Spectral Medical (EDT) Q2 2025 earnings summary

Executive summary

• Completed patient enrollment in the pivotal Phase III Tigris trial for PMX in April 2025; topline results expected mid-August 2025.

• All non-clinical PMA modules submitted to FDA; clinical data submission targeted by end of October 2025.

• Secured non-dilutive financing of up to US$10 million from commercialization partner Vantive.

• Ongoing commercialization planning with Vantive, including 510(k) submission for the PrisMax system.

Financial highlights

• Q2 2025 revenue was $813,000, up 73% year-over-year; six-month revenue rose 22% to $1,385,000.

• Q2 product revenue increased 86% year-over-year to $403,000, mainly due to Vantive's PMX purchases.

• Q2 operating expenses decreased 47% year-over-year to $2,514,000, driven by non-cash finance income.

• Q2 net loss narrowed to $1,933,000 ($0.00/share) from $4,402,000 ($0.02/share) year-over-year.

• Cash at June 30, 2025 was $3,100,000, up from $2,988,000 at December 31, 2024.

Outlook and guidance

• Topline Tigris results expected mid-August 2025; clinical PMA submission to FDA by end of October 2025.

• Market readiness and commercialization efforts aligned with potential FDA approval timelines.