Orchestra BioMed (OBIO) Barclays 28th Annual Global Healthcare Conference summary

Program overviews and strategic positioning

• Two pivotal cardiovascular programs are enrolling: Virtue Sirolimus AngioInfusion Balloon (SAB) for coronary artery disease and AVIM therapy for hypertensive heart disease in pacemaker patients.

• Strategic partnerships with Medtronic, Terumo, and Ligand have strengthened the balance sheet and minimized equity dilution, providing several years of financial runway.

• Virtue trial enrollment is about a year behind the BACKBEAT trial, with data expected after primary endpoint periods.

• The business model focuses on reaching pivotal data, with commercialization driven by partners and revenue from royalties.

• Expanded partnerships have brought in over $60 million in new commitments, supporting long-term milestones.

Drug-eluting balloon (Virtue) market and differentiation

• Virtue is the only drug-eluting balloon (DEB) in its category using sirolimus and a proprietary delivery method, differentiating it from paclitaxel-coated competitors.

• The DEB market is experiencing a paradigm shift, with high physician interest but current products not matching drug-eluting stent outcomes.

• Virtue’s liquid delivery system enables higher and sustained drug levels compared to stents and other DEBs, with pilot data showing a 2.8% target lesion failure rate.

• The product avoids problematic polymers, using a novel encapsulation approach to eliminate inflammation risks.

• Physician demand for Virtue trial participation is high, with ongoing education on sirolimus benefits and product differentiation.

AVIM therapy trial progress and outlook

• AVIM pivotal trial has expanded to over 100 sites globally, with protocol changes accelerating enrollment and strong support from Medtronic.

• The therapy is activated via pacemaker programming, showing immediate and significant blood pressure reductions in high-risk patients.

• Data presentations highlight benefits beyond blood pressure, including improved cardiac function and workload in older, high-risk populations.

• Medtronic will integrate AVIM into next-generation pacemakers, targeting initial commercialization in 2028, with global regulatory filings planned.

• The trial now includes patients with devices implanted up to six years prior, aiming to reflect real-world use and long-term therapy impact.