Orchestra BioMed (OBIO) Corporate presentation summary

Strategic partnerships and business model

• Partnerships with Medtronic and Terumo drive clinical development and commercialization of flagship technologies.

• Business model focuses on capital efficiency and royalty-based revenue from partner-driven commercialization.

• Funding is secured to support operations through key trial milestones, including BACKBEAT and Virtue trials.

Flagship technologies and clinical programs

• AVIM Therapy is a novel cardiac pacing-based treatment for hypertension, supported by robust clinical data and two FDA Breakthrough Device Designations.

• Virtue SAB is a proprietary sirolimus drug delivery balloon for artery disease, with three FDA Breakthrough Device Designations and a pivotal trial underway.

• Both technologies target large, established global cardiovascular markets with combined annual opportunities exceeding $27B.

Clinical trial progress and milestones

• BACKBEAT global pivotal study for AVIM Therapy is enrolling, targeting completion by Q3 2026 and data readout in Q2 2027.

• Virtue Trial is a pivotal, FDA IDE-approved RCT comparing Virtue SAB to AGENT DCB, enrolling 740 patients with primary endpoint at 12 months.

• Major data readouts and regulatory submissions are planned for 2027.