've been kind of in a holding pattern with them since that time I think the data that came out at the end of last year helps kind of push things forward.
Speaker Change: But I think the biggest thing we're looking forward to is the does the Swags study that we've talked about a couple of times as 800 patients five years two years of follow up so started in 2016.
Speaker Change: We have all of those samples in house now and are starting to process those.
Speaker Change: I don't control when that data gets reported out on me. So that'll go up to the game to the study. So the primary investigator and we're hopeful that that comes out towards the end of this year I think give us Antonio San Antonio breast is a natural place for triple negative breast cancer study to read out, but thats kind of reading some tea leaves there.
Speaker Change: Omar.
Speaker Change: Maybe one more question for me and then I'll hop in the queue.
Speaker Change: I would love to hear any potentially recent feedback in the last two months.
Speaker Change: In particular from some of the larger U S transplant centers I think you talked about three of the largest 10 that.
Speaker Change: That plan to beat trial participants just what are you hearing in terms of their enthusiasm for the study.
Speaker Change: Presumably these these transplant centers today, probably use one of the send out tests. So just curious how we should be thinking about.
Speaker Change: It's probably a little early for this but after securing FDA approval do you have a sense for what percentage of test they might move.
Speaker Change: Perhaps within the first year or two.
Speaker Change: I would say enthusiastic is probably the best word I have to describe.
Speaker Change: Their relationship with US I think you were feeling a lot of pull through.
Speaker Change: From these centers they want access to the technology. There is a lot of questions that they want to ask that are really hard.
Speaker Change: To do with when Theres only a send out option available so having something that they can run in 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 want to answer.
Speaker Change: We're feeling kind of this partnership approach and is creating a lot of friends.
Speaker Change: 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 are major academic centers.
Speaker Change: Nice that they'll get to interact with it it's nice that there'll be a part of creating the data that goes to the FDA. So maybe there'll be the quickest to switch, but I can't really hang a number on how quickly they'll they'll flip.
Speaker Change: 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.
Speaker Change: Alright got it I look forward to the learning the name change, but I will hop back in the queue. Thanks, guys. Thanks Mark.
Speaker Change: Thank you Mark maintain care.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Hey, guys.
Speaker Change: I think the iota.
Speaker Change: Model to kick off mid year I was curious what you are hearing from the field around how much of an impact that could have.
Speaker Change: On market growth in the back half or maybe just even moving forward.
Speaker Change: We consider it one of the wins in the sales.
Speaker Change: Donor derived cell free DNA in general.
Speaker Change: I think there there was a lot of choice words, when the program was announced by some of our partners. They are not very excited about it I think.
Speaker Change: Changes met with scepticism here in an environment that is.
Speaker Change: Increasingly full of change so I think it's going to be.
Speaker Change: I think demand increasing in general and so one thing that we pointed to for about the past year that.
Speaker Change: You use more marginal kidneys are you use more marginal organs youre going to have more adverse events and I think that leads to more testing and more demand for tools to help manage those patients.
Speaker Change: We're very hopeful that the anti CD 38 drugs get to market quickly.
Speaker Change: I think they will help offset some of the worst effects of abusing the marginal organs, but I am not a physician.
Speaker Change: All of that.
Speaker Change: My Best guess on how it is going to play out.
Speaker Change: Okay.
Speaker Change: As we kind of think about.
Speaker Change: Your test rolling out in the clinical market is there any risk of friction between.
Speaker Change: The transplant centers themselves in the physicians to work there in terms of the tests they order I guess.
Speaker Change: 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.
Speaker Change: <unk> may tend to continue leaning towards ltte's, because thats, what they are used to where that's where there's more clinical evidence.
Speaker Change: If that is the scenario I mean, how.
Speaker Change: <unk> incentives align how does that all shake out exactly.
Speaker Change: Yeah, I would say Theres 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.
Speaker Change: In most cases, it's up to the Doctor to choose what test is right for their patients obviously, we won't be <unk>.
Speaker Change: We won't have a role in deciding that'll be up to the institution, but.
Speaker Change: I think theres going to be a lot of xiaomi.
