Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Health Sciences Acquisitions Corp 2 — SPAC Merger (December 2022)

34 slides from Orchestra Biomed's SPAC merger presentation, Dec 1, 2022

  1. Slide 1: Orchestra BioMed Corporate Presentation Q4 2022

    Bringing medical inn vation to life ƌŝŶŐŝŶŐŵĞĚŝĐĂůŝŶŶ ǀĂƚŝŽŶ  ƚŽůŝĨĞ Orchestra BioMed Corporate Presentation Q4 2022

  2. Slide 2: Important Notice and Disclaimer

    Important Notice and Disclaimer 2 dŚŝƐŝŶǀĞƐƚŽƌƉƌĞƐĞŶƚĂƚŝŽŶ;ƚŚŝƐ ͞ WƌĞƐĞŶƚĂƚŝŽŶ ͟ ͿŝƐĨŽƌŝŶĨŽƌŵĂƚŝŽŶĂůƉƵƌƉŽƐĞƐŽŶůLJƚŽĂƐƐŝƐƚŝŶƚĞƌĞƐƚĞĚƉĂƌƚŝĞƐŝŶŵĂŬŝŶŐƚŚĞŝƌŽǁŶĞǀĂůƵĂƚŝŽŶǁŝƚŚƌĞƐƉĞĐƚƚŽƚŚĞƉƌŽƉŽƐĞĚ  ďƵ ƐŝŶĞƐƐĐŽŵďŝŶĂƚŝŽŶ;ƚŚĞ ͞ ƵƐŝŶĞƐƐŽŵďŝŶĂƚŝŽŶ ͟ ͿďĞƚǁĞĞŶ,ĞĂůƚŚ ^ĐŝĞŶĐĞƐĐƋƵŝƐŝ

  3. Slide 3: Important Notice and Disclaimer (Cont'd)

    Important Notice and Disclaimer (Cont’d) 3 zŽƵĂƌĞĐĂƵƚŝŽŶĞĚŶŽƚƚŽƉůĂĐĞƵŶĚƵĞƌĞůŝĂŶĐĞƵƉŽŶĂŶLJĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐƐƚĂƚĞŵĞŶƚƐ͘ŶLJĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐƐƚĂƚĞŵĞŶƚƐƉĞĂŬƐŽŶůLJĂƐ ŽĨƚŚĞĚĂƚĞŽŶǁŚŝĐŚŝƚǁĂƐŵĂĚĞ͕ďĂƐĞĚŽŶŝŶĨŽƌŵĂƚŝŽŶĂǀĂŝůĂďůĞĂƐŽĨƚŚĞĚĂƚĞŽĨƚŚŝƐWƌĞƐĞŶƚĂƚŝŽŶ͕ĂŶĚƐƵĐŚ ŝŶĨŽƌŵĂƚŝŽŶ

  4. Slide 4: Orchestra BioMed Executive Summary

    Orchestra BioMed Executive Summary Strategic collaboration Medtronic Double - digit revenue share ^ƚƌŽŶŐďĂůĂŶĐĞƐŚĞĞƚǁŝƚŚĨŝŶĂŶĐŝĂůƌƵŶǁĂLJŝŶƚŽ ϮϬϮϲ ĂŶĚŽƵƚƐƚĂŶĚŝŶŐŝŶǀĞƐƚŽƌƐ Partnership - enabled business model designed to accelerate innovation to patients, drive strong partner and shareholder

  5. Slide 5: Transaction Overview

    Transaction Overview 5 Transaction Summary • Orchestra BioMed and Health Sciences Acquisitions Corporation 2 (“HSAC2”, Nasdaq: HSAQ) have entered into a definitive busine ss combination agreement - HSAC2 is a special purpose acquisition company sponsored by an affiliate of RTW Investments, LP - Upon

  6. Slide 6: Terms of Transaction

    dĞƌŵƐŽĨdƌĂŶƐĂĐƚŝŽŶ 6 Note : Assumes HSAC 2 and Orchestra cash balances as of September 30 , 2022 . On July 22 , 2022 , in connection with the vote to approve the extension of HSAC 2 , the holders of 9 , 237 , 883 shares exercised their right to redeem their shares for cash . As a result, at closin

  7. Slide 7: Orchestra BioMed's Partnership-enabled Model Benefits All

    ŶĂďůĞŶĞǁŐƌŽǁƚŚŽƉƉŽƌƚƵŶŝƚŝĞƐ KƵƚƐŽƵƌĐĞĚĞǀĞůŽƉŵĞŶƚ DŝŶŝŵŝnjĞWΘ>ĚŝůƵƚŝŽŶ 7 Orchestra BioMed’s Partnership - enabled Model Benefits All ĞǀĞůŽƉŵĞŶƚ Strategic Partners Commercialization Improve patient lives Accelerate development Leverage expertise & resources ^ĞĐƵƌĞƐƵďƐƚĂŶƚŝĂůůŽŶŐ Ͳ ƚĞƌŵƌŽLJĂůƚ

