Orchestra BioMed (OBIO) - 2024 Q4 - Annual Report

Financial Condition - Orchestra BioMed Holdings, Inc. has a history of net losses and expects to continue incurring losses for the foreseeable future[18] - As of December 31, 2024, the company's cash, cash equivalents, and short-term investments are insufficient to fund operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern[18] - The future sales of shares by existing stockholders may adversely affect the market price of the company's common stock[20] Clinical Studies and Regulatory Approvals - The clinical study process required for regulatory approvals is lengthy, expensive, and carries substantial risks, which could harm the business if studies are unsuccessful or delayed[18] - Interim data from clinical studies may change as more patient data become available, which could result in material changes in final data[18] - The company intends to expand sales internationally but may face difficulties in obtaining regulatory approvals or successfully marketing products abroad[18] - The company intends to expand sales of its products internationally but may face difficulties in obtaining regulatory approvals or successfully marketing products even if approved[18] Dependence on Partners and Supply Chain - The company is highly dependent on partners and third-party vendors for the successful marketing and sale of its initial product candidates, with no assurance of successful partnerships[20] - The company is highly dependent on partners and third-party vendors for manufacturing and providing critical materials, with no assurance of effective supply chain management[20] - The company expects to continue relying on third parties for successful marketing and sales of its initial product candidates, with no assurance of successful partnerships[19] Intellectual Property Risks - The company may not effectively protect or enforce its intellectual property, which could adversely affect its business and financial condition[20] - The company may face substantial costs and liabilities from litigation or proceedings related to intellectual property rights[20] Market and Regulatory Pressures - Healthcare cost-containment pressures and legislative reforms could decrease demand for the company's products and affect pricing and procedure volumes[20] - Healthcare cost-containment pressures and legislative reforms could decrease demand for the company's products and negatively impact pricing and procedure volumes[20] Manufacturing Challenges - The company has limited pharmaceutical manufacturing experience, which may lead to development or manufacturing problems that could limit revenue growth[20] - The company has limited pharmaceutical manufacturing experience, which may lead to development or manufacturing problems that could limit revenue growth[20]