Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (March 2025)

28 slides from Orchestra Biomed's investor presentation, Mar 3, 2025

1. Slide 1: Orchestra BioMed Corporate Presentation Q1 2025

   KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ŽƌƉŽƌĂƚĞ WƌĞƐĞŶƚĂƚŝŽŶ Y ϭϮϬϮϱ

2. Slide 2: Forward-Looking Statements

   ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ Ϯ 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 sourc

3. Slide 3: Orchestra BioMed Executive Overview

   | Corporate Presentation Q1 2025 3 KƌĐŚĞƐƚƌĂŝŽDĞĚdžĞĐƵƚŝǀĞKǀĞƌǀŝĞǁ WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚƵƐŝŶĞƐƐDŽĚĞůĞƐŝŐŶĞĚƚŽ ĐĐĞůĞƌĂƚĞ/ŶŶŽǀĂƚŝŽŶƚŽWĂƚŝĞŶƚƐΘzŝĞůĚdžĐĞƉƚŝŽŶĂů&ƵƚƵƌĞWƌŽĨŝƚĂďŝůŝƚLJ Ψ ϭϬ  ĂŶŶƵĂůŚLJƉĞƌƚĞŶƐŝŽŶ ƚĂƌŐĞƚ ŵĂƌŬĞƚ ^ ƚĂƚŝƐƚŝĐĂůůLJ  ƐŝŐŶŝĨŝĐĂŶƚ ĞĨĨŝĐĂĐLJĚĂƚĂĨƌŽŵ  ĚŽƵďůĞ Ͳ

4. Slide 4: Partnership-Enabled Model Benefits All

   ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ 4 Orchestra BioMed’s Partnership - Enabled Model Benefits All Orchestra BioMed Development ŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ ^ƚƌĂƚĞŐŝĐWĂƌƚŶĞƌƐ ^ŚĂƌĞĚĞŶĞĨŝƚƐ /ŶŶŽǀĂƚŝŽŶ ^ĞĐƵƌĞƐƵďƐƚĂŶƚŝĂů ůŽŶŐ Ͳ ƚĞƌŵƌŽLJĂůƚŝĞƐ KƵƚƐŽƵƌĐĞ ĐŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ ŶĂďůĞŵƵůƚŝƉůĞƉŝƉĞůŝŶĞ ŽƉƉŽƌƚƵŶŝƚŝĞƐ

5. Slide 5: Advancing High-Impact Pipeline

   | Corporate Presentation Q1 2025 5 Clinical Pivotal Clinical Feasibility Preclinical Target Indications Product Platforms Hypertension (HTN) (pacing patients; HTN+P) s/DdŚĞƌĂƉLJ ;ĂůƐŽŬŶŽǁŶĂƐĂĐŬĞĂƚEd Ϳ High - Risk HTN (non - pacing patients) Heart Failure CNT - HF ŽƌŽŶĂƌLJ/Ŷ Ͳ ^ƚĞŶƚ ZĞƐƚĞŶŽ

6. Slide 6: Expert Leadership, Proven Impact

   | Corporate Presentation Q1 2025 6 Expert Leadership, Proven Impact 300+ Combined years in the industry experience  Ϯϱ н ǀĞƌĂŐĞLJĞĂƌƐŽĨ ĞdžƉĞƌŝĞŶĐĞ͕ ďƌŝŶŐŝŶŐĚĞĞƉ ĞdžƉĞƌƚŝƐĞƚŽĞǀĞƌLJ ĐŚĂůůĞŶŐĞ 100+ Successful product approvals, delivering innovation globally 600 + Authored patents shaping the f

7. Slide 7: Atrioventricular Interval Modulation (AVIM) Therapy

   Atrioventricular Interval Modulation (AVIM) therapy Also known as BackBeat CNT | Corporate Presentation Q1 2025 7

8. Slide 8: AVIM Therapy Overview

   ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ 8 AVIM Therapy Overview Hypertension is the leading global risk factor for death, particularly for older , higher risk patients , despite pharmacotherapy Risk of High Blood Pressure Pacemaker - delivered therapy designed to immediately, substantially and persistentl

