IMDX

Image source: The Motley Fool. Monday, Aug. 10, 2026 at 5:00 p.m. ET President and CEO - Josh Riggs Chief Science Officer - Ekke Schutz CFO - Andrea James Investor Relations - Gabrielle Woody Gabrielle Woody: Welcome, everyone, and thank you for joining us to discuss Insight Molecular Diagnostics' second quarter 2026 results. If you have not seen today's shareholder letter, please visit Insight Molecular Diagnostics' Investor Relations page at investors.imdxinc.com. Today's prepared remarks build upon the information already shared in this robust letter. Joining us today are Insight Molecular Diagnostics' President and CEO, Josh Riggs; Chief Science Officer, Ekke Schutz; 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 Riggs, I'd like to review our safe harbor. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forward-looking statements. These statements are made pursuant to and within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We encourage you to review the company's SEC filings, including the company's most recent Form 10-K and subsequent Form 10-Q, which identify risks and uncertainties that may cause future actual results or events to differ materially. Please note 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 Riggs. Joshua Riggs: Thanks, Gabby. It feels great to be coming to you today with line of sight on expected FDA marketing authorization for GraftAssureDx. We have 3 brief but promising takeaways today in our shareholder letter. The first is that after 3 years of rigorous kitted product development, we believe that we are seeing the light at the end of the tunnel on having a regulated product. Back in July, we got our additional information letter from the FDA. It's a normal part of the Class II process where they ask for some additional data and clarification on intended use as part of their review. Since submitting back in March, we've about tripled the amount of samples collected in the study and feel good about addressing all their questions and comments. Prior to submitting our next data package, we are going to have an SIR meeting with the FDA. This meeting is a lot like the Q-Sub process where you get direct and written feedback on your planned approach. It's an opportunity for both parties to make sure there is clear understanding on what is needed to get through to authorization and clear up any potential misunderstandings. Once we have the green light from them, the next steps are pretty straightforward. We package it all up, hit submit and wait for their response. Since March, we have been pleased with the timeliness of FDA's engagement. We continue to target receipt of FDA marketing authorization later this year with the caveat that the timing of government agency review is not completely within our control. The second takeaway is that we can see that the market landscape is likely improving for transplant rejection tests like GraftAssureDx. We believe that Medicare's recently expanded reimbursement guidelines for these tests even better [ primes ] GraftAssureDx for commercial success. We know our analysts are well familiar with the recent MolDX LCD, which boosts surveillance from 8 to 14 tests in the first 3 years post kidney transplant. This higher testing frequency is potentially great for our customers. It strengthens the economic case for bringing dd-cfDNA testing in-house. The market landscape is also improving on a competitive front. We believe that we are about 2 years ahead with regard to kitted product development among competitors. And third and finally, we've seen strong head-to-head data that favorably compares our assay to other leading assays on the market, driving increased interest from potential future customers. That includes top transplant centers and reference labs here in the United States. It feels like half the country is in a 3-point stance, waiting for the opportunity to bring dd-cfDNA testing in-house. From an expense standpoint, and Andrea will take you through some of that in a minute, we believe that we are fully staffed to support material revenue growth. So far, we have invested ahead of revenue generation, preparing for commercialization. Future investments will be tied to our expectation of revenue growth. Given where we are with the FDA, which we believe is likely in the latter stages of the review process, we are looking at all areas of the organization to make sure that we are well aligned for success. I expect that we will have opportunities to strengthen commercial and operations ahead of launch as the momentum we've built attracts more and more industry attention. Market demand for dd-cfDNA testing stretches into the hundreds of millions annually, and we are building the team that can get us there. The investments we have made have opened many doors. Over half of the top 10 transplant centers in the United States are working with us, either through our FDA program or through our registry. Going forward, we will be focusing on closing business and driving a top line and margin profile that brings us to breakeven and beyond that strong profitability. One last note before I hand the call over to Andrea. So much of our energy right now is pointed towards getting things done at the FDA. But I'd be remiss to fail and mention the progress we are making on the science side. The head-to-head data that has come out has been fantastic, showing clinical equivalents to leading tests that are performed at central laboratories. And we continue to demonstrate leadership in showing how dd-cfDNA can help manage patients on therapy for antibody-mediated rejection. We are starting to see a future where dd-cfDNA can do much more than just rule out for biopsy. This progress on the science side supports growth in our total addressable market, which Andrea will cover. Now let me turn the call over to our CFO, Andrea James, to provide a review of our financial results for the first quarter -- it should be second quarter. Andrea? Andrea James: Yes. Thanks, Josh. Hi, everyone. First, as Gabby said, I hope you've had a chance to read our shareholder letter. And if you haven't, please do go check it out. It is considerably more thorough than a typical earnings press release. And accordingly, it allows us to keep our prepared remarks relatively brief and allow more time for Q&A. This is the ninth quarterly shareholder letter we've published since I joined the company 2 years ago, and we're thrilled to be updating you about our planned transition from a product development-stage company into a revenue-generating profitable business. In the second quarter, core spending came down further from its Q4 2025 peak. You see this in the GAAP OpEx figures, as well as in the sequential narrowing of our adjusted EBITDA loss to $7.8 million. Our peak spend in Q4 2025 was tied to activity regarding our FDA submission. This and other working capital items drove cash burn of $10 million in the second quarter, which we expect to be the high watermark on cash burn for the foreseeable future. We now expect to burn approximately $8 million per quarter in the second half of this year. This is above our prior expectation of roughly $6 million per quarter, primarily reflecting the timing of costs to complete the regulatory review process, along with registry activities ahead of associated GraftAssureCore revenue and investments to prepare for commercial launch of GraftAssureDx. We continue to expect modest revenue in the second half across laboratory services, research use-only kit sales and GraftAssureCore. And remember, GraftAssureCore is our lab-developed test. We are prudently exploring all options to extend our runway, while still properly investing to meet market demand. And we will continue to enforce cost discipline across the business. Future investments will be tied to our expectation of material revenue growth. We remain very excited about the size of the market and our disruptive approach. We believe that Medicare's higher reimbursed testing frequency is favorable to our previously stated $2 billion total addressable market for kitted transplanted organ testing. You can think of our TAM as growing in concentric circles. The core TAM, which takes total kidney transplants per year and living kidney transplant recipients, multiplied by a baseline and conservative 2 tests per year at our ASP approaches $2 billion. Higher surveillance testing frequency grows this beyond $2 billion. Adding in therapy monitoring, which Josh just mentioned, grows the TAM again. And then, of course, expanded organ indications grows the TAM yet again. Remember that Dr. Ekke Schutz and his team designed the GraftAssure platform to be organ agnostic. And we've talked about how we're not stopping at kidney, but we are also investing in heart. To that end, we have a KOL call planned for August 17 to talk about heart transplant testing. It will feature Dr. Max