Insight Molecular Diagnostics Inc. (IMDX) Q2 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

Thank you for joining us today. 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. Thanks, Cathy. It feels great to be coming to you today with line of sight on expected FDA marketing authorization for Graft Assured DX. 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's a normal part of the Class 2 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 ...