Sana Biotechnology (SANA) Corporate presentation summary

Strategic focus and pipeline highlights

• Targeting type 1 diabetes (T1D) and in vivo CAR T cell therapies as major opportunities, with T1D affecting ~10M people globally and current treatments falling short.

• SC451 program aims for a one-time, immunosuppression-free cure for T1D using hypoimmune stem cell-derived islets, with IND filing and Phase 1/2 trial initiation targeted for 2026.

• In vivo CAR T cell platform leverages fusosome technology for cell-specific delivery, aiming for off-the-shelf therapies without conditioning chemotherapy.

• SG293 (CD19-targeted) and SG227 (BCMA-targeted) are lead CAR T candidates, with first-in-human data for SG293 in non-Hodgkin lymphoma expected in 2026 and SG227 clinical study in multiple myeloma by mid-2027.

Scientific and clinical validation

• Hypoimmune technology enables allogeneic cell survival without immunosuppression, validated in non-human primates and a first-in-human T1D patient.

• Clinical trial with HIP islet cells in T1D patient showed cell survival, function, and immune evasion for over 12 months, meeting all safety and efficacy endpoints.

• Imaging and C-peptide data confirmed graft survival and endogenous insulin production up to 14 months post-transplant.

• No detectable immune response against HIP-modified cells at 12 months, supporting immune evasion claims.

Development progress and next steps

• SC451 program advanced through nonclinical testing, GMP manufacturing, and regulatory engagement; clinical sites selected and activation underway.

• Next steps include completing GLP toxicology, filing INDs in multiple geographies, and initiating Phase 1 testing.

• Phase 1/2 trial will focus on safety, cell survival, and function, with potential for insulin independence within 3-6 months.