Spectral Medical (EDT) Q3 2025 earnings summary

Executive summary

• Achieved positive topline results from the Tigris Phase 3 trial, meeting primary and key secondary endpoints for PMX in endotoxic septic shock, with significant mortality reduction demonstrated.

• PMA submission for PMX now targeted for Q1 2026, following ongoing FDA interactions and feedback on non-clinical components.

• Strengthened balance sheet with $3M advanced from Vantive and $2.5M from warrant exercises, supporting regulatory and commercialization activities.

Financial highlights

• Q3 2025 revenue increased 34% year-over-year to $675,000; nine-month revenue up 26% to $2,060,000, driven by higher EAA diagnostic and PMX-related revenues.

• Q3 2025 operating expenses rose 196% to $30.8M, mainly due to non-cash fair value adjustments of derivative liabilities linked to share price increases.

• Q3 2025 net loss was $30.3M ($0.11/share) vs. $10.0M ($0.04/share) prior year; nine-month net loss $44.9M ($0.16/share) vs. $18.6M ($0.07/share) prior year.

• Gross profit for Q3 2025 was $484,000, up from $414,000 in Q3 2024.

• Cash at quarter-end was $5.9M, up from $3.0M at December 31, 2024.

Outlook and guidance

• PMA submission for PMX expected in Q1 2026, with ongoing FDA engagement to ensure a high-quality, compliant application.

• Commercialization planning with Vantive continues, with market readiness aligned to potential FDA approval timelines.