Jacob Liebo of Loyola University Medical Center, as well as our VP of Medical Affairs, Dr. Nick Ioannou; and our CEO, Josh Riggs. They will explore how in-house dd-cfDNA testing may be used for heart transplant rejection monitoring. So stay tuned for a press release with registration details. Okay. Gabby, we can now take questions. And Eric, if you could please bring us up into gallery view, that would be awesome. Thank you. Everybody has got their hands up. Gabrielle Woody: Thank you so much, Josh and Andrea. Let's -- Mason Carrico from Stephens. Mason Carrico: So you called out the SIR meeting with the FDA. Could you just expand on that meeting a bit? What was the reason the meeting was set? What's it focused on specifically? And did you call out a date for that meeting? Joshua Riggs: We did not call out a date. I'd say the -- any time you get questions, there's some interpretation that's possible there on the best way to respond to them. I think the SIR meeting is just an opportunity for us to make sure that we're 100% aligned with the FDA before we package up this additional data and hit the submit button. Mason Carrico: Got it. And I guess, if authorization were to slip into, let's say, the first half of 2027, could you walk through, I guess, the changes -- I guess, the levers that you could pull from an operations standpoint to extend the cash runway if need be? Joshua Riggs: Yes. I mean, I'd say, they're the usual ones. But I would -- the investment that we're making in the registry, I think, is probably the most significant lever. I think accelerating the enrollment there provides a revenue offset that we don't have right now going into the second half just because of some delays in getting that started. Andrea James: Remember that we have a test that we can run out of our Nashville lab that's reimbursable at $2,753 per result. So not only is it registry revenue, but we think we can attach some GraftAssureCore revenue to that along with those registry participants. Gabrielle Woody: Mark Massaro from BTIG. Mark Massaro: I'm curious about -- and I recognize it's still early days, but I am curious about some of the research use-only kit revenue you sold. I think it was $21,000 in the quarter. Can you give us a sense for what these kits were for? Was this for -- actually, I'll just leave it there. I mean, can you explain why these were ordered and for what use? Joshua Riggs: Sure. It's ex-U.S. usage right now. And so, there's some areas of the world that have trouble accessing testing here in the United States from where they're at. And so, they brought it in and validated it for clinical purposes there. I'd say that's what's driving that demand. Mark Massaro: Okay. That's helpful. And then, what is the latest thinking around the commercial opportunity with Bio-Rad? Is there any potential expansion of that agreement? And assuming you get FDA approval, what gives you confidence in the current strategy versus potentially seeking some alternate strategies? Joshua Riggs: Yes. Bio-Rad has been such a great partner for us throughout this process. They've supported us on sort of every phase of the FDA engagement. And we have an opportunity to negotiate with them, both ahead of authorization, and then there's a 90-day period after authorization. And we're -- I think we're encouraged by kind of the support that we feel. We got to sit down with them while we were at ADLM 1.5 weeks ago. And I think everybody kind of looks at the list of centers that we're engaged with here in the United States and in Europe and can kind of see how that's a real opportunity, especially for instruments that maybe don't have a natural home in the central labs, with core labs there or even in the HLA labs. That kind of adoption menu and placement is very attractive for platform manufacturers and the ability to build additional content. So I'd say, we're both motivated to figure out a great way to work together in the future and drive this high-value molecular content closer to the patient. Mark Massaro: Awesome. Last one for me, and then I'll hop back in the queue. Obviously, the final LCD for MolDX I thought was very favorable, certainly for CareDx and Natera. I'm just curious if you've had conversations -- I mean, presumably, what's good for the send-out is probably good for the kitted, right? So can you just give us a sense for any conversations you've had about your confidence around utilization of kits on a repeat surveillance basis? Joshua Riggs: Yes. It was funny. We were actually -- we were talking to MolDX the day before they put the LCD out, and we were talking to them about surveillance. And we got a lot of, well under the current LCD. So it was a very interesting conversation to be a part of. I think what we're going to see is exactly what the STAR group described back in January, which is, these centers need to have the test in their hands so that they can really build the protocols that make the most sense for them. And they want to work together as a group. And this is international as well, where they want to really figure out what's the optimum schedule. It's hard for me to gauge if the centers themselves are going to follow exactly what's in the LCD, if they're going to go beyond that. I think the medical necessity here is still being evaluated. And we're very happy to see that MolDX sees the value in early and often intervention, particularly as we see the impact that these anti-CD38 drugs are having on patients. We just published another paper a couple of weeks ago that shows that early intervention matters. And doctors aren't going to want to wait until you've had kind of a long development of AMR before they intervene. And so I think the flexibility that MolDX has given clinicians here is great to actually be aggressive in the management of patients, aggressive in the management of AMR. And I think we're building a great tool for that. And so, I think it's all good for both, I think, for the send-out labs and for those centers that choose to bring this in-house. Gabrielle Woody: Thomas Flaten from Lake Street. Thomas Flaten: Josh, anything you can comment on the nature of the questions that FDA sent back to you regarding the review and approval? Joshua Riggs: Yes. I think we're going to keep the exact questions confidential. But I would say, we didn't see anything terribly surprising in there. I mean, the questions all felt fairly routine and addressable with the data that we have in-house. Thomas Flaten: Got it. And then, you didn't mention, I don't think, in your prepared comments, anything about the self-certification process of the IVDR submission. I was curious if you had an update on that. Joshua Riggs: Yes. I'd like to hand that one to Dr. Schutz. I know he's working closely with his team on getting through the final audits here so that we can hit that submit button. So maybe Ekke, you could talk just a little bit about the work that we're doing to get ready for Europe. And you're on mute there, just in case before you dive in. Ekkehard Schutz: So what we had meanwhile was an informational meeting with our notified body, where we more or less got very good guidance. And also, I think the way that the IVDR process is going to go is a little bit more flexible and easier than what we are seeing with the FDA. So we are still really planning to get this done in the second half of this year. And I think there's a very, very realistic trend that we can do it. We are not anticipating that we need to provide large clinical studies or anything that would really put a big burden on my team. It looks really, to my mind, way easier than I actually initially thought. Of course, there are going to be a couple of hurdles that we have to address, but I'm very positive about the IVDR process and the self-certification with this IVD, which only applies to the U.K., as you might think, is even easier. Joshua Riggs: Thank you, Ekke. It certainly helps to be able to tap into the network of researchers that we have there and the long history of publications that we have in Europe. Heidelberg has been a wonderful supporter of the regulatory process. And so, we're happy to bring those samples along as well. I think we are seeing -- just on the market access side in Europe, Switzerland has figured out a way to pay for some of this testing, which is great. I think they're one of the first countries to kind of be pushing this forward. We're starting to see tenders in Italy and some of the other countries, but it still feels very early days in Europe. I think the biggest catalyst will be the approval of an anti-CD38 for routine use. I think the data is showing that there's clear clinical utility for using donor-derived cell-free DNA to manage the application of those therapeutics. And we've had kind of robust conversations with the pharma that are engaged in that and trying to pull that forward. So we