Spectral Medical (EDT) Status update summary

Tigris trial enrollment and timeline

• Enrollment reached 138 patients, with robust activity until a slowdown in October due to a nationwide saline shortage caused by Hurricane Helene.

• Full enrollment is now projected by the end of Q1 2025, with top-line data expected approximately 120 days after last patient enrollment, targeting early Q3 2025.

• FDA submission is anticipated around the end of Q3 2025, with a complete review expected by Q1 2026.

• The saline shortage reduced enrollment by about a dozen patients, but screening activity remains strong and is improving.

• Enrollment requires 150 evaluable patients, but due to some patients not receiving intervention, total enrollment will be slightly higher (157-160).

Impact of saline shortage and site performance

• The saline shortage has been a significant challenge, but production issues are resolving and allocation is expected to normalize soon.

• High-performing sites continue to drive most enrollments, with little change in site performance patterns.

• Efforts to dedicate saline to high-enrolling sites are limited by the nationwide shortage, but logistical support from Baxter has helped.

Sub-studies and additional research

• The PrisMax sub-study has enrolled 12 patients and is on track to reach its target of at least 15.

• The EDEN sub-study data are locked and primary analysis is complete, with abstracts to be presented in February and manuscript submission targeted for January.