Insight Molecular Diagnostics Inc. Q3 FY2024 earnings call

• Transplant market is changing, OncoCyte is a leading force; worked with beta sites, technology on three continents, signed leading transplant centers, and made progress in FDA program.
• GraftAssure RUO kit demand exceeding expectations in Europe; in U.S., carving out market share while staying on pace with FDA program.
• Actively talking to over 30 sites with high organ transplant volumes, on track to meet site placement goal of 20 sites by end of next year, each site potentially averaging $1M/year in revenue.
• First meeting with FDA in early December to go through validation plan; engaged with stakeholders, including strategic partnering.
• DetermaIO oncology product data validated its utility, closer to reimbursement, and supports partnering conversations.
• Raised $10.2M in private placement, welcomed support from existing and new investors, including Bio-Rad; focus on capital allocation, controlling expenses, and runway for FDA clearance and strategic partners.

No specific segment performance data on absolute terms and revenue contribution % provided in the transcript.

• On track to meet or exceed site placement goal of having 20 sites signed by end of next year.
• Expect revenue build once FDA clears kits for clinical decision making.
• First meeting with FDA in early December to go through validation plan, confident in efficient path to success.

No detailed discussion of specific risks in the provided transcript.

Q: Role of Bio-Rad over next year before FDA approval, assistance in marketing RUO product?

A: Josh said Bio-Rad has supported by opening doors in Central Europe, presence at conferences giving credibility, and Bio-Rad reps standing alongside during site setups.

Q: Reception of GraftAssure workflow, time to train physicians?

A: Josh said workflow not foreign to PCR-trained personnel, takes 1-2 weeks to get up and running.

Q: Value of VitaGraft for high-risk transplant patients?

A: Josh discussed GraftAssure RUO vs IVD product VitaGraft+, immediate testing for some, majority later, economic incentive for in-house testing.

Q: RUO product adoption, decision makers, pushbacks?

A: Josh said need buy-in from lab manager and transplant center manager, pushback on new instrument with one piece of content, but demand winning day.

Q: FDA meeting, supporting pivotal study, concordant studies on AMR?

A: Josh talked about submitting validation plan, Class 2 device, looking at biopsy as gold standard, publication on AMR detection with 10 months lead time.

Q: U.S. sales funnel conversion to revenue after FDA approval?

A: Josh said 6-9 month lead-in period from FDA clearance to meaningful revenue.

Q: Why not use NGS tests?

A: Ekke Schutz explained digital PCR is faster than NGS, NGS has high cost for singleton samples, PCR allows quick results.