NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has recently shared its financial results for the full year of 2023, accompanying these figures with a business update for the fourth quarter. The past year has been marked by significant progress for Orchestra BioMed, particularly with respect to their cardiovascular pipeline, regulatory milestones, and a noteworthy Nasdaq listing.
Spearheading the year’s achievements is the initiation of the BACKBEAT global pivotal study in December, which evaluates Orchestra BioMed’s lead program – atrioventricular interval modulation (AVIM) therapy. This program, developed in partnership with Medtronic, a leading figure in cardiac pacing therapies, has been designed for hypertensive pacemaker patients. The company views the high-risk hypertension patient population as an area with substantial market potential for AVIM therapy.
Orchestra BioMed also maintains a productive relationship with their strategic partner Terumo, with whom they are currently working to update operational and financial plans. This collaboration is geared towards advancing Virtue SAB, a novel treatment for patients experiencing coronary in-stent restenosis – a condition that currently holds a conditional Investigational Device Exemption approval from the FDA.
Looking at the global landscape, treatments for coronary in-stent restenosis and other challenging artery disease indications are rapidly shifting towards drug-coated balloons. Virtue SAB, being the only non-coated balloon angioplasty system that offers protected focal delivery of extended-release sirolimus, could potentially offer a solution that stands out in the pack. The company believes it could provide significant benefits for patients and physicians alike, in a global market that Orchestra BioMed projects to be over $4 billion annually.
Among recent developments, Orchestra BioMed has made notable advances in AVIM therapy for high unmet need hypertension populations. They initiated the enrolment for the BACKBEAT pivotal study evaluating the efficacy and safety of AVIM therapy in hypertensive pacemaker patients in December 2023, with a target to complete enrolment by mid-2025. The company also continues to explore further opportunities to utilize AVIM therapy and other forms of Cardiac Neuromodulation Therapy (CNT) for high-risk populations with hypertension and heart failure.
On the financial front, Orchestra BioMed’s cash and equivalents and marketable securities totalled to $87.6 million as of the end of 2023. Despite a net cash used in operating activities and for the purchase of fixed assets amounting to $46.2 million – an increase from $29.9 million in 2022 – the company has extended its expected runway into the second half of 2026. This projection is based on an internally prepared forecast which reflects updated operating priorities and potential future proceeds.
While revenue for 2023 was at $2.8 million, a decrease from $3.5 million in 2022, a primary cause for this dip was decreased recognition of partnership revenues under the agreement with Terumo. Increased expenses were also incurred, primarily due to costs associated with preparing for the initiation of the pivotal BACKBEAT study and expenses related to being a public company.
Despite the roller-coaster of a year that 2023 has been, Orchestra BioMed maintains an optimistic outlook for the future. The company expects to carry forward the momentum from 2023 into the new year, with a focus on strong execution, which they believe is the best validation of their partnership-enabled business model.
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