Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (July 2023)

21 slides from Orchestra Biomed's investor presentation, Jul 12, 2023

  1. Slide 1: Orchestra BioMed Corporate Presentation Q2 2023

    Orchestra BioMed Corporate Presentation Q2 2023

  2. Slide 2: Forward-Looking Statements

    | Corporate Presentation Q2 2023 2 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

  3. Slide 3: Orchestra BioMed Executive Summary

    Orchestra BioMed Executive Summary Strong balance sheet and outstanding investors: Strong 3 - year multi - center preliminary trial safety and efficacy data Plan to initiate p ivotal trial H2 2023 Strategic collaboration Double - digit revenue share Virtue® SAB targets >$3B annual artery disease mar

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

    Orchestra BioMed Development Commercialization Strategic Partners Shared Benefits ^ĞĐƵƌĞƐƵďƐƚĂŶƚŝĂů ůŽŶŐ Ͳ ƚĞƌŵƌŽLJĂůƚŝĞƐ KƵƚƐŽƵƌĐĞ ĐŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ DƵůƚŝƉůĞƉŝƉĞůŝŶĞ ŽƉƉŽƌƚƵŶŝƚŝĞƐ Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities Outsource de

  5. Slide 5: Strong Collaborations Position Us for Long-term Success

    | Corporate Presentation Q2 2023 5 ĂĐŬĞĂƚEd in collaboration with in collaboration with Virtue SAB >$1.5B $50M equity investment >$2.5B $30M upfront payment $500 - $1,600 *Total addressable market in 2025 based on company estimates; 1 Amount is based on higher of (1) a fixed dollar amount per device

  6. Slide 6: Advancing High-Impact Pipeline

    Advancing High - Impact Pipeline 1 Plan to leverage existing coronary ISR data to support potential Pivotal Study, although there have only been limited discussions with the FDA or a comparable foreign regulator in this regard. 2 Will seek to leverage data from HTN+P pilot and pivotal trials to supp

  7. Slide 7: Highly Accomplished Executive Team & Board

    Executive Team: | >350 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

  8. Slide 8: BackBeat Cardiac Neuromodulation Therapy (CNT)

    BackBeat Cardiac Neuromodulation Therapy Ρ (CNT Ρ ) | Corporate Presentation Q2 2023 8

  9. Slide 9: BackBeat CNT Overview

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

  10. Slide 10: Large Global Opportunity for Treating Hypertension in Target Populations

    | Corporate Presentation Q2 2023 10 Large Global Opportunity for Treating Hypertension in Target Populations *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 Exami

  11. Slide 11: BackBeat CNT Designed to Substantially and Persistently Lower Blood Pressure

    BackBeat CNT Ρ Designed to Substantially and Persistently Lower Blood Pressure Bioelectronic therapy designed to leverage standard dual - chamber pacemaker o Same implant procedure and lead positions o Large trained physician pool that already implant pacemakers o Same target patient population that

  12. Slide 12: MODERATO II Double-Blind, Randomized Results

    MODERATO II Double - Blind, Randomized Results 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 desp

  13. Slide 13: BackBeat CNT Pivotal Trial Design

    BackBeat CNT Ρ Pivotal Trial Design ƵƌƌĞŶƚĂŶƚŝĐŝƉĂƚĞĚƚƌŝĂůĚĞƐŝŐŶ͗ Efficacy endpoint: Safety endpoint: | Corporate Presentation Q2 2023 13

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

    sŝƌƚƵĞΠ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ;^Ϳ | Corporate Presentation Q2 2023 14

  15. Slide 15: Virtue SAB Overview

    Virtue® SAB Overview 1 von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350 – 61; Virtue SAB has received Breakthrough Device Designation for: 2 The balloon dilatation of the stenotic portion (up to 26 mm length) of a stented coronary artery (in - stent restenosis (ISR)) that is 2.25 t

  16. Slide 16: Large Opportunity for Novel AngioInfusion Balloon

    *Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral Artery D ise ase (PAD), In - stent Restenosis (ISR), Small Vessel (SV, ≤2.5mm), High bleeding Risk De Novo (>2.5mm), Below - the - Knee (BTK, Rutherford 3 - 6, w/out severe comorbidit

