Orchestra BioMed Achieves Key Financial and Operational Progress

Orchestra BioMed Reports on Financial Performance and Business Updates

Orchestra BioMed Holdings, Inc. (NASDAQ: OBIO), a pioneering biomedical innovation company, recently presented its robust financial results for Q3 2024, reflecting both significant fiscal health and promising advancements in medical technology. The company is focused on elevating patient care through high-impact technologies and strategic partnerships.

Operational Developments and Strategic Partnerships

David Hochman, Chairman and CEO of Orchestra BioMed, emphasized the company's commitment to executing the pivotal BACKBEAT study, conducted in partnership with Medtronic. This trial aims to evaluate the efficacy of atrioventricular interval modulation (AVIM) therapy, especially for older, high-risk patients experiencing hypertension. The recent FDA approval of a crucial amendment to the BACKBEAT protocol is expected to enhance patient engagement and broaden the screening process for participants.

Progress continues rapidly on the AVIM therapy front, with Hochman noting the rising enthusiasm from the medical community about this innovative treatment. The amendment not only aims to streamline patient involvement but also extends the opportunity for enrollment, which is critical for achieving optimal study results.

Innovative Products at the Forefront

Simultaneously, Orchestra BioMed is advancing its Virtue Sirolimus AngioInfusion Balloon (SAB) program, preparing to initiate pivotal trials in coronary studies. With the recent focus on the growing role of drug-coated balloons in treating arterial diseases, Virtue SAB is seen as a critical innovation that enhances drug delivery while circumventing the pitfalls linked to traditional balloon coatings. As healthcare evolves, Orchestra BioMed positions itself as a leader in these developments, particularly as 2025 approaches, which is anticipated to be a landmark year for the company.

Recent Highlights in the Company’s Journey

• Activation and active patient enrollment in the BACKBEAT pivotal study in partnership with Medtronic.
• Successful FDA approval for adjustments to the BACKBEAT study protocol to enhance patient engagement.
• Plans to commence pivotal trials for the Virtue SAB product.
• Collaboration discussions with Terumo, aiming to strengthen the Virtue SAB partnership.
• Vivasure Medical Ltd., a key holding, shared encouraging data from the PATCH pivotal study that supports the potential for regulatory approvals and product launches in the upcoming year.

Financial Overview

As of September 30, 2024, Orchestra BioMed reported cash, cash equivalents, and marketable securities totaling $66.9 million. Following the end of Q3, the company saw an increase of approximately $15 million in cash from a credit facility draw with Hercules Capital, Inc., indicating a strong operational runway anticipated through mid-2026.

Third Quarter Financial Results

During Q3 2024, Orchestra BioMed reported a net cash outflow of $13.8 million, reflecting intensified investment in research and development, particularly for ongoing studies related to BACKBEAT. Revenue surged to $1.0 million, marking a significant increase from $0.4 million in the previous year, primarily driven by the recognition of partnership revenues.

Research and development expenses totaled $11.6 million, up from $8.6 million in Q3 2023, reinforcing the company’s emphasis on accelerating product development.

Commitment to Biomedical Innovation

Orchestra BioMed remains focused on its mission to deliver groundbreaking healthcare solutions through risk-reward sharing partnerships. This approach underscores its collaboration with industry leaders like Medtronic and Terumo, leveraging their expertise to advance therapies designed to significantly improve patient outcomes. The company’s innovative pipeline, especially with products like AVIM therapy and Virtue SAB, is pivotal not just for business growth, but crucially for addressing unmet needs in the healthcare sector.

About Orchestra BioMed

Orchestra BioMed (NASDAQ: OBIO) is dedicated to accelerating high-impact biomedical technologies, aiming to revolutionize patient care through collaborative agreements with leading medical device companies. Its partnerships focus on commercializing unique product candidates, prominently including AVIM therapy and the Virtue SAB, which address hypertension and artery disease — significant public health challenges globally.

Frequently Asked Questions

What are the main products developed by Orchestra BioMed?

The company is focused on two main products: AVIM therapy for hypertension and the Virtue Sirolimus AngioInfusion Balloon (SAB) for artery disease treatment.

How does the BACKBEAT study impact patient care?

The BACKBEAT study aims to provide effective hypertension treatment options for high-risk patients, improving their management strategies through innovative therapy.

What financial health indicators were reported for Q3 2024?

Orchestra BioMed reported total cash and securities of $66.9 million, with significant investment in R&D leading to increased operational expenditures compared to the previous year.

Who are the primary partners of Orchestra BioMed?

Key partnerships include Medtronic and Terumo, which are instrumental in the development and commercialization of its innovative therapies.

What does the future hold for Orchestra BioMed?

The company anticipates a milestone year in 2025 with the potential launch of its new products following successful trials and regulatory approvals.

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