As 2025 comes to a close, I want to take the opportunity to reflect on a year of important achievements that puts Orchestra BioMed in a very strong position for the year to come. This year saw our Company make substantive clinical, strategic, and financial progress: we advanced execution of both of our pivotal trial-stage programs, we strengthened and clarified our strategic partnerships, and we secured nearly $150 million in capital and capital commitments on favorable terms.
2026 is poised to be consequential for OBIO as we move to complete enrollment of the BACKBEAT global pivotal study and gear up significant enrollment of the Virtue Trial. We will start the year well-financed, well-organized and fully focused on these critical next objectives.
Let’s take a closer look at our 2025 achievements.
At the center of Orchestra BioMed’s mission is disciplined clinical execution. In 2025, both of our flagship programs advanced materially along their regulatory and development paths.
For Atrioventricular Interval Modulation Therapy (“AVIM Therapy”), the year was highlighted by continued validation of the therapy’s potential to treat hypertensive heart disease, a key contributor to morbidity and mortality in older patients with increased cardiovascular risk. We expanded the scope and rigor of our clinical program, enhanced trial parameters, and accelerated enrollment of patients in the BACKBEAT global pivotal study. These steps were complemented by new and promising mechanistic and clinical data publications and presentations. They were further supported by growing engagement across an expanding global network of clinical investigators.
In parallel, AVIM Therapy received FDA Breakthrough Device Designation, further recognizing the unmet need in hypertensive patients at increased cardiovascular risk and the transformational potential of our patented therapy. This designation reinforces the importance of our pivotal clinical study already underway, supports more efficient interaction with regulators as the pivotal program progresses, and highlights the broader market potential for AVIM therapy beyond the substantial pacemaker-indicated patient population for which we are already aligned with Medtronic, the global leader in cardiac pacing therapies.
Our Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) program also reached a significant inflection point. In 2025, we received FDA IDE approval for a head-to-head non-inferiority trial design and advanced into active U.S. pivotal trial evaluation of Virtue SAB against AGENT™ paclitaxel-coated balloon, currently the only drug-coated balloon approved in the United States for a coronary indication. Patient enrollment began in the fourth quarter, marking the transition of this program from late development into pivotal execution.
Taken together, these milestones reflect a portfolio now operating at scale: two differentiated cardiovascular technologies, both Breakthrough Device-designated, each advancing through pivotal clinical trials specifically designed to support future regulatory approvals and commercial adoption.
Clinical progress at this level requires more than innovation alone - it requires durable partnerships structured for long-term success.
Throughout 2025, we continued to strengthen and refine our strategic collaboration with Medtronic around AVIM Therapy. This included further investment and capital commitment by Medtronic and expanding key elements of our partnership framework to open opportunities for potential integration of AVIM Therapy into future leadless pacing platforms.
We also took important steps to restructure our partnership with Terumo around Virtue SAB. By replacing the prior distribution agreement with a right of first refusal (ROFR) agreement, we preserved Orchestra BioMed’s strategic flexibility while maintaining Terumo’s continued engagement as a potential long-term partner. The revised structure reflects our view that strategic optionality is particularly important as a program enters U.S. pivotal evaluation and approaches major value inflection points.
In addition, during the year we welcomed Ligand Pharmaceuticals as a new long-term strategic partner and investor. Ligand has an established reputation as a backer of successful biopharmaceutical innovations, with a disciplined approach to capital deployment and development-stage risk. Their decision to make a long-term investment commitment alongside our existing partners provides external validation of both our programs and our partnership-driven operating model.
Across the AVIM Therapy and Virtue SAB programs, these actions reflect a consistent philosophy: structure partnerships to align incentives, reduce execution risk, and maximize long-term clinical and commercial value.
2025 was also a year of meaningful balance-sheet growth, designed to ensure that both of our pivotal-stage programs can advance without compromising scientific rigor or strategic flexibility.
During the year, Orchestra BioMed raised $147.6 million in capital and capital commitments through a combination of equity financings, strategic investments, and partnership-related transactions. These included:
In all, we have now extended our expected cash runway into Q4 2027, providing the resources needed to support full enrollment of both the BACKBEAT and Virtue pivotal trials.
As we enter 2026, Orchestra BioMed is positioned as a late-stage, partnership-driven medtech innovation company with:
Important work remains, but the progress achieved in 2025 significantly advanced our programs and clarified our path forward.
On behalf of our employees, clinical partners, and collaborators, thank you for your continued support and engagement. We remain focused on advancing therapies that address large unmet cardiovascular needs—carefully, rigorously, and in partnership with those best positioned to help bring them to patients.
Sincerely,
David Hochman
Chairman & Chief Executive Officer
Orchestra BioMed
Forward-Looking Statements
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