Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Investor Presentation (July 2023)
21 slides from Orchestra Biomed's investor presentation, Jul 13, 2023
Slide 1: Orchestra BioMed Corporate Presentation
Orchestra BioMed Corporate Presentation Q3 2023
Slide 2: Forward-Looking Statements
2 | Corporate Presentation Q2 2023 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 indic
Slide 3: 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 pivotal trial H2 2023 Strategic collaboration Double-digit revenue share Virtue® SAB targets >$3B annual artery disease markets Pr
Slide 4: Orchestra BioMed's Partnership-Enabled Model Benefits All
Orchestra BioMed Development Commercialization Shared Benefits Strategic Partners Secure substantial long-term royalties Outsource commercialization Multiple pipeline opportunities Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities Outsource d
Slide 5: Strategic partners: BackBeat CNT and Virtue SAB collaborations
5 | Corporate Presentation Q2 2023 BackBeat CNT in collaboration with in collaboration with Virtue SAB Global market leader in pacemakers: >$1.5B in annual revenues Providing leading device plus clinical & regulatory resources Exclusive global commercial rights for HTN+Pacemaker market $50M equity i
Slide 6: Advancing High-Impact Pipeline
Advancing High-Impact Pipeline 1Plan 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. 2Will seek to leverage data from HTN+P pilot and pivotal trials to support
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
Slide 8: BackBeat Cardiac Neuromodulation Therapy (CNT)
BackBeat Cardiac Neuromodulation Therapy™️ (CNT ™) 8 | Corporate Presentation Q2 2023
Slide 9: BackBeat CNT Overview
BackBeat CNT™️ Overview 1Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2Kalaras et al. Journal of the American Heart Association. ahajournals.org/doi/10.1161/JAHA.120.020492; 3Burkhoff. MODERATO
Slide 10: Large Global Opportunity for Treating Hypertension in Target Populations
10 | Corporate Presentation Q2 2023 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 National Inpatient Survey (NIS) and National Health and Nutrition Examin
Slide 11: BackBeat CNT Designed to Substantially and Persistently Lower Blood Pressure
BackBeat CNT™️ 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 a
Slide 12: MODERATO II Double-Blind, Randomized Results
MODERATO II Double-Blind, Randomized Results 1Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/doi/10.1161/JAHA.120.020492; 2Burkhoff MODERATO II Study 2-Year Results TCT 2021; 324-Hr aSBP Control (n=19),1 control patient could not be measured despite repeat
Slide 13: BackBeat CNT Pivotal Trial Design
BackBeat CNT™️ Pivotal Trial Design Current anticipated trial design: Prospective, multi-center, double-blind study investigating the efficacy of BackBeat CNT™ in patients with uncontrolled hypertension (HTN) despite the use of antihypertensive medications, who are indicated for a dual-chamber pacem
Slide 14: Virtue Sirolimus AngioInfusion Balloon (SAB)
Virtue® Sirolimus AngioInfusion™️ Balloon (SAB) 14 | Corporate Presentation Q2 2023
Slide 15: Virtue SAB Overview
Virtue® SAB Overview 1von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350–61; Virtue SAB has received Breakthrough Device Designation for: 2The balloon dilatation of the stenotic portion (up to 26 mm length) of a stented coronary artery (in-stent restenosis (ISR)) that is 2.25 to 4.0
Slide 16: Large Opportunity for Novel AngioInfusion Balloon
*Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral Artery Disease (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 comorbidities). Peri
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 AngioInfusion™️ Balloon designed to enable angioplasty with protected drug delivery to dilate vessel, to consistently deliver intended dose and to leave no metal behind 1000 100 10 1 0.1 0.01 0
Slide 18: Compelling SABRE Trial Results in Coronary ISR Patients
Compelling SABRE Trial Results in Coronary ISR Patients 1Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029-2037. DOI: 10.1016/j.jcin.2017.06.021. 2Granada 3-Year Clinical Results TCT 2018. 3-Year SABRE Trial Clinical Report on file. Definitions: Target lesion failure (TLF), late lumen lo
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 Study Obj
Slide 20: 2023 Anticipated Milestones
2023 - Anticipated Milestones BackBeat CNT HTN + Pacemaker 1 st Pt. Enrollment Planned Regulatory Milestones Planned Clinical Milestones BackBeat CNT HTN + Pacemaker FDA IDE Approval Virtue SAB Virtue-ISR US FDA IDE Approval Japan PMDA CTN Coronary ISR Approval1 Japan PMDA CTN Coronary SV Approval1
Slide 21: Bringing Medical Innovations to Life Through Partnerships
Bringing Medical Innovations to Life Through Partnerships Two Programs Targeting Large Markets Supported by Promising Trial Data Entering Pivotal Trials Strong Balance Sheet & Committed Strategic & Financial Investors Partnership-Enabled Business Model & Accomplished Leadership Team Designed to acce
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