remain hopeful that, that drives sort of market access and demand and reimbursement across Europe, which we see as largely the gating factor for them adopting the technology broadly. Thomas Flaten: And then, just one quick one. How many of the FDA study sites do you anticipate being registry sites as well? I'm trying to figure out how many of the study sites will be kind of early adopters on the commercial side versus opting for the registry. Joshua Riggs: Sure. I mean, Ekke, I mean, maybe you can comment real quick. I think the overlap is about 50% of the FDA sites who are coming into the registry, but I don't know if you would modify that. You're on mute there, brother. Ekkehard Schutz: Of course. No, I agree. I think we have a couple of candidates that I would say that they are going to be 100% in, and we have half of that where we actually have no real visibility of whether they want to do it or not. Gabrielle Woody: Mike Matson from Needham. Michael Matson: Yes. So I just want to ask one -- it was good to hear about the interest of the large reference labs in the test. But I'm wondering about like the economics of selling to them versus like the transplant centers, which would probably be buying lower volumes. I'm thinking maybe these reference labs that have like kind of a volume discount, but then maybe you wouldn't have all the -- you have to pay a sales commission or something if they're just putting in big orders. So... Joshua Riggs: Yes. Gosh, I love the question. And we spent a lot of time, as you might imagine, debating pricing power here at the company. And we're not going to publish the list price. But I think you give discounts based off of volume and threat of substitutes. And right now, there aren't a ton of substitutes out there, if any. And so, I think we expect early on that we're going to have significant pricing power. That may change over time. But to me, I think Andrea has thought a lot about this. So let me let her jump in on that. Andrea James: I just wanted to say, too -- and we build some of these thoughts into when we're building out our TAM and what our go-forward models look like. But remember that our pricing power is tied to our reimbursement, and that remains true of whoever is running the test. And so, the pricing power largely holds up. Like would there be some volume discounts for guarantees and in return, you get some visibility and predictability, which we all love? Sure. But remember, the reimbursement doesn't change. And so, as we seek to port the reimbursement for GraftAssureCore over to GraftAssureDx, that's going to port over to all of our customers as their revenue and they're reimbursed. And as reimbursement grows, as you get more private payer coverage, that also helps your pricing power. So it's not -- it is -- there are some things that are within our control so we can maintain our pricing power. It can also grow the utility of the test, right? And so, as testing frequency grows, there's more of an economic incentive to adopt in-house testing. And so, all of those things, we think, are favorable. Michael Matson: Okay. Got it. And then, I had a follow-up on -- just on the TAM. So I mean, you mentioned $2 billion. But obviously, we have this Medicare coverage or, I guess, Medicare reimbursement policy about covering more frequent tests. So -- and you called out some other things. So I guess, what I was wondering is like is that $2 billion -- I mean, the $2 billion number, is that number going up? And I guess, can you give us an estimate of what the size is, taking all those things that you've kind of listed into account? Or does it already do that? Andrea James: Yes. No, I mean, it will -- it is growing. And we think we have opportunities to grow the TAM over time even as we develop new products in the future. I mean, right now, we are published at a $2 billion TAM, and we talked about the things that grow that. But that $2 billion TAM -- and this is why it's really, really important, why we love talking about testing frequency -- that's based on 2 tests per year per patient in kidney. And so, it's like this is a really, really simple thing. And so, once you start adding -- you can read the MolDX LCD. As you start growing the reasons -- the testing frequency and the reasons why you test per year, that too becomes 2.3, then it becomes 2.5, then it becomes 3. And as that grows, it grows the TAM accordingly. Does that make sense? Michael Matson: Yes, it does. Gabrielle Woody: Are there any additional questions? Josh? Joshua Riggs: Right. So thanks, everybody, for taking time to join us today. I'd like to thank our dedicated employees for their hard work. I also want to thank our clinician partners who have helped us with the development of the assay. And finally, I'd like to thank our shareholders for giving us a chance to make managing kidney transplant easier and more accessible. We are excited about the progress we're making and look forward to sharing additional progress with you guys in the coming months and quarters. And we'll see you all on our KOL call on Monday, August 17. I hope you guys have a good day. Thank you. 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Interested in Oncocyte Corp? Here are five stocks we like better. Oncocyte continues to target FDA marketing authorization for GraftAssureDx later this year. The FDA requested additional data and clarification, and the company plans to hold a Submission Issue Request meeting before resubmitting its package. Expanded Medicare reimbursement could support commercial adoption. New MolDX guidelines increase covered kidney-transplant rejection surveillance tests from eight to 14 during the first three post-transplant years, strengthening the case for in-house testing at transplant centers. Cash burn is expected to remain elevated as Oncocyte prepares for launch. Second-quarter cash burn was $10 million, while management forecasts roughly $8 million per quarter in the second half of the year due to regulatory, registry and launch-related spending. Oncocyte (NASDAQ:IMDX) executives said they continue to target FDA marketing authorization for the GraftAssureDx kidney-transplant rejection test later this year, while preparing for a commercial launch and managing spending ahead of expected revenue growth. During the company’s second-quarter call, President and CEO Josh Riggs said the company received an additional information letter from the FDA in July as part of its Class II review. The agency requested additional data and clarification regarding the product’s intended use, he said. Riggs described the request as a normal part of the process and said the company has approximately tripled the number of samples collected for its study since the original submission in March. → MarketBeat Week in Review – 08/03 - 08/07 Before submitting its next data package, the company plans to hold a Submission Issue Request, or SIR, meeting with the FDA. Riggs said the meeting is intended to provide direct written feedback on the company’s proposed response and ensure alignment with the agency before a resubmission. “We continue to target receipt of FDA marketing authorization later this year,” Riggs said, while noting that the timing of government review is outside the company’s full control. → Quantum Earnings Week: Winners and Losers Are Finally Emerging Riggs said the FDA’s questions did not contain anything “terribly surprising” and appeared routine and addressable with data already available to the company. He declined to disclose the specific questions from the agency. Chief Science Officer Ekkehard Schütz also discussed the company’s plans for Europe. Following an informational meeting with its notified body, Schütz said the company received guidance on the In Vitro Diagnostic Regulation, or IVDR, process and remains focused on completing its submission during the second half of the year. