Insight Molecular Diagnostics (IMDX) Q2 2025 earnings summary

Executive summary

• Net revenue rose to $518,000 for Q2 2025, up 398% year-over-year, driven by Laboratory Services and initial kitted product sales, with first revenue from GraftAssureIQ research-use-only kits and second-generation kits shipped in June 2025.

• Remain on track for FDA submission of GraftAssureDx/Breptosure DX by end of 2025, with approval targeted for mid-2026 and commercial launch expected about a year from now.

• Clinical trial enrollment is underway at leading transplant centers, with positive feedback from beta sites and new data presented at major conferences supporting product differentiation.

• Company rebranded to Insight Molecular Diagnostics Inc. and relocated headquarters to Nashville, Tennessee in June 2025.

• Strategic focus remains on organ transplant diagnostics, with expansion plans for additional solid organ transplant indications and a multi-indication portfolio strategy.

Financial highlights

• Q2 2025 net revenue was $518,000, up from $104,000 in Q2 2024; six-month revenue reached $2.7 million, up from $280,000 year-over-year.

• Gross profit for Q2 2025 was $350,000, with a 67.6% gross margin, up from 62% in Q1 2025.

• Q2 2025 net loss was $9.7 million, or $(0.30) per share, compared to $4.5 million prior year; non-GAAP loss from operations was $6.0 million.

• Cash, cash equivalents, and restricted cash at June 30, 2025 totaled $26.0 million, including proceeds from recent financings.

• Outgoing cash flow from operations was $6.3 million in Q2, with capital expenditures of $349,000.

Outlook and guidance

• FDA submission for GraftAssureDx/Breptosure DX expected by year-end 2025, with approval anticipated in mid-2026 after a 6–7 month review.

• Commercial launch anticipated about a year from now, with ramp in adoption as centers validate and transition to the new test.

• Q3 2025 laboratory services revenue expected to be under $300,000, with cash burn to average $6 million per quarter, peaking in Q3.

• Plans for clinical and regulatory expansion into additional transplant indications from 2026 to 2028.

• Sufficient cash projected to meet operating requirements for at least the next twelve months.