Insight Molecular 2025 Q3 Earnings Revenue Surges 126% as Net Loss Narrows 19.6%

Insight Molecular (IMDX) reported Q3 2025 results that exceeded expectations, driven by robust revenue growth and improved profitability. The company submitted its GraftAssureDx test for FDA approval by year-end, aligning with guidance for a 2026 commercial launch.

Revenue

Insight Molecular’s total revenue surged 126.1% year-over-year to $260,000 in Q3 2025, with all revenue derived from laboratory services. This marked a significant acceleration from $115,000 in the prior-year period, reflecting strong demand for its diagnostic testing solutions.

Earnings/Net Income

The company narrowed its net loss to $10.85 million ($0.34 per share) in Q3 2025, a 19.6% reduction from $13.49 million ($0.98 per share) in Q3 2024. While still in the red, the improvement in EPS and net loss underscores progress in cost management and operational efficiency.

Post-Earnings Price Action Review

The investment strategy of buying IMDX shares on revenue announcements and holding for 30 days has delivered an average quarterly return of 12.76% over three years. Cumulative gains reached 67.15%, outperforming the SPY ETF’s 9.50% return during the same period. The strategy’s volatility, with 10% quarterly deviations, aligns with expectations for high-growth stocks.

CEO Commentary

CEO Josh Riggs highlighted the “palpable excitement” around GraftAssureDx’s FDA submission and commercial launch in 2026. The CEO emphasized progress in clinical trials, including 11 active sites and 19 transplant centers engaged with GraftAssure technology. Strategic priorities include decentralizing testing and expanding into heart transplant diagnostics, with a goal of achieving $100 million in annual revenue.

Guidance

The company remains on track to submit GraftAssureDx for FDA review by year-end 2025, with a mid-2026 launch anticipated. It aims to expand into heart transplant testing and achieve $100 million in annual revenue, leveraging CMS reimbursement and a 5,000-participant registry study to validate clinical utility.

Additional News

Recent developments include the expansion of GraftAssureDx clinical trials to 11 sites, with 19 transplant centers engaged in testing. The company also announced a 5,000-participant registry study to validate the assay’s clinical utility, a key step for market adoption. Additionally, the CEO reiterated confidence in the test’s favorable head-to-head data and its potential to disrupt the $1 billion transplant diagnostics market.