9. Slide 9: $10 Billion Annual Global Opportunity in Hypertension

   | Corporate Presentation Q 1 2025 9 $10 Billion Annual Global Opportunity Large Global Opportunity for Treating Hypertension in Target Populations * HTN + Pacemaker ~70% of pacemaker patients 1 ϳϱϬ͕ϬϬϬ ƉĂƚŝĞŶƚƐ >$2 Billion High Risk HTN ~0.2% of HTN patients 2,400,000 patients >$8 Billion Same pati

10. Slide 10: Strategic Partnership with Medtronic

    Developed AVIM therapy ( BackBeat CNT) from concept stage O wns all related intellectual property: over 110 issued global patents Conducted all prior development and the MODERATO I & II clinical studies Sponsor for the BACKBEAT Global Pivotal Study $500 - $1,600 revenue share per AVIM - enabled devi

11. Slide 11: AVIM Novel Mechanism of Action to Reduce Blood Pressure

    AVIM Therapy is Designed to Substantially and Persistently Reduce Blood Pressure Through a Novel Mechanism of Action ϭϭ AVIM On Systolic BP (mmHg) Short AV intervals: Reduce cardiac preload, immediately lowering blood pressure Intermittent longer AV intervals: modulate autonomic nervous system respo

12. Slide 12: Existing Body of Clinical Data Supporting Efficacy and Safety

    Feasibility Study in Canine HTN Model Proof of concept Acute Feasibility Study in Subjects with HTN 2012 ϮϬϭϲ MODERATO II – Pilot Study Prospective, multi - center, randomized, controlled, double - blind pilot study; Primary endpoint data late - breaking presentation at TCT ϮϬϭϵ MODERATO I - First I

13. Slide 13: MODERATO II Randomized, Double-Blind Results

    ^ƵďƐƚĂŶƚŝĂů Ͳ ϭϭ͘ϭ ŵŵ,ŐZĞĚƵĐƚŝŽŶ ŝŶ Ϯϰ Ͳ ,ŽƵƌĂ^WĂƚ ϲ ŵŽŶƚŚƐ Sustained - 17.5 mmHg Reduction in oSBP at 2 years 0 % Major Adverse Cardiac Events vs. 14.3 % in control group at 6 months 4 AVIM Therapy showed encouraging results in MODERATO II , a prospective, multi - center, randomized, con

14. Slide 14: Recent Clinical Evidence Shows Durability of AVIM Therapy

    Recent Clinical Evidence Shows Durability and Disease - Modifying Potential of AVIM Therapy | Corporate Presentation Q1 2024 14  Demonstrated Long - Term Significant Reduction in SBP Out to 3.6 Years Sustained 8.9 mmHg r eduction in 24 - hour aSBP XXX Favorably Impacted

15. Slide 15: BACKBEAT Study Objective and Design

    BACKBEAT Study Objective and Design Study objective: Evaluate the safety and efficacy of AVIM therapy in subjects indicated for a dual - chamber pacemaker who have hypertension (HTN) despite the use of antihypertensive medication Randomized (1:1) double - blind clinical trial Treatment Group: AVIM t

16. Slide 16: BACKBEAT Study Design

    Patients who have received a Medtronic dual chamber - pacemaker within 365 days or are scheduled to receive one and have hypertension despite medication* R Treatment: AVIM therapy + medical therapy Primary at 3M Control: Medical therapy &ŽůůŽǁ Ͳ ƵƉ Ăƚ ϭϮ D AVIM therapy download and set up Eligibili

17. Slide 17: Virtue Sirolimus AngioInfusion Balloon (SAB)

    Virtue® Sirolimus AngioInfusion Balloon (SAB) 17 | Corporate Presentation Q1 2025

