Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Health Sciences Acquisitions Corp 2 — SPAC Merger (July 2022)
32 slides from Orchestra Biomed's SPAC merger presentation, Jul 5, 2022
Slide 1: Orchestra BioMed Corporate Presentation July 2022
Bringing medical inn vation to life Orchestra BioMed Corporate Presentation July 2022
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This investor presentation (this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination (the “Business Combination”) between Health Sciences Acquisitions Corporat
Slide 3: Important Notice and Disclaimer (Cont'd)
Important Notice and Disclaimer (Cont’d) 3 You are cautioned not to place undue reliance upon any forward-looking statements. Any forward-looking statement speaks only as of the date on which it was made, based on information available as of the date of this Presentation, and such information may be
Slide 4: Transaction Overview
Transaction Overview 4 Transaction Summary Orchestra BioMed and Health Sciences Acquisitions Corporation 2 (“HSAC2”, Nasdaq: HSAQ) have entered into a definitive business combination agreement HSAC2 is a special purpose acquisition company sponsored by RTW Investments, LP Upon closing, HSAC2 will ch
Slide 5: Terms of Transaction
Terms of Transaction 5 Combination is structured to provide a minimum of $70 million in gross cash to the combined company Sources & Uses (Minimum G Sources ross Cash Case) Amount Pro Forma Valuation (Minimum Particulars Gross Cash Case) Amount Cash Held in Trust 1 $70,000,000 Share Price $10.00 Orc
Slide 6: Orchestra BioMed Executive Summary
Orchestra BioMed Executive Summary Strategic collaboration with Medtronic Strong balance sheet with significant financial runway and outstanding investors Medtronic Partnership-enabled business model designed to accelerate innovation to patients, drive strong partner and shareholder value, & yield e
Slide 7: Orchestra BioMed's Partnership-enabled Model Benefits All
Enable new growth opportunities Outsource development Minimize P&L dilution 7 Orchestra BioMed’s Partnership-enabled Model Benefits All Development Strategic Partners Commercializa0on Improve patient lives Accelerate development Leverage expertise & resources Secure high-margin long-term royalties O
Slide 8: Advancing a High-Impact Pipeline
Advancing a High-Impact Pipeline 8 *Plan to leverage existing coronary ISR data to support potential Pivotal Study; **Estimated global annual market opportunity for 2025. Virtue SAB has received Breakthrough Device Designation for: 1The balloon dilatation of the stenotic portion (up to 26 mm length)
Slide 9: Highly Accomplished Executive Team & Board
George Papandreou Inessa R. Wheeler Bob Laughner Stephen A. Zielinski Ziv Belsky Juan Lorenzo Bill Baumbach, Ph.D. Eileen Bailey SVP, Quality VP, Strategy & VP, Regulatory Affairs VP, Product Dev., VP, Research, VP, Product Dev., VP, Scientific Affairs, VP, Quality, Focal Marketing Bioelectronic The
Slide 10: BackBeat Cardiac Neuromodulation Therapy (CNT)
10 BackBeat Cardiac Neuromodulation Therapy (CNT ™)
Slide 11: BackBeat CNT Overview
BackBeat CNT™ Overview 1Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey 11 (NHANES); 2Kalaras et al. Journal of the American Heart Association. ahajournals.org/doi/10.1161/JAHA.120.020492; 3Burkhoff. MODERAT
Slide 12: 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; 1Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2Known and we
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 substantially red
Slide 14: MODERATO II Double-Blind, Randomized Results
MODERATO II Double-Blind, Randomized Results BackBeat CNT™ showed encouraging results in MODERATO II, a prospecQve, mulQ-center, randomized, (BackBeat CNT + Medical Therapy vs. ConQnued Medical Therapy), double-blind, pilot study of pacemaker paQents with persistent hypertension 1Kalaras et al. Jour
Slide 15: BackBeat CNT Medtronic Collaboration
BackBeat CNT™ Medtronic Collaboration Medtronic is the global leader in pacemakers >$1.5 billion annual pacemaker revenues1 Key Terms: (Hypertension + Pacemaker population) Orchestra BioMed drives and finances development as sponsor of global pivotal trial Medtronic provides certain development/clin
