Orchestra BioMed Reports $2.57 Million Revenue and $58.95 Million Net Loss for Nine Months Ended September 30, 2025

Orchestra BioMed Holdings, Inc. reported a total revenue of $2.57 million for the nine months ended September 30, 2025, reflecting an 8% increase from $2.39 million in the same period of the previous year. The revenue comprised $2.12 million from partnership agreements, primarily related to the Terumo Agreement, and $445,000 from product sales, which saw a slight decline of 3% compared to the prior year. The company incurred a net loss of $58.95 million for the nine months, a 31% increase from the $44.87 million loss reported in the same period in 2024. The increase in losses was attributed to higher research and development expenses, which rose by 30% to $41.36 million, driven by ongoing clinical studies for its flagship products.

In terms of operational changes, Orchestra BioMed has made significant strategic moves, including the termination of the Terumo Agreement on October 24, 2025, which had previously provided partnership revenue. This termination was part of a broader agreement that included a $10 million fee paid to Orchestra BioMed. The company has also initiated the Virtue Trial, a pivotal study for its Virtue SAB product, which began patient enrollment on October 27, 2025. This trial aims to support regulatory approval and is expected to enroll 740 patients across 75 centers in the U.S.

The company’s financial position improved with cash and cash equivalents totaling $42.01 million and marketable securities of $53.81 million as of September 30, 2025, compared to $22.26 million and $44.55 million, respectively, at the end of 2024. The increase in cash was bolstered by financing activities that generated $75.67 million, primarily from the sale of common stock and pre-funded warrants. The total liabilities also rose to $61.07 million from $43.22 million at the end of 2024, largely due to the new Royalty Purchase Agreement with Ligand Pharmaceuticals, which involved a $35 million investment.

Looking ahead, Orchestra BioMed anticipates continued investment in its research and development efforts, particularly for its AVIM Therapy and Virtue SAB programs. The company expects to incur significant operating losses in the foreseeable future and will require additional capital to fund its operations. Management has indicated that they may seek to raise funds through equity or debt financing, depending on market conditions and the progress of their clinical trials. The company’s ability to achieve its projected development and commercialization goals remains contingent on various factors, including the success of its clinical studies and the regulatory approval process.