After a Productive 1Q, OBIO Enters The Final Year Before the BACKBEAT Readout

研报英文原文证据摘录

After a Productive 1Q, OBIO Enters The Final Year Before the BACKBEAT Readout

Medical Supplies & Devices

Orchestra BioMed

TD SECURITIES (USA) LLC EARNINGS UPDATE

May 13, 2026

Price: $4.06 (05/12/2026) After a Productive 1Q, OBIO Enters The Final

Price Target: $15.00 Year Before the BACKBEAT Readout

BUY (1)

ESG SCORE: 67/100

Joshua Jennings, M.D. THE TD COWEN INSIGHT

646 562 1333

OBIO exited 1Q26 with strong momentum, highlighting accelerating BACKBEAT enrollment and

joshua.jennings@tdsecurities.com

clear visibility to completion by Q3’26 alongside early progress in the Virtue SAB pivotal trial.

Colin Clark With >$90M in cash and additional strategic inflows, the company is well funded through key

646 562 1441 2026–2027 clinical and regulatory inflection points. Reiterate Buy.

colin.clark@tdsecurities.com

John Rusch, CFA Strategic Updates: A Busy Quarter for AVIM Therapy, and Steady Progress on Virtue Trial

646 562 1324

During 1Q26, OBIO continued advancing both of its late-stage cardiovascular programs,john.rusch@tdsecurities.com

including AVIM Therapy's receipt of a second FDA breakthrough device designation (BDD) for

Key Data patients with uncontrolled hypertension despite the use of anti-hypertensive medications and

Symbol NASDAQ: OBIO

an indication for a pacemaker (report here). This new BDD enabled the company to reduce

Beta: 0.52 the required BACKBEAT sample size and gave management the confidence to announce

52-Week Range: $5.35-$2.35 timelines for targeted enrollment completion (by end of 3Q26), the planned primary endpoint

Market Cap: $237.6MM presentation at a major cardiovascular meeting (2Q27), and subsequent MDT submission of an

Net Debt (MM): $(74.1) AVIM Therapy marketing application for FDA approval (once primary endpoint data analyses