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Orchestra BioMed Holdings Inc Com (OBIO-3.36%) has submitted its annual report on Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details Orchestra BioMed's strategic focus on developing high-impact medical innovations through partnerships with leading medical device companies. The company's flagship product candidates include AVIM therapy for hypertension and Virtue SAB for artery disease.
Orchestra BioMed reported a net loss of approximately $61 million for the year ended December 31, 2024, compared to a net loss of approximately $49.1 million for the previous year. The company had an accumulated deficit of approximately $309.9 million as of December 31, 2024.
The company highlighted its ongoing BACKBEAT study for AVIM therapy, which has received IDE approval from the FDA. The study aims to treat hypertension in patients indicated for a pacemaker.
Orchestra BioMed also announced that the FDA granted IDE approval for its Virtue ISR-US pivotal study, which will evaluate the efficacy and safety of Virtue SAB for treating coronary in-stent restenosis.
The filing includes details on the company's strategic partnerships with Medtronic for AVIM therapy and Terumo for Virtue SAB. Orchestra BioMed is currently in mediation with Terumo regarding amendments to their agreement.
Orchestra BioMed's intellectual property portfolio includes 236 patents globally, with 82 issued U.S. patents. The company continues to focus on protecting its proprietary technologies and expanding its patent portfolio.
The report outlines the company's growth strategy, which includes advancing clinical studies for its flagship product candidates and exploring additional therapeutic applications for its technologies.
Orchestra BioMed's research and development expenses totaled $42.8 million for the year ended December 31, 2024. The company plans to continue investing in its pipeline to achieve key development milestones.
The filing also discusses the regulatory environment for medical devices and combination products, highlighting the company's efforts to comply with FDA and international regulations.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Orchestra BioMed Holdings Inc Com annual 10-K report dated March 31, 2025. To report an error, please email earnings@qz.com.