Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Corporate Update (November 2025)

17 slides from Orchestra Biomed's corporate update, Nov 13, 2025

  1. Slide 1: Orchestra BioMed Business Update November 2025

    Orchestra BioMed Business Update November 2025 Nasdaq: OBIO

  2. Slide 2: Forward-Looking Statements

    Forward - Looking Statements dŚŝƐ ƉƌĞƐĞŶƚĂƚŝŽŶ ŚĂƐ ďĞĞŶ ƉƌĞƉĂƌĞĚ ĨŽƌ ŝŶĨŽƌŵĂƚŝŽŶĂů ƉƵƌƉŽƐĞƐ ŽŶůLJ ĨƌŽŵ ŝŶĨŽƌŵĂƚŝŽŶ ƐƵƉƉůŝĞĚ ďLJ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ,ŽůĚŝŶŐƐ͕ /ŶĐ ͘ ͕ ƌĞĨĞƌƌĞĚ ƚŽ ŚĞƌĞŝŶ ĂƐ ͞ ǁĞ͕ ͟ ͞ ŽƵƌ͕ ͟ ͞ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ͕ ͟ ĂŶĚ ͞ ƚŚĞ ŽŵƉĂŶLJ͕ ͟ ĂŶĚ ĨƌŽŵ ƚŚŝƌĚ Ͳ ƉĂƌƚLJ ƐŽƵƌĐĞƐ ŝŶĚŝĐĂƚĞĚ ŚĞƌĞŝŶ ͘ ^ƵĐŚ ƚŚŝƌĚ

  3. Slide 3: Key Investment Highlights

    s/DdŚĞƌĂƉLJ WƌŽŐƌĂŵŵĂďůĞ͕ƉĂĐĞŵĂŬĞƌ Ͳ ĚĞůŝǀĞƌĞĚ ƚƌĞĂƚŵĞŶƚĨŽƌŚŝŐŚďůŽŽĚƉƌĞƐƐƵƌĞĂŶĚ ŚLJƉĞƌƚĞŶƐŝǀĞŚĞĂƌƚĚŝƐĞĂƐĞ Virtue SAB Proprietary, non - coated sirolimus balloon angioplasty system for atherosclerotic artery disease and other indications Key Investment Highlights Leveraging Partnerships to Bring Innova

  4. Slide 4: Over $147M in Strategic-Driven Financing Secured Since August 2025

    Over $147M in Strategic - Driven Financing Secured Since August 2025 Ψ ϴϱ DŽĨ^ƚƌĂƚĞŐŝĐĂƉŝƚĂůŽŵŵŝƚŵĞŶƚƐнΨ ϲϮ͘ϲ DƋƵŝƚLJ&ŝŶĂŶĐŝŶŐ Æ džƉĞĐƚĞĚƚŽWƌŽǀŝĚĞZƵŶǁĂLJŝŶƚŽ Y ϰ ϮϬϮϳ Ψ ϯϱ ŵŝůůŝŽŶ ĐŽŵŵŝƚƚĞĚƚŽƉƵƌĐŚĂƐĞƌŽLJĂůƚLJ Ͳ ďĂƐĞĚƌĞǀĞŶƵĞ ŝŶƚĞƌĞƐƚ͖ƉůƵƐ Ψ ϱ ŵŝůůŝŽŶ ĞƋƵŝƚLJŝŶǀĞƐƚŵĞŶƚ $ 31.6 million additional strategic in

  5. Slide 5: Terumo Partnership for Virtue SAB

    Orchestra developed Virtue SAB from concept stage, owns all related IP, conducted all prior studies, and retains all development and distribution rights in all indications Terumo is a global leader in interventional cardiology devices: >$2.4B in annual revenues 1 Terumo purchased ROFR for Virtue SAB

  6. Slide 6: Virtue SAB Overview

    sŝƌƚƵĞ Π ^KǀĞƌǀŝĞǁ ƌƵŐ Ͳ ĐŽĂƚĞĚďĂůůŽŽŶƐ;ͿĞŵĞƌŐŝŶŐĂƐŶĞǁƐƚĂŶĚĂƌĚŽĨĐĂƌĞ ĨŽƌŬĞLJĐŽƌŽŶĂƌLJĂŶĚ ƉĞƌŝƉŚĞƌĂůŝŶĚŝĐĂƚŝŽŶƐ ŽƐƚŽŶ^ĐŝĞŶƚŝĨŝĐ ͛ Ɛ'EdWĂĐůŝƚĂdžĞů Ͳ ĐŽĂƚĞĚďĂůůŽŽŶh^ĐŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶƵŶĚĞƌǁĂLJ ǁŝƚŚ ƉŽƐŝƚŝǀĞŝŶĚŝĐĂƚŝŽŶƐŽĨƐĂůĞƐŐƌŽǁƚŚ Paradigm Shift Unlocks High - Growth Opportunity in Large $10B Established Ma