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Schütz said the European regulatory process appears more flexible than the FDA review and that the company does not currently anticipate needing to conduct large clinical studies for the submission. He added that self-certification in the United Kingdom is expected to be less burdensome. Riggs said the company is seeing early signs of market-access activity in Europe, including reimbursement progress in Switzerland and tenders in Italy. However, he characterized the European market as still being in its early stages and said broader adoption could be aided by approval of anti-CD38 therapies for routine use. Management highlighted Medicare’s expanded reimbursement guidelines for transplant rejection testing as a potential commercial tailwind. Riggs cited the recent MolDX local coverage determination, which increased covered surveillance testing from eight to 14 tests during the first three years following a kidney transplant. The increased testing frequency could strengthen the economic case for transplant centers to perform donor-derived cell-free DNA, or dd-cfDNA, testing in-house rather than relying exclusively on centralized laboratories, Riggs said. He added that centers may ultimately develop their own testing protocols rather than follow the coverage policy exactly. The company said it has generated head-to-head data showing clinical equivalence between its assay and leading tests performed at central laboratories. Riggs said this data has driven interest from transplant centers and reference laboratories in the U.S. More than half of the top 10 U.S. transplant centers are working with the company through its FDA program or registry, according to Riggs. Schütz estimated that roughly half of the FDA study sites are expected to participate in the registry, though the company does not yet have complete visibility into participation at the remaining sites. On research-use-only kit sales, Riggs said the $21,000 reported during the quarter was associated with customers outside the U.S. that have difficulty accessing testing performed in the U.S. These customers have brought the test in-house and validated it for clinical purposes in their local markets, he said. CFO Andrea James said core spending declined further from its fourth-quarter 2025 peak, which had been tied to work related to the FDA submission. The company reported an adjusted EBITDA loss of $7.8 million for the second quarter. Cash burn totaled $10 million in the quarter, driven by the FDA submission effort and other working-capital items. James said management expects that figure to represent the high point for cash burn in the near term. The company expects to burn about $8 million per quarter during the second half of the year. That outlook is above a prior forecast of roughly $6 million per quarter. The increase reflects regulatory-review costs, registry activities ahead of related GraftAssure CORE revenue, and investments to prepare for the GraftAssureDx launch. James said the company expects modest second-half revenue from laboratory services, research-use-only kit sales and GraftAssure CORE, its laboratory-developed test. GraftAssure CORE is reimbursable at $2,753 per result when run through the company’s Nashville laboratory, she said. If FDA authorization is delayed, Riggs said accelerating registry enrollment could be a significant lever to help extend the company’s cash runway by providing a revenue offset. Management said it is also exploring options to extend its runway while maintaining cost discipline. James reiterated the company’s previously stated $2 billion total addressable market for kitted transplanted-organ testing, a figure based on kidney testing at a conservative average of two tests per patient annually. She said higher surveillance frequency, therapy monitoring and expansion into additional organs could increase that market opportunity. The company is also investing in heart-transplant testing. It plans to host a key opinion leader call on Aug. 17 featuring Loyola University Medical Center’s Dr. Max Jacob Liebo, Vice President of Medical Affairs Dr. Nick Ioannou and Riggs to discuss in-house dd-cfDNA testing for heart-transplant rejection monitoring. Riggs said Bio-Rad has supported the company through its FDA engagement and that the two parties have opportunities to negotiate their relationship before authorization and during a 90-day period afterward. He said both companies see an opportunity to place testing platforms at transplant centers, core laboratories and HLA laboratories. Management said it believes it has meaningful early pricing power because of reimbursement support and limited alternatives, though it acknowledged that volume-based discounts could be offered to larger customers such as reference laboratories. Oncocyte (NASDAQ:IMDX) is a molecular diagnostics company that develops and commercializes tests intended to improve cancer detection, risk stratification and treatment decision-making. The company focuses on creating assays that provide clinically actionable information to physicians managing patients with suspected or confirmed malignancies, with particular emphasis on tools that can help evaluate lung nodules and other oncology-related diagnostic challenges. Oncocyte's product and development efforts center on blood- and tissue-based molecular assays that analyze biomarkers and genomic signals to inform clinical workflows. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Oncocyte Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management reports a 'light at the end of the tunnel' for GraftAssureDx FDA marketing authorization following three years of kitted product development and a tripled sample size since the initial March submission. The company is utilizing a Strategic Information Review (SIR) meeting with the FDA to ensure total alignment on data requirements before final submission, aiming to mitigate regulatory misunderstandings. Performance is bolstered by a shifting market landscape where new Medicare (MolDX) guidelines have increased kidney transplant surveillance frequency from 8 to 14 tests over three years. Management believes the higher testing frequency strengthens the economic rationale for transplant centers to transition from central lab 'send-outs' to in-house kitted testing. Strategic positioning is supported by head-to-head data showing clinical equivalence to leading central lab tests, which is driving interest from top-tier U.S. transplant centers and reference labs. The company claims a two-year lead in kitted product development over competitors, positioning itself as a first-mover for in-house donor-derived cell-free DNA (dd-cfDNA) testing. Operational focus is shifting from heavy R&D investment toward commercial readiness, with current staffing levels deemed sufficient to support material revenue growth. Management continues to target FDA marketing authorization in late 2026, though they acknowledge the exact timing remains subject to government agency review timelines. Cash burn is expected to be approximately $8 million per quarter in the second half of 2026, which is higher than the previously expected $6 million due to ongoing regulatory review costs and registry activities, though it remains below the $10 million peak seen in the second quarter. The total addressable market (TAM) is projected to expand beyond the baseline $2 billion as testing frequency increases and the platform expands into heart transplant monitoring. Future capital allocation and organizational investments will be strictly tied to realized revenue growth as the company transitions to a profitable business model. European market entry via IVDR self-certification is planned for the second half of 2026, with management viewing the process as less burdensome than the U.S. FDA pathway. The Q2 adjusted EBITDA loss narrowed to $7.8 million as core spending declined from its late 2025 peak associated with the initial FDA filing. Management identified registry enrollment delays as a temporary headwind, noting that accelerating these activities is a primary lever for extending cash runway if FDA approval is delayed. The company is prudently exploring all options to extend its financial runway while maintaining the necessary infrastructure to meet anticipated market demand at launch. A KOL call is scheduled for August 17 to discuss the expansion of the GraftAssure platform into heart transplant rejection monitoring, a key component of the long-term TAM expansion strategy. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained the meeting is a proactive step to ensure 100% alignment on data interpretation before the final package submission. While a specific date was not disclosed, the meeting is intended to clear up any potential misunderstandings regarding the FDA's 'additional information' request. The primary lever is accelerating registry enrollment, which provides a revenue offset through reimbursable lab-developed tests (GraftAssureCore) priced at $2,753 per result. Management emphasized that their Nashville lab can generate immediate revenue from these registry participants while awaiting the kitted product approval. Management expects significant initial pricing power due to a lack of direct kitted substitutes and the fact that reimbursement rates remain consistent regardless of who runs the test. Volume discounts may be offered to large reference labs in exchange for volume guarantees and revenue predictability, but the underlying Medicare reimbursement provides a solid floor for ASPs. The IVDR process for Europe is viewed as more flexible than the FDA process, with no current requirement for large new clinical studies. Broad European adoption is currently gated by reimbursement, but management expects the approval of anti-CD38 drugs to serve as a major catalyst for dd-cfDNA testing demand.

