Insight Molecular Diagnostics Inc. Q2 FY2025 earnings call

• Product Development: Completed assay and workflow design improvements for ReftAssure DX, with first kits shipped to beta sites in June. Clinical trial has had its first site initiation visit, with two more upcoming, on track to submit to the FDA by the end of 2025.
• Commercial Strategy: Landed leading transplant centers with research use only (RUO) kits, shifting to precommercial mode for a launch ~1 year from now. There are 10 sites running RUO assay in multiple countries, and 5 major US hospitals are in the clinical trial.
• Innovation: Combined relative and absolute quantification of ddcfDNA to achieve ~80% positive predictive value (PPV), with data expected to be published. Plan to expand into heart, lung transplants, and therapeutics indications.
• Financials: Q2 2025 laboratory services revenue was $494,000 with gross margins near 68%. Cash burn is expected to average ~$6,000,000 per quarter until commercial launch, with Q3 cash burn higher than Q2 then lower in Q4.

In Q2 2025, laboratory services revenue was $494,000, which was previously labeled as pharma services revenue. Approximately $24,000 worth of first generation Graft Assure IQ kits were sold. Second generation RUO kits started shipping in June but do not carry revenue as customers are using them for validation in their labs.

• Target to submit the FDA data package by the end of 2025 and aim for FDA approval in 2026.
• On track to have 20 sites trained on the graft to shore workflow by the end of 2025, with 10 sites already running RUO assay.
• Expect Q3 2025 laboratory services revenue to be less than $300,000, with cash burn averaging ~$6,000,000 per quarter until commercial launch.

• Uncertainties in the FDA approval timeline beyond current projections.
• Potential impact of CMS reimbursement decisions on commercialization and pricing.
• Variability in clinical trial enrollment and site activation.

Q: Mark Massaro asked about the clinical trial timeline and CMS coordination.

A: Josh Riggs discussed the FDA review timeline of 5 months, budgeting 6-7 months for submission, and stated there has been no direct coordination with CMS regarding reimbursement.

Q: Mason Carrico inquired about utilization of the IOTA program.

A: Josh Riggs said early feedback from the World Transplant Congress was positive, but reach is limited for a broad response.

Q: Thomas Flaten asked about clinical trial sites and RUO kit improvements.

A: Josh and Ekke Schutz discussed ongoing site enrollment and RUO kit improvements combining workflows for better precision.

Q: Mike Matson asked about Medicare reimbursement and launch.

A: Josh Riggs said there is an expectation of a smooth transition to the FDA cleared product for reimbursement, with adoption ramping up post-launch.

Q: Yuan Zhi asked about the combined method and organ diagnostics.

A: Ekke Schutz explained the benefits of the combined method and the potential for organ-specific models