18. Slide 18: Virtue SAB Overview

    Virtue ® SAB Overview /ŶƚĞƌǀĞŶƚŝŽŶĂůƚƌĞĂƚŵĞŶƚŽĨĂƌƚĞƌLJĚŝƐĞĂƐĞ ŵŝŐƌĂƚŝŶŐƚŽǁĂƌĚĚƌƵŐ ĐŽĂƚĞĚďĂůůŽŽŶƐ ĂƐŶĞǁƐƚĂŶĚĂƌĚŽĨĐĂƌĞĨŽƌĐĞƌƚĂŝŶŬĞLJŝŶĚŝĐĂƚŝŽŶƐ Paradigm Shift in Treatment of Artery Disease Highly Differentiated Sirolimus DEB with Sustainable Advantages *Total addressable market in 202

19. Slide 19: Large Global Opportunity for Virtue SAB

    | Corporate Presentation Q 1 2025 19 Large Global Opportunity for Virtue SAB * Coronary In - stent Restenosis, Small Vessel De Novo ~ 2,000,000 patients хΨ Ϯ͘ϰ ŝůůŝŽŶ Peripheral Below - The - Knee ~1,250,000 patients >$1.6 Billion $ 4 Billion Annual Global Opportunity Large mature market with subo

20. Slide 20: Strategic Collaboration with Terumo

    ĞǀĞůŽƉĞĚsŝƌƚƵĞ^ ;^ŝƌŽůŝŵƵƐ&Z͕ŶŐŝŽ/ŶĨƵƐŝŽŶďĂůůŽŽŶͿ ĨƌŽŵĐŽŶĐĞƉƚƐƚĂŐĞ ͖ ŽǁŶƐĂůůƌĞůĂƚĞĚ/W ŽŶĚƵĐƚĞĚĂůůƉƌŝŽƌĚĞǀĞůŽƉŵĞŶƚǁŽƌŬŝŶĐůƵĚŝŶŐ^Z ƐƚƵĚLJŝŶĐŽƌŽŶĂƌLJ/^Z ^ƉŽŶƐŽƌŝŶŐƚŚĞsŝƌƚƵĞ/^Z Ͳ h^ƉŝǀŽƚĂůƐƚƵĚLJ;ĐŽŶĚŝƚŝŽŶĂů/ ŐƌĂŶƚĞĚͿ ϭϬ Ͳ ϭϱ йƌŽLJĂůƚLJŽŶŶĞƚƐĂůĞƐW>h^ƉĞƌƵŶŝƚƉĂLJŵ

21. Slide 21: Compelling Opportunity For Virtue SAB

    Compelling Opportunity For Virtue SAB Coatings have limitations including risk of emboli from large coating particulates, drug loss in transit and rapid navigation requirements ŶŽǀĞůƐŽůƵƚŝŽŶŝƐƌĞƋƵŝƌĞĚƚŽƌĞĂůŝnjĞĂĚǀĂŶƚĂŐĞƐŽĨƐŝƌŽůŝŵƵƐ 1 Xinlin Zhang, et. al. PLOS ONE 2014 May 20;9(5):e97934 Su

22. Slide 22: Virtue SAB – Optimal Drug, Revolutionary Delivery

    1000 100 10 1 Ϭ͘ϭ Ϭ͘Ϭϭ 0.001 0.0001 Lung, liver & kidney below level of assay quantification (0.1 ng/mg) in <1 week 0 5 10 ϭϱ ϮϬ 25 30 Target Lesion Distal Myocardium Kidney Liver Lung Time (Days) N = 753 porcine coronary artery segments Sirolimus Tissue Concentration (ng/mg) WƵďůŝƐŚĞĚĂƚĂĞŵŽŶƐƚƌ

