Spectral Medical (EDT) Status update summary

Clinical trial results and significance

• Tigris phase III trial met its primary endpoint, showing a 95.3% posterior probability of benefit at 28 days and a 99.4% probability at 90 days, with a 17.4% absolute mortality reduction at 90 days compared to standard care.

• The number needed to treat (NNT) at 90 days is 8.1, indicating strong efficacy compared to previous therapies for septic shock.

• Results are consistent with prior EUPHRATES trial data and global real-world evidence, reinforcing the therapy's potential.

• Safety profile aligns with historical and international data, with no unexpected concerns anticipated.

• Manuscript submission with full results and secondary endpoints is planned for late summer or early fall, with publication expected by year-end or early 2026.

Regulatory and commercialization pathway

• FDA submission for PMX therapy is planned for October, with non-clinical modules already accepted and clinical review expected to take about nine months.

• Collaboration with Baxter includes joint regulatory efforts to align device and therapy approvals, aiming for simultaneous market entry.

• Commercial preparations are underway, leveraging Baxter's infrastructure and experience in critical care to support rapid adoption upon approval.

• Financing milestones tied to trial results are expected to be met, with additional funding tranches anticipated soon.

• No immediate plans to utilize the CAD 100 million shelf offering; financial flexibility is maintained for future needs.

Market positioning and future outlook

• TREA Therapy integrates diagnostic and therapeutic components for targeted, rapid intervention in endotoxic septic shock.

• The therapy targets a well-defined patient population, supporting a precise label and focused commercial strategy.

• Robust 90-day mortality benefit is expected to support reimbursement and adoption, with additional health economic analyses forthcoming.

• Ongoing and future studies may expand indications to other conditions with high endotoxin levels, such as cardiac surgery or organ transplantation, post-FDA approval.

• Long-term (12-month) outcome data are being collected and will be reported in future analyses.