Spectral Medical (EDT) investor relations material

Executive summary

• Targeting FDA PMA submission for Toraymyxin (PMX) on May 29, 2026, incorporating 12-month mortality data from the Tigris study in alignment with FDA feedback.

• Vantive committed to additional funding support ahead of the PMA acceptance milestone, reflecting strong partnership and commercialization readiness.

• Tigris trial results published in The Lancet Respiratory Medicine confirm positive survival and safety outcomes for PMX in endotoxic septic shock.

Financial highlights

• Revenue for Q1 2026 was $891,000, up 56% from $572,000 in Q1 2025, driven by higher product and instrumentation sales and PMX pre-commercialization activities.

• Operating expenses decreased 72% year-over-year to $3,633,000, mainly due to lower fair value adjustments on derivative liabilities.

• Net loss for Q1 2026 was $2,938,000 ($0.01 per share), a significant improvement from $12,605,000 ($0.04 per share) in Q1 2025.

• Interest expense increased due to higher outstanding debt and full-quarter accrual of paid-in-kind interest.

Outlook and guidance

• Topline 12-month mortality data from the Tigris study expected in June 2026, supporting the PMA submission.

• Ongoing collaboration with Vantive on commercialization planning and market readiness aligned with potential FDA approval timelines.