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Orchestra BioMed Holdings (OBIO) investor relations material

Orchestra BioMed Holdings Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary12 Aug, 2025

Executive summary

  • Net loss for the six months ended June 30, 2025 was $38.1 million, up 29% year-over-year, with an accumulated deficit of $348.0 million as of June 30, 2025.

  • Secured over $111 million in proceeds and committed capital through strategic transactions and equity offerings, with major contributions from Medtronic and Ligand.

  • Achieved key FDA milestones: Breakthrough Device Designation for AVIM therapy, expanded BACKBEAT study enrollment, and IDE approval for Virtue SAB pivotal trial.

  • Expanded strategic collaboration with Medtronic for future AVIM therapy-enabled leadless pacemakers.

  • Intellectual property portfolio for AVIM therapy grew to 137 issued patents worldwide.

Financial highlights

  • Total revenue for the six months ended June 30, 2025 was $1.7 million, up 22% year-over-year.

  • Cash and marketable securities totaled $33.9 million at June 30, 2025, estimated at $101 million as of August 12, 2025, including recent financings.

  • Net cash used in operating activities was $32.1 million for the six months ended June 30, 2025.

  • Research and development expenses increased 35% to $27.3 million for the six months ended June 30, 2025.

  • Net loss was $19.4 million ($0.50 per share) in Q2 2025, compared to $16.0 million ($0.45 per share) in Q2 2024.

Outlook and guidance

  • Cash runway, including recent financings and committed future proceeds, is expected to fund operations into the second half of 2027.

  • Increased spending planned for pivotal clinical trials of AVIM therapy and Virtue SAB, with enrollment and regulatory milestones anticipated in 2025-2026.

  • BACKBEAT study enrollment completion targeted for mid-2026; Virtue Trial initiation planned for the second half of 2025.

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Frequently asked questions

Orchestra BioMed Holdings, Inc. is a biomedical innovation company focused on accelerating the development and commercialization of high-impact medical technologies. The company operates through a partnership-enabled business model, collaborating with leading medical device companies to bring its innovations to market. Its key product candidates include BackBeat Cardiac Neuromodulation Therapy (CNT), which is designed to treat hypertension in patients with pacemakers, and Virtue Sirolimus AngioInfusion Balloon (SAB), intended for the treatment of atherosclerotic artery disease. Orchestra BioMed has strategic partnerships with companies like Medtronic and Terumo Corporation to advance the development and global commercialization of these products. The company is headquartered in New Hope, Pennsylvania, and its shares are listed on the Nasdaq.

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