Q3 2025 Insight Molecular Diagnostics Earnings Call

Eric It says we're still in practice session do you have to kick off the meeting okay. There we go.

Okay.

Hello, everyone and welcome everyone and thank you for joining us to discuss in fact, molecular diagnostics third quarter 'twenty twenty-five results.

Josh Riggs: As you probably recall, our PCR-based technology is already much simpler and faster than sequencing-based technology used by major centralized labs. With our one-step workflow, we have further increased these advantages. Just last month, we published a white paper that showed that our assay performance across multiple centers from Singapore to Switzerland had exceeded expectations. You can find this white paper on our website. This gives us high confidence that the assay will perform well in the very rigorous FDA process. Across the board, in the US and Europe, we are feeling pent-up demand for in-house testing. Because we are a kit-first company, we are seen as a partner in patient management, and institutions are eager to support our mission of broadening access. I should point out that just getting through the FDA is not enough to give us the market.

If you have not seen today's shareholder letter. Please visit insight molecular diagnostics Investor Relations page at investors Dodge I N D X I N C dot com.

Today's prepared remarks build upon the information already shared in this robust letter.

Joining us today, our insight molecular diagnostics, president and CEO, Josh Riggs, Chief Science Officer, AGGY shoots and CFO Andrea James We also have our analysts with us as panelists after our prepared remarks, our analysts may ask questions.

Before turning the call over to Josh ranks 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.

Josh Riggs: The expectation is that clinicians will want to familiarize themselves with GraftAssure and compare it to legacy technology before making a switch. This could look like head-to-head comparison or interacting through the registry program we recently announced. Case in point, earlier this year, we saw data come out of Heidelberg, a research transplant center in Germany, where they compared the performance of our test to another commercially available RUO assay that is on market in Europe. This data showed statistical equivalence on the relative measurement of dd-cfDNA between the two tests, which is great because the market today is largely dominated by the relative measurement method, showing that we get to the same answer with an easier-to-use technology, reduces the barriers to adoption.

These statements are made pursuant to and within the meaning of the safe Harbor provision of the private Securities Litigation Reform Act of 1995.

We encourage you to review the company's S E 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.

Please note that the forward looking statements made during today's call speak only to the date. They are made and insight molecular diagnostics undertakes no obligation to update them and with that I would like to now turn the call over to Josh Regs.

Thanks, Gabby and welcome everybody.

Josh Riggs: Recently, we've also seen preliminary results from a 100-plus patient study at a major center here in the US that is a direct head-to-head against a leading US centralized lab test. We and the researchers are very happy with those results. Showing that you can get equivalent to better results with on-site technology is critical to our success. There are more of these types of studies ongoing. We expect that data will start coming out in the new year that shows clearly that GraftAssure is reliable, and that it compares well to legacy technology. The feedback we get from transplant centers, primarily in the US, is that they are optimistic about being able to bring testing in-house, but fully expect that some level of head-to-head work will be needed to fully support conversion and internal adoption within their center. We welcome this activity.

You've had a chance to look at our shareholder letter, you'll see that our momentum is building.

I'd like to talk a little bit about how we got here before shifting to how we are positioning ourselves for success in 2026.

A couple of years ago, we set out to change how transplant patients are managed the idea was in as simple transplant centers should have the tools onsite to monitor their patients.

Speaker #2: All right, everyone, and welcome, everyone. And thank you for joining us to discuss insight molecular diagnostics, third quarter, 2025 results. If you have not seen today's shareholder letter, please visit insightmoleculardiagnostics.investorrelations page at investors.imdxinc.com.

Intuitively that makes a lot of sense.

Each year hundreds of thousands of tests and hundreds of millions in payments go out for post transplant monitoring as of today not one of those tests has performed at a transplant center and not one dollar of reimbursement of crews to be centers benefit.

In 2026 with the expected FDA authorization of grabbed assure dx.

Speaker #2: Today's prepared remarks build upon the information already shared in this robust letter. Joining us today are Insight Molecular Diagnostics President and CEO, Joshua Riggs; Chief Science Officer, Eki Schutz; and CFO, Andrea James.

This is going to change.

Last summer we started a pilot program that put a research version of the assay. The same design, we were taken to the FDA into the hands of researchers around the world.

Josh Riggs: The more data that gets out there showing positive comparison to cumbersome legacy providers, the faster we'll see broad adoption. Alongside the generation of head-to-head data, we announced the launch of a registry program. The goal of this program is to capture how the industry uses our alternative measurements of dd-cfDNA, namely absolute quantification, and our proprietary Combination Model Score algorithm, while they use our currently available relative measurement for patient management. The benefits of this approach in our registry are twofold. Firstly, it familiarizes clinicians with our report and test, probably making them more likely to use the technology once it's available in-house. Secondly, it generates real-world data on the utilization and performance of our alternative measures. Early data and publications suggest that these alternative methods may be superior ways of quantifying and analyzing dd-cfDNA data.

We wanted to do three things one get feedback on the workflow. So that we could get ideas on what needed to be improved to get technical data on the performance of the assay. So we could have a sense of how robust our design was in the field.

Speaker #2: We also have our analysts with us as panelists. After our prepared remarks, our analysts may ask questions. Before turning the call over to Joshua Riggs, I'd like to go over our safe harbor.

And three engage with clinicians researchers so we could get a look into what clinical demand might be for regulated product.

Speaker #2: 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.

Feedback from transplant centers labs helped us optimize our tests workflow from two steps down to one step.

That improves our turnaround time and ease of use which means faster results with less labor for our customers.

As you probably recall, our PCR based technology is already much simpler and faster and sequencing based technology used by the major centralized labs.

Speaker #2: We encourage you to review the company's SEC filings including the company's most recent form 10-K in subsequent forms 10-Q. Which identify risks and uncertainties that may cause future actual results or events to differ materially.

With our one step workflow we have further increased these advantages.

Just last month, we published a white paper that showed that our assay performance across multiple centers from Singapore to Switzerland. It exceeded expectations. You can find this white paper on our website, which gives us high confidence that the assay will perform well in the very rigorous FDA process.

Josh Riggs: If we are successful, we should see improved biopsy yield at transplant centers that are using the Combination Model Score because of its expected higher positive predictive value. When the CM Score data first came out at the World Transplant Congress this summer, we saw an immediate spike in interest from our clinical partners. We have been moving as quickly as possible to get the novel score into production. I expect that we will see the first reports going out with the new CM Score in the first half of 2026. Early access is likely to be limited to participants in the registry. Once the peer-reviewed publication is out, we will start to make it more broadly available and begin a conversation with MolDX on any potential positive billing impact. I'm amazed by the progress we made in such a short time.

Speaker #2: Please note that the forward-looking statements made during today's call speak only to the date they are made, and Insight Molecular Diagnostics undertakes no obligation to update them.

Speaker #2: And with that, I would like to now turn the call over to Joshua Riggs.

Across the board and in the U S and Europe, we are feeling pent up demand for in house testing.

Speaker #3: Thanks, Gabby. And welcome, everybody. If you've had a chance to look at our shareholder letter, you'll have seen that our momentum is building. I'd like to talk a little bit about how we got here before shifting to how we are positioning ourselves for success in 2026.

Because we are a kit first company, we are seen as a partner in patient management and institutions are eager to support our mission of broadening access.

I should point out that just getting through the FDA is not enough to give us the market the.

Speaker #3: A couple of years ago, we set out to change how transplant patients are managed. The idea was and is simple: transplant centers should have the tools on site to monitor their patients.

The expectation is the clinicians will want to familiarize themselves with graft assure and compare to legacy technology before making a switch this could look like head to head comparison or interacting through the registry program, We recently announced.

Speaker #3: Intuitively, that makes a lot of sense. Each year, hundreds of thousands of tests and hundreds of millions in payments go out for post-transplant monitoring.

Josh Riggs: That is attributable to our team of researchers and development scientists, clinicians, and centers around the world that have embraced our partner-first approach, and the strong support from Bio-Rad, who have been with us every step of the way in our planning engagement with the FDA. Now, after almost three years of absolutely grinding on product development with a modest staff, here we are in November 2025, very close to our planned FDA submission. While the shareholder letter details our recent accomplishments and our FDA submission timeline, I'd like to add some color on our clinical trial. You can really feel the energy at the sites right now. They're excited, they're engaged, and we love to partner with them. Tampa General was the first to bring in samples, and Vanderbilt and Cleveland Clinic were up and running shortly thereafter.

Case in point earlier this year, we saw data come out of Heidelberg, a research transplant center in Germany, where they compared the performance of our test to another commercially available are you owe assay that is on market in Europe.

Speaker #3: As of today, not one of those tests is performed at a transplant center and not one dollar of reimbursement accrues to these centers' benefit.

Speaker #3: In 2026, with the expected FDA authorization of graft-assured DX, this is going to change. Last summer, we started a pilot program that put a research version of the assay, the same design we were taking to the FDA, into the hands of researchers around the world.

This data showed statistical equivalents on the relative measurement of DDC F. DNA between the two test just grade because of the market today is largely dominated by the relative measurement method showing that we get to the same answer with an easier to use technology reduces the barriers to adoption.

Speaker #3: We wanted to do three things: one, get feedback on the workflow so that we could get ideas on what needed to be improved; two, get technical data on the performance of the assay so we could have a sense of how robust our design was in the field; and three, engage with clinician researchers so we could get a look into what clinical demand might be for a regulated product.

Recently, we've also seen preliminary results from a 100 plus patient study at a major center here in the U S that has a direct head to head against a leading U S. Centralized lab test and we and the researchers are very happy with those results.

Josh Riggs: These are leading transplant centers in the US, and they are genuinely committed to this effort, and that makes all the difference for us. Some of you may have recognized this sentiment in the comments from Dr. Anthony Langone of Vanderbilt University on our 15 August 2023 KOL call. He pointed out the issues with the current paradigm of send-out transplant monitoring, many of which can be resolved with in-house testing. Now, I'm going to take a few moments to talk about what's going on at the FDA. After our planned submission in December, we start the clock on their review process, which is listed as 150 days on their website. That being said, the FDA is not accepting new submissions while the government is shut down.

Speaker #3: Feedback from transplant centers' labs helped us optimize our test workflow from two steps down to one step. That improves our turnaround time and ease of use, which means faster results with less labor for our customers.

Knowing that you can get equivalent to better results with onsite technology is critical to our success.

There are more of these types of studies ongoing and we expect that data will start coming out in the new year that shows clearly the graft assures reliable and that it compares well to legacy technology.

Speaker #3: As you probably recall, our PCR-based technology is already much simpler and faster than the sequencing-based technology used by major centralized labs. With our one-step workflow, we have further increased these advantages.

Yes.

The feedback we get from transplant centers, primarily in the U S is that they are optimistic about being able to bring testing in house, but fully expect that some level of head to head work will be needed to fully support conversion and internal adoption within their center.

Speaker #3: Just last month, we published a white paper that showed that our assay performance across multiple centers, from Singapore to Switzerland, had exceeded expectations. You can find this white paper on our website.

Josh Riggs: We have been told that our FDA reviewer team is still working through the shutdown, which is good for clearing their docket and review backlog. At the same time, the FDA has paused answering questions from companies like ours that are preparing a new submission. It's common for companies like ours to ask the FDA questions on their preferences, and what they would like to see. We do have some outstanding questions that we asked in September, and since the government shut down on 1 October 2023, we have not received those answers. We are staying focused on what we can control, which is completing our clinical trial and being ready to submit to the FDA by the end of the year. I want to make clear that the government shutdown does not affect our ability to drive engagement with customers.

Speaker #3: This gives us high confidence that the assay will perform well in the very rigorous FDA process. Across the board, in the US and Europe, we are feeling pent-up demand for in-house testing.

We welcome this activity the more data that gets out there showing positive comparison to cumbersome legacy providers the faster, we'll see broad adoption.

