Orchestra BioMed (OBIO) Q2 2026 earnings summary

Executive summary

• Focused on advancing AVIM Therapy and Virtue SAB, both in pivotal trials targeting large market opportunities, with BACKBEAT trial on track for 284 evaluable patients by end of Q3 2026 and primary data expected in Q2 2027.

• Virtue pivotal trial is progressing with additional site activations and patient enrollments.

• $110 million cash balance at quarter-end, bolstered by $35 million in strategic capital from Medtronic and Ligand, provides runway into Q4 2027.

• Added to the Russell 3000 and Russell 2000 indexes in June 2026, increasing visibility among institutional investors.

• R&D Day scheduled for November 12, 2026, to review AVIM Therapy and Virtue SAB programs.

Financial highlights

• Cash and marketable securities totaled $110.0 million as of June 30, 2026.

• Total revenue for the six months ended June 30, 2026 was $198,000, down 88% year-over-year due to the termination of a major partnership.

• Research and development expenses rose 20% year-over-year to $16.6 million in Q2 2026 and 18% year-over-year to $32.4 million for the six months ended June 30, 2026, driven by clinical trial activity.

• Selling, general and administrative expenses decreased 7% year-over-year to $5.8 million in Q2 2026 and 3% year-over-year to $12.2 million for the six months ended June 30, 2026.

• Net cash used in operating activities was $41.5 million for the six months ended June 30, 2026, and $19.6 million in Q2 2026, mainly due to increased R&D and personnel costs.

Outlook and guidance

• Cash and marketable securities are expected to fund operations into Q4 2027, supporting advancement of pivotal programs through key milestones.

• Ongoing pivotal trials for AVIM Therapy and Virtue SAB are prioritized, with major clinical milestones expected in 2027.

• BACKBEAT Trial expected to reach enrollment target by end of Q3 2026, with primary endpoint data presentation planned for Q2 2027.

• Additional capital may be raised through equity, debt, or partnerships as needed.