Insight Molecular Diagnostics Inc. Q3 FY2025 earnings call

Josh Riggs discussed the building momentum, with the expected FDA authorization of GraftAssure DX in 2026. A pilot program last summer provided feedback to optimize the workflow from two steps to one step. A white paper was published showing strong performance across multiple centers. A registry program was announced to familiarize clinicians with the technology and generate real-world data. Clinical trial sites are engaged, with leading transplant centers participating. Progress at the FDA was discussed, with a planned submission in December but noting the FDA is not accepting new submissions during the government shutdown. Plans for 2026 include validating heart and lung assays, and submitting for reimbursement for heart in 2026 and lung in 2027. Andrea James highlighted financial highlights, discussed the total addressable market (TAM), and mentioned the shift from a development-stage company to a commercial organization.

Finished the quarter with $20 million in cash and equivalents and no debt. Lab services revenue came in as expected, and is modeled to be sequentially flat in Q4. Q3 cash burn was below the stated goal of $6 million per quarter, and Q4 cash burn is expected to tick up a bit due to expenses associated with the FDA submission and clinical trial. There has been incremental investment in research and development throughout the year in preparation for the FDA submission, and this has been absorbed while maintaining cash burn levels at $6 million per quarter by generating gross profit from additional lab services work at the Nashville lab.

Expect to move forward with validating heart and lung assays in 2026. Plan to submit for reimbursement for heart in 2026 and lung in 2027. The registry study design is complete, with 10 centers lined up, and the registry study is expected to appear on clinicaltrials.gov early next year.

The government shutdown affects the FDA's ability to answer questions and accept new submissions, which could impact the timeline. Clinical trial sample enrollment progress may have an impact on the timeline for the FDA submission.

Q: About the LCD for kidney protocol and potential for improvement and limits removal A: Hopeful that brakes get taken off and clinicians can manage patients as they see fit, supporting industry efforts to expand, and having no special knowledge on current negotiations with MolDx Q: On IOTA and utilization of transplant testing A: Natural that using more at-risk organs drives demand for testing Q: On GraftAssure core LDT and strategy A: Tied to the registry, engaged with 10 sites, and the revenue profile is expected to improve next year Q: On conversion curve and gating factors for GraftAssure DX A: The market wants to see results, and efforts are being made to influence the curve now Q: On PPV feedback from clinicians A: Broadly positive, with clinicians seeing value in higher positive predictive value Q: On mid-2026 launch timeline risks A: The biggest risk is the FDA, and the government shutdown can impact the timeline Q: On trial enrollment metrics and registry purpose A: Enrolling samples with 5 sites, and the registry is for familiarization and generating real-world data Q: On head-to-head testing reimbursement and registry help A: Clinical evaluation program for head-to-head, and registry for familiarization Q: On trial sample enrollment and submission timeline A: 5 sites are enrolling, and the submission is being prepared with clinical data being the smallest part of the overall submission