  7. Slide 7: Protected Delivery of Extended Release Sirolimus

    Protected Delivery of Extended Release Sirolimus Virtue ® SAB – Optimal Drug, Dose and Delivery 1 Granada et al. EuroIntervention 2016;12:740 - 747. 2 Animals included in the analysis of distant organs received average dose of 20.4 mg ≈10X the largest clinical dose ^ŝƌŽůŝŵƵƐ&Z DŝĐƌŽƉŽƌŽƵƐŶŐŝŽ/ŶĨƵƐŝŽ

  8. Slide 8: Compelling SABRE Trial Results in Coronary ISR Patients

    >Žǁ Ϯ͘ϴ йdĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ ;d>&ͿĂƚ ϭ LJĞĂƌ >Žǁ Ϭ͘ϭϮ ŵŵ>ĂƚĞ>ƵŵĞŶ>ŽƐƐ ;>>>ͿĂƚ ϲ Ͳ ŵŽŶƚŚƐ 0% Target Lesion Revascularization (TLR) between 1 - 3 years Virtue® SAB demonstrated encouraging safety and efficacy results in patients with coronary in - stent restenosis (ISR) in prospective, multi - center S

  9. Slide 9: AGENT and SELUTION ISR Trial Results Show Clear Opportunity for Virtue SAB

    Target Lesion Failure 13.5% (AGENT) and 13.2% (SELUTION) (TLF) at 1 year No angiographic follow - up in both IDE AGENT LLL = 0.397mm at 6 months 4 ; SELUTION LLL not reported for coronary ISR 'EdΘ^>hd/KE ϰ /^Z/dƌŝĂůZĞƐƵůƚƐ^ŚŽǁůĞĂƌ KƉƉŽƌƚƵŶŝƚLJĨŽƌsŝƌƚƵĞ^ 0% 5% 10% 15% 20% 25% 20.2% ϭϯ͘ϱ й ϭ zĞĂƌ 2 Yea

  10. Slide 10: The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial

    The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial Designed to Secure Regulatory Approval & Showcase Differentiation of Virtue SAB R ϳϰϬ WƚƐǁŝƚŚ/^Z>ĞƐŝŽŶƐŝŶƌƚĞƌŝĞƐ Ϯ͘ϬϬ ʹ ϰ͘ϬϬ ŵŵ sŝƌƚƵĞ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ ĂůůŽŽŶ 1:1 ϯϳϬ WƚƐ͘ ϯϳϬ WƚƐ͘ 12 M 12 M Clinical Follow - Up out to 5 Years WƌŝŵĂƌ

  11. Slide 11: AVIM Therapy Overview

    AVIM Therapy Overview Hypertension is the leading global risk factor for death, affecting 1.2B patients Uncontrolled HTN in older, higher - risk patients drives MI, stroke and heart failure Reductions as small as 5 mmHg in office systolic bloo d pressure substantially decrease the relative risk of m

  12. Slide 12: The BACKBEAT Study – Global Pivotal Hypertension Trial

    The BACKBEAT Study – Global Pivotal Hypertension Trial ĞƐŝŐŶĞĚƚŽ^ĞĐƵƌĞZĞŐƵůĂƚŽƌLJƉƉƌŽǀĂůΘ^ŚŽǁĐĂƐĞEŽǀĞůƉƉƌŽĂĐŚƚŽůŽŽĚWƌĞƐƐƵƌĞDĂŶĂŐĞŵĞŶƚ WƌŝŵĂƌLJĨĨŝĐĂĐLJŶĚƉŽŝŶƚ͗ D ĞĂŶĐŚĂŶŐĞŝŶ Ϯϰ Ͳ ŚŽƵƌĂ^WĂƚ ϯ Ͳ ŵŽŶƚŚƐ WƌŝŵĂƌLJ^ĂĨĞƚLJŶĚƉŽŝŶƚ͗ &ƌĞĞĚŽŵĨƌŽŵƵŶĂŶƚŝĐŝƉĂƚĞĚƐĞƌŝŽƵƐĂĚǀĞƌƐĞĚĞǀŝĐĞĞǀĞŶƚƐĂƚ ϯ ŵŽŶƚŚƐ ĚĚŝƚŝŽŶĂů^ĞĐŽŶĚĂƌLJŶĚ

