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Spectral Medical (EDT) investor relations material
Spectral Medical Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary6 Nov, 2025
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.
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Next Spectral Medical earnings date
Q4 202527 Mar, 2026
Next Spectral Medical earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
Spectral Medical Inc is a Canadian biotechnology company focused on the development of diagnostics and therapeutics for sepsis and septic shock. The company’s product portfolio includes medical devices and biologics that aid in early detection and targeted treatment of systemic inflammatory conditions. It works with clinical partners and regulatory authorities to support commercialization efforts. The company is headquartered in Toronto, Ontario, and its shares are listed on the TSX.
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