  8. Slide 8: Highly Accomplished Executive Team & Board

    George Papandreou S VP, 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 Therapies Bill Baumbach, Ph.D. VP, Scientific Affai

  9. Slide 9: Product Platforms and Next Milestones

    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) Medtronic Global Pivotal Study Start H2 2023 High - Risk HTN

  10. Slide 10: BackBeat Cardiac Neuromodulation Therapy (CNT)

    10 BackBeat Cardiac Neuromodulation Therapy (CNT Ρ )

  11. Slide 11: BackBeat CNT Overview

    BackBeat CNT Ρ Overview 11 Opportunity • Hypertension is #1 comorbidity in pacemaker population affecting over 70% of patients 1 • Older population at increased risk for major events & challenges with drug compliance Innovation • Bioelectronic therapy designed to substantially & persistently lower b

  12. Slide 12: Large Global Opportunity for Treating Hypertension in Target Populations

    >ĂƌŐĞ'ůŽďĂůKƉƉŽƌƚƵŶŝƚLJĨŽƌdƌĞĂƚŝŶŐ,LJƉĞƌƚĞŶƐŝŽŶŝŶdĂƌŐĞƚWŽƉƵůĂƚŝŽŶƐ *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

  13. Slide 13: 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

  14. Slide 14: MODERATO II Double-Blind, Randomized Results

    MODERATO II Double - Blind, Randomized Results ĂĐŬĞĂƚEd Ρ  ƐŚŽǁĞĚĞŶĐŽƵƌĂŐŝŶŐƌĞƐƵůƚƐŝŶ DKZdK//͕ĂƉƌŽƐƉĞĐƚŝǀĞ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ ƌĂŶĚŽŵŝnjĞĚ͕;ĂĐŬĞĂƚEdнDĞĚŝĐĂůdŚĞƌĂƉLJǀƐ͘ ŽŶƚŝŶƵĞĚDĞĚŝĐĂůdŚĞƌĂƉLJͿ͕ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƉŝůŽƚƐƚƵĚLJ ŽĨƉĂĐĞŵĂŬĞƌƉĂƚŝĞŶƚƐǁŝƚŚƉĞƌƐŝƐƚĞŶƚŚLJƉĞƌƚĞŶƐŝŽŶ 1

  15. Slide 15: BackBeat CNT Medtronic Collaboration

    BackBeat CNT Ρ Medtronic Collaboration • 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 deve

  16. Slide 16: BackBeat CNT Pivotal Trial Design

    BackBeat CNT Ρ Pivotal Trial Design 16 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

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

    17 Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB)

  18. Slide 18: Virtue SAB Overview

    sŝƌƚƵĞΠ^KǀĞƌǀŝĞǁ 18 Opportunity • Significant need for “leave nothing behind” treatment for coronary and peripheral indications representing an > $3B global market opportunity 1 • Current drug - eluting stents (DES) carry risks of long - term restenosis and late thrombosis; require extended dual

  19. Slide 19: Large Opportunity for Leave Nothing Behind Solution

    Large Opportunity for Leave Nothing Behind Solution 19 >$3 Billion Annual Global CAD & PAD Market Opportunity * • Artery disease is the primary cause of death worldwide • Large mature market with significant unmet need – Suboptimal treatments for coronary ISR, coronary SV de novo and BTK • Designed

  20. Slide 20: Virtue SAB AngioInfusion Balloon

    Virtue® SAB ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ  ĂůůŽŽŶ ĚĞƐŝŐŶĞĚƚŽĞŶĂďůĞĂŶŐŝŽƉůĂƐƚLJ ǁŝƚŚƉƌŽƚĞĐƚĞĚĚƌƵŐĚĞůŝǀĞƌLJƚŽĚŝůĂƚĞǀĞƐƐĞů͕ƚŽĐŽŶƐŝƐƚĞŶƚůLJ ĚĞůŝǀĞƌŝŶƚĞŶĚĞĚĚŽƐĞĂŶĚƚŽůĞĂǀĞŶŽŵĞƚĂůďĞŚŝŶĚ Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind 20 1 Granada et al.

  21. Slide 21: 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 dĂƌŐĞƚů

  22. Slide 22: Virtue SAB Terumo Partnership

    Virtue® SAB Terumo Partnership • Terumo is a global leader with >$2.5 billion annual interventional cardiology revenues 1 • Virtue SAB positioned to become Terumo’s flagship therapeutic offering with potential to drive significant future growth • Key Terms: - $30 million upfront and potential future

  23. Slide 23: Virtue SAB Coronary ISR US Pivotal Trial

    Virtue® SAB – Coronary ISR US Pivotal Trial 23 Double - blind, multi - center, prospective, randomized controlled study in patients with single - layer coronary ISR Virtue® SAB N=200 R dĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ  ;͕ds Ͳ D/ĂŶĚd>ZͿĂƚ ϭϮ ŵŽŶƚŚƐ WƌŝŵĂƌLJŶĚƉŽŝŶƚ Statistical Assumption 90% powere

