NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) reported second-quarter 2025 results alongside a series of major financing and regulatory developments that position the company to advance its late-stage cardiovascular treatment programs.
The company secured $111.2 million in gross proceeds through strategic transactions, public and private equity offerings, and royalty-based funding agreements with Medtronic and Ligand Pharmaceuticals. The deals include $55 million in non-dilutive investments, with Ligand committing $35 million in exchange for future royalty interests and Medtronic providing $20 million via a convertible note tied to prepaid revenue share. Additional funding came from a $40 million underwritten public offering and private placements of $11.2 million and $5 million from Medtronic and Ligand, respectively.
Orchestra BioMed expects the capital to extend its cash runway into the second half of 2027, supporting key milestones such as completion of enrollment in its BACKBEAT study by mid-2026 and substantial progress in the Virtue Trial. The financing also supports an expanded collaboration with Medtronic to explore AVIM-enabled leadless pacemakers.
Regulatory wins in the quarter include FDA Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy for patients with uncontrolled hypertension and high cardiovascular risk; FDA approval to expand eligibility for the BACKBEAT study, increasing the potential patient pool by more than 24-fold; and Investigational Device Exemption approval for a U.S. pivotal trial of the Virtue Sirolimus AngioInfusion Balloon (SAB) against a commercially available paclitaxel-coated balloon.
CEO David Hochman said the financing and regulatory progress mark “significant steps” toward bringing AVIM therapy and Virtue SAB to market, noting the potential for enhanced reimbursement and expanded clinical adoption.
Financially, Orchestra BioMed ended the quarter with $33.9 million in cash, cash equivalents, and marketable securities, rising to an estimated $101 million by August 12, factoring in recent funding. Quarterly revenue held steady at $0.8 million year-over-year. Research and development spending increased to $13.9 million from $11.1 million, driven by the BACKBEAT global pivotal study, while selling, general, and administrative expenses dipped slightly to $6.3 million. Net loss widened to $19.4 million, or $0.50 per share, from $16.0 million, or $0.45 per share, a year earlier.
The company’s intellectual property portfolio for AVIM therapy now includes 137 issued patents worldwide, covering applications in both hypertension and heart failure.
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