Spectral Medical (EDT) Status update summary

Key milestones and financing

• Achieved full enrollment of the Tigris study with 157 patients, marking a major step in sepsis research.

• Secured a $10 million debt facility from Vantive, structured in four tranches, to fund operations through potential PMX clearance and commercialization.

• Financing terms include a 9% annual interest rate, four-year term, and no dilution or conversion features.

• Tranches are tied to clinical and regulatory milestones, including data release, warrant exercises, and FDA submission acceptance.

Regulatory and clinical trial update

• Data monitoring and cleaning for all Tigris trial patients is underway, with data lock expected by end of July.

• Top-line results, focusing on 28-day and 90-day mortality using Bayesian analysis, are expected by mid-August.

• Results will be submitted for publication in late August or early September, with FDA submission targeted for October.

• FDA review is anticipated to take about nine months, leveraging both trial and extensive external safety/effectiveness data.

Market opportunity and commercialization

• Estimated addressable market is 120,000–130,000 patients annually in the US and Canada.

• Vantive is positioned as the primary commercialization partner, leveraging its acute therapy distribution expertise.

• Adoption is expected to be driven by survival benefit, health economic impact, and lack of competing therapies.

• Product is anticipated to become the standard of care for eligible septic shock patients.