  24. Slide 24: 2023 Anticipated Milestones

    ϮϬϮϯ Ͳ  ŶƚŝĐŝƉĂƚĞĚDŝůĞƐƚŽŶĞƐ ŽƌƉŽƌĂƚĞ ‡ ůŽƐĞƵƐŝŶĞƐƐŽŵďŝŶĂƚŝŽŶ ‡ >ŝƐƚŽŶEĂƐĚĂƋ;K/KͿ sŝƌƚƵĞ^ ʹ  ŽƌŽŶĂƌLJ/^Z ‡ sŝƌƚƵĞ/^Z Ͳ h^&/ƉƉƌŽǀĂů ‡ ϭ ƐƚWƚ͘ŶƌŽůůŵĞŶƚ;h^Ϳ H1 2023 H2 2023 24 BackBeat CNT – HTN + Pacemaker • FDA IDE Approval • 1 st Pt. Enrollment (EU & US) • Japan P

  25. Slide 25: Use of Proceeds

    Use of Proceeds 25 Activity Description Estimated Expenses H2 2022 - 2025 General Research & Development • BackBeat CNT - Firmware integration into Medtronic device; testing and validation activities - Clinical trial planning and preparation - IDE preparation and submission • Virtue SAB - GLP and bi

  26. Slide 26: Two Programs Targeting Large Markets Entering Pivotal Trials

    26 Two Programs Targeting Large Markets Supported by Promising Trial Data Entering Pivotal Trials – BackBeat CNT Ρ • >$10 billion annual market • R andomized , controlled study shows efficacy potential • Collaboration with Medtronic – V irtue ® SAB • ∼ $3 billion annual market • 3 - year pilot study

  27. Slide 27: Partnership-Enabled Business Model

    WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚ ƵƐŝŶĞƐƐDŽĚĞů Ϯϳ

  28. Slide 28: Significant Barriers Prevent Innovation From Reaching Patients

    Significant Barriers Prevent Innovation From Reaching Patients 28 Startups often struggle for resources to reach commercial value inflection Large companies’ constrained R&D budgets limit innovation & acquisitions Increasing burden of cost, time, and work to bring medical innovation to patients Prod

  29. Slide 29: Orchestra BioMed Can Accelerate Innovation to Patients

    Orchestra BioMed Can Accelerate Innovation to Patients 29 Risk - Reward Sharing Partnerships Can Overcome the Barriers to Innovation

  30. Slide 30: Large Market with Unmet Needs, Potential for High Impact

    30 >ĂƌŐĞDĂƌŬĞƚǁŝƚŚhŶŵĞƚEĞĞĚƐ WŽƚĞŶƚŝĂůĨŽƌ,ŝŐŚ/ŵƉĂĐƚ Favorable for Partnering Key Pipeline Criteria Large market, significant unmet needs, established distribution channels Designed to improve standard of care, fit existing treatment paradigm, disrupt market dynamics Significant differentiatio

  31. Slide 31: Orchestrating Innovation

    Orchestrating Inn vation 31 Created Pipeline, Pioneered Business Model and Established Partnerships Combined, our leadership team has zĞĂƌƐŽĨ ĞdžƉĞƌŝĞŶĐĞ ǀĞƌĂŐĞLJĞĂƌƐ ŽĨĞdžƉĞƌŝĞŶĐĞĞĂĐŚ New product approvals/clearances Authored patents 250 + 25 100+ 600+ ĐĐŽŵƉůŝƐŚĞĚ>ĞĂĚĞƌƐŚŝƉdĞĂŵ

  32. Slide 32: Appendix: Summary of Risk Factors

    ƉƉĞŶĚŝdž͗^ƵŵŵĂƌLJŽĨZŝƐŬ&ĂĐƚŽƌƐ Risks Related to Orchestra’s Business and Products • Orchestra has a history of net losses, expects to continue to incur losses for the foreseeable future and may never become pr ofi table. • If Orchestra does not achieve its projected development and commercializat

  33. Slide 33: Appendix: Summary of Risk Factors (Cont'd)

    Appendix: Summary of Risk Factors (Cont’d) Risks Related to Orchestra BioMed’s Reliance on Third Parties • Orchestra expects to be highly dependent on partners and third - party vendors to manufacture and provide important materials and components for its products and product candidates. • Orchestra

  34. Slide 34: Appendix: Summary of Risk Factors (Cont'd)

    ƉƉĞŶĚŝdž͗^ƵŵŵĂƌLJŽĨZŝƐŬ&ĂĐƚŽƌƐ;ŽŶƚ ͛ ĚͿ Risks Related to Orchestra’s Intellectual Property • Orchestra may be unable to protect or enforce its intellectual property rights. • Third parties may assert that Orchestra’s employees or consultants have wrongfully used or disclosed confidential inform

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