Discussions with FDA advance toward expected marketing authorization for GraftAssureDx FDA completes current portion of substantive review in a timely manner Favorable Medicare reimbursement policy issued in July significantly increases GraftAssureDx surveillance testing opportunity Strong head-to-head data drive kitted customer interest NASHVILLE, Tenn., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its first quarter results: Fellow shareholders, We continue to be encouraged by progress toward our most important priority, which is to attain regulatory authorization of GraftAssureDx. In late July, the FDA completed the current phase of its substantive review of GraftAssureDx in a timely manner. The agency requested additional information from us, which is typical in a regulatory authorization process such as this. We view ourselves as being in the later stages of the review process, and after a thorough dialogue with the agency, we are encouraged to be working with a clear, well-defined set of remaining items. This welcome milestone comes after three years of rigorous kitted product development. We also have been pleased regarding the agency’s swift engagement and its ability to deliver timely feedback throughout. We have had productive dialogue with the agency since submitting GraftAssureDx for regulatory review in late March, and we expect that to continue. We would characterize our dialogue with the FDA as routine and within the realm of our expectations. Our submission was, to our knowledge, the first-ever kitted dd-cfDNA assay to be submitted for FDA authorization. As a reminder, we are not building this product alone. Our GraftAssure assay runs on a digital PCR instrument made by Bio-Rad Laboratories (NYSE:BIO), which has invested in our company. Bio-Rad commented: "Our collaboration with iMDx on GraftAssureDx reflects the kind of innovative thinking we look for in a partner. Droplet Digital™ PCR is well suited to the demands of transplant monitoring, where precise and reproducible measurement matters, and GraftAssureDx brings that capability into the clinical laboratory setting. We are proud to partner with iMDx on this program and remain confident in the path forward and positive impact to patient lives." –Jonathan Seaton, SVP Corporate Business Development, Bio-Rad Laboratories We also have expanded dialogue with several additional players in the diagnostics industry. We now believe that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, with their interest bolstered by reimbursement clarity from Medicare and the release of favorable head-to-head data regarding our assay, both of which are described in more detail below. High-volume labs that are performing other routine transplant tests are considering the addition of a reimbursed dd-cfDNA test. We believe they may see our test as a natural product line extension for their other transplant test offerings, and as a great way to serve their existing transplant center and nephrology clinic customers nationwide. We believe that these labs value the ability to deliver all the testing needed for a patient in one patient visit for blood draws, and even potentially via one report for clinicians. Contextual overview for investors: iMDx aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. We have designed the GraftAssureDx molecular test to be sold as a test kit so that transplant center laboratories can run tests locally. By running tests locally, laboratories can deliver critical test results to the physicians of transplant patients much more quickly than can be done with the currently available send-out tests. Our company is now seeking FDA marketing authorization to sell these kits in the U.S. If GraftAssure technology becomes available commercially as a test kit, it may be an industry-transforming event for transplanted organ rejection monitoring. Over time, iMDx sees three potential paradigm shifts in transplanted organ health monitoring: Bringing testing closer to the patient: The first is a shift in the location of where donor-derived cell-free DNA (dd-cfDNA) testing is performed – migrating out of a send-out service model and into hospital-based laboratories that can deliver results locally. iMDx seeks to demonstrate that in-house testing is better for patients and physicians. (As a reminder, dd-cfDNA is an established biomarker for assessing the health of a transplanted organ through a simple blood draw.) Expanding the clinical role of dd-cfDNA: The second shift is the growing potential for dd-cfDNA testing, powered by digital PCR technology, to support earlier detection of allograft injury, longitudinal monitoring of transplant health, and assessment of response to emerging anti-rejection therapies. Advancing from rule-out testing to comprehensive decision support: The third shift is the expansion of dd-cfDNA testing from mainly being used to rule out patients’ need for confirmatory biopsy testing, to also being used proactively to predict whether a patient may be progressing toward organ rejection. This important shift is enabled by GraftAssure’s ability to measure both dd-cfDNA percentage and absolute, true concentrations as copies per milliliter of plasma. Other highlights since our May 2026 update: Reimbursement and market access A favorable Medicare local coverage decision (LCD) was issued by MolDX that expands the reimbursement framework for dd-cfDNA testing by covering surveillance testing at an increased frequency compared to a draft policy released last year. This includes doubling testing rates in the second and third years post-kidney transplant to four tests per year and allowing for a frequency per year thereafter according to peer-reviewed literature and societal guidelines. The new Medicare policy also cites iMDx-affiliated research. (July 16 release) Medicare (MolDX) confirmed iMDx’s reimbursement coverage for treatment-response monitoring. We believe clinicians intend to increasingly use dd-cfDNA testing to guide ongoing anti-rejection drug therapy. MolDX has confirmed that testing under this rationale is reimbursed. (July 23 release) Clinical evidence and peer-reviewed publications A new multicenter study conducted across eight transplant centers in Germany and Austria, published in Kidney International, adds to the growing evidence that donor-derived cell-free DNA (dd-cfDNA) can do more than rule out biopsy. The retrospective study evaluated 70 kidney transplant recipients treated with Johnson & Johnson’s daratumumab (DARZALEX®) for microvascular inflammation (MVI) and antibody-mediated rejection (AMR), using our GraftAssure test to monitor therapeutic efficacy. Daratumumab treatment was associated with stabilization of kidney function, with dd-cfDNA and albuminuria levels declining early in treatment. We believe this reinforces dd-cfDNA's expanding role in actively guiding and monitoring rejection treatment. The American Journal of Transplantation published data on iMDx's new GraftAssure Combination Model (CM)-Score. Results demonstrated that our test roughly doubled positive predictive value (81% vs. a 54% published benchmark) versus single-metric dd-cfDNA measurement in kidney transplant patients, while retaining a high negative predictive value (91%). The company has launched its GALACTIC registry to build on these findings. (June 11 release) Clinical Chemistry (the journal of the Association for Diagnostics & Laboratory Medicine) published the first head-to-head comparison of GraftAssure's digital PCR-based technology against a leading NGS-based competitor assay, showing 99.2% agreement across a wide range of dd-cfDNA results under real-world clinical conditions. GraftAssure demonstrated superior analytical sensitivity and a lower limit of quantification. (June 16 release) The Lancet Regional Health – Europe published an extension of the 2024 New England Journal of Medicine felzartamab study, showing GraftAssure-guided dd-cfDNA monitoring enabled roughly two-thirds drug-sparing versus fixed dosing while maintaining treatment efficacy and safety — pointing to a market-expansion use case for GraftAssure beyond rejection detection and biopsy rule-out testing. (July 23 release) Chief Science Officer Prof. Dr. Ekkehard Schuetz, co-inventor of the underlying dd-cfDNA technology, published his 200th scientific paper. He is ranked in the top 2.5% of researchers worldwide by H-index (58) and top 2% within laboratory diagnostics. (June 29 release) Commercial and scientific community engagement iMDx showcased its GraftAssure technology, hosted a key opinion leader reception, and presented third-party head-to-head data at the American Transplant Congress in Boston, from June 20–24. (June 9 release) iMDx partnered with the American Society of Transplant Surgeons (ASTS) to name the recipients of a $100,000, company-funded health-economics research grant (Drs. Kenneth Andreoni of Thomas Jefferson University and Kenneth Chavin of Temple Health) to study the economics of in-house versus send-out dd-cfDNA testing. This research is intended to support GraftAssureDx commercialization planning. (June 22 release) Upcoming KOL call on August 17th to highlight heart transplant testing: As we continue to plan for commercializing a kitted version of GraftAssure for kidney transplant testing, the next organ of focus for GraftAssure’s application is heart transplant testing. To that end, we will be hosting a virtual key opinion leader (KOL) event to discuss in-house heart transplanted organ rejection testing on Monday, August 17, 2026, at 10:00 a.m. ET. The event