Speaker Change: And the market once we get out there, they're going to want to see that it performs as well as what they've been using.
Speaker Change: One of the hardest things to change in the world is physician behavior.
Speaker Change: But I think where we're comfortable that our technology performs and that it will stand up to any kind of comparative analysis.
Speaker Change: Got it Okay and last one for me and I'll hop back in the queue.
Speaker Change: Could you just walk us through how youre thinking about the final Q sub meeting what do you expect to be the focus there and given the discussions.
Speaker Change: <unk> already had.
Speaker Change: De risked.
We're at versus what will be the focus here.
Speaker Change: I would like to invite <unk> to respond on this one because I know he's been doing a lot of prep work can you just had a call with them teaching the FDA about that.
Speaker Change: Im not donor derived the digital droplet Pcr, but yes.
Speaker Change: I'd say, we've we've slimmed down the assay made it more user friendly and developed a trial design that really really simple, but I don't <unk> I mean, maybe you can talk a little bit about sort of the last few sub that we've got coming up and what you see as kind of the big topics there.
Speaker Change: Yes.
Speaker Change: We are on track with submitting this week, the coos up to the FDA.
Speaker Change: As Doug said, we had the first pre meeting I talked about that over the last call.
Speaker Change: The outcome loss, which was kind of a little bit in favor to us. This.
Speaker Change: This informational meetings. Since then you need to understand what digital PCR is and what are the specifics.
Speaker Change: I think that went very well and we also had the opportunity to.
Speaker Change: To ask about.
Speaker Change: Certain things and the FDA will say.
Speaker Change: Very forthcoming and told US Okay. We want to see this we want to see that we want to see this.
Speaker Change: That was actually very very good. So we took the opportunity in base more or less everything what they were asking for into our Coos up now and.
Speaker Change: The two sub is more.
Sylvia: Kind of a question and answer game Sylvia.
Speaker Change: Five.
Speaker Change: The questions that we want to ask.
Speaker Change: That I think will give us a lot of comfort.
Speaker Change: If.
Speaker Change: You get to an agreement with the FDA that our final submission.
Speaker Change: It's going to be accepted and is this more or less answering.
Speaker Change: Everything that they could think golf and so thats still on track as per said by.
Speaker Change: Yes, and yes.
Speaker Change: E.
Speaker Change: I don't know to address if you said it but you have received.
Speaker Change: So called Central IRB.
Speaker Change: Already that was approved in.
Speaker Change: And the good news is that our largest center is one of the centers that are using a central IRB. So what that means.
As soon as we have our documentation and our content angle Commendation ready, which we think is next week.
Speaker Change: Got the kits.
Speaker Change: Produce which might take another two weeks.
Speaker Change: That we can collect the first samples for the clinical trial.
Speaker Change: Got it. Thank you that's helpful. I appreciate it guys.
Speaker Change: Thanks, guys.
Amy: Thank you Amy.
Speaker Change: Thomas Martin.
Speaker Change: Yes.
Speaker Change: Hey, guys I appreciate you taking the questions.
Speaker Change: Josh just following on from the prior questions.
Mark Massaro: From the study is there anything else that you guys need to do from an FDA submission perspective to complete that.
Speaker Change: That document our filing.
Speaker Change: No. It's I mean, it's all about the data generation at this point there is a lot of work that we do in house. So theres a lot of the verification and validation work that is done at our lab in Nashville, Thats, a big lift there is the software development that you heard us talk about.
Speaker Change: All of that is kind of proceeding on pace, but the biggest piece is getting these these clinical samples collected and accrued and ready to run.
Speaker Change: Got it.
Speaker Change: Then of the two centers that you are hoping to have by year end.
Speaker Change: The three of the 10, you have already or in the U S would it be proportional when we get to the end of the year will have six of the <unk> in the U S are you trying to skew that more U S oriented ahead on launch I think we'll see it see more in the U S ahead of launch.
Speaker Change: Got it and then Andrew just a quick one for you with respect to sales and marketing spend.
Speaker Change: How are you thinking about ramping that ahead of launch is that more of a 2026 activity should we anticipate anything that towards the tail end of this year.
