To complement our two-part summary of Orchestra BioMed’s recent shareholder update call, we are highlighting the Q&A session that followed the prepared remarks. Given strong shareholder interest in the types of questions asked - and the additional clarity provided by management during the discussion - we believe a concise summary of the major themes will be helpful.
For shareholders who would like to review the full transcript, including all analyst questions and management’s answers, the Company’s Form 8-K filing contains a transcript of the complete call and Q&A.
The Q&A discussion was driven by questions from several research analysts that cover or closely follow the Company, each probing different aspects of the Company’s pivotal programs, financing structures, competitive positioning, and strategic flexibility.
The questions were wide-ranging, and management’s answers provided additional insights beyond management’s business update. Below, we summarize the most notable commentary for shareholders.
Regarding the Virtue Trial, management provided new insight into how the study’s structure is expected to support steady enrollment. CEO David Hochman noted that the comparator balloon (AGENT™) is now broadly available in the U.S. following its FDA approval in 2024, lowering barriers for physicians to randomize patients in the pivotal trial.
He also highlighted the significant site engagement work already underway and expressed confidence that enrollment would build momentum through 2026. While the Company is targeting mid-2027 for enrollment completion, the Q&A provided additional color on the factors that support this trajectory.
The Q&A also included questions regarding the Company’s strategic rights agreement with Terumo. Mr. Hochman clarified that the right of first refusal applies only to certain transactions in the coronary market. The arrangement with Terumo provides strategic optionality for both parties and it does not restrict Orchestra BioMed’s ability to pursue potential opportunities in peripheral vascular disease, including below-the-knee interventions, or additional therapeutic areas where Virtue SAB or SirolimusEFR may offer clinical value. The agreement with Terumo also leaves Orchestra BioMed free to pursue potential M&A activity related to the Company as a whole. The Company maintains full
strategic control of Virtue SAB outside coronary applications, which enhances Orchestra BioMed’s platform optionality as new clinical opportunities emerge.
Several analysts asked about the scope of AVIM Therapy’s applicability beyond the initial pacemaker-indicated hypertension population. In response, Mr. Hochman provided expanded context around the clinical characteristics of patients who may benefit from AVIM Therapy, including those with isolated systolic hypertension, diastolic dysfunction, and/or increased cardiovascular risk.
While the BACKBEAT pivotal study remains focused on pacemaker-indicated patients, management noted that Breakthrough Device Designation covers a much broader population of patients that fit the criteria of the designation.
This added detail reinforced the potential for long-term category expansion beyond the initial indication.
CFO Andrew Taylor offered commentary on how the Company’s financing structures with Medtronic and Ligand flow through the Company’s financials. Several aspects of this discussion provided incremental accounting clarity and the additional color reinforced the Company’s strategic approach to strengthening its balance sheet while protecting shareholder value.:
The analyst Q&A session highlighted key topics of growing investor interest in Orchestra BioMed’s pivotal programs, and the confidence expressed by management in the Company’s operational, clinical, and strategic trajectory.
The discussion reinforced a central takeaway: Orchestra BioMed is advancing two late-stage, Breakthrough Device-designated programs with the financial strength, partnerships, and execution plan necessary to achieve important clinical and regulatory milestones over the next two years.
We encourage shareholders to review the full Q&A transcript in the Company’s Form 8-K filed with the SEC on November 13, 2025 for additional context.
— Team OBIO
Published December 2025
Certain statements included in the content distributed by Orchestra BioMed Holdings, Inc. (the “Company”) to which this disclaimer relates (including, but not limited to, visual, auditory, or written statements accessible through the link included in the Company’s digital communication) (the “Content”) that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials and reporting of top-line results, the potential benefits of regulatory approvals or designations received from domestic and foreign regulatory bodies with respect to the Company’s product candidates and/or ongoing trials, the potential safety and efficacy of the Company’s product candidates, the ability of the Company’s partnerships to accelerate clinical development, the realization of the clinical and commercial value of the Company’s product candidates, the Company’s ability to achieve expected regulatory and business milestones, the anticipated effects of the Company’s existing financing structures and their impact on future financial reporting, the Company’s ability to maintain strategic optionality in light of the Terumo right of first refusal it has granted Terumo with respect to certain Virtue SAB transactions in the coronary market. These statements are based on various assumptions, whether or not identified in the Content, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive
products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2024, and under the heading “Item 1A. Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of the Content. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made in the Content, except as required by law.