T2 Biosystems (TTOO) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Diagnostic innovation and market position

• Developed the only FDA-cleared products detecting sepsis-causing pathogens directly from blood, targeting a market over $2 billion and selling in 45+ countries.

• Customers include top hospitals globally and in the U.S., with products reimbursed under the DRG system.

• Focused on sepsis, a leading cause of death and hospitalization costs, with significant global and U.S. impact.

• Current standard of care is slow and insensitive, relying on blood culture with up to 5-day delays and 60% sensitivity.

• FDA and CDC issued alerts in July 2024 about blood culture supply shortages, affecting half of U.S. hospitals.

Product portfolio and clinical impact

• T2Dx instrument runs seven tests simultaneously; panels include T2Candida, T2Bacteria (both FDA-cleared), and T2Resistance (CE marked, FDA submission planned Q4 2024).

• T2Resistance, T2Lyme, and Candida auris tests have FDA Breakthrough Device Designation for prioritized review.

• T2Bacteria Panel received NTAP from CMS, covering two-thirds of costs above DRG.

• Meta-analysis of 14 studies showed T2 products reduced time to species ID by 77 hours, targeted therapy by 42 hours, and hospital stay by 5 days compared to blood culture.

• Case studies highlight faster targeted treatment and improved patient outcomes in critical cases.

Commercial strategy and expansion

• Nearly 200 instruments installed globally, with a balanced U.S. and international presence.

• Expanding distribution in 40+ countries and negotiating a major U.S. commercial partnership.

• Four-phase commercial execution: education, implementation, launch, and expansion.

• Commercial focus on sepsis: adding customers, accelerating implementation, and expanding within existing accounts.

• Technology also applied to bioterrorism (T2Biothreat Panel) and Lyme disease (T2Lyme Panel, LDT launch planned Q3 2024).