Spectral Medical (EDT) Q4 2025 earnings summary

Executive summary

• Completed enrollment and released positive topline results for the Tigris trial, advancing PMX toward FDA Premarket Approval submission.

• Achieved key milestones: Tigris manuscript published in The Lancet Respiratory Medicine and presented at SCCM Annual Congress.

• Focused on high-quality PMA submission and building clinical/commercial foundation for PMX adoption.

Financial highlights

• Q4 2025 revenue was $382,000, down from $645,000 in Q4 2024; full-year 2025 revenue rose 7% to $2,442,000 year-over-year.

• Operating expenses for 2025 increased to $49,394,000 from $16,862,000 in 2024, mainly due to non-cash fair value adjustment of derivative liabilities.

• Loss from continuing operations for 2025 was $47,689,000, up from $15,395,000 in 2024, driven by derivative liability adjustments and higher interest expense.

• Ended 2025 with $4,071,000 in cash, up from $2,988,000 at end of 2024.

• 292,562,913 common shares outstanding as of December 31, 2025.

Outlook and guidance

• PMA submission for PMX expected between late April and mid-May 2026, incorporating complete 12-month mortality data.

• Topline 12-month mortality and outcome data anticipated in late May or early June 2026.

• Commercialization planning ongoing with Vantive, aligning market readiness with potential FDA approval.