OBIO · Orchestra BioMed Holdings, Inc.

Revenue and Gross Profit

Revenue for Q1 FY2026 totaled $110.0K, a decline of 87.3% compared to $868.0K in Q1 FY2025. This decrease was due to a decrease in purchase volume, primarily of FreeHold Duo and Trio intracorporeal organ retractors. Gross profit was $78.0K, down 90.5% year-over-year, resulting in a gross margin of 70.9%. Our gross margin has been, and will continue to be, affected by a variety of factors, including finished goods manufactured component parts, as well as the cost to assemble and warehouse the FreeHold product finished goods inventory — all of which are managed through a third-party vendor.

Operating and Net Income

Operating income was -$22.1M, a 16.7% decline from -$18.9M in the prior-year quarter. Net income was -$20.7M, down 10.3% versus -$18.8M in Q1 FY2025. Diluted EPS was -$0.33, an improvement from -$0.49, reflecting the change in weighted-average shares outstanding. These results reflect continued investment in clinical development: this is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and to advance Virtue SAB into the Virtue Trial. We expect to continue to incur significant losses for the foreseeable future.

Liquidity and Capital Resources

Net cash used in operating activities was -$22.2M, and capital expenditures were $184K, resulting in free cash flow of -$22.4M. From inception through March 31, 2026, we have incurred significant operating losses and negative cash flows from our operations. The company remains focused on advancing its clinical pipeline, with the Virtue Trial — designed to support regulatory approval of Virtue SAB — expected to enroll 740 patients in the United States, with enrollment completion currently planned for 2027. No post-quarter financing or cash balance figures are included, as those values were removed during audit for lack of authoritative support in the XBRL packet.