Alongside the generation of head to head data, we announced the launch of our registry program. The goal of this program is to capture how the industry uses or alternative measurements of DDC F DNA, namely absolute quantification and our proprietary combination model score algorithm, while they use our currently available relative measurement for patient management.

Speaker #3: Because we are a kit-first company, we are seen as a partner in patient management and institutions are eager to support our mission of broadening access.

Speaker #3: I should point out that just getting through the FDA is not enough to give us the market. The expectation is that clinicians will want to familiarize themselves with graft-assured and compare to legacy technology before making a switch.

The benefits of this approach in our registry are twofold, firstly and familiarize us clinicians with our report in test, probably making them more likely to use the technology. Once it's available in house and secondly, it generates real world data on the utilization and performance of our alternative measures.

Speaker #3: This could look like head-to-head comparison, or interacting through the registry program we recently announced. Case in point, earlier this year, we saw data come out of Heidelberg.

Josh Riggs: We can process tests at our Nashville CLIA lab and pursue our registry study even while the government is closed. Looking forward to 2026, we expect to move forward with validation of both heart and lung assays in our lab. That work sets us up to submit for reimbursement for heart in 2026, and lung in 2027. The nice part is that for heart and lung, we can leverage all of the analytical work already done for kidney when we go to the FDA, which really streamlines the regulatory submission process. We are excited about HeartNext. You'll see a chart in our shareholder letter that showcases our assay versus legacy technology regarding the threshold for rejection detection in heart transplant patients. We are in the rare event detection business, and so lower on the bar chart is better.

Speaker #3: A research transplant center in Germany where they compared the performance of our test to another commercially available RUO assay that is on market in Europe.

Early data and publications suggest that these alternative methods may be superior ways of quantifying and analyzing D. C. F. DNA data. If we are successful we should see improved biopsy yielded transplant centers that are using the combination model score because of its expected higher positive predictive value.

Speaker #3: This data showed statistical equivalence on the relative measurement of DDCF DNA between the two tests. It's great because the market today is largely dominated by the relative measurement method.

When the C. M score data first came out at the World transplant Congress. This summer we saw an immediate spike in interest from our clinical partners. So we've been moving as quickly as possible to get the novel score into production.

Speaker #3: Showing that we get to the same answer with an easier-to-use technology reduces the barriers to adoption. Recently, we've also seen preliminary results from 100-plus patient study at a major center here in the US that is a direct head-to-head against a leading US centralized lab test.

I expect that we'll see the first reports going out with a new C. M score in first half of 2026 early access is likely to be limited to participants in the registry.

Speaker #3: And we and the researchers are very happy with those results. Showing that you can get equivalent to better results with on-site technology is critical to our success.

Once the peer reviewed publication is out we will start to make it more broadly.

Josh Riggs: Being able to quantify at low volumes matters when you need to establish a trend line prior to reaching the clinical threshold. We've also made real progress on our registry study, which we announced in September. The study design is complete, the protocol is written, and we already have 10 centers, including three of the top 10 programs in the country, lined up and working their way through legal. We expect that you'll see the registry study show up on clinicaltrials.gov early next year. As we approach FDA submission, we believe the excitement around our company is building. This excitement extends to other companies with whom our products and services are symbiotic. We continue to be thrilled with our relationship with Bio-Rad, which has been mutually supportive and productive.

Bailable and begin a conversation with multi eggs on any potential positive billing impact.

Speaker #3: There are more of these types of studies ongoing. We expect that data will start coming out in the new year that shows clearly that graft-assured is reliable and that it compares well to legacy technology.

I'm amazed by the progress we've made in such a short time.

That is attributable to our team of researchers and development scientists clinicians and centers around the world that have embraced our partner first approach and the strong support from bio Rad, who have been with US every step of the way in our planning engagement with the FDA.

Speaker #3: The feedback we get from transplant centers primarily in the US is that they are optimistic about being able to bring testing in-house but fully expect that some level of head-to-head work will be needed to fully support conversion and internal adoption within their center.

And now after almost three years of absolutely grinding on product development with a modest staff here. We are in November 'twenty twenty-five very close to our planned FDA submission.

While the shareholder letter details our recent accomplishments and our FDA submission timeline I'd like to add some color on our clinical trial.

Speaker #3: We welcome this activity. The more data that gets out there showing positive comparison to cumbersome legacy providers, the faster we'll see broad adoption. Alongside the generation of head-to-head data, we announced the launch of a registry program.

Josh Riggs: We continue to pursue strategic relationships that can support our increasing reach and need to scale as we go into 2026. We've been a development-only stage company for the past two to three years, and that period of time is coming to an end. Now we are focused on shifting into a commercial organization. We believe we are building a product that is going to be the de facto standard of care assay. We also have opportunities to grow the pie. There are developments changing the structure of the market itself. We see tailwinds when we look at the potential for reference lab adoption, anti-CD38 drug approval, and dd-cfDNA guideline adoption. We believe we are bringing to the market the most precise testing for transplant rejection, while broadening access to the test for patients.

You can really feel the energy at the sites right now they're excited they are engaged and we love to partner with them Tampa.

Tampa General was the first to bring in samples and Vanderbilt and Cleveland Clinic, we're up and running shortly thereafter. These are leading transplant centers in the U S and they are genuinely committed to this effort and that makes all the difference for us.

Speaker #3: The goal of this program is to capture how the industry uses our alternative measurements of DDCF DNA, namely absolute quantification and our proprietary combination model score algorithm.

Speaker #3: While they use our currently available relative measurement for patient management. The benefits of this approach in our registry are twofold. Firstly, it familiarizes clinicians with our report and test probably making them more likely to use the technology once it's available in-house.

Some of you may have recognized the sentiment and the comments from Doctor Anthony Leung gone a Vanderbilt University on our August 15th K O L call. He pointed out the issues with the current paradigm of send out transplant monitoring many of which can be resolved with in house testing.

Speaker #3: And secondly, it generates real-world data on the utilization and performance of our alternative measures. Early data and publications suggest that these alternative methods may be superior ways of quantifying and analyzing DDCF DNA data.

Now I'm going to take a few moments to talk about what's going on at the FDA.

After our planned submission in December we start the clock on their review process, which is listed as 150 days on their website.

Josh Riggs: The margins available to us in GraftAssure, along with a highly concentrated market, represent a rare opportunity to create an exceptionally profitable business line with operating margin that should be industry-leading. Now, let me turn it over to Andrea, and then we can take questions. Thank you, Josh. Hi, everyone. Thank you for joining us. I also just want to do a quick shout-out to Gabby Woody, who's emceeing this call and whose Zoom decided to malfunction right before we went live. Anyway, you've got our financial tables in the shareholder letter and in the 10Qs. I'm just going to touch upon the highlights. We finished the quarter with $20 million in cash and equivalents and no debt. Lab services revenue came in as expected, and you can model that sequentially flat in Q4.

That being said the FAA is not accepting new submissions while the government has shut down we have been told that our FDA reviewer team is still working through the shutdown, which is good for clearing their docket and review backlog.

Speaker #3: If we are successful, we should see improved biopsy yield at transplant centers that are using the combination model score because of its expected higher positive predictive value.

Speaker #3: When the CM-scored data first came out at the World Transplant Congress this summer, we saw an immediate spike in interest from our clinical partners.

At the same time, the FDA has paused answering questions from companies like ours that are preparing a new submission.

Speaker #3: So we've been moving as quickly as possible to get the novel score into production. I expect that we'll see the first reports going out with the new CM-score and first half of 2026.

It's comping, it's common for companies like ours to ask the FDA questions on their preferences and what they would like to see we do have some outstanding questions that we ask in September and since the government shutdown in October 1st we have not received those answers. We are staying focused on what we can control, which is completing our clinical trial and being ready to some.

Speaker #3: Early access is likely to be limited to participants in the registry. Once the peer-reviewed publication is out, we will start to make it more broadly available and begin a conversation with mold DX on any potential positive billing impact.

Josh Riggs: Last year, recall that we did perform some work late in Q4 that came in unexpectedly. We'd be thrilled to do that again if the work comes in. So far in the fourth quarter, we've billed for about $100,000 worth of these services. We kept our cash burn in Q3 below our stated goal of $6 million per quarter, and we expect that $6 million to tick up a bit in Q4 due to expenses associated with our FDA submission and clinical trial. This is the same as our prior communication, with one small change. The Q3 cash burn came in favorably because some expenses did shift into Q4 instead. You can see that we've invested incrementally in research and development over the course of this year as we prepared for FDA submission.

<unk> to the FDA by the end of the year.

I want to make clear that the government shutdown does not affect our ability to drive engagement with customers. We can process tests in our Nashville, CLIA lab and pursue our registry study even while the government is closed.

Speaker #3: I'm amazed by the progress we've made in such a short time. That is attributable to our team of researchers and development scientists, clinicians, and centers around the world that have embraced our partner-first approach and the strong support from Bio-Rad, who have been with us every step of the way in our planning engagement with the FDA.

Looking forward to 2020 six we expect to move forward with validation of both heart and lung assays in our lab that works at this up to submit for reimbursement for heart in 2026 and lung in 2027. The nice part is dead for heart and lung we can leverage all of the analytical work already done for kidney when we.

Speaker #3: And now, after almost three years of absolutely grinding on product development with a modest staff, here we are in November 2025, very close to our planned FDA submission.

Speaker #3: While the shareholder letter details our recent accomplishments in our FDA submission timeline, I'd like to add some color on our clinical trial. You can really feel the energy at the sites right now.

Go to the FDA, which really streamlines the regulatory submission process.

We're excited about heart next you'll see a chart in our shareholder letter that showcases our assay versus legacy technology regarding the threshold for rejection detection in heart transplant patients.

Josh Riggs: We were able to absorb these expenses while still maintaining our cash burn levels at $6 million a quarter. We achieved that by continuing to deliver gross profit by performing extra lab services work at our Nashville lab. We're really proud of that, actually. We expect to continue to cultivate activities like this and others that extend our cash runway. Also, it's worth noting that going into next year, we have the option to scale back select expenses as needed because much of the incremental 2025 research and development expenses are tied to consulting, software development, and laboratory supplies and materials associated with our FDA program. Okay, onto some quick housekeeping for our analysts. Historically, our company has presented its operating loss on both a GAAP and a non-GAAP basis.

Speaker #3: They're excited. They're engaged. And we love to partner with them. Tampa General was the first to bring in samples, and Vanderbilt and Cleveland Clinic were up and running shortly thereafter.

We are in the rare event detection business and so lower on the bar chart is better being able to quantify at low volumes matters. When you need to establish a trend line prior to reaching the clinical threshold.

Speaker #3: These are leading transplant centers in the US, and they are genuinely committed to this effort. And that makes all the difference for us. Some of you may have recognized this sentiment in the comments from Dr. Anthony Langone of Vanderbilt University on our August 15th KOL call.

We've also made real progress on our registry study, which we announced in September. The study design is complete the protocol as written and we already have 10 centers, including three of the top 10 programs in the country lined up and working their way through legal we expect that Youll see the registry study show up on clinical trials Dot Gov early next year.

Speaker #3: He pointed out the issues with the current paradigm of send-out transplant monitoring. Many of which can be resolved with in-house testing. Now, I'm going to take a few moments to talk about what's going on at the FDA.

Speaker #3: After our planned submission in December, we start the clock on their review process, which is listed as 150 days on their website. That being said, the FDA is not accepting new submissions while the government is shut down.

As we approach FDA submission, we believe the excitement around our company is building. This excitement extends to other companies with whom our products and services are symbiotic.

Josh Riggs: Starting next quarter, we will begin talking about adjusted EBITDA instead, which is essentially the same line item as non-GAAP operating loss, but it's just more intuitive phrasing for investors. We also intend to introduce non-GAAP net income and a corresponding non-GAAP EPS. The primary reason for this is we want to give you metrics that help you to track the underlying profitability of the business that we are building. To do this, it makes sense to back out certain non-cash items, such as the contingent consideration line that fluctuates from quarter to quarter. Contingent consideration, for those of you who are not familiar, relates to acquisition accounting. In our case, it's tied to certain earnout arrangements related to our prior acquisitions. Okay, I want to leave you with two ideas as I close.