will feature Dr. Max Jacob Liebo, M.D., Associate Professor and Program Director, Advanced Heart Failure and Transplant Cardiology Fellowship at Loyola University Medical Center. The call will also feature brief remarks from CEO Josh Riggs and iMDx Vice President of Medical Affairs Dr. Nick Ioannou, whose extensive experience includes previously serving as a medical science liaison for organ health and genetics at Natera. We will be issuing a separate press release with further information. Thank you for your interest in iMDx and we look forward to updating you as we transition into commercialization. Sincerely,iMDx Management Second Quarter 2026 financial overview In Q2 2026, our revenues were approximately $239,000. We reported gross profit of $157,000 in Q2 2026, representing a 65.7% gross margin. In Q2 2026, operating expenses of $11.6 million included a non-cash loss of $2.3 million from a change in the fair value of our contingent consideration, as well as $661,000 in non-cash stock-based compensation expenses, and $641,000 in non-cash depreciation and amortization expenses. The contingent consideration relates to acquisition accounting and certain earn-out arrangements related to our prior acquisitions, under which payments become due only as we achieve certain milestones or generate revenue. It is remeasured each period based on assumptions including the expected timing and amount of future revenue, probability of achieving certain earnout milestones, and discount rates. Our Q2 2026 net loss was $11.3 million, or $0.31 net loss per share. Our Q2 2026 per share results reflect 36.8 million weighted average shares outstanding and include the effects of 4.1 million unexercised pre-funded warrant shares that were issued in April 2024, February 2025, and February 2026 to a certain investor. Our cash, cash equivalents, and restricted cash balance at the end of the second quarter was $18.7 million. Our Q2 2026 outgoing cash flow from operations (net cash used in operating activities) of $9.3 million, combined with capital expenditures of about $779,000, resulted in outgoing free cash flow of approximately $10 million. While core operating expenses declined in the second quarter, outgoing cash flow widened due to working capital timing, including our annual bonus payment and vendor payments. We expect outgoing free cash flow to narrow in the back half of the year. As noted in our May update, in 2026, we expect to continue to be thoughtful about capital allocation, hiring, and expense growth. Webcast and Conference Call Information Live Zoom Call and Webcast on August 10, 2026, at 2:00 PM PT / 5:00 PM ET. Those interested may access the live Zoom call by registering here: iMDx Q2 2026 Earnings Webinar A replay of the Zoom call will be available on the Company's website shortly after the call. iMDx Transplant Products and Product Candidates in Development iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following: GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx’s CLIA-certified laboratory in Franklin, Tennessee. GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications. GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA review for use in clinical decision-making. About Insight Molecular Diagnostics, Inc. Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information. GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc. Forward-Looking Statements Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, the company’s efforts to commercialize its GraftAssure technology, discussions with the FDA and expected FDA marketing authorization to sell GraftAssureDx, the belief that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, interest from industry participants and investors, the company’s plans to deliver proven, more affordable and faster tests that can be run in-house at local transplant center laboratories, anticipated paradigm shifts in transplanted organ health monitoring, the belief that clinicians tend to increasingly use dd-cfDNA testing to guide ongoing anti-rejection drug therapy, potential use cases for GraftAssure beyond rejection detection and biopsy rule-out testing, the company’s upcoming KOL call to highlight heart transplant testing, transplant and other product candidates in development, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Insight Molecular Diagnostics’ third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Insight Molecular Diagnostics or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Insight Molecular Diagnostics, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Insight Molecular Diagnostics’ Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. FDA CAUTION: This press release concerns certain products that are under clinical investigation, and which have not yet been cleared or authorized for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated. Investor Contact: Douglas FarrellLifeSci Advisors LLC [email protected] Financial Tables Follow In addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release also includes non-GAAP financial measures (as defined under SEC Regulation G). We believe that disclosing the adjusted amounts is helpful in assessing our ongoing performance, providing insight into the Company’s core operating performance by excluding certain non-cash and other non-operating items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP financial measures, provide an additional way of viewing the Company’s results of operations and factors and trends affecting the Company’s business. These non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the respective financial results presented in accordance with GAAP. The following is a reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measure:

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management reported high engagement with the FDA following the late March submission of GraftAssureDx, maintaining a productive dialogue as the review process commences. The company is leveraging its GALACTIC registry to transition clinicians from fractional measurements to absolute and combined donor-derived cell-free DNA (dd-cfDNA) metrics, which management believes offer superior clinical utility. Early international adoption of the research-use-only GraftAssureIQ in Switzerland and Southeast Asia serves as a proof point for demand driven by faster turnaround times and absolute quantification. Market research involving over 200 U.S. purchasers affirmed the perceived value of GraftAssure, supporting management's strategy to deliver software-like margins through a kit-based model. The company is pursuing an organ-agnostic strategy, with plans to expand the kidney-validated GraftAssure technology into heart transplant testing via a simplified 510(k) pathway. Management emphasized that generating head-to-head data against legacy technologies is the primary strategic lever for establishing clinical trust and accelerating adoption. First U.S. orders for GraftAssure are expected later this year, with initial volume likely driven by sites currently participating in the FDA study that already have instruments on-site. The company is targeting regulatory compliance in the U.K. under IVDD in the coming months, followed by an IVDR submission in the EU which may take 6 to 12 months for approval. Management expects to reach its goal of 50 U.S. transplant centers for the GALACTIC registry, noting that 34 centers have already expressed interest. Financial projections assume cash burn will peak in Q2 2026 at over $9 million before declining to approximately $6 million per quarter in the second half of the year as FDA-related expenses subside. Long-term gross margin targets are set at 70% or higher, though management cautioned that initial 6-12 month margins may be lower due to introductory pricing and a 10% revenue share agreement. A 10% revenue share obligation to former Chronix shareholders exists as a permanent 'off the top' deduction from gross revenue. Q2 2026 revenue is projected at approximately $0.25 million, reflecting the pre-commercial stage of the lead diagnostic product. The company recently achieved TUV SUD ISO 13485 certification, a critical prerequisite for its European regulatory expansion strategy. Management identified instrument placement as a primary rate-limiting factor for the commercial rollout post-FDA clearance. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to disclose specific details regarding clock stoppages, citing the confidentiality of the back-and-forth process. The CEO characterized all interactions with the agency to date as productive and professional. Management views the registry and commercial success as 'one and the same,' using the registry to introduce new clinical scores while preparing sites to eventually purchase kits. The registry serves as a bridge to get instruments into the field and establish the clinical reports in real-world workflows. Pricing for the Dx product is expected to be 'well into the hundreds' per result, aligned with CMS reimbursement rates and private payer expectations. Cost of goods sold is currently slightly under $100 per result, with expectations to drive this down as volume scales. Initial gross margins will be impacted by 'leader pricing' for early adopters and the 10% IP revenue share. The U.S. market is expected to scale faster due to established reimbursement pathways. European demand is high, but growth is contingent on breaking through payer systems in Germany and the U.K. (NICE), where management sees 'cracks in the door' for coverage.

