NEW HOPE, PA — Orchestra BioMed Holdings Inc. (Nasdaq: OBIO) reported its full-year 2025 financial results and said it is advancing two pivotal clinical trials for therapies targeting hypertension and coronary artery disease.
The company said it ended 2025 with $106.5 million in cash, cash equivalents, and marketable securities.
Orchestra BioMed expects its cash position to increase through additional proceeds, including $35 million expected from Medtronic and Ligand in the second quarter of 2026 and payments tied to Haemonetics’ acquisition of Vivasure Medical.
Chairman and Chief Executive Officer David Hochman said the company strengthened its financial position during 2025 through partnerships and financing agreements.
“We are very proud of our significant clinical, strategic and financing accomplishments in 2025,” Hochman said. “We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs.”
The company said its lead programs include Atrioventricular Interval Modulation Therapy, known as AVIM Therapy, and the Virtue Sirolimus AngioInfusion Balloon, or Virtue SAB.
Orchestra BioMed is conducting the BACKBEAT global pivotal study with Medtronic (NYSE: MDT) to evaluate AVIM Therapy for the treatment of uncontrolled hypertension in patients who require pacemakers.
The company said patient enrollment in the study accelerated following protocol changes implemented during the fourth quarter of 2025.
“We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter,” Hochman said.
The company also began enrolling patients in the Virtue SAB U.S. pivotal trial during the fourth quarter of 2025.
The trial compares Virtue SAB with the AGENT paclitaxel-coated balloon in patients with coronary in-stent restenosis.
Hochman said the company expects to provide additional updates on the trial as enrollment progresses.
“We are also pleased with the early progress of the Virtue Trial,” Hochman said.
In October 2025, Orchestra BioMed also entered into an agreement with Terumo that granted the company a right of first refusal related to certain strategic transactions involving Virtue SAB.
The agreement included a $10 million fee and a $20 million investment from Terumo in non-voting convertible preferred stock.
For 2025, the company reported revenue of $33.5 million, compared with $2.6 million in 2024.
The increase was primarily driven by revenue associated with the Terumo agreement and the recognition of deferred revenue following the termination of a previous distribution agreement.
Research and development expenses rose to $58.2 million from $42.8 million in the prior year, reflecting costs tied to clinical trials and product development.
Selling, general and administrative expenses totaled $26.9 million, compared with $23.9 million in 2024.
The company reported a net loss attributable to common stockholders of $52.7 million, or $1.11 per share, compared with a net loss of $61.0 million, or $1.66 per share, in 2024.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.