Insight Molecular Diagnostics Inc. Common Stock KOL event

Please go ahead, Josh. Thanks, Sarah, and welcome everybody.

We are going to just do one quick slide on forward-looking statements. All right, there they are. Thank you. We can move forward. Last year, we did our first KOL call, with Dr. Anthony Langone of Vanderbilt University, about how blood-based DNA tests have made it easier to manage kidney transplant patients. Now, our test, GraftAssureDx, is working its way through the FDA for exactly that indication. After we finish with kidney, our team is preparing to start work on a claims expansion into heart. Today, we are grateful to have transplant cardiologist, Dr. Max Lebo of Loyola University, on to talk about how these types of tests are used to manage heart transplant patients here in the U.S. Thank you, Dr. Lebo, for joining and offering to share some of your time and expertise.

Guiding us through the conversation will be our very own Dr. Nick Ioannou, our Vice President of Medical Affairs, to whom I will now turn the call over.

Thank you. Thank you, Josh.

Josh started by telling us what was happening a year ago with Dr. Kenneth, who came and talked about kidney transplants. I want to start by telling you what was happening about 10 years ago when I started talking to my fellow colleagues, transplant nephrologists, transplant cardiologists, about these donor-derived cell-free DNA tests. Ultimately, most of them, when I was in there talking to them about these tests, they were saying, "These are great tests. Will we be able to do these here in our labs?" The answer back then was no. But you know what? Now that answer is yes. I want to walk you through, I want to take about 5 minutes, maybe even less, then walk you through some milestones, probably like seven dates, how heart transplant has evolved.

It starts off back in 1967 when the first heart transplant was performed by a fellow South African colleague, Dr. Christiaan Barnard. After that, heart transplant became pretty common. Many hearts were transplanted, but the problem is there was a lot of rejection due to the body's immune system protecting itself. It would see a foreign heart, and it would say, "This is not part of me. I have to reject it." In 1983, things changed because in 1983, the FDA approved cyclosporine, and that drug works by suppressing the body's immune system. This led to an increase in heart transplantation rates. The health of the newly transplanted hearts is monitored by performing biopsies. These biopsies, also known as endomyocardial biopsies, where a catheter is inserted from one of the veins and it removes pieces of heart for microscopic examination.

There's 3 to 5 samples that are removed, and the pathologists look at those, and they can tell if there's biopsy or not. Now, that first year after a heart transplant, on average, it's between 14 to 18 biopsies. Only in that first year. There's a lot of biopsies that are happening in that first year. Between 2019 and 2023, there were prospective multi-center trials that validated donor-derived cell-free DNA as a biomarker for acute rejection. In 2022, expert review by the American College of Cardiology highlighted donor-derived cell-free DNA as a promising non-invasive alternative to endomyocardial biopsies. In 2024, as per the SRTR, the Scientific Registry of Transplant Recipients, there were 4,636 heart transplants performed in the U.S.A. Max and I have known each other for a while now. Max, I'm going to ask you a few questions.

You're here because you're the expert, so please tell us how you guys are doing these things. My first question is, at your center, prior to donor-derived cell-free DNA testing, how many protocol biopsies were performed that first year on your patients?

Great. Max, thanks, and especially thank you for telling us about the for-cause and the surveillance biopsies and differentiating there. Most of us, I think you are the only cardiologist on this call, so most of us are not cardiologists. Please help us understand, after you get that positive biopsy, what is the process? What is your treatment regimen?