- Orchestra BioMed Holdings, Inc. has secured over **$147 million in strategic-driven financing since August 2025**, including **$85 million in strategic capital commitments** and **$62.6 million in equity financing**, which is expected to provide a cash runway into **Q4 2027**.  **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:2]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:3]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:7]** 
- The company is advancing two pivotal-stage therapies: **AVIM Therapy** for hypertension, in collaboration with Medtronic, and **Virtue SAB** for atherosclerotic artery disease, with a Right of First Refusal agreement with Terumo.  **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:2]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:3]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:6]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:7]**   Both programs have received **FDA Breakthrough Designation**.  **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:2]** 
- These therapies target significant global markets, with AVIM Therapy addressing a >**$17 billion annual opportunity** and Virtue SAB targeting a >**$10 billion annual opportunity**.  **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:2]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:3]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:5]** 
- The **BACKBEAT Global Pivotal Study** for AVIM Therapy is currently enrolling, with estimated completion of enrollment in **mid-2026**, and the **Virtue Trial**, a U.S. randomized pivotal study for Virtue SAB, is planned for initiation in **2H 2025**.  **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:2]** **[1814114_0001104659-25-104016_tm2529796d1_ex99-1.htm:5]**

Orchestra BioMed Holdings, Inc. secures over $147M in financing and updates on pivotal trials

- Orchestra BioMed Holdings, Inc. (OBIO) and Terumo Medical Corporation (Terumo) entered into new strategic agreements on **October 24, 2025**, which include the termination of their prior Virtue SAB distribution agreement.  **[1814114_0001104659-25-102862_tm2529597d1_8k.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** 
- Terumo will pay OBIO a **$10 million fee** for a right of first refusal (ROFR) regarding Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) for coronary artery disease.  **[1814114_0001104659-25-102862_tm2529597d1_8k.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** 
- Additionally, Terumo will invest an **additional $20 million** in OBIO through a new series of non-voting preferred stock, convertible into common stock at a minimum of **$12 per share**.  **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex10-2.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_8k.htm:2]** **[1814114_0001104659-25-102862_tm2529597d1_ex10-1.htm:3]** 
- OBIO retains all development and distribution rights for Virtue SAB in indications not covered by the ROFR, and has initiated patient enrollment for the Virtue Trial, its U.S. pivotal IDE trial for coronary in-stent restenosis.  **[1814114_0001104659-25-102862_tm2529597d1_8k.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_ex99-1.htm:0]** **[1814114_0001104659-25-102862_tm2529597d1_8k.htm:8]**

Orchestra BioMed Holdings (OBIO)