Insight Molecular Diagnostics Inc. Q4 FY2024 earnings call

• Launched GraftAssure kidney transplant test with leading centers, feedback led to improvements in user experience and assay design. - A groundbreaking study in the New England Journal of Medicine led to FDA breakthrough designation for felzartamab. - Published data showing assay detects organ rejection 11 months ahead of standard protocols in high-risk populations, and Medicare claims expanded. - Partnered with Bio-Rad, strengthened team with CFO Andrea James and Consulting Chief Medical Officer Dr. Paul Billings. - Had first positive pre-submission meeting with FDA, projecting mid-2026 for approved product. - Target to sign 20 transplant centers by end 2025, halfway there. - Pharma services revenue in Q4 was $1.5M, expected to vary as focus shifts to transplant assay development.

In Q4, pharma services revenue was $1.5 million with a 40% gross margin. Cash position: ended the year with $10 million in cash, and in February successfully raised an additional $29 million. The five largest shareholders, including Bio-Rad, led the funding round.

• Projected timeline for approved product on market is mid-2026. - Expect pharma services revenue to naturally vary as balanced with strategic priorities. - Target $6 million per quarter cash burn in 2025, with Q2 and Q3 expected to be the heaviest spend quarters. - Successfully raised $29M in February, with Bio-Rad making third equity investment and pledging support.

• Macro uncertainties around federal government affecting FDA timeline and staffing. - Uncertainty in DC regarding FDA funding and staffing levels, which is being monitored.

Q: About the regulatory pathway, timing, de novo vs 510(k) pathway.

A: Budgeting 7 months for de novo pathway. No real advantage of de novo vs 510(k) as there's no clear predicate device for donor-derived cell-free DNA.

Q: Number of centers and patients for the trial.

A: Need about 150 biopsy-matched samples for clinical trial with sufficient statistical power. Expect 6 centers, with some samples from Europe.

Q: Submission timeline shift.

A: Cautious due to DC uncertainty, but confident 6 centers can enroll 150 patients quickly.

Q: Revenue from RUO product and commercialization.

A: No material revenue from RUO product this year; focus on regulated product in US and Europe.

Q: Bio-Rad support details.

A: Bio-Rad to support clinical trial and commercialization, offsetting spend this year.

Q: Clinical evidence priorities post-approval.

A: Focus on kidney first, then heart, liver, lung; bridge reimbursement via MolDX.

Q: Workflow integration and competition.

A: Workflow is easy to integrate, competition will point to existing samples, but data will be key.