Xeris Biopharma (XERS) Status update summary

Strategic vision and growth trajectory

• The strategy focuses on building a fast-growing commercial enterprise and advancing a robust pipeline, with XP-8121 as the lead asset for long-term growth.

• Current products are performing well, supporting a goal of $750 million in total revenue by 2030.

• Long-term goal is multi-billion total revenue and positioning as a leading biopharmaceutical company by 2035.

Clinical need and innovation

• XP-8121 targets 3–5 million U.S. hypothyroid patients not achieving biochemical control with current oral levothyroxine due to GI absorption issues.

• XP-8121 is a once-weekly subcutaneous levothyroxine formulation that bypasses GI absorption, aiming to improve outcomes for these patients.

• The product is protected by strong IP covering composition of matter and methods of use, with patents extending to at least 2043.

Clinical development program

• The comprehensive program includes Cornerstone (phase III pivotal study), Capstone (pediatric study), Touchstone (special population study), and real-world evidence initiatives.

• Cornerstone will enroll 500 adults and adolescents, comparing weekly subcutaneous XP-8121 to daily oral therapy over 54 weeks, with primary and key secondary endpoints focused on TSH normalization and time in range.

• Statistical design features a 15% non-inferiority margin and over 90% power, with FDA feedback incorporated.

• Capstone extends safety and dosing data to pediatric populations, while Touchstone targets inadequately controlled patients.

• Real-world evidence and investigator-initiated research support clinical differentiation and market readiness.