Speaker #3: We have been told that our FDA reviewer team is still working through the shutdown, which is good for clearing their docket and review backlog.

We continue to be thrilled with our relationship with bio Rad, which has been mutually supportive and productive.

And we continue to pursue strategic relationships that can support our increasing reach and need to scale as we go into 2026.

Speaker #3: At the same time, the FDA has paused answering questions from companies like ours that are preparing a new submission. It's common for companies like ours to ask the FDA questions on their preferences and what they would like to see.

We've been a development only stage company for the past two to three years in that period of time is coming to an end now.

Speaker #3: We do have some outstanding questions that we ask in September. And since the government shut down on October 1st, we have not received those answers.

Now we are focused on shifting into a commercial organization. We believe we are building a product that is going to be the de facto standard of care assay.

We also have opportunities to grow the pie there are developments changing the structure of the market itself, we see tailwind when we look at the potential for reference lab adoption anti CD 38 drug approval and DDC F DNA guideline adoption.

Speaker #3: We are staying focused on what we can control, which is completing our clinical trial and being ready to submit to the FDA by the end of the year.

Josh Riggs: The first is I want to give you an easy way to think about our total addressable market, or TAM, and how it's growing. The second thing is I want to give you fly-on-the-wall visibility into our strategic planning meetings that we hosted all last week at our Nashville headquarters. On our TAM, I'm going to throw a bunch of numbers at you, but I think you can follow this. We publicly state that we have a greater than $1 billion TAM, and this is for kitted transplant testing. I want to walk you through some of the easy math on our assumptions and how to think about our growth relative to TAM expansion itself. We assume about 150,000 transplanted organs per year in our key markets. That's US, Europe, some of Asia, and Latin America.

Speaker #3: I want to make clear that the government shutdown does not affect our ability to drive engagement with customers. We can process tests at our Nashville CLIA lab and pursue our registry study even while the government is closed.

We believe we're bringing to the market. The most precise testing for transplant rejection, while broadening access to the tests for patients the margins available to us in graft assure along with a highly concentrated market represent a rare opportunity to create an exceptionally profitable business line with operating margin that should be industry leading.

Speaker #3: Looking forward to 2026, we expect to move forward with validation of both heart and lung assays in our lab. That work sets us up to submit for reimbursement for heart in 2026 and lung in 2027.

Speaker #3: The nice part is that for heart and lung, we can leverage all of the analytical work already done for kidney when we go to the FDA.

Now, let me turn it over to Andrea and then we can take questions.

Thank you guys hi, everyone. Thank you for joining us and I also just wanted a quick shout out to Gabby ready, whose and seamless calling his zoom decided to malfunction right before we went live.

Speaker #3: Which really streamlines the regulatory submission process. We are excited about heart next. You'll see a chart in our shareholder letter that showcases our assay versus legacy technology, regarding the threshold for rejection detection in heart transplant patients.

Josh Riggs: We talk about total patients under management being 10x the annual transplant volume, and that's based on estimated median graft survival rates. The total expected patients under management is simply 10x 150,000, or 1.5 million patients. Next, you take the 1.5 million patients under management, and you assume a number of tests per year per patient. You're going to see a lot of numbers out there floating around, but the most conservative is two per year per patient. This number factors in higher testing volumes in earlier years post-transplant and lower testing volumes in later years for an average of two. In fact, the MolDX draft LCD, which many of our analysts are very familiar with on kidney surveillance testing, is for four tests in the first year of a transplant and two tests per year thereafter.

So anyway, you've got our financial tables in the shareholder letter and in the 10-Q I'm just going to touch upon the highlights we finished the quarter with $20 million in cash and equivalents and no debt.

Speaker #3: We are in the rare event detection business. And so lower on the bar chart is better. Being able to quantify at low volumes matters.

Services revenue came in as expected and you can model that sequentially flat in Q4 last year recall that we did perform some work late in Q4 that came in unexpectedly and of course I'd be thrilled to do that again, if the work comes in so far in the fourth quarter, we've built for about a $100000 worth of these services.

Speaker #3: When you need to establish a trend line, prior to reaching the clinical threshold. We've also made real progress on our registry study, which we announced in September.

Speaker #3: The study design is complete. The protocol is written. And we already have 10 centers, including three of the top 10 programs in the country, lined up and working their way through legal.

We kept our cash burn in Q3 below our stated goal of $6 million per quarter, and we expect that 6 million to kick up a day in Q4 due to and expenses associated with our FDA submission in clinical trial. This is the same as our prior communication with one small teams. The Q3 cash burn came in favorably because some.

Speaker #3: We expect that you'll see the registry study show up on ClinicalTrials.gov early next year. As we approach FDA submission, we believe the excitement around our company is building.

Speaker #3: This excitement extends to other companies with whom our products and services are symbiotic. We continue to be thrilled with our relationship with Biorad, which has been mutually supportive and productive.

Josh Riggs: You can see that assuming two tests per year per patient under management is a conservative and reasonable number. If you take the 1.5 million patients under management and multiply it by two tests per year, you get 3 million testing opportunities per year. You multiply 3 million testing opportunities per year times our expected ASP on our kit, and you can easily get an expected TAM of over a billion dollars. That ASP is supported by the fact that our laboratory version of our kidney test is reimbursed by Medicare at $2,753 per result. We believe we can sell our kits to hospital customers for a significant fraction of the reimbursed value. You'll hear us talk about market expansion a lot, and it's usually focused on one of those key levers that I just described.

Expenses did shift into Q4 instead.

And you can see that we've invested incrementally in research and development over the course of this year as we prepared for FDA submission, we were able to absorb these expenses, while still maintaining our cash burn levels at $6 million a quarter and we achieved that by continuing to deliver gross profit by performing extra lab services work at our National Lab.

Speaker #3: And we continue to pursue strategic relationships that can support our increasing reach and need to scale as we go into 2026. We've been a development-only stage company for the past two to three years.

Speaker #3: And that period of time is coming to an end. Now, we are focused on shifting into a commercial organization. We believe we are building a product that is going to be the de facto standard of care assay.

We're really proud of that actually and we expect to continue to cultivate activities like this and others that extend our cash runway.

Speaker #3: We also have opportunities to grow the pie. There are developments changing the structure of the market itself. We see tailwinds when we look at the potential for reference lab adoption, anti-CD38 drug approval, and DDCFDNA guideline adoption.

Also it's worth noting that going into next year, we have the option to scale back select expenses as needed because much of the incremental 2025 research and development expenses are tied to consulting software development and laboratory supplies and materials associated with their FTA program.

Josh Riggs: For example, expanding into more solid organs helps us to grow into our state of TAM. Also, some organs, such as heart, require more than two tests per year. Investments in market access and geography should also help us expand into our state of TAM. There are some things that could grow the TAM itself, and this is what Josh was talking about when he talks about growing the pie. Remember the multiplier of two tests per year. When Josh mentions reference lab adoption, anti-CD38 drug approval, DDCFDNA guideline adoption, we're actually talking about developments that would help the industry to increase its testing volumes well beyond an average of two tests per year.

Speaker #3: We believe we are bringing to the market the most precise testing for transplant rejection while broadening access to the test for patients. The margins available to us in graft assure, along with a highly concentrated market, represent a rare opportunity to create an exceptionally profitable business line with operating margin that should be industry-leading.

Okay, and just some quick housekeeping for analysts historically, our company has presented its operating loss on both a GAAP and a non-GAAP basis, starting next quarter. We will begin talking about adjusted EBITA, instead, which is essentially the same line item in non-GAAP operating loss. They just more intuitive phrasing for investors.

Speaker #3: Now, let me turn it over to Andrea and then we can take questions.

We also intend to introduce non-GAAP net income and corresponding non-GAAP EPS. The primary reason for that is you want to give you metrics that help you to track the underlying profitability of the business that we are building to do this it makes sense to back out certain noncash items, such as the contingent consideration line that fluctuates from quarter to quarter.

Speaker #2: Thank you, Josh. Hi, everyone. Thank you for joining us. I also just want to do a quick shout-out to Gabby Woody, who is emceeing this call and who Zoom decided to malfunction right before we went live.

Josh Riggs: Also, any therapies that extend the lives of patients grow the patients under management because they're living longer, and therapies that require testing to manage dosage already grow the testing opportunities per year. Organ transplant itself, sorry, this is so macro, but I think it's important. Organ transplant itself is growing as a category. Remember that our kitted testing strategy sits within the macro truth about the strong benefits of organ transplants. For example, kidney transplants not only dramatically improve a patient's life, but also can represent a tremendous cost savings over dialysis. We believe we are so well situated with these tailwinds. That's just in transplant. We haven't talked about oncology today. Our long-term objective after we establish our GraftAssure franchise is to also unlock whole new testing markets in cancer, which of course grows our TAM substantially.

Speaker #2: So anyway, you've got our financial tables in the shareholder letter. And in the 10Qs, I'm just going to touch upon the highlights. We finished the quarter with $20 million in cash and equivalents and no debt.

Contingent consideration for those of you who are not familiar relates to acquisition accounting in our case, it's tied to certain earn out arrangements related to our prior acquisitions. Okay. I want to leave you with two ideas as they close.

Speaker #2: Lab services revenue came in as expected. And you can model that sequentially flat in Q4. Last year, recall that we did perform some work late in Q4 that came in unexpectedly.

The first is I want to give you an easy way to think about our total addressable market or Tam and how its growing and then the second thing is I want to give you a fly on the law of visibility into our strategic planning meetings that we hosted all last week at our National headquarters.

Speaker #2: And, of course, we’d be thrilled to do that again if the work comes in. So far in the fourth quarter, we’ve billed for about $100,000 worth of these services.

Speaker #2: We kept our cash burn in Q3 below our stated goal of $6 million per quarter. And we expect that $6 million to tick up a bit in Q4 due to expenses associated with our FDA submission and clinical trial.

Okay, So honor Tien.

And then just the religion number that you, but I think you can follow them. So we publicly state that we have a greater than a 1 billion dollar can and this is for kidney transplant testing and you want to walk you through some of the easy math on your assumptions and how to think about our growth relative to Tam expansion itself. Okay. So we assume about 130000 transplanted organs per.

Speaker #2: This is the same as our prior communication, with one small change. The Q3 cash burn came in favorably, because some expenses did shift into Q4 instead.

Josh Riggs: Another thought I want to leave you with, I can see you guys putting your hands up. I love it. Another thought I want to leave you with is we're shifting from a development stage company to an integrated commercial operation. This is obviously very exciting. Our strategic planning meetings last week were appropriately intense, and pinpoint-focused on driving engagement and utilization of our assay via our Nashville laboratory. This is something we can do now, even before we have achieved FDA marketing authorization for our test kits. We're also honing and streamlining our market access strategy in the US and EU, which we believe will set us up with some nice, natural growth over the coming years as we achieve expanded coverage.

Speaker #2: You can see that we've invested incrementally in research and development over the course of this year as we prepared for FDA submission. We were able to absorb these expenses while still maintaining our cash burn levels at $6 million per quarter.

A year in our key markets. That's U S. Europe, some of Asia and Latin America, then we talk about total patients under management being 10 times the annual transplant volume and that's based on estimated median graft survival rates.

Speaker #2: And we achieved that by continuing to deliver gross profit by performing extra lab services work at our Nashville lab. We're really proud of that, actually.

The total expected patients under management is simply 10 times 150000, or $1 5 million patients.

Speaker #2: And we expect to continue to cultivate activities like this and others. But extend our cash runway. Also, it's worth noting that going into next year, we have the option to scale back select expenses as needed, because much of the incremental 2025 research and development expenses are tied to consulting, software development, and laboratory supplies and materials, associated with our FDA program.

