Orchestra Biomed Holdings, Inc.: BACKBEAT Enters Final Lap, On-Track for Q3 Completion and Filing in 1H26; Reit OW, Raising Price Target

Research evidence excerpt

Orchestra Biomed Holdings, Inc.: BACKBEAT Enters Final Lap, On-Track for Q3 Completion and Filing in 1H26; Reit OW, Raising Price Target

Equity Research

U.S. Medical Supplies & Devices

12 May 2026

Orchestra Biomed Holdings, Inc.

BACKBEAT Enters Final Lap, On-

Track for Q3 Completion and Filing

OBIO OVERWEIGHTin 1H26; Reit OW, Raising Price

Unchanged

U.S. Medical Supplies & POSITIVETarget Devices

Better than expected Q1 results included a positive update on Price Target USD 13.00

the BACKBEAT pivotal trial (studying AVIM in hypertension), a raised 8% from USD 12.00

key milestone for OBIO’s strategic and commercial Price (12-May-26) USD 4.06 Potential Upside/Downside +220.2%

Source: Bloomberg, Barclays Researchpartnership with MDT. We reit our OW rating on OBIO and

remain bullish on this compelling opportunity for both OBIO

Market Cap (USD mn) 243

and MDT. Shares Outstanding (mn) 59.88

Free Float (%) 76.61

BACKBEAT On Track to Complete by End of Q3, with the FDA’s Approval for a Smaller Trial 52 Wk Avg Daily Volume (mn) 0.3

Sample Size: Mgmt announced earlier today that they received FDA approval of a reduction in Dividend Yield (%) N/A

the sample size for the clinical trial from ~500 patients down to an enrollment target of 316 Return on Equity TTM (%) -138.08

patients (including a buffer for loss to follow-up). We view the approval of the reduced sample Current BVPS (USD) 0.76

size by the FDA as supportive and positive. The primary efficacy endpoint (changed in 24-hour Source: Bloomberg

ambulatory systolic BP at 3 months) and primary safety endpoints remain well powered at

>90% statistical power. Mgmt expects to complete the trial by the end of Q3, which is a touch Price Performance Exchange-Nasdaq

beyond prior comments targeting mid-2026.