Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (September 2026)

26 slides from Orchestra Biomed's investor presentation, Sep 8, 2026

  1. Slide 1: Corporate Overview | September 2026

    Accelerating high - impact technologies to patients through risk - reward sharing partnerships Corporate Overview | September 2026 Nasdaq : OBIO

  2. Slide 2: Forward-Looking Statements

    Forward - Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , referred to herein as “we,” “our,” “Orchestra BioMed,” and the “Company,” and from third - party sources indicated herein . Such third - pa

  3. Slide 3: Accelerating innovation to patients through partnerships

    Accelerating innovation to patients through partnerships CAPITAL - EFFICIENT ROYALTY PARTNERSHIP MODEL We drive R&D through pivotal trials in strategic collaboration with partners that can optimize global commercialization TWO PIVOTAL - STAGE PROGRAMS TARGETING LARGE MARKETS Our flagship technologie

  4. Slide 4: Our partnership model optimizes execution and capital efficiency

    Our partnership model optimizes execution and capital efficiency WE FOCUS ON BEING GREAT AT: High - impact innovation differentiated technology with strong IP Expert clinical execution global pivotal trials that support regulatory approvals and optimized reimbursement Value - creating partnerships c

  5. Slide 5: Therapy for uncontrolled hypertension in the $4 billion pacemaker market

    Therapy for uncontrolled hypertension, the #1 comorbidity in the $4 billion pacemaker market 1 Patented therapy delivered by a pacemaker that can immediately, substantially and persistently lower blood pressure AVIM THERAPY Atrioventricular Interval Modulation FOCUSED STRATEGIC APPROACH OUR MODEL IN

  6. Slide 6: Our product pipeline targets large immediate and future opportunities

    Our product pipeline targets large immediate and future opportunities OUR PRODUCT PIPELINE AVIM THERAPY Atrioventricular Interval Modulation LAUNCH MARKET | PIVOTAL TRIAL STAGE Hypertension + Pacemaker up to $6B global annual total addressable market (TAM) • Uncontrolled hypertension in pacemaker pa

  7. Slide 7: Strategic investments & payments from industry leaders

    $185M > Strategic investments & payments from industry leaders total strategic capital invested in & paid to OBIO by its partners 21%** owned by strategic partners* led by Medtronic at ~15%** ~ $81.6M Equity & $20M strategic capital $40M $35M for revenue participation right plus $5M equity investmen

  8. Slide 8: A potent hypertension therapy delivered by a pacemaker

    A potent hypertension therapy delivered by a pacemaker Designed to lower blood pressure and improve cardiac function through well - characterized mechanisms Short AV delays reduce blood pressure IMMEDIATE Longer AV delays maintain BP reduction SUSTAINED Short AV intervals reduce ventricular filling

  9. Slide 9: Hypertension is leading cardiovascular risk factor, affecting ~1.4B adults

    ¹World Health Organization, Global Report on Hypertension 2025 (an estimated 1.4B adults aged 30 – 79 with hypertension in 2024, 3 3% of that age group; ~23% controlled). ²Lewington et al., Lancet 2002;360:1903 – 13 (each 20 mmHg higher usual systolic BP associated with approximately two - fold high

  10. Slide 10: More than a decade of evidence supporting AVIM Therapy

    More than a decade of evidence supporting AVIM Therapy PRECLINICAL & FIRST - IN - HUMAN RANDOMIZED CLINICAL EVIDENCE PARTNERSHIP & PIVOTAL TRIAL 2016 2019 2021 2022 Feasibility Study in Canine HTN Model Preclinical proof of concept Acute Feasibility Study in Subjects with HTN First acute mechanistic

  11. Slide 11: MODERATO II demonstrated immediate, substantial and sustained BP reduction

    MODERATO II demonstrated immediate, substantial and sustained BP reduction AVIM Therapy significantly reduced systolic blood pressure compared to control with no medication changes & low MACE 1 0 - 5 - 10 - 15 - 20 Δ in SBP (mmHg) AVIM Therapy Set - Up 2 1 Day 6 Months 24 Months oSBP - 13.2 N=39 P<0

  12. Slide 12: AVIM is designed to address the needs of high-risk, comorbid, older patients

    AVIM is designed to address the needs of high - risk, comorbid, older patients MODERATO II results show AVIM Therapy offers disease - modifying potential benefits for hypertensive heart disease REDUCED PULSE PRESSURE IN ISH In Isolated Systolic Hypertension patients (ISH), AVIM Therapy significantly

  13. Slide 13: The BACKBEAT Global Pivotal Trial nearing completion

    The BACKBEAT Global Pivotal Trial nearing completion • Double - blind, randomized, 1:1 • 284 evaluable randomized patients target • ~120 sites globally • >90% statistical power (safety & efficacy) • Actively enrolling trial participants PATIENTS IMPLANTED WITH OR INDICATED FOR A DUAL - CHAMBER PACEM

  14. Slide 14: Medtronic collaboration: uncapped royalty-based revenue share

    $81.6M invested in Orchestra BioMed Right of First Negotiation for non - pacemaker HTN OBIO earns an uncapped, double - digit royalty - based revenue share of every AVIM Therapy - enabled device sold The global market leader will drive commercialization DEVELOPMENT & CLINICAL EXECUTION Invented AVIM

  15. Slide 15: Large, established market of pacemaker patients with hypertension

    Large, established market of pacemaker patients with hypertension S ubstantial uncapped royalties can drive significant OBIO topline growth and accelerated profitability AVIM THERAPY | MARKET & ACCESS $4B annual global pacemaker market >1M pacemaker patients per year have hypertension +$1B +$1B Exis

