NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) widened its second-quarter loss by 23% as spending increased on two pivotal cardiovascular trials, while $35 million of strategic capital from Medtronic and Ligand lifted its cash position to $110 million and extended its projected runway into the fourth quarter of 2027.
The biomedical company reported a net loss attributable to common stockholders of $24.1 million, or 38 cents a share, for the quarter ended June 30. That compared with a $19.4 million loss, or 50 cents a share, a year earlier.
Research and development expenses rose 20% to $16.6 million from $13.9 million, primarily reflecting costs for the BACKBEAT pivotal trial and development of the company’s Virtue Sirolimus AngioInfusion Balloon, including its own pivotal study.
Cash used in operating activities and fixed-asset purchases increased to $19.6 million from $15.6 million a year earlier as clinical-trial, personnel and consulting expenditures rose.
Orchestra BioMed ended June with $110 million in cash, cash equivalents and marketable securities after receiving $35 million during the quarter under previously disclosed agreements with Medtronic (NYSE: MDT) and Ligand Pharmaceuticals (Nasdaq: LGND).
Medtronic has now contributed nearly $82 million to Orchestra BioMed, while Ligand has provided $40 million, according to the company. Orchestra BioMed projects its current resources will fund operations into the fourth quarter of 2027 and through upcoming clinical milestones.
The company’s most advanced program is Atrioventricular Interval Modulation Therapy, or AVIM Therapy, being developed with Medtronic for uncontrolled hypertension in patients who are indicated for pacemakers.
The BACKBEAT trial remains on track to reach its target of 284 evaluable randomized patients by the end of the third quarter, Orchestra BioMed reported. Assuming the trial meets its primary endpoints, the companies plan to seek presentation of the primary data as a late-breaking study at a major cardiovascular conference in the second quarter of 2027.
Marketing applications to the U.S. Food and Drug Administration and other global regulators are planned after the data presentation if the trial results support submissions.
AVIM Therapy also received a second FDA Breakthrough Device Designation during the quarter, this time covering patients with uncontrolled hypertension despite medication who are indicated for a pacemaker.
Together, the two designations cover the broader population of patients with uncontrolled hypertension and elevated cardiovascular risk as well as the pacemaker-indicated population being evaluated in BACKBEAT. Breakthrough designation is intended to facilitate development and regulatory review but does not constitute marketing approval.
“The second FDA Breakthrough Device Designation for AVIM Therapy earned during the second quarter strengthens potential regulatory and reimbursement upside for this high-impact program,” Chief Executive Officer David Hochman stated.
Orchestra BioMed is simultaneously advancing its Virtue SAB program for coronary in-stent restenosis. The company reported additional site activations and patient enrollment in its pivotal trial.
That multicenter, randomized investigational device exemption study is comparing Virtue SAB directly with the commercially available AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis.
Selling, general and administrative expenses declined 7% to $5.8 million from $6.3 million, primarily because of lower stock-based compensation.
Interest expense increased to $2.7 million from $500,000, with a portion of the current-period expense noncash. Stock-based compensation declined to $2.5 million from $3.2 million.
Orchestra BioMed was also added to the Russell 3000 and small-cap Russell 2000 indexes following the June 2026 annual reconstitution, potentially increasing exposure to institutional investors and funds that track the benchmarks.
The company plans to provide further updates on AVIM Therapy and Virtue SAB at an R&D Day scheduled for Nov. 12 in New York City. Registration and webcast information will be released later.
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