Core Insights - Orchestra BioMed Holdings, Inc. announced financial results for Q2 2025, highlighting significant capital raised and regulatory achievements [1][2][3] Financial Highlights - The company secured over $111 million in proceeds from strategic transactions and equity offerings, including $71 million from Medtronic and Ligand [4][5] - Cash and cash equivalents totaled $33.9 million as of June 30, 2025, with an estimated position of $101 million as of August 12, 2025, after recent financing [11] - Revenue for Q2 2025 was $0.8 million, unchanged from Q2 2024, while net loss increased to $19.4 million, or $0.50 per share, compared to a net loss of $16.0 million, or $0.45 per share, in the prior year [11][20] Regulatory Milestones - The FDA granted Breakthrough Device Designation for AVIM therapy aimed at treating uncontrolled hypertension, which may enhance future regulatory submissions and reimbursement pathways [4][6] - The BACKBEAT study protocol was updated and approved by the FDA, significantly expanding patient enrollment criteria [4][6] - IDE approval was received for the Virtue SAB U.S. pivotal trial, which will compare Virtue SAB with commercially available paclitaxel-coated balloons [4][6] Strategic Collaborations - The company has expanded its collaboration with Medtronic to develop AVIM therapy-enabled leadless pacemakers [5] - Ligand Pharmaceuticals committed $35 million for a tiered revenue interest in future royalties from AVIM therapy and Virtue SAB [5] Product Development - AVIM therapy has shown promising results in pilot studies, demonstrating significant reductions in blood pressure [12] - Virtue SAB is designed to deliver sirolimus effectively, with positive clinical data supporting its use in treating coronary in-stent restenosis [13]

Table of Contents As filed with the Securities and Exchange Commission on October 10, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ORCHESTRA BIOMED HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 3841 (Primary Standard Industrial Classification Code Number) 92-2038755 (I.R.S. Employer Identificatio ...