IMDX · Insight Molecular Diagnostics Inc.

Insight Molecular Diagnostics (iMDx) reported Q1 2026 results that reflect its pre-revenue status for its kitted GraftAssureDx product, with total revenue of just $32,000 from laboratory services. The company posted a GAAP net loss of $4.3 million ($0.12 per share) and a non-GAAP net loss of $9.6 million ($0.28 per share), with adjusted EBITDA loss of $9.1 million. Operating expenses of $4.4 million included a $5.9 million non-cash gain from fair value change of contingent consideration, partially offset by $615,000 in stock-based compensation and $610,000 in depreciation. Research and development expenses decreased 15% sequentially to $5.0 million as the company completed its FDA submission work streams, while sales and marketing increased to $2.4 million as it prepares for commercial launch. The company ended the quarter with $29.4 million in cash, after a $24.6 million net proceeds from a February 2026 registered direct offering. Management highlighted progress toward FDA authorization for GraftAssureDx, with productive dialogue and expectation of authorization later in 2026. The GALACTIC registry study signed its first clinical trial agreement with a top-10 U.S. transplant center, and the company booked its first research-use-only purchase from a Swiss hospital, with an APAC order expected soon. The company remains focused on commercializing its kitted dd-cfDNA assay for kidney transplant rejection monitoring, targeting a $2 billion annual market.