Orchestra BioMed (OBIO) investor relations material

Strategic vision and business model

• Focused on leveraging partnerships to deliver innovative cardiovascular therapies and drive future profitability through a royalty-based revenue model.

• Actively enrolling pivotal trials for two proprietary programs: AVIM Therapy and Virtue SAB, targeting large global markets with unmet clinical needs.

• Commercialization strategy centers on strategic collaborations with industry leaders, including Medtronic and Terumo.

• Secured funding through completion of pivotal trial enrollments and AVIM Therapy primary endpoint data readout.

Flagship technologies and clinical programs

• AVIM Therapy: Cardiac pacing-based treatment for uncontrolled hypertension, integrated into pacemaker firmware, with FDA Breakthrough Device Designation.

• Virtue SAB: Extended-release sirolimus drug delivery via a non-coated, microporous balloon for artery disease, also FDA-designated as a Breakthrough Device.

• Both programs are in pivotal trial stages, targeting multi-billion dollar global opportunities in hypertensive heart disease and atherosclerotic artery disease.

Recent accomplishments and upcoming catalysts

• Expanded eligibility for the BACKBEAT pivotal study and secured FDA Breakthrough Device Designation for AVIM Therapy.

• Launched the Virtue Trial in coronary in-stent restenosis (ISR) and entered a new strategic rights agreement with Terumo.

• Achieved a cash runway into Q4 2027 through strategic transactions and received significant tranche payments from partners.