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DATE

Wednesday, May 13, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Joshua Riggs
  • Chief Financial Officer — Andrea Susan James

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TAKEAWAYS

  • GraftAssure Dx FDA Submission -- Submitted to the FDA in late March; management described ongoing engagement with the agency and anticipates continued interaction during the review process.
  • GALACTIC Registry Study Progress -- 34 U.S. transplant centers have expressed interest in the GALACTIC registry, up from 28 centers six weeks ago, advancing toward a 50-center goal and with the first clinical trial agreement signed.
  • Initial U.S. Orders for GraftAssure -- First domestic commercial orders for GraftAssure are expected later this year, following pricing validation from market research with over 200 surveyed centers.
  • International Adoption -- Early research-use-only sales of GraftAssure IQ have occurred in Switzerland and Southeast Asia with one center securing reimbursement; these sites are anticipated to become recurring customers.
  • Regulatory Milestones -- TÜV SÜD ISO 13,500 certification achieved in February; regulatory compliance in the UK under IVDD targeted within months; EU IVDR submission planned soon after, with a review timeline guided at six to twelve months.
  • Medicare Reimbursement Rate -- GraftAssure CORE receives $2,850 per result from Medicare.
  • Q2 2026 Revenue Projection -- Projected at $250,000, primarily from laboratory services and minimal GraftAssure IQ sales.
  • Q2 2026 Cash Burn -- Expected to exceed $9 million, including outflows for bonuses and prior-period FDA submission costs, representing the peak quarterly burn for the year.
  • Second-Half 2026 Cash Burn Outlook -- Anticipated to decline to approximately $6 million per quarter as one-time FDA costs subside and working capital improves, contingent on revenue realization.
  • Long-Term Gross Margin Target -- Expected to reach around 70% or higher; an initial 10% revenue share commitment with former Chronix shareholders and cost of goods sold just under $100 per result will affect short-term margin realization.
  • Graft2Sure Development -- Expansion into heart transplant testing is underway with protocol finalization and anticipated first patient enrollment; management noted most development work transfers from kidney to heart.
  • Total Addressable Market -- Confirmed at $2 billion, with survey-based pricing research supporting previously issued TAM and price assumptions.

SUMMARY

The company reported continued progress toward commercialization, highlighting an expanding clinical registry and advancing regulatory milestones in key markets. Executives stated that strategic investments and capital management would moderate cash burn after a forecasted peak in the second quarter. The call underscored movement toward international market entry, new test indications, and a path to software-like margins, all built on a $2 billion addressable market.

  • Riggs said, "We expect our first U.S. orders for GrafAssure later this year," and referenced strong demand signals validated by market research with more than 200 surveyed decision-makers.
  • The CFO expects that, "As revenue ramps, of course, this will significantly reduce our quarterly cash burn," indicating that future commercial activity may support improved operating leverage.
  • International market entry to date has focused on research-use-only sales, with one European hospital establishing market-based test reimbursement, presenting a proof point for adoption outside the United States.
  • Head-to-head data versus legacy dd-cfDNA diagnostics are emerging; management views these as the fastest route to clinical trust and adoption for GraftAssure.
  • Management said, "our Graft2Sure technology is designed to be organ agnostic," with early-stage expansion into heart transplants enabled by shared assay development.

INDUSTRY GLOSSARY

  • GALACTIC registry: A clinical study enrolling transplant centers to collect data on GraftAssure test utility and outcomes.
  • GraftAssure Dx, GraftAssure IQ, GraftAssure CORE: Proprietary diagnostic products/platforms for post-transplant monitoring and test result delivery at IMDX.
  • TÜV SÜD ISO 13,500 certification: International quality certification required for certain medical devices and diagnostics.
  • IVDD: In Vitro Diagnostic Directive, the regulatory framework for diagnostics in the UK.
  • IVDR: In Vitro Diagnostic Regulation, the updated EU regulatory regime for in vitro diagnostics.
  • dd-cfDNA: Donor-derived cell-free DNA, a biomarker measured to monitor transplant rejection risk.
  • IOTA model: Increasing Organ Transplant Access model, a framework intended to expand transplant patient screening and surveillance.
  • AMR: Antibody mediated rejection, a cause of transplant failure detected by immune monitoring assays.

Full Conference Call Transcript

Joshua Riggs: Thanks, Gabby, and thanks, everyone, for joining us today. We are excited to share with you this business update and our progress in creating value at IMDx for patients, clinicians, our employees, our shareholders. Since submitting GraftAssure Dx to the FDA in late March, we have had a high degree of engagement from them and expect that will continue as we move through the review process. We continue to enroll patients under the study protocol building the dataset and sample bank, to support potential future publications, research, and claims expansion. We have committed to delivering software like margins with GraftAssure.

