NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) reported third-quarter financial results and detailed a series of strategic and regulatory milestones that collectively secured more than $147 million in fresh capital and extended the company’s cash runway into late 2027. Executives said the strengthened balance sheet positions the company to advance two pivotal cardiovascular programs now moving through global registrational trials.
The financing momentum stems from a mix of public and private equity offerings and strategic investments, including $71.6 million in committed capital from Medtronic and Ligand Pharmaceuticals and a $30 million investment from Terumo. The company also executed a new rights agreement granting Terumo a right of first refusal tied to its Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) program.
Pivotal Studies Gain Traction
Orchestra BioMed has initiated patient enrollment in the U.S. pivotal Virtue Trial, a randomized, head-to-head study comparing Virtue SAB with Boston Scientific’s AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis. Enrollment is expected to continue through mid-2027, with Orchestra retaining full operational control of the trial.
At the same time, enhancements to the FDA-approved BACKBEAT global pivotal study protocol widened eligibility criteria, resulting in what the company says is a more than 24-fold increase in the potential candidate pool. BACKBEAT, which evaluates the company’s atrioventricular interval modulation (AVIM) therapy in hypertensive patients already indicated for a cardiac pacemaker, is expected to complete enrollment by mid-2026.
Strategic Partnerships Deepen
Alongside the Terumo agreement and new preferred stock investment, Orchestra expanded its collaboration with Medtronic to support the potential development of AVIM-enabled leadless pacemakers — a move that could broaden the reach of the company’s proprietary therapy. Management described the recent transactions as validation of its partnership-driven model, aimed at leveraging global device leaders while retaining core development and commercial optionality.
CEO David Hochman said the past several months marked “a period of exceptional execution,” citing aligned incentives with strategic partners and capital raised on terms favorable to shareholders. “We believe 2026 will be a landmark year for Orchestra,” he said, pointing to expected BACKBEAT enrollment completion and steady progress in the Virtue Trial.
Third-Quarter Financials Reflect Increased R&D Spend
As of September 30, the company held $95.8 million in cash and marketable securities, before receiving an additional $30 million from Terumo in early November. Another $35 million in committed capital from Medtronic and Ligand is expected by May 2026.
R&D spending rose to $14 million for the quarter, driven by costs associated with the ongoing BACKBEAT pivotal trial. Selling, general, and administrative expenses climbed to $7.1 million due to higher professional fees. Net loss widened to $20.8 million, or $0.40 per share, compared with $15.4 million a year earlier.
With its cash runway extended and two late-stage programs entering critical phases, Orchestra BioMed is preparing for a decisive period in its push to bring novel cardiovascular technologies toward the market.
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