Insight Molecular Diagnostics (IMDX) Q4 2025 earnings summary

Executive summary

• Submitted GraftAssureDx, a dd-cfDNA assay for kidney transplant rejection, to the FDA, marking a significant regulatory milestone and the first kitted assay of its kind, with commercialization and adoption ramp planned post-authorization.

• Raised $26 million in a registered direct offering, with Bio-Rad increasing its equity stake, supporting expansion into heart transplantation, commercialization, and R&D.

• Engaged with 37 U.S. and 11 international transplant centers, representing over 25% of annual U.S. transplants, with 28 centers onboarded to the GALACTIC registry.

• Favorable head-to-head data from independent studies and peer-reviewed publications demonstrated equivalence to national reference labs and clinical differentiation, accelerating interest in in-house testing.

• Appointed Dr. Nick Ioannou as VP of Medical Affairs to prepare for commercial launch.

Financial highlights

• Q4 2025 revenue was $1.1 million; full year 2025 revenue reached $4.1 million, up from $1.9 million in 2024.

• Q4 2025 gross profit was $496,000 (43.5% margin); full year gross profit was $2.3 million (56.7% margin).

• Q4 2025 net loss was $23.0 million ($0.72 per share); adjusted net loss was $8.7 million ($0.27 per share).

• Maintenance spending is approximately $5.5 million per quarter, with growth spending at $2 million per quarter; cash burn is higher in H1 due to timing of payments and lower early-year revenue.

• Q4 included a $14.6 million non-cash impairment charge for oncology assets, excluded from adjusted EBITDA.

Outlook and guidance

• Expect FDA authorization for GraftAssureDx in 2026, with a 150-day review timeline, and anticipate U.K. CE marking in Q2 2026 and EU IVDR submission.

• Focused on commercializing the kidney transplant assay and expanding into heart transplant testing in 2025.

• Project average cash burn of $7.5 million per quarter in 2026, with higher outflows in H1 and lower in H2.

• Targeting engagement with 50 transplant centers for the registry and aiming for 5,000 patients enrolled, each tested about 10 times.

• Plan to transition from development to commercialization, targeting sustained free cash flow and high-margin revenue.