Next you take the one 5 million patients under management and you assume a number of tests per year per patient youre going to see a lot of numbers out there floating around but the most conservative is two per year per patient and this number of factors and higher testing volumes in earlier years post transplant and lower testing volumes.

Josh Riggs: I believe that if an investor or an analyst could have been a fly on the wall during these meetings, you would have seen that we are a company that is playing and preparing to win. We want to enable our customers, which are the transplant centers themselves, to participate in the testing value chain, and we want to drive better, more localized, accessible patient care. This does not mean that we intend to lose our hard-earned cost discipline. If you look at the market capture activities that we seek to invest in, we see customer acquisition costs that are quite favorable relative to these customers' expected long-term value. This is particularly owing to the fact that we are targeting a highly concentrated market, with only about 100 transplant centers doing most transplants in the US, for example.

Speaker #2: OK, onto some quick housekeeping for our analysts. Historically, our company has presented its operating loss on both a gap and a non-gap basis. Starting next quarter, we will begin talking about adjusted EBITDA instead, which is essentially the same line item as non-gap operating loss, but it's just more intuitive phrasing for investors.

In later years for an average of killed in fact, the mold ex draft LCD with many of her answer very familiar with on kidney surveillance testing is for forecast in the first year of a transplant in two tests per year. Thereafter. So you can see that assuming two tests per year per patient under management as a conservative and reasonable number if you take the $1 5 million patients under man.

Speaker #2: We also intend to introduce non-GAAP net income and a corresponding non-GAAP EPS. The primary reason for this is that we want to give you metrics that help you to track the underlying profitability of the business that we are building.

Isn't it and multiply it by two tests per year, you got 3 million testing opportunities per year, you multiply 3 million testing opportunities per year times, our expected ASP on our kit and you can easily get unexpected tam of over $1 billion.

Speaker #2: To do this, it makes sense to back out certain non-cash items, such as the contingent consideration line that fluctuates from quarter to quarter. Contingent consideration, for those of you who are not familiar, relates to acquisition accounting.

Josh Riggs: It is also owing to the fact that the life sciences industry, and particularly kitted diagnostic tests, usually enjoy a nice degree of customer stickiness that we believe should help us to retain our customers for many years. Okay, now we can take questions. Just IT housekeeping, Eric, if you could please bring everybody up into gallery view. We also have Gabby back on screen. Yay. Go ahead. Wonderful, Gabby appears to be frozen. I will just start. Marc Massaro, you popped up on my screen first. Marc Massaro at BTIG, go ahead. We'll take your question. Hey, thanks, Andrea. Yeah, congrats on the progress. I wanted to start with maybe a macro question just about the LCD that we're waiting for with Palmetto GBA. I think if I heard you correctly, you're talking about the 422 kidney protocol.

ASP is supported by the fact that our laboratory version of our kidney test is reimbursed by Medicare at $2753 per result, and we believe we can sell our kits to hospital customer experienced significant fraction of the reimbursed value.

Speaker #2: And in our case, it's tied to certain earnout arrangements related to our prior acquisitions. OK, I want to leave you with two ideas as I close.

Speaker #2: The first is I want to give you an easy way to think about our total addressable market, or TM. And how it's growing. And then the second thing is I want to give you fly on the wall visibility into our strategic planning meetings that we hosted all last week at our Nashville headquarters.

So you'll hear us talk about market expansion, a lot and it's usually focus on one of those key levers that I. Just described so for example, expanding into more solid Oregon's helps us to grow into our state of Tim also some oregon's such as heart require more than two tests per year investments in market access and geography should also help us expand into a state of 10, but then there.

Speaker #2: OK, so on our TM, I'm going to throw a bunch of numbers at you. But I think you can follow this. So we publicly state that we have a greater than a $1 billion TM.

Some things that could grow the Tam itself and this is what Josh was talking about when he talks about growing the plot Pi. So remember the multiplier to test per year, when Josh men sit mentioned reference lab adoption anti CD 38 drug approval DTC Athene, a guideline adoption, we're actually talking about developments that would help the industry to increase its testing volumes well.

Speaker #2: And this is for kitted transplant testing. And I want to walk you through some of the easy math on our assumptions and how to think about our growth relative to TM expansion itself.

Speaker #2: OK, so we assume about 150,000 transplanted organs per year in our key markets. That's US, Europe, some of Asia, and Latin America. Then we talk about total patients under management being 10 times the annual transplant volume.

I'll be on an average of two tests per year also any therapy that extend the lives of patients.

Josh Riggs: Is it safe to say that even if the interval is finalized as is, you expect to have that billion-dollar opportunity in front of you? Maybe, Josh, if I could just get your latest temperature on how you think the final LCD might come in, do you see there's any opportunity for improvement from the interval? Also, do you think there's a possibility that the limits could potentially be removed? Oh, man, some great questions there, Marc. I think I'll start by saying I think we're hopeful, along with the rest of the industry, that the brakes get taken off here. It feels unnatural to limit access to a technology that a clinician feels they need to manage their patient. I think we heard some of that commentary from Dr. Langone when he was speaking in the KOL call. We're behind him 100%.

The patients under management, because they are living longer and therapies that require testing to manage dosage already grow their testing opportunities per year.

Speaker #2: And that's based on estimated median graft survival rates. So the total expected patients under management is simply 10 times 150,000 or 1.5 million patients.

And then Oregon transplant itself as there is no macro but I think it's important organ transplant itself is growing as as a category. So remember that our kid assessing strategy sits within the macro truth about the strong benefits of Oregon transplants. For example, kidney transplants not only dramatically improve a patient's life, but also can represent a tremendous clos.

Speaker #2: Next, you take the 1.5 million patients under management. And you assume a number of tests per year per patient. You're going to see a lot of numbers out there floating around.

Speaker #2: But the most conservative estimate is two per year per patient. This number factors in higher testing volumes in the earlier years post-transplant and lower testing volumes in the later years, averaging two.

Savings over dialysis until we believe we are so well situated with these tailings.

And that's just in transplant, we haven't talked about oncology today, our long term objective. After we establish our graph to show our franchise is to also unlock whole new testing markets in cancer, which of course grows our Tam substantially.

Speaker #2: In fact, the MOLDEX draft LCD, which many of our analysts are very familiar with on kidney surveillance testing, is for four tests in the first year of a transplant and two tests per year thereafter.

Speaker #2: So you can see that assuming two tests per year per patient under management is a conservative and reasonable number. If you take the 1.5 million patients under management and multiply it by two tests per year, you get 3 million testing opportunities per year.

Another thought I wanted to leave you I can see you guys, putting your hand up I love. It another thought I want to leave you with is we're shifting from a development stage company to an integrated commercial operation. This is obviously very exciting our strategic planning meetings last week were appropriately intense and pinpoint focus on driving engagement and utilization of our assay via our National Laboratory.

Josh Riggs: He expects that if he had this technology in-house, he'd be doing four tests a year. Right now, he wouldn't get paid for that under the current draft of the LCD, which is unfortunate. I think we'll support him in that process as far as negotiating with MolDX on expanding. We haven't heard anything around how that conversation is going, so I don't have any special knowledge there. We agree with the industry that this needs to be a clinical decision. Okay. I don't think you mentioned this, but certainly the Increasing Organ Transplant Access model, or IOTA. I wanted to just maybe pick your brain on that. To what extent do you think that could be helpful to utilization of transplant testing? I'm just curious if you have any thoughts on that as a potential driver.

Speaker #2: You multiply 3 million testing opportunities per year times our expected ASP on our kit, and you can easily get an expected TM of over $1 billion.

This is something we can do now even before we have achieved FDA marketing authorization for our test kits. We're also honing in streamlining our market access strategy in the U S and EU, which we believe will set us up with some nice natural growth over the coming years as we achieve expanded coverage.

Speaker #2: That ASP is supported by the fact that our laboratory version of our kidney test is reimbursed by Medicare at $2,753 per result. And we believe we can sell our kits to hospital customers for a significant fraction of the reimbursed value.

Speaker #2: So you'll hear us talk about market expansion a lot. And it's usually focused on one of those key levers that I just described. So for example, expanding into more solid organs helps us to grow into our stated TM.

I believe that if an investor or an analyst could have been a fly on the wall. During these meetings you would have seen that we are a company that is playing in preparing to win we want to enable our customers, which are the transplant centers themselves to participate in the testing value chain, and we want to drive better and more localized accessible patient care.

Speaker #2: Also, some organs, such as heart, require more than two tests per year. Investments in market access and geography should also help us expand into our stated TM.

Speaker #2: But then there are some things that could grow the TM itself. And this is what Josh was talking about when he talks about growing the plot pie.

But this doesn't mean that we intend to lose our hard earned cost discipline. If you look at the market capture activities that we seek to investing we see customer acquisition costs that are quite favorable relative to these customers expected long term value. This is particularly owing to the fact that we are targeting a highly concentrated market with only about.

Speaker #2: So remember the multiplier two tests per year. When Josh mentions reference lab adoption, anti-CD38 drug approval, DDC FDNA guideline adoption, we're actually talking about developments that would help the industry to increase its testing volumes well beyond an average of two tests per year.

Josh Riggs: It's another great reason why you don't take the clinical decision out of the hand of clinicians, right, as you're changing how transplant centers are being incentivized to use more at-risk organs and then tell them, well, they can't monitor them on the scale and schedule that they need, feels counterintuitive to me. We have seen some positive feedback, some negative feedback on the program itself. In general, I think it drives demand for testing. I think it's natural as you use more at-risk organs that you're going to want to follow those patients more closely. You should expect to see higher rates of AMR in that population. You need to know if you can bring in these next-generation drugs like the Felsartamab or Daratumumab. We're optimistic that it increases demand for technology and more kidneys going into patients. Okay.

100 transplant centers doing most transplants in the U S. For example is also owing to the fact that the life sciences industry, and particularly Kid of diagnostic tests, usually enjoy a nice degree of customer stickiness that we believe should help us to retain our customers for many years.

Speaker #2: Also, any therapies that extend the lives of patients grow the patients under management, because they’re living longer. And therapies that require testing to manage dosage already grow the testing opportunities per year.

Speaker #2: OK, and then organ transplant itself is already so macro. But I think it's important. Organ transplant itself is growing as a category. So remember that our kitted testing strategy sits within the macro truth about the strong benefits of organ transplants.

Okay now we can take questions and just a housekeeping Eric if you could please bring everybody up into gallery P. M.

And we also have gabby back on screen Yay.

Speaker #2: For example, kidney transplants not only dramatically improve a patient's life, but also can represent a tremendous cost savings over dialysis. And so we believe we are well situated with these tailwinds.

It's.

Go ahead.

Yeah.

And wonderful Gabby appears to be frozen so I will just start.

Speaker #2: And that's just in transplant. We haven't talked about oncology today. Our long-term objective, after we establish our graft-assure franchise, is to also unlock whole new testing markets in cancer, which of course grows our TM substantially.

Mark Massaro, you popped up on my screen first Mark Massaro of BTG go ahead, we'll take your question.

Thanks Andrea.

So yeah congrats on the progress.

I wanted to start with maybe a macro question.

Josh Riggs: I'll just ask one more if I can and then leave some FDA questions for others. I wanted to ask about GraftAssure Core LDT. Recognizing you've got the lab up and running in Nashville, maybe just walk me through how you're thinking about that as a potential source of upside. Obviously, I think that could be potentially a source of, if you will, cash preservation. Can you just give me a sense for what the strategy is on the LDT? Thank you. It's very closely tied to the registry for us. I mean, when we looked at the market initially, I think one of the big reasons we went kit is that we didn't feel like we could compete, at least initially, toe-to-toe with the big guys that are out there.

Speaker #2: Another thought I want to leave you with, I can see you guys putting your hands up. I love it. Another thought I want to leave you with is we're shifting from a development stage company to an integrated commercial operation.

