Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (November 2023)

22 slides from Orchestra Biomed's investor presentation, Nov 14, 2023

  1. Slide 1: Orchestra BioMed Corporate Presentation Q4 2023

    Orchestra BioMed Corporate Presentation Q4 2023

  2. Slide 2: Disclaimer and forward-looking statements

    | Corporate Presentation Q4 2023 2 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 thir

  3. Slide 3: Orchestra BioMed Executive Overview

    3 Expected c ash runway into 2H 2026 Major strategic & institutional investors • Statistically significant double - blind, randomized pilot study trial efficacy data • IDE approved • Global pivotal study starting Q4 2023 >ĞĂĚWƌŽŐƌĂŵ ĂĐŬĞĂƚEd Ρ ;s/DΎƚŚĞƌĂƉLJͿ dĂƌŐĞƚƐхΨ ϭϬ ĂŶŶƵĂů ŚLJƉĞƌƚĞŶƐŝŽŶŵĂƌŬĞƚƐ St

  4. Slide 4: Orchestra BioMed's Partnership-Enabled Model Benefits All

    Orchestra BioMed Development ŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ Strategic Partners Shared Benefits Innovation Secure substantial long - term royalties Outsource commercialization Multiple pipeline opportunities Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities

  5. Slide 5: Footnotes on regulatory leverage and designations

    1 Will seek to leverage data from HTN+P pilot and pivotal trials to support clinical and regulatory development for High - Risk HTN indication given that age and other demographic factors of the target population are expected to be similar, the type of hype rte nsion treated will likely be isolated

  6. Slide 6: Highly Accomplished Executive Team & Board

    Executive Team: | >300 Years of Experience | ~25 Avg Industry Years | >100 Product Approvals | >600 Authored Patents David Hochman Chairman, CEO, Founder Darren R. Sherman President, COO, Director, Founder Andrew Taylor Chief Financial Officer Yuval Mika, Ph.D. GM & CTO, Bioelectronic Therapies Geor

  7. Slide 7: BackBeat CNT: Atrioventricular interval modulation (AVIM) therapy

    BackBeat CNT Ρ Atrioventricular interval modulation (AVIM) therapy 7 | Corporate Presentation Q4 2023

  8. Slide 8: AVIM Therapy Overview

    AVIM Therapy Overview 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Exa min ation Survey (NHANES) Collaboration with 8 Hypertension is the leading global risk factor for death and #1 comorbidity in the pacemaker population

  9. Slide 9: Large Global Opportunity for Treating Hypertension in Target Populations

    9 *Total addressable market in 2025 based on company estimates; 1Company estimates based on published sources, including Nation al Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); Definition: Hypertension (HTN) Annual Global Opportunity Large Global Opportunity f

  10. Slide 10: Strategic Collaboration with Medtronic

    o Developed BackBeat CNT (AVIM therapy) from concept stage; owns all related IP o Conducted all prior development work including MODERATO I & II clinical studies o Partnered with Medtronic for global regulatory approval and commercialization o Sponsor for the BACKBEAT Study o $500 - $1,600 revenue s

  11. Slide 11: Bioelectronic Control of Ventricular Filling Immediately Reduces Blood Pressure

    Short AV pacing Pressure overshoot indicating increased Total Peripheral Resistance (TPR) ANS response drives blood pressure back toward baseline Bioelectronic Control of Ventricular Filling Immediately Reduces Blood Pressure 11 AVIM - Mediated Pressure Patterns Modulate Autonomic Nervous System (AN

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

    12 Feasibility Study in Canine HTN Model Proof of concept in 5 dogs Acute Feasibility Study in Subjects with HTN 18 patients 2012 ϮϬϭϲ MODERATO II – Pilot Study Prospective, multi - center, randomized, controlled, double - blind pilot study in 47 patients – 6 - month primary endpoint data late - bre

  13. Slide 13: Significant Reduction in 24-Hr aSBP and oSBP

    1 Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/ doi /10.1161/JAHA.120.020492; 2 Burkhoff MODERATO II Study 2 - Year Results TCT 2021; 3 24 - Hr aSBP Control (n=19),1 control patient could not be measured despite repeat measurement (patient had extremely h

  14. Slide 14: BACKBEAT Study Summary

    FDA IDE - approved Efficacy endpoint: Safety endpoint: at 3 months post randomization Secondary/additional endpoints 500 patients across ~80 study sites 14 <d^ƚƵĚLJ^ƵŵŵĂƌLJ | Corporate Presentation Q4 2023

  15. Slide 15: BACKBEAT Study Design

    NO DEVICE IMPLANTS IN STUDY Hypertensive patients with a recent Medtronic pacemaker implant 15 Test eligibility at end of Run - in R Treatment: AVIM therapy + medical therapy WƌŝŵĂƌLJ Ăƚ ϯ D Control: Medical therapy Follow - up at 12M AVIM therapy download and set up Run - In Phase Standard Pacing on

  16. Slide 16: Virtue Sirolimus AngioInfusion Balloon (SAB)

    Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB) ϭϲ | Corporate Presentation Q4 2023

  17. Slide 17: Virtue SAB overview

    17 o Significant opportunity in an established multi - billion dollar market migrating toward drug - eluting balloons as the new standard of care o Highly - differentiated, best - in - class non - coated drug/device combination designed to overcome limitations of drug - coated balloons o Strategic c

  18. Slide 18: Virtue SAB – Redefining the Class of Drug-Eluting Balloons

    ŶŐŝŽƉůĂƐƚLJǁŝƚŚ WƌŽƚĞĐƚĞĚĞůŝǀĞƌLJ ŽĨdžƚĞŶĚĞĚZĞůĞĂƐĞ ^ŝƌŽůŝŵƵƐ Virtue ® SAB – Redefining the Class of Drug - Eluting Balloons 1000 100 10 1 0.1 0.01 Ϭ͘ϬϬϭ 0.0001 Required Therapeutic Concentration > 1ng/mg Lung, liver & kidney below level of assay quantification ( 0.1 ng/mg) in < 1 week 0 5 10 15 ϮϬ 25

  19. Slide 19: Virtue SAB: Highly Differentiated

    sŝƌƚƵĞ^ ;^ŝƌŽůŝŵƵƐ&ZͿ Paclitaxel - coated balloons Sirolimus - coated balloons Superior Pharmaceutical Agent for Restenosis Based on 26 DES coronary RCTs ض X ض Peer - Reviewed Pharmacokinetics Data for >28 days elution ض - X No Coating No rush to target lesion, no large particulate ض X X Protected D

  20. Slide 20: Compelling SABRE Trial Results in Coronary ISR Patients

    Compelling SABRE Trial Results in Coronary ISR Patients 1 Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029 - 2037. DOI: 10.1016/j.jcin.2017.06.021. 2 Granada 3 - Year Clinical Results TCT 2018. 3 - Year SABRE Trial Clinical Report on file. Definitions: Target lesion failure (TLF), late

  21. Slide 21: Key investment highlights summary

    21 Lead program, BackBeat CNT (AVIM therapy) positioned to enter global pivotal trial by end of 2023 with strong strategic partner ▪ 70% of pacemaker patients also have hypertension, equating to an addressable annual market opportunity of approximately 750,000 patients worldwide valued at over $2 bi

  22. Slide 22: Bringing Medical Innovations to Life Through Partnerships

    Bringing Medical Innovations to Life Through Partnerships 22 | Corporate Presentation Q 4 2023

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