Orchestra BioMed (OBIO) TD Cowen 45th Annual Healthcare Conference summary

Business model and partnerships

• Pursues a partnership-enabled model, focusing on innovation and leveraging strategic partners for commercialization and revenue sharing.

• Two lead programs: AVIM Therapy for hypertension (partnered with Medtronic) and Virtue Sirolimus AngioInfusion Balloon for coronary and peripheral artery disease (partnered with Terumo).

• Partners handle commercialization, allowing for capital efficiency and scalability.

• Revenue sharing and royalty structures are in place, with significant upside potential.

• Board and leadership team have extensive med tech and biotech experience.

AVIM Therapy program

• AVIM Therapy targets hypertension in pacemaker patients, representing a $2 billion market opportunity.

• Medtronic partnership includes equity investment and exclusive rights for pacemaker population; future expansion possible.

• Over 110 issued patents, with IP extending to 2040 and beyond.

• Clinical data shows immediate, sustained blood pressure reduction and improved cardiac function, with favorable safety trends.

• Pivotal BackBeat study underway, targeting 500 patients, with primary endpoints at three months and follow-up to 12 months; regulatory submission planned based on these results.

Virtue Sirolimus AngioInfusion Balloon program

• Targets large global markets in coronary and peripheral artery disease, with FDA breakthrough designation for key indications.

• Terumo partnership includes $30 million upfront, equity investment, and Terumo responsible for later-stage clinical and regulatory costs.

• Proprietary SirolimusEFR technology enables high, sustained drug delivery without the drawbacks of coated balloons.

• Pilot SABER study showed best-in-class clinical results, with a 2.8% TLF rate at one year, outperforming competitors.

• Plans to initiate a head-to-head randomized study versus Boston Scientific's Agent Balloon in the second half of the year.