Just about the LCD that we're waiting for with Palmetto GBA.

I think if I heard you correctly.

Speaker #2: This is obviously very exciting. Our strategic planning meetings last week were appropriately intense and pinpoint-focused on driving engagement and utilization of our assay via our Nashville laboratory.

Youre talking about the four Q2 kidney protocol.

Is it safe to say that.

Even if the integral is finalized as is you expect to have that billion dollar opportunity in front of you and then maybe Josh if I could just get like your latest temperature on how you think the final LCD might come in.

Speaker #2: This is something we can do now, even before we have achieved FDA marketing authorization for our test kits. We're also honing and streamlining our market access strategy in the US and EU, which we believe will set us up with some nice natural growth over the coming years as we achieve expanded coverage.

Do you see there is any.

Opportunity for improvement from the interval and also do you think theres a possibility that the the limits.

Speaker #2: I believe that if an investor or an analyst could have been a fly on the wall during these meetings, you would have seen that we are a company that is playing and preparing to win.

<unk> could potentially be removed.

Oh man some great questions there Mark I think.

Speaker #2: We want to enable our customers, which are the transplant centers themselves, to participate in the testing value chain. And we want to drive better and more localized accessible patient care.

All surfacing you I think were.

Josh Riggs: When the opportunity to do the registry came up, it seemed like a natural fit for us and a reason to kind of spool up sort of our capabilities with the CLIA lab. We think the process is going to be, call it somewhere between four and six months with each site as we kind of negotiate through the various contracts. I think we've engaged with about 10 right now. That puts us kind of end of Q1, middle of Q2 before we start to see patients coming in off of that registry. The expectation is that we'll be able to bill for the relative measurement of dd-cfDNA, which is what our current claim is with MolDX, while we capture the information around those other measures that we have. I'd say in general, I mean, this has been very normal for the industry.

We're hopeful along with the rest of the industry the brakes get taken off here.

Speaker #2: But this doesn't mean that we intend to lose our hard-earned cost discipline. If you look at the market capture activities that we seek to invest in, we see customer acquisition costs that are quite favorable relative to these customers' expected long-term value.

Feels unnatural to limit access to a technology that a clinician feels they need to manage their patients.

I think we heard some of that commentary from Dr. Langdon when he was speaking in the Q1 call.

Speaker #2: This is particularly owing to the fact that we are targeting a highly concentrated market, with only about 100 transplant centers doing most transplants in the U.S., for example.

We're behind him 100% <unk>.

He expects.

That if he had this technology in house that you'd be doing four tests a year and so.

Speaker #2: It is also owing to the fact that the life sciences industry, and particularly kitted diagnostic tests, usually enjoy a nice degree of customer stickiness that we believe should help us to retain our customers for many years.

You're right now he wouldn't get paid for that under the current draft of the OCD wishes.

Unfortunate noise, Inc.

We will support him in that process as far as negotiating with <unk>.

Speaker #2: OK, now we can take questions and just IT housekeeping Eric if you could please bring everybody up into gallery view. And we also have Gabby back on screen.

Dx on expanding.

We haven't heard anything around how that conversation is going so I don't have any <unk>.

Josh Riggs: I think we've seen very successful registries out there for our competitors. I think we're kind of following in that vein, although with a slightly different clinical question that we're asking. Yes, it should improve the revenue profile for next year, but we're not predicting that that starts in a meaningful way in Q1 or Q2. That's kind of like just when it starts to pick up. Andrea, anything that you would add to that? I know you've been a little bit closer to the numbers on that than I have. No, I love it. The only thing I would add is you might be wondering, well, what changed? Why are we doing this? It really is we press released that late-breaking data at the World Transplant Congress. We do have the opportunity to look to see if there is extra clinical utility in our assay.

Special knowledge there but.

We agree with the industry this needs to be a clinical decision.

Okay and then.

I don't think you mentioned this but certainly the increasing organ transplant access model or iota.

Mark Massaro, you popped up on my screen first Mark Massaro of BTG go ahead, we'll take your question.

Wanted to just maybe pick your brain on that.

You know to what extent do you think that could be helpful to utilization of.

Thanks Andrea.

Congrats on the progress.

Of transplant.

Testing and I am just curious if you have any thoughts on that as a potential driver.

I wanted to start with maybe a macro question.

About the LCD that we're waiting for with Palmetto GBA.

It's another great reason why you don't take the clinical clinical decision out of the hands of clinicians right as you're changing how transplant centers are being incentivized to use more at risk organs, and then tell them well they can't monitor them on the scale and schedule that they need as fuels counterintuitive to me.

I think if I heard you correctly.

Youre talking about the <unk> kidney protocol.

Is it safe to say that.

Josh Riggs: That's really what changed and what's driving the strategy. We've had new data come out in our favor. Got it. Thanks, guys. I'll hop back in the queue. Thanks, Marc. I'll just keep calling on people. Harrison Parsons at Stephens. Please go ahead. Hey, yeah, this is Harrison on formation. Thanks for taking the questions this afternoon. As institutions validate GraftAssure DX head-to-head against current readout assays, what conversion curve are you expecting over the next 12 to 18 months post-clearance? What are the gating factors to go from early adopter physicians to center-wide adoption? Yeah, I'd say Andrea put out a curve in our shareholder letter back in, I think, August of last year, so coming out of Q2 of last year, which gives at least a look at it. I think what we're trying to do is influence that curve right now.

Even if the interval is finalized as as you expect to have that $1 billion opportunity in front of you and then maybe Josh if I could just get like your latest temperature on how you think the final LCD might come in.

We have seen.

Some positive feedback some negative feedback on the program itself, but in general I think it drives demand for testing and I think it said, it's natural as you use more at risk organs that youre going to want to follow those patients more closely you should expect to see higher rates of <unk> in that population.

Do you see there is any.

Opportunity for improvement from the interval and also do you think there is a possibility that the the limits.

<unk> could potentially be removed.

And so then you need to know if you can even bring in these next generation drugs like the film's artem Aberdare tumor map so.

Oh man some great questions there Mark I think.

I'll start by saying I think we're we're hopeful along with the rest of the industry the brakes get taken off here.

We're we're optimistic that it increases demand for technology and no more work kidneys going into patients.

It feels unnatural to limit access to a technology that a clinician feels they need to manage their patients.

Okay.

And I'll just ask one more if I can and then.

I think we heard some of that commentary from Dr. <unk>. When he was speaking in the Q1 call.

Leave some FDA questions for others, but but I wanted to ask about graft assure core L. D T.

We're behind him 100% he.

Recognizing you've got the lab up and running in Nashville.

He expects.

That if he had this technology in house that you'd be doing four test of the year and so.

Maybe just walk me through how youre thinking about that as a potential source of upside.

Josh Riggs: I think when we get a little bit more confidence in how clinicians are feeling about the technology and what kind of engagement we're getting, I think we'll update that curve. Right now, that should be considered our best thinking. We can share that with you afterwards if you don't have access to it. I think in general, the market's going to be very much show me, which is they've been very comfortable using technology that has helped them manage their patients for five, six, seven years now. I think they're going to want to see that they're getting similar to better results before they jump. I think once there's enough data out there, there's kind of a saturation point where the question comes off of the table.

Right now he wouldn't get paid for that under the current draft of the LCD, which is.

Obviously, I think that could be potentially.

Unfortunate Inc.

A source of.

We will support him in that process as far as negotiating with <unk>.

If you will cash preservation. So can you just give me a sense for what the strategy is on the LPT.

<unk> on expanding.

We haven't heard anything around how that conversation is going so I don't have any.

Thank you and it's very closely tied to the registry for us I mean, we've.

Special knowledge there but.

When we looked at the market initially I think one of the Big reasons. We went kit is that we didn't feel like we can compete.

We agree with the industry this needs to be a clinical decision.

Okay and then.

At least initially toe to toe with with the big guys that are out there.

I don't think you mentioned this but certainly the increasing organ transplant access model or iota.

When the opportunity to do the registry came up it seems like a natural fit for us and a reason to kind of spool up.

Wanted to just maybe pick your brain on that.

Josh Riggs: Certainly in the early days, it's incumbent upon us to help generate that data and get it out there for the industry. Yeah. Harrison, if you look in the shareholder letter, we actually put a launch framework graphic where we talk about driving engagement and utilization with potential future customers. We can't start talking about GraftAssure DX as a kitted test until we have FDA marketing authorization. There's a wall there, and you can't. We can start to drive utilization of our Nashville lab, start talking about our registry setting. When we talk about influencing the slope of that curve, these are activities that we can do now, today, and we are doing them actively today. Got it. Yeah, I think that all makes sense.

Sort of our capabilities with the CLIA lab.

To what extent do you think that could be helpful to utilization.

And we think the process is going to be call. It somewhere between four and six months with each site as we kind of negotiate through the various contracts and we I think we are engaged with about 10 right now.

A transplant.

Testing.

Just curious if you have any thoughts on that as a potential driver.

It's another great reason why you don't take the clinical clinical decision out of the hands of clinicians right as you're changing how transplant centers are being incentivized to use more at risk organs, and then tell them well they can't monitor them on the scale and schedule that they need as fuels counterintuitive to me.

That puts us kind of end of Q1 middle of Q2 before we start to see patients coming in off of that registry.

The expectation is that we'll be able to bill.

For the relative measurement of DTC at DNA, which is what are our current claim is with multi X. While we capture the information around those other measures that we have.

We have seen.

Some positive feedback some negative feedback on the program itself, but in general I think it drives demand for testing.

I'd say in general I mean, this has been very normal for the industry. I think are we've seen very successful registries out therefore for our competitors I think where we're kind of following in that vein, although with a slightly different.

Josh Riggs: I guess next, you previously highlighted the favorable PPV data and how this could be a differentiator for your kitted product. Could you share any broader feedback you've received from clinicians on this point? Yeah, I think I'm happy to. Ecky, if you have any comments, I think you've been out there on the front end with some of our research partners. I'd love to hear how you think about it. I'd say it's broadly been very positive. I think there is a general sense that we are applying biopsy too frequently and that a higher positive predictive value perhaps is better suited to the screening application that the world is looking at right now. Let me hand it over to Dr. Schütz, who's been out there.

It's natural as you use more at risk organs that youre going to want to follow those patients more closely you should expect to see higher rates of <unk> in that population.

Current clinical question that we're asking so yes. It will it should improve the revenue profile for next year, but we're not predicting that that starts in a meaningful way in Q1 or Q2 that was kind of like just when it starts to pick up.

And so then you need to know if you can bring in these next generation drugs like the <unk>.

<unk> so.

We're optimistic that it increases demand for technology and kidney.

Andrew anything that you would add to that I know you've been a little bit closer to the numbers on that and I have.

Kidney is going into patients.

Okay.

And I'll just ask one more if I can and then Lee.

No I love it the only thing you would add is you might be wondering Luke let changed why are we doing this and it really is we press released that late breaking data at World transplant Congress.

Some FDA questions for others, but but I wanted to ask about graph to show our core LDC.

Recognizing you've got the lab up and running in Nashville.

We do have the opportunity to look to see if there is extra clinical utility in our assay and so that's really what changed and what's driving the strategy. It's we've had new data come out in her fever.

Maybe just walk me through how youre thinking about that as a potential source of upside.

Josh Riggs: He's obviously the one that created the score and been working with our research partners on it and sort of why they're looking at it and what they're looking for. Thank you, John. Yeah, Harrison, I think what the entire field in transplant was always missing is a way of using cfDNA as a rule-in test as well. Right now, it's a rule-out testing, which also gets to the fact that if cfDNA is normal, you might forfeit a biopsy. If it's not, then you do a biopsy. Under those where you are doing a biopsy, way more than 50% are not turning out to have a rejection. That's actually the, I would say, conundrum clinicians are in.

Obviously, I think that could be potentially.

Got it thanks, guys I'll hop back in the queue.

