Sana Biotechnology (SANA) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic partnerships and platform overview

• Entered a collaboration with Mayo Clinic, providing equity investment and clinical trial support for SC451.

• Developing two main platforms: a hypoimmune cell therapy for type 1 diabetes and an in vivo CAR T platform targeting cancer and autoimmune diseases.

• The hypoimmune platform aims for a one-time, immunosuppression-free treatment for type 1 diabetes.

• The in vivo CAR T platform seeks to eliminate conditioning chemotherapy and improve manufacturability and safety.

Type 1 diabetes program progress

• Preparing to file an IND for SC451 and initiate a phase I/II trial by year-end.

• Previous IIT study (UP421) in Sweden met all primary and secondary endpoints, showing 14 months of islet cell survival without immunosuppression.

• SC451 will use stem cell-derived islets, aiming for scalable manufacturing and intramuscular delivery.

• Key next steps include completing GLP toxicology, GMP tech transfer, and scaling up manufacturing.

• Early clinical success will be measured by immune evasion and insulin production within 28 days, with longer-term insulin independence as a goal.

In vivo CAR T platform advancements

• Lead program SG293 targets non-Hodgkin's lymphoma, with first-in-human data expected in the first half of 2027.

• The fusosome vector system enables cell-specific delivery and integration, aiming to reduce off-target toxicity and allow redosing.

• Platform refinements include minimizing CAR surface expression to lower immunogenicity and improve manufacturability.

• NHP studies showed significant CAR T expansion, B cell depletion, and evidence of B cell reset.

• SG227, a BCMA-directed CAR T, is also advancing, with plans to expand into multiple myeloma and autoimmune diseases.