Orchestra BioMed Holdings Inc.
OBIO evidence brief
What we can confirm
- BioSniper Score:
- 6.9 / 10
- Market Cap:
- $347.4M
- Lead Asset:
- avim therapy (Phase 3)
What it means
What to watch
Prepared research question
What matters most for OBIO—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · OBIO
Orchestra BioMed Holdings Inc. (OBIO) is a biomedical company that partners with global medical device leaders to advance cardiovascular and bioelectronic therapies, with two Phase 3 programs — Virtue SAB and AVIM Therapy — and a cash balance of $20.5M as of 2026-06-30 [sec].
Key risk: Pre-revenue stage with net losses
BioSniper Score
Based on 4 of 6 signals
Market Cap
$347.4M
Cash Runway
—
Lead Asset
avim therapy (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates for Orchestra BioMed Holdings Inc..
Orchestra BioMed Holdings Inc. (OBIO) is a biomedical company that partners with global medical device leaders to advance cardiovascular and bioelectronic therapies, with two Phase 3 programs — Virtue SAB and AVIM Therapy — and a cash balance of $20.5M as of 2026-06-30 [sec].
- Cash & equivalents of $20.5M, total revenue of $0.1M, and net income of -$23.8M as of 2026-06-30 [sec].
- BACKBEAT global pivotal trial (AVIM Therapy) exceeded its target with 330 patients randomized as of September 30, 2026, and primary data presentation targeted for Q2 2027 [news · 2026-10-01].
- Virtue SAB (sirolimus-coated balloon) is in Phase 3 for atherosclerotic artery disease, with Breakthrough Device status and a partnership with Terumo Medical Corporation [pipeline].
- AVIM Therapy is a bioelectronic therapy for hypertension in pacemaker-indicated patients, developed with Medtronic under an exclusive global commercialization agreement [pipeline].
- Orchestra BioMed received a $6.1 million milestone payment from the acquisition of Vivasure by Haemonetics in September 2026, adding to prior proceeds [news · 2026-09-15].
What works
- Two Phase 3 programs (Virtue SAB and AVIM Therapy) are partnered with established medical device companies (Terumo and Medtronic), providing development and commercialization infrastructure [pipeline].
- BACKBEAT trial enrollment exceeded the target (330 patients vs. 284 target), indicating strong clinical execution and momentum toward a Q2 2027 data readout [news · 2026-10-01].
- The company has a cash runway projected into Q4 2027, supported by a $110M cash balance as of August 2026 and additional milestone payments [news · 2026-08-10].
What to weigh
- The company has minimal current revenue ($0.1M as of 2026-06-30) and a net loss of -$23.8M, reflecting a pre-commercialization stage with high R&D costs [sec].
- Both lead programs are still in Phase 3 and have not yet generated regulatory approval or commercial sales, creating binary outcome risk [pipeline].
- The company faces competition from multiple players in atherosclerotic artery disease, including Eli Lilly, Hudson Biotech, and ImmuneOnco, which could affect Virtue SAB's market position [competitor_trial].
From the filings
Quoted directly from source documents.
BACKBEAT trial enrollment exceeded target
“330 patients randomized as of September 30, 2026, surpassing full trial enrollment target”
News · October 1, 2026
Cash runway into Q4 2027
“$110 million cash balance provides projected runway into Q4 2027 and through key upcoming milestones”
News · August 10, 2026
Virtue SAB is partnered with Terumo
“Terumo responsible for device manufacturing, commercial sales, marketing and distribution; Orchestra BioMed receives double-digit royalties and per-unit payments for SirolimusEFR.”
AVIM Therapy is partnered with Medtronic
“Exclusive license and collaboration agreement; Medtronic provides development, clinical and regulatory support; Orchestra BioMed is responsible for pivotal study costs; Medtronic has exclusive global commercialization rights upon approval.”
Risks & what to watch (3)›
Key risks
- Pre-revenue stage with net losses — Revenue of $0.1M and net loss of -$23.8M as of 2026-06-30, indicating heavy reliance on cash reserves and partnership funding [sec].
- Phase 3 binary outcome risk — Both lead programs (Virtue SAB, AVIM Therapy) are in Phase 3 and have not yet achieved regulatory approval or commercial sales [pipeline].
- Competition in atherosclerotic artery disease — Multiple competitors (Eli Lilly, Hudson Biotech, ImmuneOnco) are running trials for similar indications, potentially limiting Virtue SAB's market share [competitor_trial].
What to watch
- Primary endpoint data from the BACKBEAT trial expected in Q2 2027, which will determine AVIM Therapy's regulatory path [news · 2026-10-01].
- Virtue SAB pivotal trial progress and site activations, as it advances toward potential regulatory submission [news · 2026-08-10].
- Cash runway and any additional milestone payments or financing events that could extend the company's operational horizon [news · 2026-09-15].
Sources: Competitor trials · News · Pipeline · Generated October 3, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$24M
Lead: Phase 3
3 candidates
No upcoming catalysts tracked
6 buys · 4 sells (180d)
Pipeline
Financials
Short Interest
as of May 13, 2026- % of float
- 2.6%
- Days to cover
- 6.3
- Shares short
- 972,590
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
OBIO short interestGovernance
Frequently asked questions
What is the AI investment thesis for Orchestra BioMed Holdings Inc.?
Orchestra BioMed Holdings Inc. (OBIO) is a biomedical company that partners with global medical device leaders to advance cardiovascular and bioelectronic therapies, with two Phase 3 programs — Virtue SAB and AVIM Therapy — and a cash balance of $20.5M as of 2026-06-30 [sec].
What is Orchestra BioMed Holdings Inc.'s lead drug candidate?
Orchestra BioMed Holdings Inc.'s most advanced tracked candidate is avim therapy (Phase 3) for Hypertension in patients indicated for a cardiac pacemaker.
Who is the CEO of Orchestra BioMed Holdings Inc.?
Mr. David P. Hochman is the chief executive officer of Orchestra BioMed Holdings Inc. (OBIO).
Where is Orchestra BioMed Holdings Inc. headquartered?
Orchestra BioMed Holdings Inc. (OBIO) is headquartered in New Hope, PA, United States.
What therapeutic areas does Orchestra BioMed Holdings Inc. focus on?
Orchestra BioMed Holdings Inc. develops therapies across Oncology, Cardiovascular.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.