Orchestra BioMed (OBIO) Sidoti Small-Cap Virtual Investor Conference summary

Business model and partnerships

• Focus on leveraging partnerships to advance high-impact medical device therapies, enabling capital efficiency and profitability through royalty-based revenue shares.

• Two flagship technologies in pivotal trial stages targeting major cardiovascular device markets.

• Medtronic holds exclusive global commercial rights for the AVIM therapy in pacemaker patients, with a significant revenue-sharing arrangement.

• Terumo has a right of first refusal for the Virtue SAB program's coronary applications, supported by a $65 million investment.

• Ligand Pharmaceuticals invested $40 million, purchasing a portion of future royalties, further strengthening financial position.

AVIM therapy and BACKBEAT trial

• AVIM is a proprietary cardiac pacing therapy for hypertension and hypertensive heart disease, targeting older, comorbid patients.

• The pivotal BACKBEAT trial is nearing completion, with enrollment expected to finish by the end of next quarter and primary endpoint data by year-end.

• Clinical data show immediate, substantial, and sustained blood pressure reduction, with robust safety and efficacy out to two years.

• Medtronic will take over regulatory filings and commercialization, aiming for U.S. and global launches in 2028.

• Expansion into a broader hypertensive heart disease market could multiply the addressable market size.

Virtue SAB program and market opportunity

• Virtue SAB is a novel drug delivery system using extended-release sirolimus for coronary and peripheral artery disease.

• Targets a $10 billion global market, with the paradigm shifting from drug-eluting stents to drug-coated balloons.

• Demonstrated superior pharmacokinetics and durable clinical outcomes compared to current market leader AGENT balloon.

• Pivotal Virtue trial is enrolling up to 740 patients, with completion targeted for 2027.

• Plans for expansion into peripheral applications, with updates expected later this year.