Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (March 2023)

27 slides from Orchestra Biomed's investor presentation, Mar 13, 2023

  1. Slide 1: Orchestra BioMed Corporate Presentation Q1 2023

    Bringing medical inn vation to life Orchestra BioMed Corporate Presentation Q1 2023

  2. Slide 2: Forward-Looking Statements

    Forward - Looking Statements 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 third - par

  3. Slide 3: Orchestra BioMed Executive Summary

    Orchestra BioMed Executive Summary Strategic collaboration Double - digit revenue share Strong balance sheet and outstanding investors Partnership - enabled business model designed to accelerate innovation to patients, drive strong partner and shareholder value and yield exceptional future profitabi

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

    Enable new growth opportunities Outsource development Minimize P&L dilution 4 Orchestra BioMed’s Partnership - enabled Model Benefits All Development Strategic Partners Commercialization Improve patient lives Accelerate development Leverage expertise & resources ^ĞĐƵƌĞ ƐƵďƐƚĂŶƚŝĂů ůŽŶŐ Ͳ ƚĞƌŵ ƌŽLJĂůƚ

  5. Slide 5: Highly Accomplished Executive Team & Board

    Avi Fischer, M.D. SVP, Medical Affairs & Innovation J.C. Simeon SVP, Quality Inessa R. Wheeler VP, Marketing Bob Laughner VP, Regulatory Affairs Stephen A. Zielinski VP, Product Dev., Bioelectronic Therapies Ziv Belsky VP, Research, Bioelectronic Therapies Juan Lorenzo VP, Product Dev., Focal Therap

  6. Slide 6: Product Platforms and Target Indications

    Product Platforms Target Indications Preclinical Clinical Feasibility Clinical Pivotal Partner Study Sponsor Next Milestones & Expected Timing 6 BackBeat Cardiac Neuromodulation Therapy (CNT Ρ ) Hypertension (HTN) (pacing patients; HTN+P) Global Pivotal Study Start H2 2023 High - Risk HTN (non - pac

  7. Slide 7: BackBeat Cardiac Neuromodulation Therapy (CNT)

    7 BackBeat Cardiac Neuromodulation Therapy (CNT Ρ )

  8. Slide 8: BackBeat CNT Overview

    BackBeat CNT Ρ Overview 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey 8 (NHANES); 2 Kalaras et al. Journal of the American Heart Association. ahajournals.org/doi/10.1161/JAHA.120.020492; 3 Burkhoff. MODE

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

    Large Global Opportunity for Treating Hypertension in Target Populations *Total addressable market in 2025 based on company estimates; 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2 Known and

  10. Slide 10: Designed to Substantially Lower BP & Maintain Reduction

    • Bioelectronic therapy designed to leverage standard rhythm management device procedures (dual - chamber pacemaker) - Same implant procedure and lead positions - Large trained physician pool - Same target patient population - Leverageable existing reimbursement • Mechanism of action - Designed to s

  11. Slide 11: MODERATO II Double-Blind, Randomized Results

    MODERATO II Double - Blind, Randomized Results ĂĐŬĞĂƚ Ed Ρ ƐŚŽǁĞĚ ĞŶĐŽƵƌĂŐŝŶŐ ƌĞƐƵůƚƐ ŝŶ DKZdK //͕ Ă ƉƌŽƐƉĞĐƚŝǀĞ͕ ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ ƌĂŶĚŽŵŝnjĞĚ͕ ;ĂĐŬĞĂƚ Ed н DĞĚŝĐĂů dŚĞƌĂƉLJ ǀƐ͘ ŽŶƚŝŶƵĞĚ DĞĚŝĐĂů dŚĞƌĂƉLJͿ͕ ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƉŝůŽƚ ƐƚƵĚLJ ŽĨ ƉĂĐĞŵĂŬĞƌ ƉĂƚŝĞŶƚƐ ǁŝƚŚ ƉĞƌƐŝƐƚĞŶƚ ŚLJƉĞƌƚĞŶƐŝŽŶ 1 Kalaras et al. Jou

  12. Slide 12: BackBeat CNT Medtronic Collaboration

    ĂĐŬĞĂƚ Ed Ρ DĞĚƚƌŽŶŝĐ ŽůůĂďŽƌĂƚŝŽŶ • Medtronic is the global leader in pacemakers - >$1.5 billion annual pacemaker revenues 1 • Key Terms: (Hypertension + Pacemaker population) - Orchestra BioMed drives and finances development as sponsor of global pivotal trial - Medtronic provides certain developm

  13. Slide 13: BackBeat CNT Pivotal Trial Design

    BackBeat CNT Ρ Pivotal Trial Design 13 Current anticipated trial design: • Randomization of ~650 - 750 patients with uncontrolled HTN despite medical therapy who are indicated for a dual - chamber pacemaker • Inclusion and exclusion criteria for enrollment in the BackBeat CNT Pivotal Study will be s

