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Insight Molecular Diagnostics (IMDX) investor relations material
Insight Molecular Diagnostics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary10 Nov, 2025
Executive summary
Building momentum toward FDA submission for GraftAssureDx, targeting a mid-2026 commercial launch and aiming to transform transplant patient monitoring with in-house testing at transplant centers.
Net revenue for Q3 2025 was $260,000, up 126% year-over-year, and $2.9 million for the nine months ended September 30, 2025, up 638% year-over-year, driven by Laboratory Services and initial kitted product sales.
Net loss for Q3 2025 was $10.9 million, a 20% improvement from Q3 2024, with a cash balance of $20.2 million and no debt at quarter-end.
Strategic shift from development-only to commercial operations, with a focus on scaling, market access, and customer engagement, supported by expanded Bio-Rad partnership.
Expanding clinical engagement, with registry studies, pilot programs, and 19 global transplant centers engaged in research or trials.
Financial highlights
Q3 2025 net revenue: $260,000; nine months: $2.9 million; gross margin for Q3: 53.5%.
Net loss for Q3 2025: $10.9 million, or $(0.34) per share; cash and equivalents at quarter-end: $20.2 million.
Q3 cash burn was below $6 million, with Q4 expenses expected to exceed $6 million due to FDA program investments.
Research and development expenses for nine months: $10.1 million, up 33% year-over-year.
Maintained gross profit by performing extra lab services work at the Nashville lab.
Outlook and guidance
Preparing for a mid-2026 commercial launch of GraftAssureDx, with FDA submission expected by year-end 2025.
Anticipates material revenue growth post-regulatory clearance, targeting $100 million in annual high-margin revenue.
Cash burn expected to remain flat or tick up slightly in early 2026, with flexibility to scale back expenses if needed.
Focused on expanding transplant and oncology product lines, with regulatory submissions and clinical trials ongoing.
Plans to introduce Adjusted EBITDA, adjusted net loss, and adjusted EPS metrics in 2026.
CM score: How does it change dd-cfDNA utility?
How will you capture market share pre-FDA approval?
What is the cash burn flexibility post-FDA submission?
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Next Insight Molecular Diagnostics earnings date
Q4 202527 Mar, 2026
Next Insight Molecular Diagnostics earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
OncoCyte Corporation develops and markets molecular diagnostics for use in oncology and transplantation. The company focuses on liquid biopsy technologies and gene expression testing to support clinical decision-making in patient care. Its services are aimed at healthcare providers and research institutions. The company is headquartered in Irvine, California, and its shares are listed on the NASDAQ.
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