Slide 16: Virtue Sirolimus AngioInfusion Balloon (SAB)
16 Virtue® Sirolimus AngioInfusion™ Balloon (SAB)
Slide 17: Virtue SAB Overview
Virtue® SAB Overview 17 Opportunity Significant need for “leave nothing behind” treatment for coronary and peripheral indications representing an ∼$3B global market opportunity1 Drug-eluting stents (DES) carry risks of long-term restenosis and late thrombosis; require extended dual antiplatelet ther
Slide 18: Large Opportunity for Leave Nothing Behind Solution
Large Opportunity for Leave Nothing Behind SoluRon 18 ~$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 to lever
Slide 19: Virtue SAB AngioInfusion Balloon
Virtue® SAB AngioInfusion™ Balloon designed to enable angioplasty with protected drug delivery to dilate vessel, to consistently deliver intended dose and to leave no metal behind Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind 19 1Granada et al. EuroIn
Slide 20: 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. 4Data is based on per protocol populahon criteria revise
Slide 21: Virtue SAB Terumo Partnership
Virtue® SAB Terumo Partnership Terumo is a global leader with >$2.5 billion annual interventional cardiology revenues1 Virtue SAB positioned as the flagship therapeutic offering with potential to drive significant future growth Key Terms: $30 million upfront and potential future clinical and regulat
Slide 22: Virtue SAB Coronary ISR US Pivotal Trial
Virtue® SAB – Coronary ISR US Pivotal Trial 22 Double-blind, mul_- center, prospec_ve, randomized controlled trial in pa_ents with single-layer coronary ISR Virtue® SAB N=200 R Target Lesion Failure (CD, TV-MI and TLR) at 12 months Primary Endpoint Statistical Assumption 90% powered for superiority
Slide 23: Use of Proceeds
Use of Proceeds 23 AcRvity Description Estimated Expenses H2 2022 - 2025 Research & Development General R&D enabling work for BackBeat CNT™ and Virtue® SAB BackBeat CNT Firmware integration into Medtronic device; testing and validation activities Clinical trial planning and preparation IDE preparati
Slide 24: Two Programs Targeting Large Markets Supported by Promising Trial Data
24 Two Programs Targe0ng Large Markets Supported by Promising Trial Data Entering Pivotal Trials BackBeat CNT™ >$10 billion annual market Randomized, controlled study shows efficacy potengal Collaboragon with Medtronic Virtue® SAB ∼$3 billion annual market 3-year pilot study results show potengal safe
Slide 25: Partnership-Enabled Business Model
Partnership-Enabled Business Model 25
Slide 26: Significant Barriers Prevent Innovation From Reaching Patients
Significant Barriers Prevent Innovation From Reaching Patients 26 1Pitchbook – Analysis of 430 companies since 2015 that completed at least Series B financing 2SVB Healthcare Report 2019 3Capital IQ Startups often struggle for resources to reach commercial value inflection Large companies’ constrain
Slide 27: Orchestra BioMed Can Accelerate Innovation to Patients
Orchestra BioMed Can Accelerate Innovation to Patients 27 Risk-Reward Sharing Partnerships Can Overcome the Barriers to Innovation
Slide 28: Selecting Optimal Opportunities
28 SelecRng OpRmal OpportuniRes Develop for Partnership Pre-partnered Acquisitions 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 parad
Slide 29: Orchestrating Innovation: Accomplished Leadership Team
Orchestrating Inn vation 29 Created Pipeline, Pioneered Business Model and Established Partnerships Combined, our leadership team has Years of experience Average years of experience each New product approvals/clearances Authored patents 250+ 25 100+ 600+ Accomplished Leadership Team
Slide 30: Appendix: Summary of Risk Factors
Appendix: Summary of Risk Factors 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 profitable. If Orchestra does not achieve its projected development and commercialization go
Slide 31: 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 may b
Slide 32: Appendix: Summary of Risk Factors (Cont'd)
Appendix: Summary of Risk Factors (Cont’d) 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 information
Health Sciences Acquisitions Corp 2 — SPAC Merger (July 2022) on 6ix