  14. Slide 14: Virtue Sirolimus AngioInfusion Balloon (SAB)

    ϭϰ Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB)

  15. Slide 15: Virtue SAB Overview

    Virtue® SAB Overview 1 Total addressable market is 2025 market data based on company estimates; ; 2 von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350 – 61; Virtue SAB has received Breakthrough Device Designation for: 3 The balloon dilatation of the stenotic portion (up to 26 mm leng

  16. Slide 16: Large Opportunity for Leave Nothing Behind Solution

    Large Opportunity for Leave Nothing Behind Solution 16 >$3 Billion Annual Global CAD & PAD Market Opportunity * ‡ ƌƚĞƌLJ ĚŝƐĞĂƐĞ ŝƐ ƚŚĞ ƉƌŝŵĂƌLJ ĐĂƵƐĞ ŽĨ ĚĞĂƚŚ ǁŽƌůĚǁŝĚĞ ‡ >ĂƌŐĞ ŵĂƚƵƌĞ ŵĂƌŬĞƚ ǁŝƚŚ ƐŝŐŶŝĨŝĐĂŶƚ ƵŶŵĞƚ ŶĞĞĚ Ʌ ^ƵďŽƉƚŝŵĂů ƚƌĞĂƚŵĞŶƚƐ ĨŽƌ ĐŽƌŽŶĂƌLJ /^Z͕ ĐŽƌŽŶĂƌLJ ^s ĚĞ ŶŽǀŽ ĂŶĚ d< ‡ ĞƐŝŐŶĞĚ ƚŽ

  17. Slide 17: Virtue SAB AngioInfusion Balloon

    Virtue® SAB ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ĚĞƐŝŐŶĞĚ ƚŽ ĞŶĂďůĞ ĂŶŐŝŽƉůĂƐƚLJ ǁŝƚŚ ƉƌŽƚĞĐƚĞĚ ĚƌƵŐ ĚĞůŝǀĞƌLJ ƚŽ ĚŝůĂƚĞ ǀĞƐƐĞů͕ ƚŽ ĐŽŶƐŝƐƚĞŶƚůLJ ĚĞůŝǀĞƌ ŝŶƚĞŶĚĞĚ ĚŽƐĞ ĂŶĚ ƚŽ ůĞĂǀĞ ŶŽ ŵĞƚĂů ďĞŚŝŶĚ Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind 17 1 Granada et al. EuroIn

  18. Slide 18: Compelling SABRE Trial Results in Coronary ISR Patients

    ŽŵƉĞůůŝŶŐ ^Z dƌŝĂů ZĞƐƵůƚƐ ŝŶ ŽƌŽŶĂƌLJ /^Z WĂƚŝĞŶƚƐ 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 lumen

  19. Slide 19: Virtue SAB Terumo Partnership

    Virtue® SAB Terumo Partnership ‡ dĞƌƵŵŽ ŝƐ Ă ŐůŽďĂů ůĞĂĚĞƌ ǁŝƚŚ хΨ Ϯ͘ϱ ďŝůůŝŽŶ ĂŶŶƵĂů ŝŶƚĞƌǀĞŶƚŝŽŶĂů ĐĂƌĚŝŽůŽŐLJ ƌĞǀĞŶƵĞƐ ϭ ‡ sŝƌƚƵĞ ^ ƉŽƐŝƚŝŽŶĞĚ ƚŽ ďĞĐŽŵĞ dĞƌƵŵŽ ͛ Ɛ ĨůĂŐƐŚŝƉ ƚŚĞƌĂƉĞƵƚŝĐ ŽĨĨĞƌŝŶŐ ǁŝƚŚ ƉŽƚĞŶƚŝĂů ƚŽ ĚƌŝǀĞ ƐŝŐŶŝĨŝĐĂŶƚ ĨƵƚƵƌĞ ŐƌŽǁƚŚ ‡ <ĞLJ dĞƌŵƐ͗ Ψ ϯϬ ŵŝůůŝŽŶ ƵƉĨƌŽŶƚ ĂŶĚ ƉŽƚĞŶƚŝĂů ĨƵƚƵƌĞ

  20. Slide 20: Virtue SAB Coronary ISR US Pivotal Trial

    sŝƌƚƵĞΠ ^ ʹ ŽƌŽŶĂƌLJ /^Z h^ WŝǀŽƚĂů dƌŝĂů 20 Double - blind, multi - center, prospective, randomized controlled study in patients with single - layer coronary ISR Virtue® SAB N=200 Z Primary Endpoint Target Lesion Failure (CD, TV - MI and TLR) at 12 months ^ƚĂƚŝƐƚŝĐĂů ƐƐƵŵƉƚŝŽŶ ϵϬ й ƉŽǁĞƌĞĚ ĨŽƌ ƐƵƉĞƌ

