Insight Molecular Diagnostics Inc.

Welcome, everyone, and thank you for joining us to discuss Insight Molecular Diagnostics first quarter 2026 results. If you have not seen today's shareholder letter, please visit Insight Molecular Diagnostics Investors 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 Eki 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 go over our safe harbor. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forward-looking statements. These statements are made pursuant to and within the meaning of the safe harbor provision of the Private Securities Litigation Reform Act of 1995. We encourage you to review the company's SEC filings, including the company's most recent Form 10-K and subsequent Forms 10-Q, which identify risks and uncertainties that may cause future actual results or events to differ materially. Please note that the forward-looking statements made during today's call speak only to the date that 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.

Thanks, Gabby, and thanks, everyone, for joining us today. We are excited to share with you this business update and our progress creating value at IMDx for patients, clinicians, our employees, and our shareholders. Since submitting Graft Assured DX to the FDA in late March, we've had a high degree of engagement from them and expect that that will continue as we move through the review process. We continue to enroll patients under the study protocol, building the data set and sample bank to support potential future publications, research, and claims expansion. We've committed to delivering software-like margins with Graft Assured. Over the past several months, we surveyed over 200 likely U.S. purchasers working through multiple pricing and purchasing scenarios to guide our pricing strategy. This market research has affirmed our confidence in Graph Assure's perceived value and our ability to translate that into strong margin for both the company and the shareholders who funded its development. We expect our first U.S. orders for Graph Assure later this year. Outside of the U.S., we've seen some encouraging market access progress for sites using the research-use-only version of our technology Graftassure IQ. In recent weeks, a Swiss transplant hospital purchased a small number of kits, and we are expecting our first orders out of Southeast Asia. These early milestones, though immaterial to revenue, represent important proof points to us about the need being addressed by Graftassure. At least one of these centers was able to establish coverage and reimbursement for the test in its market. Purchase decisions are being driven by demand for faster turnaround time, access to absolute quantification, and the ability to get reimbursed. We anticipate that these sites will become repeat customers as they continue to establish GDC-FP&A testing in their respective countries. On the back of receiving Tuftsud ISO 13485 certification in February, we are targeting regulatory compliance in the UK under IBDD in the coming months and plan to submit for in vitro diagnostic regulation, or IBDR, approval, and the EU soon thereafter. In our March update, I explained that to be prepared for the successful launch of Graft Assured DX, we want to achieve or witness three key trends. Those are strong engagement in the galactic registry study, early adopters using Graft Assured IQ, and seeing more head-to-head data establishing parity with legacy technology. We continue to make progress against all three. First, our galactic registry is designed to drive the clinical adoption and understanding of our absolute and combined measurements of donor-derived cell-free DNA. The current standard of care is the fractional or percentage measurement. We believe these alternative measures offer incremental information for the clinician and could prove to have additional utility in certain clinical contexts. This self-funding study will help more clinicians become familiar with our clinical reports and establish their usefulness. in diverse real-world clinical situations. So far, 34 U.S. transplant centers have expressed interest in being part of our registry. This is up from 28 centers just six weeks ago and represents remarkable progress toward our 50-center goal. In addition, we recently signed our first clinical trial agreement with one of those 34, putting us closer to first patient in. This is encouraging since successful enrollment generates revenue for the company this year. As a reminder, Medicare reimburses Graftassure Core at a rate of $27.53 per result. Second, later this year, we expect to see initial orders of Graftassure IQ in larger volumes than we've seen before from our first U.S. customers. Third, we are seeing the emergence of head-to-head data comparing our Graftassure AdSense with other commercially available technologies. We mention these studies in our shareholder letter. Just to emphasize, Generating head-to-head data is the fastest path to establishing trust for a new diagnostic, so we are very enthusiastic about what's been reported to date. Finally, I will close my remarks by touching briefly upon our expansion into heart transplant testing. As a reminder, our graft-to-short technology is designed to be organ agnostic, so the assay that we build for kidney will work in heart. Clinicians and researchers at leading transplant institutions and first patient in as quickly as possible. We have made a lot of progress this year and look forward to updating shareholders as we push to make managing patients post-transplant easier for clinicians here in the U.S. and abroad. Now, let me turn the call over to our CFO, Andrea James, to provide a review of our financial results for the first quarter. Andrea?

Thanks, Josh. Hi, everyone. Our first quarter results are in line with what we told you they would be and our preliminary release of our cash balance and revenue, which we made on April 14th. From where we sit today, our financial projections remain consistent with the update that we provided in late March. Our Q2 2026 revenue projection is for about a quarter million dollars, comprised mostly of laboratory services and a very low level of Gratissure IQ sales. We're projecting second quarter cash burn above 9 million, which will be the high watermark for the year. In the second quarter, we paid out bonuses and addressed other working capital needs associated with the graft-assured DX FDA submission expenses, which we incurred in prior quarters. We expect cash burn to come down in the back half of the year, closer to historical levels of $6 million per quarter, driven by working capital favorability and reduced research and development expenses, as many of our FDA program expenses will not repeat. This, of course, is also subject to revenue that can be difficult to predict. As revenue ramps, of course, this will significantly reduce our quarterly cash burn. This management team remains highly thoughtful about extending our cash runway and focusing our commercialization investments toward the areas that we believe will drive optimal ROI for the company. Finally, I'll close by reflecting on my almost two-year anniversary with this company, which is coming up in June. We have been building a foundation from which we expect to launch a rapidly growing company that has the potential to be highly profitable, and I am incredibly excited about our future. I told you on my first earnings call in summer of 2024 that we have a compelling opportunity to achieve market disruption and in so doing, create a multibillion-dollar company. We are closer than ever to that vision, and we continue to retire risk on the path to initial and then material revenue. Gabby, we can now take questions. And Eric, if you could please bring us up into gallery view. Thank you. Thank you, Andrea. And we've got Thomas Flatton from Lake Street.