Orchestra BioMed Investor Relations Blog | August 2026
Orchestra BioMed recently announced financial results for the second quarter of 2026 and provided a business update across our two pivotal-stage cardiovascular programs. The quarter delivered meaningful clarity on the timeline for primary endpoint results from the BACKBEAT global pivotal trial (“BACKBEAT Trial”) as well as planned regulatory submissions for AVIM Therapy, assuming endpoints are met. We also continued to advance the Virtue SAB in the Treatment of Coronary In-Stent Restenosis Trial (“Virtue Trial”), our investigational device exemption (IDE) randomized pivotal trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis. At the same time, we strengthened our financial foundation to support both programs through their next major milestones.
The second quarter of 2026 was defined by execution against the objectives we laid out earlier this year. The BACKBEAT Trial, conducted in collaboration with Medtronic, remains on track to reach its target of 284 evaluable randomized patients by the end of the third quarter of 2026. Assuming primary endpoints are met, Orchestra BioMed and Medtronic intend to submit primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by regulatory submissions to the FDA and global health authorities.
During the quarter, the FDA also granted AVIM Therapy a second Breakthrough Device Designation (BDD), this one specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. AVIM Therapy's two BDDs now cover the broad population of patients with uncontrolled hypertension and elevated cardiovascular risk, as well as the pacemaker-indicated population being studied in the BACKBEAT Trial. This dual designation strengthens the potential regulatory and reimbursement upside for the program as it approaches pivotal data.
In parallel, our Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) program continued to make important progress. We are accelerating site activations and patient enrollments in the Virtue Trial, our head-to-head IDE registrational study comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis.
Finally, we ended the quarter with $110 million in cash, cash equivalents and marketable securities, following the receipt of $35 million in strategic capital from Medtronic and Ligand, a strategic capital partner, funding both programs through their next major milestones, with projected runway into the fourth quarter of 2027.
Orchestra BioMed is entering the most consequential stretch in its history, and the second quarter reinforced that each element of our path is on track.
For AVIM Therapy, the milestones ahead are clear: completion of BACKBEAT Trial enrollment and – assuming primary endpoints are met – primary endpoint data presentation targeted as a late-breaker in Q2 2027 and regulatory submissions by Medtronic in the U.S. and other key global markets thereafter.
The second FDA BDD earned in the second quarter adds to our momentum, supporting regulatory interaction and highlighting the significant unmet need AVIM Therapy is designed to address in patients with uncontrolled hypertension who also need a pacemaker; this launch market for AVIM Therapy comprises an estimated one million patients annually. Medtronic, our partner on the AVIM Therapy program, is the established global leader in cardiac pacemakers and holds over half the U.S. market, which is the largest in the world by both unit volume and total dollar value.
Virtue SAB is our other highly differentiated, pivotal trial-stage program targeting a multibillion-dollar established global market. While the Virtue Trial only began recently, progress in site activations and patient enrollments is key to building the head-to-head clinical evidence designed to support future regulatory approval and market adoption. Progress in the Virtue Trial also strengthens our position for a potential strategic partnership for Virtue SAB, another potential value-creating milestone on the horizon.
The second quarter also broadened our visibility in the capital markets: effective after U.S. market close on June 26, 2026, the Company was added to the Russell 3000® and Russell 2000® Indexes as part of the 2026 Russell indexes reconstitution, expanding our reach among institutional investors and index funds benchmarked to the Russell indexes.
We’re excited to host an R&D Day on November 12, 2026, in New York City, featuring presentations from management and leading physician investigators covering both the AVIM Therapy and Virtue SAB programs. Additional details will be announced in the future.
With BACKBEAT Trial target enrollment nearly complete, pivotal data presentation targeted for Q2 2027, and the Virtue Trial advancing, Orchestra BioMed's focus remains where it has consistently been: disciplined execution against the milestones that matter most for patients, physicians and shareholders.
- Team OBIO
Published August 2026
Forward-Looking Statements
Certain statements included in the content contained in or accessible through this blog post (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 enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the Company’s ability to find a strategic partner for its Virtue SAB program, the potential safety and efficacy of the Company’s product candidates, the potential benefits of the Breakthrough Device Designations, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. 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 Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. 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.