  21. Slide 21: 2023 Anticipated Milestones

    ϮϬϮϯ Ͳ ŶƚŝĐŝƉĂƚĞĚ DŝůĞƐƚŽŶĞƐ Virtue SAB – Coronary ISR ‡ sŝƌƚƵĞ /^Z Ͳ h^ & / ƉƉƌŽǀĂů ‡ ϭ Ɛƚ Wƚ͘ ŶƌŽůůŵĞŶƚ H1 2023 , Ϯ ϮϬϮϯ 21 BackBeat CNT – HTN + Pacemaker • FDA IDE Approval • 1 st Pt. Enrollment Ed Ͳ ,& ‡ ĐƵƚĞ ůŝŶŝĐĂů ZĞƐƵůƚƐ sŝƌƚƵĞ ^ ʹ ŽƌŽŶĂƌLJ /^Z ‡ :ĂƉĂŶ WD dE ƉƉƌŽǀĂů ϭ sŝƌƚƵĞ ^ ʹ ŽƌŽŶĂƌLJ ^s ‡

  22. Slide 22: Two Programs Targeting Large Markets Supported by Promising Trial Data

    22 dǁŽ WƌŽŐƌĂŵƐ dĂƌŐĞƚŝŶŐ >ĂƌŐĞ DĂƌŬĞƚƐ ^ƵƉƉŽƌƚĞĚ ďLJ WƌŽŵŝƐŝŶŐ dƌŝĂů ĂƚĂ ŶƚĞƌŝŶŐ WŝǀŽƚĂů dƌŝĂůƐ – BackBeat CNT Ρ • >$10 billion annual market • Randomized, controlled study shows efficacy potential • Collaboration with – Virtue® SAB • ∼ $3 billion annual market • 3 - year pilot study results show po

  23. Slide 23: Partnership-Enabled Business Model

    Partnership - Enabled Business Model Ϯϯ

  24. Slide 24: Significant Barriers Prevent Innovation From Reaching Patients

    Significant Barriers Prevent Innovation From Reaching Patients 24 Startups often struggle for resources to reach commercial value inflection >ĂƌŐĞ ĐŽŵƉĂŶŝĞƐ ͛ ĐŽŶƐƚƌĂŝŶĞĚ ZΘ ďƵĚŐĞƚƐ ůŝŵŝƚ ŝŶŶŽǀĂƚŝŽŶ Θ ĂĐƋƵŝƐŝƚŝŽŶƐ Increasing burden of cost, time, and work to bring medical innovation to patients Prod

  25. Slide 25: Orchestra BioMed Can Accelerate Innovation to Patients

    Orchestra BioMed Can Accelerate Innovation to Patients 25 ZŝƐŬ Ͳ ZĞǁĂƌĚ ^ŚĂƌŝŶŐ WĂƌƚŶĞƌƐŚŝƉƐ ĂŶ KǀĞƌĐŽŵĞ ƚŚĞ ĂƌƌŝĞƌƐ ƚŽ /ŶŶŽǀĂƚŝŽŶ

  26. Slide 26: Selecting Optimal Opportunities

    26 ^ĞůĞĐƚŝŶŐ KƉƚŝŵĂů KƉƉŽƌƚƵŶŝƚŝĞƐ Develop for Partnership WƌĞ Ͳ ƉĂƌƚŶĞƌĞĚ ĐƋƵŝƐŝƚŝŽŶƐ Key Pipeline Criteria Large Market with Unmet Needs Large market, significant unmet needs, established distribution channels Potential for High Impact Designed to improve standard of care, fit existing treatment p

  27. Slide 27: Orchestrating Innovation

    Orchestrating Inn ǀĂƚŝŽŶ 27 ƌĞĂƚĞĚ WŝƉĞůŝŶĞ͕ WŝŽŶĞĞƌĞĚ ƵƐŝŶĞƐƐ DŽĚĞů ĂŶĚ ƐƚĂďůŝƐŚĞĚ WĂƌƚŶĞƌƐŚŝƉƐ Combined, our leadership team has zĞĂƌƐ ŽĨ ĞdžƉĞƌŝĞŶĐĞ Average years of experience each New product approvals/clearances Authored patents ϮϱϬ н 25 ϭϬϬ н 600+ ĐĐŽŵƉůŝƐŚĞĚ >ĞĂĚĞƌƐŚŝƉ dĞĂŵ

Orchestra BioMed Holdings — Investor Presentation (March 2023) on 6ix