Over the past several months, we surveyed over 200 likely US working through multiple pricing and purchasing scenarios to guide our pricing strategy. This market research has affirmed our confidence in GraftAssure's perceived value and our ability to translate that into strong margin for both the company and the shareholders who funded its development. We expect our first U.S. orders for GrafAssure later this year. Outside of the US, we have seen some encouraging market access progress for sites using the research use only version of our technology, GraftAssure IQ. In recent weeks, a Swiss transplant hospital purchased a small number of kits and we are expecting our first orders out of Southeast Asia.

These early milestones, though immaterial to revenue, represent important proof points to us about the need being addressed by GraftAssure. At least 1 of these centers was able to establish coverage and reimbursement for the test in its market. Purchase decisions are being driven by demand for faster turnaround time, access to absolute quantification, and the ability to get reimbursed. We anticipate that these sites will become repeat customers as they continue to establish dd-cfDNA testing in their respective countries.

On the back of receiving TÜV SÜD ISO 13.5 thousand certification in February, we are targeting regulatory compliance in the UK under IVDD in the coming months and plan to submit for in vitro diagnostic regulation or IVDR approval in the EU soon thereafter. In our March update, I explained that to be prepared for the successful launch of GraftAssure Dx, we want to achieve or witness 3 key trends. Those are strong engagement in the GALACTIC registry study, early adopters using GraftAssure IQ, and seeing more head-to-head data establishing parity with legacy technology. Can continue to make progress against all 3.

First, our GALACTIC registry is designed to drive the clinical understanding of our absolute and combined measurements of donor derived cell free DNA. The current standard of care is the fractional or percentage measurement. We believe these alternative measures offer incremental information for the clinician and could prove to have additional utility in certain clinical contexts. This self funding study will help more clinicians become familiar with our clinical reports and establish their usefulness in diverse real-world clinical situations. So far, 34 US transplant centers have expressed interest in being part of our registry. This is up from 28 centers just 6 weeks ago and represents remarkable progress toward our 50-center goal.

In addition, we recently signed our first clinical trial agreement with 1 of those 34 putting us closer to first patient in. This is encouraging since successful enrollment generates revenue for the company this year. As a reminder Medicare reimburses GraftAssure CORE at a rate of $2.85 thousand per result. Second, later this year, we expect to see initial orders of GraftAssure IQ in larger volumes that we have seen before from our first US customers. Third, we are seeing the emergence of head-to-head data comparing our GraftAssure with other commercially available technologies. We mentioned these studies in our shareholder letter. Just to emphasize, generating head-to-head data is the fastest path to establishing trust for a new diagnostic.

So we are very enthusiastic about what is been reported to date. Finally, I will close my remarks by touching briefly upon our expansion into heart transplant testing. As a reminder, our Graft2Sure technology is designed to be organ agnostic. So the assay that we built for kidney will work in heart. Clinicians and researchers at leading transplant institutions have expressed their excitement about our planned expansion We are working with them to get the protocol finalized and first patient in as quickly as possible. We have made a lot of progress this year and look forward to updating shareholders as we push to make managing patients post transplant easier for clinicians here in The US and abroad.

Now let me turn the call over to our CFO, Andrea Susan James, to provide a review of our financial results for the first quarter. Andrea?

Andrea Susan James: Thanks, Joshua. Hi, everyone. Our first quarter results are in line with what we told you they would be in our preliminary release of our cash balance and revenue, which we made on April 4. From where we sit today, our financial projections remain consistent with the guidance that we provided in late March. Our Q2 26 revenue projection is for about $250 thousand comprised mostly of laboratory services and a very low level of GraftAssure IQ sales. We are projecting second quarter cash burn above $9 million which will be the high watermark for the year.

In the second quarter, we paid out bonuses and addressed other working capital needs associated with the GraftAssure Dx FDA submission expenses, which we incurred in prior quarters. We expect cash burn to come down in the back half of the year closer to historical levels of $6 million per quarter driven by working capital favorability and reduced R&D expenses, as many of our FDA program expenses will not repeat. This, of course, is also subject to revenue that can be difficult to predict. As revenue ramps, of course, this will significantly reduce our quarterly cash burn.

This management team remains highly thoughtful about extending our cash runway and focusing our commercialization investments toward the areas that we believe will drive optimal ROI for the company. Finally, I will close by reflecting on my almost 2-year anniversary with this company, which is coming up in June. We have been building a foundation from which we expect to launch a rapidly growing company that has the potential to be highly profitable and I am incredibly excited about our future. I told you on my first earnings call in 2024, that we have a compelling opportunity to achieve market disruption and in so doing create a multi-billion-dollar company.

We are closer than ever to that vision, and we continue to retire risk on the path to initial and then material revenue.