A source of.

If you will cash preservation. So can you just give me a sense for what the strategy is on the LPT.

Thanks Mark.

I'll I'll, just keep calling on people and Harrison Parsons at Stevens. Please go ahead.

Thank you and it's very closely tied to the registry for us I mean, we've.

Hi, Yes. This is Harrison all information thanks for taking my questions. This afternoon.

When we looked at the market initially I think one of the Big reasons. We went kit is that we didn't feel like we can compete.

So as institutions validate grafts assured Dx head to head against current.

At least initially toe to toe with with the big guys that are out there.

Readout assays, what conversion curve are you expecting over the next 12 to 18 months post clearance and what are the gating factors to go from early adopter physicians to center wide adoption.

When the opportunity to do the registry came up it seems like a natural fit for us and a reason to kind of spool up.

Sort of our capabilities with the CLIA lab.

And we think the process is going to be call. It somewhere between four and six months with each site as we kind of negotiate through.

Yes, I'd say of entry to put out a curve in our shareholder letter back in I think August of last year, So coming out of Q2 of last year, which gives at least to look at it what we're trying to do is influence that curve right now.

Josh Riggs: What we are able to provide is a way of testing that if you see, okay, this patient doesn't look normal, which means I would not forgo a biopsy, then your chance of having really a rejection is way over 50%. It is actually really good for the patient. You are not biopsying patients when you only have a 30% chance that the patient has even had something. That is clearly something that clinicians understand. They don't want to do a biopsy if it's not really necessary. We have only had really a lot of positive feedback.

Various contracts and we I think we are engaged with about 10 right now.

That puts us kind of end of Q1 middle of Q2 before we start to see patients coming in off of that registry.

I hate when we're when we get a little bit more confidence in how clinicians are our feeling about the technology and what kind of engagement. We're getting I think we'll update that curve, but right now that that should be considered our best thinking and then we can share that with you. Afterwards, if you don't have.

The expectation is that we'll be able to bill.

For the relative measurement of DTC at DNA, which is what are our current claim is with <unk>, while we capture the information around those other measures that we have.

Access to it.

But I think in general it's the markets can be very much xiaomi.

I'd say in general I mean.

This has been very normal for the industry I think we've.

You know, which as you know they've been very comfortable using technology that is help them manage their patients for 567 years now and I think they're going to want to see that theyre getting similar to better results before they jump.

We've seen very successful registries out therefore for our competitors I think we're kind of following in that vein, although with.

Slightly different clinical questions that we're asking so yes it should.

I think once there's enough data out there there's kind of a saturation point, where the question comes off of the table, but you know certainly in the early days, it's incumbent upon us to help generate that data and get it out there for the industry.

Prove the revenue profile for next year, but we're not predicting that that starts in a meaningful way in Q1 or Q2 that was kind of like just when it starts to pick up.

Josh Riggs: It's really up to people are saying, oh, that's a change in paradigm for cfDNA. Yeah, that's why we put it in the center of our registries, and okay, let's convince the field that this is really a huge step forward for your clinical interpretation of cfDNA. I think it's going to more or less get into a world of its own. Once we can show that, there's going to be a lot of clinical debates around, are you using—do you want to use a test that really has no positive predictive value, or do you want to use a test where you can also make the positive decision for a biopsy with way better chance of doing it in the right situation? Great, thank you, Ecky. I just had one more last question, and then I'll let others go.

Andrew anything that you would add to that I know <unk> been a little bit closer to the numbers on that than I have.

Yeah, and Harrison if you look in the shareholder letter, we actually put a launch framework graphic where we talk about driving engagement and utilization with a potential future customers. We can start talking about graft assured he acts as a kitted test until we have FDA marketing authorization. So theres a wall there and you can but we can start to drive utilization of our national labs are talking about our industry.

No I love it the only thing you would add is you might be wondering what changed why are we doing this and it really is we press released that late breaking data at World transplant Congress.

We do have the opportunity to look to see if there is extra clinical utility in our assay and so that's really what changed and what's driving the strategy, we've had new data come out and her fever.

And so when we talk about influencing the slope of that curve. These are activities that we can do now today and we are doing them actively today.

Got it thanks, guys I'll hop back in the queue.

Yes.

Thanks Mark.

Got it yeah, I think that all makes sense.

I'll, just keep calling on people.

And then I guess next so you've previously highlighted the favorable PPV data and how this could be a differentiator for you.

Harrison Parsons at Stevens. Please go ahead.

Hi, Yes. This is Harrison all for medicine, thanks for taking the questions. This afternoon.

Kitted product could you share any broader feedback you've received from clinicians on this point.

So as institutions validate grafts assured Dx head to head against current.

Yeah, I think I'm happy to and actually if you have any comments I think you've been out there on the front end with some of our our research partners I'd Love to hear how you think about it.

Readout assays, what conversion curve are you expecting over the next 12 to 18 months post clearance and what are the gating factors to go from early adopter physicians to center wide adoption.

But I'd say, it's probably been very positive I think.

There is a general sense that we are applying biopsy to frequently and that a higher positive predictive value perhaps is better.

Josh Riggs: I guess, at this point, after the government shutdown, is mid-2026 still the right timeline to think about potential regulatory approval and commercial launch? Has that timeline been pushed out at all, if any? Thanks. It's tough. Government ever opens again. Yeah, I think we're hopeful that the government gets funded and stays funded. Obviously, the current conversation that's going on in Washington only funds the government through January. I can't predict what happens if the government shuts back down. I can't predict what's going to happen to our reviewers. I would say it helps that these reviewers are funded by industry, by and large, through MDUFA. I can't guess. I mean, I assume as long as everything's normal and we get through the FDA fine, then yes, we're still on pace. Outside of that, there's things that we don't control.

Yes, I would say of entry to put out a curve.

In our shareholder letter back in I think August of last year, So coming out of Q2 of last year, which gives at least to look at it.

Suited to the screening application that the world is looking at right now.

What we're trying to do is influence that curve right now.

But let me hand, it over to Dr. <unk>, who has been out there.

When we're when we get a little bit more confidence in how clinicians are feeling about the technology and what kind of engagement. We're getting I think we'll update that curve, but right now that should be.

Obviously, the one that created the score and been working with our research partners on it and sort of why there why theyre looking at and what they're looking for.

Thank you dropped.

Considered our best thinking and then we can share that with you afterwards, if you don't have.

The head was in I think more towards the entire field and trends men will always missing is is a way of using cell free DNA as a rule in test as well right now.

Access to it.

But I think in general.

The market is going to be very much xiaomi.

Which is they have been very comfortable using technology that is help them manage their patients for 567 years now.

Rollout testing salvage which also.

Yeah.

And I think theyre going to want to see that theyre getting similar to better results before they jump.

Gets to the fact that if every DNA as normal.

I think once there is enough data out there there's kind of a saturation point, where the question comes off of the table.

<unk> forfeit a biopsy, but it's not the new blue biopsy.

But under those.

Where you are doing a biopsy.

Certainly in the early days it is incumbent upon us to help generate that data and get it out there for the industry.

We're more than 50% download clothing, all travel rejection, so and that's actually.

Josh Riggs: If I could just add, Harrison, I think the takeaway is that we are still preparing for a mid-2026 launch, and we're not changing anything. There are things that we can do regardless of the government shutdown, which is focus on the engagement and utilization of our assay, which we are very much going to focus on. We can drive revenue out of our Nashville lab. We don't need the government to be open to do those things. The other thing—we pointed this out in the shareholder letter—we got word that our reviewer was working. That's nice to hear that they were working, even though they were not accepting new submissions. We're just focused on that.

Yeah, and Harrison if you look in the shareholder letter, we actually put a launch framework graphic where we talk about driving engagement and utilization with a potential future customers. We can start talking about <unk> Dx as a kitted test until we have FDA marketing authorization. So there is a wall there and you can't but we can start to drive the utilization of our National Labs are talking about a registry study in <unk>.

I would say conundrum clinicians are in.

And what we are.

Able to provide.

As a way of testing that if youll see okay. This patient doesn't look normal.

Which means I would not forgo a biopsy then your chance of.

When we talk about influencing the slope of that curve. These are activities that we can do now today and we are doing them actively today.

Having really a rejection is.

Way over 50%.

So it's actually really good for the patients. So you want your node biopsies in patients when you only have a 30%.

Josh Riggs: The final thing I would say is when we've talked about the FDA review timeline, we did bake in some time for them to ask questions and for them to respond. The FDA would say that the review timeline is actually shorter than the number of months we gave you because we did bake in a bit of cushion for them to ask questions. They stop the clock, we respond, and we're still planning on the same thing we've been planning on all along. Of course, we have as much insight as you do into what's going to happen with the government. Great, thank you. Of course. Thanks, Harrison. Okay, Mike Matson, I'm going to take your question. Thank you for coming on video. Oh, at Needham. No problem. Thanks.

Got it yeah, I think that all makes sense.

And then I guess next so you.

You've previously highlighted the favorable PPV data.

Transalta the paces even had something.

And that is clearly something that technicians understand.

This could be a differentiator for you.

Kitted product could you share any broader feedback you've received firm.

They don't want to do a biopsy, if it's not really necessary.

Clinicians on this point.

And we.

Yes, I think I am happy to and actually if you have any comments I think you've been out there on the front end with some of our research partners I'd Love to hear how you think about it.

We have.

Only had really a lot of positive feedback, it's really up to people I'm, saying all of that to change in paradigm for cell free DNA.

But I'd say, it's probably been very positive I think.

And so yes, that's why why we put it in the center of our register isn't Okay. That's.

There is a general sense that we are applying biopsy to frequently and that a higher positive predictive value.

Convince the field that this is a relief.

Josh Riggs: Just in terms of the trial, it sounds like it's still on track for the end of the year. I was wondering, can you give us any sort of metrics around enrollment or samples that have been collected to date? Yeah, I would say, gosh, I guess everybody would say that sample enrollment is going slower than they would like. We are enrolling samples. I think we can't actually update our clinical trials listing right now because the government has shut down. I think we actually have five sites that are actively enrolling patients at this point. I think we're medium to high confidence that we're going to have all of the samples that we need to complete the submission by year-end. Okay.

Perhaps is better.

Suited to the screening application that the world is looking at right now.

Huge step forward for your clinical interpretation of cell free DNA.

But let me hand, it over to Dr. <unk>, who has been out there.

And.

I think it's going to.

Obviously, the one that created the score had been working with.

More or less gets.

Our research partners on it and sort of why there why theyre looking at it and what they are looking for.

And tool.

A word of as its own once we can show that.

Thank you Jonathan.

That's going to be a lot of clinical.

I think the.

The entire field and trend spend will always missing.

Debates around are you using do you want to use a test that really has no positive predictive value.

It's a way of using cell free DNA.

Test as well right now.

Or do you want to use a test where you can also make the positive decision for a biopsy was way better trends.

Yes.

Rollout testing so it's also.

Get through the fact that if every.

Of doing it in the right situation.

Josh Riggs: You mentioned that in terms of once the test is commercialized, the centers and the doctors are likely to try to do head-to-head testing or maybe potentially use the registry. Can you maybe just explain—I guess I'm a little confused in terms of how the registry would help them figure out. I understand head-to-head, you run both tests and kind of compare them. The registry, how does that kind of serve that same purpose, I guess? Oh, it's a wonderful question. I think it's really on the engagement and utilization front. It's an opportunity for a clinician who's never used our technology before to have our report in their hands, see how it comes out, see the data, and then use it in their patient and see how it performs in kind of a real-world setting.

DNA is normal if you will.

<unk> forfeit the biopsy, but it's not the new biopsy.

Okay great.

Okay.

But under those.

And then.

Youre doing a biopsy.

I just had one more last question and then I'll, let others go.

More than 50% that clothing, all drive a rejection.

I guess so at this point after the government shutdown is mid 2026 cylinder that timeline to think about potential regulatory approval and commercial lot shirt.

