Sernova Biotherapeutics (SVA) H.C. Wainwright 26th Annual Global Investment Conference summary

Key presentations and announcements

• Introduced a regenerative medicine platform using a Cell Pouch transplant system for chronic diseases.

• Lead program is a Phase I/II clinical trial for insulin-dependent Type 1 diabetes, with observed insulin independence in patients.

• Preclinical programs are ongoing for thyroid disease and hemophilia, with a thyroid clinical trial planned for early next year and an iPSC-derived islet trial set for 2026.

• Partnership with Evotec focuses on developing iPSC-derived islet-like clusters (ILCs) for broader diabetes treatment.

• Additional clinical data to be presented at the European Association for the Study of Diabetes.

Clinical trial insights and data

• Cell Pouch system creates a vascularized, organ-like environment for therapeutic cell transplantation.

• Phase I/II trial includes 13 long-term Type 1 diabetic patients with severe hypoglycemia history.

• Cohort A completed with five of six patients achieving insulin independence for 9 months to over 4 years.

• Optimal islet dose determined at approximately 14,000 IEQ/kg; immunosuppression regimen optimized after initial challenges.

• HbA1c levels improved or sustained post-treatment, even in patients previously on intensive insulin therapy.

Preclinical and future development plans

• Preclinical studies show ILCs perform equivalently to human donor islets in animal models, with sustained glucose normalization.

• ILCs can be cryopreserved, enhancing commercial viability and global distribution.

• Next clinical trial with iPSC-derived ILCs planned for 2026, aiming for an unlimited cell supply.

• FDA authorized additional patients in Cohort B to further validate optimized immunosuppression.

• Patient testimonials highlight long-term insulin independence and improved quality of life.