  17. Slide 17: Virtue SAB Designed to Enable Angioplasty with Protected Sirolimus Delivery

    Virtue ® SAB Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ĚĞƐŝŐŶĞĚƚŽĞŶĂďůĞĂŶŐŝŽƉůĂƐƚLJǁŝƚŚƉƌŽƚĞĐƚĞĚĚƌƵŐĚĞůŝǀĞƌLJƚŽĚŝůĂƚĞǀĞƐƐĞů͕ƚŽ ĐŽŶƐŝƐƚĞŶƚůLJĚĞůŝǀĞƌŝŶƚĞŶĚĞĚĚŽƐĞĂŶĚƚŽůĞĂǀĞŶŽŵĞƚĂůďĞŚŝŶĚ 1000 100 10 1 0.1 0.01 0.001 Ϭ͘ϬϬϬϭ Required

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

    Compelling SABRE Trial Results in Coronary ISR Patients ϭ sĞƌŚĞLJĞĞƚĂů͘:ĂƌĚŝŽǀĂƐĐ /ŶƚĞƌǀ ϮϬϭϳ KĐƚ Ϯϯ ͖ ϭϬ ; ϮϬ Ϳ͗ ϮϬϮϵ Ͳ ϮϬϯϳ ͘K/͗ ϭϬ͘ϭϬϭϲ ͬũ͘ũĐŝŶ͘ ϮϬϭϳ͘Ϭϲ͘ϬϮϭ ͘ Ϯ 'ƌĂŶĂĚĂ ϯ Ͳ zĞĂƌůŝŶŝĐĂůZĞƐƵůƚƐdd ϮϬϭϴ ͘ ϯ Ͳ zĞĂƌ^ZdƌŝĂůůŝŶŝĐĂůZĞƉŽƌƚŽŶĨŝůĞ͘ ĞĨŝŶŝƚŝŽŶƐ͗ dĂƌŐĞƚůĞƐŝŽŶĨĂŝůƵƌĞ;d>&Ϳ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ͕ƚĂƌŐĞ

  19. Slide 19: Virtue SAB Coronary ISR US Pivotal Trial

    Virtue® SAB Coronary ISR US Pivotal Trial Statistical Assumption 90% powered for superiority Virtue SAB TLF ≤ 19% vs. PBA TLF ≥ 30% Success Considerations Virtue SAB: 2.8% TLF at 12 months in SABRE trial per protocol population PBA: 33 - 46% TLF at 12 months in coronary ISR published studies ^ƚƵĚLJKď

  20. Slide 20: 2023 Anticipated Milestones

    2023 - Anticipated Milestones BackBeat CNT HTN + Pacemaker 1 st Pt. Enrollment Planned Regulatory Milestones Planned Clinical Milestones Ed ,dEнWĂĐĞŵĂŬĞƌ&/ƉƉƌŽǀĂů Virtue SAB Virtue - ISR US FDA IDE Approval Japan PMDA CTN Coronary ISR Approval 1 Japan PMDA CTN Coronary SV Approval 1 ϭ dŝŵŝŶŐĞƐƚŝŵĂƚĞ

  21. Slide 21: Bringing Medical Innovations to Life Through Partnerships

    Bringing Medical Innovations to Life Through Partnerships dǁŽWƌŽŐƌĂŵƐdĂƌŐĞƚŝŶŐ>ĂƌŐĞ DĂƌŬĞƚƐ^ƵƉƉŽƌƚĞĚ ďLJWƌŽŵŝƐŝŶŐdƌŝĂůĂƚĂ ŶƚĞƌŝŶŐWŝǀŽƚĂůdƌŝĂůƐ Strong Balance Sheet & Committed Strategic & Financial Investors WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚ ƵƐŝŶĞƐƐDŽĚĞů Θ ĐĐŽŵƉůŝƐŚĞĚ >ĞĂĚĞƌƐŚŝƉdĞĂŵ Designed to accelerate innovat

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