Actually.

I would say conundrum clinicians are in.

And.

Yes.

Has that timeline been pushed out.

Okay.

Able to provide.

At all if any.

As a way of testing that is you'll see okay. This patient doesn't look normal.

Thanks.

You know, it's it's tough government NGO opens again.

I would not forgo a biopsy then your chance of <unk>.

I think we're hopeful that the government gets funded and in stays funded obviously the current.

Having really a rejection.

Conversations going on in Washington, only funds the government through January I can't predict.

Way over 50%.

So it's actually really good for the patients. So you wont youre node biopsies in patients the venue only have a 30%.

What happens if the government shuts back down I can't predict what's going to happen to us.

Josh Riggs: That's that familiarization piece that we're trying to get to. Also, show them the new ways of measuring donor-derived cell-free DNA to engage that kind of intellectual curiosity that they have around it. That, I think, is not head-to-head. That's more getting in their head, if you will, and getting them comfortable using our technology. All right. In terms of if the doctors or the centers are doing head-to-head testing, how would that work from a reimbursement standpoint? I imagine they can't bill for both. Would you be sort of helping them out with that? I mean, I don't even know if you're allowed to do that, but giving them a price break or free test or something like that. Yeah. It's a great question.

Sandals at the paces even had something.

Two our reviewers I would say you know it helps the these reviewers are funded by industry by enlarge here through <unk> through <unk>.

And that is clearly something that clinicians understand.

They don't want to do a biopsy, if it's not really necessary.

But I can't I can guess I mean, I assume as long as everything is normal.

And.

We have.

And and we get through the FDA. Five then yes, we're we're still on pace.

Only had really a lot of positive feedback, it's really up to people on saying all of that.

But I'll tell you.

And paradigm for cell free DNA.

But we don't control and if I can just add Harrison I think the takeaway is that we are still preparing for a mid 26 launch and we're going we're not changing anything and there's things that we can do regardless of the government shutdown, which is focus on engagement and utilization of our assay, which we are very much going to focus on we can drive revenue out of our National lab, we don't need the government to be open to it.

And so yes, that's why.

We put it in the center of our registry is an okay. That's.

I'm convinced.

The field this is real.

<unk>.

You would step forward for York physically interpretation of cell free DNA.

Josh Riggs: We've done this before in some of our oncology assays in what we call a clinical evaluation program. It's a specific program where we sign an agreement with them for a certain quantity of samples. I think the number is 20 samples, where they send 20 out to our competitors, they send 20 to us. We don't bill for those samples. We just generate a report because under CMS rules, only one center is allowed to bill per patient. We basically just eat the cost on that to generate the data for them. Okay, got it. Finally, just stepping back, the mid-2026 launch, what do you think are the biggest risks to that timing? Is it mainly the FDA, as you mentioned, in terms of them back and forth there, kind of stopping the clock?

Do those things and then the other thing and we pointed this out in the shareholder letter that we got word that our reviewer was working.

And.

I think it's going to.

More or less get.

Yeah, that's nice to hear that they were working even though they were not accepting new submission. So we're just focused on that and the final thing I would say is when we've talked about the FDA review timeline.

And tool.

A word of his own once we can show that.

That's going to be a lot of.

Clinical.

Debates around are you using.

We did bake in some time from them to ask questions and for them to respond. So the FDA would say that the review timeline is actually shorter than that the number of months we gave you.

You want to do the test that really has no positive predictive value.

Or do you want to use a test failure.

Because we are baking, we did bake in a bit of cushion for them to ask questions. They stopped the clock, we respond and so we're still planning on the same thing we've been planning on all along.

We'll make the positive decision for a biopsy was way better trends.

Of doing it in the right situation.

But of course, we have as much insight as you do into what's going to happen with the government.

Okay great.

Great.

And then.

I just had one more last question and then I'll, let others.

Great. Thank you.

Alright, thanks, guys.

Okay, Mike Mattson and I take your question. Thank you for coming on video.

I guess at this point after the government shutdown is mid 2026 cylinder right timeline to think about potential regulatory approval and commercial launch or.

Josh Riggs: Is there something else you would point to, I guess? Yeah, I guess there's always unknown unknowns. We feel like we've checked a lot of boxes, kind of your retiring risk over the past two and a half years. Obviously, the government being in flux right now is a big one for us that can immediately impact the timeline. Outside of that, I think that's probably the biggest risk. I don't know, Andrea, if you've got some—I know we get this question a lot, and I think you generally have better answers because I'm so optimistic on all of this stuff. It's hard for me to say where it's all going to blow up. Andrea is much more level-headed than I am. Go ahead, Ecky. Yeah. I think, Mike, we are pretty confident with production and everything.

I'd made up there and a problem. Thanks, So just in terms of the trial.

Sounds like it's still on track for the end of the year, but I was wondering can you give us any sort of metrics around enrollment and are samples have been collected to date.

Has that timeline been pushed out.

At all if any.

Thanks.

Yeah.

It's tough government opens again.

Yes, I would say the.

Yes, I think we're hopeful that the government gets funded and stays funded obviously the current.

Gosh, I guess, everybody would say that sample enrollment is going slower than they would like.

Conversation, that's going on in Washington, only funds the government through January I can't predict.

But we are we are enrolling samples there are I think we can.

Can't actually update our clinical trials Gov listing right now because the government has shut down but I think we actually have five sites that are actively enrolling patients at this point and so I think were you.

What happens if.

The government shuts back down I can't predict what's going to happen too.

Two our reviewers I would say it helps that these reviewers are funded by industry by and large through <unk>.

Your medium to high confidence that we're going to have all of the samples that we need to complete the submission by year end.

Josh Riggs: I think we don't have really a big risk in-house. We are right now producing our third lot for the FDA trial, and it's working out pretty well. Just looked at the results today. I would really think our biggest risk is the FDA. If they drag it out, then there's not much we can do about it. My philosophy or strategy right now is that whatever we can think of that the FDA might ask us, we shall be prepared to have the answer already before they ask, which means it's not really stopping the clock. They're always, if they're sending out a question, they stop the clock until they have the answer. My wish is that when they send us a question in the morning, the answer goes out in the afternoon. That's more or less what I'm trying to do. Yeah. Okay.

But I can't I can't guess.

Okay and then.

I've mentioned that in terms of what the test is commercialized.

I assume as long as everything is normal.

And and we get through the FDA. Five then yes, we're we're still on pace.

Centers of the doctors are likely to try to.

Do head to head testing or maybe.

But I will say that there is.

We don't control and if I can just add Harrison I think the takeaway is that we are still preparing for a mid 26 launch and we're going we're not changing anything and there's things that we can do regardless of the government shutdown, which is focused on engagement and utilization of our assay, which we are very much going to focus on we can drive revenue out of our National lab, we don't need the government to be open to.

And to use the registry. So can you maybe just explain I guess I'm a little confused in terms of how the the register and help them figure out and I understand you want both had some kind of comparator, but the registry how does that happen.

Serve ethane purpose I guess.

It's a wonderful question and I think it's really on the engagement in utilization front and.

Do those things and then the other thing we pointed this out in the shareholder letter that we got word that our reviewer was working.

And so it's an opportunity for a clinician who's never used our technology before to have our report in their hands, you'll see how it comes out. So you can see the data and then use it in their patient and see how it performs as kind of a real world setting and so that's that familiarization piece.

That's nice to hear that they were working even though they were not accepting new submission. So we're just focused on that and the final thing I would say is when we've talked about the FDA review timeline, we did bake in some time from them to ask questions and for them to respond. So the FDA would say that the review timeline is actually shorter than that the number of months we gave.

That we're trying to get to also show them the new ways of measuring donor derived cell free DNA, so to engage that kind of intellectual curiosity and that they have around it. So that I think is that's not head to head that's more getting in their head if you will.

<unk>.

Because we are baking, we did bake in a bit of cushion for them to ask questions. They stopped the clock, we respond and so we're still planning on the same thing we've been planning all along.

Josh Riggs: That makes sense. Kind of like prepping for an earnings call, and you want to try to predict what the analysts are going to ask you guys, right? All right. Thank you. I love that. Mike, the other thing is we've communicated with you guys. We had all those pre-submission meetings with the FDA. That's great because the team has been getting feedback from the FDA, so it's not like the first time the FDA sees our submission, they're like, What is this? There have been meetings. Yeah. Okay. All right. Thank you. Thomas Flaten at Lake Street. Hey, guys. Thanks for taking the question. Not to get too granular, Josh, but there's 51 days or so until the end of the year and a bunch of holidays.

And you are getting them comfortable using our technology.

But of course, we have as much insight as you do into what's going to happen with the government.

And then in terms of if the doctors or the centers are doing head to head testing how would that work from a reimbursement standpoint, I imagine they can bill or both and then.

Great. Thank you.

Alright, thanks, guys.

Okay, Mike Mattson and I'll take your question. Thank you for coming on video.

These sort of helping them all of that I mean, I don't know if that.

Yes, Sir.

Thanks.

So just in terms of the trial it sounds like it's still on track for the end of the year, but I was wondering can you give us any sort of metrics around enrollment in our sample that's been collected to date.

You're allowed to do that by giving them a price break our protest or something like that.

Yeah, No. It's a great question and we've done this before in some of our oncology assays and what we call as a clinical evaluation program and so that's a specific program.

Yes, I would say.

Gosh, I guess, everybody would say that sample enrollment is going slower than they would like.

We are.

Signing an agreement with them for a certain quantity of samples and so I think the number's 20 samples where they send 20 out to our competitors. They say 20 to US we don't bill for those samples we just generate a report because under CMS rules only one center has allowed to bill per patient and so we are basically just eat.

Josh Riggs: With 5 of 10 sites recruiting, are the others going to meaningfully contribute to the number of samples? How many days do you guys need to take that data, analyze it, compile it, and get it into a format that is acceptable to FDA and squeeze it into an application, then send it off? Can you just walk us through? I know we're getting way in the weeds here, but. Sure. Sure. Sure. Yeah. I'll take the first half of the question, and I'll hand the second half to Dr. Schütz, who's a lot more closer to it than I am. I'd say there are sites that won't contribute to the first phase of the submission. We are looking at this in two waves with the FDA. The first is to get basically just over the bar, which is that 85% negative predictive value.

But we are we are enrolling samples there are I think we can.

Can't actually update our clinical trials Gov listing right now because the government has shut down but I think we actually have five sites that are actively enrolling patients at this point and so I think were you.

Medium to high confidence that we're going to have all of the samples that we need to complete the submission by year end.

The cost on that to generate the data for them. Okay got it and then finally just stepping back you know the mid 26 launch what do you think are the biggest risks to that timing is it mainly to FDA as he mentioned in terms of them back and forth. There has stopped the clock or.

Okay and then.

You mentioned that in terms of what the test is commercialized.

Centers of the doctors are likely to try to.

Head testing or maybe.

You should use the registry. So can you maybe just explain I guess im a little confused in terms of how the register and help them figure out.

Is there something else, you're pointing to I guess.

Yes, I guess theres always unknown unknowns.

Kind of a comparator, but the registry how does that helpful.

Josh Riggs: There's the combo score, which is kind of the second wave of this. That's where the other side's coming on. We're going to continue to enroll past the new year. Andrea talked about this in the shareholder letter. I think we have a few more points to prove with this study that will create kind of follow-on submissions. Ecky, maybe you kind of talk us through. I know there's a lot of focus on the number of events as much as the number of samples that are going into the study. Yeah. Thomas, if we are recruiting as we think we are, we know from each and every one of our sites how many biopsies they are doing per month. From there, we can more or less calculate, are we on track? We are on track.

We feel like we've checked a lot of box is kind of you're retiring risk over the past two and a half years.

Surpassing purpose I guess.

It's a wonderful question and I think it's really on the engagement in utilization front.

Obviously, the government being in flux right now is a big one for us that can immediately impact the timeline.

