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Orchestra BioMed Holdings Inc.

Orchestra BioMed Holdings, Inc. operates as a biomedical company in the United States. The company's flagship product candidates include Atrioventricular Interval Modulation, a bioelectronic therapy candidate designed to immediately, substantially, and persistently lower blood pressure; and Virtue Sirolimus AngioInfusion Balloon for the treatment of atherosclerotic artery disease. It also develops Cardiac Neuromodulation Therapy for heart failure, or potential treatment of clinical indications, such as urology or osteoarthritis; and CNT-HF, a bioelectronic product candidate that aims to reduce chronic sympathetic nervous system activity in heart failure. In addition, the company offers FreeHold devices and additional minimally invasive surgery enabling devices; and Pure-Vu system, a medical device to facilitate the cleansing of a poorly prepared gastrointestinal tract during colonoscopy and upper gastrointestinal endoscopy procedures. It has a collaboration agreement with Medtronic, Inc. for the development of AVIM therapy for the treatment of HTN in pacemaker-indicated patients; and a strategic collaboration with Terumo Corporation and Terumo Medical Corporation for the development and commercialization of Virtue SAB for the treatment of coronary and peripheral vascular disease. Orchestra BioMed Holdings, Inc. was founded in 2018 and is headquartered in New Hope, Pennsylvania.

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Orchestra BioMed Reports Q2 Loss of $0.38 Per Share, Misses Revenue Estimates

Orchestra BioMed Holdings, Inc. reported a second-quarter loss of $0.38 per share, missing the Zacks Consensus Estimate of a loss of $0.35 and representing an earnings surprise of negative 8.57%. The company posted revenues of $0.09 million for the quarter ended June 2026, falling short of the consensus estimate by 32.31% and down from $0.84 million in the year-ago period. Over the last four quarters, Orchestra BioMed has surpassed consensus EPS estimates twice and topped revenue estimates twice. Shares have added about 2.2% since the start of the year, underperforming the S&P 500's gain of 13.3%. The current consensus EPS estimate stands at a loss of $0.37 on $0.12 million in revenues for the coming quarter and a loss of $1.47 on $0.48 million in revenues for the current fiscal year.
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Orchestra BioMed expects BACKBEAT trial enrollment target by Q3 2026, data in Q2 2027

Orchestra BioMed announced that its BACKBEAT global pivotal trial, conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by the end of the third quarter of 2026, with primary data presentation targeted for the second quarter of 2027. The company reported a cash balance of $110 million as of June 30, 2026, providing projected runway into the fourth quarter of 2027, following $35 million in strategic capital from Medtronic and Ligand during the quarter. AVIM Therapy received a second FDA Breakthrough Device Designation, now covering both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial. The Virtue pivotal trial for coronary in-stent restenosis is advancing with further site activations and patient enrollments. Orchestra BioMed will host an R&D Day on November 12, 2026, in New York City to review both programs.
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