NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) this week announced its third quarter financial results for 2024, alongside significant updates on its clinical programs. The company is making strides in the BACKBEAT global pivotal study, in partnership with Medtronic, and in its Virtue SAB program.
CEO David Hochman shared insights on the company’s progress, stating, “The Orchestra BioMed team is focused on execution of the BACKBEAT global pivotal study alongside our strategic partner, Medtronic. We are excited about the enthusiasm we have seen from the clinical community for the potential of AVIM therapy.” He highlighted that the recent FDA approval for an amendment to the study protocol is expected to enhance patient engagement and enrollment processes.
Orchestra BioMed is also preparing to launch coronary pivotal studies for its Virtue Sirolimus AngioInfusion Balloon, which promises advanced drug delivery methods for artery disease treatments. Hochman emphasized the importance of this development, noting, “We view Virtue SAB as a revolutionary innovation that can elevate this rapidly accelerating therapeutic trend.”
In other developments, the company continues discussions with Terumo about restructuring their Virtue SAB partnership. Additionally, Vivasure Medical, a strategic holding of Orchestra BioMed, presented positive data at the TCT 2024 conference, which could lead to regulatory approval and a commercial launch of its PerQseal Closure Device in 2025.
Financially, Orchestra BioMed reported $1.0 million in revenue for the third quarter of 2024, up from $0.4 million in the same period the previous year, driven by increased partnership revenues. The company’s net loss for the quarter was $15.4 million, compared to $13.3 million last year, with research and development expenses rising due to the ongoing BACKBEAT study.
Looking forward, Orchestra BioMed expects its cash runway to extend into the second half of 2026, supported by a recent $15 million draw from its credit facility with Hercules Capital, Inc. The company remains committed to advancing its innovative solutions and making a meaningful impact on patient care.
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