  13. Slide 13: FDA Breakthrough Device Designation for AVIM Therapy

    FDA Breakthrough Device Designation Highlights Potential For AVIM Therapy to Impact Hypertensive Heart Disease ΎĂƐĞĚŽŶĐŽŵƉĂŶLJĞƐƚŝŵĂƚĞƐ͘ WŽƉƵůĂƚŝŽŶŽĨƉĂĐĞŵĂŬĞƌ Ͳ ŝŶĚŝĐĂƚĞĚƉĂƚŝĞŶƚƐǁŝƚŚ ƵŶĐŽŶƚƌŽůůĞĚŚLJƉĞƌƚĞŶƐŝŽŶ ĚĞƐƉŝƚĞŵĞĚŝĐĂƚŝŽŶ ŐĞŶĞƌĂůůLJŵĞĞƚƐ& ďƌĞĂŬƚŚƌŽƵŐŚĐƌŝƚĞƌŝĂ HTN Despite Medication Increased 10 -

  14. Slide 14: AVIM Therapy Clinical Results Show Potential to Treat ISH

    &ĂǀŽƌĂďůĞ/ŵƉĂĐƚŽŶ,LJƉĞƌƚĞŶƐŝǀĞ,ĞĂƌƚŝƐĞĂƐĞ AVIM Therapy Clinical Results S how Potential to T reat ISH , Induce Reverse Remodeling, and Improve Diastolic Dysfunction ϭ ƵƌŬŚŽĨĨDKZdK//^ƚƵĚLJ Ϯ Ͳ zĞĂƌZĞƐƵůƚƐdd ϮϬϮϭ ͘ Ϯ sĂĐĐĂƌŝŶŽs͕ĞƚĂů͘ŵ: ĂƌĚŝŽů ͘ ϮϬϬϭ ϯ Eс ϭϰ s/DƚŚĞƌĂƉLJĂŶĚŶс ϭϭ ĐŽŶƚƌŽůŐƌŽƵƉ͘ ϰ &ƵĚŝŵD͕d,d

  15. Slide 15: AVIM Therapy Demonstrates Sustained aSBP Reductions

    s/DdŚĞƌĂƉLJĞŵŽŶƐƚƌĂƚĞƐ^ƵƐƚĂŝŶĞĚĂ^WZĞĚƵĐƚŝŽŶƐǁŝƚŚ ZĞƉƌŽĚƵĐŝďůĞĨĨĞĐƚĂŶĚEŽZĞďŽƵŶĚ,LJƉĞƌƚĞŶƐŝŽŶ 15 115 120 125 130 135 Baseline 6-Month Endpoint Day 0 Day 1 Day 7 Day 8 24 - Hr aSBP (mmHg) 122.8 ц 11.6 ϭϯϯ͘ϭ ц ϭϲ͘ϲ ϭϯϮ͘Ϯ ц ϭϯ͘ϰ 124.4 ц 10.1 Ɖс Ϭ͘ϬϬϭ Ɖс Ϭ͘ϬϬϮ 132.2 ц 7.0 122.8 ц 11.5 p < 0.001 DKZdK// s/Dd

  16. Slide 16: Key Investment Highlights

    WŝǀŽƚĂů^ƚĂŐĞ͕,ŝŐŚ Ͳ /ŵƉĂĐƚdŚĞƌĂƉŝĞƐ Large, Established Target Markets WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚƵƐŝŶĞƐƐDŽĚĞů džƉĞĐƚĞĚ&ƵŶĚŝŶŐŝŶƚŽY ϰϮϬϮϳ 16 Key Investment Highlights Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability | Business Update November 2025

  17. Slide 17: Bringing Medical Innovations to Life Through Partnerships

    ƌŝŶŐŝŶŐ DĞĚŝĐĂů /ŶŶŽǀĂƚŝŽŶƐ ƚŽ >ŝĨĞ dŚƌŽƵŐŚ WĂƌƚŶĞƌƐŚŝƉƐ

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