  16. Slide 16: Significant expansion opportunity beyond the pacemaker market

    Significant expansion opportunity beyond the pacemaker market 7.7M+ HTN despite medication, increased 10 - year ASCVD risk & preserved LVEF 2.4M+ ISH / Diastolic Dysfunction 1.4M+ HTN + HFpEF 300K HTN+PPM 1 U.S. patient population estimates based on company analysis; populations are nested, not addi

  17. Slide 17: BACKBEAT Trial & AVIM Therapy Catalysts

    2H 2027 Q2 2027 BACKBEAT Trial & AVIM Therapy Catalysts Target enrollment completion BACKBEAT Global Pivotal Trial Primary endpoint data Present BACKBEAT primary endpoint data FDA review of PMA submission oUS regulatory submissions Potential FDA approval and commercial launch Potential OUS commercia

  18. Slide 18: Proven gold standard sirolimus; Virtue SAB designed to optimize delivery

    Proven gold standard sirolimus The anti - restenotic and anti - inflammatory, cytostatic drug with a broad safety margin 1 Virtue SAB: designed to optimize sirolimus dosing, uptake and release SirolimusEFR formulation • Rapidly infuses particles transmurally • Sustains sirolimus release through the

  19. Slide 19: Why there is a compelling opportunity for Virtue SAB

    Why there is a compelling opportunity for Virtue SAB VIRTUE SAB | OPPORTUNITY DRIVERS 19 Corporate Overview | September 2026 Superior safety and efficacy over paclitaxel across 76 DES studies, including 26 RCTs 1 &ĂƐƚĞůƵƚŝŽŶ ;ф ϭϱ ĚĂLJƐͿ ŶĚĞĂǀŽ ƌ ĚƌƵŐ Ͳ ĞůƵƚŝŶŐ ƐƚĞŶƚ ; ^Ϳ ŝŶĨĞƌŝŽƌƚŽ ^ƚĂŶĚĂƌĚĞůƵƚŝŽŶ ;

  20. Slide 20: Virtue SAB | Opportunity Drivers

    VIRTUE SAB | OPPORTUNITY DRIVERS /ŶƉƵďůŝƐŚĞĚW<ƐƚƵĚLJ͕sŝƌƚƵĞĚĞůŝǀĞƌĞĚͬŵĂŝŶƚĂŝŶĞĚŵŽƌĞƐŝƌŽůŝŵƵƐƚŚĂŶ^ĂŶĚ Virtue achieved high drug concentrations in tissue through critical healing period , exceeding published levels of proven DES ( Xience ) and leading Sirolimus - coated balloons VIRTUE® SAB XIENCE SIRO

  21. Slide 21: SABRE pilot trial results showcase opportunity for Virtue SAB

    SABRE pilot trial results showcase opportunity for Virtue SAB Virtue SAB demonstrated encouraging safety and efficacy results in patients with coronary ISR in the prospective, multi - center SABRE trial — single - layer restenosis with 6 month angiographic follow up , per - protocol analysis. 1 - 4

  22. Slide 22: The Virtue Pivotal Trial actively enrolling patients with ISR lesions

    The Virtue Pivotal Trial actively enrolling 740 patients with ISR lesions in arteries 2.00 – 4.00 mm Randomize 1:1 370 pts ϯϳϬ ƉƚƐ Virtue Sirolimus AngioInfusion Balloon AGENT Paclitaxel - Coated Balloon 12 M 12 M PRIMARY ENDPOINT Target Lesion Failure (TLF) at 12 months ANALYSIS ‡ EŽŶ Ͳ ŝŶĨĞƌŝŽƌŝƚLJ

  23. Slide 23: Virtue SAB product differentiation and coronary market

    Virtue SAB product differentiation offers potentially significant, sustainable commercial advantages • $65M in payments & equity investments to Orchestra 2 • ROFR does not restrict any strategic activity today and expires 90 days after Virtue Trial data disclosure • 30 days to exercise after notice

  24. Slide 24: Led by a team with a proven cardiovascular innovation track record

    >ĞĚďLJĂƚĞĂŵǁŝƚŚĂƉƌŽǀĞŶĐĂƌĚŝŽǀĂƐĐƵůĂƌŝŶŶŽǀĂƚŝŽŶƚƌĂĐŬƌĞĐŽƌĚ David Hochman Chairman & CEO, Founder Darren R. Sherman President & COO, Director, Founder Andrew Taylor Chief Financial Officer Bill Little sW͕ŽƌƉŽƌĂƚĞĞǀĞůŽƉŵĞŶƚΘ^ƚƌĂƚĞŐLJ COO, Neovasc (→ Shockwave); Abbott Vascular; St. Jude Medical; Boston S

  25. Slide 25: The Bottom Line

    THE BOTTOM LINE CAPITAL - EFFICIENT ROYALTY ECONOMICS High - margin potential royalties on partner - driven sales; no sales, marketing or manufacturing to fund We deliver value for patients, partners and shareholders MEDTRONIC COLLABORATION FOR AVIM THERAPY ^ƉĂŶƐĚĞǀĞůŽƉŵĞŶƚ͕ƌĞŐƵůĂƚŽƌLJΘŐůŽďĂůĐŽŵŵĞƌĐŝ

  26. Slide 26: Bringing medical innovations to life through partnerships

    BRINGING MEDICAL INNOVATIONS TO LIFE THROUGH PARTNERSHIPS Nasdaq: OBIO | investors.orchestrabiomed.com

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