Earnings

Orchestra BioMed Reports Wider Nine-Month 2026 Net Loss

The Tip Desk · November 12, 2026 · 3 min read

Revenue fell 89% to $289,000 for the nine months ended September 30, 2026. The company raised about $80.5 million in a November equity offering after closing enrollment with 349 randomized patients.

Orchestra BioMed Holdings, Inc. (OBIO) reported revenue of $289,000 and a net loss of $63.2 million for the nine months ended September 30, 2026, compared with revenue of $2.57 million and a net loss of $58.9 million a year earlier.

The company completed enrollment in its BACKBEAT pivotal trial with 349 randomized patients across 92 clinical sites in 15 countries, about half of them from the United States, and said it is now focused on the three-month follow-up period and primary endpoint analysis.

The biomedical innovation company had previously targeted 284 evaluable randomized subjects and 316 total randomized patients, allowing for potential loss to follow-up, with enrollment completion targeted for the end of the third quarter of 2026. Assuming primary endpoints are met, Orchestra and Medtronic plan to submit the data as a late-breaking clinical trial presentation at Heart Rhythm 2027 in May, after which Medtronic is expected to file a Premarket Approval application supplement with the FDA and applications to other global agencies. AVIM Therapy has received two FDA Breakthrough Device Designations.

For the nine months ended September 30, 2026, total revenue was $289,000, down 89% from $2.57 million a year earlier, as partnership revenue fell to zero after the October 2025 termination of the Terumo Agreement. Product revenue, from FreeHold Surgical’s intracorporeal organ retractors, was $289,000, down 35% from $445,000, which the company attributed to lower purchase volume with no change in per-unit price. Cost of product revenue was $85,000.

Research and development expenses were $50.1 million for the nine months, up 21% from $41.4 million a year earlier. Selling, general and administrative expenses were $17.8 million. Loss from operations was $67.7 million. Net loss was $63.2 million, versus $58.9 million a year earlier.

Interest expense, net, was $5.05 million for the nine months, versus $385,000 a year earlier, reflecting the Ligand royalty purchase and the Medtronic convertible note. The company recognized an $8.4 million gain on sale of strategic investments related to Haemonetics’ acquisition of Vivasure. The effective annual interest rate on the Ligand Royalty Purchase Agreement was approximately 21.3% as of September 30, 2026. The effective interest rate on the Medtronic Note was 15.2%.

Cash and cash equivalents and marketable securities were $101.9 million at September 30, 2026, comprising $27.8 million in cash and cash equivalents and $74.1 million in marketable securities, down from $110.0 million at June 30, 2026. The company said it expects to continue to incur significant losses for the foreseeable future and had an accumulated deficit of $425.8 million as of September 30, 2026.

On November 9, 2026, Orchestra closed an underwritten public offering of 17,250,000 shares of common stock at $5.00 a share, resulting in net proceeds of approximately $80.5 million after underwriting discounts, commissions and estimated offering expenses, including the underwriters’ full exercise of their option to purchase additional shares.

Virtue SAB, the company’s second flagship candidate, remains in enrollment in the Virtue Trial, a global investigational device exemption (IDE) pivotal trial comparing the balloon head-to-head with Boston Scientific’s AGENT paclitaxel-coated balloon. The trial is expected to enroll 740 patients in the United States, with enrollment expected to be completed by the end of 2027; the company said it cannot provide assurance it will complete enrollment in that timeframe. In November 2026, Virtue SAB was featured at Transcatheter Cardiovascular Therapeutics, where a co-principal investigator presented preclinical sirolimus tissue-concentration data, three-year SABRE pilot results in coronary in-stent restenosis including a 14.3% target lesion failure rate, and the Virtue Trial design. Orchestra also announced plans to host an R&D Day on November 12, 2026, in New York City and via webcast, focused on uncontrolled hypertension in pacemaker-indicated patients and coronary restenosis.

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