Speaker Change: There'll be some incremental spend tied to unlocking our U S sites.
Speaker Change: Which is already baked into the 6 million cash burn. So we've got some incremental <unk> 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 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 sale.
Speaker Change: Fourth.
Speaker Change: There's just a handful of me to 100 call points in the U S.
Speaker Change: Similarly in Europe and so.
Speaker Change: The sales team they are 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 to the <unk> site unlock will be able to divert some of those dollars over there.
Speaker Change: Awesome I appreciate it thank you.
Speaker Change: Thank you Thomas Mike Matt.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: So just a few on some of the transplant center B and the.
Speaker Change: The study so you have three U S centers right now using dropped a crap.
Speaker Change: Sure IQ.
Speaker Change: Are any of those that you can youre expecting three more in the study. So are the 30 for this study going to be different than that through you have right now.
Speaker Change: Yes, theres going to be a mix of incremental and some some that are current users, but it's going to be much more than three.
Speaker Change: And then for the new ones that come online that are going to be involved in the trial do you have any if any is there any how are incurred that he needs to get some experience with.
Speaker Change: Graph sure IQ before they move on to the actual trial.
Speaker Change: No. It's a good question I think it's.
Speaker Change: Fortunately, it's PCR so it's pretty easy for these guys to come up on the workflow.
Speaker Change: There'll be an instrument dropped there'll be about a week and a half of training and then they're they're ready to go.
Speaker Change: Okay, Alright, and then just the current mix of centers.
Speaker Change: Got six in Europe, and three in the U S. So I mean does that is that reflective at all of the relative kind of interest and demand I mean, I don't think they have they don't have to send out tests over there as I understand it right. So maybe there's more even more of an appetite obviously that there is an appetite here, but you can make.
Speaker Change: Got that.
Speaker Change: Yeah, no absolutely. So what happened is we did feel it 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 youre going to see a lot more pop up in the U S. Just by virtue of that.
Speaker Change: Okay got it thank you.
Speaker Change: Thank you, Mike and to have you on site.
Speaker Change: All right guys. Thank you for taking our questions maybe Josh can you remind us within the current standard of care. How many tests do you need to run to detect the transplant retraction in the first year of keeping your cost guidance and what it what does that look like beyond one year a follow up question.
Speaker Change: Will it be what is the compliance of grades for those tasks right now.
Speaker Change: Yes.
Speaker Change: We're not out commercializing a ton right now so most of my information here is going to be second hand, I mean, there are publications that recommend four or more tests in the first year.
Speaker Change: And then maybe quarterly to biannual the after that I would say in general the average is somewhere around two three to $2 five tests per patient under management.
Speaker Change: And that gives you kind of an average to think through as you're as you're looking at market sizes.
Speaker Change: And the New York Harbor acquire Hum Housebroken led to a patient on the grid.
Speaker Change: Costs.
Speaker Change: So it's single time point in our study.
Speaker Change: Got it.
Speaker Change: So for one of the benefit of your house, if you will be able to attack some of the subclinical infections. So if it goes off the tax rate.
Speaker Change: Let me actually two of the patients and doctors, what kind of treatment with various stock after that and in other words, what is the additional benefits to detect subclinical.
Speaker Change: Subclinical rejections.
Speaker Change: I'd like to hand, this one to Eke because you know he was a part of that groundbreaking research that came out last year.
Speaker Change: If you could talk just a little bit about why catching.
Speaker Change: Matters now, especially with your sort of the anti CD 30, eights that are coming out.
Speaker Change: Yes.
Speaker Change: Thank you for the question so.
Speaker Change: The cuatro last year that using our test in patients that are at high risk for antibody mediated rejection.
Speaker Change: Which are those patients with certain types of antibody kardono specific antibodies.
Speaker Change: And.
Speaker Change: It was also up to the same time that you could say it doesn't matter because there is no treatment.
Speaker Change: In parallel to that we were evaluating.
Speaker Change: New treatment that.
Speaker Change: Should really work very well.
Speaker Change: On MTV anything that is antibody related and so that is.
Speaker Change: A drive cord fed taught them up but just the CD 38 antibody.
