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Orchestra BioMed Holdings, Inc. develops biomedical technologies through strategic partnerships with global medical device companies. Its recurring news centers on two late-stage cardiovascular programs: Atrioventricular Interval Modulation Therapy, or AVIM Therapy, for hypertension, and Virtue Sirolimus AngioInfusion Balloon, or Virtue SAB, for atherosclerotic artery disease.
Company updates commonly cover pivotal trial activity, clinical and mechanistic data presentations, FDA Breakthrough Device Designation matters for AVIM Therapy, strategic financing from partners, revenue participation arrangements, and equity-based employee inducement grants. Financial-result releases also discuss cash resources, non-recurring revenue tied to program agreements, and execution of the company's partnership-driven development model.
Orchestra BioMed (Nasdaq: OBIO) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Cash and cash equivalents: $65.2 million as of June 30, 2024
- Revenue: $0.8 million, down from $0.9 million in Q2 2023
- Net loss: $16.0 million ($0.45 per share), compared to $12.0 million ($0.35 per share) in Q2 2023
- R&D expenses: $11.1 million, up from $8.5 million in Q2 2023
The company remains focused on its AVIM therapy for hypertension and Virtue SAB program. The BACKBEAT global pivotal study is ongoing, with updates on the Virtue SAB program expected in H2 2024. Orchestra BioMed anticipates its cash runway to extend into H2 2026.
Orchestra BioMed Holdings (Nasdaq: OBIO) has appointed John Mack to its Board of Directors, effective July 29, 2024. Mack brings over 30 years of experience in medical devices, healthcare technology, and finance. He most recently served as President of Cardiac Surgery at Medtronic, where he led the division to market leadership. His previous roles at Medtronic included Vice President & General Manager of Extracorporeal Therapies and Vice President of Business Development, Strategy & Portfolio Management.
David Hochman, Chairman and CEO of Orchestra BioMed, expressed confidence in Mack's ability to contribute to the company's growth and leverage its partnership-enabled business model. Mack's extensive experience in cardiovascular therapy markets and his industry-wide relationships are expected to be valuable assets to the company.
Orchestra BioMed Holdings (Nasdaq: OBIO) will host an in-person R&D day on June 11, 2024, at the Lotte New York Palace Hotel, focusing on its AVIM therapy for hypertensive pacemaker patients. The event will feature presentations on the unmet need for hypertension treatments, the AVIM therapy's mechanism, and supporting clinical data. Esteemed physicians, including Dr. David Kandzari and Dr. Vivek Reddy, will discuss the BACKBEAT global pivotal study. The day will conclude with a live Q&A session.
Orchestra BioMed (Nasdaq: OBIO), a biomedical company specializing in high-impact technologies through risk-reward sharing partnerships, announced its participation in the Jefferies Global Healthcare Conference.
The event will take place in New York, NY, from June 4-6, 2024. Company management will present at a fireside chat on June 5 at 4:00 PM ET.
The presentation will be webcast and available on the company's website for 90 days.
Orchestra BioMed (Nasdaq: OBIO) announced its Q1 2024 financial results and business updates on May 13, 2024. Highlights include the ongoing BACKBEAT global study on AVIM therapy in collaboration with Medtronic, showing long-term reductions in systolic blood pressure. The company highlighted positive data from various cardiovascular studies and presented future plans, including an R&D day event in June 2024. Financially, the company held $75 million in cash and equivalents, with a net cash outflow of $13.1 million. Revenue decreased to $0.6 million from $1.2 million YoY, while R&D expenses rose to $9.1 million. Net loss widened to $13.5 million, or $0.38 per share, compared to $10.9 million, or $0.40 per share, in Q1 2023.
Orchestra BioMed announced that its AVIM Therapy Global Intellectual Property Estate has reached 110 issued patents worldwide, with 37 in the U.S. and 73 internationally. The patents cover over 1,800 claims related to hypertension treatment. The company is currently studying AVIM therapy in the BACKBEAT global pivotal study with Medtronic. Orchestra BioMed will provide an overview of AVIM therapy and the study on June 11, 2024, at an R&D day in New York City.
Orchestra BioMed, a biomedical company, will host an R&D day in New York on June 11, 2024, to discuss their AVIM therapy program for hypertensive pacemaker patients. Key opinion leaders will present on the program's mechanism of action, clinical evidence, and study design.
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