Progressing toward commercialization with third-party head-to-head data publications and GALACTIC registry study engagement Northeast kidney transplant center (among the top 10 in the U.S.) is first to sign clinical trial agreement to participate in GALACTIC study Booked research-use-only purchase by E.U. transplant center and APAC purchase expected in coming days Anticipate significant U.S. orders to follow FDA marketing authorization Encouraging dialogue with FDA supports expected authorization later in 2026 NASHVILLE, Tenn., May 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its first quarter results: Fellow shareholders, We are pleased to report that customer demand for our kitted kidney transplant monitoring assay is growing and that we are moving quickly to capture what we believe to be a $2 billion annual market opportunity. iMDx is at a pivotal stage in commercializing GraftAssureDx, which we expect to be an industry-transforming transplanted organ rejection monitoring test. We aim to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. To do this, we have designed a molecular test that we can sell as a high gross margin kit. These test kits enable transplant center laboratories to run tests locally and deliver critical test results far more quickly than the current standard of care tests. We are now seeking FDA authorization to sell these kits. Since submitting GraftAssureDx for FDA review in late March, we have had productive dialogue with our FDA reviewers and have been encouraged by their swift engagement. As is the case with any in vitro diagnostic, the FDA is seeking to ensure that our test is safe, effective, and performs as intended. We expect to continue to have meaningful and frequent engagement with the FDA throughout the review process. Meanwhile, the GraftAssureIQ research-use-only pilot program that launched in summer 2024 is beginning to produce tangible results. So far in the second quarter, we have seen new traction with one small commercial order outside of the U.S. and another that we expect soon. This summer, we expect to achieve our first significant U.S. order of GraftAssureIQ from a major transplant hospital. Our goal with the pilot program was to put our dd-cfDNA technology into the hands of researchers and clinicians, which is something to which they historically did not have direct access. Since then, they have been using our GraftAssureIQ kits and we are seeing expanded research and development utilization of our dd-cfDNA technology by the experts closest to transplantation. Researchers and laboratory clinicians enjoy this type of exploration. Our future potential customers are highly engaged and passionate about transplant medicine, advancing science, and helping patients. Now, we are thrilled to share with our investors that independent researchers have begun to publish their own data using our assay. This spring, we were delighted to see a strong slate of international conference activity with new, independent, real-world data involving our assay being presented across leading global forums: Positive head-to-head data on our GraftAssure assay were presented at the 39th European Immunogenetics and Histocompatibility Conference (EFI2026), April 21–24, 2026, in Edinburgh, Scotland; Three posters are scheduled to be presented at the 63rd European Renal Association (ERA) Congress, June 3–6, 2026, in Glasgow, Scotland; and A favorable real-world evidence poster is scheduled to be presented at the American Transplant Congress (ATC), June 20–24, 2026, in Boston. At EFI2026 in Scotland, referenced above, independent researchers presented two GraftAssureIQ posters. One poster, with researchers from Marseille, France, evaluated our technology head-to-head with a leading competing technology and supported both the accuracy and clinical differentiation of our technology. A second poster from a U.K. National Health Service laboratory highlighted GraftAssureIQ’s quality, practical workflow and clinical performance. We are pleased to share that head-to-head data generated using GraftAssure technology now demonstrates comparable performance to the two leading players in the field, supporting equivalence with two commercially available assays currently on the market. Notably, the above-referenced study represents the second head-to-head comparison between GraftAssure and other technologies on the market. In June 2025, we announced separate favorable head-to-head data that was presented at the European Society of Organ Transplantation (ESOT) Congress in London as well as at the European Renal Association (ERA) meeting. This data has now been accepted for publication in the major laboratory diagnostics journal, Clinical Chemistry. Our Q4 2025 shareholder letter, published six weeks ago on March 26, outlined six goals for 2026. We will briefly provide an update on each: 1) Bring GraftAssureDx to market in the U.S.: We are finalizing our pricing strategy after surveying more than 200 likely purchasers of our test kits. This market research affirmed our confidence in the value delivered by our kitted clinical assay and in our ability to gain adoption while also retaining value for our company and the shareholders who have funded the development of this assay. Also, as noted above, dialogue with the FDA has been productive, and we continue to target receipt of FDA marketing authorization later this year, with the caveat that the timing of a government agency review is not completely within our control. 2) Obtain GraftAssureDx regulatory approval in the U.K. and E.U.: Following the receipt of TÜV SÜD ISO 13485 certification on February 26th, we are targeting receiving CE Mark under the U.K. In Vitro Diagnostic Directive (IVDD) in the coming months, and plan to submit for In Vitro Diagnostic Regulation (IVDR) approval in the E.U. soon thereafter. 3) Commence GraftAssureIQ RUO sales: In recent weeks, a transplant hospital in Switzerland purchased a small number of GraftAssureIQ research-use-only kits. In addition, a hospital in Southeast Asia began the process to purchase our kits. This milestone, though immaterial to revenue, is an important proof point for us. When disrupting a market, securing the first customers is often the most challenging and time-consuming task. While these initial orders are just the beginning, we anticipate that these sites will become repeat customers as they continue to establish dd-cfDNA testing in their respective countries. We expect to realize our first U.S. orders, in greater quantities, later this year. 4) Make progress toward establishing absolute quantification as an important metric: Our GALACTIC registry study (GraftAssure Lowering Allograft rejeCTIon by Combination) is designed to drive clinical adoption and build a scientific case for our combined score (CM-score). This self-funding study will help clinicians across the country to become familiar with our clinical reports and to evaluate the utility of having access to both the absolute quantification of dd-cfDNA in the blood and the CM-score. So far, 34 U.S. transplant centers have expressed interest in being part of our registry, which we believe represents remarkable progress toward our 50-center goal. In addition, we recently signed our first clinical trial agreement with a Northeast kidney transplant center that is among the largest 10 centers in the U.S. You may read more about the GALACTIC registry study by viewing its listing on clinicaltrials.gov. 5) Market GraftAssureCore and drive samples to our Tennessee clinical lab: GraftAssureCore is the lab-developed test form of our assay. It can give customers an opportunity to see the benefits of our test in a format consistent with their current send-out testing modality with the future potential benefit of bringing our technology’s fast turn-around time in-house. As a reminder, Medicare reimburses GraftAssureCore at a rate of $2,753 per result. 6) Commence R&D to expand GraftAssure utility into heart transplant rejection: Our GraftAssure technology is designed to be organ agnostic. Clinicians and researchers at leading transplant institutions have expressed their excitement about our planned expansion into heart transplant rejection testing. We look forward to updating you on our progress with this over the next year. Finally, in case you missed it, CEO Josh Riggs’s second annual letter to shareholders was published in our proxy statement, which was filed on April 30, 2026. We believe it provides a little more detail about the business that we are seeking to build — and why. As Josh notes in that letter, transformational change in any industry rarely is obvious — at first. Three years ago, we saw a clear opportunity to strategically pursue high-value content that appeared to be trapped in inefficient business models. We believe that we are making notable progress towards launching our first in vitro diagnostic test kit and achieving this vision. Sincerely, iMDx Management First Quarter 2026 Financial Overview In Q1 2026, our revenues were approximately $32,000. All our revenues were derived from laboratory services performed at our clinical laboratory in Tennessee. Relative to our strategic goal of selling diagnostic test kits for clinical use, we remain essentially “pre-revenue.” Our laboratory services are performed at the request of select clients, and we see our laboratory services revenue as a testament to our team’s ability to achieve the on-time delivery of clear, scientifically sound, and accurate data sets to our clients. In Q1 2026, our laboratory staff was focused on research and development work to support our FDA submission, inhibiting its ability to perform revenue-producing laboratory services on behalf of clients. We did not realize any kitted product revenue in the first quarter. As previously communicated, we do not expect material revenue on our kitted product sales until after we have achieved regulatory authorization to market GraftAssureDx. We reported gross profit of $15,000 in Q1 2026, representing a 46.9% gross margin. In Q1 2026, operating expenses of $4.4 million included a non-cash gain of $5.9 million from a change in the fair value of our contingent consideration, as well as $615,000 in non-cash stock-based compensation expenses, and $610,000 in non-cash depreciation and amortization expenses. Excluding the impact of these non-cash net adjustments in Q1 2026, our non-GAAP operating expenses decreased 1% sequentially over the fourth quarter of 2025, and increased 45% year over year, as we invested more heavily in our FDA program ahead of commercial launch. In Q1 2026, research and development expenses