Insight Molecular (NASDAQ:IMDX) held its first-quarter earnings conference call on Wednesday. Below is the complete transcript from the call.
This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/.
The full earnings call is available at https://imdxinc.zoom.us/webinar/register/WN_1wfEuYIiTN2_qMWR2anaow#/registration
Summary
Insight Molecular Diagnostics Inc submitted GraftAssuredX to the FDA in March 2026 and expects continued engagement during the review process.
The company conducted market research with over 200 US purchasers, affirming confidence in GraftAssure’s value and potential for strong margins.
International progress includes research use of GraftAssure IQ in Switzerland and Southeast Asia, with some centers establishing coverage and reimbursement.
Financial projections for Q2 2026 include revenue of about $250,000, primarily from laboratory services, and a high cash burn of over $9 million, expected to decrease in the year’s second half.
The company is targeting regulatory compliance in the UK and plans to submit for EU IVDR approval later this year.
The Galactic Registry study is gaining momentum, with 34 US transplant centers interested, aiming for a 50-center goal.
Future developments include expansion into heart transplant testing and expected initial orders of GraftAssure IQ in the US.
Management is focused on extending cash runway and optimizing ROI, with long-term gross margin targets around 70%.
Full Transcript
OPERATOR
Welcome everyone and thank you for joining us to discuss Insight Molecular Diagnostics Inc’s first quarter 2026 results. If you have not seen today’s shareholder letter, please visit Insight Molecular Diagnostics Investors relations page@investors.imdxinc.com Today’s prepared remarks build upon the information already shared in this robust letter. Joining us today are Insight Molecular Diagnostics Inc’s President and CEO, Josh Riggs, Chief Science Officer, Eky 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 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 10K and subsequent Forms 10Q, 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 Inc undertakes no obligation to update them. And with that I would like to now turn the call over to Josh Riggs.
Josh Riggs (President and CEO)
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 GraftAssure 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 GraftAssure. Over the past several months we surveyed over 200 likely US purchasers working through multiple pricing and purchasing scenarios to guide our pricing strategy. This market research has affirmed our confidence in GraftAssure’s perceived value and our ability to translate that into strong margin for both the company and the shareholders who funded its development. We expect our first US Orders for Graftasure later this year. Outside of the US 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 the though immaterial to revenue, represent important proof points to us about the need being addressed by graftesure. 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 dd-cfDNA testing in their respective countries. On the back of receiving TÜV SÜD ISO 13485 certification in February, we are targeting regulatory compliance in the UK under IVD in the coming months and plan to submit for In Vitro Diagnostic Regulation or IVDR (In Vitro Diagnostic Regulation) approval in the EU soon thereafter. In our March update, I explained that to be prepared for the successful launch of GraftAssure DX, we want to achieve or witness three key trends. Those are strong engagement in the Galactic Registry study, early adopters using Graftasure 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 2,753 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 US Customers. Third, we are seeing the emergence of head to head data comparing our graft assure assay with other commercially available technologies. We mentioned these studies in our shareholder letter just to emphasize generating head to head data is the fastest path to establishing trust for a new diagnostic, so we are very enthusiastic about what’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 assured technology is designed to be organ agnostic, so the assay that we built for kidney will work in heart. Clinicians and researchers at leading transplant institutions have expressed their excitement about our planned expansion. We are working with them to get the protocol finalized and first patient in as quickly as possible. We have made …
This post was originally published here