Operator: Gabby, we can now take questions. And, Eric, if you could please bring us up into gallery view. Thank you. Thank you, Andrea. And with that, Thomas Flaten from Lake Street.

Analyst (Thomas Flaten): Yeah. Hey, guys. Appreciate you taking the questions. Joshua, I apologize if I missed this. Any clock stoppages in the FDA review so far? I know it has not been very long, but just curious.

Joshua Riggs: Yeah. No. We are, we are gonna treat sort of all the back and forth, with the FDA as confidential. But I would say we are pleased with the conversation. All those have been productive so far.

Analyst (Thomas Flaten): I know this has come up previously, but how are you balancing the desire of accounts to participate in the registry study versus getting commercial wins? And I know you are going to make money on the registry study, but how are you thinking about that? Are you going to exclude anyone from the registry study, or is it an all comers type of approach?

Joshua Riggs: Yeah. I would say we are being selective on the sites that we are bringing into the registry. I would say the commercial success is 1 and the same for us. We expect that most of these centers that join in the registry are going to be kit customers for us. Long term. it is something that we talk to them about as they are coming into the study. Where we, you we say that the purpose of this is to introduce our new scores but also you know, give you a chance to bring this in house once there is a the when there is a regulated product out there.

So, we see the that both things are serving 1 end goal, which is to get instruments into the field and kits out there. Right. Appreciate it.

Operator: Thank you. Thanks, Thomas. Hey, Sean. Let's go with Mason Carrico from Stephens, please.

Analyst (Mason Carrico): Hey, guys. Yeah. Appreciate the questions here, Joshua. On the survey you conducted around pricing, any incremental detail you are willing to share around maybe the learnings from that survey and your updated thoughts on pricing?

Joshua Riggs: No. Thanks for the question, Mason. I would say, you know, the guidance that we have kind of given before around how centers are going to look at pricing on day 1, which is relative to what they expect. They will get reimbursed, from CMS, and then what they will not get reimbursed from the private payers on day 1 is playing out. And so everybody's kind of seeing the same math that we saw. You know, that pricing is going to be, you know, well into the hundreds. For the Dx product. And I think Andrea wants to massage that a little bit, so I will let her jump in.

Andrea Susan James: No, it is great. I just wanted to add 1 more thing. You know, we have given you that $2 billion total addressable market, and the pricing research is really affirming the numbers that we have already given you on the size of the market.

Analyst (Mason Carrico): Got it. Okay. And then you guys have also referenced the software like longer term gross margins. I guess, could you talk about how we should be thinking about what gross margins will look like maybe in the first 12 to 24 months post commercialization. When volumes are ramping.

Joshua Riggs: Yeah. I know, Andrea, if you want to take a look at that. I know you spent a lot of time with the numbers.

Andrea Susan James: Yeah. So you are going to model in an ASP that is in the hundreds and then you are going to model in a cost of goods sold. So slightly under a $100. Now we can bring that cost of goods sold per result down over time. The other thing you want to think through is that our initial go to market customers will or maybe will get some sort of leader pricing. And so grow into that gross margin profile over time. The other thing to note is that we do have a revenue share with the former Chronix shareholders from which we acquired the IP. And so that also takes 10% off the top.

So, you know, we have a long term gross margin of around 70% or higher. I do not know if the initial contracts will come in at that. So I would not model that for your first 6 to 12 months.

Analyst (Mason Carrico): Got it. Thank you, guys.

Operator: Thank you. Thank you. Mike Matson from Needham.

Analyst (Michael Matson): Yeah, thanks. So just once you get the FDA clearance, how quickly can you start to drive sales of the kits? And, are there any hurdles you have to cross once you get the FDA clearance in place, or can you kind of hit the ground running there?

Joshua Riggs: I would say 1 of the rate limiters that we will face is the placement of the instrument. And so that is where we have talked about in the past, you know, the sites that are participating in the FDA study itself are the most likely day 1 adopters just because they will have the instrument on hand. I think what you will expect to see from us is to take advantage of all these instruments that we have had in house to support the FDA program. We have now finished all of that work, and so we are starting to try and get those out in the field.

And I think we will be able to update you guys on the progress of progress of sort of getting some additional instruments out there, as we go forward throughout the year.

Analyst (Michael Matson): Okay. Great. And then with the EU IVDR cannot talk. The EU IVDR submission-- kind of a mouthful there. What if you submit it later this year, I mean, how long do you think that process will take?

Joshua Riggs: Yeah. What we have been given Yeah. Yeah. I would say what we have been given is guidance, and, yeah, I mean, this can change but is, you know, somewhere between, you know, 6 and 9 months all the way up to a year depending on how much the backlog builds with TÜV SÜD. So I would say once we submit, we will probably have a better idea. We will get the guidance from them. At that point, and so we will be able to update you then.