23. Slide 23: Virtue Achieves Therapeutic Sirolimus Tissue Concentrations

    ͞ >ŝŵƵƐ ͟ dŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶ;ŶŐͬŵŐͿ sŝƌƚƵĞ^ĐŚŝĞǀĞƐ dŚĞƌĂƉĞƵƚŝĐ^ŝƌŽůŝŵƵƐdŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶƐ dŚƌŽƵŐŚƚŚĞƌŝƚŝĐĂů,ĞĂůŝŶŐWĞƌŝŽĚ | Corporate Presentation Q1 2025 23 0.1 1.0 10.0 100.0 0 10 20 30 dĂƌŐĞƚdŚĞƌĂƉĞƵƚŝĐŽŶĐĞŶƚƌĂƚŝŽŶ  х ϭ ŶŐͬŵŐ sŝƌƚƵĞ^ΘWƌŽǀĞŶ^ĐŚŝĞǀĞdŚĞƌĂƉĞƵƚŝĐ^

24. Slide 24: Compelling SAB Trial Results in Coronary ISR Patients

    >Žǁ Ϯ͘ϴ йdĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ ;d>&ͿĂƚ ϭ LJĞĂƌ Low 0.12mm Late Lumen Loss (LLL) at 6 - months 0 % Target Lesion Revascularization (TLR) between 1 - 3 years sŝƌƚƵĞΠ^ ĚĞŵŽŶƐƚƌĂƚĞĚ  ĞŶĐŽƵƌĂŐŝŶŐƐĂĨĞƚLJ ĂŶĚĞĨĨŝĐĂĐLJƌĞƐƵůƚƐ ŝŶƉĂƚŝĞŶƚƐǁŝƚŚ ĐŽƌŽŶĂƌLJŝŶ Ͳ ƐƚĞŶƚ ƌĞƐƚĞŶŽƐŝƐ ;/^ZͿŝŶ ƉƌŽƐƉĞĐƚ

25. Slide 25: AGENT IDE Results

    ϭϯ͘ϱ йd>&Ăƚ ϭ LJĞĂƌ EŽĂŶŐŝŽŐƌĂƉŚŝĐĨŽůůŽǁ Ͳ ƵƉ To date, 1 year follow - up only AGENT IDE demonstrated a reduction vs. POBA in TLF at 1 - year in patients with single - layer restenosis 'Ed/ZĞƐƵůƚƐ Ϯϱ | Corporate Presentation Q1 2025 0% 5% 10% 15% 20% 25% 20.2 % ϭϯ͘ϱ й d>& TLF Event Rates

26. Slide 26: Upcoming Virtue SAB Program Milestones

    hƉĐŽŵŝŶŐsŝƌƚƵĞ^WƌŽŐƌĂŵDŝůĞƐƚŽŶĞƐ Planning to conduct US pivotal study in coronary ISR randomizing Virtue SAB vs. BSC AGENT DCB 26 ͮŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϭϮϬϮϱ WƌŝŵĂƌLJĞŶĚƉŽŝŶƚd>&ŶŽŶ Ͳ ŝŶĨĞƌŝŽƌŝƚLJ ^ƚƵĚLJƚŽĞŶƌŽůůĂƉƉƌŽdžŝŵĂƚĞůLJ ϳϰϬ ƉĂƚŝĞŶƚƐ /ĂŵĞŶĚŵĞŶƚĞdžƉĞĐƚĞĚ ϭ , ϮϬϮϱ dĂƌŐĞƚŝŶŐŝŶ

27. Slide 27: Key Investment Highlights

    Lead Partnered Program Enrolling Pivotal Study <ĞLJ/ŶǀĞƐƚŵĞŶƚ,ŝŐŚůŝŐŚƚƐ ^ƚƌŽŶŐ^ŚĂƌĞŚŽůĚĞƌĂƐĞ AVIM Therapy is compelling HTN therapy in pivotal study Actively enrolling with market - leading strategic partner S ubstantial revenue share with s ignificant follow - on market opportunity Enabled by

28. Slide 28: Bringing Medical Innovations to Life Through Partnerships

    ƌŝŶŐŝŶŐDĞĚŝĐĂů /ŶŶŽǀĂƚŝŽŶƐƚŽ>ŝĨĞ dŚƌŽƵŐŚWĂƌƚŶĞƌƐŚŝƉƐ 28 | Corporate Presentation Q1 2025

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