Orchestra BioMed (OBIO) investor relations material

Executive summary

• Advanced AVIM Therapy for hypertension and Virtue SAB for artery disease, both in pivotal trials targeting large market opportunities, with key regulatory milestones including a second FDA Breakthrough Device Designation for AVIM Therapy.

• BACKBEAT Trial enrollment targeted for completion by end of Q3 2026, with late-breaking data presentation planned for Q2 2027 and subsequent regulatory submissions.

• Net loss for Q1 2026 was $20.7M, up from $18.8M in Q1 2025, with an accumulated deficit of $383.3M as of March 31, 2026.

• Raised $367.2M in gross proceeds to date, with $35M in new capital from Medtronic and Ligand received after quarter-end.

Financial highlights

• Q1 2026 revenue was $110K, down from $868K in Q1 2025, due to the termination of the Terumo partnership.

• Research and development expenses rose 17% year-over-year to $15.8M, driven by clinical trial activity.

• Selling, general and administrative expenses were $6.4M, up 2% year-over-year.

• Cash and marketable securities totaled $94.4M at quarter-end, with an additional $35M received in May 2026.

• Net cash used in operating activities and fixed asset purchases was $22.4M in Q1 2026, up from $16.7M in Q1 2025.

Outlook and guidance

• Cash runway expected to fund operations into Q4 2027, with flexibility to raise up to $92.4M via at-the-market equity sales.

• BACKBEAT Trial enrollment targeted for completion by end of Q3 2026; Virtue Trial enrollment planned for 2027.

• Medtronic to submit FDA application for AVIM Therapy after primary endpoint data in 2027, pending trial success.