NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) recently reported its financial results for the second quarter ended June 30, 2024, alongside significant business developments. The company is steadfast in its mission to advance treatments for hypertension and coronary artery disease, inspired by a renaissance in cardiac pacing and balloon angioplasty.
During its inaugural R&D Day on June 11, Orchestra BioMed showcased its pioneering work in these fields. The company presented its leading programs—AVIM therapy for hypertension and Virtue SAB for coronary artery disease—highlighting their potential to improve patient outcomes. Esteemed cardiology leaders, Drs. David Kandzari and Vivek Reddy, discussed the critical unmet needs in high-risk hypertension and expressed enthusiasm for AVIM therapy’s potential impact.
Strategic Collaborations and Innovations
Orchestra BioMed has formed a strategic collaboration with Medtronic (NYSE: MDT) to develop and commercialize AVIM therapy for hypertension in patients requiring a pacemaker. This partnership promises to enhance the therapeutic landscape by integrating advanced pacing techniques to manage blood pressure effectively.
During the R&D Day, key opinion leaders emphasized the transformative potential of AVIM therapy. Dr. Kandzari underscored the significant need for better hypertension treatments, noting that nearly 75% of hypertensive individuals in the U.S. do not achieve recommended treatment goals. Dr. Reddy elaborated on the AVIM therapy mechanism, explaining how programmed pacing that alternates between short and long AV intervals can reduce blood pressure utilizing established cardiology principles.
Clinical Evidence and Future Plans
Clinical evidence from the MODERATO I and II studies supports the efficacy of AVIM therapy in significantly and persistently reducing blood pressure. The upcoming BACKBEAT global pivotal study aims to generate robust safety and efficacy data for AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension. This double-blind, randomized study will focus on primary efficacy and safety endpoints over a three-month period, with additional secondary endpoints and novel patient enrollment pathways.
Orchestra BioMed continues to activate sites and enroll patients for the BACKBEAT study. The company is also on track to provide strategic, clinical, and regulatory updates on its Virtue SAB program in the latter half of 2024. The addition of cardiovascular device industry expert John Mack, former President and General Manager of Cardiac Surgery at Medtronic, to the Board of Directors further strengthens the company’s leadership team.
Financial Results for Q2 2024
For the second quarter of 2024, Orchestra BioMed reported cash and cash equivalents and marketable securities totaling $65.2 million. The company’s cash position was bolstered in July 2024 by an additional $15 million from the sale of common stock to an institutional investor. This financial runway is expected to support operations into the second half of 2026, based on internal forecasts and potential future proceeds.
Net cash used in operating activities and for the purchase of fixed assets was $10.3 million for Q2 2024, compared to $10.5 million for the same period in 2023. The decrease was primarily driven by reduced cash outflows for research and development.
Revenue for Q2 2024 was $0.8 million, slightly down from $0.9 million in Q2 2023. This decline was mainly due to decreased recognition of partnership revenues under the agreement with Terumo. Research and development expenses rose to $11.1 million, up from $8.5 million in Q2 2023, primarily due to costs associated with the BACKBEAT study. Selling, general, and administrative expenses were $6.5 million, up from $5.3 million in the same period last year due to increased personnel, legal, insurance, finance, and regulatory costs.
Net loss for Q2 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 Q2 2023. This net loss included non-cash stock-based compensation expenses of $2.8 million, compared to $1.7 million for the same period last year.
Conclusion
Orchestra BioMed’s second-quarter results and business updates reflect a company poised for significant advancements in cardiovascular care. With a strong focus on innovation and strategic collaboration, the company is well-positioned to drive meaningful progress in the treatment of hypertension and coronary artery disease. The ongoing pivotal studies and recent leadership enhancements signal a promising future for Orchestra BioMed and its mission to improve patient outcomes.
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