Insight Molecular Diagnostics | 8-K: FY2025 Q2 Revenue Beats Estimate at USD 518 K

Revenue: As of FY2025 Q2, the actual value is USD 518 K, beating the estimate of USD 291.95 K.

EPS: As of FY2025 Q2, the actual value is USD -0.3, missing the estimate of USD -0.23.

EBIT: As of FY2025 Q2, the actual value is USD -9.742 M.

Segment Revenue

• Laboratory Services: $494,000 in Q2 2025, up from $104,000 in Q2 2024. For the six months ended June 30, 2025, revenue was $2,632,000, up from $258,000 in the same period in 2024.
• Kitted Products: $24,000 in Q2 2025, with no revenue reported in Q2 2024. For the six months ended June 30, 2025, revenue was $24,000, with no revenue reported in the same period in 2024.
• Total Revenue: $518,000 in Q2 2025, up from $104,000 in Q2 2024. For the six months ended June 30, 2025, total revenue was $2,656,000, up from $280,000 in the same period in 2024.

Operational Metrics

• Gross Profit: $350,000 in Q2 2025, representing a 67.6% gross margin, up from 62% in Q1 2025.
• Operating Expenses: $10.2 million in Q2 2025, including $2.8 million in a non-cash change in the fair value of contingent consideration, $504,000 in non-cash stock-based compensation expenses, and $538,000 in non-cash depreciation and amortization expenses.
• Net Loss: $9.7 million in Q2 2025, or - $0.30 per share.
• Non-GAAP Loss from Operations: $5.98 million in Q2 2025, excluding certain non-cash items.

Cash Flow

• Cash, Cash Equivalents, and Restricted Cash: $26.0 million at the end of Q2 2025, including $28.7 million in net financing cash flow from a registered direct offering and private placement in February 2025.
• Net Cash Used in Operating Activities: $6.3 million in Q2 2025.
• Capital Expenditures: $349,000 in Q2 2025.

Unique Metrics

• Medicare Reimbursement: Boosted reimbursement for the Lab Developed Test (LDT) version of GraftAssureCore to $2,753 per result.
• Clinical Trials: Listing includes top transplant hospitals such as Mayo Clinic, Tampa General Hospital, Cleveland Clinic, Vanderbilt University, and Intermountain Health.
• New Data: Published head-to-head data favorably comparing digital PCR-based test kits with NGS kits.

Outlook / Guidance

• FDA Submission: On track to submit GraftAssureDx for FDA review by the end of 2025, with potential marketing authorization as soon as mid-2026.
• Product Pipeline: Plans for clinical and regulatory expansion of dd-cfDNA kitted assays from 2026 to 2028, including monitoring therapeutic response to drugs, recurrence monitoring for kidney transplant rejection, and expansions into heart, lung, and liver transplant rejection testing.
• Strategic Collaborations: Signed a non-binding development letter of intent with a major instrument maker regarding the DetermaIO immuno-oncology assay.