Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Investor Presentation (March 2024)
23 slides from Orchestra Biomed's investor presentation, Mar 7, 2024
Slide 1: Orchestra BioMed Corporate Presentation Q1 2024
Orchestra BioMed Corporate Presentation Q1 2024
Slide 2: Disclaimer and forward-looking statements
| Corporate Presentation Q1 2024 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
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 • Global pivotal study initiated in December 2023 >ĞĂĚWƌŽŐƌĂŵ ĂĐŬĞĂƚEd Ρ ;s/DΎƚŚĞƌĂƉLJͿ dĂƌŐĞƚƐхΨ ϭϬ ĂŶŶƵĂů ŚLJƉĞƌƚĞŶƐŝŽŶŵĂƌŬĞƚƐ Strateg
Slide 4: Orchestra BioMed's Partnership-Enabled Model Benefits All
Orchestra BioMed Development Commercialization Strategic Partners ^ŚĂƌĞĚĞŶĞĨŝƚƐ /ŶŶŽǀĂƚŝŽŶ Secure substantial long - term royalties Outsource commercialization Multiple pipeline opportunities Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities
Slide 5: Pipeline footnotes and regulatory notes
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 hypertension treated will likely be isolated sy
Slide 6: Executive Team and Board
Executive Team: | >300 Years of Experience | >25 Avg Industry Years Each | >100 Product Approvals | >600 Authored Patents ĂǀŝĚ,ŽĐŚŵĂŶ ŚĂŝƌŵĂŶ͕K͕ &ŽƵŶĚĞƌ Darren R. Sherman President, COO, Director, Founder Andrew Taylor Chief Financial Officer Yuval Mika, Ph.D. GM & CTO, Bioelectronic Therapies Georg
Slide 7: BackBeat CNT Atrioventricular interval modulation (AVIM) therapy
BackBeat CNT Ρ Atrioventricular interval modulation (AVIM) therapy 7 | Corporate Presentation Q1 2024
Slide 8: BackBeat CNT (AVIM Therapy) Overview
BackBeat CNT Ρ (AVIM Therapy) Overview Hypertension is the leading global risk factor for death, particularly older , higher risk patients such as the pacemaker population, where it is the # 1 comorbidity Risk of High Blood Pressure Pacemaker - delivered therapy designed to immediately, substantiall
Slide 9: Orchestra BioMed and Medtronic partnership roles
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 Global Pivotal Study o $500 - $
Slide 10: Novel AVIM Therapy Mechanism of Action
Novel AVIM Therapy Mechanism of Action Designed to Substantially and Persistently Reduce Blood Pressure • AVIM therapy uses a dual - chamber pacemaker to deliver programmed sequences of short AV intervals interspersed with longer AV interval s designed to to reduce blood pressure by: • Reducing card
Slide 11: Existing Body of Clinical Data Supporting Efficacy and Safety
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 - breaki
Slide 12: MODERATO II results and references
1 Kalaras et al. Journal of the American Heart Association. 2021 ; 10 :e 020492 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
Slide 13: Long-Term Blood Pressure Reduction with AVIM Therapy
* - 8.9 mmHg in 24 - Hour aSBP from baseline at 3.6 years ( - 12.5 mmHg in oSBP at 3.6 years 100 % of patients with reduction in aSBP at 3.6 years Long - term blood pressure from a follow - up study* of 16 patients from MODERATO II • 8 AVIM therapy & 8 control patients who crossed - over to AVIM the
Slide 14: BACKBEAT Study Summary
Enrollment underway Primary Efficacy endpoint: Primary Safety endpoint: at 3 months post randomization Secondary/additional endpoints 500 patients across ~80 study sites 14 BACKBEAT Study Summary | Corporate Presentation Q1 2024
Slide 15: BACKBEAT Study Design
DEVICE IMPLANTS OUTSIDE STUDY Hypertensive patients with a recent Medtronic pacemaker implant 15 Test eligibility at end of Run - in R Treatment: AVIM therapy + medical therapy Primary at 3 M Control: Medical therapy Follow - up at 12M AVIM therapy download and set up Run - In Phase Standard Pacing
Slide 16: Virtue Sirolimus AngioInfusion Balloon (SAB)
Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB) 16 | Corporate Presentation Q1 2024
Slide 17: Collaboration with Virtue SAB Overview
17 C ollaboration w ith Virtue ® SAB Overview | Corporate Presentation Q 1 2024 Interventional treatment of artery disease migrating toward paclitaxel - coated balloons as new standard of care for certain key indications Paradigm Shift in Treatment of Artery Disease N on - coated drug/device combina
Slide 18: Paclitaxel Used for Coated Balloons Because it is Easier, Not Better
realize advantages of sirolimus novel solution that enables sufficient drug uptake and extended drug release Large meta - analysis clearly demonstrates superiority of sirolimus to paclitaxel sirolimus benefits only achievable with 30+ days of elution 18 Paclitaxel Used for Coated Balloons Because it
Slide 19: Virtue SAB – A True Sirolimus-Eluting Balloon
Angioplasty with Protected Delivery of Extended Release Sirolimus Virtue ® SAB – A True Sirolimus - Eluting Balloon 1 Granada et al. EuroIntervention 2016;12:740 - 747 | Corporate Presentation Q1 2024 19 1000 100 10 1 0.1 0.01 0.001 0.0001 Required Therapeutic Concentration > 1 ng/mg Lung, liver & k
Slide 20: 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 (
Slide 21: Virtue SAB: Highly Differentiated
Virtue SAB: Highly Differentiated Ϯϭ *Boston Scientific AGENT paclitaxel - coated balloon expected launch 1H2024 Definitions: DES = drug - eluting stents; RCT = randomized control trial | Corporate Presentation Q 1 2024 Virtue SAB (SirolimusEFR) Paclitaxel - coated balloons* Superior Pharmaceutical
Slide 22: Summary of key investment points
22 Global pivotal study actively enrolling for lead program, BackBeat CNT (AVIM therapy) with market - leading 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 bill
Slide 23: Bringing Medical Innovations to Life Through Partnerships
Bringing Medical Innovations to Life Through Partnerships Ϯϯ | Corporate Presentation Q1 2024
Orchestra BioMed Holdings — Investor Presentation (March 2024) on 6ix