decreased 15% sequentially, or by about $876,000, to $5.0 million, reflecting lower laboratory and supplies costs as we concluded our FDA submission work streams. As noted last quarter, Q4 2025 represented higher-than-average research and development expenses as we approached FDA submission, including FDA-compliant software development expenses, laboratory supplies, kit production, and personnel costs associated with our clinical trial, including regulatory consulting fees. As expected, Q1 2026 R&D expenses declined sequentially and we expect these expenses to decline again in Q2 2026, as the heavy expenses associated with our FDA submission regarding GraftAssureDx for kidney are behind us. In Q1 2026, sales and marketing expenses increased $111,000 sequentially to $2.4 million. We continue to invest in go-to-market activities as we prepare for commercial launch, including marketing, advertising, travel, consulting fees and personnel. General and administrative expenses rose to $3.0 million in Q1 2026. In the prior quarter, Q4 2025, general and administrative expenses of $2.3 million reflected a favorable employee-retention credit of $337,000 related to payroll taxes, which did not repeat in Q1 2026. Our Q1 2026 net loss was $4.3 million, or $0.12 net loss per share. Non-GAAP Net Loss: Our Q1 2026 adjusted net loss of $9.6 million represented a loss of $0.28 per share. Our adjusted net loss excludes the non-cash charges of stock-based compensation expenses and the change in fair value of our contingent consideration (“Non-GAAP Net Loss”). Please refer to the table below, “Reconciliation of Non-GAAP Financial Measures,” for additional disclosures and information. Non-GAAP Adjusted EBITDA Loss: Our Q1 2026 adjusted earnings or loss before interest, income taxes, depreciation, amortization, stock-based compensation, change in fair value of contingent consideration, and other non-operating items (“Adjusted EBITDA Loss”) was $9.1 million. The sequential change in Adjusted EBITDA Loss represented cost discipline offset by lower gross profit in the quarter. Please refer to the table below, “Reconciliation of Non-GAAP Financial Measures,” for additional disclosures and information. Our Q1 2026 per share results reflect 34.5 million weighted average shares outstanding and include the effects of 4.5 million pre-funded warrant shares that were issued in April 2024, February 2025, and February 2026 to a certain investor. Inclusive of all outstanding shares, pre-funded warrants, and subsequent issues for stock awards, our pro-forma fully weighted share count would be 36.7 million shares. Our cash, cash equivalents, and restricted cash balance at the end of the first quarter was $29.4 million. On February 12, 2026, we completed a $26.0 million registered direct offering, which after deducting fees, resulted in net proceeds of approximately $24.6 million. As expected and projected, our Q1 2026 outgoing cash flow from operations (net cash used in operating activities) of $7.6 million, combined with capital expenditures of about $613,000, resulted in outgoing free cash flow of $8.3 million. As noted in our March update, in 2026, we expect to continue to be thoughtful about capital allocation, hiring, and expense growth. Webcast and Conference Call Information Live Zoom Call and Webcast on Wednesday, May 13, 2026, at 2:00 p.m. PT / 5:00 p.m. ET. Those interested may access the live Zoom call by registering here: iMDx Q1 2026 Earnings Webinar A replay of the Zoom call will be available on the Company’s website shortly after the call. iMDx Transplant Products and Product Candidates in Development iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following: GraftAssureCore – The Company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx’s CLIA-certified laboratory in Franklin, Tennessee. GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications. GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making. About Insight Molecular Diagnostics, Inc. Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information. GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc. Forward-Looking Statements Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, demand for iMDx’s products and what the Company is building, the expectation that decentralized testing will deliver new value in the roughly $2 billion-plus addressable market for kitted transplant rejection testing, the Company’s competitive advantage and path to supplying the world’s most widely used dd-cfDNA assay, iMDx’s expectations for FDA review and authorization and its 2026 goals (including but not limited to commercial, regulatory and R&D goals), iMDx’s expectations regarding orders of, and the timing of orders of, GraftAssureIQ in the U.S., iMDX’s beliefs regarding the timing of its launch of its in vitro diagnostic test kit, management’s thoughts on where transplant patient management is headed and why the Company is well-positioned, emerging clinical utility of dd-cfDNA testing, the belief that democratizing access to transplanted organ rejection testing creates a rapidly growing, high-margin, recurring business model, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Insight Molecular Diagnostics’ third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Insight Molecular Diagnostics or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly, such statements should be evaluated together with the many uncertainties that affect the business of Insight Molecular Diagnostics, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Insight Molecular Diagnostics’ Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. FDA CAUTION: This shareholder letter concerns certain products that are under clinical investigation, and which have not yet been cleared or authorized for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated. Investor Contact: Alexandra Grossman LifeSci Advisors LLC [email protected] Tables Follow INSIGHT MOLECULAR DIAGNOSTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) INSIGHT MOLECULAR DIAGNOSTICS INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) INSIGHT MOLECULAR DIAGNOSTICS INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) INSIGHT MOLECULAR DIAGNOSTICS INC. RECONCILIATION OF NON-GAAP FINANCIAL MEASURES NON-GAAP NET LOSS AND ADJUSTED EBITDA LOSS In addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release also includes non-GAAP financial measures (as defined under SEC Regulation G). We believe that disclosing the adjusted amounts is helpful in assessing our ongoing performance, providing insight into the Company’s core operating performance by excluding certain non-cash and other non-operating items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP financial measures, provide an additional way of viewing the Company’s results of operations and factors and trends affecting the Company’s business. These non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the respective financial results presented in accordance with GAAP. The following is a reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measure: (1) The March 2025 reconciliation line-items have been presented to conform to the current presentation. The newly titled total “Adjusted EBITDA loss, a non-GAAP financial measure” reported for March 2025 is unchanged from the March 2025 “Consolidated non-GAAP loss from operations, as adjusted” as previously reported.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Insight Molecular Diagnostics Inc (NASDAQ:IMDX) has submitted Graftassure DX to the FDA and is experiencing high engagement, indicating progress in the review process. The company is expanding its market presence with early orders from a Swiss transplant hospital and expected orders from Southeast Asia, demonstrating international interest. The Galactic Registry study is gaining traction with 34 U.S. transplant centers expressing interest, up from 28 centers six weeks ago, showing strong engagement. Insight Molecular Diagnostics Inc (NASDAQ:IMDX) has achieved TUFSUD ISO 13,485 certification and is targeting regulatory compliance in the UK and EU, indicating a focus on international expansion. The company is planning to expand its Graftassure technology into heart transplant testing, leveraging its organ-agnostic design, which could open new market opportunities. The company's Q2 2026 revenue projection is modest at about a quarter million dollars, with a significant portion from laboratory services rather than product sales. Projected cash burn for the second quarter is high at over $9 million, which is expected to be the peak for the year, indicating financial strain. There is uncertainty in revenue predictions, which could impact cash burn and financial stability. The company faces challenges in placing instruments in the field, which could delay the commercialization of Graftassure DX post-FDA clearance. The European market's reimbursement landscape remains uncertain, which could affect the speed and volume of market penetration compared to the U.S. Warning! GuruFocus has detected 6 Warning Signs with IMDX. Is IMDX fairly valued? Test your thesis with our free DCF calculator. Q: Any clock stoppages in the FDA review so far? A: Josh Riggs, CEO: We're treating all interactions with the FDA as confidential, but we're pleased with the productive conversations so far. Q: How are you balancing the desire of accounts to participate in the registry study versus getting commercial wins? A: Josh Riggs, CEO: We are selective with registry sites, but commercial success aligns with our goals. Most registry participants are expected to become long-term kit customers. Q: Can you share details from the pricing survey and your updated thoughts on pricing? A: Josh Riggs, CEO: Centers are aligning with our pricing expectations, which are well into the hundreds for the DX product. Andrea James, CFO, added that the pricing research supports the $2 billion total addressable market. Q: What gross margins should we expect in the first 12 to 24 months post-commercialization? A: Andrea James, CFO: Model an ASP in the hundreds with a cost of goods sold slightly under $100. Long-term target gross margin is around 70%, but initial contracts may not reach this immediately due to revenue sharing agreements. Q: Once FDA clearance is obtained, how quickly can you start driving sales of the kits? A: Josh Riggs, CEO: The placement of instruments is a rate limiter. Sites participating in the FDA study are likely day-one adopters. We are working to get instruments into the field. For the complete transcript of the earnings call, please refer to the full earnings call transcript.