Spectral Medical (EDT) Q1 2025 earnings summary

Executive summary

• Completed full enrollment of the Tigris Phase III trial for PMX in endotoxic septic shock; topline results expected August 2025.

• Entered into a US$10 million promissory note with Vantive to fund regulatory and commercialization activities.

• Focused on regulatory submission and commercialization in partnership with Vantive following Baxter's divestiture of its Kidney Care business.

Financial highlights

• Revenue for Q1 2025 was $572,000, down 14% year-over-year; royalty revenue increased by $7,000, while product revenue declined due to billing timing.

• Operating expenses rose 173% to $13,174,000, mainly from a non-cash fair value adjustment on derivative liabilities.

• Net loss for Q1 2025 was $12,605,000 ($0.04/share), compared to $4,160,000 ($0.01/share) in Q1 2024.

• Cash at March 31, 2025 was $1,670,000, down from $2,988,000 at year-end 2024.

Outlook and guidance

• Topline Tigris trial results expected in Q3 2025, with PMA clinical submission targeted by end of October 2025.

• Commercialization plans for PMX in the U.S. are advancing in anticipation of positive trial outcomes and regulatory approval.