Insight Molecular Diagnostics Inc. Common Stock 2026 Q2 Earnings Call

Thanks, Gabby. It feels great to be coming to you today with line of sight on expected FDA marketing authorization for GraftAssureDx. We have three brief but promising takeaways today in our shareholder letter. The first is that after three 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 is 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 have 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 is 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 eight to 14 tests in the first three 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 two years ahead with regard to kitted product development among competitors. Third, and finally, we have 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 U.S.

It feels like half the country is in a three-point stance waiting for the opportunity to bring dd-cfDNA testing in-house. From an expense standpoint, 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 U.S. 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 break even 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 equivalence to leading tests that are performed at central laboratories. 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. Should be second quarter there.

Andrea. Yeah. Hi. 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 two 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 cost to complete the regulatory review process, along with registry activities ahead of associated GraftAssure CORE 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 GraftAssure CORE. Remember, GraftAssure CORE 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 two 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.

Expanded organ indications grows the TAM yet again. Remember that Dr. Ekkehard Schütz 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 17th 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's got their hands up.