Speaker Change: And.
Speaker Change: So shortly after you have shown that we can shorten the time to diagnose a b M. B could show that there is a very effective treatment for <unk>.
Speaker Change: <unk>, which actually really.
James: James the complete perspective.
Speaker Change: On <unk>.
Speaker Change: Testing for four <unk>.
Speaker Change: Because now we are able as soon as we can catch it to treat the patient.
Speaker Change: <unk> specialty chronic long lasting a b M.
Speaker Change: Major pause of graft loss.
Speaker Change: So it was always a very.
Speaker Change: Bad prognosis and when you have to tell a patient.
Speaker Change: Of antibody mediated rejection.
Speaker Change: Not going away and most probably you are going to lose your fuel.
Speaker Change: Graft over the next three or four years and that has completely changed.
Speaker Change: So and there are additional drugs upcoming that are targeted to.
Speaker Change: Antibody mediated rejection.
Speaker Change: Participating.
Speaker Change: In one phase II trial.
Speaker Change: As the measuring partner for them.
Speaker Change: Donor derived cell free DNA and we are also having.
Speaker Change:
Speaker Change: Investigator initiated study that is.
Speaker Change: Happening.
Speaker Change: In Germany, Austria and.
Speaker Change: Right.
Speaker Change: And speaking countries.
Speaker Change: That'd be a testing another CD 38 antibody, which is quite dark to warm up.
Speaker Change: The beauty of this drop is that is it.
Speaker Change: It's already approved in the U S.
Speaker Change: It's just not for us.
Speaker Change: Play BMI, but it's it's a drug that you can give us half a day bill.
Speaker Change: And I think the other positive.
Speaker Change: Event was that the FDA gave some thought about the breakthrough.
Speaker Change: Device approvals, so the west Norfolk, southern that can be used for APM.
Speaker Change: And what.
Speaker Change: What we showed in the studies is that it's really.
Speaker Change: Very beneficial if you awesome monitory.
Speaker Change: Why do you are giving this dropped no drug has no side effects and it's.
Speaker Change: Fear that you don't want to give a drug forever.
Speaker Change: So thats usually gave them for about half a year and then stop.
Speaker Change: And what we have seen already in the study that was published in nuclear genre is dead.
Speaker Change: At <unk>.
Speaker Change: Once the <unk>.
Speaker Change: Disease the ABM.
Speaker Change: Is going into a recurrence then donor derived cell free DNA.
Speaker Change: Is rising again.
Speaker Change: So.
Speaker Change: That's really a good tool that you can say okay at this point.
Speaker Change: <unk> was pretty much cured from this ABM.
Speaker Change: The next cycle of the drug so that's I think where it's going to go over the next year.
Speaker Change: And.
Speaker Change: Especially in this case I think dollar wise cell free DNA plays that really appeal to enroll for these patients.
Speaker Change: Yes.
Speaker Change: Yes, that's very helpful.
Speaker Change: Rebecca yes.
Rebecca: Yes, no. Thanks, and I think 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 those types of the claims expansion that we got last fall, where we've been looking at the de Novo DSA positive patients, where we basically got a screening claim there when you need to test those patients six times at the first sign up.
Rebecca: De Novo DSA. So we're we're excited I mean, we feel like the market is growing in general per testing. So the pie is getting bigger for everybody and I think that that feels really good.
Speaker Change: Really quickly I wanted to do a housekeeping before we do another round to see if anyone has any follow ups I just want to get on our wonderful ear with joining us and wanted to get your firm means into the the transcript. So we have mark massaro with BTG. Thank you for your question Nathan Kericho. It's Steven. Thank you for your question Thomas Flaten Lake Street. Thank you Mike.
Speaker Change: Mattson at Needham, Thank you and Jan <unk> Z at B Riley Securities. We appreciate you guys being here you wanted to get your firm names into the transcript.
Speaker Change: Alright, if there are no follow up questions.
Speaker Change: We will say, thank you and look forward to catching up with you guys on the follow ups.
Speaker Change: Thank you Phoenix quarter tier one.
Speaker Change: Yes.