And so it's an opportunity for a clinician who's never used our technology before to have our report in their hands Youll see how it comes out and see the data and then use it in their patient and see how it performs as kind of a real world setting and so thats that familiarization piece.

Outside of that I think.

I mean, that's probably the biggest risk kind of Andrea if you've got some I know we get this question a lot and I think you generally have better answers because I'm. So optimistic on all of this stuff. It's hard for me to say, where it's all going to blow up but it's much more level.

That we're trying to get to also show them the new ways of measuring donor derived cell free DNA, so to engage that kind of intellectual curiosity that they have around it. So that I think is that's not head to head thats more getting in their head if you will.

Good I E.

I think Mike we are pretty confident this production and everything so I think we don't have really a big risk in house.

We are now producing our third not for the FDA.

And you are getting them comfortable using our technology.

Josh Riggs: We are right now full steam writing the submission already. We are not waiting until we have this data. This clinical data are, believe it or not, the smallest part of the entire submission. It's, if you wish, a very simple evaluation. What is the sensitivity? What is the specificity? I can do the calculations in an hour. What we are doing, we are really preparing the entire submission right now. At the very last day, if you wish, we just plug in these two numbers from our clinical study and push the submit button. Yeah. Got it. Super. Yeah. All right. Yeah. Okay. Super helpful. Andrea, I know you said your expenses were ticking up a little bit because of the study, FDA expenses, etc. How should we think about the first half of next year?

Ah trial.

And then in terms of if the doctors or the centers are doing head to head testing how would that work from a reimbursement standpoint, I imagine they can bill for both and then.

And it's working.

Pretty well booked at the results today.

So.

I would really think our biggest risk is to the FDA.

<unk>.

These start helping them out with that.

Drag it out than then there's not much we can do about it.

Sure Bob to do that but giving them a price break or three tests or something like that.

My.

If you'll also fee or strategy right now is.

Yeah, No. It's a great question and we've done this before in some of our oncology assays and what we call as a clinical evaluation program and so it's a specific program.

That whatever we can think of that the FDA might.

Asked us we shall be prefab prepared to hit the answer already before the hospital.

We signed an agreement with them for a certain quantity of samples and it's I think the number's 20 samples where they send 20 out to our competitors. They say 20 to US we don't bill for those samples. We just generated report because under CMS rules only one center has allowed to bill per patient and so.

Which means it's not really stopping the clock there always is theyre, sending all the question they stop the clock.

Until they have the answer in my.

My.

Yeah.

Which is that that when they send US one question in the morning. The answer goes out in the afternoon, so that that's more or less what I'm truck yes.

We are basically just to keep the cost on that to generate the data for them. Okay got it and then finally just stepping back the mid 26 launch what do you think are the biggest risks to that timing is it mainly to FDA as you've mentioned in terms of them back and forth. There has stopped the clock.

Yes, Okay that makes the cut kind of like prepping for an earnings call and you want to try to predict what the analysts are going to ask you guys.

Josh Riggs: I know we haven't gotten there yet, but do you expect the cash burn to moderate a little bit, or do you expect it to go up as you prepare for launch? That's a great question. Right now, I would say we're preparing to keep it flat. If we were to go faster and we want to go faster for some reason, we would communicate that to you. I would keep your expenses flat for now. I would say flat to—I mean, I think they're going to go up a little bit. We are looking at areas where we could invest to go faster. We scrutinize every dollar, and we haven't greenlit anything yet. I think we'll come back at you in March, and we'll update you on how we think 2026 is going to look. Got it. Appreciate it, guys. Thank you. Thank you.

Alright, thank you.

I love that and Mike. The other thing is we have communicated with you guys. We had all this pre submission meetings with the FDA. So that's great because the team has been getting feedback from the FDA and so it's not like the first time the FDA either submission there like what is this there have been meetings.

Or is there something else you're pointing to I guess.

Yes, I guess theres always unknown unknowns.

We feel like we've checked a lot of box is kind of you're retiring risk over the past two five years.

Alright, thank you.

Tommy Thomas Flaten at Lake Street.

Obviously, the government being in flux right now is a big one for us that can immediately impact the timeline.

Hey, guys. Thanks for taking the question not to get too granular, Josh, but so theres 51 days or so until the end of the year and a bunch of holidays.

Outside of that I think.

And with five of 10 sites recruiting.

I mean, that's probably the biggest risk kind of entry if <unk> got some I know we get this question a lot and I think you generally have better answers because I'm. So optimistic on all of this stuff. It's hard for me to say, where it's all going to blow up as much of our level.

The other is going to meaningfully contribute to the number of samples and then how many days do you guys need to take that data analyze a compile it and get it into a format that is.

Josh Riggs: Thank you, Thomas. All right. Any other questions? All right. Well, guys, thank you so much for making time for us today. It was fun to get to share sort of the results of all the hard work that the team has put in. I think we're encouraged, we're excited. We've been waiting to celebrate submission for about two and a half years, and it feels like we're finally about to give birth. We're excited and looking forward to sharing this positive news when it happens. Thank you, everybody, and we'll talk soon. Thank you all.

Acceptable to FDA and squeeze it into an application and then send it off can you just walk us through I know, we're getting way in the weeds here, but sure sure sure.

Good.

I think Mike we are pretty confident with production and everything so I think we don't have really a big risk in house.

I'll take the first half of the question and then I'll hand, the second half to Doctor shoots who's a lot more closer to it than that.

We are now producing our not for the FDA.

And I am.

I'd say there are sites that won't contribute to the first phase of the of the submission.

Trial.

And it's working.

Yeah, we are looking at this in two waves with the FDA. So the first is to get basically just over the bar, which is about 85% negative predictive value.

Pretty well booked at the results today.

So.

I would really think our biggest risk is to the FDA.

<unk>.

Drag it out and then there is not much we can do about it.

And then there's the combo score, which is kind of a second wave of this and that's where you know the other sites coming on we're going to continue to enroll past the new year Andrew talks about this in the shareholder letter I think we have a few more points to prove.

Mike.

We'll also fee or strategy right now is.

That whatever we can think of that the FDA might.

Hum.

Asked us.

With with this study that will create kind of like follow on submissions.

That'd be prefab prepared to hit the answer already before the hospital.

Maybe you kind of talk us through I know Theres a lot of focus on the number of events is as much as the number of samples that are going into the study.

Which means it's not really stopping the clock there always is.

We're sending out a question they stop the clock.

Until they have the answer in my.

So Thomas we are recruiting is the thing we obviously know from each and every of our.

Bye.

Yeah.

This is Ben.

Sandoz.

Our sites, how many biopsies that are doing per months and from there he became more or less calculate.

In the morning, the answer goes out in the afternoon.

That's what I'm trying to do.

Okay that makes sense.

You're on track we are on track.

Alright, prepping for the call and want to try to predict what the analysts are going to ask you guys.

And B.

B B.

We are right now full steam writing the submission already.

Alright, thank you.

I love that and Mike. The other thing is we've communicated with you guys. We had all those pre submission meetings with the FDA. So that's great because the team has been getting feedback from the FDA and so it's not like the first time the FDA sees our submission there like one is that there have been meetings okay.

So we are not waiting until we get these data. This this clinical data are believe it or not the smallest part.

Off the entire submission.

If you wish a very simple.

Alright, thank you.

Evaluation of what is the sensitivity was the specificity.

Tommy Thomas Flaten Lake Street.

And I can do the calculations in an hour. So what we are doing there.

Hey, guys. Thanks for taking the question not to get too granular, Josh, but so there's 51 days or so until the end of the year and a bunch of holidays and with five of 10 sites recruiting.

It really preparing the entire.

The submission right now and at the very last day, if you wish we just product.

There is going to meaningfully contribute to the number of samples and then how many days do you guys need to take that data analyze the compile it get it into a format that is.

These two numbers from alone are critical.

The study and and push the submit button.

So got it.

Acceptable to FDA and squeeze it into an application and then send it off can you just walk us through I know, we're getting way in the weeds here, but sure sure sure I'll.

Alright.

Okay Super helpful. Andrea I know you said you were expenses are ticking up a little bit because of the study and FDA expenses et cetera, how should we think about the first half of next year I know, we haven't gotten there yet, but do you expect the cash burn to moderate a little bit or do you expect it to go up as you prepare for launch.

I'll take the first half of the question and then I'll hand, the second half to Dr shoots who has a lot more closer to it than that.

And then I am.

I'd say there are sites that won't contribute to the first phase of the of the submission.

It's a great question.

We are looking at this in two waves with the FDA. So the first is to get basically just over the bar, which is that 85% negative predictive value.

Right now I would say, we're preparing to keep it flat. If we were to go faster and we want to go faster for some reason we would communicate that to you.

I would keep your expenses flat for now and I would say.

And then there is the combo score, which is kind of a second wave of this and Thats, where the other sites coming on we're going to continue to enroll past the new year Andrew talks about this in the shareholder letter I think we have a few more points to prove.

Flattish.

I think theyre going to grow up go up a little bit.

We are looking at areas, where we could invest to go faster we scrutinize every dollar and so we havent greenlight anything yet.

But I think we'll we'll come back at you in March and we will update you on how we think 2026 is going to work.

With with this study that will create kind of like follow on submissions.

<unk>, maybe you kind of talk us through I know Theres a lot of focus on the number of events is as much as the number of samples that are going into the study.

Got it I appreciate it guys. Thank you.

Thank you.

Guilt on us.

All right any other questions.

Yes, so Thomas.

Recruiting is.

We think we obviously know from each and every of our.

Alright, guys. Thank you so much for making time for us today.

Sites, how many biopsies doing per month and from there we can.

It is fun to get to share.

Sort of the results of all the hard work that the team has put in.

More or less calculate.

You're on track we are on track.

I think we're.

We're encouraged we're excited.

And.

The.

We've been we've been waiting two to celebrate submission for about two and a half years and.

We are right now fluid steam writing the submission already.

Yeah.

So we are not waiting around to be at these data.

It feels like we're finally about to give birth, so where we're excited and looking forward to sharing this.

Clinical data with EBIT or not the smallest part.

Positive news when it happens so thank.

Of the entire submission.

If you wish.

Thank you everybody and.

Simple.

We will talk soon.

Evaluation of what is the sensitivity specificity.

Thank God.

And I can do the calculations in an hour so what we're doing there.

Really preparing we have tayo.

The submission right now and at the very last day, if you wish we just product.

These two numbers.

Hello.

In the study.

Push the submit button.

So got it alright.

Alright.

Okay Super helpful. Andrea I know you said expenses are ticking up a little bit because of the study and FDA expenses et cetera, how should we think about the first half of next year I know, we haven't gotten there yet, but do you expect the cash burn to moderate a little bit or do would you expect it to go up as you prepare for launch.

It's a great question.

Right now I would say.

Pairing to keep it flat if we were to go faster and we want to go faster for some reason we would communicate that to you.

I would keep your expenses flat for now and I would say.

Flattish.

I think theyre going to grow up go up a little bit.

We are looking at areas, where we could invest to go faster.

Scrutinize every dollar and so we havent greenlight anything yet.

But I think we will come back at you in March and we will update you on how we think 2026 is going to work.

Got it I appreciate it guys. Thank you.

Thank you.

Bill Thomas.

All right any other questions.

Alright, guys. Thank you so much for making time for us today.

It is fun to get to share.

Sort of the results of all the hard work that the team has put in.

I think we're.

We're encouraged we're excited.

We've been we've been waiting two to celebrate submission for about two and a half years and.

Yeah.

It feels like we're finally about to give birth. So we're excited and looking forward to sharing this.

The positive news when it happens so thank.

Thank you everybody and.

We will talk soon.

Thank you all.

The recording has stopped.

Hello.

Mike Mike can you hang up.

Because to let 40 punches yeah, you can see it.

Thank you.

Speaker #4: think we are still broadcasting live to everyone. So we should probably just hang up. Bye-bye.