Analyst (Michael Matson): Okay. Alright. And then just next steps for heart, what is next for heart and you know, what impact would that have on your operating expense and cash burn?

Joshua Riggs: Yeah. Thanks. I would say it is baked in to the numbers that Andrea has given you. You know, fortunately, 95% of the work that goes on, between, you know, sort of heart and kidney is copy and paste. So because the underlying information is all the same. I would say the clinical piece is a much simpler study here where it looks more like a head-to-head where we believe we have a 510(k) pathway available.

Andrea Susan James: And just to build on what we said last quarter, you know, we had done the capital raise in February that allows us to sustain our R&D spending at a higher level than it was, say, back in 2024. And so we expect R&D expenses to come back down closer to first half 26 levels, but not go all the way back to where they were at 2024 levels. And so we expect R&D to continue to come down in the back half of the year, but not back to where it was a couple of years ago. So sustaining investment in heart is what that looks like on the R&D line, if that helps.

Analyst (Michael Matson): Thank you.

Operator: Thanks, Mike. Mark Massaro from BTIG.

Analyst (Mark Massaro): Hey, guys. Thanks for the questions. Joshua, 1 for you. Can you just speak to your latest thoughts on the IOTA model and whether or not you think that can be 1 of the growth drivers for your business? And if so, is there anything about the, you know, your particular strategy relative to send outs that you think you could capitalize on?

Joshua Riggs: No. it is a great question, and thanks for it, Mark. I would say, you know, we are encouraged by sort of some of the volume growth that we are seeing around IOTA. I think anytime you can create a high risk pool of patients, the more likely it is that the payers will support a higher screening, you know, protocol. I think that is, you know, where we have been focused is on identifying higher risk groups like the de novo DSA positive patients, as kind of a ground where we really need to be screening these people more aggressively.

And so I think, you know, us and other you know, dd-cfDNA companies are going to lean into this going forward. And, try to push those numbers up a bit because we know that, you know, catching AMR early is going to become more and more important as these anti CD38 drugs come to market. And so I think that will have a much bigger clinical impact for those patients that are potentially getting the marginal organs out of the IOTA program. So I think it is a rising tides.

I think we talked a little bit about this on the last call, and I think if that is where you are going with it, that is I completely agree with you that there is opportunity for increased screening across the board.

Andrea Susan James: And if I could just throw out some acronym help for some of the generalists that have come into the stock in the recent months. Increasing organ transplant access model and then AMR's antibody mediated rejection.

Analyst (Mark Massaro): Awesome. Thank you for that, guys. You know, it is nice to see you move the ball forward in Europe. You know, this is sort of a theoretical question, but assuming I know that these will not have the same start dates, but assuming that, like, Europe and US had a similar start date, which market are you now thinking will probably pull forward the biggest volume, you know, in your initial launch?

Joshua Riggs: Yeah. I would say the reimbursement being solved in the United States makes things a lot easier here. For the initial adopters. I would say the pent up demand in Europe is strong. I think that you have got several countries where you have very loud clinical groups that are kind of banging on the door, with their payers saying that we need access to this technology. We need better access to this technology. And, you know, there is competitive, you know, technology out there that is you know, competes with ours. And they have been out there for years, you know, working on the same argument.

I think the we saw in Europe, which is kind of like the first crack in the door that our centers that are getting paid, at this point is a great positive sign. And I think, you know, we are very hopeful that we will see a couple more cracks in the door here in the second half of this year. We know that there was a recommendation made to NICE, in the fall of last year. We were hopeful that, they finally come to that positive decision. And I would say, you know, we have a strong presence in Germany and a lot of work that is been going on there.

We have been fortunate to have a good group of clinicians that have been working with the payer system and have been pushing there as well. I mean, obviously, we cannot predict, you know, when the payers are going to finally break on this topic. But it seems like the evidence is overwhelming at this point that there is clinical utility here, that there is clinical need, to address this. And so we will keep our fingers crossed that the European market starts to look a lot more like the US over the next, call it, 12 months. And I think we have seen some early positive signs.

Analyst (Mark Massaro): Awesome. Alright. that is it for me. Congrats on the progress.

Operator: Thanks, Mark. Any additional questions? Thank you so much, analysts. And, Joshua, I will turn the call back over to you.

Joshua Riggs: Sure. Thanks, Gabby, and thanks, everybody. know, we appreciate you guys taking time, with us today. I want to thank our dedicated employees for their hard work. I also want to thank our clinician partners who have helped with the development of our assay. And finally, thanks to our shareholders for believing that we have the opportunity to disrupt and transform transplant testing and for providing us with the capital to help make that a reality. We are excited about the progress being made, and we look forward to sharing additional updates with you in the coming months and quarters. You guys have a good day.

Operator: Thank you.