Orchestra BioMed Q2 2024 Financial Results and Business Update

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO), a biomedical innovation company, recently announced its financial results for the second quarter of 2024 and provided a business update. The company focuses on advancing medical technologies through strategic partnerships. During their inaugural R&D day in June, the company highlighted progress and future plans for its leading programs, AVIM therapy and Virtue SAB.

David Hochman, founder, CEO, and chairman of Orchestra BioMed, emphasized the company's alignment with innovations in cardiac pacing and balloon angioplasty. He noted the significant unmet needs in treating high-risk hypertension and the company's commitment to improving patient outcomes through advanced therapies. Renowned cardiologists Drs. David Kandzari and Vivek Reddy discussed these innovations at the event, underscoring the potential impact of AVIM therapy on patient care.

Key updates and recent developments were shared during the R&D Day on June 11th. The event featured insights into AVIM therapy, designed for treating hypertension in patients requiring pacemakers. Orchestra BioMed has collaborated with Medtronic to develop and commercialize AVIM therapy. Discussions included the treatment mechanism, clinical data from MODERATO I and II studies, and the design of the BACKBEAT study.

The R&D day highlighted several points:
1. Innovations in cardiac pacing and balloon angioplasty are transforming foundational cardiovascular treatments, promising improved clinical outcomes.
2. There remains a significant need for hypertension treatments, especially in older, high-risk patients. Dr. Kandzari pointed out that nearly 75% of hypertensive patients in the U.S. do not meet recommended blood pressure goals.
3. Clinical evidence supports the mechanism of AVIM therapy. Dr. Reddy explained how programmed pacing modulates AV intervals to reduce blood pressure.
4. Clinical results from MODERATO I and II studies show substantial, immediate, and sustained blood pressure reductions with AVIM therapy.
5. The BACKBEAT global pivotal study aims to provide crucial safety and efficacy data for AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension.

Orchestra BioMed is actively focusing on site activations and patient enrollment for the BACKBEAT study. The company also plans to provide updates on the Virtue SAB program in the latter half of 2024. Additionally, John Mack, an expert in cardiovascular devices and former President and General Manager of Cardiac Surgery at Medtronic, has joined the company's Board of Directors.

Financially, Orchestra BioMed reported cash and cash equivalents and marketable securities totaling $65.2 million as of June 30, 2024. In July, the company increased its cash reserves by $15 million through the sale of common stock. The company expects its operating cash to last into the second half of 2026, based on internal forecasts.

During the second quarter of 2024, the company used $10.3 million in net cash for operations and fixed asset purchases, a slight decrease from $10.5 million in the same period of 2023. The second-quarter revenue was $0.8 million, a minor decline from $0.9 million in 2023, mainly due to decreased partnership revenue from Terumo. Research and development expenses rose to $11.1 million from $8.5 million in 2023, driven by costs associated with the BACKBEAT study. Selling, general, and administrative expenses increased to $6.5 million from $5.3 million in 2023, primarily due to added personnel and regulatory costs. The net loss for the second quarter of 2024 was $16.0 million, or $0.45 per share, compared to a net loss of $12.0 million, or $0.35 per share, in 2023.

Orchestra BioMed continues to advance its mission of accelerating high-impact medical technologies to patients through strategic partnerships. The company's lead products, AVIM therapy and Virtue SAB, are aimed at addressing significant unmet medical needs in hypertension and arterial disease, respectively. The strategic collaborations with Medtronic and Terumo are integral to driving the development and commercialization of these therapies on a global scale.